Entrepreneurs

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PharmaVOICE Staff

NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.

PV0715_ElizabethHolmesElizabeth Holmes
Title: Chairman, CEO, Founder
Company: Theranos
Education: Honorary doctorate degree, Pepperdine University
Awards/Honors:  Youngest person to be awarded the Horatio Alger Award; TIME 100 Most Influential People in the World in 2015; Best Health Startup, Crunchies Awards, 2015; Top 10 Medical Innovations, Cleveland Clinic Medical Innovation Summit, 2015; Edison Award – Gold, Lab Diagnostics Category, 2014; The Bay Area’s 10 Most InDemand Startups of 2014, LinkedIn, 2014.
Associations: Harvard Medical School Board of Fellows

A Woman with a Non-Negotiable Mission

What’s it like to be America’s youngest female self-made billionaire with a net worth of $4.6 billion? You’d have to ask Elizabeth Holmes, Theranos chairman, CEO, and founder, but that won’t be easy. She works from the time she gets up until she goes to sleep, every day. Ms. Holmes is singularly focused on enabling early detection and intervention of disease, and empowering individuals with information they need to live healthier lives.

The FDA has authorized Theranos to process complex, authoritative blood tests outside of a lab, signaling a sea-change that could greatly diversify the company’s business model.

“People don’t even know that they have a basic human right to be able to get access to information about themselves and their own bodies that can change their lives,” she says. “Every person needs to have the ability to get that type of test because if you understand early that you are at risk, you can do something about it.”

So Ms. Holmes dropped out of Stanford 12 years ago as a 19-year-old sophomore to develop a new approach to blood testing and start her company Theranos. This was not her first entrepreneurial venture, however. She also started a business as a teenager when her family lived in China, selling C++ compilers to Chinese universities. According to Business Insider, at the age of 9, Ms. Holmes wrote a letter to her father that read: “What I really want out of life is to discover something new, something that mankind didn’t know was possible to do.”

Three factors came together to make that “something” Theranos. She was inspired by her great great grandfather who was a surgeon; her uncle died of cancer when she was young; and her own fear of needles.

Theranos is a $9 billion biotech company that has a new approach to blood testing. The organization’s breakthrough advancements have made it possible to quickly process the full range of laboratory tests from a few drops of blood — instead of numerous tubes — from a small prick of the finger at unprecedented low costs.

The tests are directly accessible to people and their physicians through Theranos Wellness Centers opening nationwide, and these are already being set up in major drugstores chains such as Walgreens in California and Arizona.

In other accomplishments, Ms. Holmes has 84 patents to her name (18 in the United States and 66 non-U.S.), as of 2014. She led the passing of the first law in the nation’s history to give individuals the explicit right to direct access laboratory testing. The law was based on a draft she wrote, enfranchising 7 million Arizonans, facilitating engagement with and protection of physicians, and creating a model for other states across the country to shift toward preventive care, individual empowerment, and price transparency. She was also to serve as a U.S. Presidential Ambassador for Global Entrepreneurship.

Ms. Holmes surrounds herself with like-minded visionary thinkers and doers, as her board of directors includes Dr. Henry Kissinger, Samuel Nunn Jr., senior advisor, RRE Ventures, and George Shultz, Ph.D., director emeritus, Gilead Sciences.

According to a profile in The New Yorker, Holmes can quote Jane Austen by heart, but no longer devotes time to novels or friends, doesn’t date, doesn’t own a television, and hasn’t taken a vacation in 10 years. She is a vegan, and several times a day she drinks a pulverized concoction of cucumber, parsley, kale, spinach, romaine lettuce, and celery. She is photographed frequently wearing only black.

In a graduate address to Pepperdine University, this May — earning her own honorary doctorate at the same time — Ms. Holmes told the class of 2015 that they will have to work smarter and harder than everyone else.

“In the journey of life we are always tested,” she told the audience. “When it’s hardest is when it matters most to stay the course. Define what is non-negotiable to you, what you are willing to fight for, die for, live for. Many of us know too well how helpless we feel when someone we love is ill and we want to help them become well again. That is my non-negotiable.”


PV0715_DrDenaMarrinucciDr. Dena Marrinucci
Title: Chief Scientific Officer
Company: Epic Sciences Inc.
Education: Ph.D., Chemical and Biological Sciences, The Scripps Research Institute; B.S., Chemistry, University of Vermont
Family: Husband, Shane Copelin; German Shepherd, Kili(manjaro)
Hobbies: International travel, hiking, great food and wine, spending time with family and friends
Bucket List: Travel to Egypt to see the pyramids with her mom; learn to speak Italian; hike through Patagonia
Awards/Honors: 2015 MIT Technology Review: Top 35 Innovators Under 35
Associations: American Society for Clinical Oncology (ASCO); American Association of Cancer Research (AACR); Athena San Diego
Tweet: @DenaEpicSci

Breaking Through Barriers for Cancer

Dena Marrinucci was not a conventional Ph.D. student. She arrived at The Scripps Research Institute (TSRI) in La Jolla, Calif., with no interest in pursuing an academic career or doing basic research. Instead, she wanted to be part of a translational laboratory where she would have the opportunity to bridge science, medicine, and business to achieve breakthrough results that could enhance and save lives.

In her first week at Scripps, she met Dr. Peter Kuhn who shared his vision for building a translational team that would bring chemists, biologists, engineers, and physicians together to develop technologies that would improve and impact patients’ lives.

They discussed several projects, and Dr. Kuhn had one specific initiative in mind for her: build a rare cell detector for cancer. An hour later, she left that meeting inspired about the opportunity to lead this project.

“I couldn’t sleep that night thinking about the potential of a technology where we could improve how cancer is treated through a simple blood test,” she says.

Shortly after she began her dissertation work, her grandmother was diagnosed with stage 3 melanoma. Her primary tumor was removed, but about a year later she collapsed from widespread metastasis and died shortly thereafter.

“I remember thinking: why didn’t we see this earlier,” Dr. Marrinucci says. “If we had, could we have prolonged her life with the right treatments? The loss of this magnificent individual, who I loved dearly, fueled my passion for developing and commercializing a technology that could one day help people like my grandmother.”

Over the next four years, with the help of collaborators, Dr. Marrinucci developed the foundation for a technology that could identify rare circulating tumor cells (CTCs) through a simple blood draw to create a non-invasive test for profiling cancer in real time. But to bring this “liquid biopsy” technology to patients, it was necessary to start a business.

She launched Epic Sciences in 2008, before she turned 30, which was a virtual company for about two years while the team improved the platform. During this time, the company faced challenges in securing funding to improve the technology, and she started to question whether the business would make it.

As she considered different options, she recalled a comment from Epic’s CEO, who had told her that he had never seen a technology with as much potential to help patients in his more than 20 years in the San Diego biotech industry.

“As I thought about this, I couldn’t leave the business behind,” she says. “If there was any potential at all for helping patients who were battling a disease like the one that claimed my grandmother’s life, I knew I had to see it through.”

Over the next few years, Dr. Marrinucci and her colleagues reimagined the technology and improved the sensitivity and specificity of the platform.

They worked to develop a business model that would allow them to work with drug companies to provide them with a non-invasive, real-time biopsy to guide drug development and personalized medicine.

By the end of 2011, the team had secured funding and Dr. Marrinucci started the company’s laboratory operations and pharma partnering business, managing to secure partnerships with several large pharmaceutical companies.

Since then, Epic has raised $50 million, hired more than 120 employees, and developed more than 40 partnerships with the world’s top pharmaceutical company, biotechnology, and cancer research centers across more than 45 clinical trials to help develop better cancer therapies using its liquid biopsy test. Epic also has partnerships with several leading cancer research institutions to track CTCs and therapeutic response, which will eventually give doctors better tools to personalize therapies for patients.

“Our mission at Epic is deeply personal to me,” Dr. Marrinucci says. “The opportunity to work with an exceptional team who shares the same vision is an incredibly rewarding and humbling experience, and I am truly grateful for the opportunity to do so.”

As chief scientific officer, Dr. Marrinucci leads research and development and genomics initiatives. She also oversees all pharma partnerships, from assay development of new CTC tests to their incorporation into clinical trials.

On a philanthropic level, Dr. Marrinucci launched the Epic Gives Back internal community service program. Through this program, Epic partners with cancer-related non-profit entities such as the American Cancer Society and the Movember Foundation.

“It’s a program that reflects Epic’s mission and core values, builds team spirit, and provides our employees with the opportunity to make positive contributions to our community in Southern California and beyond,” Dr. Marrinucci says.


Laura Liotta
Title: Founder and President
Company: Sam Brown Inc. Healthcare Communications
Education: B.A., Communications, Specialty in Public Relations, Rowan University
Family: Husband, John; children, Nicholas, 14; Matthew, 12; Ava, 9
Hobbies: Spectator of her kids’ sporting events; chilling on any beach in Avalon, N.J.; hanging out with celebrities on red carpets
Bucket List: Contemplate life’s purpose over iced tea with Oprah on her porch in Hawaii; live in Tuscany for a month with no phone and unlimited wine, cheese, and gelato; a get away on the white sands and blue waters of Fiji
Associations: Public Relations Society of America; National Investor Relations Institute

The Personal Touch
PV0715_LauraLiotta

When Laura Liotta started her healthcare communications agency in 1999, few had ever heard of personalized medicine…or Sam Brown Inc.

Today, personalized medicine is the future of healthcare. And Ms. Liotta’s company, Sam Brown Inc. Healthcare Communications, is well-known throughout the pharmaceutical, biotechnology, and healthcare industries for its personalized services, successful communication and PR strategies, and enduring client relationships.

The story behind her agency’s name goes back to when Ms. Liotta’s grandfather, Samuel Mastrangelo Sr., started a Big Band orchestra in Atlantic City, N.J., in the Roaring ‘20s, which he named “The Sam Brown Orchestra.” Her grandfather thought the name was more memorable and kept it when he later became a public official and eventually the county sheriff.

When Ms. Liotta was a kid walking with him on the street, passersby would shout out, “Hey Sam Brown!” Her father, her biggest fan, also adopted the moniker and today her communications firm honors this family legacy.
Like its namesake, Sam Brown knows what it takes to get its clients noticed and be memorable.

An entrepreneur, Ms. Liotta accomplishes this through her innovative business model and by cultivating and nurturing long-term relationships with clients and her Sam Brown teammates.

She is committed to quality and to providing the highest quality service to clients, while allowing her team to have an excellent quality of life.

“I really like winning too, and fortunately we have been winning for 16 years,” Ms. Liotta says.

She understands that it’s impossible to be perfect or to control everything, especially when it comes to public relations, which often cannot be controlled.

“Public relations is an art, not a science, so I go with my gut as it has rarely failed me,” she says.

Sam Brown was one of the first healthcare communications agencies in the country based on a network model of senior healthcare professionals, who are entrepreneurs, not employees.

Ms. Liotta and her team have helped hundreds of clients, including GlaxoSmithKline, Astellas, and Incyte develop and tell their stories to the industry, financial community, and professional/patient communities.

For many years Sam Brown’s public relations work for TogetherRx Access helped hundreds of thousands of patients without prescription drug coverage gain access to immediate savings on their medications.

The agency has also helped raise awareness nationwide of Rare Disease Day and the incredible challenges facing the 30 million Americans living with rare diseases for the National Organization for Rare Disorders (NORD).

Ms. Liotta rates one of her greatest early career highlights as having the opportunity in the 1990s while at DuPont Merck to work with some of the best PR people in the pharmaceutical industry on the inter-company collaboration for AIDS drug development.

“The industry, government, and activist/advocacy community opened communications to better work together to help speed AIDS combination therapy development and expand patient access to these life-saving medicines,” she says. “I believe this was the foundation of what patient advocacy is today.”

The one great challenge that continues, she says, is empowering and communicating with patients about treatment options in a highly regulated environment.

“While regulations are needed of course, they also can block valuable information, patient engagement, and scientific exchange,” she says. “Where should that perfect line be drawn?”

She strives to raise herself to the highest standards so others will do the same. She fosters innovation by listening to the customer and encouraging her colleagues to find a way to do it better.

“Our team members know they need to stay on top of their area of communications expertise and continuously bring innovation and solutions to the agency and to our clients,” she says.

Ms. Liotta says she would change nothing about her career, noting that she gained strong industry PR experience early in her career, and then was able to use that experience to create the perfect balance of work and life by building her own unique agency.

“I am most proud of the Sam Brown team,” she says. “They are the best in the business and are like family to me. Together, we work hard and play hard and really enjoy what we do.”


Jennifer Peters
Title: Founder and CEO
Company: Greenphire Inc.
Education: B.S. and M.S., Pace University
Family: Husband, Sam; two sons, Oliver, 5, and Greyson, 20 months
Hobbies: Running, snowboarding, reading, dancing, music
Bucket List: Travel to six continents, foregoing Antarctica; complete the Rock Run ultra-marathon; climb Everest; see the Northern Lights; buy a 1951 Ford F-100 completely restored; learn to play the drums
Awards/Honors: Best Places to Work —Philadelphia — 2012, 2014; Smart CEO, CXO of the Year — 2015; Marcum Innovator Award — 2014
PV0715_JenniferPeters

Driving Efficiencies Through Smart Payment

Jennifer Peters founded Greenphire with a vision to automate global payment processes and help sponsors and CROs drive new efficiencies and strategic value.

She has been relentless in educating thought leaders on the multiple advantages of implementing Greenphire’s Web-based payment technologies and demonstrating the little understood benefits that can be achieved by simply automating payments in clinical trials.

Ms. Peters has been instrumental in leading Greenphire through an unprecedented period of growth, taking the business from a small tech start-up to a major industry player with incredible year-on-year growth and an expert staff of more than 80.

Over the past 18 months, she has helped the company grow sales by more than 100%. She works closely with Greenphire’s sales team and provides open and honest feedback, which has enabled her to enhance and improve Greenphire’s internal processes.

She has focused on bringing together a team of experts from the pharmaceutical, clinical trials, and financial worlds, to create powerful in-house knowledge and experience.

The greatest challenge, she says, has been to not lose the company’s identity while driving growth, developing a strong internal team, and making sure that the company hires individuals that fit culturally.

“Sometimes it is tempting to hire the intelligent, well-qualified candidate who may not be a cultural fit, but we have learned over the years, it’s worth the wait,” she says.

She has worked tirelessly to establish a culture at Greenphire that emphasizes innovation, trust, and enjoying what the company achieves every day.

Ms. Peters takes a holistic view of the business from all vantage points and is highly adept at detecting market changes and helping steer the direction the organization should take to serve our clients better and deliver products that are truly valuable to the market.

Her goal is to continue to make Greenphire a “Best Place to Work” and to add value to clients in a meaningful way by hiring the brightest, most committed, service-oriented professionals in the industry.

She has an encyclopedic knowledge of the inner workings of highly regulated industries and draws on her background to advise clients on the best way to overhaul time-consuming manual processes associated with financial payments in trials.

As a leader, she always works to do the right thing. Colleagues describe her as the glue that keeps the company’s many operational teams solidly stable and she is the driver for Greenphire’s industry-leading status among its customers.

She has helped carve a businesswide definition of success as shared accountability, vision, and most importantly, enthusiasm.

Ms. Peters asks that her team members join her in practicing active reflection and believes that constantly analyzing what is working, where opportunities lie for improvement, and how strategies can be executed is the best way of taking the company forward.

“If something is not working, we have a responsibility to the company and to ourselves to change it,” she says.

In the pursuit of new strategies and opportunities, she advocates that the whole team is patient with each other, encourages an open environment to experience trial and error and, when faced with complexity, go beyond comfort zones, individually and collectively, which she believes is a source of innovation and fulfillment.

“Everyone at Greenphire has the ability to share, create, and drive what we are doing,” she says. “We have a collaborative work environment and want the employees to work cross functionally with other team members.
Some of the best ideas come from looking at a challenge through a different lens.”

A mentor and role model to her team, Ms. Peters is dedicated to helping every member of the team be as successful as possible.

She has high expectations of the people that she works with and ultimately thinks that most people want to do a good job.

“People are capable of great things, and that in and of itself is motivating,” she says.


Bill Drummy
Title: Founder and CEO
Company: Heartbeat Ideas (Drumbeat Digital LLC)
Education: B.A., Magna Cum Laude, Henry Rutgers Scholar, Rutgers College, Glasgow University, Scotland
Family: Wife, Barrie; son, Will
Hobbies: Photography, reading, gadgets, travel
Bucket List:  Spend extended time on every continent; stare at the Hudson River without interruption for a couple of weeks; visit every major league baseball ballpark with his son; complete five multi-city bike tours
Awards/Honors: Member of the Google Healthcare Advisory Board; Digital Health Coalition Scholar; PharmaVOICE 100 honoree; company has won more than 180 major industry awards, including a CLIO
Associations: Google Healthcare Advisory Board; Pharmaceutical Executive Editorial Advisory Board; Digital Healthcare Coalition; DTC Perspectives Editorial Advisory Board; Blueprint Health; New York City Health Business Leaders
Tweet: @drumbeat
PV0715_BillDrummy

On the Pulse of Innovation

This is Bill Drummy’s second appearance on the PharmaVOICE 100 list. He was honored in 2008, and his influence on life-sciences marketing has not slowed. According to colleagues, no one embodies the spirit of innovation, motivation, and inspiration more than Mr. Drummy. For more than a quarter of a century, he has been calling for and inspiring innovation in pharmaceutical and healthcare advertising. He began by creating an interactive agency, then known as Drumbeat Digital, in 1998, and grew the business into a full-service AOR company, now known as Heartbeat Ideas (and Heartbeat West on the West Coast). In 2013, Heartbeat merged with Publicis Healthcare Communications Group.

He may have been in the game a long time, but he has not lost any passion for leading-edge technology or strategy. He passionately encourages his teams to seek out and employ the latest leading-edge solutions for a myriad of marketing challenges, including using 3D technology to simulate unique patient experiences; championing open-comment social media pages for pharma; and blinded, shared-data health tracking Web apps for patients to monitor symptoms of chronic disease against community data. He strives to create something better every day, examining how to modernize and improve approaches, and to educate doctors, nurses, patients, and caregivers, while providing the best possible care and value beyond the pill.

As Heartbeat’s founder, mentor, and hands-on leader, Mr. Drummy has built a true meritocracy that is open to new ideas, all the while proactively instilling the organization with three core driving principles:  to be insightful, inventive, and courageous. The supportive and nurturing culture has given Heartbeat one of the industry’s best talent retention rates, as well as annual 80%-plus employee satisfaction rates based on companywide surveys. The environment he has created has proven ideal for finding, developing, and most importantly keeping some of the industry’s best talent. The inspired work that results has garnered more than 180 major awards in the company’s 17-year history, keeping Heartbeat universally considered to be on the cutting edge of creativity for the healthcare space.

Outside of the office, he serves as a mentor for Blueprint Health, a community network and startup accelerator program focused on helping entrepreneurs innovate within the health technology space. Mr. Drummy also serves on the Google Healthcare advisory board, a diverse group of healthcare industry experts and thought leaders selected by Google to discuss the changing healthcare landscape, implications of health reform, the empowered consumer, the digital doctor, and short- and long-term opportunities for partnership.

Beyond his professional endeavors, Mr. Drummy makes a concerted effort to ensure that community service and a true spirit of philanthropy are cultivated within Heartbeat’s office walls. Annual events that promote giving time or raising money for a plethora of charitable organizations are the norm — staples like Career Day for underprivileged youth from the Fresh Air Fund, the New York Cares Coat Drive, adopting a family for the holidays through Sanctuary for Families, raising money for City Harvest to provide needy families with meals for Thanksgiving, and cooking a healthy meal for more than 200 members of LA’s Skid Row community with the Los Angeles Downtown Women’s Center.


PV0715_DrTheodoreSearchDr. Theodore Search
Title: CEO
Company: Skipta LLC
Education: Pharm.D., University of Pittsburgh
Family: Wife, Veronica; daughter, Eva Gabriela
Hobbies: Playing guitar and ukulele, playing sports
Bucket List: Take a trip around the world
Awards/Honors: Forty under 40 Award for Professional Excellence, National Multiple Sclerosis Leadership Award
Associations: American Pharmacist Association, Pennsylvania Pharmacists Association, Lancaster County Pharmacists Association, The University of Pittsburgh Alumni Association, Phi Delta Chi Professional Pharmacy Fraternity
Tweet: @DrTSearch

Making Good Connections to Advance Medicine

With the spirit of a true innovator, Theodore Search, Pharm.D., identified an unmet need in the practice of medicine and addressed that need with a breakthrough advanced social networking technology for improved patient care. From there his mission involved not only to enable effective communication and collaboration within his own profession as a pharmacist, but to allow other healthcare professionals the same opportunity through an extensive network of specialized online medical communities.

Dr. Search took Skipta from an idea to a successful company in a short amount of time. The idea started while he was at CVS when he was compounding medicines and later as an infusion pharmacist, when he realized he needed to reach out to other infusion pharmacists for their advice. And so he created a community exclusively built for the needs of pharmacists. This network would use all of the current technology that the world was becoming familiar with, and would include tools and resources built specifically for pharmacists. Most importantly, the community would be verified so that only pharmacists and pharmacy students could have access.

The company’s mission is to develop verified medical specialist communities to enhance real-time collaboration and communication among medical practitioners. In fact, Skipta is an Icelandic word that can be used as many different parts of speech. When used as a noun or a verb it can mean exchange or to exchange.

In collaboration with his business partner Nick Doherty, he began the initial creation of the first Skipta network, Pharmacist Society. Since the Pharmacist Society launched, the company has developed 17 additional specialty networks, including recently launched sites for gastroenterologists, nephrologists, and endocrinologists.

Dr. Search is driven to make the world a better place and is passionate about everything he does.

His goal is to be viewed as an industry innovator and a leader who forever changed the way healthcare providers and the industry connect and collaborate. He is motivated by the fact that what he does empowers professionals to be more successful.

As a leader, his greatest concern is knowing that the decisions he makes impact the lives of many others.

“With leadership comes accountability and responsibility to all those who view you as a leader,” he says.

Dr. Search leads an open and collaborative environment where employees across all levels are encouraged and expected to contribute and challenge each other to ensure continuous professional growth. His leadership style is centered on clear direction and expectations, and Dr. Search cultivates an environment of collaboration, integrity, and accountability through which the highest quality of work is achieved.

He never asks more of his employees than he would be willing to do himself, believing that it is best to inspire by example and through his own work ethic. Dr. Search takes pride in the work his team accomplishes, shows appreciation for the hard work they do, and is always available for support and to serve as sounding board.

He has enabled innovation in the company by leveraging Skipta’s technology as an internal company social network so that everyone within the organization has the direct opportunity to constantly contribute and share his or her thoughts and ideas.


PV0715_MelissaEasyMelissa Easy
Title: Founder of DrugDev and President, DrugDev SiteStart
Company: DrugDev
Education: B.Sc., Biotech (microbiology), University of Technology, Sydney
Family: Husband: Mark; Sons, Maxwell, 3, Samuel, 4 months old
Hobbies: Photography, traveling, eating, and drinking
Bucket List: Continue traveling
Awards/Honors: Partnerships in Clinical Trials Woman of the Year; chosen for the Philadelphia Business Journal 40 Under 40 award
Associations: Healthcare Businesswomen’s Association and Women in Bio

A Voice for the Investigator

With a mission to change the way the pharmaceutical industry conducts clinical trials by helping sponsors and CROs connect with and support investigators worldwide, Melissa (Liss) Easy founded DrugDev.

While working in the clinical research industry, Ms. Easy was challenged with serious inefficiencies in the process of matching investigators with pharmaceutical protocols.

In founding DrugDev in 2007, her goal was to enable sponsors, CROs, and investigators to do more trials together by focusing on the needs of the doctors, and providing them with greater visibility into clinical trial opportunities, better and more personal service, and open communication.

DrugDev began with a network of cardiologists who consented to share their information with sponsors and CROs seeking sites. The network grew rapidly through referrals and invitations and has now become one of the world’s largest investigator networks and data sharing platforms. Today, DrugDev’s data sharing platform hosts a network of more than 80,000 active investigators in 115 countries in addition to profile and experience information for more than 400,000 investigators from major pharmaceutical companies and CROs. As a result, the company enables sponsors to find the right sites around the world for their protocols, thereby increasing site performance and speed while reducing administrative burden for both parties.

A breakthrough moment for Ms. Easy was when DrugDev was selected by the Investigator Databank to be the third-party host of its investigator collaboration. It was, she says, the first of a number of wins that triggered the investment in DrugDev, which enabled the company to do bigger and better things.

“I went to the Investigator Databank pitch alone and convinced them to use us,” she says. “I was up against armies of people from other large companies bidding on the work. The Investigator Databank executives said it was my passion and the relationships we already had with investigators that got us the job.”

After receiving strong financial backing from Invesco, DrugDev continued to invest in efficiency solutions by acquiring CFS Clinical, a specialized site payments provider, and the award-winning TrialNetworks study optimization platform, as well as launching its own Innovation Lab as a clinical technology incubator. Earlier this year, the company’s SiteCloud platform, featuring the DrugDev Golden Number universal identifier, was selected to power the TransCelerate Investigator Registry.

Ms. Easy is committed to continuing to grow DrugDev and making sure the company focuses on making investigators’ lives easier.

Ms. Easy began her career at a small CRO in Sydney called Health Research Solutions, later the company was acquired by Quintiles. HRS was led by Hugo Stephenson, M.D., who is now DrugDev’s executive chairman.

Challenges have helped Ms. Easy to excel and develop the confidence to be a business leader. When she was in her early 20s, the large CRO she worked for sent her to Japan for two weeks and told her to figure out if there was a market for late phase trials.

“They gave me an English-Japanese translator and I had to go around and meet people, gather information, and make recommendations,” she says. “It was terrifying and exhilarating at the same time; I was a young woman, in a country where I didn’t speak the language or know the customs, with an enormous task. But I kept asking questions and got so much information that I was able to complete the analysis.”

Ms. Easy’s advice to young professionals is to enjoy what they do and get out there and explore the world. Seeing how other people live and think helps in one’s work and personal life and to gain a bigger-picture perspective for one’s career.

“Having global experience gives one a different understanding of the world and the industry,” she says.

She seeks to earn the respect of those she leads by working hard, being approachable, and expecting the same from everyone else.

“As a leader you need to be supportive and create an environment where people are willing to try something new,” she says. “Offer flexibility to change processes and procedures. Communicate your goals and let the team come up with the best way to get it done. Listen to your customers and staff — after all, they’re on the frontlines.”

Ms. Easy makes it a priority to foster a flexible culture that values family. She takes great pride in helping stay-at-home Moms or Dads transition back to the workforce by providing flexible work hours and meaningful projects for those who want to contribute in a significant way. She has also pioneered a global culture and positive attitude around remote working at DrugDev, having worked in her native Australia, London, and now at the corporate headquarters in King of Prussia, Pa.

A strong advocate for professional women, she strives to help female employees build their confidence.
DrugDev offers a female friendly environment with 56% of the total workforce are women, 52% of total leadership are women, and 35% of senior leadership — VP and above — are women.

A natural optimist, Ms. Easy says her glass is always half full — except when it’s French champagne, and then it’s half empty.


PV0715_MaxKanevskyMax Kanevsky
Title: Founder and CEO
Company: Pinnacle 21 LLC
Education: B.S., Biochemistry, University of the Sciences; M.S., Software Engineering, Drexel University
Family: Wife, Inna; cat, Gigi
Hobbies: Ice hockey, traveling, and Belgian beer
Associations: CDISC, PhUSE, DIA

Opening the Way for Data Validation

A visionary and innovator, Max Kanevsky created an open source, freely available toolkit that has boosted the implementation of CDISC standards, revolutionizing the way the life-sciences industry exchanges clinical data.
Mr. Kanevsky and his partners founded Pinnacle 21 in 2011 to provide software for managing CDISC compliance. This came after he created OpenCDISC Validator in 2008, an open-source tool for ensuring SDTM and ADaM compliance. OpenCDISC later spawned an enterprise-level collaborative environment for defining and enforcing business rules across the entire study lifecycle.

At the regulatory agency level, Mr. Kanevsky’s technology helped FDA re-design the review process to create an environment in which reviewers would have access to standard, high-quality automated analyses.

One of the challenges in achieving this goal was that while sponsors were submitting standard CDISC data, the information was not standardized in a way that would support predictable, reproducible, standardized analyses from submission to submission. Companies would read the implementation guides and convert the data into that standard, but there was no reliable way to check it.

The FDA CDER Computational Science Center (CSC) realized that to succeed, it would need to be able to first identify its analytic needs and then make those data requirements available to sponsors so that they could successfully submit high-quality standard data that would support a more efficient, consistent review process.
A priority was to make sure that any company, including smaller companies with limited resources, could have free access to not only FDA’s data requirements but an easy way to assess their data for compliance.

Through OpenCDISC Mr. Kanevsky, made it possible to bring data validation to everyone in a way that could support the FDA’s product review modernization goals. The tool was the first step; the next was to include in that tool data validation specifications that are relevant to the new FDA review process.

Mr. Kanevsky helped the FDA develop specific data validation profiles. By working closely with CSC during the process, he was able to identify data standard requirements that would enable and support an automated review environment/process, which is now referred to in FDA as JumpStart.

Furthermore, his work enabled the FDA to perform data-quality assessments at the time of NDA submission so that reviewers were able to understand how well the submitted data would support the review process. This is now implemented at FDA through a tool that Mr. Kanevsky developed that’s referred to in FDA as DataFit. The tool is being used on a large number of submissions with the goal of expanding its use to all submissions. Data specifications from DataFit, which provide specifics for how to submit standardized data, are made available to the industry.

This work has been a foundational requirement for all product review modernization, and would not have happened with the same speed and effectiveness without Mr. Kanevsky’s ingenuity and collaborative spirit.

From the point of view of the sponsor, OpenCDISC Validator lifted many of the challenges of using external solutions to prepare data and in-house software to validate it, in particular the need to consistently update and validate the software. Sponsors no longer are left to guess and hope that the data they’ve prepared will be adequate, thus reducing the risk of interruptions in the review process and the need for data requests.

He credits Drupal founder Dries Buytaert as the inspiration behind OpenCDISC. During a network event in Boston, Mr. Buytaert told him why he created Drupal, and shared his philosophy that an open source project that helps a community can flourish and become the basis for a high-growth business. At the time he was contemplating a similar project, but didn’t know where to start.

“This short encounter pushed me on to the idea and OpenCDISC was launched shortly thereafter,” Mr. Kanevsky says.

He believed in open source when no one else did. And he moved the project forward when resources were scarce. He says watching OpenCDISC grow from a pet project to a universally adopted standards compliance tool is his biggest accomplishment to date.

The launch of his company Pinnacle 21 has enabled Mr. Kanevsky and his colleagues to unleash their innovative capabilities thanks to commercial backing that gives the company the resources to create new technologies that the industry is hungry for.

“We are planning to improve efficiencies across all phases of clinical development, and we are well on our way with more than 300% growth in the first three years,” he says.

Beyond his knack for innovation, Mr. Kanevsky listens to, and empathizes with, the programmers. He and the team at Pinnacle 21 travel to different locations to provide tutorials and user group seminars. He motivates others by making them feel appreciated, and says he is lucky to have a bright group of individuals on his team.

Starting his own company required him to learn how to be an accountant, lawyer, salesman, manager, and mentor, all at once.

“I have no idea what entrepreneurs did before Google,” Mr. Kanevsky jokes.


John Nosta
Title: President
Company: NostaLab
Education: Boston University, Harvard University
Family: Wife; twin daughters, 6; son, 3
Bucket List: 
Drive digital health in areas around the world that have limited or no access to healthcare
Awards/Honors: Top 18 Influencers Shaping Digital Health
Associations: Google Health Advisory Board; nuviun
Tweet: @JohnNosta

PV0715_JohnNostaDigital Health Philosopher

John Nosta is the type of person who it is impossible to capture in a few hundred words. A futurist, a philosopher, a scientist, a digital health advocate who possesses boundless energy and passion for everything he does — he is a true innovative leader. On top of all that, he is the father of twins, went to school with Jon Bon Jovi, writes beautiful poetry, drives critical thought leadership in the digital health world, and has delivered two babies in his lifetime working as an EMT.

According to those who work with him, he is driven by creativity, thought leadership, and science. As a strategic advisor in the digital space, Mr. Nosta “helps move the entropic forces in digital health by weaving together his poetry, thoughtful rigor, and his scientific experience into meaningful vectors of change for medicine.”

Mr. Nosta works at the intersection of healthcare, innovative technology, and media and is deeply knowledgeable, passionate about, and insightful when it comes to the application of technology to health and healthcare. His voice helps bring attention to important issues surrounding the latest innovation in the space.
He sincerely believes technologies such as the mobile phone can become the conduit through which health and health literacy can flow. Bringing these fundamental changes to the developing world can have a transformative and profound impact on life as we know it.

He is consistently ranked among the top names in almost every digital list and has sustained that position for several years. He serves on the Google Health Advisory Board and authors the blog Health Critical for Forbes.
In the past 12 months ending September 2014, Mr. Nosta has had more than 35 million #digitalhealth impressions on Twitter and more than 2 million page views on the Forbes blog.

His think tank, NostaLab, focuses on the emergence of digital health and the implications to health, wellness, medicine, and the pharmaceutical industry. In his new role, he works with digital health and life-sciences startup companies to help them talk about and market their innovations in ways that drive market uptake.

Mr. Nosta is unique in that he combines clinical experience with marketing savvy. He is uber-passionate about digital health, so much so that he has become of one of the industry’s premier thought leaders, who now is at the leading edge of innovation in the life-sciences industry. As a scientist, he drives the technology back to the life sciences and pharmaceutical connection, showing it all as comprehensive and intertwined.

Mr. Nosta spent more than a decade in various leadership positions, including chief creative officer, chief strategic officer, and unit president at Ogilvy CommonHealth, the world’s largest healthcare communication company, before leaving to start his think tank and take on several advisory positions.

Colleagues say Mr. Nosta is known for his fresh ideas and insights that have long been overlooked. Leveraging his medical training, inquisitive nature, and creative mind, he has the capability to understand and authentically empathize with the mindset of the conservative gatekeeper physician, as well as the prospective patient struggling with an incurable chronic disorder, or fear of brain surgery. These insights have enabled the organizations he has led to understand these attitudes and develop effective strategies to change long-standing behavior and run successful campaigns.

His parents wanted him to become a doctor, so at 16, he enrolled in an advanced summer program at Harvard to test the waters. Mr. Nosta attended Boston University as an undergrad with an independent concentration in biophysics, then took a full year off to do cardiac research at Harvard Medical School and was mentored by several influential cardiologists.

But there was always the pull of words, poetry, creativity, and communication. He graduated from BU, but he never finished his medical degree, although he did publish several scientific papers with his mentors at Harvard.

“No one is more surprised than I am about my role in digital health,” Mr. Nosta says. “Everyone has some desire to help change the world, but my intention was simple. I wanted to use my strengths in communication and science to help leverage digital health into a practical reality.”


PV0715_DeborahWoodDeborah Wood
Title: Founder, Owner, CEO
Company: DWA Healthcare Communications Group, including Avant Healthcare and Forefront Collaborative
Education: Masters of Fine Art, University of Evansville; University of Nebraska – Lincoln
Family: Husband, Willie; daughter, Miranda; son-in-law, Sean; granddaughter, Eleanor Joyce; son, Christopher William
Hobbies: Gardening, spending time with grandchildren
Awards/Honors: Starkey Entrepreneurial Woman Award, 2014; PharmaVOICE 100, 2010; Certified by the Women’s Business Enterprise National Council; DWA Healthcare Communications Group, ranked third among the Top 25 Woman-Owned Businesses in Indiana; Avant Healthcare, top 100 healthcare marketing agencies, MM&M, 2012 and 2013; Avant Healthcare, 2010 Sustained Supplier of the Year award
Associations: Member, United Way Women’s Leadership Council; President of the Board of Directors for St. Vincent Carmel Hospital; Member of the Board of Directors for the Diversity Alliance for Science Inc. (DA4S); Secretary of the Board of Directors for The Children’s Museum of Indianapolis; Board member for The Alliance—A Forum of Indiana Business Leaders; Member Women’s Business Enterprise National Council and the Healthcare Businesswomen’s Association
Tweet: @DeborahWood_DWA

Adapt and Thrive

After 21 years, Deborah Wood’s DWA Healthcare Communications Group continues to grow and evolve. With a focus on sensitivity and integrity as well as creativity and flair, Ms. Wood exemplifies and instills five core company values that are known as the “H4S”: healthy, honorable, humble, hungry, and smart.

She encapsulates a combination of entrepreneurial spirit, business savvy, strategic vision, execution excellence, humility, comic relief, mentoring, and caring.

Ms. Wood has persevered through external obstacles, including the loss of two blockbuster accounts due to patent expiry, internal restructuring, and resource shortages as the healthcare marketing and education industries faced changing regulations, increasing restrictions, decreasing funding, and a rapidly evolving communications landscape.

In the face of these challenges, she boldly changed course, reorganizing the company to better address client needs and take advantage of employees’ unique skillsets. She did this in collaboration with both external experts and internal staff. All employees could weigh in, and when the final, yet still evolving, plan was unveiled, it was an energizing experience that unleashed a surge of creativity and innovation. New clients and new opportunities followed, along with renewed prosperity. Employees learned how to be nimble, create on a dime, anticipate change, and innovate solutions.

“I strive to continually hone my skills to be the best leader I can be, increase my business acumen, and continue to help shape the future of our company to help meet our changing customer needs in this ever-evolving world,” she says. “I also want to continue to foster the sort of environment where our people have rich and long careers with us.”

Motivation comes from DWA’s people and culture, collaborative efforts to overcome barriers and solve problems, bringing value to customers, while taking care of people and supporting them in their career ambitions.

Ms. Wood says while the agency does not practice medicine it is in a trusted partnership with clients and partners who help those who do.

“We can help HCPs make better and informed decisions with compelling and memorable education that can improve the value and quality of patient care and outcomes,” she says. “So, we keep the patient in view, in our work examples and in person. We are all motivated in our different ways by patients.”

Innovation is a priority and Ms. Wood looks to her people to think of the “next big thing” that can change the medical education landscape.

“We have hosted three innovation festivals to showcase big ideas from our employees and have vetted these ideas to identify viable opportunities for improvements,” she says.

She is hands-on without micro-managing, and gives clear guidance and support. Ms. Wood brings everyone into her vision so that staff members have a stake in making the company and themselves into the best that they can be.

To inspire, she says you have to believe what you’re saying, you have to care, and you have to be honest.

The well-being of her employees and her community is a top priority. Ms. Wood knows each of her employees by name and keeps an open door, encouraging employees to stop by with any issues, concerns, or just to chat.
This attitude toward her company, her clients, and her staff sets the tone for the entire company. She believes in providing rich career paths and opportunities to learn and grow across the company. Ms. Wood also recognizes and promotes the need for fun and whimsy in the workplace, as well as striving for a work-home life balance.

In addition, Ms. Wood is a true mentor, spending one-on-one time to groom individuals into leaders as their promise and abilities shine forth.

Ms. Wood is also as an agent of change within the industry, and this year was elected to the Diversity Alliance for Science (DA4S) board of directors. Through her work with the DA4S, Ms. Wood champions “the little guy,” fostering relationships between big pharma and small, diverse agencies with the goal of elevating competition, quality, and growth.

Her DWA Cares, which is dedicated to giving back to the community; Green; and LiveWell, which is focused on fitness and initiatives, reinforce her commitment to employees’ charitable interests, the health of the environment, and overall health and wellness.


PV0715_DrStanleyCrookeDr. Stanley Crooke
Title: Founder, CEO, and Chairman of the Board
Company: Isis Pharmaceuticals Inc.
Education: Ph.D., M.D., Baylor College of Medicine; B.S., Pharmacy, Butler University
Family: Wife, Rosanne; son, Evan; granddaughter Ashley
Hobbies: Hiking, chess, sports, reading American history
Bucket List: Visit Mars
Awards/Honors: Scrip Lifetime Achievement Award, London, 2014; SMA Breakthrough Award, part of the Cure SMA Gala of Hope, 2014; Distinguished Scientist Award presented by the San Diego section of the American Chemical Society (ACS), 2013; AAAS Fellow (for distinguished contributions), American Association for the Advancement of Science, 2008; Distinguished Individual in Biotech, Reader Selected, Nature Biotechnology, 2006; Finalist for The 2003 World Technology Awards for Biotechnology and Fellow of The World Technology Network, San Francisco, CA, 2003; Helix Award for Corporate Excellence, presented by the Long Island Life Sciences Initiative, 2002; The Ernst & Young Entrepreneur of the Year Award Recipient, 2002; BioFUSION Life Sciences Innovator Award presented by the T-Sector and Biocom, San Diego, 2002;  Technology Leader of the Year Award, T-Sector Magazine, 2001
Associations: BIO; American Association for the Advancement of Science

The Creator of Antisense Technology

There was a great need for a new drug discovery technology paradigm that could leverage modern insights into biology and turn them into meaningful therapeutic products. Dr. Stanley Crooke met that need by creating and validating antisense technology that focuses on oligonucleotides, a much deeper understanding of RNA as a drug target, and, from literally a blank canvas, developed major innovations required to make this technology a successful commercial and scientific enterprise. As founder, chairman, and CEO of Isis Pharmaceuticals, he has led the scientific development of the antisense technology and engineered the creation of one of the largest and more advanced development pipelines in the biotechnology industry. Currently, Isis has more than 38 drugs in development, including several drugs in Phase III and a larger number in Phase II clinical trials.

Isis has made broad progress in advancing the technology and has achieved commercialization of the first two antisense drugs to reach the market, Vitravene and Kynamro. Kynamro, approved in January 2013, is the first systemically administered antisense drug to be approved and the first to be approved for life-long treatment of a chronic disease, homozygous familial hypercholesterolemia.

Accomplishing this feat meant creating unique analytical methods, manufacturing, and all the other elements necessary to advance new drugs to meet the requirements of this novel technology. Numerous potential mechanisms of action of antisense drugs needed to be evaluated and a specific antisense drug had to be designed to exploit each mechanism invented. Additionally, methods to evaluate the effects in cells, animal and man, had to be invented.

This resulted in the creation and development, from preclinical models through clinical trials, of numerous exemplary antisense drugs. Clinical successes of these drugs in man validate the technology and demonstrate that it could be broadly applied to enhance human health.

Isis Pharmaceuticals is not the only company to benefit from its technology. Partnerships with other companies, including Alnylam, Regulus, Ibis, OncoGenex, ATL, and others have led to the creation of a large portfolio of strategic relationships.

Over his career, Dr. Crooke has directly and indirectly created hundreds of jobs at start-ups and other drug development and device companies nationwide; generated billions of dollars in wealth for investors and other stakeholders; and, more importantly, brought to life dozens of marketed and experimental therapeutics that will bring immeasurable benefit to patients suffering from some of humanity’s most intractable diseases.

“Sick people depend on me and my company,” he says. “Leading the creation of RNA-focused drug discovery has been a 25-year, $4 billion experiment, and my greatest challenge.”

Early in Dr. Crooke’s career, he led the creation of the first broad anticancer program in the industry at Bristol-Myers Squibb, bringing nine anticancer drugs to the market in the first five years of his career. He then assumed responsibility for worldwide R&D at SmithKline Beckman. While at SmithKline, he led the restructuring of the R&D organization and was involved in commercializing numerous new drugs in broad therapeutic areas. He also coordinated all research activities, including instruments and diagnostics.

He has published more than 450 scientific publications, edited more than 20 books, and has authored numerous patents. Dr. Crooke has also been a medical educator and was a professor of pharmacology at Baylor College of Medicine and at the University of Pennsylvania Medical School. He has served as an adjunct professor at UCSD School of Medicine and SDSU, and he is currently a member of the board of directors of BIO. Dr. Crooke was named by Nature Biotechnology as one of the most influential individuals in biotechnology and he has received numerous other awards.

And lastly, he wins the PharmaVOICE 100 honor for best answer to what he would do with an extra hour a day: “Goof around,” he says. (PV)

 

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