The Entrepreneurs

Contributed by:

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.

Natalie McDonald
Driving Advertising Efficiency

Title: Founder and President
Company: Create NYC
Education: BS, Chemistry/Business, University of Pittsburgh; MBA, Marketing, Drexel
Hobbies: Cooking
Bucket List: Travel globally with her family to see the world
Awards/Honors: Women Presidents’ Organization 50 Fastest women-owned/led company, 2017; Inc. 5000 List of Fastest Growing Private Companies in the U.S. (twice); MM&M Top 100 Agency; Crain’s New York Business Fast 50, 2016; Smart CEO Corporate Culture winner, 2016; Enterprising Woman of the Year, 2015
Associations: Women’s Business Enterprise National Council

In 2009 Natalie McDonald recognized first-hand a long-standing challenge in healthcare advertising. Her conviction came from more than a decade at Pfizer in sales and marketing followed by a leadership role at a traditional agency, where she headed up the largest account. Through her experience across healthcare companies, portfolios, and brands, she saw a new reality emerge in which blockbuster brands and huge budgets were no longer the norm. In fact, marketers were now challenged to do more with less. Seeing a large unmet need in advertising, she imagined an outside-the-box solution that could bring new meaning to the word efficiency in the execution of advertising for healthcare brands.

“There was a need for a different agency model grounded in efficiency,” she says. “I set out to not evolve the traditional agency mold, but rather create a new agency option that delivered quality advertising that is consistently on time and in budget. My goal was to develop several unique and innovative aspects of the model in order to strategically drive efficiency and value for today’s marketer.”

Ms. McDonald’s passion resulted in a company that offers three core services: flat-fee advertising, flat-fee adaptation, and short-term marketing. These services focus the company exclusively in the area of execution of healthcare advertising.

A partnership with Create NYC means clients pay for advertising deliverables, not time and materials, through its advertising services. The end result is top-notch creative with senior-level account support in developing core tactics for marketing plans across customers all based on a flat-fee rate card.

In recognizing a key reality of work in the healthcare industry, Ms. McDonald created a model wherein projects such as those impacted by label changes are funneled through Create NYC’s flat-fee adaptation service. By using its own customized agency process for specific client-provided changes, the group delivers quality tactics revised with speed to market based on a flat-fee rate card.

Eight years after launch, Ms. McDonald is leading her growing agency with her sights set on a clear path with the same core focus: breaking the mold and delivering the best.

Led by Ms. McDonald’s vision, the Create NYC leadership team is always looking for ways to inspire and challenge team members, uncover efficiencies, and smartly grow the agency. In 2016, she added a mentorship program to the list of employee benefits that connects a mentee and mentor to work one-to-one for a six-month period. The pair focuses on a set of goals to help set the stage for career development at Create NYC.

Colleagues say Ms. McDonald sees the development of her people as core to the agency’s success. She is personally invested in the success of her people, not just in the work. She has high expectations for results, but provides her people with the resources and the autonomy to reach their goals.

In short, Ms. McDonald is a visionary who built an agency model for the healthcare industry that fills a true gap by offering an innovative approach to efficiency and quality. This, coupled with team members who are energized to provide quality advertising more efficiently, has been the driving force behind the success of Create NYC. In the last five years, the company has seen significant growth of greater than 1,400% with first-quarter 2017 performance indicating another record-growth year for the young company. (PV)

Steve Gens
When Results Matter

Title: Managing Partner and Founder
Company: Gens and Associates Inc.
Education: BS, Business Computer Science, Lock Haven University; MSOD (Master of Science Organization Development), with distinction for field work, American University
Family: Wife, Alice Gens, MBA; two children
Hobbies: Mountain biking, Alpine hiking, relaxing at any beach, fishing, world travel
Bucket List: Travel, including most of the U.S. National Parks, Japan, China, and Africa
Awards/Honors: Imaging Technology Innovation Award; several Johnson & Johnson achievement awards and top professional services professional for EMC
Associations: Drug Information Association, Organization Development Network
Social Media:

Steve Gens has developed a reputation as the go-to authoritative source of knowledge on technology topics supporting critical business processes, including regulatory affairs/operations and its connection to clinical, safety, commercial, and the health authorities.

Mr. Gens started his business, Gens & Associates, with a folding table, chair, phone, and laptop, set up in a spare room in his home during 2005. Today, his company is networked with more than 20 other small businesses globally.

He is deeply respected for his ability to identify, articulate, and provide actionable, executive insights into those trends and changes in technology that have the power to transform the industry and the business processes that underpin R&D activities.
Mr. Gens has the instinctive ability to be able to spot, understand, distill, and then communicate about innovative technology developments and their application within key R&D functions. He can collate substantial volumes of data, create objective, empirical analyses and deliver succinct, perceptive, and consumable reports that make sense of the data, enabling transformative business decisions to be taken.

The consequence of Mr. Gens’ work is that organizations can optimize their use of technology to maximize their investment to deliver better results faster, and with higher quality, such as a new regulatory submission that gets a product to market more efficiently, with a higher chance of successful approval.

Gens & Associates large biennial survey is conducted free for the industry and is a vehicle to support the collective improvement of those that participate. The surveys are used extensively to determine individual company performance when compared with peers, understanding of key trends, and a “collective” view of the status and health of the provider landscape. Most participants use the benchmark data to support their internal strategy, business cases, and organizational goals, such as measuring improvement.

Arguably, it is through Mr. Gens’ work, research, and shaping of the industry that RIM has developed into a key global capability. In 2016, the 30th Gens and Associates life-sciences survey was published: Pursuing World Class Regulatory Information Management (RIM); Strategy, Measures and Priorities. In that survey, and through his firms’ efforts, Mr. Gens has brought the biopharmaceutical industry the standard by which to measure world-class RIM.

The company also works with software and solution providers to enhance their products and services to not only meet current sponsor’s needs, but to align their investments to meet where industry will be in two to three years.

“Our goal is to facilitate this collaboration to enhance the performance of both industry and the providers, push innovation, and share common practices that ultimately result in better information for patients and health authorities,” Mr. Gens says.
Mr. Gens draws on his industry experience in much of what he does, including some of the toughest assignments. Early in his career at J&J, he was a co-implementation lead for a R&D project that fundamentally changed how clinical data were harvested from the clinical sites. This required completely new technology, which he and his colleagues co-developed with an integrator and later won an industry innovation award. The project resulted in major process changes and a major organizational redesign.

“Executive leadership wanted us to find a way to reduce by 80% the time to capture and process clinical data as the clinical trial volume was increasing exponentially,” he says. “This eventually led to reducing time —  an average of five months — from last patient visit to regulatory submission for new marketing applications. I learned a tremendous amount through this experience. As with any major transformation, some aspects went well and others didn’t: learn, adjust, and move on.”

Passionate about the work he does and making a difference, Mr. Gens commits to providing his best thinking with every client engagement, providing key insights that will make the greatest contribution and impact. The client experience is paramount and Mr. Gens measures success based on a simple question: did his work with clients make a measurable positive difference?
He would like to be remembered for his company having a positive impact in greatly improving how regulatory and other critical functions work in the global environment.

“For example, in the regulatory space, there is more sharing of operational practices, performance measures, provider insight that makes these groups better at global submissions, registration life cycle management, information transparency and sharing, and cost-effective compliance,” he says.

As a business leader, he inspires others by working from a mindset of what is possible as opposed to what is wrong or a hard challenge. This mindset helps people and groups transition and achieve what they aspire to. Innovation, he says, stems from vision, curiosity, experimentation, and the pursuit of excellence. (PV)

Mike Marett
Bringing Cutting-Edge Solutions to Marketing

Title: Founder
Company: Confideo LLC
Education: BA, Economics and Communications, Boston College
Family: Wife, Carla; daughter, Nina; baby Marett due early September
Hobbies: Skiing, surfing, soccer, auto racing
Bucket List: 
Drive in the Mille Miglia
Awards/Honors: PharmaVOICE 100, 2016 and 2017; AdAge Small Agency of The Year, 2010; DM News Thirty Under 30, 2011; PM360 Pharma’s Outstanding Innovators, 2012; PM360 Exceptional Innovators, 2013; PM360 Trailblazer Gold Award, 2014; PM360 Outstanding Innovators in Pharma Marketing, 2014; PM360 Digital Healthcare Startups You Really Should Know About, 2015; SXSWi Impact Pediatric Health Pitch Contest Winner, 2016; PM360 ELITE Entrepreneur Award Winner, 2016 and 2017; PM360 Trailblazer Gold Award, Best Sales Aid, 2016; PM360 PharmaChoice Gold Award, Best Sales Aid, 2016; PM360 Exceptional Innovators, 2016; Telly Award, Non Broadcast Film, Pharmaceuticals, 2016 and 2017
Associations: Sports Car Club of America — Barber Formula Race Series Driver
Social Media:
Tweet at: @mikemarett

Always seeming to have his finger on the pulse of what’s next, Mike Marett has guided the evolution of numerous companies and products within healthcare and beyond. Most recently he’s led Confideo Labs to become a highly regarded award-winning digital media firm, after creating the pharma industry’s first VR engagement platform, DoctorVirtualis, in 2014.

Having been a pioneer in virtual reality, Confideo Labs has shaken up pharma marketing by producing and deploying a wide range of immersive multimedia tactics for many of the largest pharmaceutical companies in the United States, Australia, Brazil, and across Europe. With Mr. Marett at the helm, the company is helping brands achieve unprecedented engagement with target audiences, and the organization is growing and diversifying rapidly.

Having been an industry trailblazer for years, his accomplishments are a testament to the possibilities of what’s to come in this space. Colleagues report that whatever problem Mr. Marett is working to solve, the result is always the same: he quickly identifies innovative, disruptive, efficient, and effective solutions that bring new value to healthcare marketers and industry stakeholders.

In an industry not necessarily eager enough to embrace innovation, Mr. Marett has been able to continuously bring a collection of cutting-edge marketing tools, technologies, and platforms to fruition.

“Implementing new media strategies and tactics across the marketing side of pharma is challenging,” he says. “As an example, at Confideo Labs when the team launched our VR platform we spent a lot of time advocating the category and demonstrating the value of immersive multimedia before clients became receptive. As the story goes, this felt like pushing a boulder uphill, but with conviction and willpower we stayed the course and secured and deployed the first of many projects for pharma. With our client’s support and confidence, our initial project evolved across channels to become the industry’s first VR detail and was met with a lot of fanfare and success. It followed quickly by dozens of innovative projects that are in turn transforming delivery of medical media and scientific content across channels and audiences. By breaking down barriers and forging ahead we were able to establish best practices and help lead the charge.”

Through Confideo Ventures, the management-consulting arm of his company, Mr. Marett also counsels and guides the commercialization of several health tech startups. One of the recent and more memorable highlights for Mr. Marett was presenting for his client, Cohero Health on stage at TechCrunch Disrupt San Francisco 2015 with another PharmaVOICE 100 honoree, Melissa Manice.

“It was exhilarating for both of us,” he says.   “Cohero Health is developing innovative tools and technologies to improve respiratory care, reduce avoidable costs, and optimize medication use. Cohero offers connected devices and mobile applications that actively engage and empower respiratory patients by measuring lung function and tracking adherence.”

In his career Mr. Marett has built products and led teams in the United States and around the world, winning awards, and working with global healthcare brands to advance technology and communication platforms within healthcare. Colleagues who have worked with him say they are grateful for the opportunity to work alongside a disciplined visionary. They say his passion for innovation is contagious and inspiring. And it is a mutual benefit for Mr. Marett, who finds inspiration in those he works with.

“The highlights of my career are the people who I work with; each serves as my inspiration to keep pushing boundaries,” he says.  “Everyday, I am fortunate to collaborate with passionate and innovative leaders, and for this I am very grateful.” (PV)

Lorna Weir
Elevating the Bar

Title: Founding Partner
Company: Elevate Healthcare
Education: AB, History, with honors, Kenyon College; JD, University of Maine School of Law
Family: Parents; husband, Mark Sheehan; daughter, Grace, 12
Hobbies: Hiking, tennis, knitting
Bucket List: Sabbatical in Egypt and Europe studying history and art
Awards/Honors: MM&M Hall of Femme
Social Media:
Tweet: @LornaMWeir

Twenty years ago, Lorna Weir traded in her Lady Justice hat for a creative marketing one, and she has not looked back.

“Transitioning from the practice of law to marketing and advertising, I felt as if I had been given the most incredible gift through a job and a career that allowed me to apply the analytical and advocacy skills of law with the strategy, creativity, and fun of marketing and communications,” she says. “And just when I thought it couldn’t get better, I transitioned into healthcare and have never looked back.”

Ms. Weir’s career includes running multiple agencies and successfully marketing brands across a myriad of therapeutic areas. Her leadership has proven inspiring and highly transformative for her clients, her peers, and her employees. A true leader, Ms. Weir has helped guide clients, as well as staff, to strategic higher ground. Colleagues say her ability to build bridges between agency and client, between strategic planning and creative thinking, marketing and sales, regulatory and medical, commercial objectives and down-to-the-last-detail tactical excellence, is legendary.

She steps up to take key leadership roles for clients in critical situations, or in support of a cause, when it’s needed most. The array of leadership roles she has assumed for clients is staggering: building marketing plans, leading strategy and brand development, helping to drive sales planning and training, and other key roles for start-up clients at critical junctures.

Ms. Weir also fosters the career development of others, especially women and those from diverse backgrounds. Her commitment to inspiring a new generation of women agency leaders is evident in the numbers.

Through her decades of leadership, she has been personally responsible for hiring, training, mentoring, and promoting dozens of women who have now risen to positions of leadership at multiple agencies and marketing companies. And now, she is putting her beliefs in to practice in her own successful agency where the majority of senior managers and associates are women.

To have the power to nurture Elevate to these heights, Ms. Weir had to break down the barriers of entry into leadership herself. First on Wall Street, then as an attorney, and again in pharmaceutical marketing and advertising, and even now in the C-suite and boardrooms of pharma companies.

Colleagues say she has been an inspiration, and has taught them to overcome challenges by facing them head-on and pressing on. Because of her experiences, she reaches out to help other women leaders to successfully navigate their career journeys. She encourages women and others in her organization to take advantage of the hard-fought achievements and incredible strides made by the women leaders in the industry by seeking them out and developing a mentoring relationship.

“I’ve been fortunate to experience many career highlights, having positive impact on brands that help patients with particular disease states, working with tremendously smart people and helping build amazing organizations, and of course, building and launching this different kind of marketing firm called Elevate Healthcare,” she says. “At the center of it all are the lasting relationships with clients and colleagues.”

While championing other’s achievements, Ms. Weir can celebrate a few of her own.

Some of her more inspiring accomplishments the past year include assembling a team of agency veterans and diverse talent to launch Elevate Healthcare, which was named one of the most innovative start-up agencies for 2016 and one of the top 100 agencies in healthcare in just its first year.

Ms. Weir played a key role in the successful startup of a long-time client’s new specialty pharmaceutical company. Her expertise in bridging commercial strategy and brand strategy helped a midsized pharma organization reset and  refocus its commercial and marketing strategies in the face of marketplace challenges. (PV)

Dr. Laura Lande-Diner
Taking the World by Storm

Title: Associate
Company: Flagship Pioneering
Education: BSc, Med, Medical Sciences; PhD, Genetics and Molecular Biology, Hebrew University Medical School
Family: Husband, Ami; sons, Ben and Adam
Hobbies: Hiking, fitness, inventing new recipes for snacks with targeted macronutrient profiles
Bucket List: Hike the Annapurna; fly an airplane
Social Media:

Creative, energetic, and innovative Laura Lande-Diner, Ph.D., is a truly inspirational leader in the entrepreneurial community. As an associate with Flagship Pioneering, which conceives, creates, resources and grows first-in-category life-sciences companies, Dr. Lande-Diner is creating some of the most innovative and potentially impactful start-up companies to emerge in the biotech industry in the last decade.

Since she joined the Flagship family less than three years ago, Dr. Lande-Diner has been the force behind several new technologies and scientific approaches and has authored more than 12 patents.

In 2016, Dr. Lande-Diner was part of the Flagship team that defined and founded the first rational plant design company, which is working to break the information limitations of agriculture and produce crops that can meet the urgent needs of society. In addition, she has conceived and built two companies, Evelo Biosciences, which is pioneering the immuno-microbiome, and more recently, a company pioneering native gene therapy.

At Evelo, Dr. Lande-Diner helped to evolve the field of microbiome-mediated immunomodulation, inventing and developing a first-in-kind method to identify bacterial strains that induce immune tolerance, particularly in food allergies and autoimmune diseases.

Dr. Lande-Diner rapidly assembled the key opinion leaders in the space, helping the company to establish itself in its first target area, food allergy. The company has raised more than $100 million in two years, anchored by Flagship’s largest-ever investment into a single company.

“The concept of harnessing the power of an internal process, such as microbiome-mediated immunomodulation, to cure disease is part of a bigger idea that is the focus of some of my current efforts, and that is to leverage the body’s own resources to cure itself,” she says. “As modern medicine advances, we become more ambitious with our therapeutic goals: we strive to extend lifespan, significantly improve quality of life and cure the big diseases that are still unresolved. Ambitious goals require ambitious approaches. The utilization of our own body’s arsenal as a rich source of such therapies could be such an approach.”

Another next-generation organization is Dr. Lande-Diner’s most recent company, which has recruited world leaders in gene control and outstanding leadership to develop unique therapeutics that can allow people to potentially treat their own diseases.
In addition, she is leading the development of two earlier stage efforts. The first one provides a novel and elegant solution for targeted metabolic control. The second exploits the biology behind a potentially pathological subcellular phenomenon and transforms it into a targeted therapeutic approach.

Dr. Lande-Diner can take any novel idea and define a nascent company’s vision, identify the key scientific issues, and outline clear and actionable paths to prove therapeutic hypotheses. She is constantly seeking to identify unmet needs, interrogating scientific knowledge, and finding new ways to apply that knowledge.

Dr. Lande-Diner impresses colleagues with her audacious creativity, her prolific innovative drive, her infectious passion, and her commitment to collaborative and constructive scientific debate.

Fearless in her thinking, Dr. Lande-Diner loves to learn and won’t allow herself to be restricted by any type of constraint as she considers an idea. She is comfortable spending time in a space where hypotheses are not quite reasonable, and using that place as a starting point to define an actionable path. In fact, Dr. Lande-Diner says it’s important to recognize that the path to success isn’t linear.

“Things can go wrong or mistakes can happen, but everything is recoverable,” she says.

She is constantly challenging the status quo and exploring the possibilities that lie on the other side of the current paradigms.
Described by those she works with as a “force of nature,” she is fully invested in everything she does and the people she cares about.

She would like to be remembered for creating paradigm-breaking companies that make a real difference in how the industry treats disease and provides sustainable solutions to non-renewable resource utilization.

Determined in her quest to uncover ideas, Dr. Lande-Diner would advise her younger self to do what she loves and excels at, and never to settle or to think her goal doesn’t exist.

“It is out there; don’t stop looking until you find it,” she says.

In addition to being a prolific inventor and entrepreneur, Dr. Lande-Diner is a highly collaborative and thoughtful colleague and member of the scientific community. She inspires with her passion, conviction, and vision, and helping others to realize they can impact the therapeutic world and create value in transformative, ambitious companies.

“By truly believing in the value of what I do, I get people to join me in my efforts, and in doing so, I help them realize their potential and their dreams,” she says. (PV)

Nithiya Ananthakrishnan
Heeding the Entrepreneurial Call

Title: Founder and CEO
Company: Algorics
Education: BE, Electronics and Communication, Bharathiar University; PGDBA, Human Resource Management, Symbiosis Institute of Management Studies; MSc, Psychology, University of Madras
Family: Mother, Shantha; wife, Sathya; daughter, Arundhati
Hobbies: Cooking, drawing, listening to music
Bucket List:  Write a best-selling book
Awards/Honors: IE50 Top 50 Indian Emerging Companies, 2016/2017; Top Ten Most Promising IT Venture Awards – Rice Alliance for Technology and Entrepreneurship, 2014; CII Best Healthcare Startup Award, 2014
Associations: Indian Association of Statistics in Clinical Trials, Phuse
Social Media:
Tweet at: @Nithiya_ananth; @Algorics

Nithiya Ananthakrishnan founded Algorics with a single goal: to change the way companies look at analytics not just as a dashboard but as a tool for data-driven decision-making and enabling actions in a time bound manner. The company is a provider of clinical analytics solutions and software, and its flagship solution Acuity allows organizations to assess and capture the risk profile for a clinical trial and map risks to intelligent actions as part of the risk-based monitoring paradigm.

Mr. Ananthakrishnan believes in positive change, has a respect for innovation, and invests in people and technologies.
Throughout his life-sciences career, he has recruited and mentored individuals who have a shared vision of positive action.
His passion for change threads strongly through both his commercial and personal life, as CEO of the fast-growing start-up company and as chair of the nonprofit organization, Smile Welfare Foundation.

Entrepreneurship has always been in Mr. Ananthakrishnan’s DNA. He began his career in the life-sciences sector at Cognizant Technology Solutions. Throughout his career, he has been tasked with building teams from scratch, navigating the hurdles of start-ups, and managing the scale-up phase in the corporate sector. While at ICON, he set up a division of more than 120 technologists working for their technologies group and another 80-plus programmers for the statistical programming group — an assignment that he says is a career highlight.

A dual interest in technology and statistics was the basis for Mr. Ananthakrishnan’s starting Algorics. He knew assembling the right team was crucial to the success of the venture. Within three years of start up, he has scaled the organization to a 20-plus strong team.

Colleagues say Mr. Ananthakrishnan is one of the few entrepreneurs who possess the holy trinity skill set of: customer focus, technical know-how, and market needs insight.

Throughout his career, he has worked hands-on across all phases of the software development life cycle and knows what it takes to be a programmer, validator, and production support analyst. He bridges the customer requirements to the R&D staff with ease, in the language they understand. And he was able to spot a gap in the market for a clinical analytics platform, developed by technology and clinical experts, rather than as a service offering requiring much larger financial investment.

Mr. Ananthakrishnan is driven, both commercially and personally, to be working toward a future in which the data visualization that his team’s technology generates will support greater derivation of actionable insights from the mass of data available now and in a future of wearables, consumables, and AI.

Those who know him say he has a passion to build an organization that contributes toward the greater goal of building a better world through its work.

It is his zeal to be at the top that keeps him going and fuels his desire to continue to build and define the future of Algorics.

“I believe my passion for people is infectious,” he says. “I always aim to see things from other’s perspective, which helps a great deal in communicating and achieving what needs to be done together. I don’t believe in focusing on 100 reasons for why something cannot be done but just need one purpose to accomplish what needs to be achieved.”

He believes simplicity is the ultimate form of sophistication and this philosophy has driven the way Algorics innovate. He would like to be remembered as a serial entrepreneur who found ways to disrupt the status quo in the slow to change and highly regulated pharma industry. He maintains, spending too much time in thinking rather than acting will stop the company being innovative and producing results.

Mr. Ananthakrishnan believes the industry could better collaborate in the area of data standardization.

“Data standardization has been a lowest priority in the pharma industry while other industries like banking and aviation truly runs only on standards,” he says. (PV)

Daniel de Boer
Relentless Commitment to Treatments

Title: Founder and CEO
Company: ProQR Therapeutics NV
Family: His children, who are an endless source of inspiration
Hobbies: Music
Bucket List: Curing CF
Social Media:
Tweet at:  @danieldeboerNL

Finding treatments for rare diseases is a personal imperative for Daniel de Boer. After his son was diagnosed with cystic fibrosis, Mr. de Boer left the IT industry, where he had been a serial entrepreneur, to start a philanthropic fund, and then a fully formed drug development company, to accelerate the search for possible new treatments for the condition.

Given his personal story, he didn’t want to be on the sidelines. He was driven to make a difference for his family and for the lives of many patients with rare diseases. He and his team have built the Netherlands-based ProQR from an idea and a passion to cure CF into something much bigger that can make an impact on many diseases.

“Getting to this point took a number of things: keeping a patient-centric mindset, attracting the right people, and having the ability to raise capital,” he says, adding that it took two years from inception to IPO.

In that time, Mr. de Boer built ProQR into a company with more than 140 employees across the United States and Europe. Under his direction and leadership, the company has taken an RNA-based compound from preclinical to clinical stage in less than five years, and the pipeline has been expanded to to RNA compounds for a wide range of severe and rare genetic diseases, including Leber’s congenital amaurosis, dystrophic epidermolysis bullosa, Usher syndrome, Fuchs endothelial corneal dystrophy, and Alzheimer’s disease.

Mr. de Boer draws on his entrepreneurial background to drive ProQR to success. He founded and led a number of tech companies through phases of growth, initiating development and launch of several IT related products in several European countries. Mr. de Boer served as a founder and CEO of RNA Systems; was founder and CEO of PC Basic; and also founded and served as CEO of Running IT.

Mr. de Boer says compared with the IT sector, the timelines in biotech were a shock.

“These seemed very long,” he says. “For many of severe diseases patients are waiting, I like to have a sense of urgency.”

He says the challenge he faces every day is that, given his impatience and drive, he wants things to happen fast, but drug development is a methodical and patient process.

“Fortunately, I have a great group of people around me so they balance the need for both,” he says.

He is committed to the goal of developing orphan drugs for patients in need better and faster. It is the patient who matters, and to help colleagues overcome challenges Mr. de Boer helps to link what they are doing to the impact they can have on patients’ lives.

Innovation, he understands, requires learning from mistakes and taking calculated risks, and for people to be willing to take those risks.

As a young CEO — Mr. de Boer is just 34 — he appreciates the benefits and risks that come from giving greater responsibility in terms of decision-making and implementing solutions to younger employees.

He brings three human qualities sorely needed in the drug development universe, in addition to the science to produce a drug that works. First, enormous drive; second, a lack of fear to try new things, to leave no stone unturned; and third, impatience. (PV)

Dr. Laura Niklason
Quest for Patient Well-Being

Title: Founder
Company: Humacyte
Education: BS, Physics, BA, Biophysics, University of Illinois (Urbana-Champaign); MD, University of Michigan;
PhD, Biophysics, University of Chicago
Awards/Honors: LAS Achievement Award, College of Liberal Arts & Science, 2016; elected to the National Academy of Medicine, 2015; work cited as one of the top 50 most important inventions of the year by Time Magazine, 2010; inducted into the National Academy of Inventors, 2014; one of only 19 “Innovators for the Next Century” by U.S. News and World Report, 2001
Associations: National Academy of Medicine (NAM)

In 2004, Laura Niklason, M.D., Ph.D., founded Humacyte, a regenerative medicine company, with a steadfast commitment to improving treatment outcomes for patients with a variety of disease conditions. This desire and the credibility of her clinical work stems from a life-long commitment to the scientific disciplines of bioengineering and transplantation.

Dr. Niklason exemplifies excellence in scientific innovation and possesses a true visionary’s desire to improve patients’ quality of life. She is committed to bringing new technologies to market, developing new options for clinicians and patients, and helping to change lives.

Dr. Niklason’s career-long quest and development of an investigational, off-the-shelf bioengineered blood vessel started during her training at Massachusetts General Hospital. She saw a problem in the operating room when vascular and heart surgeons were searching for good, quality replacement veins in legs, arms, and even the abdomen. Dr. Niklason set out to develop an alternative solution for patients. She had a vision to develop lab-grown replacement vessels constructed of human tissue — human acellular vessels (HAV).

In her third year at Massachusetts General Hospital, she discovered a cell-seeding concept and spent several years developing a process to create lab-grown blood vessels as an alternative for patients. The product she envisioned, Humacyl, has advanced to global Phase III clinical trials to provide a new option for vascular access for thousands of patients who suffer from end-stage renal disease (ESRD), in need of hemodialysis, and who are not good candidates for fistula.

This vision to pave the way for patients suffering with ESRD was not a task that was accomplished overnight; indeed, there are still many necessary steps yet to come. It took years of determination, and the culmination of hard, problem-solving work, patience, and diligence.

In 2017, the FDA granted Humacyl the Regenerative Medicine Advanced Therapy (RMAT) designation, expediting evaluation for vascular access in performing life-sustaining hemodialysis.

“My team and I continue to stay fully committed to Humacyl, with the hopes that one day the technology will help patients lead more normal lives,” Dr. Niklason says.

She finds fulfillment in voicing her passion and findings in novel cellular and tissue therapies, and hopes to inspire others who are interested in innovations in the pharma and healthcare industries.

In addition, Dr. Niklason speaks at national and international forums about novel cellular and tissue therapies. She has participated in and been a keynote speaker of multiple presentations at major biotechnology industry events, including the American Heart Association Scientific Sessions, the 9th Annual Stem Cell Meeting on the Mesa presented by the Alliance for Regenerative Medicine, and the 4th TERMIS World Congress.

Dr. Niklason is also a highly respected researcher, and she is the co-author of more than 120 peer-reviewed publications.
“I take deep pride in educating the next generation of scientists by teaching biomedical engineering and anesthesiology students at Yale University,” Dr. Niklason says.

Colleagues say Dr. Niklason’s culmination of life-long contributions to scientific advancements have allowed her to be recognized and elected into renowned academies, including: the prestigious National Academy of Medicine (NAM), an independent organization of eminent professionals from diverse fields including health and medicine.

Dr. Niklason was named one of only 19 “Innovators for the Next Century” by U.S. News and World Report; and her work on lung regeneration was cited as one of the top 50 most important inventions of 2010 by Time magazine.

Her work is recognized as having a considerable impact in the world of science and medicine, far beyond current applications. (PV)

Rishi Shah
Creating Better Outcomes

Title: CEO and Founder
Company: Outcome Health
Awards/Honors: Crain’s Business 40-Under-40 Class of 2009
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While studying at Northwestern, Rishi Shah decided to take a dramatic career step. He had witnessed several relatives battle with chronic conditions and struggle to make healthy lifestyle changes. That’s when he decided to leave college and pursue his goal of delivering actionable healthcare information when and where it can improve health outcomes — most notably in the physicians’ waiting room.

In 2006, he co-founded ContextMedia:Health with Shradha Agarwal, building one of the largest health information services companies in the industry. In January 2017, the company rebranded as Outcome Health with a renewed mission to activate the best health outcome possible for every person in the world. The rebranding followed the acquisition in November 2016 of AccentHealth, further expanding the company’s footprint to more than 55,000 outpatient facilities.

Underscoring his commitment to identifying unmet needs, Mr. Shah has helped launch five products that serve the needs of healthcare stakeholders by powering collaboration between patients and their healthcare providers.

In 2006, the company launched its Waiting Room TV, a suite of educational TV networks delivering hyper-targeted health information in the critical moments when patients are waiting for the doctor. Mr. Shah commercialized a technology that has become the standard in digital education at the point of care, and led a team that would soon become the fastest-growing in the industry.

While the company now has more than 700 full-time employees, when he and Ms. Agarwal started Outcome Health he was the sole salesman, driving from one doctor’s office to another with Waiting Room TVs in the trunk of his car.

“The most important thing I’ve learned building Outcome Health is the value of resilience and never giving up for the wrong reasons,” he says. “Innovating in healthcare, along with many complex, regulated, and critical industries, comes with its fair share of friction and challenges, so it’s critical to persevere through to drive transformation.”

In 2013, under Mr. Shah’s leadership and commitment to innovation, the company launched its second product, the Exam Room Tablet, which delivers interactive media to patients in the exam room. The Exam Room Tablet took a touch tablet and created a new market opportunity by giving the medical and pharmaceutical industries the ability to deliver messaging to patients in the critical moments before they spoke to their doctor.

Over the past two years, under the Outcome Health brand, the company launched three new products: The Digital Anatomy Board, Patient Wifi, and the Infusion Room Tablet. Each product addresses a unique need: The Digital Anatomy Board drives a physician-led dialogue, Patient Wifi allows geo-targeted messaging on a patient’s mobile device, and the Infusion Room Tablet delivers messaging to the patient in the infusion room.

In 2015, Mr. Shah moved to custom manufacturing products so that designers could have end-to-end control, and best address the needs of physicians, patients, and pharmaceutical marketers.

The tremendous impact and growth of Outcome Health is only part of Mr. Shah’s story as an entrepreneur.

A born entrepreneur, at the age of 12, Mr. Shah founded his first company — a home computer consulting company that he sold by the age of 16.

Ever since, he has continued his outstanding ability to create new opportunities to improve the lives of others.

“All great things, including companies, products, and teams start with a dream,” he says. “It’s important to keep dreaming and imagining what can be done better.”

Colleagues describe him as a role model and mentor, who is selflessly committed to improving the lives of those around him. While his life continues to get increasingly busy, he always makes time to help his employees grow, mentor other entrepreneurs, and give back to the community. (PV)

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