Daniel Ghinn
Digital Engagement
Driven to innovate by Vision

As cofounder of Creation Healthcare, a digital training, research, and planning consultancy, Daniel Ghinn is focused on helping some of the world’s largest healthcare and pharmaceutical organizations integrate digital channels into their corporate and brand campaigns. He started Creation Healthcare with his wife Joanna, and together, the couple have steered the company through change and innovation.

One of his big achievements is the invention and launch of Creation Pinpoint, which allows conversations among healthcare professionals in public social media to be studied. Insights from Creation Pinpoint, a proprietary technology, allow pharmaceutical companies to plan messaging, learn about unmet customer needs, and identify digital opinion leaders.

As a direct result of Creation Pinpoint, which was launched last year, the company is now working with 40% of the world’s largest pharmaceutical companies, and Mr. Ghinn believes the greatest use of the technology will be in informing new practice modalities and ideas in health, benefiting healthcare professionals, governments, and global health systems.

During the early 2000s, a few years into the company’s growth, Mr. Ghinn and his wife and business partner navigated through a very tough period of business that caused him to question everything about what they were doing and why. Later, and with greater clarity, he was able to lead the business through significant changes that have been integral to Creation Healthcare’s success. He implemented a refined business focus, which led to providing consulting only to the healthcare industry.

“I introduced a flexible workplace model whereby our team is able to work from home or virtually from any location, instead of commuting to the office," he says.

This saved hours of travel time and brought about big improvements in productivity. It also allowed the company to grow a worldwide team of associate consultants.

“Today, our core team meets every day via video from wherever they are working; and when we get together in person, the time spent together is highly focused, often including some time having deliberate fun too," he says.

He is now working with the team at Creation Healthcare to implement new technology innovations and develop the commercial success of Creation Pinpoint.

Mr. Ghinn has a special interest in the role of emerging channels in improving all areas of health from medical marketing to supporting clinical trials to improving health literacy to the elimination of disease. In 2009, he established the Healthcare Engagement Strategy Awards, which recognize outstanding outcomes in healthcare engagement. The stories told about successful initiatives discovered through the awards continue to leave a legacy upon which others are innovating. Mr. Ghinn is also editor of Healthcare Engagement Strategy, an e-journal that provides insights into changing healthcare communications and marketing, and recently launched HCPDOLS.com, a free digital resource dedicated to sharing insights from healthcare professionals in public social media.

He also established Hit Communications Ltd. in 2005 when he saw a gap in the market for a truly integrated communications agency. The company later acquired Red Plane Design and was relaunched as The Wonderful Creative Agency. And in 2006, he established Interactive Strategy Ltd., which provided workshops and training focused on the definition and implementation of interactive media strategies.

His passion for the power of data can be traced back to a job he took in his gap year after high school; he deferred an offer to study mechanical engineering at Brunel University in London. Mr. Ghinn took a job in seismic exploration, with a company called Simon Petroleum Technology, where he used computers to process signal data coming from explorations beneath the surface of the earth. He even spent six weeks in the Persian Gulf on a ship producing real-time 3-D views of the earth’s crust.

He learned so much on the job, and was so excited by what could be accomplished with data, that he never looked back. At the end of the year he turned down the chance to attend university, and stayed on for two more years, which allowed him opportunities to learn even more in how to analyze data, a move he describes as one of the best career decisions he made.

Mr. Ghinn went from that company to Medicare Audits in the mid-1990s, where he developed computer programs to analyze prescription data from hospital pharmacies for pharmaceutical companies. This introduction to the world of big pharma allowed him to keep developing his skills in data analysis, technology programming, and visualization.

Fast-forward to today, and Mr. Ghinn had the opportunity to attend the 67th World Health Assembly at the United Nations in Geneva, as part of an engagement strategy assignment he is leading for the World Health Organization. He considers this a personal and professional highlight.

As a leader, Mr. Ghinn seeks to inspire by being the proof of his ideas.

“I prefer practice over theory and would rather share a true story to illustrate a point than simply sharing an idea about what’s possible," he says. “This makes it easier for me and others to imagine what could be. I n this way I hope to inspire others to develop their own vision."

What motivates Mr. Ghinn is knowing that he can make a difference, even in small way, starting from where he finds himself on any day. And he tries to show those around him that their skills, talents, and character can make a difference too.

“I like to ensure that team members are aware of how their own work connects with that of their colleagues and how each individual in the team is playing a part in Creation Healthcare’s success," he says.

Committed to helping people to move out of systemic poverty, Mr. Ghinn and Creation Healthcare support a number of charities that provide food, shelter, and education.

“Tackling poverty is not just about feeding the hungry, it’s about changing systems that keep people in poverty — from giving people hope that they can develop a career to tackling modern day slavery," he says.

Getting to Know…
Daniel Ghinn
Title: CEO and Cofounder
Company: Creation Healthcare
Family: Wife, Joanna, cofounder of Creation Healthcare; three children
Hobbies: Photography; sailing; playing trumpet; restoring a 15th-century medieval house
Bucket List: Hang gliding
Tweet at: @EngagementStrat
Social Media: LinkedIn, Twitter, Facebook, Google+, YouTube, Pinterest, foursquare

 

Dr. Jules Mitchel
Pushing for Paperless Clinical Trials
Driven to innovate by Passion

If you gave Jules Mitchel, Ph.D., an extra hour a day, the native New Yorker would use it to do one of his favorite things: take a walk in Central Park with his wife and business partner, Joyce Hays.

As president of Target Health Inc., a New York-based full-service CRO, Dr. Mitchel has been instrumental in the move toward a paperless clinical trial environment. He started the drive toward paperless trials more than 20 years ago, when technology entailed floppy discs and clunky laptops.

At the time, he worked for Ayerst Laboratories, where he was unable to get the buy-in from the top for remote monitoring. But when he and Ms. Hays established Target Health in 1993, she tasked him with creating an electronic solution to collecting clinical trial data.

The biggest challenge back then was to find sponsors that were comfortable with abandoning paper CRFs, he says, but that challenge is less difficult to overcome in today’s environment.

“We started Target e*CRF (EDC) in 1999 and since that time we have transitioned to a fully paperless operation," Dr. Mitchel says. “Now the challenge is to find sponsors willing to move from paper-source records to eSource and eTrial Master Files (eTMF). Thankfully, it is becoming an easier journey with a lot less resistance."

Colleagues who have been collaborating with Dr. Mitchel over the past 20 years or so say he is tireless in his work to create and champion a paperless clinical trial platform database.

As one of the leading innovators in the industry, Dr. Mitchel has gone out on a limb many times to implement new creative ideas and incorporate cutting-edge technologies; he has been, and continues to be, a pioneer in improving clinical trials efficiencies.

Dr. Mitchel’s first proprietary EDC system was remarkable at the time in its simplicity, ease of use, flexibility for making mid-study changes, and user acceptance. This first step in his vision eliminated paper case report forms and paper monitoring reports, and was just the beginning of an ever-evolving plan to turn the entire clinical trial enterprise paperless as a way to increase the speed and efficiency of collecting, reviewing, and acting on clinical data.

Step by step, he developed his paperless solutions to include more functions and attract more stakeholders. Eventually, the system was designed to accommodate a Part 11 compliant document system requirements for a paperless trial master file for both the investigator and the sponsor communities.

The most recent development has been expanding the concept of the paperless clinical trial by providing an eSource solution as a substitute for clinical site paper source records, and an innovative ongoing program to integrate the clinical trial database with the electronic medical record.

The company expects to submit a PMA this year and an NDA next year using its paperless solutions.

Dr. Mitchel is using his broad base of experience in drugs, biologics, devices, and diagnostics, including multiple NDA approvals, numerous IND/IDE submissions, FDA meetings, study reports, manuscripts, and strategic planning, to move the needle and achieve his ultimate goals.

Dr. Mitchel is also relying on his pharmaceutical experience, which stems from various roles at American Home Products, Pfizer Laboratories, and Pfizer Consumer Health Care as well as academic positions at New York Medical College, Cornell University School of Medicine, NYU School of Medicine, Stony Brook University School of Medicine, and the Ernest Mario School of Pharmacy (Rutgers) to keep sponsors’ clinical trial needs in mind.

According to colleagues, the pharmaceutical industry needs and will benefit from more forward-thinking pioneers such as Dr. Mitchel. Passionate about his work, he also enjoys outside interests, including working with the homeless, as they need help desperately. And if Dr. Mitchel were a super hero, he would make sure no one ever went to bed hungry, and that everyone had the opportunity to have an education.

His hopes for the future in healthcare include fully paperless clinical trials, including integration with electronic medical records. For this motivated, inspiring man, accomplishing this should be just another walk in the park.

Getting to Know…
Jules T. Mitchel, Ph.D.
Title: President
Company: Target Health Inc.
Education: B.S., Queens College; M.S., University of Oregon; Ph.D., New York University; MBA, Pace ­University
Family: Wife, Joyce; four children, Alex, Daniel, Rachel, and Vanessa
Hobbies: Walking in Central Park; going to the theater and opera
Bucket List: Learn to sing
Awards/Honors: Certificate of Appreciation In Recognition of Outstanding Service and Contributions on Behalf of CTTI (Clinical Trials ­Transformation Initiative); Sponsor of the Year, Center for Dermal Research Leaders Society, Dermatology Foundation
Associations: ASCPT, ASCO, AUA, CTTI, ACRP, DIA
Tweet at: @JulesMitchel
Social Media: Twitter

 

Chris Trizna
The Power of the Site
Driven to innovate by Fear

A true leader, a trailblazer, and an innovator, Chris Trizna founded his own patient recruitment company, Clinical Site Services, based on his belief in the power of site performance.

Last year, Mr. Trizna led the charge to re-launch Clinical Site Services as CSSi to reflect the evolution of the company, which has grown to a global patient recruitment provider motivated to provide innovative enrollment solutions to sponsors and CROs for clinical trials. While still focused on the site performance model, this re-launch also introduced the local enrollment specialist, an individual who works directly with the investigator and study coordinator to help with the identification of patients who may qualify for a study.

At CSSi, Mr. Trizna has built a company that provides strategic and innovative services that range from patient recruitment campaign strategies to full-service enrollment planning, including study start-up and media planning. He has seen his dream come to fruition — his company is truly a full-service, global patient enrollment solutions provider and is an advocate of patients receiving the highest quality of medical care while enrolled in a clinical trial.

Always seeking to move forward and do better, Mr. Trizna has just started CSSi’s life-sciences arm, which focuses on expediting the clinical trial process early in preclinical/phase on by ensuring an expeditious pathway to commercial success.

Mr. Trizna lives by a few mottos, such as “you may not always be the best, but always do your best," and “do what you love, and you’ll never work another day."

He is committed, saying whatever he decides to do, he wants to make sure he accomplishes it and does the best he can. And he is compassionate, caring deeply about family and friends, and noting that rarely does anything come between them.

He cares about building a company that excels in providing stellar customer service, delivering results for clients, as well as fostering a work environment that encourages teamwork, innovative thinking, and an enjoyable atmosphere for each employee.

Mr. Trizna likes to challenge and leads by example by doing the best he can.

“If people see the effort I give, hopefully they will do the same," he says. “I also set lofty goals and challenge people to do the same. If we don’t stretch ourselves, we will never get better."

His career highlight came from an email from the HR department five years after he started the business, which pointed out that the company supports 30 different families representing more than 100 people, 56 being children.

“We have annual family functions and it thrills me every time to see the kids and families that the company supports," Mr. Trizna says.

Community service and philanthropy are important to Mr. Trizna, who founded Clinical Site Services in the Community two years ago to strive to make a difference in the quality of life in communities where the company operates and has a presence. Employees have been involved with everything from Easter basket creations for those less fortunate, to Turkey Trots that benefit a local food shelter, to a diaper drive, to welcoming soldiers home from war, and countless other endeavors. Employees are passionate about finding new ways to help as many organizations as possible because of Mr. Trizna’s attitude of serving others.

Clinical research and finding a cure unfortunately became even more personal for Mr. Trizna when his sister-in-law, Maggi, was diagnosed with breast cancer in 2008. She went through several rounds of treatment and went into remission. Shortly after her diagnosis, Mr. Trizna teamed up with Darby Steadman, a local mom battling metastatic breast cancer (and also involved in a breast cancer vaccine clinical research study) who started a foundation for women who needed financial help during their time in the study. His sister-in-law’s cancer returned two years later and she sadly passed away in September 2013.

CSSi sponsored and became a significant supporter of “Driving Miss Darby," with the goal to further the overall message of the importance of clinical research, as well as reducing the burdens that trial patients face during their treatment commitment by defraying the costs associated with travel, lodging, and medical expenses.

Mr. Trizna draws inspiration from his brother, who has started multiple companies while still being a great dad to his five children.

“He showed unbelievable strength while dealing with his terminally ill wife and also starting Maggi’s House, a charity for homeless mothers," Mr. Trizna says.

Getting to Know…
Chris Trizna
Title: President
Company: CSSi
Education: B.A., Business, Virginia ­Commonwealth University
Family: Wife, Laura; son, Spencer, 15; daughter, Bridget, 13
Hobbies: Soccer, running, fishing, and mini projects around the house
Bucket List: Run a marathon, set up a nonprofit, get his kids off to college
Associations: DIA, ACRP, CISCRP, SCRS — Global Impact Board member
Tweet at: @enrollmentnow
Social Media: LinkedIn, Twitter, Facebook, YouTube

 

Jean Hendrickson
Tackling Clinical Resource Obstacles
Driven to innovate by Failure

An innovator in the clinical research arena, Jean Hendrickson has been at the forefront of strategic resourcing of development programs for years.

Ms. Hendrickson is an outstanding leader with an entrepreneurial spirit, who can build companies and divisions from nothing to become multimillion-dollar revenue generators.

It all began with Ms. Hendrickson’s first job in the industry, where she was involved in marketing, proposals, and business development for the CRO ClinTrials Research. She hasn’t looked back.

While a member of the business development team at a large multinational CRO, Ms. Hendrickson became increasingly aware of the deficit between product pipeline demands and access to the right talent and expertise required to bring new products to market.

In 1995 she cofounded The Woolf Group as a means of increasing the industry’s talent pool and providing a just-in-time, cost-effective approach to product development and outsourcing strategies. Building and selling The Woolf Group and creating its reputation for integrity and quality is a career highlight for Ms. Hendrickson.

Realizing that the use of technology would be a catalyst to drive the industry forward, she joined forces with Novella Clinical Inc. (then PharmaLinkFHI), a full-service CRO, to create eReady Monitors, now Novella Clinical Resourcing (NCR), a staffing arm specializing in the rapid deployment of e-clinically trained professionals in support of global product development. This was a highly challenging endeavor because many changes were required in how things were done. It also required changing the mindsets of decision makers.

“It’s kind of like remodeling a home you never know what you are going to run into, and it’s more challenging to work within the existing framework than to build new," she says.

After the success of NCR, she created a global network of physician experts to meet the growing needs of therapeutic-specific strategies and to provide tactical medical advice and medical oversight in support of both Novella’s and sponsors’ global product development programs.

Her entrepreneurial leanings resurfaced, and in July 2013 she cofounded Catalyst Clinical Resourcing, a boutique firm dedicated to bringing therapeutically aligned and innovative resourcing and outsourcing concepts to large and small CROs and sponsor companies throughout the world.

Her enthusiasm and optimistic outlook inspire those around her. For Ms. Hendrickson, the glass is always half full. She has an ability to motivate a team and to provide support in approaching solutions strategically.

She leads by example and by providing those around her with the big picture — background, their importance to the company, goal setting, and how each person is a major contributor to those goals.

“I have found that when people gain an understanding on how they fit into the big picture and how their actions can make an impact, it’s a huge motivator — personally and for the team," she says. “Finally, it’s important to let people know they are doing a good job when they are. This goes a long way to boost morale and motivate people."

Ms. Hendrickson says she is so focused on the growth and health of Catalyst that she has been reading the same book — The Goldfinch — for a month and still hasn’t got past page 65. But that’s not to say she doesn’t believe in taking time out. She holds to three sage pieces of advice: work hard but take time to smell the roses — her father’s advice; don’t take life too seriously, it’s only a temporary situation; and failure is a detour, not a dead-end street per Zig Zigler.

On a charitable front, anything to do with animal protection resonates with Ms. Hendrickson, who says innocent creatures need advocates too.

As for other interests, Ms. Hendrickson is a self-confessed real-estate addict and says she needs to book herself into treatment.

“I’d love to be a land developer and build something from nothing," she says.

She’s already achieved that in the CRO world, so why not in real estate?

Getting to Know…
Jean Hendrickson
Title: Cofounder and Principal
Company: Catalyst Clinical Resourcing LLC
Education: B.A., University of Minnesota
Family: Husband, Dennis, and two Shih Tzus, Sadie and Lily
Hobbies: Travel, dogs, beach, wine, puzzles
Bucket List: Seeing the Taj Mahal, Great Wall, Patagonia, Terra Cotta Warriors, Katmandu, Iceland, Angkor Wat
Associations: Association for Clinical Research Professionals, DIA, Society for Clinical Research ­Associates
Social Media: LinkedIn, Facebook

 

Dr. Jonathan de Pass
The Doctor/Industry Analyst/Entrepreneur is in the House
Driven to innovate by Patients

Former medical practitioner and respected pharmaceutical industry analyst Dr. Jonathan de Pass had a vision — one that has kept expanding over the years. He realized that senior decision makers and their advisers in the life-sciences industries needed a better way of tracking the performance of their peer companies, markets, and products.

And so in 1996 he established Evaluate Ltd. and its flagship service, EvaluatePharma, which has established itself as an industry leader providing expert insights, strategic analysis, and consensus forecasts of commercial performance for the pharmaceutical and biotech sectors.

In 2007, Dr. de Pass established EP Vantage, an independent editorial team, to provide forward-looking commentary and analysis based on EvaluatePharma’s analytics and forecasts. In 2011, EvaluateClinical Trials was launched to provide deeper insight into global R&D and clinical trial activities, and in 2012, EvaluateMedTech set a new standard in integrated analysis and consensus forecasts, currently to 2020, of the medical device and diagnostic industries.

Dr. de Pass’s vision has been, and continues to be, to make Evaluate the market intelligence service of choice in the life- sciences industry, providing expertly curated insights that drive sector performance and help advance healthcare globally. This is achieved through Evaluate’s client focus and engagement, and continual investment to support its clients’ business objectives. Evaluate executes on its vision to provide trusted intelligence its clients can act on to help speed innovation, generate value, and drive sustainability in healthcare, ultimately benefitting patients around the world.

Under his leadership and through the assembly of a talented group of individuals, Evaluate is known for its dynamic, creative, self-motivated, and client-centric environment.

Customers include the majority of the top 100 international pharmaceutical companies and biotech companies, their advisors within investment banking and management consulting, as well as other service providers.

His expertise in the healthcare industry and financial markets gives him a unique understanding of evolving market needs and he consistently seeks new ways to add value for clients and help them serve their patients better.

To that end, Evaluate was the lead investor in a recent financing for AdverseEvents Inc., a healthcare informatics company focused on drug safety and side effects, with activities that are highly complimentary to Evaluate.

He is always learning, growing and stretching himself, which has a positive impact on his staff and results in continuous business growth through innovative concepts.

But he also believes in work-life balance.

“Creating a great workplace makes good business sense," he says. “I seek to create conditions so that people can both love their work and have a life. They shouldn’t have to choose one or the other."

A career highlight for Dr. de Pass was winning the Queens Award for Enterprise in 2009, one of the UK’s most prestigious business awards. The award validated the hard work of his Evaluate colleagues and the decision he took to start the business.

Getting Evaluate off the ground and to sustainability so he could start to draw a salary took several years and pushed Dr. de Pass to his absolute limit.

“When our first child was born, there was no money coming into our household," he says. “It was a wake-up call. Fortunately, from that point on things got better."

Even though he has been on the business side of healthcare for quite some time, he has never let go of his clinical roots and his dedication to helping people and advancing science has never waned. For example, Dr. de Pass continues to support medical research directed toward Parkinson’s disease through a small program out of Bristol University.

For the past 20 years, Dr. de Pass has mentored young entrepreneurs through the Princes Trust, a well-regarded UK-based charity that has helped more than 700,000 disadvantaged young people move into work, education, or training.

Evaluate has supported Centrepoint, a UK charity that works with homeless young people, and in November 2013, Dr. de Pass encouraged his co-workers to join him in a chartable sleep out in London to raise money for the charity.

As for the future, Dr. de Pass says he’s on to career No. 3 now, and he hopes there is at least another one to come.

Getting to Know…
Jonathan de Pass, M.B., Ch.B
Title: Founder and Chief Executive
Company: Evaluate Ltd.
Education: M.B. Ch.B. (Bachelor of Medicine, Bachelor of Surgery), University of Bristol Medical School; MSc, London Business School
Family: Married; two children
Hobbies: Sailing; cycling
Bucket List: Visit Antarctica; live long enough to meet his grandchildren
Awards/Honors: Queens Award for Enterprise 2009
Associations: Sloan Fellow of London Business School
Tweet at: @EvaluatePharma, @EvaluateMedTech,
@EPClinicalTrials
Social Media: LinkedIn, Twitter

 

Leerom Segal
Decoding Success
Driven to innovate by Patients

Having founded his first company at 12, before eventually cofounding Klick Inc. at 17, Leerom Segal has been on an extraordinary journey. He has built Klick into the world’s largest independent digital health agency, competing head-to-head with global network agency giants.

According to Mr. Segal, Klick is unique not just because of what the company does, but how it does it. The “how" revolves around the company’s data-driven, talent-centric business approach. That is, the ability to orchestrate complex work streams and use technology to engineer an empowering and engaging ecosystem that enables employees to execute and evolve faster.

Through Mr. Segal’s leadership, Klick has made substantive investments to help organizations execute predictably and consistently. For example, the company recently expanded Klick Labs, its in-house consulting service for strategic innovation, research, and product development. The company also designed patent-pending Dynamic ISI (Important Safety Information) technology that saves pharma and biotech companies time and money with a new way of digitally updating regulatory-required info in digital marketing materials.

Mr. Segal looks at things not as they are, but as they should be; he consistently rejects the status quo and applies human intelligence, empathy, and technology to invent smarter ways to work. For example, he banned email for internal task-related work, replacing it with a custom-built operating system designed to enhance workflow, and in the process, employee engagement, communication, and philanthropy.

Bucking trends, Mr. Segal disagrees with the widely held business philosophy that customers come first. For Mr. Segal, employees trump customers — and he has the numbers to prove it: 30% to 50% average annual growth rates, a team of almost 400 “Klicksters," and a new office in San Francisco, not to mention a New York Times bestselling book that he co-wrote on the subject, The Decoded Company.

With this approach in mind, Klick just launched Sensei Labs, consulting services and technology solutions to help pre-commercial and rapidly scaling biotech companies evolve and execute faster using the data-driven, employee-centric philosophy.

“Fundamentally, for anything strategic, Klick builds solutions from first principles rather than accepting other people’s paradigms," he says. “As an organization, we’re always in Beta mode and we are constantly experimenting with everything using a very data-driven approach to ensure we have both an agility and intelligence advantage."

Looking forward, Mr. Segal is preparing for even greater growth in the year ahead, focusing on biopharma and medical devices with 50% growth projected for Klick in 2014.

Before Mr. Segal started Klick he and the company’s other cofounders sold a previous business to a large public company that was very financially driven and at odds with motivating talent. The business was run by administrators instead of role models. The rules were rigid and the decisions shortsighted. As a result, the outputs were uninspiring and the best talent left the company.

“The takeaway for us was that the business was managed to optics instead of outcomes," he says. “For a group of entrepreneurs with a bias for action, it was very frustrating. We ultimately exited the company and today, we attribute Klick’s consistent and predictable growth to our obsession with outcomes over optics."

What motivates him is playing a role in educating and enriching patients, caregivers, and healthcare practitioners’ lives, adding that one day, we’re all going to be patients or caregivers.

He motivates others by giving them the tools they need to do their best job, meaning the kind of customized technology most people associate with smartphone apps, such as Google Maps or Netflix.

A committed philanthropist, Mr. Segal believes so strongly in paying it forward that he and his partners even designed their philanthropic program, named Klick it Forward, right into the company’s workflow. Klick it Forward enables employees, who come in under budget on a program, to donate funds to a charity of their choosing — conferring a personal touch to corporate philanthropy. The program is also integrated into the company’s social media platform to reinforce the key value of giving back and create an open dialogue about how employees are rising to the occasion to help others in need.

For example, Klick it Forward raised $88,620 to buy 265 malaria nets in Africa; fund 386 Kiva microfinance loan; and donate almost 1,300 goats, pigs, and chickens to families in sub-Saharan Africa. To bring the program full circle, Klick sent five employee ambassadors on a 10-day trip to Rwanda to track the impact of their donations, meet with local villagers, and visit schools in 12 communities. The program was so successful that Klick sent another team to build a school in Kenya in June with Free the Children.

Giving back, in fact, has become an integral part of Klick culture. Last November, employees raised over $10,000 in donations in a single week for the Red Cross Philippine Typhoon fund; the donation was subsequently matched both by Klick and the Canadian government for a total donation of more than $40,000. Since its inception, Klick has donated more than $1.5 million to charities at home and around the world.

Getting to Know…
Leerom Segal
Title: Cofounder and CEO
Company: Klick Health
Hobbies: Skiing, mountaineering, racecar driving, scuba diving, any extreme sports
Bucket List: Having recently become a New York Times bestselling author (on his bucket list last year) with The Decoded Company, his real quest now is to shape a “Decoded" movement that creates and celebrates talent-centric workplaces
Awards/Honors: 85 awards in 2013, including MM&M Agency of the Year, Med Ad News Manny ­Vision Award, PharmaVOICE 100, Nielsen Norman Group (NNG) Intranet Design Award, Web Marketing Award, Branham 300 Top ICT Company Awards; Top 10 Best Workplaces, Top 10 Most Admired Corporate Cultures, 50 Best Managed Companies, and 50 Best Employers Awards. Also named Youngest CEO of a Profit 100 Company, an Ernst and Young Young Entrepreneur and a Globe and Mail Top 40 Under 40
Associations: Dundee REIT Board of Trustees, YPO, Clinton Global Initiative, TED, Summit Series.
Tweet at: @LeeromSegal, @KlickHealth
Social Media: LinkedIn, Facebook, Instagram, Twitter

 

Mark Laabs
Channeling Energy
Driven to innovate by Necessity

At just 28 years old, Mark Laabs seemed to have it all. At the top of his game, the former McKinsey consultant was helping to run a profitable renewable energy business in China, and then he suddenly lost his vision in his right eye. Doctors had suggested retinal detachment, a tumor, or granuloma caused by tuberculosis; then the bottom dropped out of his world, when the dean of ophthalmology at a major medical school, said she believed it was a rare cancer called ocular melanoma. Making matters worse, his tumor was apigmented, making it even more rare.

A Google search of ocular melanoma revealed that the most prolific researchers on the subject seemed to be Jerry and Carol Shields at the Wills Eye Institute in Philadelphia. It was time to head home; he booked a one-way ticket and emailed his contacts letting them know that he was boarding a plane to Philadelphia — he would be there in 18 hours — and needed to get an appointment with the Shields.

By the time he landed, more than 35 people, including the Shields, had emailed him back, and he had an appointment the next day.

His good fortune in having deep social capital did not escape him. Though he seemed to have every resource at his disposal, the prognosis wasn’t good. At his meeting with the Shields, Mr. Laabs learned that the form of ocular melanoma he had a greater than 50% incidence of metastasizing, most likely to the liver; if it does, his chance of surviving more than five years would be less than 10%. Moreover, there is no recommended treatment available to reduce the chance that the cancer will spread.

The first step was to destroy the tumor, and within 48 hours he underwent surgery. Then he started looking for alternative treatments, and it was at this point he was confronted with many challenges.

Firstly, researchers in rare cancers work in an insular environment and often don’t communicate with each other. While they may have seen one another’s journal articles, they don’t necessarily share information on trials or treatments. That means patients are getting neither the benefit of the latest information nor the best outcomes.

Secondly, while a fair amount of research exists for skin melanoma, researchers tend to exclude ocular melanoma from trials because it may behave differently and could skew results. This means that many treatments haven’t been tested, leading to a dearth of innovation in ocular melanoma. Between 1974 and 2010, skin melanoma outcomes in the United States have improved by more than 11%, yet patients with ocular cancer have actually lost ground over the last 40 years.

A third challenge is that publication often trumps patient outcomes in motivating research. For academic researchers, publication is everything because it dictates promotions, even tenure. What is most novel is what gets published, not necessarily the innovation that makes the biggest difference to outcomes. Ocular melanoma has some remarkably effective tools to provide an accurate prognosis; the treatments, however, have seen less innovation.

After he sought options, Mr. Laabs, like many cancer survivors, became an advocate.

Mr. Laabs is looking to re-organize the incentives, motivating researchers to find ways to quickly help patients with rare cancers. He cofounded the Rare Cancer Research Foundation (RCRF) with a friend, Ben Abram, to take that first step, and sought to learn quickly if existing therapies for more prevalent cancers could translate to rare cancers. RCRF has partnerships with foundations for other rare cancers for which there are no cell lines; cell lines help determine the avenue of research.

RCRF is following a model created by the Chordoma Foundation, which offers a financial prize to research innovators who produce cell lines for this rare cancer of the bones of the skull and spine.

RCRF is embarking on its first step: the cell-line prize. And when this is solidified, the foundation will move on to phases two and three: genome sequencing to identify SNPs — the genetic mutations that cause cancers — and then creating animal models.

Now, two years cancer-free, Mr. Laabs has quarterly MRIs and CT scans to search for metastases. While he is focused on looking ahead to do what he can for people suffering from rare cancers, he can’t help but look back with gratitude that when he was confronted with a diagnosis, he had the social network to get him to the best medical oncologists with the right expertise. He recognizes that getting to the right hospital did affect his outcome. Now he is hoping to share his good fortune with others.

“Personally, I strive to make the greatest positive impact that I can over the course of my lifetime," he says. “Perhaps my greatest challenge to date lay in realizing that I could best achieve my own goal by channeling my energies into others’ successes."

His next goal is to build an enterprise that accelerates the translation of oncology treatment innovations from common cancers to rare cancers.

“I rarely set out to inspire others, but I hope my actions can speak for themselves," he says.

Beyond RCRF, Mr. Laabs supports charitable causes that work to achieve scalable and sustainable impact on a major societal challenge — be that cancer, climate change, or education.

“Whenever possible, I believe in building enterprises where the good they do in the world is directly tied to how they secure funding to continue their work," he says.

Getting to Know…
Mark J. Laabs
Title: Cofounder and Chairman
Organization: Rare Cancer Research Foundation
Education: B.A., University of North Carolina at Chapel Hill; Robertson Scholar, Duke University
Family: Mother, Meta, and father, Albert, brother, Keith, sister-in-law, Denise
Hobbies: Traveling, mentorship, swimming, running
Bucket List: Extend the lives of patients with rare cancers; change the way people produce and consume energy; run an Ironman; write a novel
Tweet @markjlaabs
Social Media: LinkedIn, Twitter Facebook

 

Kathy Giusti
In Relentless Pursuit of a Cure
Driven to innovate by Cure

As founder of the Multiple Myeloma Research Foundation (MMRF), Kathy Giusti has been inspiring patients and the research community since she first took that powerful and visionary step.

Her and MMRF’s success has been built on three cornerstones: setting the vision and plan; hiring talented people; and building a strong collaborative community.

After her diagnosis with multiple myeloma, Ms. Giusti formed a collaboration with like-minded professionals from academia and industry to embark on the unique mission that is the MMRF.

She set the organization on a path of relentlessly pursuing innovative means that accelerate the development of next-generation multiple myeloma treatments to extend the lives of patients and lead to a cure.

Ms. Giusti continues to rely on her broad pharmaceutical background and wide network to propel the organization forward. Her scientific background allows her to understand the research into new compounds in the pipeline. In addition, she is tapping key opinion leaders in the field of myeloma.

In addition to the MMRF, Ms. Giusti and her collaborators established the Multiple Myeloma Research Consortium (MMRC), now 21 centers strong, to accelerate high-priority Phase I/II clinical trials. This was one highlight for Ms. Giusti, who says in addition to that significant accomplishment has been the launch of a 1,000-patient study called CoMMpass.

What makes CoMMpass pivotal is that all participating centers (more than 85) had to agree to put the data in the public domain.

“We’re following patients longitudinally, collecting their genomic and clinical data, and sharing that high-quality, robust data set publicly on our MMRF Researcher Gateway," Ms. Giusti says. “Scientists worldwide can go on to our Gateway and access the data. Sharing quality data will drive new hypotheses on targets, biomarkers, and subtypes faster than before."

Ms. Giusti and her colleagues are working collaboratively with experts in lung cancer, breast cancer, and also with the FDA. Some of the research has uncovered that much like other tumor types, myeloma is not one disease, it’s many; there’s not one clone but several.

“All cancers are going to keep being broken down, and by working with the FDA and conducting targeted, efficient trials, we can once again change the paradigm and accelerate cures." she says. “This how to put speed in the system. I’ve been a passionate advocate for myeloma, but I have great admiration for what other people are doing in other cancers and I think the most important thing we can do is learn from each other."

The progress Ms. Giusti and her team have made is phenomenal.

“Nobody in myeloma, including me, ever expected to see six drugs approved in the last decade." she says. “And the pipeline now is more robust than ever; so the opportunities to find a cure — and I never used to say that word — are there, I actually now believe that we will see myeloma patients cured in my lifetime. What an extraordinary gift to our patients and the myeloma community that works tirelessly together."

What motivates Ms. Giusti and her team, is knowing that research that might have taken five years before, may now get done in two, if new technologies are pursued and funded.

“We only have a certain amount of funding," she says. “We’ve had to reevaluate portfolios and the programs we support. We’re in the midst of creating an immunotherapy fund to accelerate new trials, novel antibody, and vaccine approaches."

Ms. Giusti hopes to write a book about what she has learned as a patient to inspire other patients to become part of the research solution.

Patients have to learn so much because maneuvering through clinical trials and the maze of healthcare is confusing, but each patient has the ability to make a difference in finding cures and finding the best path for his or her own journey.

Ms. Giusti feels there is a journey in oncology; patients don’t have to know every answer but they need to have the right information to ask the right questions.

Ms. Giusti has inspired many people in healthcare but she says that no matter what she has done, her greatest goal in life has still been to be the best wife and mom she could be; her children, after all, her inspiration from the beginning.

For the patients who have watched her, it’s the fact that she tried to garner the knowledge, and build a stronger, faster better system.

Getting to Know…
Kathy Giusti
Title: Founder and CEO
Company: The Multiple Myeloma Research Foundation
Education: MBA, concentration in marketing, Harvard Business School; B.S., magna cum laude, Biology, ­University of Vermont
Family: Husband, Paul; daughter, Nicole; son David
Hobbies: Running, yoga, spinning
Bucket List: Write a book about what she has learned as a patient; travel, she has a trip to South Africa planned with her husband and kids
Awards/Honors: 2014, The World’s 50 Greatest Leaders list, Fortune Magazine
Associations: Harvard Business School Healthcare Board

 

Kenneth VanLuvanee
Uncommon Solutions to Common Problems
Driven to innovate by Imagination

Take a clinical and regulatory R&D expert, add an entrepreneurial spirit, mix in a creative approach to solving business problems, plus some mud, and you have Kenneth VanLuvanee, president and CEO of Virtual Regulatory Solutions. A frequent Spartan Racer and Tough Mudder, Mr. VanLuvanee is a serial entrepreneur who is focused on developing and deploying novel software and service solutions to support global regulatory processes.

At Virtual Regulatory Solutions, his second start-up company, he provides insight and guidance based on more than 20 years of practical consulting experience, translating his industry knowledge into valuable products and services that move the industry toward greater efficiency, transparency, and collaboration. VRS fills a regulatory expertise need for small teams with big goals, because therapy developers of any size must meet the same compliance requirements, whether they can afford it or not. For growing biopharma, resources are often scarce.

Large company or small, Mr. VanLuvanee’s focus is always on finding creative solutions to fit the client’s needs. He applies his experience and knowledge to common industry problems and always comes up with unique solutions that more than exceed client expectations.

Mr. VanLuvanee says he often gets his inspiration from other innovators from all industries.

“I read about and pay attention to innovation wherever it happens," he says. “I marvel at the different ideas, try to assess the basic principles of each, then ask myself ‘Does any of this apply to what we do and, if so, how?’"

Colleagues report that Mr. VanLuvanee’s creativity and innovative spirit provide a strong foundation that guides his teams toward success and motivates individuals to go beyond the status quo. His leadership experience includes recruiting, training, and coaching small teams to manage, mentor, and motivate successful multinational, cross-functional teams.

Leading by example, his management policy is simple: “I would never ask someone to do something I wouldn’t," he says.

He also likes to be hands on, and wherever it’s not detrimental, he’s usually in the middle of things somehow.

He admits that one of his toughest challenges to date was hiring and then adjusting to having director level staff.

“Not being the guy who always made the direct calls was a tough adjustment for me," he says.

Now he is more comfortable letting those he has hired assume their roles and responsibilities while he “gets out of their way."

“The people hired into their roles can do those jobs better than I can," he says. “I make sure they have the trust, authority, and support to reach their goals, and my job is to clear their path."

In his latest venture, he has attracted a talented group of professionals who want to remove barriers that keep small companies from leveraging technology across R&D processes. His innovative approach to technology enabled services turns the outsourcing model on its side and allows small teams to access big capabilities.

His low-key leadership style naturally invites collaboration and his vision motivates delivery of superior solutions.

His motivates himself by starting every day with the hope of creating something new.

“I love going to work every day with the idea that we can always seek new ways to do things," he says. “The ability to focus on ‘new’ every day is energizing."

Mr. VanLuvanee is a frequently requested speaker in the regulatory arena and has extensive knowledge of clinical and regulatory R&D processes. Throughout his career, Mr. VanLuvanee has consistently served on industry leadership teams, including the TOPRA North America Leadership Team, TOPRA Editorial Board, and the DIA Advisory Council of North America (ACNA). He is a former chair of the ERS community and a founding member of the Document Management Reference Model Working Group and the Document and Records Management Community.

However, he is most proud of the success of his first company, Apyx, which he operated for more than six years before selling to ISI in 2009. He fondly remembers the turning point from his first year in business to his second, which was a career highlight.

“Year two was when I decided to build a company, not stay solo as an independent consultant," he says. “That first year, I had no expectations. Year two, we had expectations and more than hit them."

Mr. VanLuvanee’s charitable works stay local to his home and business. He supports the efforts of Philabundance, a metro Philadelphia charity that provides food to the hungry in the area.

Getting to Know…
Kenneth R. VanLuvanee
Title: President and CEO
Company: Virtual Regulatory Solutions Inc.
Education: BBA, St. Bonaventure University
Family: Son, daughter
Hobbies: Cooking, running, weight training, outdoor obstacle courses, aka — Mud Runs
Bucket List: Visiting the pyramids in Egypt
Social Media: LinkedIn, Facebook, Google+

 

Dr. Graham Wylie
Patient Force for Recruitment ­Innovation
Driven to innovate by Interest

At a time when clinical trials were struggling for efficiency and slow to recruit, Dr. Graham Wylie, recognized the opportunity to bring patient engagement to the forefront and built a leading organization to make trials easier and more patient-centric. As CEO of Medical Research Network (MRN), he has had a significant impact across the medical research and drug development industries.

Dr. Wylie’s career spans more than 24 years, moving from a research division of a big pharmaceutical company to a commercial R&D role in a global CRO. From there he set up a commercial research division in a health provision company, before establishing MRN.

Dr. Wylie constantly challenges any business he is associated with to improve itself, its services, its reputation, and its market position. His success boils down to his ability to look at the big picture and calculate the steps required to achieve both short- and long-term goals.

At Pfizer, he helped develop the first EDC system, the first PM software-based method in trials, and the first implementation of competitive patient enrollment. During three years heading the Hermes Program in New York, an enterprise-wide initiative implementing patient data and clinical trial management systems globally, he redefined the ability to combine data across a variety of research groups and manage clinical trials across many R&D units and countries. This was his toughest challenge.

He then returned to the UK to head Pfizer’s business quality development group before joining Parexel to become medical director for Northern Europe. He rebuilt the U.K. department, which was in disarray. Most of the staff had left or were leaving and the morale was low. He rebuilt the group over the space of a few months and then set to work fixing the causes of the problem by focusing on developing quality focused tools allowing the team to reduce their major error rate from one per month to one per year. The team blossomed under his leadership, becoming more and more integral to the overall European group and the company as a whole.

In 2005 he was recruited to lead the clinical research division at Healthcare at Home, which, by November 2006, led to a management buy-out of the division, creating MRN.

Dr. Wylie’s vision for MRN was to build a platform of services for community-based trials, focused on faster recruitment and enhanced retention of patients.

MRN operates a radical new trials model, running trial visits in patients’ own homes, basing their care in the community rather than channeling everything through research sites. This hugely reduces the impact of the trial on the patient’s life — one of the first true patient-centric services — and thus makes them much more likely to consent to participate and then to stay in the trial for its duration.

The approach has led to a documented 50% increase in recruitment rates in sites using the service and a 92% retention rate across the entire MRN portfolio of trials. This has saved many trials from total failure and sped up already well-run recruiting efforts.

Under Dr. Wylie’s guidance, MRN is now exploring the use of social media in providing big data analytical tools for recruitment planning, protocol design, and site selection. The company is also developing a global network of pharmacy services to support complex drug administration in patients’ homes, with other services planned to follow over the next three to five years.

Running his own business has been a real career highlight; revenue has increased from £250k to £4 million at CAGR of 40% over MRN’s first eight years. But the most rewarding part of the journey for Dr. Wylie has been growing the company from two people to more than 45 dedicated employees.

“Outside the numbers, the ability to create and develop a new way of doing clinical trials, breaking the mold, and tackling some of the most fundamental issues in the conduct of modern commercial clinical trials is amazingly rewarding," he says.

Dr. Wylie combines a very approachable personality with a driven leadership style that inspires everyone who works with him. He believes in doing what seems right and developing the people around him, and if that inspires them, then he counts that as a success.

Community-minded, Dr. Wylie supported Bowel Cancer UK in the London marathon in 2012 on behalf of MRN. The company raised £14,000 during the year. It is a cause that is close to his heart, since his mother died from bowel cancer.

He also runs a work experience program for his daughter’s school and other schools in Milton Keynes. He takes eight students for a week each year and gives them exposure to working in a small organization. The students work in teams to design their own clinical trial, and are encouraged to keep a diary to help them in future interviews and with personal statements.

Dr. Wylie also talks at schools, colleges, and universities and at professional networking events, promoting the pharmaceutical industry and the role of scientists, medics, and nurses. He has also participated in the Cranfield University School Business Challenge, sponsoring and mentoring groups of students in a contest to run a virtual company. Dr. Wylie also lectures at the British Association of Pharmaceutical Physicians’ survival course three times a year to help physicians transition into the industry as easily as possible.

Getting to Know…
Dr. Graham Leatham Wylie
Title: CEO
Company: Medical Research Network
Education: B.Sc., Kings College, London University; MB.BS., St Bartholomew’s Hospital Medical School, ­London University
Family: Wife, Dr. Elaine Wylie, co-owner of MRN; four ­children: Alexander, 24, Fraser, 22, Susannah, 20, and Harriet, 18; grandaugher, Poppy
Hobbies: Skiing, speed boats, sailing, reading, philosophy (beginner), walking, running long and short distances
Bucket List: Visit the Namibian desert, go to a polar ice cap, write a book, walk the UK coastal path, run the NY marathon, spend a whole season skiing, learn how to sail
Associations: EMIG, VISTAGE, BrAPP
Tweet at: @MedResNet
Social Media: LinkedIn, Twitter

 

Bob Chandler
Patient Empowerment Pioneer
Driven to innovate by Delivery

When it comes to empowering patients and patient-centric medicine, Bob Chandler is well-ahead of his time.

For PR executives who are relatively new to the profession, it’s hard to step back 30 years and grasp how much the field has changed. Many important campaigns in the 1980s and 1990s showed little direct involvement with patients. But Mr. Chandler knew the industry could do better, and needed to.

Long before the Internet or talk of patient-centric medicine, Mr. Chandler envisioned the possibilities of the “activated patient," and the power he believed would be released by giving patients a voice in their own treatment.

Mr. Chandler’s life-long mission to improve communications among patients, physicians, insurers, and product providers was sparked by his experiences as an administrator at Methodist Hospital in Brooklyn in the late 1970s, where he witnessed patients suffering in different stages of cancer, looking at the difficult decisions ahead, and confronting possible outcomes with limited ongoing encouragement from the professional staff.

This experience set the stage for Mr. Chandler’s most innovative campaigns, first at Burson-Marsteller, and then at the agency he started with Gianfranco Chicco in 1995, Chandler Chicco.

Mr. Chandler understood that by arming patients with knowledge about their diseases and treatment options, the healthcare industry could produce better clinical outcomes.

He created a corporate positioning campaign to introduce Bayer Pharma to the North American market, which was one of the first educational programs designed to improve communications between physicians and patients using active listening techniques. Initially, the curriculum doubled as a vehicle to bring sales reps together with physicians. However, the training and communications aspects were so effective, that insurers started offering discounts on malpractice coverage to physicians who participated in the program.

Eventually, the curriculum was spun off as a nonprofit, the Institute for Healthcare Communication.

Today, the institute continues to create interactive educational materials and training modules for hospitals, charitable foundations, and healthcare researchers.

Long before the mass media trumpeted the potential of big data in healthcare, Mr. Chandler realized that patient records, health trends, and clinical trial results were not the only data troves that healthcare stakeholders would try to mine. A PR agency’s own clients would eventually start requesting evidence-based views of a campaign’s impact. This insight led to the 2003 creation of Determinus, the research arm of Chandler Chicco, which today helps clients create customized score cards and other tools to measure engagement of target audiences.

Mr. Chandler has set the gold standard for an employee-friendly company. When he and cofounder Mr. Chicco launched their new agency, there were just five people on staff, and it was easy for him to jettison conventions such as executive titles and walled offices with engraved nameplates.

What is more remarkable has been Mr. Chandler’s ability to sustain the original intent — a flat organization with an empowered workforce — for more than two decades as the company grew from five to 400 staff and expanded from New York to Washington, D.C., Los Angeles, London, and Paris. As Chandler Chicco expanded, Mr. Chandler built out his template for a new breed of PR agency where each employee could initiate projects, use judgment, and work creatively. His motto of the freedom to see and the power to do remains true to this day.

When inVentiv Health acquired Chandler Chicco in 2007, Mr. Chandler applied his vision on a larger stage as inVentiv’s senior VP of marketing and communications.

Diagnosing the difficulties in getting commercial, clinical, and research communities around the world to talk clearly to one another and to patients, Mr. Chandler led the integration of the parent company’s disparate advertising, public relations, public policy, medical communications, media, and digital services, fostering collaboration, and innovation under a “Done As One" operating philosophy.

Despite all his achievements, Mr. Chandler has always been a truly humble leader. In an age when even high school students are encouraged to become “brands" on social media and to assert themselves as influencers, it’s rare to encounter a media industry pioneer who likes to work almost entirely behind the scenes, promoting the talent he has gathered in his circle and basking in their reflected glow.

If you asked him, Mr. Chandler would decline credit for specific programs, deferring to the teams who produced the content. But the consensus at Chandler Chicco has always been that Mr. Chandler has inspired the most innovative and effective work by the trails he blazed, by his boundless imagination, and his passion for improving the lives of patients around the globe.

Getting to Know…
Robert L. Chandler
Title: President Emeritus
Company: Chandler Chicco Companies
Education: MBA, Health Services Administration, Wagner College; M.S., Journalism, Ohio University; B.S., Journalism, Bowling Green State University
Family: Wife, Pam; two daughters: Jillian, 11, and Morgan, 10; son, Brooks, 5
Hobbies: Running, cars
Bucket List: To race a Porsche Turbo at Nurburgring, Germany
Awards/Honors: Global Healthcare Agency of the Year, 2012; Healthcare Agency of the Decade, 2000-2010; Agency of the Year, 2002 to 2009; Specialist Agency of the Year, 2006 and 2007; Creative Agency of the Year, 2006
Associations: American College of Healthcare ­Executives; Public Relations Society of America; Sigma Delta Chi Foundation; Board member, Ranney School
Social media: LinkedIn, Facebook

 

Miranda Pothiawala
Single Point of Truth
Driven to innovate by Possibilities

After almost 30 years as an entrepreneur and software development professional, Miranda Pothiawala’s crowning moment came in 2010, when her company, Samarind, earned The Organisation for Professionals in Regulatory Affairs (TOPRA) innovation award for its on-demand regulatory management software.

“It was such a big deal to us; as a small software company to get noticed in a world of big players was a mixture of disbelief, relief, pride, and elation — a fantastic moment," says Ms. Pothiawala, director of software and cofounder of Samarind.

Ms. Pothiawala spearheaded a solution that is innovative and uniquely designed to meet the needs of the industry in the regulatory European marketplace. The company recognized early on the increasing adoption of cloud-based Web applications and the cost barriers that often prevent smaller organizations from investing in complex database solutions. Samarind RMS is a robust, user-friendly software application that precisely manages the key areas of product license acquisition and maintenance, including eCTD. During its years of evolution and development, Ms. Pothiawala insisted that the RMS service provide a “single place of truth" for pharmaceutical regulatory affairs professionals — in other words, a complete end-to-end system that handles all of the regulatory and pharmacovigilance disciplines in a clear and concise manner.

Clients say they have found Ms. Pothiawala and her team to be ahead of the game, especially regarding EMA’s EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) requirements. Samarind was among the first to implement a functional solution when other IT companies were still struggling with the specifications.

Ms. Pothiawala is open to listening to and working with clients’ ideas, and figuring out how to integrate her company’s solution within their existing systems.

This openness to new ideas and the ability to recognize the potential impact creates a strong partnership with pharma companies.

Ms. Pothiawala cofounded Samarind with her husband Sadik in 1987. Ever since they have been ahead of the curve, evolving the company’s products as fast or ahead of the needs of the industry. What started as a custom software company has emerged into a specialist regulatory software and services company.

More than 10 years ago, the company developed some of the first Internet-based RMS products. Samarind RMS was the first company to market with an EVMPD submission management solution in 2004, and it has been evolving services to keep pace with XEVMPD requirements ever since.

Colleagues say the company owes its growth to Ms. Pothiawala’s progressive thinking and her expertise in regulatory submissions and data management in the pharmaceutical and medical device industries. Ms. Pothiawala’s wide knowledge of regulatory issues and deep understanding of regulatory submissions has put her company on the software development map, however, she says her success stems from some good career advice: employ people better than yourself.

Ms. Pothiawala is smart, detail-oriented, and driven, but her greatest asset, according to colleagues, is her positive and approachable nature and her communication skills. She can take highly complex issues and break them down and communicate them with ease. She has a tremendous eye for detail, a skill that underpins much of the success of her regulatory submissions business.

Ms. Pothiawala coauthors a company blog, Pharma Whispers, which is devoted to providing insights and updates on key regulatory issues that impact pharmaceutical, medical device, and biotechnology companies and includes news about eCTD, EVMPD, EudraVigilance, Medical Device Unique Device Identification regulations (UDI), and Identification of Medicinal Products (IDMP).

When she is finished sharing her insights about all things regulatory at the end of the day, Ms. Pothiawala is a competitive and avid Words with Friends player — invite her to play, if you dare: MirandaPothiawala.

Getting to Know…
Miranda Pothiawala
Title: Cofounder, Director and Head of ­Software
Company: Samarind Ltd.
Education: B.A., English and Math, University of Liverpool
Family: Husband, Sadik; daughters, Emma and Kate; son, Alex
Hobbies: Music, puzzles and games, hill walking, cycling, cooking, DIY tiling, crafts
Bucket List: Walk up Machu Picchu, sail down the Nile in a luxury yacht and see the ­pyramids, see the Northern lights, learn to play the guitar, learn to play the flute, design her own house, organize the family archive
Awards/Honors: TOPRA Innovation Award
Professional associations: TOPRA, ISPE, IRISS, IDMP
Tweet at: @MirandaPoth
Social Media: LinkedIn, Twitter, Facebook, Flickr

 

Dr. Chitra Lele
Forging New Models in Clinical Outsourcing
Driven to innovate by Improvement

A pioneer in operationalizing a globally distributed model to support design, analysis, and reporting of clinical trials, Dr. Chitra Lele has been blazing trails in this arena for 20 years. Her contributions, particularly in the offshoring of biometrics and medical writing, have created a shift in how the industry now sources clinical trial related services.

In 2007, she co-founded Sciformix Corp., with business partner Ajit Nagral, to establish a knowledge-process outsourcing company that could provide specialized science-based services to pharmaceutical organizations. Dr. Lele has displayed a strong entrepreneurial spirit in continuing the growth and success of Sciformix by focusing on capabilities and opportunities across industry segments, geographies, and partnership models, along with conceptualizing new solutions and offerings.

Colleagues credit Dr. Lele with creating a solid foundation for Sciformix in all respects, from the management of operations and delivery, to strategizing the organizational path and trajectory. Sciformix partners with clients through the entire drug development cycle to provide a full range of services from study design to postmarketing surveillance and commercialization support.

Dr. Lele didn’t just help establish the company, but started the operations with a new project in hand. This was one of her biggest professional challenges to date, she says.

“To start a pharmacovigilance project when the company is just being established and having to meet SLAs with the majority of the team being domain-naive, while also simultaneously creating the organizational framework and trying to grow the business was a tremendous challenge," she says.

Before Sciformix, Dr. Lele worked for Pfizer as executive director of India operations of global R&D and head/director of biometrics. In this role, she led India’s first biometrics center, growing it to more than 400 staff in clinical data management, clinical programming, medical writing, and clinical statistics. During her almost 10 years at Pfizer, Dr. Lele was also instrumental in developing an outsourcing strategy for clinical data management in India, strategizing and implementing a new model for partnering with contract research organizations.

The result of these initiatives was increased capacity building in the Indian CRO industry, leading to large-scale offshoring of biometrics and medical writing in a functional service provider model from cost-effective locations, with several pharma companies taking advantage of the new talent pool.

“It was challenging to build a group at a time when the skill set wasn’t available in the geography and the culture of offshoring such services was new for the pharma industry," Dr. Lele says.

However, challenges don’t slow her down much, and colleagues say they are continually amazed at her ability to add one more thing to her to-do list and take on more work, as well as her roll-up-her-sleeves attitude to making sure projects are executed effectively.

Dr. Lele’s plans for the future include creating new cross-functional innovative technology offerings to fill the unmet need in today’s environment of new operating and partnership models emerging across product development and life-cycle maintenance.

As a mentor, Dr. Lele has instructed the next generation of scientists through her work as a visiting faculty member at the University of Pune, teaching statistics courses and supervising Ph.D. students. She has also worked as a faculty member at the School of Statistics at the University of Minnesota, and IIT, Bombay. She was instrumental in setting up the Academy for Clinical Excellence at the Bombay College of Pharmacy. She is one of the founding members of the Indian Association for Statistics in Clinical Trials.

Dr. Lele is also always happy to mentor her colleagues.

“Since I have been part of an emerging area of business, I have always worked with colleagues who were relatively less exposed to the area and who were making the switch to a new and emerging area," she says. “Hence several of them were in need of coaching and mentoring, which I gladly provided since it was my responsibility to help them shape their careers."

Dr. Lele supports several charitable causes, but her passion is education for the underprivileged, and especially for women.

“Education has helped me become what I am today," she says. “I would like to help provide educational opportunities to girls in rural areas and also to handicapped girls."

She also strives to support those who do not receive adequate healthcare due to their financial status.

“Everyone is aware of the skyrocketing costs of specialized healthcare that prevents those in need from getting treated," Dr. Lele says. “I support an initiative, which is an excellent public-professional partnership aimed at providing affordable/subsidized quality healthcare to the less fortunate sections of society."

It is her hope in the healthcare world of the future that safer medicines become more available to a larger section of the population.

Seemingly mild mannered, Dr. Lele has an adventurous side: she enjoys roller coaster rides, Alfred Hitchcock movies, and Agatha Christie mysteries.

Getting to Know…
Chitra Lele, Ph.D.
Title: Chief Scientific Officer
Company: Sciformix Corp.
Education: Ph.D., Stanford University; M.Sc., Indian Institute Technology-Bombay; B.Sc., Bombay
University
Family: Husband
Hobbies: Reading fiction and nonfiction; traveling; ­listening to music; watching plays and movies; cooking; exercising; watching Olympics, tennis, basketball
Bucket List: Travel to all continents; visit UNESCO World Heritage Sites and Wonders of the World — ancient and modern
Associations: The Academy for Clinical Excellence; The Indian Association for Statistics in Clinical Trials; Drug Information Association (DIA); Society of ­Actuaries USA

 

David Cunningham
Driving Access to Medication
Driven to innovate by Imagination

In 2001, David Cunningham had an innovative idea for a solution that would provide patients greater access to medications and care. This idea became the foundation for TrialCard, the company he co-founded that same year.

Now 13 years, nine patents, more than $3.4 billion dollars in patient benefits, and 250 million patient transactions later, TrialCard and Mr. Cunningham are continuing to cultivate new cutting-edge solutions to increase patient-care access. A highlight for Mr. Cunningham came in 2010 when TrialCard reached the milestone of managing $1 billion in patient reimbursement.

“As much as it is a career highlight for me personally, it is also incredible to think of the number of patients TrialCard helped to access their medications through our programs," he says. “Just recently, TrialCard surpassed managing more than $3 billion in patient reimbursement. This career highlight continues to grow."

From the beginning, Mr. Cunningham has provided leadership that has guided the TrialCard team to incredible accomplishments.

The creative and forward-thinking culture Mr. Cunningham has formed created “adjusting value," “pay no more than," and “save up to" as examples of TrialCard’s advanced patented co-pay features.

These patents enhance the original co-pay patent the company was founded on more than 10 years ago, and provide pharmaceutical brands with the technology to optimize promotional programs to increase patient access. These patented programs also increase adherence rates by 18% which improve patient health outcomes.

These patents enhance the original co-pay patent the company was founded on more than 10 years ago, and provide pharmaceutical brands with the technology to optimize promotional programs to increase patient access and adherence rates on average by 16%.

For Mr. Cunningham, the company’s past and future innovations are driven by patients’ access to their medication.

“We always go back to helping pharmaceutical brands remove the barriers that impact a healthcare provider and a patient’s ability to choose the right treatment," he says.

Another example of Mr. Cunningham’s leadership for innovative problem-solving is seen in TrialCard’s recent launch of RxSaver. Between 5% and 30% of prescriptions are abandoned at the pharmacy, and RxSaver is a first-of-its-kind solution to reduce prescription abandonment rates, delivered by the pharmacist at the point of sale. Results show that one out of five patients who were at high risk for abandoning their therapy filled their prescription with RxSaver.

In addition, while big data has become the latest buzz in the pharmaceutical industry, TrialCard has been using pharmacy data and marketing trends to help maximize brand programs since the company’s foundation. TrialCard applies advanced analytics to optimize program designs and target physicians. Having profiled 60% of active prescribers in the country, TrialCard is able to advise clients on the best prospects for their programs based on the level of responsiveness, patient enrollment, and the overall value to the brand.

Mr. Cunningham’s innovative solutions have opened up new avenues for specialty and rare disease drugs. Specialty pharmaceuticals are growing rapidly because of the need to provide care for disease states, such as cancer and HIV. TrialCard solutions increase patients’ access to specialty medications, enabling patients to start therapy sooner and stay on therapy.

Keeping the personalized touch, Mr. Cunningham has maintained all aspects of TrialCard in-house. TrialCard Customer Experience Specialists are representatives of the brand and strive to make each patient, pharmacist, and physician contact a positive experience.

He has invested in people, process, and technology to position TrialCard as a top solution to specialty pharmaceuticals. He understood that a top-tier customer experience center was needed to properly support hub services for brand manufacturers. He invested in top technology solutions and brought in a team of highly trained and experienced staff to handle all of the needs of patients who are on specialty medications.

Local and national charities are very near and dear to Mr. Cunningham and his teams. The company has a group of employees who create opportunities throughout the year for the entire team to participate in and donate to.

Recently, TrialCard participated nationally with the American Cancer Society, Alzheimer’s Foundation of America, and American Diabetes Association to name a few.

TrialCard employees are inspired by the fact that the company’s leadership never asks anyone to do anything they aren’t willing to do themselves.

“When we say all hands on deck that means my hands as well," Mr. Cunningham says. “My desire to be and stay involved with all aspects of TrialCard continues to inspire others."

As for motivation, Mr. Cunningham goes back to what his father taught him, which is that his job is not to motivate people but rather to block areas that de-motivate people.

“I have found this to be true for our teams," he says. “We empower our people and allow our people to make hard decisions. Our team is told to think and do, not be told what to do. We are a highly motivated team."

Mr. Cunningham’s dad’s lesson continues to hold true.

Getting to Know…
David Cunningham
Title: CEO and Cofounder
Company: TrialCard
Education: BAA, Marketing, University of Texas at Arlington
Family: Wife; three kids
Hobbies: Golfing, following world news and politics
Bucket List: Visit Malta Knights of St. John
Awards: 2013, Benchmark Portal Top 10 Call Center Award; 2014 & 2013, Center of Excellence from ­Benchmark Portal; 2012, PM360 Innovators: Services; 2011, Fast 50: 50 fastest-growing private companies Triangle Business Journal; nine patents from USPTO
Associations: National Association for Chain Drug Stores; National Council for Prescription Drug Programs
Social Media: LinkedIn

Dr. George Savage
Digital Medicine Pioneer
Driven to innovate by Challenge

There is never a dull moment when working with George Savage, M.D.

Dr. Savage is an entrepreneur with a disruptive idea: improve healthcare and reduce the cost of healthcare for the entire world, not just well-to-do countries but for all places and people. He is one of the forerunners of digital medicine, with the goal to improve treatment outcomes that are both affordable and scalable.

As the co-founder and chief medical officer of Proteus Digital Health, Dr. Savage is responsible for generating the evidence and advocacy needed to bring digital medicines to patients and families everywhere.

Dr. Savage and his colleagues at Proteus invented the world’s first food-based computer that can work as an ingestible sensor small enough to be embedded in tablets and capsules and thus communicate drug adherence when the medicine is ingested in the stomach.

“I am working to introduce digital medicines to the world, and with them, the notion of information — dose, response, and relevant behavior — built into chronic ambulatory pharmacotherapy," Dr. Savage says.

To bring this innovation to patients, Dr. Savage embarked on years of product development involving testing the ingestible sensor in bench, animal, and clinical studies, and communicating the results with the FDA.

Development required assembling a multi-disciplinary team from the worlds of pharma, medical devices, and semiconductor fabrication. Market clearance entailed a multi-year engagement with regulators to work out the appropriate evidence standard and approval classification.

Under Dr. Savage’s leadership, Proteus gained FDA clearance in 2012 as the world’s first ingestible sensor and created a new Code of Federal Regulation for Ingestible Event Markers, therefore paving the regulatory pathway for future digital medicines.

Digital medicine is redefining pharmacotherapy by leveraging the ubiquity of mobile technology to bring accurate information about medication adherence and improve it with increased patient engagement.

Dr. Savage’s dedication to partnership and transparency with the FDA has established a solid foundation for the future of digital medicine.

Taking a playful approach to innovation, Dr. Savage likes to approach new ideas with a sense of exploration, trying out ideas the way a child plays with a new toy. All the while he remains adaptable, saying one can’t control the circumstances, but one can control the response.

Passionate about learning, Dr. Savage says he enjoys learning the ins-and-outs of most occupations. But he learned from management author Jim Collins many years ago to prune by letting go of something already mastered, in order to move ahead and accomplish something new. After all, there are only 24-hours in a day.

To his team at Proteus, Dr. Savage is dedicated, forward-thinking, understanding and above all, a leader.

Colleagues describe him as thorough in his preparations, consistent in his arguments, congenial in his interactions, and willing to give consideration to his teams and to include alternative views.

Leadership by example, in service of a compelling vision, clearly and authentically articulated, is the best way to inspire others, he maintains.

As for motivation, he says the opportunity to change the world is a heady thing, and is enough to propel him to work on most days. “On the others, there is always fear," he says.

In addition to his commitment to realizing the potential of digital medicines, Dr. Savage is strongly committed to delivering health in the developing world. Since 2008, Dr. Savage has undertaken four medical missions to Ethiopia, delivering medical care and health advice to poor patients living with HIV alongside a team of volunteer doctors and nurses from his church.

He describes the problems in Ethiopia as so enormous that you can feel hopeless – it’s overwhelming. But by seeing so many patients each day, he and other volunteers can make a difference to those individuals.

“I have the opportunity to serve the full-time staff and program beneficiaries each year as a member of a visiting medical team," he says. “The program demonstrates how a collective response to acute need can be administered in a highly personal and holistic manner."

Getting to Know…
George Michael Savage, M.D.
Title: Co-founder and Chief Medical Officer
Company: Proteus Digital Health
Education: MBA, Stanford University Graduate School of Business; General Surgery (Resident), University of ­Massachusetts Medical School; M.D., Tufts University School of Medicine; B.S. Biomedical Engineering, Boston University College of Engineering, (Magna Cum Laude, Tau Beta Pi)
Family: Married; three children: Matthew, deceased; Andrew,21; William, 19
Hobbies: Running, automobile maintenance, history, and public policy
Bucket List: Becoming proficient in another language, staying employable
Awards/Honors: Fast Company — the world’s top 10 most innovative companies in healthcare (2013); Edison Award: Science & Medical, Analytic Systems; Gold, 2014
Associations: Massachusetts Medical Society, California Healthcare Institute
Tweet at: @ProteusDH, @George_Savage
Social Media: LinkedIn, Twitter, Facebook, Google+, YouTube, Pinterest, Instagram

 

Alex Sefanov
Cloud-Based, Cloud-Focused
Driven to innovate by Challenges

Alex Sefanov has made many solid business decisions since his entry into the life-sciences field in 1993, but two stand out in particular: creating a company from the ground up, and then selling it. He took a risk and started BioPharm Systems, an IT consulting company that specialized in the implementation and integration of Oracle Health Sciences applications in 1995, when he had a wife and three young children at home to support. Just this year, he made the decision to sell the company to Perficient, a strategy that was never his initial goal in establishing the firm. Mr. Sefanov grew BioPharm Systems to 50 people and sales of $15 million a year before selling in April 2014.

“Deciding whether or not I should sell the company was one of the toughest decisions I have ever made, since I never had the goal to build the company in order to sell it," he says.

Mr. Sefanov once received this very important career advice: Never make an important decision before sleeping on it. He took that advice and is now looking forward to his new challenge of growing the life-sciences practice at Perficient through his role as general manager of life sciences industry solutions.

Up until the point of sale, however, BioPharm was Mr. Sefanov’s baby. He built it from the ground up to a company with more than 70 employees in the United States and Europe, with five operating practices, which include clinical data management and EDC, clinical trial management, clinical data warehousing and analytics, safety and pharmacovigilance, and healthcare. Leading through innovation, Mr. Sefanov played a key role in defining the company’s overall strategy, services, and products. He created the company’s long-standing partnership with Oracle, relationships with clients, and business development. BioPharm became well known as one of the fastest-growing private companies in the United States (four times in a row, since 2010), and earned a place on Silicon Valley Business Journal’s list of the 52 fastest-growing private companies in Silicon Valley in 2013.

In 2013, BioPharm was also named to Talkin’ Cloud’s list of the top cloud services providers for the third consecutive year. This particular award stems from an innovative service that Mr. Sefanov originally spearheaded in 2002, a time when cloud computing was essentially unheard of. In 2002, the company started offering private cloud hosting services, when he realized smaller companies could not effectively manage or afford to have their systems implemented on-site. These sophisticated clinical and pharmacovigilance applications require significant technical and financial resources that many SMBs simply could not afford. Hosting applications in the cloud with a provider such as BioPharm was a cost-effective alternative that allowed companies to focus less on systems and servers and more on building their drug/device pipelines and CRO services.

In November 2013, Mr. Sefanov was selected to Nine Lives Media’s sixth annual MSPmentor 250. The list identifies the world’s leading managed service provider (MSP) executives, entrepreneurs, experts, coaches, and community leaders. He was also able to place BioPharm on the sixth annual MSPmentor 501 list of the world’s top 501 MSPs.

Mr. Sefanov was also instrumental in creating a great working culture for the company, often earning praise and gratitude from his own employees. Former staff members tell us that he created a family-oriented environment where people wanted to work. Colleagues say Mr. Sefanov is a compassionate, personable, non-bureaucratic, and accessible leader who expects a lot from his employees. He pushes them to strive for excellence and to provide the best possible service to clients. Although he has high expectations for his employees, he constantly recognizes individuals for jobs well done and employees are truly valued. In recent years, BioPharm was even recognized for exemplary workplace practices by the Families and Work Institute and the U.S. Chamber of Commerce’s Institute for a Competitive Workforce. This prestigious award recognizes employers across the United States that are using flexibility as a strategy to increase workplace effectiveness and enhance business and employee success.

“I try to acknowledge people’s achievements and let them know they’re valuable," Mr. Sefanov says. “Everyone in our practice plays a vital role in our business."

The combination of business acumen and his ability to inspire others provides Mr. Sefanov with a true formula for success. Born in the Ukraine, he played on the Ukrainian national youth volleyball in high school, and his first job was as a COBOL programmer at a shipyard in Odessa, Ukraine.

His father and his volleyball coach were inspirational figures for him, as well as his colleague Keith Howells at Oracle.

“My father was a strong and loving person, with excellent knowledge and understanding of art, music, and world politics, besides having been well-known in his profession, psychiatry," Mr. Sefanov says of his mentors. “Valentin Golduber, my high school volleyball coach, was very motivational, and we all believed that we were going to be World and Olympic champions. One of his students did become a member of the winning Olympic team, but it wasn’t me, unfortunately."

As head of Oracle Pharmaceutical Applications, Keith Howells taught Mr. Sefanov to take a 60,000-foot view of the industry and the business, while keeping a close eye on the technical details.

Getting to Know…
Alex Sefanov
Title: General Manager, Life Sciences
Company: Perficient Inc.
Education: M.S. and B.S., Odessa Maritime Institute
Family: Wife, three sons, five grandchildren
Hobbies: Traveling and listening to audiobooks
Bucket List: Travel around the world
Awards/Honors: Inc. magazine’s list of the fastest-growing private companies in the United States 2010, 2011, 2012, and 2013; Silicon Valley Business Journal’s list of the 52 fastest-growing private companies in ­Silicon Valley for 2013; Talkin’ Cloud’s list of the top cloud services providers for 2011, 2012, and 2013; Nine Lives Media’s sixth annual MSPmentor 250 in 2013; Nine Lives Media’s MSPmentor 501 list of the world’s top 501 MSP in 2013
Associations: Oracle Health Sciences User Group

 

Arif Butt
Starting Conversations
Driven to innovate by Interest

When scientists don’t communicate, potential solutions and cures take longer to develop. Arif Butt recognized the need to enable online conversations for the scientific community to help accelerate critical research.

As CEO, co-founder, and publisher of SelectScience, an online B2B platform for life scientists, Mr. Butt has revolutionized the way scientists communicate, educate, and disseminate information. Since its launch in 1998, Mr. Butt has successfully steered SelectScience to be an independent, expert-led scientific review resource for the worldwide scientific community, a platform that empowers the life-science industry to innovate through easy access to expert advice and opinions on the latest developments within the scientific industry.

Over the last 15 years, he has built his business up steadily, surviving the dot-com boom and bust cycle and SelectScience has now become a microcosm of knowledge for the whole industry.

SelectScience is recognized by scientists and manufacturers as the go-to place for communicating science from the latest laboratory equipment to new techniques. With more than 250,000 members who engage with each other through product reviews, videos, webinars, and other services, the site welcomes more than 1,000 new subscribers monthly and sponsorships from more than 200 manufacturers globally.

What he has achieved is unique within the B2B industry; it’s not just a transaction of information, but a place where truly interesting conversations take place in the scientific arena.

With a background in life-science publishing, Mr. Butt’s knowledge and understanding of the type of editorial content that interests and benefits the life-sciences industry in an online peer-to-peer community has enabled him to continue to build SelectScience from strength to strength.

He adopted successful community engagement methods being used in other industries, particularly in B2C environments, such as online travel agencies and review sites, and translated those ideas into a platform that would benefit the scientific community.

Mr. Butt’s success in using these tools and platforms has been recognized throughout the industry; he has secured the involvement of a number of Fortune 500 businesses that work in partnership with the organization to ensure their products are visible and recognized by their target market.

A testament to the authenticity and independent nature of SelectScience is the fact that the site is endorsed by Google as one of the top review sites in the industry, up there with Amazon and Trip Advisor. In 2013, SelectScience was awarded The Queen’s Awards for Enterprise International Trade 2013, a career highlight for Mr. Butt.

For Mr. Butt, it’s vital that content is unique and user-generated so Google can effectively capture the content from users of the Web.

He also wanted to create a great experience for all users who visit the website, encouraging them to return where they can find personalized and relevant content for groups of people with common interests, goals, and problems.

SelectScience uses a conversational, scientific journalism style that reflects Mr. Butt’s vision of creating meaningful conversations. This has had a huge impact on how the scientific industry communicates interesting science to the wider market and to each other.

SelectScience is leading the way in terms of Internet technology through a dynamic and innovative approach; currently, more than 250,000 scientists contribute to the site and there are thousands of product reviews.

These reviews are not dry or boring; they are independent and provide useful information that can be used by Google as snippets of key information and can be easily and quickly imported to other websites to help facilitate conversations and showcase value. Clients gain traffic and credibility by having scientists review their products on SelectScience.

By developing breakthrough strategies, products, and services Mr. Butt has created a reputation for himself while lifting his company to new heights. SelectScience has successfully penetrated the North American and European markets and there is planned expansion in the emerging markets.

Mr. Butt fosters a culture of success and achievement, both for the company as a whole and for individuals within the company. He is committed to taking the time to mentor the next generation of industry leaders, ensuring that SelectScience continues to combine science and technology with a creative and dynamic approach that will translate effectively to scientific communities on a global basis.

By encouraging people to put ideas forward, take the initiative, make the case for change, take responsibility, and be accountable, Mr. Butt has developed a company where bureaucracy does not stand in the way and each individual is encouraged to suggest and make changes.

He encourages individuals to fulfill their full potential, enabling them to reach their own personal career ambitions and goals. He listens to what people want and strives to understand what success means to them.

Through Mr. Butt’s inspirational leadership, people at SelectScience work together as teams, helping one another to achieve goals. He says he inspires by not being perfect so his staff think they can do better than him; indeed his next goal is build the team so he is redundant.

Mr. Butt supports charities that help those at risk of anaphylaxis, as his son has multiple food allergies and asthma and his daughter suffers from chronic fatigue syndrome.

Getting to Know…
Arif Butt
Title: CEO and Cofounder
Company: SelectScience
Education: Loughbourgh University; Queen Mary ­College, University of London
Family: Wife, Louise; daughter, Francesca; son, Alexander
Hobbies: Flying helicopters, playing tennis, astronomy, and watching the Baggies, the West Bromwich Albion football team
Bucket List: See K2, the second highest mountain on earth
Awards/Honors: Queens Award for Enterprise; Cogent Life Science Employer of the year award
Tweet at: @arifbutt
Social Media: LinkedIn, Twitter, Facebook

Dr. Iya Khalil
Building Bridges to Improve Lives
Driven to innovate by Knowledge

Not many people get invited to the White House for a recognition dinner, but Iya Khalil, Ph.D., is not just any anyone. She is a brilliant scientist and entrepreneur who has made great strides in the industry in just a few short years.

Dr. Khalil was invited to the White House as part of a group of Muslim American leaders invited to share an iftar dinner to celebrate the end of Ramadan.

At the dinner in 2013, President Obama called Dr. Khalil a pioneer. Her father came to the United States from Libya to finish his education and Dr. Khalil grew up watching her father in his lab and dreamed of being a scientist herself.

Today, she calls herself a “recovering physicist" and she puts her talents to work as an entrepreneur.

She cofounded GNS Healthcare, which employs almost 50 people and is a leader in big data and genomic medicine, which makes it possible for doctors to prescribe personalized treatment plans for patients with diseases such as cancer, and giving new hope to people around the world.

Colleagues who have worked with Dr. Khalil say she is not just a brilliant physicist, but she also has a very loving and open personality, and it is her compassion that sets her apart and makes her a successful leader and entrepreneur.

She has innovated ground-breaking technologies and created consortiums that seemed impossible.

The technology that she co-invented involves a scalable supercomputer-enabled framework for discovering new knowledge from real-world healthcare data. She achieved all of this without ever losing touch of the human aspect of what she was doing.

Dr. Khalil is able to comprehend difficult strategic thinking layered with complex mathematical formulas, while simultaneously being able to interact with others with understanding, compassion, and respect.

She builds bridges that the life-sciences and healthcare communities need to embrace predictive modeling and drive improvement in the lives of patients. Dr. Khalil has accomplished more in 10 years than some life scientists do in 30, colleagues say.

This efficiency may be because she is a career risk-taker. Right out of graduate school, without a penny to her name, she decided to start a company, Via Science, which has been in operation for more than 13 years. From Via Science, GNS Healthcare was born to focus specifically on healthcare data.

Via Science is a big data analytics company that developed a patented software platform that helps clients better understand the causal relationships in their data that support predictions relevant to everyday business issues.

Most theoretical physicists head to Wall Street to take on management consulting roles after graduation, but Dr. Khalil believed very strongly in her mission.

Her co-invention of a modeling and simulation engine known as reverse engineering/ forward simulation (REF), which is able to crunch billions of genomic, molecular, and clinical data points and identify cause-and-effect relationships directly from data, will change the lives of many.

Such technology creates insights to help pinpoint predictive biomarkers for experimental drugs and new targets for therapies — all of which are necessary for the advancement of personalized medicine.

She has been advocating personalized medicine for more than a decade and she is already a highly regarded pioneer in this field.

While many talk about a need to collaborate between different sectors of healthcare, Dr. Khalil has already been instrumental in several important alliances, including one with Orion Bionetworks, which focuses on transforming the study of brain disorders.

Dr. Khalil also dedicates much of her time to the New Libya Foundation, an organization she co-founded to nurture the successful development of civil society organizations in Libya through training, education, access to resources, and financial assistance.

Senior colleagues respect her and look to her to teach them about the new world that healthcare must embrace. She is both teacher and student, and mentoring goes both ways for her. Colleagues describe her as a scientist, an entrepreneur, an inventor, a technologist, a pioneer, a collaborator, and a visionary — relentlessly pushing scientific and technical boundaries in ways that have never been done before. She is considered a leader of the next generation in healthcare. The force of her will and charisma, combined with all of her other traits, make her unstoppable. And she has just begun.

Getting to Know…
Iya Khalil, Ph.D.
Title: Co-founder and Executive VP
Company: GNS Healthcare
Education: Ph.D., Theoretical Physics, Cornell University; B.S., Physics, University of Washington
Family: Parents, two sisters, and a brother
Hobbies: Cooking, being outdoors, hiking, all water related sports, kayaking, and paddle boarding
Bucket List: Take two years to travel the world and soak up and learn about what other cultures have to offer
Awards/Honors: Recognized by President Obama at White House dinner
Associations: Healthcare Businesswomen’s Association
Tweet at: @iyakhalil.
Social Media: LinkedIn, Twitter, Facebook, Pinterest

 

Fabio Gratton
Following the Right Path
Driven to innovate by Vision

Former owner of Ignite Health, Fabio Gratton has been spectacularly successful in a career he never thought he would be in. Although his father is a leader in biophysics facilitating multinational collaborations with clinical trials, Mr. Gratton had no intention of going into the life-sciences field. He was going to direct films, write screenplays, make it big in Hollywood.

Even after dabbling in his father’s business at 16, helping him create a logo and later a website for his biotech company, he did not feel the call.

“It was just something I was doing to make extra money between mowing lawns when I was 16," he says. “It was certainly not something I thought about doing."

But after six years at Paramount Pictures, reading scripts, and taking a position for a year as Tom Cruise’s personal and professional assistant, Mr. Gratton ended up coming full circle, taking a job as digital project manager for several biotech companies. From there he became the interactive guru in the field, and established his own company, Ignite, in 2000.

He credits a lot of his success to his parents, but also to a stranger he met on a plane.

At the age of 24, he sat next to a man on a plane who quizzed him about his career aspirations. At that time Mr. Gratton was spending 110% of his time trying to get a screen play to an agent, and he was 110% sure this was his only career choice. In short, the man advised him to be open to other options along the career path, because “you never know what you might be missing out on."

During his 14-year career in digital marketing, Mr. Gratton has worked with some of the largest pharmaceutical and medical device companies in the world, including Medtronic, Merck, Pfizer, Roche, Genentech, Bausch & Lomb, and Abbott.

Using some of his film and technology experience, Mr. Gratton helped create a ground-breaking, award-winning animated series for people living with HIV, as well as the first Sim-style game for children living with diabetes, and led the unprecedented FDASM movement — an online twitter-fueled initiative that brought together agencies and pharmaceutical companies to discuss, debate, and share ideas regarding the impending FDA guidelines on the use of the Internet and social media.

After selling his award-winning agency Ignite in 2007, Mr. Gratton now has his hand in four projects: co-founder and innovation catalyst at Sonic Health, a digital consultancy; co-founder and CEO of Vocalize, a tech startup that created a new, industry-first platform, Truvio, that connects 65,000 consumer health opinion leaders directly to companies that want to hear what they think; and he serves as chief alchemist at a new incubator he founded called Alchemy Factory, where he will be focused on helping health tech startups accelerate and commercialize their products.

And he is working on a non-monetized project called pocket.md, the world’s first and only online service focused exclusively on providing the most comprehensive directory of physician-specific mobile apps.

His current goal, however, is to develop a new model of collaboration so that people from diverse industries and fields can come together in shared office space to swap ideas.

“I’d say the biggest challenge of all in building this model is creating an operational system that can make it all tick; working with people who are in different places in their careers and have different goals; creating an alignment and the community and the belief in the system. It is definitely by far my biggest career highlight to date."

Mr. Gratton is a big believer in the power of using technology to be able to work from anywhere in the world. But he also believes people work better if they can interact face to face in the same space, and he is striving to come up with a solution that will work.

Getting to Know…
Fabio Gratton
Title: Chief Alchemist and Founder
Company: Sonic Health, Vocalize, Alchemy Factory
Education: BFA, School of Film and Television, UCLA
Family: Wife, Kim; daughter, Isabella, 2
Hobbies: Collecting gadgets
Bucket List: Attend the World Cup in Brazil
Tweet at: @skypen
Social Media: LinkedIn, Twitter, Facebook, YouTube, Pinterest, Instagram, foursquare

 

Dr. Jeffrey Adelglass
One Step Ahead with Ideas
Driven to innovate by Ambition

Commitment for Jeffrey Adelglass, M.D., means an obligation to both patients and his team at Research Across America (RAA).

Dr. Adelglass founded RAA with a clear commitment to finding medical treatments that will improve patients’ lives.

RAA is a nationwide site network that has conducted more than 1,000 clinical trials over a broad range of specialties in its 20-year history. In addition, Dr. Adelglass also founded Skintastic Medical and Surgical Skin Rejuvenation Centers, performing ground-breaking cosmetic studies.

Under his leadership, RAA has thrived and remains one of the most respected research networks in the country. He takes a multi-faceted, innovative, and creative approach to the research process. For example, RAA has one of the largest and most sophisticated recruitment teams of any private site network.

Driven by an entrepreneurial spirit, he constantly seeks new opportunities for the business and employs new strategies that keep his employees excited and motivated.

RAA houses its own call center, staffed by a well-trained team of people. The staff are mostly medically trained mothers who require flexible scheduling, which suits the needs of a 24-hour call center well. An example of additional creative thinking is the development of a mobile recruitment van — painted purple and fondly known as Barney — that is used to promote studies through the placement of banners on the sides of the van and also to screen patients in mobile locations.

The company strives to be an innovator related to the performance of community outreach initiatives, and the team is constantly evaluating new retention and recruitment tactics. Dr. Adelglass consistently evaluates and seeks out new opportunities to promote awareness of clinical trials. He has even been a national reality TV celebrity as the resident doctor for reality series, Big Rich Texas, which provided significant awareness of Dr. Adelglass and his work.

He says everything is bigger in Dallas so it’s his vision and ambition to innovate: “People who are negative frustrate me, I believe in ‘yes’ not ‘no’," he says.

Well ahead of his time, Dr. Adelglass recognized technology-based strategies, such as patient diaries using cell phone capabilities, as an option to be considered long before others implemented such strategies.

The company employs more than 50 staff in multiple locations in Texas as well as New York City and Reading, Pa.

He keeps his employees on their toes, whether it is a new social media-based idea or driving his team to higher standards of quality, and he always has the integrity of clinical research at heart. With many changes in the field of research today and the requirement to strengthen both business practices and work product, he supports the team with his extensive experience and perspective.

He encourages ideas from others and once a new idea begins germinating, he allows autonomy and flexibility in carrying out both strategy and tactics.

Dr. Adelglass provides an unparalleled opportunity to help others learn and implement what it takes to sustain not only a research site, but a network of sites. He believes in leading by example and always rewarding the achievement of others.

Starting companies and watching them grow and succeed while helping people live longer and stronger has been a true highlight for Dr. Adelglass.

“A great example of this is my new investment in Alphaeon, a lifestyle healthcare company dedicated to meeting individual healthcare and wellness goals," he says.

Next on the agenda is to focus on new therapies in lifestyle medicine and healthcare, and he is writing a book on the topic called “Body Computing for the Advancement of Healthcare."

In addition to his own companies, Dr. Adelglass has served on the advisory boards of several pharmaceutical companies, performing an indispensable role in consulting on protocol design and development.

He is a Fellow of the American College of Surgeons, the American Academy of Cosmetic Surgery, the American Academy of Facial Plastic and Reconstructive Surgery, and the American Academy of Otolaryngology and Head and Neck Surgery. He is also a Fellow of Pharmaceutical Medicine of the Royal College of Physicians in the United Kingdom, which is a demonstration of the international recognition his work has received.

As a resident of Dallas, Dr. Adelglass is chair of the Dallas Mayor’s Task Force on high technology/biotechnology, driving forward the city’s goal to promote and expand the sector.

Getting to Know…
Jeffrey Adelglass, M.D.
Title: Medical Director and Founder
Company: Research Across America
Education: M.D., George Washington University; FACS, University of New York at Stony Brook
Family: Wife, Barbara Adelglass; two children; granddaughter, Zella Adel
Hobbies: Reading, traveling, movies, and looking for new opportunities
Bucket List: Leave an incredible footprint and see the world
Awards/Honors: 2014, Skinstastic, Best Facial, Addison Magazine; 2013, Best Plastic Surgeon, Plano Star Courier, Plano, Texas; 2011 and 2012, Best Place to Work, Dallas Business Journal, Dallas
Associations: Fellow, American Academy of Cosmetic
Surgery; Member, American Academy of Facial Plastic and Reconstructive Surgery; Fellow, American College of Surgeons; National Education Committee for Botox; Certified Site for Pollen Counting Station (Dallas); American Academy of Allergy, Asthma and Immunology Aeroallergen Network
Social Media: LinkedIn, Twitter, Facebook, Google+, YouTube, Pinterest, Flickr

Download PDF