Taren Grom, Editor
NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.
Drawing on her highly successful new product development skills in consumer products, Amy Ellis embarked on an ambitious journey: to resolve one of the industry’s most intractable problems, the unsustainably high rate of inconclusive CNS trials.
With the goal to help bring better mental health therapeutics to market, Ms. Ellis and her partner, Paul Gilbert, founded MedAvante in January 2002. Facing an almost impossible array of barriers from the start, including no pharma experience, no science or medical background, no funding, and no team, she and Mr. Gilbert spent three years building, designing the model, and creating the infrastructure for the company before the company’s first contract was signed. Ms. Ellis and Mr. Gilbert believed so much in their shared vision that they worked relentlessly, without a salary for more than three years and another two years at fractional salaries, to build the company and a solution to deliver a new way to test CNS therapeutics.
Despite the many challenges, Ms. Ellis understood that the principles of creating success for a new product were universal and spanned all categories: identify a significant, painful, and critically important problem for a segment of consumers; identify a solution; make the solution elegant and pivotal to a successful outcome; and then own it.
The problem was CNS trials were failing at an increasing rate. Furthermore, the active comparator drug arms, the known drugs used as controls, were themselves increasingly unable to show efficacy compared with the placebo controls.
Research with key pharmaceutical industry opinion leaders led Ms. Ellis to surmise that a large part of the problem was the unique nature of the assessment method used to evaluate CNS drugs’ efficacy, namely subjective clinician-administered rating scales. She, along with Mr. Gilbert, concluded that conducting studies with large numbers of sites and multiple investigators, all of whom operated with local autonomy, led to lethal levels of variability and bias in the aggregated study measurements.
Mental health trials require so many patients because patients are evaluated using subjective interviews, not objective measures, to determine eligibility and rate of improvement.
Starting from scratch, the mission was to design a holistic solution to conducting CNS drug trials by centralizing the administration and rating of patient assessments for mental health drug trials using videoconferencing or remote telecommunications. The solution also involved connecting clinicians at investigative sites to MedAvante’s network.
But in order to centralize clinicians and create one virtual study network, they had to develop an entirely new operational paradigm. The result was Central Ratings, a real-time solution, which is now available to a global network of investigative sites across geographies and time zones. The solution required innovative technology to build an international telecommunications systems and a way to match the correct rater with the requirements of individual studies.
The challenges included the time and cost to develop a fully FDA-compliant and 100% reliable infrastructure. Ms. Ellis also had to overcome market challenges that included a paradigm shift in how trial assessments were budgeted and administered based on a call center model, not a transactional-based model. Just as importantly, she had to make the case to pharmaceutical companies that the return would far exceed the one-time incremental costs to the existing trial budget.
With MedAvante’s method now being adopted by some of the largest global pharmaceutical companies, Ms. Ellis is successfully overcoming one of the major challenges of any new model and that is convincing decision makers to objectively evaluate data that conflict with established models.
Unbowed by uncertain times, Ms. Ellis remains confident in the company’s mission; she assures each and every colleague that the job can’t be done without him or her by creating a progressive and energetic workplace, and as such every MedAvante employee is committed to the company’s mission.
“I believe in complete transparency; I want every employee to feel that he or she is an owner,” Ms. Ellis says. “Our global town hall meetings, conducted every six weeks or so, update our employees on our year-to-date financial performance, our pipeline forecast, and notable developments by department. Regardless of role, every employee understands our overall product strategy.”
The result of building such a motivated workforce is that in just five years a small core of dedicated employees scaled the company from one country and one language to a global organization spanning 27 countries, 30 languages, and 240 employees.
Ms. Ellis has been recognized for her many successes, including the American Marketing Association’s Edison Award in 1998 for Best New Product of the Year for her work behind putting blister-packed chewing gum into dental care aisles, which was ultimately undertaken as a mainstream solution by all major gum brands.
As a marketer, Ms. Ellis knows there are two unwritten rules: always understand that perception is reality; and if an idea can’t be stated on the back of a matchbook keep distilling it.
Amy Ellis has overcome a near impossible array of barriers to not only build MedAvante but to change an industry in the process.
Title: Co-Founder and Chief Strategy and Marketing Officer
Company: MedAvante Inc.
Education: BA, University of Rochester; MLS and MBA, University of Chicago
Family: Husband, son and daughter
Hobbies: Photography, painting, reading, writing, hiking
Bucket List: Finish writing her gothic romance novel
Awards/Honors: American Marketing Association’s Edison Award for the 1998 Best New Product of the Year
The Internet Advertising Guru
RJ Lewis’ instincts prompted him to take a risk 14 years ago and create a unique business, eHealthcare Solutions, which he has grown with dedication and love. He has followed a simple mantra: do what you love and whatever it is, be the best at it.
At the cutting-edge of digital marketing, Mr. Lewis is the man many pharma marketers turn to when they need to learn how to make Internet advertising work.
Under Mr. Lewis’ leadership, eHealthcare Solutions now represents more than 85 premium medical societies, associations, journal and digital publishers, and has worked with most major pharmaceutical companies and their agencies to build and grow revenue and recognition of pharma brands.
His success might be attributed to the fact that the business has customer service at its core.
“We answer to clients on both ends of our business — we sit between advertising/marketing clients and digital publishing, association, and society clients — and we have to earn their business every day,” Mr. Lewis says.
Continuing in his entrepreneurial endeavors, he has co-founded Ad-Juster, a San Diego-based online advertising operations company that delivers software solutions to more than 80 customers both within and beyond healthcare to companies such as Facebook, YouTube, WebMD, EverydayHealth, and Remedy Health. Ad-Juster has been nominated for INC 5,000’s fastest growing companies in 2013.
Ahead of his time, Mr. Lewis created an online program for an antibiotic brand in the mid-1990s, before most people even knew what the Internet was. The program targeted a list of authenticated physician prescribers with dynamic data-driven creative. The individually customized ads read, for example, “Dr. Lewis, the Ewing, NJ, area is on alert status for the Flu,” with the physician’s last name, location, and the flu status in the geography — all database driven. The data were based on a live SDI data feed documenting the flu status by geography.
No one thought it could be done, including Mr. Lewis’ bosses at the time. But thanks to a creative brand manager who was willing to take a risk, and a great development team, Mr. Lewis and his colleagues did it.
The importance of putting clients’ needs first was reinforced for Mr. Lewis back when Andrew Witty, CEO of GlaxoSmithKline, was GSK’s VP of marketing. Mr. Witty renewed a significant piece of business with Mr. Lewis, when he was at Physicians Online, based primarily on the quality of the relationship Mr. Lewis had developed with the product team and the commitment he showed to making GSK’s brands successful. Even though the experimental program in question had failed to deliver measureable ROI, Mr. Witty knew it was not for lack of effort, drive, or passion to deliver.
Mr. Lewis is a frequent speaker at major industry conferences and his knowledge of the major issues, trends, and challenges in healthcare marketing makes him a sought-after thought leader.
Giving back to others in the industry, Mr. Lewis graciously shares his expertise and sound advice about building and sustaining a first-class organization. He is always willing to make time to answer questions and help people in the industry, and he does it all with a smile.
Every day, he acts with the best intentions for his business and his employees. He motivates his employees by painting the picture of success, assists in drawing the map, and then lets them go, all the while encouraging and coaching where he can.
Outside the workplace, he has an unwavering commitment to the community, surpassed only by his love for his family.
He has been an active member of the Trenton Rotary Club for almost a decade. He has served on the board for five years, is a past president, and is current chairperson of its charitable 501c3 foundation. What Mr. Lewis likes most about Rotary is its decentralized nature and collective influence. There are more than 32,000 Rotary clubs in the world in more than 200 countries, yet support is driven on a local level and is focused on the community of the club’s location.
“When we exercise our collective strength, borders dissolve and great things happen,” he says.
For example, since 1985 Rotary has been working to eradicate polio from the planet. Recently the Bill & Melinda Gates Foundation pledged more than $200 million to help finish the job and eliminate polio from the last three countries that still deal with this epidemic.
“There is no other organization, government, or otherwise that is better equipped to deal with a worldwide calamity like this,” Mr. Lewis says. “Rotarians are everywhere, are vastly different ethnically and geographically, but are all very similar people in that they all live each day by the motto Service Above Self.”
Mr. Lewis also volunteers for and supports through both his time and resources numerous other charities, such as the Salvation Army, Mt. Carmel Guild, and the Boys & Girls Club of Trenton.
Innovative by nature, R.J. Lewis has always marched to his own drummer, and he has created unique business opportunities.
Title: Founder, President, and CEO
Company: eHealthcare Solutions LLC
Education: BS, Marketing, University of Delaware; MBA Marketing & Information Systems, Stern School of Business, New York University
Family: Wife, Cathy; son, Alexander Joseph (aka A.J.);
Hobbies: Reading, dog training, surfing (both Internet and real waves), traveling, chess, angel investing, running, learning/self-improvement
Bucket List: More than 100 different activities and pursuits
Awards/Honors: Action Coach NJ, Client of the Year;
Ad-Juster nominated for INC 5,000’s fastest-growing companies in 2013; Paul Harris Fellow and Charlie Bain Award, Rotary Club
Associations: Association of Medical Media (AMM) Member; Rotary International; Entrepreneur’s Organization; Interactive Advertising Bureau (IAB); Delaware Crossing Angel Investment Group
Tweet at: @rlewis
Breaking Down the Disconnect
in Patient Understanding
Starting a technology company with virtually no technology experience takes some courage and a powerful concept. With a vision to create new and effective ways to address the abysmal state of healthcare literacy in the world, one that is costly in both dollars and lives, Darik Volpa believed he could make a real difference for patients.
As a medical device representative in the 1990s, Mr. Volpa witnessed the huge disconnect in what patients knew and what they should know for better clinical outcomes. Exploring multiple approaches, he set out to create programs that were grounded in visually based learning and interactivity.
Knowing that visual aids can increase understanding and retention by 400%, based on Wharton Applied Research Center statistics, Mr. Volpa wanted his vision to go even further; he wanted to use learning and understanding to influence patient compliance.
This was the genesis of founding Understand.com in 2003.
Often called a medical education think-tank, Understand.com maintains exclusive partnerships with leading medical societies, academic institutions, and businesses in medical devices, pharmaceuticals, and public education.
His passion for patients has led Understand.com to educate more than 5 million patients worldwide and has licensed content, including medical animations, interactive modules, and mobile learning, to more than 3,000 physicians globally.
Understand.com wasn’t an overnight success, and Mr. Volpa says the first months taught him that it’s important to be flexible and be willing to rethink strategy, but never to quit.
When Mr. Volpa started Understand.com in 2003, he forecast that he would have 500 physicians licensing its content by the end of calendar year one. He launched the first product in September, so he had four months to achieve this goal — with no employees and working out of his home.
When Dec. 31 rolled around he had signed up seven physicians. He had missed his goal by 493. He had barely enough revenue to pay for his Internet and phone expenses.
Undaunted, Mr. Volpa never lost confidence and his leap of faith in starting a business based on innovation, new technology, and maintaining the required scientific accuracy was always grounded on more than dollars and cents.
He takes pride in knowing that there is documented improvement in patient care and improved outcomes based on his original vision. Mr. Volpa has a sincere passion to innovate, to create great products, and improve healthcare literacy.
Colleagues and peers commend Mr. Volpa for taking on such a complex issue of patient education. And Mr. Volpa is an evangelist in bringing this national as well as global problem to the forefront. His company’s content has been featured on The Doctors, Good Morning America, Dr. Phil, and Bodies The Exhibition, to name a few national venues. Recently, the company was recognized by Inc Magazine as one of the fastest-growing privately held companies in the United States. The company was also a finalist as one of the Best Places to Work.
Understand.com might never have existed were it not for Mr. Volpa being bypassed for promotion at his previous employer.
“While devastating at the time, that experience resonated with me in such a way that I never wanted another person to tell me what I would do, determine how much I would make, or tell me where I would live,” he says “Dark moments filled with self-doubt can inspire one to take risks and do new things. It’s always darkest before dawn.”
But success in business is only part of Mr. Volpa’s contribution to society and health.
He supports the American Cancer Society, the MDA Telethon, The Children’s Cabinet, the Boys and Girls Club, and the Reno Veterans Guest House. With a tremendous respect for the military, in 2013 Mr. Volpa started a special fundraising effort for the families of deceased and injured Navy SEALS. Working with participating clients, related company profits are pledged to the Navy SEAL Foundation. Understand.com has donated $25,000 year to date with this effort.
Mr. Volpa takes education to a local level as well; he is involved with local colleges — the University of Nevada and Truckee Meadows Community College — and he is an active participant and sponsor for The Governor’s Cup Business Plan Competition, which promotes innovation, entrepreneurship, and technology for college students in Nevada.
Understand.com also participates in an internship program associated with the highly regarded graduate program in Biomedical Visualization at the University of Illinois Medical Center in Chicago — one of only three accredited programs in the United States.
Darik Volpa has dedicated his career to the pursuit of educating, informing, communicating, and essentially, changing lives.
Title: Founder and CEO
Education: California State University, Fresno
Family: Wife Tiffany, daughters Morgan and Tatum
Awards/Honors: 5,000 Fastest Growing Privately Held Companies, Inc. Magazine 2010; 20 Under 40 Award, Nevada Business Journal 2010; 20 Under 40 Award, Reno Gazette Journal, 2009; Business Visionary Award, Nevada Business Journal, 2009; Best Places to Work Finalist, Northern Nevada Human Resource Association (NNHRA) 2009; Entrepreneur of the Year, The Business Report of Northern Nevada/ Reno Gazette Journal, 2007; Best of Show Silver & Gold Venture Capital Conference, 2006; Marketing Professional of the Year, Stryker Corp., 1999
Dr. Jay Udani
Redefining the CRO Process
It’s a fair bet that many of us have at one time caught a glimpse of Jay Udani, M.D., as he was an extra in the very popular 1986 film, Ferris Bueller’s Day Off. Being an extra in that movie about a high school slacker is pretty ironic, since he was running a clinical trial in the neonatology unit of a Chicago hospital at the age of 16.
A board-certified internist, who served as chief resident at Cedars-Sinai Medical Center in Beverly Hills, he was among the first physicians in America to become a certified physician investigator for clinical trials.
His most noteworthy achievement to date, however, may be the founding of his company, Medicus Research, a contract research organization for the natural health products industries, including botanical drugs, dietary supplements, and functional foods. His suite of automation tools combined with his expertise in clinical research have had industrywide implications.
Colleagues report that in the world of clinical research, it is a rarity to cross paths with such an enigmatic man whose genius, inventiveness, and commitment have been instrumental beyond the path of medicine and clinical research. His influence in bringing innovative technology applications to the clinical field is what sets him apart from others. Dr. Udani realized early on that automation could greatly improve efficiency in clinical trials, so he built the tools needed to meet this goal.
This suite of tools, SysteMedicus, is now used by many players in the pharmaceutical industry, including patients, physicians, manufacturing companies, research organizations, and government regulating agencies. For the next generation of scientists, technology leaders, and businessmen, Dr. Udani’s story is very inspiring, say his colleagues, who add that it is truly an honor to have a leader whose brainchild is a suite of solutions that touch all stakeholders in the health industry and who provides answers to everyday challenges. His work is having a profound effect on scientists and technology leaders in the United States, Asia, and Europe.
Dr. Udani’s bent toward natural product research is his passion, so much so that he feels it’s not even a job.
“I don’t consider this work,” he says. “This is my passion; I would be doing it anyway.”
Those who work with him know that he is not about glamour, but about getting things done right, and about making a difference in the world around him. To that end, the managing director of the Medicus office in the Philippines organized a number of employees to volunteer to clean the streets of an impoverished area in Manila to honor Dr. Udani for his birthday. Dr. Udani says this was definitely a career highlight for him, adding simply, “That was the best.”
Dr. Udani inspires his employees by being genuine, sincere, driven, and passionate. He instills in them his ability to look toward the future while being firmly focused on today. He calls this his dual vision.
“I always see the world as it will be in five to 10 years, but at the same time, I can see the world that exists today and what needs to be done on a day-to-day basis,” he explains. “Balancing those two is what allows us to change the world, but we can’t get so lost in the future that we aren’t living in today.”
The turning point in his career became clear to Dr. Udani when he was working both as a PI for pharma and building his own CRO for the natural products industry. It all boiled down to a limousine and an alarm clock. As the pharma PI, Dr. Udani was flown across the country for an all day meeting, picked up at the airport in a limousine and driven to a Ritz-Carlton. Directly after the PI meeting, he flew to a meeting involving his new natural product CRO company.
“I picked up my low-budget rental car and drove to a Motel 6 next to a train track,” he says. “There was no alarm clock in the room and when I called the front desk the clerk said there weren’t any alarm clocks because people kept stealing them. He said, tell me when you want get up and we will bang on your door. This was a defining moment. I wish that the situation had been reversed on that particular day. The expense spent at the investigator meeting opened my eyes to the amount of waste that existed in the industry as a whole.”
Dr. Udani says that PI meetings don’t have to be held at the Ritz, and PIs don’t have to be picked up by limousine. Alarm clocks, however, are still relevant in either situation.
Dr. Jay Udani is building tools to help all healthcare stakeholders — from patients to scientists — more effectively manage data.
Title: Founder and CEO
Company: Medicus Research
Awards/Honors: Natural Products Association Clinician of the Year 2008; AMA National Achievement Award; The Harvard Medical School Pinkney Fellowship in Orthopedic Research; Pasadena Magazine Fifth Annual Top Doctors 2012, Pasadena Magazine Top Doctor Internal Medicine 2010, L.A. Daily News HealthBeat Elite Awards: Best Physician Specialist, Best Medical Speaker, Best Alternative Medicine Facility
Associations: ACRP, DIA, ACN, CHPA, UNPA
Dr. Robin Winter-Sperry
Science Meets Business
Recognizing that there was a need for a company that focused on providing medical affairs services and medical liaison support, Robin Winter-Sperry, M.D., started her own company, Scientific Advantage, 10 years ago. It was a huge step to take, especially as she had three young children at the time.
A trendsetter, Dr. Winter-Sperry has been able to merge the two worlds of business and medical affairs into sound and compliant medical teams. What sets her apart is her ability to adapt her business to the needs of the customer, going over and above to supply companies with medical affairs business plans, training, and strategies.
She says it’s critical to align scientific endeavors with the strategic focus of companies while striving to satisfy previously unmet patient needs. Dr. Winter-Sperry believes it is possible to improve the delivery of healthcare through scientific innovations, medical education, and cultural understanding.
“It’s all about people, interactions, and looking for creative solutions that meet a company’s needs, which is hopefully a win-win for all parties involved,” she says.
Starting her own company and working in the MSL arena has allowed Dr. Winter-Sperry to combine her love of business and science, and this has enabled her to help more people from an industry standpoint than as one individual healthcare provider.
Her attention to detail, sense of urgency, and outstanding leadership have been instrumental to the success of clients’ product launches.
A physician by training, Dr. Winter-Sperry started working in the commercial pharma arena in the dermatology division of Schering-Plough. She spent years in the medical affairs arena working on major brands for Novartis and Sanofi before starting Scientific Advantage.
She is a frequent speaker, author, and quoted authority on medical affairs and MSL strategy, training, team motivation, and compliance. She views obstacles and challenges as opportunities and strives to persuade everyone around her to think likewise.
Dr. Winter-Sperry maintains that in all things it’s vital to be true to yourself and make sure that whatever decisions you make, you can face yourself in the mirror the next day.
This successful entrepreneur has an enormous network and she generously taps into her connections to help those in need. She makes the time to share ideas, listen, and support family, friends, and acquaintances.
Dr. Winter-Sperry is an inspiration to many women in the pharmaceutical industry. She has been a mentor and has helped many women set career goals and navigate the male-dominated executive level. She has even assisted two colleagues in starting their own businesses.
Both male and female colleagues alike say she is always available to listen to their issues, help them find solutions to their challenges, look at things from different perspectives, and be as supportive as possible. Counseling, especially coaching and mentoring, is something that she enjoys. In fact, she started her career working as a resident assistant and at a crisis center hotline while in college.
“For me, it’s about finding the heartstrings of what motivates the individual and trying to work through their strengths and often help them see what’s in it for them,” Dr. Winter-Sperry says.
She encourages people to reach outside of their comfort zone, to be creative, and to realize that change and working in a dynamic environment can be a very positive experience.
“Remember what happened to the dinosaurs that couldn’t adapt,” she cautions.
Title: President and CEO
Company: Scientific Advantage
Education: M.D., University of Miami, Noreste
Family: Husband, Jonathan; three children, Samantha, Hunter, Katelynd; two German Shepherds, Barney & Betty aka, The Rubbles
Hobbies: Sailing, sports, art, and friends
Bucket List: Running at least a half marathon, traveling to unusual places, and trying to find that perfect work-life balance
Awards/Honors: August 2005, PharmaVOICE 100; 2006 Madison Who’s Who of Professionals; Recipient of the 2008 Women Business Leaders (WBL) award; 2010, honored in the Tribute to Women by the Somerset County Boy Scouts of America
Associations: Healthcare Businesswomen’s Association, Rutgers Ernest Mario School of Pharmacy (Adjunct Professor); Mt. Sinai Medical Center, Department of Dermatology (Assistant Professorship); Women’s Health & Counseling Center (2013 board member)
Making a Medical Education Impact
Talk to David Rear for two minutes and his mission is clear: to arm physicians with the education and knowledge they need to make better clinical decisions and deliver better patient care.
Keenly aware of the challenges faced by HCPs, Mr. Rear believed there was a need to change the type of information they were receiving. His goal was to establish a company that would improve the quality of patient care through medical communications. The result was Advanced Clinical Concepts (ACC).
Starting and building a company from the ground up is no easy task, yet his enthusiasm and dedication to his work remains undaunted seven years into it.
About 10 years ago, Mr. Rear was leading a team that was being divided up due to internal company compliance requirements.
“It was at that point that the change in the way our industry operates became a reality and it forced me to think hard about what I wanted to do with the rest of my career,” he says. “ACC was the result of that experience.”
Starting and running ACC has been both a thrill and a challenge.
“The requirements with regard to the number of hats you must wear, the intensity associated with major decisions, and the responsibility you carry with regard to your livelihood and that of the staff carries a heavy burden,” he says. “Watching the wins that occur with internal teams and receiving praise from clients makes the hard work all worthwhile.”
Mr. Rear is an outspoken champion of patient care. He focuses on translating core science from the complexity of the early discovery phase development into clear, precise, and understandable benefits that physicians will use to improve their decision-making and deliver better care to their patients.
That commitment, detail, clarity, and focus on patient care shines through in every ACC program.
He’s scientifically sound, strategic, and creative in his approach to brand data. He never holds back his opinion, even in client meetings where he may be the lone dissenting voice. And although his focus is promotional med ed, Mr. Rear never takes his eye off the big picture or passes up an opportunity to express an idea, no matter what channel it may be appropriate for.
His ability to effectively communicate his vision and thoughts quickly transcends a project’s complexity, resulting in programs that are highly regarded by his clients. The respect he has garnered from clients is borne out by the fact that he has supported the same brand for seven years and continues to do so.
While working at Novo Nordisk, where he was associate director, medical education, in diabetes marketing, and earlier at Johnson & Johnson, he honed his ability to identify medical education trends early, and capitalize on them to create successful communications strategies for healthcare professionals.
During his tenure at Novo Nordisk, Mr. Rear and his colleagues ran a program called the Diabetes Summit, a three-day meeting that brought together more than 1,000 clinicians who treated patients with diabetes along with thought leaders, clinical experts, and high-level government officials. The goal was to create a dialogue for improving care for patients with diabetes. He was responsible for overseeing the day-to-day activities related to the project, which was quite complex.
“It was a thrill to be engaged in a project that required collaboration among people from so many different facets of medicine,” he says.
Mr. Rear inspires by enthusiastically painting a vision that is bigger than one single person can achieve, holding unconditional positive regard for the team that is attempting to achieve it, encouraging everyone to participate in the solution, and then getting out of the way.
He believes in listening, being authentic, providing regular feedback, and facilitating efforts toward a shared goal.
“As much as I love what I do, what I really want to be remembered for is being a good friend, colleague, husband, and father,” he says.
A respected mentor, Mr. Rear was one of the earliest supporters of the Healthcare Businesswomen’s Association’s Metro Chapter’s mentoring program. In addition, he has laid the groundwork for many other mentoring programs in other HBA chapters throughout the country.
One area that is particularly important to Mr. Rear is children’s health. His son was born seven weeks early and had some early developmental challenges. Mr. Rear and his wife contribute to the Make a Wish Foundation, Toys for Tots, Autism Speaks, and March of Dimes. He also held a position as a board member of the Care to Share Support Network, a local charitable organization providing resources to families of children with special needs.
After long days of travel he makes it a specific point to spend time with his son Kyle at soccer, Boy Scouts, or just plain hanging out together. He extends that same family/life commitment to his staff, providing them with the flexibility to adjust their schedules, often working from home to spend time with their families.
Title: President and Founder
Company: Advanced Clinical Concepts LLC
Education: BS, Pharmacy, Rutgers College of Pharmacy
Family: Wife, Tina; daughter, Katie, 20; son, Kyle, 9
Hobbies: Fishing; hunting; hiking; cycling; gardening; cooking, including sourcing his own food; playing guitar
Bucket List: Climb the Grand Tetons
Associations: American Medical Writers Association; the Medical Marketing & Communications Group; the Healthcare Marketing, Communications and Education Professionals; the Medical Education Communications and Pharmaceutical Marketing Group
Tweet at: @drr51664
David Rear offers a depth of scientific knowledge and insights
that colleagues and partners rely upon.
One Step Ahead in Copay Innovation
Reward success and learn from failure. This is what guides Bob Previdi, co-founder of PSKW, to inspire others and build a positive work environment. And he has succeeded, according to those who work with him. Mr. Previdi has built an organization that has garnered widespread respect for innovation and vision, and for its progressive approach to motivating employees.
The history and growth of PSKW is a testament to Mr. Previdi’s entrepreneurial leadership. From its earliest days to its place as a leader in the copay arena today, the company has been driven by his creative thinking and strategies and is ahead of the curve when it comes to integrating technology with copay assistance initiatives. He continues to be a trendsetter and a motivator to all who work with him — employees and clients alike.
Under his leadership, PSKW’s programs have helped pharmaceutical companies further their brands while assisting patients to overcome financial barriers to gain access to, and stay on, the medicines they need. He achieved this by pioneering the use of copay programs at pharmacies, filling patients’ needs for lower copays and pharmaceutical marketers need to promote brand loyalty.
Recognizing that e-prescribing was the way of the future, Mr. Previdi began committing resources to such channels, allowing the company to be ahead of the curve.
He allows each of his employees to be autonomous, creative, and a leader in his or her role, and he creates a culture that encourages open communication, flexibility, and teamwork.
He is a leader who understands the value that his employees bring to his organization and recognizes these efforts.
Mr. Previdi strives to create a strong and favorable working environment. For example, PSKW has made a special effort to create an environment that fits the needs of successful working parents, especially working mothers.
“We believe that working mothers are some of our greatest assets, and we’ve gone to great lengths to craft a modern company that takes advantage of technology in ways that allow our team members to work remotely and off-hours,” he says.
Mr. Previdi has learned that by rewarding success, team members take ownership of their work and in the success of the company. Transparency is key too, particularly in the way the company adjusts its approach in response to failures in new processes or other business decisions and how those learnings are incorporated into best practices for clients. Such transparency shows staff members that risk and failure are okay; the key is to move forward successfully.
He has crafted work teams that truly collaborate for companywide benefit and leads the organization with a quiet strength that fosters commitment at all levels.
With an astute understanding of the pharma and political landscape, Mr. Previdi is able to ascertain what challenges patients and prescribers will face and what services could help those audiences maintain workflow, product adherence, and brand success.
Mr. Previdi has been in the industry his entire career. His father, Bob Previdi Sr., was an icon in pharmaceutical publishing, creating ideas, selling advertising, and launching several publications. The younger Previdi adopted much of his father’s creativity, industry knowledge, and entrepreneurial aptitude while carving out his own path.
After working at BMS and Abbott, Mr. Previdi joined his father in business before venturing into a different side of the pharma services business, starting Touch Tone RX that provided marketers with a way to collect survey information about their products from patients before developing copay initiatives.
The move from the industry side of the business to the supplier side was a challenging one because, as Mr. Previdi says, it’s a lot easier having a budget than convincing folks to part with their budgets.
Mr. Previdi is strongly committed to the Healthcare Businesswomen’s Association and supports the N.J. educational system by sponsoring schools in inner city areas such as Newark. And he is a strong supporter of the U.S. Military Academy at West Point.
Title: Chairman and CEO
Company: PSKW LLC
Education: BS, Marketing, Rowan University
Hobbies: Golfing, boating, cooking, playing poker, and sports
Bucket List: Play in the World Series of Poker
Awards/Honors: Ernst and Young 2012 Regional Entrepreneur of the Year and named as a National Finalist; 2012 PharmaVOICE 100; 2012 Inc. Magazine Fastest Growing Private Companies; 2011 Inc. Magazine Fastest Growing Private Companies; 2011 Fastest Growing Company in New Jersey – Number Two; 2010 Fastest Growing Company in New Jersey – Number One
Associations: Alpha Phi Delta National Fraternity; Rowan University Alumni Association
Bob Previdi is a gifted visionary who has built viable products and services that meet unmet needs.
Disrupting the Status Quo
Jonathan Bush hates things that are broken, whether the problem is lines of taxis waiting at the airport an eighth of a mile from hundreds of people lined up needing a cab, or doctors talking with patients about the effectiveness of a drug that the patient never took.
“Broken-ness makes me sick,” Mr. Bush says.
While he may be secretly working on a solution for the taxi line situation, he is highly visible in working toward a solution for a broken healthcare system.
His dedication to fixing healthcare began in 1997, when Mr. Bush and business partner Todd Park opened a new type of birthing center in southern California, called Athena Women’s Health.
Despite their good intentions, the two entrepreneurs quickly found themselves inundated with paperwork, spending the bulk of their time just trying to get paid.
When they couldn’t find a practice management solution for their needs, they developed their own. The result: athenahealth, a leading provider of cloud-based services for electronic health records (EHR), practice management, and care coordination.
Mr. Bush’s background — as an EMT in New Orleans, as a medic in the U.S. Army, and as a management consultant with Booz Allen Hamilton — provided the perfect overlay in understanding, on a tactical and business level, where the gaps are in terms of healthcare process. Mr. Bush formed the skill set and discipline needed to drive to a solution based on identifying those gaps from a data standpoint, understanding what’s not working, and providing greater access and transparency.
Today, Mr. Bush’s future vision is centered around information flow.
“I am fixated on the idea of a healthcare Internet where information relevant to care can flow to those charged with delivering care in a frictionless and instantaneous way,” he says. “There are massive obstacles to this: vendors, academic medical centers, and government agencies that are inadvertently crushing us with obsolete ways of doing things. But we see a path to this place and we’re running like hell to get there.”
Mr. Bush has been an effective evangelist on the subject. He is a sought-after speaker and presenter who is eager to share his views about the broken profit motives in healthcare and the opportunities to help make healthcare work as it should.
“Healthcare is plagued with inefficiencies that can jeopardize quality care,” he says. “We are striving to address that by becoming the nation’s health information backbone and enabling the easier flow of patient information.”
A presenter at the 2013 TedMed event in Washington, D.C., Mr. Bush delivered a talk to 1,800 leaders and thinkers about broken profit motives in healthcare, how innovation and change has been stunted, and the need to explore new frontiers.
“My plea to the TedMed community was to create healthy competition in healthcare so that patients and providers have choice and can shop,” he says. “By being able to shop, we not only join the rest of the 21st century, but we drive down costs and incent innovators to make healthcare work as it should. Healthcare as it exists today is not a reflection of our humanity and it needs to change.”
The reception to his energetic and passionate talk was equally as passionate.
“The most important thing healthcare needs today is disruption of the federally mandated EHR,” he says. “What we need is a Facebook/texting type-medium for secure patient evaluation and communication among licensed caregivers. With athenahealth and Epocrates, we have the infrastructure in place to do this. Medical information today is too static; we need medical information flow.”
Mr. Bush backs it up with athenahealth’s More Disruption Please (MDP) innovation and partnership program. It’s aimed at like-minded entrepreneurs, healthcare IT companies, investors, and thought leaders — anyone who shares its vision of changing the status quo in healthcare through openness and connectivity of disruptive solutions. Through MDP, athenahealth will continue to introduce new services and accelerate the introduction of high-value innovation via the cloud. To inspire and invigorate the larger MDP community, the company sponsors hack-a-thons, conferences, and other community events.
That same passion and out-of-the-box thinking is reflective in the culture that Mr. Bush and his executive team have cultivated at athenahealth. Some say his take on energizing his teams can be somewhat unorthodox, others say it’s refreshing.
“I try to motivate through a balance of meaningful goals and tactical incompetence,” he says. “If a goal is juicy enough, but the boss has all the answers, no one wants to get their feet wet. If the goal is visible, but the boss can’t get of his own way, it’s too tempting not to get in and swim.”
Employees, who are called athenistas, embrace a culture that is highly energetic, collaborative, and focused on helping clients improve their financial bottomline.
This approach appears to be working. In 2013, athenahealth was named one of the best places to work in Massachusetts by The Boston Business Journal for the second year in a row. The company also was named a 2013 National Top Workplace and to Forbes’ annual list of America’s 25 Fastest-Growing Tech Companies for the second year in a row.
Jonathan Bush is fixated on the idea of a healthcare Internet where information relevant to care can flow to those charged with delivering care in a frictionless and instantaneous way.
Title: Co-Founder, CEO, Chairman, and President
Company: athenahealth Inc.
Education: BA, Wesleyan; MBA, Harvard Business School
An Ironman Takes
Driving developments at an oncology company is a bit like competing in an Ironman triathlon, says Punit Dhillon, president, CEO, and co-founder of OncoSec Medical.
He is an expert in both. Competitive sports have given him the endurance and edge he needs to pursue his mission of discovering new ways to kill cancer tumors.
“Starting and running a biotech company requires the same kind of drive and determination as when you’re out of water on mile 13 and you need to get home — it takes a lot out of you mentally and physically,” he says. “We face similar challenges — struggling with shoestring budgets, trying to get all team members to focus in on one particular project, and then driving toward the finish line.”
OncoSec strives to create methods of treating tumors in patients whose skin cancers cannot be treated effectively with already approved products. Under Mr. Dhillon’s leadership, the hope is to successfully prove that advanced stage skin cancers can be treated by targeting the tumor locally while achieving a systemic response. The goal is to ensure that the drug or other therapeutic agent is immediately absorbed by the cancer cells by stimulating a desired immune response.
The company is currently conducting Phase II studies for three cancers in particular: metastatic melanoma, Merkel cell carcinoma, and cutaneous T-cell lymphoma. One of its targeted therapies currently under development is called ImmunoPulse, which uses the OncoSec Medical System, an electroporation platform, to dramatically enhance the delivery and uptake of a specific DNA-based cytokine called DNA IL-12, a substance known to boost the human immune system against cancer cells.
“We recognize that no treatment is going to be the single panacea for any cancer indication, but we want to make sure that we have the opportunity to use our technology in the right way where it can be applied with a front-line therapy,” he says.
Currently, Mr. Dhillon is most focused on moving the two discovery programs for melanoma and Merkel cell carcinoma forward into the next clinical development stage.
OncoSec’s mission to pioneer and refine new electroporation technologies parallels Mr. Dhillon’s personal goal of promoting health any way he can.
“A major theme in my life right now is definitely health,” he says. “I am very much into promoting health and wellness as part of everyone’s overall experience.”
Whether at work, at home, or in his charitable endeavors, Mr. Dhillon is laying the groundwork for healthy lifestyles.
Mr. Dhillon provides his employees with communal bicycles, and urges them to bike during their lunch time. He also encourages employees to take midday walks and runs and to participate in a weekly step count challenge.
In addition, unless an impending deadline looms, his staff works from 8 a.m. to 6 p.m. Monday through Thursday and gets out at 1 p.m. every Friday.
He advocates a balanced lifestyle through healthy living, nutrition, and meditation. He has started an organization, InBalance Network, partly dedicated to these ideals.
“Being healthy and strong both physically and emotionally is important,” Mr. Dhillon says. “I think a lot of the qualities I embody in the business world come from the discipline I learned from training. Physical training helps maintain level-headedness around all of the different priorities that need to be balanced.”
Mr. Dhillon also contributes and supports charities that are connected with improving health, such as the British Columbia Cancer Foundation and American Cancer Society. He is a member of CEOs Against Cancer, a group of CEOs who promote health and wellness within their companies in the hopes that this will deter the incidence of cancer. Last year, Mr. Dhillon led a cycling team for the Ride to Conquer Cancer, an annual 150-mile ride from Vancouver to Seattle sponsored by the British Columbia Cancer Foundation. His team raised $30,000 for the event. As part of the American Cancer Society, his family recently hosted the Northern California Blossom Ball, raising more than $150,000.
“This was a meaningful accomplishment in terms of the dollars that we raised by hosting the event,” he says.
Earlier this year, he started a third initiative, the Young Entrepreneurship & Leadership Launchpad, or YELL, dedicated to youth education, specifically toward leadership and entrepreneurship, The mandate of YELL is to help students in grade 11 and 12 build entrepreneurship and leadership skills and facilitate a curriculum that allows them to experience some of the things that they would go through in a real business scenario. Mr. Dhillon created the group after mentoring a team of high school children in a global business competition in which they won the global championship.
“It’s a nice feeling to have an impact on students who are interested in pursuing a post-secondary education, who can then eventually apply these skills in the real world,” he says.
Title: President, CEO, Co-Founder
Company: OncoSec Medical Inc.
Education: BA Hons, Political Science and Business Administration, Simon Fraser University
Family: Wife; two daughters
Hobbies: Competing in triathlons, Ironman
Bucket List: To own a theater company
Associations: British Columbia Cancer Foundation, American Cancer Society, CEOs Against Cancer, Young Entrepreneurs Council, YEC, American Society of Cancer Oncology, ASCO
Tweet at: @punitdhillon
Punit Dhillon is on a mission: promoting health and wellness as part of everyone’s overall experience.
Creating a Center of Gravity for Talent
In addition to being a two-time PharmaVOICE 100 honoree, Leerom Segal, co-founder, president, and CEO of Klick Health, has received many industry accolades not just for the work Klick does on behalf of its clients but for its innovative culture. The awards are great, but for this entrepreneurial rock star it’s all about his people and cultivating a culture that is empathetic and caring — not just for his employees but for clients as well.
Mr. Segal has always had a passion for management innovation. Colleagues say his passion has manifested itself in the unique and highly lucrative way that he has managed Klick — investing internally and using the latest technologies to support his employees and help them to achieve greater results. He currently strives to revolutionize the way that business leaders think about running their organizations, and as well as being invited to share his thought leadership at many speaking engagements and he has even written a book on the subject, to be released this year.
“At the center of our business is talent,” Mr. Segal says. “We support that talent with a culture that’s based on empathy. Then we add in our internal systems that drive efficiency, collaboration, and financial oversight, and we create an organization that can be future-proof. It will have the right balance of empathy for our talent, our customers, and our customers’ customers and the communities in which they work.”
Mr. Segal believes data are the most valuable resources in uncovering insights about behavior and motivations and is using Klick’s internal systems to gather data and insights. He believes the next wave of market leaders will be the companies that shift that analytical focus inward, concentrating on understanding their talent as well as they do their customers. In other words, focusing the algorithms on people, to shape markets by first shaping internal culture. He is obsessed with understanding this opportunity, and applying the most popular transformative technologies of the last decade.
Under Mr. Segal’s leadership and guidance, Klick is bringing together a talented team of diverse individuals who have a wide range of capabilities, perspecties, and experiences.
The primary vehicle for actualizing an employee-centric approach at Klick is Genome. Mr. Segal’s leadership truly shines through in the way that he manages Klick through analytics supported by technology. Klick leverages technology to enable incredible productivity improvements and predictability in everything that it does. These systems create accountability and a culture of performance throughout the organization. Genome is a custom-built intranet with a full suite of tools aimed at managing time, budgets and people; Genome replaces e-mail, timesheets, spreadsheets, and memos by harnessing big data and social technologies.
Employees say it’s been the key competitive advantage that has allowed Klick to maintain unprecedented growth levels.
“I think the culture that we have created is at the center of gravity for talent,” he says. “My role is to get out of the way and allow brilliant people to do their best in an environment where it’s safe and they are expected to experiment and innovate.”
Mr. Segal leads as he performs. He is an innovator at heart and draws inspiration from a variety of areas.
“I’ve been very fortunate to become involved with different communities, such as TED, the Young Presidents’ Organization, the Clinton Global Initiative, and the World Economic Forum,” he says. “Being able to draw inspiration directly from the world leaders within these organization is a great opportunity.”
Title: President and CEO
Company: Klick Health
Hobbies: MMA; skiing; race car driving; mountaineering; extreme sports of any kind
Bucket List: Learn to fly a helicopter; write a New York Times bestseller
Awards/Honors: MM&M Advertising Agency of the Year, 2013; PR News Overall Leader in CSR Best Practices (Companies under 10,000), 2013; Digi Award — Top Digital Company in Canada, 2012; World Economic Forum — Global Growth Company to Watch, 2010; 50 Best Managed Companies in Canada, 2008, 2009, 2010, 2011, 2012; 50 Best Small and Medium Employers in Canada, 2010, 2011, 2012, 2013; Deloitte Technology Fast 500 — Fastest Growing Technology Companies in North America, 2003, 2009, 2010, 2011, 2012; Profit 200 — Fastest Growing Companies in Canada, 2004, 2006, 2007, 2008, 2011, 2012; Branham 300 — 250 Top Information Technology Companies in Canada, 2007, 2008, 2009, 2010, 2011, 2012
Associations: Clinton Global Initiative; Young President’s Organization; TedMed; TED Global; the World Economic Forum
Tweet at: @Leeromsegal and @klickhealth
Lee Segal is gaining an international reputation for his vision and management innovation.
Building A New IT Backbone
for Clinical Trials
Jud Gardner, co-founder and chief technology officer of Comprehend Systems, is a techie who has challenged the status quo from a young age. In the fourth grade, Mr. Gardner hooked up his classroom’s computer to the proto Internet to use Gopher and WAIS, two searching systems that lost out to the dominant WWW system in the early 1990s.
“I’ve been into technology ever since,” the 30-something entrepreneur says. “It makes me seem older than I am and surprises people. Borland OWL anyone?”
In the early days of his career working as a freelance consultant while in college, his ability to jump in and solve IT problems in the eleventh hour routinely saved the integrity of clinical data for some of the biggest pharmaceutical companies and served as his motivation to change the cumbersome and costly way clinical trials are conducted.
In 2010, Mr. Gardner co-founded Comprehend Systems with a drive to disrupt the old-guard pharma mentality and enable sponsors to improve clinical development through IT innovation.
“Throughout my life seemingly intractable challenges spanning technical, bureaucratic, and team orientation have arisen,” he says. “My answers to these challenges have at times been suboptimal, but in the end I have always been able to execute a plan of action that progresses myself or my company to the next step, whatever it takes.”
At Comprehend Systems, Mr. Gardner leads a team of developers who are constantly refining the company’s clinical data insights tool to connect clinical data from multiple disparate sources and deliver real-time dashboards, ad-hoc reporting, alerting, and drill-downs in one comprehensive platform.
Mr. Gardner inspires his team by encouraging them to challenge the norm — and even his own ideas — if it results in better approaches.
Mr. Gardner takes pride in leading by example and making decisions that will enable his team to grow and realize the impact they have on solving pharma industry issues.
Before making a permanent shift into the life-sciences industry, Mr. Gardner honed his leadership skills at a few small companies, including Byram Laboratories. He credits working in a close-knit, flat management structure as key to developing his leadership style, as he wore a variety of different hats and ascended from software engineer to chief technology officer in a five-year span.
In 2010, Mr. Gardner seized the opportunity to partner with his childhood friend Rick Morrison to launch Comprehend Systems. They each put personal finances and established careers on the line to launch the company, a risk that has paid off.
A software coder at heart, Mr. Gardner is quick to admit that he jumps out of bed every morning as he considers his role at Comprehend Systems as a clinical data guru to be his self-actualization in life. Raised by a single mother who gave up her job as a teacher to support his upbringing, Mr. Gardner draws inspiration from his mother’s selfless ability to put others before herself and to stay true to her definition of success.
This perseverance fuels Mr. Gardner’s own leadership style; he leads by example and pushes his teams to exceed expectations, challenge the often stodgy mentality of pharma, and constantly connect with the mission of helping bring new treatments to patients in need.
Jud Gardner hopes to not only enable sponsors to improve clinical development through IT innovation, but to also disrupt industry old guard thinking.
Title: Co-Founder and Chief Technical Officer
Company: Comprehend Systems Inc.
Education: BS, Computer Science, Rutgers
Family: Mother, two very influential grandfathers
Hobbies: House music production, scuba diving, software engineering, photography, left-handed drawing
Changing the Payment Process
It takes strength, endurance, and a whole lot of determination to grow a two-man start-up into a game-changing provider of clinical payment technologies operating at a global level — Greenphire’s CEO and founder Sam Whitaker fits the bill.
Anyone who can survive a five-day, 150-plus mile foot race through the Sahara Desert has what it takes to drive his own business to incredible success. In 2009, Mr. Whitaker proved his physical and emotional mettle when he completed the Marathon des Sables (MdS), a grueling multi-stage race through the formidable landscape of one of the world’s most inhospitable climates. The race requires runners to carry all equipment and food, everything except water and a tent, that they need to survive for five days. Those who complete the race walk away with a new slant on life and the belief that they have the power to achieve anything.
For the past six years, Mr. Whitaker has led his company through a remarkable period of growth, experiencing three times year-on-year growth, and in 2012, not only reaching, but exceeding its profitability goal.
When Mr. Whitaker chose to establish a business in the clinical payments field, he did so in the face of a number of challenges, but he was willing to take the risks to facilitate what he believed would be real improvements across the industry. One of the toughest tests was marketing technology solutions in an industry that is highly regulated and largely reliant on manual processes. Convincing big players that new technologies could replace traditional manual methods was difficult, but Mr. Whitaker laid the groundwork in the early years, educating the market and establishing proof of concept for the value of Greenphire’s technology. Despite initial resistance, which would have deterred many, Mr. Whitaker’s persistence and Greenphire’s value proposition resonated with the industry.
“Driving adoption of a clinical technology that has never been used by our industry is easily one of the most difficult challenges I could have never imagined before being in the middle of the process,” he says.
Mr. Whitaker is never satisfied with the status quo and continuously looks for alternative opportunities and ways of doing things, and then developing new strategies that improve, and in most cases, revolutionize process within his field. His determination to facilitate change and inspire the industry to do something different has helped him carve a reputation as a respected key opinion leader across the pharmaceutical and clinical trials sectors.
A key tipping point in the industry has contributed to his success, he says.
“The wide spread adoption of technologies, such as IVRS and EDC, has been a turning point for the industry,” he says. “These first steps continue to be built upon with new critical technologies and were a sign that the industry was willing to try something new.”
As a result, Greenphire has grown from a staff of two to more than 40, and has experienced increasing adoption of its technologies from several top-30 pharmaceutical companies. Strategic partnerships have been developed with companies, including Almac Clinical Technologies, Merge Healthcare, Bio-Optronics, Mytrus, the Biomedical Research Alliance of New York, MasterCard, Citigroup, Wells Fargo, FIS, and the Bancorp Bank, as well as newly announced collaborations with E&Y London, Oracle, and IMS Health.
Mr. Whitaker strives to understand the pharmaceutical and clinical trials sectors from the ground up. Maintaining his customer-based focus is what really allows him to develop solutions that improve the clinical trial process for all parties involved. He possesses a rare combination of exceptional business acumen, financial technology expertise, and unparalleled devotion to improving processes within clinical trials. His entrepreneurial spirit and thorough understanding of the needs of the industry, as well as his commitment to helping others achieve their goals sets him apart from his peers, his colleagues say.
He also uses his entrepreneurial expertise and drive to inspire the next generation of business leaders.
“I have participated in mentor programs for young entrepreneurs through the Wharton School’s Venture Initiation Program,” he says.
Mr. Whitaker also established a formal mentorship program at Greenphire for its up-and-coming leaders. He also values giving back to the community, with his favorite local organization being KIPP Public Charter Schools.
“I believe that everyone should have access to education regardless of socio-economic situation,” he says.
All Greenphire employees took part in a service day last year for the charter school that serves children in the highest-poverty neighborhoods in Philadelphia and helps send them to college. Greenphire is also currently working to build a long-term partnership with KIPP Philadelphia, and Mr. Whitaker donates his own time and resources to support scholarships to the school. The Greenphire team organizes a number of fundraisers each year to help benefit local charities, such as competitions to raise money for breast and prostate cancer groups and Kyle’s Quillows, a local organization that makes pillows and blankets for critically ill children. These initiatives build on Mr. Whitaker’s personal concerns for the community and have been spearheaded by him since the early days of the company.
And back to the foot race across the Sahara — not only did Mr. Whitaker finish the MdS, he also raised $30,000 for Urban Blazers, a volunteer organization that serves youth from Philadelphia’s most under-resourced communities, while doing so.
Whether it’s surviving a five-day, 150-plus mile foot race across the Sahara, or growing his business at record speed, Sam Whitaker has what it takes to succeed.
Title: CEO and Founder
Company: Greenphire Inc.
Awards/Honors: Philadelphia Business Journal’s Best Places to Work 2012; PACT Enterprise Award, technology start-up category 2012; AlwaysOn Venture Summit Mid-Atlantic Top 100 company; Partnerships in Clinical Trials’ 2011 Hall of Fame Award for Technology and Innovation; Ernst & Young Entrepreneur of the Year Great Philadelphia Finalist in 2012 and 2013; CenterWatch 20 Innovators Changing the Face of the Clinical Trials Industry, 2013
Tweet at: @samwhitaker
Dr. Kevin Lustig
Calling Citizen Scientists
Fueled by a 30-year history as a scientist in both academic and corporate settings, Kevin Lustig, Ph.D., was convinced drug discovery could be done much more efficiently, innovatively, and effectively.
Dr. Lustig responded to the drastic slowdown in drug discovery by founding Assay Depot in 2007, a marketplace for scientific services. His belief is that by empowering drug researchers through broad access to research services this would dramatically improve the effectiveness of drug research, result in lower costs, shorter drug cycle times, and improved clinical success.
It was a bold move, especially given that the company was built on a shoestring budget, but as Dr. Lustig puts it, if not us, who?
Dr. Lustig has since facilitated agreements for customized research exchanges with four major pharmaceutical companies, including Pfizer and AstraZeneca, as well as major research institutes, such as the National Cancer Institute.
Assay Depot is a cloud-based drug research platform that allows researchers to locate services from high-quality vendors quickly, efficiently, and at no cost. This online research exchange streamlines purchases between scientists and a list of 8,000-plus global research vendors. And — for the first time —makes it possible to develop a drug in an entirely virtual fashion using only research providers found through the site.
As part of its commitment to open science, Assay Depot dedicates a portion of revenue from its private pharmaceutical network to subsidize a free and public version of its research exchange for the wider scientific community. This allows any academic scientist, citizen scientist, or small company researcher to access all of the tools of modern molecular medicine free of charge. To date the public site has users from 126 different countries and handles tens of thousands of requests annually.
By making available all of the tools of modern molecular biology to anyone who wants to make use of them, Dr. Lustig has in essence taken healthcare out of the hands of a few massive corporations and academic institutions and placed it squarely in the hands of anyone — from a scientist pursuing a theory to the concerned parent of a sick child, to a forward-thinking high school student.
Dr. Lustig is lowering the barrier to innovation by creating an environment in which scientists can express their passion. And he is motivated to offer solutions that can make an enormous difference in the lives of billions of future humans.
Throughout his career, Dr. Lustig has never lost sight of the importance of fostering citizen scientists or supporting the life-sciences community.
To further lower the barriers to life-science research, Dr. Lustig recently co-founded Bio, Tech and Beyond, a community garage laboratory in Carlsbad, Calif. Opened in July 2013, the 6,000-square-foot lab empowers citizen scientists by giving them access to scientific equipment that has traditionally been restricted to professional research laboratories. The hope is that the lab will serve as a startup incubator and community science center, allowing scientists to translate their ideas into experiments, and their experimental results into new companies.
In 2012, Dr. Lustig helped create and run Open Science Challenges with the community labs BioCurious and Genspace. Five outstanding citizen scientists were awarded research grants of $5,000, with smaller grants going to three researchers under the age of 18.
Assay Depot also teamed up with the Rare Genomics Institute to design and run a highly successful rare disease Be HEARD Challenge (Helping Empower and Accelerate Research Discoveries) that brought together nonprofits, academic researchers, rare disease advocacy groups, families of rare disease patients, and for-profit companies to collaborate to advance rare disease research. In total, more than $500,000 of research services and $10,000 in cash were awarded to 26 different research groups studying 26 rare diseases, including alkaptonuria, Rett Syndrome, and X-linked intellectual disability (XLID).
“These types of challenges bring the life-sciences community together in a unique way and create an unprecedented opportunity to accelerate the science behind a cure for rare diseases,” he says.
Science offers moments of levity as well as seriousness, Dr. Lustig knows.
While working at Harvard Medical School in the late 1990s he discovered a novel gene that caused a very unusual puckered phenotype when injected into early-stage frog embryos.
A well-known scientist happened to visit the lab that day and after Dr. Lustig showed him the injected embryos he asked Dr. Lustig what he thought they were. Jokingly, he replied that they look like little buttholes. His response was, “Kevin, maybe they are.”
“To make a long story short, he was correct,” Dr. Lustig says. “I had cloned a gene that helped form the frog anus. I named it Xombi, which I find funny to this day. It’s also my car’s license plate number.”
Dr. Kevin Lustig has taken bold steps to empower citizen scientists.
Title: Founder and CEO
Company: Assay Depot Inc.
Education: AB, Cornell; MS, UCSF; Ph.D., Harvard Medical School
Family: Wife, Monica; son, Milo, 6; daughter, Amaya, 4
Hobbies: Surfing, citizen science, open science
Bucket List: Visit prehistoric cave paintings in Spain and France
Awards/Honors: Finalist — San Diego’s Most Innovative Companies (Assay Depot), San Diego Business Journal 2013; CIO 100 Award Winner (Assay Depot), CIO Magazine 2013; Finalist — San Diego’s Most Admired CEO, San Diego Business Journal 2012; Finalist — Top 100 Americas Award (Assay Depot), Red Herring 2012; PharmaVOICE 100, 2012; The Fierce 15 Top Emerging Companies (Kalypsys), Fierce Biotech, 2004; Richard Feinberg Memorial Teaching Award, University of California, San Francisco 1993
Associations: Bio, Tech and Beyond (BTnB), San Diego Biotechnology Network (SDBN), BIOCOM
Tweet at: @kevlustig
Breaking Down Regulatory
Connections matter to Mauricha Marcussen. As CEO of two regulatory services businesses, she is known and respected for being able to reach across the global regulatory environment to build creative solutions for the challenges facing the industry.
When an individual can combine the domain knowledge of his or her field with an entrepreneurial drive to create a successful and growing business in their field, the result is an innovative and pioneering approach to fill an industry need.
Ms. Marcussen’s knowledge, passion, leadership, and expertise have paved the road for innovative technological approaches to the challenges of regulatory affairs. Ms. Marcussen started Agano Solutions to fill a gap in the regulatory affairs services space. She recognized the convergence between technological advances and the need to create solutions that combined this technology with regulatory expertise. This was the genesis for another company she started, Auditgraph and one of the solutions has already been nominated for a life sciences award by Microsoft.
Using the knowledge she gained while working in the forefront of electronic submissions in the late 1990s and helping lead efforts to the eventual evolution to eCTD, she recognized that the industry has multiple needs for technology applications to improve existing business processes. In addition, she has been focusing efforts on the challenges of managing labeling on a global level. As a result of her keen understanding of regulatory requirements and her continuing interest in emerging technologies, she led the effort to develop a solution that essentially applies advanced mathematics to automate manual tasks in the regulatory label content review process.
By combining technology behind the scenes with regulatory expertise, she developed a solution that helps companies increase efficiency and significantly decrease the time and resources required to align global regulatory label content around the world. This unprecedented approach enables regulatory teams to focus on priorities and removes administrative tasks that can be automated or resourced in a more appropriate manner.
Ms. Marcussen is focused next on designing, building, and implementing technology solutions to meet regulatory affairs compliance needs in areas where document alignment and content harmonization are required. These include end-to-end global labeling alignment, compliance reporting, pharmacovigilance and label management and tracking solutions for the life-sciences industry; and a chemistry, manufacturing, and controls compliance platform.
She works to stay ahead of new regulatory affairs guidances and to help companies respond to the evolving regulatory landscape and keep product safety information up to date globally.
“To keep ahead, this requires subject matter expertise across a broad area of interest, coupled with technology strategies that are non-invasive, lightweight, and deployable in a variety of ways that we have not even considered today,” she says.
Ms. Marcussen is also committed to improving patient safety. She recalls a day at the FDA when a visiting scientist from the Middle East brought a sample of her country’s pertussis vaccine (pre September 11) in a large glass jar for the purpose of testing its safety and efficacy and to learn how to perform vaccine testing in her country.
“When she pulled the jar out from her bag and set it on the table, there was no sign of clear liquid; it was fully contaminated with long chains of putrid bacterial colonies,” Ms. Marcussen says. “I looked at the jar in amazement and asked her very carefully, ‘Is this the vaccine you give to the children in your country?’ She shook her head and adamantly said, ‘Yes. All kids get this.’ I held back tears with the thought that these children were dying from the contamination in the vaccine; not from the preventable disease for which the vaccine was intended. This was the defining moment for my career path: to seek ways to improve global patient safety from the laboratory, in the regulatory affairs environment, and throughout the life-sciences industry.”
By taking a consultative approach to each client and each challenge and being able to see the challenge from the view of regulatory professionals, Ms. Marcussen has developed strong relationships across the industry. Her work ethic and reputation as the quiet perfectionist have positioned her as a trusted partner.
Always willing to give her time, she is eager to help others achieve their career goals. Over the years, she has graciously accepted the role of teacher, mentor, and advisor while also looking at each client project and each colleague as a source of knowledge and an opportunity to learn. Her goal is to make a difference for patients, and she is motivated daily because she sees the difference she and her team are making in protecting global patient safety.
“We work in order to give back, and our clients provide us with the opportunity to ultimately improve the quality of life for a vast number of people throughout the world — professionally and personally,” she says
Mauricha Marcussen is always looking ahead and thinking about how to improve upon current situations and provide innovative solutions to major industry challenges.
Title: Founder and CEO
Company: Auditgraph LLC and Agano Solutions LLC
Education: BS, Biology and Spanish, Ohio Northern University; MBA, Pennsylvania State University
Family: Husband; four sons, 14, 13, 6, 4
Hobbies: Cycling, writing
Bucket List: A mission trip to Tanzania and China and competing in the Amazing Race with her eldest son
Awards/Honors: Auditgraph nominated for the 2013 Microsoft Life Sciences Innovation Award; Auditgraph nominated for the 2013 TOPRA Regulatory Affairs Communication Award
Associations: Drug Information Association; Informa Life Sciences; TOPRA: North American Leadership Team
Dr. Dominic Behan
A Scientific Goal Scorer
Dominic Behan, Ph.D., co-founder, director, executive VP, and chief scientific officer at Arena Pharmaceuticals, is obsessed with soccer and science.
He’s “mad about” the sport and has been since he was 4 years old, but luckily for patients with hypertension, dyslipidemia, or type 2 diabetes who require weight loss, he chose to pursue science for his career.
Dr. Behan’s company recently launched its first drug, Belviq, to be used as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with at least one weight-related comorbid condition.
Born and educated in the United Kingdom, Dr. Behan moved to San Diego in 1990 to complete his postdoctoral work at the Salk Institute.
Around the same time, the human genome was being cloned and he recognized the potential of the G protein-coupled receptor (GPCR) class for the treatment of human disease and that many of these receptors were untapped targets. As a result, Dr. Behan wanted to create a platform based on novelty and innovation to identify completely new approaches to the treatment of disease.
In 1997, Dr. Behan co-founded Arena Pharmaceuticals with Jack Lief, CEO, to identify novel ways to address GPCRs to modulate systems in the body for the treatment of human disease. Belviq was the first pharmaceutical approved by the FDA for the treatment of weight management in 13 years. Dr. Behan spearheaded Belviq’s development from conception to FDA approval, while continuing to build a sustainable pipeline of follow-on candidates based on Arena’s expertise and proprietary technology platform.
Dr. Behan’s career highlight to date is of course the approval and launch of Belviq, and taking his start-up company public.
“The approval of Belviq and Arena’s IPO in 2000 were big achievements,” he says. “Starting a company from scratch and then taking it public was a huge milestone for us.”
Another major highlight for him was one of his early successes in the lab — the isolation of CRF binding protein when he was a graduate student at the Salk Institute. This was important because the binding protein could block the actions of corticotrophin releasing factor (CRF), which is the main biochemical mediator of the body’s response to stress.
“I’ll never forget the first time that the sequence came out,” he says. “I was in the lab in the early hours of the morning when the amino acid sequence of the CRF binding protein came off for the first time. It’s a feeling that never gets old.”
It is the thrill of science that keeps him inspired and motivated, and helps him motivate his team.
“The excitement of sharing results with colleagues and team members is a great feeling,” he says.
Watching his team get excited about a discovery and seeing people’s energy also provides a big kick for him.
“I get a great deal of satisfaction when I see a team functioning at very high levels, with high energy, and making a difference,” he says. “We all want to make a difference to patients, and the passion of my team members who are excited by science drives me each day.”
On a scientific level, sustaining an innovative pipeline of new products is always a hurdle, and the development and approval of Belviq only emphasizes those challenges, he says.
Revenue from Belviq sales will provide a support system for the ongoing development of candidates, including APD811 for the treatment of pulmonary arterial hypertension, which is in Phase I; temanogrel, in partnership with Ildong, for the treatment of thrombotic diseases; and APD371 for the treatment of pain, which is in the preclinical stage.
Keeping focused on the goal is the key to success, Dr. Behan says. Giving his own best business advice, he says conviction, perseverance, and staying on course are crucial when it comes to innovation.
“As a leader, it’s important to stay on course or else you can be pulled in so many different directions that you’ll never achieve anything,” he says. “Once you have one success, you have to be looking to the next one and the next one. It’s important to celebrate those successes, but to stay successful you have to keep looking forward.”
And this is just what he is doing.
“As we look forward, I’d like us to bring a second product through to approval,” Dr. Behan says.
When he’s not focused on science, Dr. Behan is all about soccer and his team Liverpool. When asked what he would choose for an alternative profession: soccer. Items on his bucket list: soccer, soccer, and more soccer — watch Liverpool play in the Champions’ League, which is the biggest cup final in Europe, and attend a World Cup soccer final.
Whether in the board room, the lab, or on the soccer field, Dr. Behan knows how to score a winning goal.
Dr. Dominic Behan discovered, developed, and received FDA approval for the first weight management drug in 13 years.
Title: Co-Founder, Director, Executive VP, Chief Scientific Officer
Company: Arena Pharmaceuticals Inc.
Education: BSc, Biochemistry, Leeds University; Ph.D., Biochemistry, Reading University
Family: Wife, Gaynor; two daughters, Bridget, Shannon
Hobbies: Soccer, playing tennis, mountain hiking, woodcarving
Bucket List: Watch Liverpool play Champions’ League, watch a World Cup soccer final live, travel the world, explore the U.K. and Ireland with his wife
Awards/Honors: British Medical Research Council fellowship’s Innovative New Product award for Belviq, 2005
Associations: The Obesity Society, American Diabetes Association, Society for Neuroscience, The Endocrine Society (past and present)
Catalyst for Change
Pay attention — this is one of DJ Mitsch’s keys for great leadership.
It also defines her skill as a coach and helps her to uncover people’s true potential by inquiring about what they really most want to do and then encouraging them to find a way to do that.
Ms. Mitsch has spent more than 18 years coaching people within the healthcare industry to expand their thinking, enhance their career possibilities, and strengthen their commitment and work ethic.
As co-founder of Pyramid Resource Group, she has pioneered the use of a coaching solution that includes executive and team coaching, leadership development processes, and continuous improvement strategies to enable pharmaceutical executives to lead their organizations to meet industry challenges.
She recently launched the Healthcare Coaching Institute, which is a coaching certification program designed specifically for leaders and professionals working in the fast-paced and changing healthcare environment. The institute will be accredited through the International Coach Federation and teach leaders to “coach” and lead differently at many levels throughout the world.
Another innovation is Pyramid’s Team Advantage, which is designed to produce sustainable improvements in team performance, engagement, and ownership from team members that organizations need to succeed. The program is transformative in that it inspires people to work together in new ways and eliminates the need for internal competition.
Clients say she not only trains future leaders but empowers organizations to create a culture of differential advantage and to become “catalysts of awesomeness.” She helps those she coaches to overcome obstacles and see fresh paths of possibility.
Her proactive vision helps client companies stay ahead of all the changes in healthcare, which in turn has an immeasurable positive impact on patients.
Ms. Mitsch is also an energy worker and is focused on having people take good care of their bodies, minds, and spirits.
Ms. Mitsch is a role model for executive coaching and team-building within the pharma/biotech sector. She dreams of building The Pyramid Coaching institute for enlightened leaders and change agents.
She says the real turning point in the industry came around 2004 when people stopped asking “what is coaching,” and started asking “where is my coach.”
Ms. Mitsch is a serial entrepreneur, author, coach, leader, challenger, and enthusiast. Publishing her first two books — The Team Advantage, The Complete Coaching Guide for Team Transformation and Coaching for Extraordinary Results — was a career highlight. She looks forward to publishing her next book: Revolution, Coaching TEAMs to Change the Game of Work in 2014.
Ms. Mitsch views herself as a creator, which captures how she views the world around her and works within it. And while an expert coach, she also considers herself to be a guide.
“On a flight to Zurich, an 85-year-old woman told me that coaching was too harsh a word for what I do, and what I do is guide people to their inner wisdom, hopefully before they are 85 years old,” she says.
Ms. Mitsch is a committed mentor and believes when she explores and teaches someone else, she learns.
“I am a seeker; mentoring fuels me,” she says.
Ms. Mitsch likes to also give back through a nonprofit organization called Dress for Success, which helps disadvantaged women enter the workplace through mentoring, coaching, dressing, and preparing for interviews.
“We help these women see new possibilities,” she says. “Each time we help a woman find meaningful employment, we help her children thrive and stay away from socially impossible situations. This changes the world around us — one ‘sister,’ one family at a time.”
DJ Mitsch is a role model for executive coaching and
team-building within the pharma and biotech sectors.
Title: Co-Founder and President
Company: The Pyramid Resource Group Inc.
Family: Husband and business partner Barry; daughter, Jessica, 24; son, Hank, 20
Hobbies: Traveling, adventures, writing, biking, hiking, walking her boxer Abe
Bucket List: Writing a best seller, sky-diving, visiting Nepal and Tibet, living in Italy for a while to write and sip wine
Awards/Honors: NC Small Business of the Year, 2000 and 2004
Associations: Healthcare Businesswomen’s Association; ICF –Raleigh Area Chapter; SPBT
Tweet at: @DJMitsch
Ringing in Patient Engagement
Almost anything is achievable if you take a practical approach, says Tim Davis, whose astute business model and pioneering use of business technology is reshaping the way that the pharma industry conducts clinical trials.
With 17 years of experience in the clinical research technology industry, Mr. Davis has long understood the potential that mobile technology has to improve the patient experience and the quality of clinical trials.
Mr. Davis was one of the first people to truly grasp the concept of patient engagement throughout the life of a clinical research trial, and then develop a solution to provide the data. He believed if there was a way to track a patient’s journey, starting with patient recruitment continuing through the end of the trial, there would be higher levels of engagement in clinical trials, which would lead to better study compliance and lower drop-out rates.
When he introduced the potential of mobile technology in clinical trials in the mid-2000s, he faced resistance, because like so often, there were not enough metrics to support his vision.
But by translating his deep knowledge of electronic communications and devices into a language that the industry could understand and trust, Mr. Davis has helped bring this powerful new approach to many industry leaders through Exco InTouch, which he co-founded in 2004.
His vision was to use mobile technology to communicate with patients and remind them of medication regimens. The ultimate goal was to improve the healthcare experience for patients and reduce their suffering by providing support through everyday technology.
Mr. Davis has seen the scope of mHealth programs grow from simple, static tools, such as health apps, to the creation of sophisticated multi-level solutions. As a result, today’s mHealth programs can now be implemented so that they automatically adapt, based on data gathered, and drive engagement so patients can better manage their condition over time.
In 2005, he led Exco InTouch to develop a two-way messaging system, which led to the first-ever mobile phone e-diary.
His vision for electronic patient reported outcomes (ePRO) is leading the industry with device independent applications that make it easier for clinical trial subjects to provide information and remain compliant with the study requirements. Sites and sponsors also have faster access to better quality data through ePRO.
In 2010, Mr. Davis worked with Pfizer and the FDA to leverage the potential of the e-diary and incorporate it as part of a first-ever participatory patient-centered (PPC) virtual clinical trial. The study used Exco InTouch’s e-diary technology and training materials, enabling patients to participate regardless of location, age, or proximity to site. The focus was on the new REMOTE (Research on Electronic Monitoring of OAB Treatment Experience) study for the treatment of overactive bladder, which mimicked a previously completed trial to replicate the results and validate this novel approach.
This was a first for the industry and required lateral thinking and plenty of energy and determination to work through the process and get everything in place to gain study authorization.
His groundbreaking approach to mHealth has led to a partnership with AstraZeneca to develop a program of intelligent solutions using interactive mobile phone and Internet-based health tools that will help patients and their healthcare providers track and manage chronic conditions, starting with chronic obstructive pulmonary disease (COPD).
Mr. Davis’ next goal is to ensure that a device-independent approach to engaging patients and capturing data is realized to its full potential across the industry.
He is motivated by the goal of helping individuals get better, or cope better, with their condition, and says that the fact that he works with a dynamic team with diverse experiences and backgrounds is a close second.
Always approachable, Mr. Davis has engendered a culture of empowerment and innovation within Exco InTouch, and his open-door ethos means that employees always have his expertise at hand. Employees say he has created a culture that is both engaged and engaging, one that encourages hard work as well as fun.
“It’s important to be approachable, my door is always open, and I like to help those around me, share knowledge, and learn from their experiences,” he says.
In addition, he works within wider industry forums dedicated to innovation and improving patient retention through technology.
Tim Davis is passionate about leveraging advances in everyday technology to simplify the process of clinical data capture for both patients and the pharmaceutical industry.
Title: Co-Founder and CEO
Company: Exco InTouch Ltd.
Education: BSc, Dual Honors, Microbiology and Biotechnology, University of Sheffield
Family: Married; daughter, Stella, 4; son, Henry, 2
HOBBIES: Road cycling, snowboarding, listening to music
Bucket List: Complete the classic cols that dominate the Giro D’Italia and Tour De France cycling races
Awards/Honors: European Outsourcing Award winners for Best eBusiness/IT strategy, 2008, 2010, 2011, 2012; Deloitte’s Technology Fast 50 in 2011
Associations: C-Path’s Electronic Patient-
Reported Outcome (ePRO) Consortium
Tweet at: @excointouch or @exco_ceo
Dr. Christian Behrenbruch
An entrepreneur at heart, Dr. Christian Behrenbruch has started several companies himself, invested in
several start-ups, and mentors those who are interested in blazing
Chris Behrenbruch, Ph.D., is a leader renowned for his unconventional thinking and perpetual drive to solve difficult healthcare problems. As CEO of ImaginAb, an innovative early-stage biotech company that specializes in molecular imaging with positron emission tomography (PET), he is tackling precision medicine in new and innovative ways. Through his leadership of ImaginAb, a company he co-founded and has led from inception, he and his team are transforming antibody drug development and addressing major unmet needs in the management of cancer and autoimmune diseases.
ImaginAb re-engineers therapeutic antibodies against biologically important targets into smaller proteins optimized for diagnostic imaging with PET. ImaginAb’s molecular imaging agents enable clinicians and patients to understand in real time what is happening to individual proteins and cells in their body. This means that drug developers, clinicians and patients don’t have to wait to know if a therapeutic intervention is working — they can image it in real time.
A proven leader and negotiator, Dr. Behrenbruch’s strength lies in bringing talent together from academia and industry to create interdisciplinary teams. ImaginAb has successfully concluded more than 20 collaborations with global biopharmaceutical companies and has several clinical programs in progress with leading companies in cancer and immunology. His goal is always to deliver the best science and undertake collaborations with the highest level of integrity and respect for patient outcomes.
Dr. Behrenbruch has always loved science and technology, but realized that a fundamental research or clinical pathway wasn’t right for him.
“I went down the business track instead because I knew I was never going to be the real brains of a laboratory,” he says. “I learned that what I could do best was partner with scientists and clinicians to get their great ideas into the commercial domain. To be honest, my job is the easy part.”
During challenging times for early-stage biotech companies, Dr. Behrenbruch successfully grew ImaginAb organically by building close collaborative relationships with leading academic institutions, the National Cancer Institute, and ultimately, securing Series-A financing from a top-tier syndicate of investors, including Novartis Venture Funds, Nextech, Merieux, and Cycad.
“We have a great investor team,” Dr. Behrenbruch says. “But it was wonderful support from the NCI that enabled us to create the data we needed to engage with VCs.”
His high-energy and straightforward approach has been vital to the company’s success, but he also remains fairly philosophical about the mercurial nature of business.
“Great technology and a compelling business plan are important, but people and a dose of luck count for a lot too,” he says.
A serial entrepreneur, Dr. Behrenbruch has either co-founded or mentored more than 20 university spin-outs over the past decade. He began his career in the energy sector and then, in the late 1990s, was involved in starting several UK-based companies, including Oxford Medical Image Analysis and Mirada Solutions, which was sold to CTI Molecular Imaging and ultimately became part of Siemens Healthcare. After that he decided to return to early-stage companies, which is what he enjoys the most.
“I had done quite a bit of technology transfer over the years with SoCal institutions such as UCLA and Caltech, and I had a lot of good relationships there,” he says. “As a result, I spent two years as an ‘entrepreneur in residence’ at UCLA and my basic mission was to help spin out as many companies as possible. ImaginAb was one of those really exciting opportunities.”
Dr. Behrenbruch and his co-founders — Anna Wu, Rob Reiter, and Tove Olafsen — launched ImaginAb with the support of a small faculty-led venture fund associated with UCLA and Caltech called Momentum Biosciences, which Dr. Behrenbruch also co-founded. Unfortunately when the global financial crisis hit they found themselves, as he says, “in the badlands of start-up purgatory,” and struggled to raise onward financing. So Dr. Behrenbruch rolled up his sleeves and took on the role of interim CEO of ImaginAb, before ultimately staying on as full-time CEO.
The opportunity to develop new ideas that can impact healthcare motivates Dr. Behrenbruch, who is excited about working with people who tackle big problems for which there are currently no solutions.
“I’m probably not going to be the guy who comes up with a brilliant technology that gets a new start-up across the financial abyss, but I might be the guy improves the probability that we at least have a little plank hanging out over the edge of it,” he says. “Sometimes, it seems, developing an innovative idea requires taking measured steps.”
But he also acknowledges that the global financial turbulence of the past five years, and the impact it has had on startups and research budgets, can take a toll.
“It’s been a truly hair-raising time for entrepreneurs and it’s been really tough to raise capital, even superb startups from top-tier universities are struggling to engage VCs,” he says.
He notes that he didn’t take a salary for over four years while ImaginAb got off the ground, and he’s proud of the fact that he kept his team together even when financial resources got thin.
For Dr. Behrenbruch, success is all about the team and sharing accomplishments together.
Company: ImaginAb Inc.
Education: BEng, Monash University; MBA, New York
University and the London School of Economics; D.Phil., Biomedical Engineering, Oxford
Family: Wife, Zhenya; son, Max, 1
Hobbies: Scuba diving, playing the saxophone
Bucket List: Run the New York Marathon, take on a
nonprofit global public health challenge
Awards/Honors: Advance Global Australian Award for Biotechnology, 2012; Young Global Leader, World Economic Forum, 2011
Building an enterprise is tough. Business doesn’t just get thrown at you; you have to go get it. You have to prove yourself again and again, year in and year out, in any economy. Julie Kampf launched her executive search firm JBK Associates 10 years ago during a downturn, and has not only managed to sustain growth, but has increased her company’s revenue by more than 155% over the past three years.
Under her joyful and energetic leadership, JBK is going from strength to strength, expanding internationally by opening a London office in response to the needs of clients as they move into global markets.
All the while, Ms. Kampf has managed to balance family, a commitment to her community, and expand her company, giving her best to all three areas, all of which connect to her larger mission of helping others to grow and succeed.
Early on, her father instilled in her the belief that she could overcome any obstacle, and inspired her with the words of Earl Nightingale: “What the mind can see and believe, it can achieve.”
She launched her first business when she was a single mother in transition with a 10-year-old son.
“Once I saw myself as an entrepreneur, there was no stopping me,” she says.
Ms. Kampf’s career is not just about building a business; it’s about empowering people to fulfill their professional dreams. In 10 years, she has done that for thousands of healthcare professionals and scores of businesses by creating three N.J.-based talent management companies.
In addition to founding JBK in 2003, Ms. Kampf in 2007 founded SummitSearch U.S., which helps clients find middle-management talent and develop future leadership. That firm doubled its revenue in the first year. Still not stopping to take a breath, in 2008 she launched CareerCentral, a career consulting firm that provides personalized organizational and leadership development programming and education to all levels of executives.
Ms. Kampf treats each client relationship as a partnership and an extension of the client company’s mission to attract the best, most innovative, and brightest talent the industry has to offer. She views leadership and leadership potential as the greatest attributes a person can bring to the table these days, and when she brings a candidate forward, she looks well beyond that person’s ability to fill immediate needs. She drills down hard to understand what motivates that person, and whether his or her style and vision are the right fit for a particular company, job, and challenge.
Long-term clients seek her counsel on a diverse range of leadership and talent questions and issues. It’s not just about search, it’s about being a trusted partner and sounding board when the needs arise around succession planning, coaching, team building, leadership training, and more.
With her deep commitment to diversity, Ms. Kampf has always challenged and encouraged her clients to build more diverse leadership teams, including those with women. JBK is nationally recognized for diversity leadership, and has been honored two years running with the 2013 and 2012 Diversity Leader Awards from Profiles in Diversity.
Moreover, for Ms. Kampf it’s never been a matter of running with an assignment and automatically looking externally. She encourages clients to first consider internal talent, and she often responds to “he/she is not ready” with the suggestion that a development plan be put in place so that the next time an opportunity arises, an internal candidate is up to the challenge.
When she passes on advice to others, she is honest and open about her own struggles, while seeking to understand what others want to accomplish and helping them figure out a way to get there.
She hires people who are self-motivated and then provides them with opportunities to advance in an atmosphere of respect.
“I want my team to be happy to come to work as often as possible, and provide opportunities to learn new things,” she says.
One of Ms. Kampf’s greatest accomplishments is her commitment to women and diversity, both in the workplace and in the community. She uses her volunteer work, such as with the HBA, as a way to connect and help others grow.
One association that truly resonates for Ms. Kampf is Good Grief, which helps children and teens cope with loss.
“I lost my mother to cancer when I was 15, and working with Good Grief has given me an opportunity to create a legacy for her,” she says.
Julie Kampf challenges and encourages her clients to build more diverse leadership teams.
Title: Founder, CEO, President
Company: JBK Associates International
Education: BA, Political Science, University of Rhode Island
Family: Husband, Andrew; son Adam
Hobbies: Golfing, interior design, real estate, food
Bucket List: Ensuring her son is successful in his life, getting over the fear of flying so she can travel to some great places, getting her golf handicap down to a 10, and reinventing herself every 20 years
Awards/Honors: Inc.500|5000 list of America’s fastest-growing private companies; New Jersey’s Top 25 Leading Women Entrepreneurs from New Jersey Monthly magazine; Business of the Year in the category of 1-50 employees from NJBIZ magazine; Innovations in Diversity Award from Profiles in Diversity Journal; Corporate Leadership Award from Good Grief, NJ, resource for grieving children; Diversity Leader Award from Profiles in Diversity Journal; CEO in Action Leadership Award from Profiles in Diversity Journal; DiversityBusiness.com Top Business; Garden State Woman of the Year; Girl Scout Woman of Achievement; Enterprising Women magazine’s Enterprising Women of the Year; Working Mother Magazine’s Best Women-Owned Companies
Associations: Healthcare Businesswomen’s Association; American College of Healthcare Executives; BioNJ; Healthy Women; Healthcare Marketing Council; Association of Executive Search Consultants; Cosmetic Executive Women; Fashion Group International; Bergen County chapter of Women United in Philanthropy; Board of Visitors of Howard University John H. Johnson School of Communications; Executive Board of Good Grief; Bergen County Girl Scouts
Tweet at: @JBK_Associates
Breaking the Rule for Patients
Within months after launching, PatientsLikeMe was named by CNN Money as one of “15 Companies That Will Change The World.”
PatientsLikeMe was co-founded in 2004 by three MIT engineers: brothers Jamie and Ben Heywood and longtime friend Jeff Cole. Six years earlier, their brother and friend Stephen Heywood was diagnosed with ALS (Lou Gehrig’s disease) at the age of 29. The Heywood family soon began searching for ideas that would extend and improve Stephen’s life. Inspired by Stephen’s experiences, the co-founders and team conceptualized and built a health data-sharing platform that many in the industry believe can transform the way patients manage their own conditions, change the way industry conducts research, and improve patient care.
At the time of Stephen’s diagnosis, Jamie Heywood founded ALS TDI to accelerate the development of new treatments. ALS TDI was the world’s first nonprofit biotechnology company and has become widely recognized as one of the most innovative research organizations.
ALS TDI implemented an industrialized therapeutic validation process and built a world-class discovery program.
“We were the first organization to run an open-research program, posting in real time the results of our studies for patients, doctors, and the research community,” Mr. Heywood says. “Overall, during my time as CEO, we raised $50 million, including the historic discovery partnership in 2007 with Augie’s Quest and the Muscular Dystrophy Association.”
The Heywood brothers’ story has been well-chronicled over the years. Jamie and his brother were the subject of Pulitzer Prize-winning author Jonathan Weiner’s biography His Brother’s Keeper: One Family’s Journey to the Edge of Medicine and the documentary So Much So Fast.
Today, PatientsLikeMe follows four core values: putting patients first, promoting transparency — no surprises; fostering openness; and creating wow. These values guide the company as it continues to enhance its platform, where patients can share and learn from real-world, outcomes-based health data.
The company’s platform, which has earned numerous accolades, including being named one of “the seven apps and sites that may save your life” by CBS News, achieves its core goals by providing a better, more effective way for patients to share their real-world health experiences in order to help themselves, other patients, and medical research.
PatientsLikeMe is also changing the rules in medical care by giving patients in-depth information on outcomes, treatments, and symptoms that they can use to make more effective decisions on managing life-changing illness.
“We’ve centered our business around these values by aligning patient and industry interests through data-sharing partnerships,” Mr. Heywood says. “We work with trusted nonprofit, research, and industry partners that use this health data to improve products, services, and care for patients.”
Inspired by his brother Stephen, who let him break all the rules, Mr. Heywood inspires his team and colleagues by creating a concrete vision of what could be and remaining relentlessly optimistic about the future while providing a brutal assessment of the present.
Mr. Heywood is absolutely devoted to changing the healthcare system.
“The medical system could be better in so many ways, and over the last decade my passion has been to find ways to both improve the way treatments are developed for disease and the way patients receive medical care,” he says. “We are entering a new era that will be as big a shift in the life-sciences sector as the computing industry went through when it transitioned from mainframes to personal computers. The emergence of new human networks and the reduction in the cost of de-novo discovery technologies combined will redefine health, illness, and treatment at a pace that is unimaginable today. Who will survive, die, or thrive will depend on knowing how to connect to the new emerging networks that will define health and value in the future.”
Mr. Heywood is well on his way toward making the world one in which healthcare is not defined by what we do but is defined by the impact it has; where the outcome as defined by the patient for the patient determines the value of each part of the system; and where treatments, diagnoses, and the practice of medicine itself are all for the first time measured and rewarded for the real-time value they create for each individual.
Jamie Heywood is working toward a world where healthcare is not defined by what we do but by the impact it has.
Title: Co-Founder and Chairman
Education: BS, Mechanical Engineering, MIT
Family: Liza and Zoe, 13; Alden, 5; Miles, 2
Bucket List: Fixing healthcare and discovery
Awards/Honors: PatientsLikeMe named to Healthcare Internet Hall of Fame, 2012; PatientsLikeMe ranked by MIT Technology Review as one of 50 Most Innovative Companies, 2012; PatientsLikeMe named one of “7 apps and sites that may save your life” by CBS News, 2011; PatientsLikeMe ranked No. 23 in Fast Company’s 50 Most Innovative Companies issue, 2010; Jamie Heywood named an Innovator in Health by the New England Healthcare Institute (NEHI), 2010; Jamie Heywood named to WIRED Magazine’s 2009 Smart List, 2009; Jamie and Ben Heywood named to the Future Health 100 list by HealthSpottr, 2009; PatientsLikeMe receives Prix Ars Electronica’s Award of Distinction, 2008; FierceHealthIT names PatientsLikeMe Top Health IT Innovator, 2007
Tweet at: @jamie_heywood
Setting Her Sites on Success
The signs of a budding clinical trial entrepreneur came early in Christine Pierre’s life. As a teenager, she organized a neighborhood group of babysitters and managed their schedules — it ended up being a true service for the neighbors and the babysitters. Ever since, this second-time PharmaVOICE 100 honoree has been a driving force for collaboration. Her first industry job was as an open-heart/trauma critical care nurse, where she received the opportunity to be the study coordinator for a traumatic brain injury study. She was so enthralled and passionate by the possibilities of research that she never looked back.
“I got bitten by the research bug,” she says. “I carried a pager for many years and enrolled more subjects than any other site for years. The rest is history.”
Today, Ms. Pierre is making clinical trial history with her latest endeavor, the formation of the first trade organization for global clinical research sites, The Society for Clinical Research Sites (SCRS). In October of last year, Ms. Pierre, along with the SCRS leadership council, which includes members from Lily, PPD, and several other sites, introduced and launched the SCRS.
Colleagues say the innovation and impetus behind the concept of this new organization may indeed change the way research sites are perceived, as well as the critical elements of the research process going forward.
After seven years of hosting the Site Solutions Summit, which has grown to 500 participants, including all major stakeholders, Ms. Pierre was inspired to fill the need for an organization committed to advocating on behalf of sites and fostering site performance and building meaningful relationships between sites and sponsors, CROs, and professional service providers. While the clinical enterprise relies on sites for subject recruitment, investigator acumen, and protocol management, sites are often left out of the conversation with regard to process or operational improvement. Ms. Pierre felt strongly that sites needed a voice within industry to really drive change.
The new organization, after only nine months of open membership represents almost 1,300 research sites in 24 countries. This is indeed impressive and illustrative of the need for such representation for sites around the world and Ms. Pierre’s influence.
The CEO and founder of both SCRS and RxTrials says a defining moment in her career was the day she publically announced SCRS as the first global trade organization to provide sites with a voice and a community and started after 20 years of having run RxTrials she was turning over the day-to-day operations of RxTrials to its seasoned management team.
“Either one of those statements alone would have been a defining moment, together it was a day I will never forget,” she says. “Sites now have a voice and a community.”
SCRS’ next goal is to facilitate the global expansion of the organization to ensure to provide sites the voice, community, and tools they need to succeed, and she looks forward to seeing SCRS mature and turn 20 and the next group of leaders taking the helm.
RxTrials’ 20th anniversary was also a big career highlight for her.
Her biggest challenge with RxTrials over the past two decades, as well as the challenge for all sites, is the struggle to deal with quarterly payment terms.
“This payment system brings sites to their knees and we’re seeing today more sites closing their doors then every before,” she says. “It’s an incredibly difficult business to manage and SCRS will work fearlessly to influence industry to change this out-of-date system of payment to the sites, along with many other activities that bring needless processes to the sites. Today 70% of sites are conducted outside a large institution; it’s time everyone pays sites monthly for the work they’ve completed.”
Internationally known for her experience and expertise in clinical research site management and patient recruitment and retention for the clinical trials, she co-authored the book Responsible Research: A Coordinators Guide, and has contributed to several recognized publications related to clinical site management.
A sought-after advisor to clinical research organizations around the world, she is described by those who work with her as a fearless leader who has provided vision and direction in business, volunteerism, and in the relationships she has built with many involved in clinical research.
As a past chairman of the board of the Association of Clinical Research Professionals, she led the board through some challenging issues around global development, was integrally involved in the restructuring and rebranding of the organization, and carried the torch for participants through higher visibility and emphasis on the role of the research volunteer.
Her sincerity, commitment, and drive carry her through each task, whether at work or planning Disney cruises for her five grandchildren, or bike trips across the globe for she and her husband or healthcare mission trips to Columbia.
And if you bump in to her on a cross-country flight, ask her to knit you a scarf. She can knit so fast she was able to start and finish a scarf, which she gave to a flight attendant on a single fight from D.C. to California. However, scarves are the only things she can knit, so don’t ask for socks.
Christine Pierre is making clinical trial history with her latest endeavor, the formation of the first trade organization for global clinical research sites: The Society for Clinical Research Sites.
Titles and companies: Founder and President Society for Clinical Research Sites (SCRS) and CEO and Founder of RxTrials Inc.
Education: RN, Prince George College
Family: Husband, four children, five grand daughters
Hobbies: Bike riding, cooking, knitting, and travel
Bucket List: ?Why wait, eat dessert first!
Awards/Honors: Brava CEO Award, Washington DC, 2013, Professional Woman of the Year, National Association of Professional Women, 2011, PharmaVOICE 100 Most Inspiring People, 2009, Top female executive in Maryland
Associations: Association of Clinical Research Professionals, Clinical Trials Transformation Initiative, Metric Champion Consortium, Center for Information & Study on Clinical Research, Hands Across the Americas
Dr. Joseph Kim
Visionary and centered, Joseph Kim, Ph.D., thinks big and works to make his company fly, all the while keeping both feet on the ground. A biotech entrepreneur, Dr. Kim took his innovative vaccines company Inovio (formerly VGX) public in 2009, in the middle of the country’s financial crisis, yet managed to raise $30 million to support the company’s programs — one of the largest microcap-biotech financing rounds in the last two years. He understands when raising capital that the key to success is to never leave any money on the table.
Dr. Kim is revolutionizing the vaccine market; his company developed the first significant upgrade to vaccines in 60 years by bringing a DNA-sequenced vaccine to market. The company is developing prophylactic and therapeutic vaccines targeting both large as well as underserved disease areas. These include a therapeutic cervical cancer vaccine currently in Phase II clinical studies and a universal flu vaccine program.
The opportunity to develop new life-saving therapies for cancer, HIV, influenza, and other infectious diseases is what inspires him to come to work each day.
“Our next-generation vaccines have the potential to further enhance health and prolong life around the world,” Dr. Kim says. “This is why I and my colleagues come to work each day; and there is reason to hope for better vaccines tomorrow.”
His goal is to redefine what a vaccine is —not simply for disease prevention but also to treat and cure disease or infection — and gain medical acceptance for this broader use.
Inovio’s universal flu vaccine program has the potential to transform the way the industry thinks about and develops flu vaccines in response to the constantly changing flu virus strains. Through its SynCon technology, Inovio has developed synthetic consensus DNA vaccines that generate broad immune responses against known as well as unknown strains of H5N1, H1N1, H3N2, and H2N2.
In addition, at a time when many large pharma companies were exiting HIV vaccine development in the aftermath of the Merck-STEP trial and following years of clinical failures of other high-profile programs, Dr. Kim and Inovio made a bold commitment to develop HIV vaccines in partnership with NIAID/DAIDS and the HVTN. The leading programs are now in Phase I clinical studies in multi-center trials.
Another measure of Dr. Kim’s commitment to disease prevention and treatment has been his fostering of a preclinical research pipeline that includes newly emerging disease targets such as dengue fever and chikungunya and hard to prevent targets such as malaria.
Recognizing the importance of developing much needed prophylactic/therapeutic interventions against these targets that have the potential to impose a high disease burden on the global population, and yet recognizing a lack of investor appetite in supporting such development because of modest commercial potential, Inovio has successfully adopted a strategy of partnering with government and non-government organizations or with direct grant support to carry out the development programs and create shareholder value.
Dr. Kim has won support from important sources: the NIH granted him $25 million to speed development of his HIV vaccine — both preventive and therapeutic — while the Bill & Melinda Gates Foundation is funding his malaria vaccine.
Dr. Kim, with previous experience as a lead vaccine developer at Merck, has deep-rooted connections within the pharmaceutical industry, which has also shaped his vision for what the future of the industry could be. He is challenging companies to examine how to become more efficient.
He inspires others by treating them as he would want to be treated and laying out the vision and the plans, then executing them alongside his team.
“I want to help and guide young professionals in their growth as a way of giving back to those who had helped me,” he says.
Dr. Joseph Kim is tireless in communicating the company’s mission, vision, and milestones, then ensuring Inovio meets those milestones on time and on budget.
Title: President and CEO
Company: Inovio Pharmaceuticals Inc.
Education: BS, MIT; MBA, Wharton; Ph.D., University of Pennsylvania
Family: Wife; 2 sons and 1 daughter
Hobbies: All sports, especially golf
Bucket List: Serve the US government as an ambassador, blue ribbon panelist, elected position
Awards/Honors: One of the world’s Top 100 Young Innovators, MIT’s Technology Review; One of “40 under 40” dynamic professionals, Philadelphia Business Journal; “50 Most Influential Men,” Details Magazine; “30 Technology Pioneers” World Economic Forum; One of 10 leaders, scientists, and executives at the forefront of change and impact in the world, Newsweek International; Forum of Young Global Leaders, an affiliate of the World Economic Forum; Named a Young Global Leader among 175 leading executives, public figures and intellectuals under the age of 40 from 50 countries; One of Biotech’s “Future Leaders,” BioCentury Magazine; Best Therapeutic Vaccine, World Vaccine
Congress 2013; Best Early Stage Biotech Company, World Vaccine Congress 2013
Dr. Daniel Kraft
The Sky’s the Limit
Daniel Kraft, M.D., is more than a physician-scientist; this innovator, visionary, and futurist has a unique view on what healthcare can be. He believes that many of today’s challenges can be approached by democratizing healthcare, empowering patients, clinicians, and the biotechnology world through new, powerful, and connected tools and platforms.
And the way to get there is through the convergence of big data — genomics and beyond — with big analytics — such as IBM-Watson — connected to mobile technologies and diagnostics in the hands of empowered patients, which will lead to better outcomes, lower costs, and a healthier society.
As executive director of FutureMed and chair of Medicine at Singularity University, he is leading the charge to change the perception of what medicine can be.
FutureMed educates, informs, and prepares physicians, innovators, inventors, investors, and senior healthcare executives to understand and recognize the opportunities and disruptive influences of exponentially growing technologies within medicine and healthcare, and to understand how many rapidly developing and converging fields affect the future of wellness, prevention, clinical practice, and the biomedical industry.
Singularity University includes the cutting-edge programs of FutureMed, as well as the Graduate Studies Program (GSP), which convenes future leaders, entrepreneurs, and technologists to work on team-based technology solutions to widespread global challenges, and The Executive Program (EP), which dives into the tools that corporate specialists and entrepreneurs need to ride the wave of accelerating change.
Dr. Kraft says pulling together and launching the first FutureMed programs at Singularity University has been a career highlight.
“FutureMed has enabled me to integrate many of my friends and colleagues across my clinical, biomedical research, innovation paths, and has inspired and enabled several new impactful companies to form, including Scanadu (medical tricorder) and Jointly.
As a Stanford- and Harvard-trained physician-scientist with more than 20 years of experience in clinical practice, Dr. Kraft believes that never have the challenges in healthcare been greater — ranging from rising costs, aging demographics, the obesity epidemic to primary-care shortages.
“The opportunities to re-invent and rethink how we practice healthcare have also never been greater,” Dr. Kraft says. “There is an incredible array of new technologies ranging from mobile and wearable devices, to low-cost genomics, artificial intelligence, stem cell biology, and 3-D printing, which are converging and can be leveraged in powerful new ways.”
Dr. Kraft is board certified in both internal medicine and pediatrics following residency at the Massachusetts General Hospital. He completed Stanford fellowships in hematology/oncology and bone marrow transplantation, and extensive research in stem cell biology and regenerative medicine. He has multiple scientific publications, medical device, immunology, and stem cell-related patents through faculty positions with Stanford University School of Medicine and as clinical faculty for the pediatric bone marrow transplantation service at University of California San Francisco.
Dr. Kraft also invented the Marrow Miner, an FDA-approved device that harvests life-saving bone marrow with minimal pain to the donor. He emphasizes that the adult stem cells found in bone marrow can be used to treat many terminal conditions, from Parkinson’s to heart disease.
He also founded RegenMed Systems, a company developing technologies to enable adult stem cell-based regenerative therapies.
Dr. Kraft’s latest venture is IntelliMedicine, which he founded to focus on connected, data-driven, and integrated personalized medicine.
His goal is to build IntelliMedicine into an impactful and transformative personalized healthcare company. IntelliMedicine offers a number of solutions, addressing short-term and long-term needs consistent with the trends observed in healthcare and precision medicine, including platforms, technologies, and therapeutics.
Dr. Kraft is an avid pilot and serves as an officer and flight surgeon with an F-16 Squadron in the California Air National Guard. He has conducted research on aerospace medicine that was published with NASA, where he was a finalist for astronaut selection.
Dr. Kraft is generous with his time and resources. He is a mentor for Rock Health, an organization that is powering the future of the digital health ecosystem by bringing together the brightest minds in technology and medicine to build better solutions, and a seed-incubator for digital health.
He also mentors many students from Singularity University’s Graduate Studies Program, Stanford medical students, and others.
“My goal is to help them see what is possible, where the puck is going, and how technologies can come together to provide new possibilities for health and medicine,” he says.
Dr. Daniel Kraft believes that many of today’s challenges can be approached by democratizing healthcare.
Education: BA, Brown University; M.D., Stanford University, MGH, Harvard Residency Program; Hematology/Oncology and BMT, Stanford
Family: Daughter, Alex, 10
Hobbies: Aviation, traveling, photography
Bucket List: Going into orbit; visiting Antarctica; owning and flying a P-51 Mustang (WWII fighter)
Awards/Honors: Adaptive Business Leaders ABL — Abby Award for Leadership in Innovation
Associations: American Society for Hematology (ASH); American Society for Bone Marrow Transplantation (ASBMT)
Tweet at: @daniel_kraft
Hedging His Bets on Rare Diseases
Martin Shkreli has shifted away from the world of hedge funds to tackle a tougher task of helping patients with rare diseases.
From activist investor to pharmaceutical CEO, there are many sides to Martin Shkreli’s story. Mr. Shkreli raced through college and got his first job in finance at age 17; today he is CEO of Retrophin.
Mr. Shkreli has never been afraid to make tough decisions. While a hedge fund manager at MSMB Capital Management, he took some very firm steps, including derailing a proposed merger between AMAG Pharmaceuticals and Allos Therapeutics, fighting efforts to oust Pfizer CEO Jeffrey Kindler, and forcing out some pharma CEOs when he felt they weren’t doing their jobs.
Today, though, he has taken on a different fight, helping patients with rare conditions. He says that his 10 years in finance and “swashbuckling” were fun, but his interest is now on finding more interesting ways of helping people, while making money at the same time.
Mr. Shkreli founded Retrophin in 2011 with funding from MSMB, as well as several notable private investors, including former Schering-Plough CEO Fred Hassan and Brent Saunders, CEO of Bausch & Lomb.
His story is all the more remarkable because he is just 30 years old — a true wunderkind.
Despite having no formal education in biology — his degree is in business administration — he wrote the genetic sequence to the compound on which Retrophin was founded, RE-001, for the treatment of Duchenne Muscular Dystrophy, in which the lack of the protein dystrophin causes muscles to deteriorate and break down, leading to progressive difficulty with walking and general mobility.
He was inspired to do so after meeting a patient who passed away from the condition shortly thereafter. The name Retrophin is short for recombinant dystrophin, an engineered form of a protein that DMD patients lack.
Despite his reputation for being outspoken in the industry, Mr. Shkreli has a deep-seated compassion for patients, especially children suffering from debilitating and life-threatening diseases. You can see it in his eyes and hear it in his voice when he talks about these patients.
He is truly committed to developing treatments for uncommon diseases, and is doing everything in his power, alongside his team, to make them available to patients as soon as possible.
He has been quoted as saying that solving the world’s diseases one at a time is his new mission.
Mr. Shkreli has led Retrophin through multiple milestones in a short time. In February 2012, Retrophin licensed the rights to its lead compound, RE-021, from Ligand and Bristol-Myers Squibb. RE-021 is being investigated for the potential treatment of Focal Segmental Glomerulosclerosis (FSGS), a rare and severe nephropathy that is defined by diminished glomerular filtration in the kidneys, which leads to progressive scarring of the glomeruli and increased levels of proteinuria. RE-021 was originally developed to treat hypertension but recent studies have shown that lowering proteinuria leads to reduced morbidity of the disease.
In December 2012, the company completed a reverse merger to become publicly traded. In February 2013, it raised $10 million in a private placement offering.
Retrophin is collaborating with St. Jude Children’s Research Hospital to study a replacement therapy compound for PKAN, a rare pediatric disease, and recently announced positive preclinical results. Now, Retrophin is continuing to advance its pipeline, including RE-021, for which it plans to start enrolling patients in a potentially pivotal Phase II clinical trial.
As a testament to his many accomplishments, Mr. Shkreli was recently included in Forbes 30 Under 30 list.
Company: Retrophin Inc.
Education: BA, Baruch College
Hobbies: Playing chess, guitar, watching professional wrestling
Awards/Honors: Forbes 30 Under 30 list
Dr. Marc Buyse
Statistical thinking will one day be as necessary for efficient citizenship as the ability to read and write.” This quote from widely respected statistician Samuel Wilks paraphrasing H.G. Wells resonates today in biomedical research, particularly when affected by truly innovative biostatisticians, such as Marc Buyse, Sc.D.
Dr. Buyse demonstrates the true value of statistics in medical research. He is the founder of CluePoints Inc., a company that specializes in central statistical monitoring of clinical trials and a subsidiary of the International Drug Development Institute (IDDI). He is also the chairman of IDDI Consultants at the IDDI in Houston, and associate professor of biostatistics at the Universiteit Hasselt, Belgium.
CluePoints has developed an intelligent statistical approach — SMART — for an optimal approach to targeted monitoring and reduced source data verification (SDV). The SMART (Statistical Monitoring Applied to Research Trials) engine — the brainchild of Dr. Buyse is a software solution — patent pending in the U.S. — that allows researchers to assess the quality and integrity of clinical trial data. The goal is to provide statistical monitoring with an ability to detect the heterogeneity in the data throughout investigational centers and to create a “quality label” for these centers.
SMART has the ability to drive intelligent onsite monitoring strategies that will result in significant cost and resource savings; improve the quality and integrity of data; and reduce regulatory submission risk. The engine comprises a comprehensive range of inter-connected statistical tests that make no distributional assumptions about the clinical data but, when aggregated together, highlight difficult-to-detect issues in the data from specific centers.
Despite his high level of statistical knowledge, Dr. Buyse is always able to explain things in easy-to-understand terms and takes the time to educate those he is working with.
Open-minded and curious about new ways of applying statistical theory to real-world problems, Dr Buyse has worked over the last 10 years on demonstrating the role of surrogate outcome measures in clinical research. Recently, he served as principal statistical advisor to the National Cancer Institute of France. In this position, he was able to advance the practice of oncology clinical trials on an international basis.
Today’s clinical research environment owes a great deal to biostatistics and bioinformatics. The pressures on companies mean there is a need to determine efficacy and risk early in the development process. This is made possible through the use of biomarkers and surrogate endpoints; the ability to conduct interim analyses and adaptations whenever possible; and a focus on endpoints that combine clinical relevance and statistical sensitivity.
Dr. Buyse also proposed a new method of analysis that is useful when interest focuses on multiple, prioritized outcomes. The outcomes can be of any type, such as binary responses, times to event, or even repeated measurements over time. The method is fully non-parametric and leads to a universal measure of treatment effect.
He has published extensively in the fields of clinical trial methodology, meta-analysis, statistical detection of fraud, validation of surrogate endpoints, and drug development in oncology.
Furthermore, he has successfully launched some of his ideas through the creation of companies hiring by young and talented people.
Dr. Buyse was president of the International Society for Clinical Biostatistics, president of the Quetelet Society, and Fellow of the Society for Clinical Trials. He worked at the EORTC (European Organization for Research and Treatment of Cancer) in Brussels and at the Dana-Farber Cancer Institute in Boston before founding IDDI in 1991. He currently serves on the editorial board of the journals Cancer Investigation, Clinical Trials, Biometrical Journal, Journal of Clinical Oncology, Statistical Methods in Medical Research, and Statistics in Biopharmaceutical Research. He has degrees in engineering and statistics from Brussels University, management from the Cranfield School of Management (UK), and a doctorate in biostatistics from Harvard University.
Dr. Marc Buyse has successfully launched many of his statistical ideas through the creation of
companies and hiring young and
Titles and Companies: Founder, CluePoints Inc. and Founder, International Drug Development Institute (IDDI)
Education: Eng, MSc, Statistics, Université libre de Bruxelles; MBA, Cranfield School of
Management; Sc.D., Harvard University
Associations: International Society for Clinical Biostatistics, Quetelet Society, Society for Clinical Trials, Drug Information Association, American Statistical Association, American Society for Clinical Oncology, American Association for Cancer Research
Advocate for Unmet Need
It all began with selling eggs from her family’s chickens to raise allowance money. Since then, Rachel King has had the entrepreneurial bug and was just looking for the right opportunity.
In 2003, she founded GlycoMimetics, a privately held clinical-stage biotechnology company that uses novel and proprietary glycobiology technology to develop treatments. The company’s mission is to continue to advance its pipeline, providing hope for patients with sickle cell disease and various cancers.
The impetus for starting GlycoMimetics occurred while Ms. King was working at New Enterprise Associates (NEA) as an entrepreneur in residence. Her goal was to identify a technology around which a company could be started, a company that would be interesting to her, and that would have enough potential return so NEA would support it.
She met John Magnani, now GlycoMimetics’ chief scientific officer, at a time when he was looking to take science to the next level, and their goals aligned.
“I’ve had the entrepreneurial bug ever since being in the egg business,” she says. “I wanted to do something that was entrepreneurial, that was creative, and had the potential to be transformative for patients if it was successful.”
She is committed to developing therapies for diseases with high unmet needs where her contributions can have the biggest impact on open patient treatment, including for those living with sickle cell disease, one of the most common genetic diseases in the United States.
Under Ms. King’s strong stewardship, GlycoMimetics entered into a worldwide license agreement with Pfizer in 2011 for its lead investigational drug candidate, GMI-1070, to treat vaso-occlusive crisis (VOC) of sickle cell disease. GMI-1070 has received orphan drug and fast track status from the FDA.
In April this year, GlycoMimetics completed a Phase II clinical trial of GMI-1070 and announced positive results from that study, a high point for Ms. King, particularly because the compound came from the company’s own lab.
For Ms. King, the focus on sickle cell was its potential to be transformative for patients if it was successful.
“This is a patient population that’s been underserved for decades, so the potential of bringing to market a drug that might have benefit is really satisfying,” she says.
Her next goal is to see the product through a successful Phase III trial and hopefully product launch.
“I’m also hoping that we’re going to be able to get some follow-on programs successfully into the clinic and through critical proof of concept and ultimately to commercialization,” she says. “My goal is to continue to develop the technology platform that we have at GlycoMimetics and to get some additional drugs to market, where they’re really going to have benefit to patients.”
It is her commitment to making a difference in the lives of those with rare diseases that makes Ms. King’s work so inspirational.
Though deeply rewarding, Ms. King says running a small company has many challenges because there is so much uncertainty and because of the need to be constantly raising funds.
Ms. King seeks to guide and inspire her team by keeping them focused on the task at hand, treating people with respect and courtesy, and ensuring they have fun together. She leads by giving broad goals and targets, a shared sense of the mission, and the freedom to be creative and solve problems, with guidance from her.
“We have to constantly challenge ourselves to be creative because circumstances change and opportunities are different,” she says.
Taking a straightforward philosophy to success, Ms. King maintains it’s important to work with people you can respect and learn from, that the priority should be to follow excellence with real clinical relevance, and finally, that loving what you do will increase your odds of success.
She loves what she does and looks forward to the work week. In particular, she loves digging into the biological mechanisms behind what the company is trying to do, what critical indications the science points to, and if studies show an effect on a particular mechanism, what benefit that could that hold.
“I’m very grateful that I like what I do, because a lot of people don’t and that’s unfortunate,” she says.
Ms. King is a true thought leader and advocate for the life-sciences industry, as well as a source of inspiration for women leaders in biotechnology.
Ms. King was recently named chairwoman of the Biotechnology Industry Organization (BIO) for the 2013-2014 term. She is the first woman to be elected to the post in the trade organization’s history. As the first woman in the role, Ms. King says she feels a responsibility because she understands, whether fairly or not, that how she performs can reflect on women more generally, and she is grateful for the opportunity.
She also chair of the Maryland Life Sciences Advisory Board.MW,
Her accomplishments have been widely lauded. In 2012, the Tech Council of Maryland (TCM) named GlycoMimetics the Life Sciences Company of the Year, and in 2013 the TCM named Ms. King winner of its 2013 Executive of the Year award.
Rachel King is committed to the biotech industry and what it means for humanity, and works to ensure her team remains creative and diligent in the search for treatments.
Title: Co-Founder and CEO
Company: GlycoMimetics Inc.
Education: BA, Dartmouth College; MBA, Harvard Business School
Family: Husband, John; daughter and son
Hobbies: Hiking, reading, knitting, cooking
Bucket List: Travel more, read more, write more
Awards/Honors: 2013 Executive of the Year award, the Tech Council of Maryland (TCM); Life Sciences Company of the Year 2012; Top Ten Women in Biotech, FierceBiotech, 2012
Associations: Chairwoman of the Board of BIO; Chair, Life Sciences Advisory Board in Maryland
Dominic Behan, Ph.D. Arena Pharmaceuticals
Christian Behrenbruch, Ph.D. ImaginAb
Jonathan Bush athenahealth
Marc Buyse IDDI
Tim Davis ExcoInTouch
Punit Dhillon OncoSec Medical Inc.
Amy Ellis MedAvante
Jud Gardner Comprehend Systems
Jamie Heywood Patientslikeme
Julie Kampf JBK Associates
Joseph Kim, Ph.D. Inovio Pharmaceuticals
Rachel King GlycoMimetics Inc.
Daniel Kraft, M.D. IntelliMedicine
R.J. Lewis eHealthcare Solutions
Kevin Lustig Assay Depot
Mauricha Marcussen Agano Solutions and Auditgraph
DJ Mitsch Pyramid Resource Group
Christine Pierre Society for Clinical Research Sites and TrialRx
Bob Previdi PSKW
David Rear, R.Ph. Advanced Clinical Concepts
Leerom Segal Klick Health
Martin Shkreli Retrophin Inc.
Jay Udani, M.D. Medicus Research/SysteMedicus
Darik Volpa Understand.com
Samuel Whitaker Greenphire
Robin Winter-Sperry, M.D. Scientific Advantage LLC