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PharmaVOICE Staff

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These visionary leaders recognized an opportunity to fill an industry need and are successfully leading their companies to new heights.

Do you have CLAS?
(Culturally and Linguistically Appropriate Strategies)

Igniting change by…
Having courageous conversations about race, ethnicity, culture and health in America

Sheila L. Thorne
Title: Founder, President, and CEO
Company: Multicultural Healthcare Marketing Group LLC
Education: B.A., Hunter College of the City University of New York
Personal Awards: Unsung Heroes Award/National Black Leadership Initiative on Cancer
Company Awards: Nominated Obamacare “Champions for Coverage” by The White House Office of Public Engagement
Community Awards: Patient Advocate of the Year, Englewood Hospital Medical Center; Freedom Fund Healthcare Award, NAACP; Citizen of the Year Health Award, Omega Psi Phi Fraternity; Community Service Award, Elks Civil Liberties Division
Associations: Students 2 Science; Summit Health Institute for Research and Education; National Association of Black Law Enforcement Executives; Medical, Marketing & Media Editorial Advisory Board
Hobbies: Music, dance, art
Twitter handle: @sthornemhmg

Sheila Thorne started her company Multicultural Healthcare Marketing Group LLC back in 2003 at a time when very few were thinking about diversity, inclusion, or equity in commercial operations. But Sheila was. And she has continued to evangelize that stakeholders across the industry need to acknowledge and work to address and dismantle systemic and institutional racism in the healthcare system.

As a former senior executive with global experience working with several preeminent healthcare marketing and communications companies, Sheila brings an international perspective to health and healthcare marketing strategies.

Over her storied career, she has worked with healthcare professionals around the world representing the top 50 pharmaceutical, biotechnology, and medical device companies and 20 U.S. hospital systems in the clinical research and marketing of prescription medicines and consumer health products to people of color.

Anybody who has been in her presence for more than two minutes immediately recognizes that Sheila is a force of nature. She is undaunted by the word “no,” she is courageous in the face of adversity, and she simply ignores barriers that try to prevent her from advocating the ideals that she has been espousing for more than two decades.

She describes her leadership style as collaborative, motivational, and educational, which makes sense as Sheila is a former high school teacher of foreign languages as well as serving in professorial roles at several universities and colleges.

Connections are everything, and Sheila, a natural convener, has developed long-standing relationships with numerous health leaders of Black, Latino, Asian, and Native American medical societies and has worked extensively with Congressional Black and Hispanic Caucuses, National Black Caucus of State Legislators, National Association of Latino Elected Officials, and the Asian-Pacific Islander American Health Forum.

She is known for sparking innovation and engaging diverse community partners who can address and affect social determinants of health. “I lead by example,” she says. “I ‘walk’ the diversity ‘talk’ through the health programs and campaigns that I develop from molecule to market.”

And by listening to diverse patient stories and using the insights learned, she and her team have developed evidence-based programs, strategies, and tactics that have received wide acclaim and awards, including the NAACP Freedom Fund Award for her efforts to seek quality healthcare for all, the National African American Leadership Initiative on Cancer “Unsung Heroes” Award, and the Community Service Patient Advocacy Award from Englewood Hospital Medical Center.

Sheila also was recognized by The White House Office of Public Engagement for her volunteer work to educate communities of color in New York, New Jersey, and Washington, D.C., about the landmark Patient Protection and Affordable Care Act (Obamacare).

Sheila says the best advice she ever received was from her mother, a nurse, who told her: speak truth to power; be a woman of your word; have integrity; never forget who you are; and embrace and be proud of your cultural heritage. (PV)

Seize new opportunities

Blazing new trails to…
wipe the old ways of doing business off the board and
rethinking how to grow and sustain our business in the new world of medical education

Dave Oury
Title: President and Founder
Company: Medical Leverage
Education: B.S., Finance and Real Estate; University of Arizona
Associations: Forbes Agency Council; Mentor University of Arizona, Eller College of Management; American Medical Writers Association; International Society for Medical Publication Professionals; and the Council of Science Editors

Dave Oury, founder of Medical Leverage, was recently asked to join the Forbes Agency Council, an invitation-only community for owners of and executives in successful public relations, media strategy, creative, and advertising agencies. He was vetted and selected by a review committee based on the depth and diversity of his experience. Criteria for acceptance include a track record of successfully impacting business growth metrics, as well as personal and professional achievements and honors.

This honor, along with being named to the 2021 PharmaVOICE 100, are true testaments to his ability to lead both as a mentor and as an expert in the business of medical communications. Over the past 20 years, Medical Leverage has worked with more than 100 client companies, helping to launch over 75 new products, with brand revenue greater than $50 billion. Medical Leverage’s average client retention span is a whopping seven years.

Starting out, the company consisted of just three employees trying to figure out how to execute and manage each individual project. Today, the agency employs nearly 30 full-time employees, with single-digit turnover rates. “Through the help of many, we have built a sustainable company, exponentially growing year-on-year, with high standards of excellence for the clients we serve, and for the patients our clients’ medicines provide benefit to,” Dave says.

Over the course of his career, Dave has personally led more than 250 advisory boards, championed the development of various state-of-the-art platforms to support small to mid-sized pharma companies, developed important relationships with hundreds of thought leaders and experts across numerous therapeutic areas, and participated in a leading role for the successful launch of hundreds of products and biotech devices. He has developed a creative team of writers, developers, and designers to support the creation of medical, training, and promotional materials. His participation in international committees for the design of product marketing, communication, and commercial plans has allowed him to partner with clients over the past 20 years to support their key strategic imperatives.

Dave has not only created a successful company that partners with pharmaceutical and biotech companies through the development of seamless services and deliverables, he also continually mentors individuals to high levels of performance. Dave is truly a “talent developer” to his core. He has the ability to identify the gaps that would make a project, idea, person, or presentation truly excel.

Investing time and resources in finding the right people to help create the right culture, process, platform, and training pays off in the long run, which Dave says is one of the important lessons he has learned through his career.

Colleagues say Dave is one of the nicest guys in the industry. His company has grown steadily since its inception, and in 2021 it will double in size. Co-workers credit Dave’s communication style, strength, and his character for this exponential growth.

One of the formulas for Dave’s success is that he has infused a few large pharma protocols into the way Medical Leverage operates. From the moment one of his employees is onboarded, they become indoctrinated into living every workday by these guiding principles. The weekly departmental meetings follow the same doctrine and use a scorecard to measure the past week’s productivity. Each meeting starts with the members of that department giving their professional and personal best moments from the previous week. Quarterly goals are set, issues and to-do’s are discussed, and every meeting ends with rating it on a scale from 1 to 10 based on efficiency and effectiveness. This practice has created a work environment that motivates and empowers employees while rewarding them for their efforts, both in salary and year-end bonuses.

To maximize the talent, he is constantly evaluating to ensure that each employee is not only the right fit for the company, but they are sitting in the right seat. It is common for employees to switch roles within the organization, which allows them to better use their specific skill set. This allows both the company and employee to continue to grow and learn while increasing company output.

Dave strives to live by standards instilled in him by his parents: Work hard, be fair, and good things will happen. He adds to that his own advice: Listen more than you speak; give more than you take; treat people better than you expect to be treated; and, make fun of yourself, not others. Be happy.

Colleagues say he truly embodies these core values and more, and represents what being a great person and leader looks like. (PV)

There’s always a way

Igniting change by…
engaging in Partnerships that bring problem solvers together

Amir Malka
Title: CEO and Co-founder
Company: Bioforum the Data Masters
Education: Commercial law, Bar-Ilan University; B.A., Law, Netanya Academic College
Associations: Society for Clinical Data Management (SCDM), Clinical Data Interchange Standards Consortium (CDISC)

Amir Malka had a vision to create a community focused on knowledge-sharing and connecting life-sciences professionals from the academic, business, and government sectors. To fulfill that mission, Amir established Bioforum in Israel in 1998, and along with his co-founders, he identified not only a need, but an opportunity.

What developed is the Bioforum Applied Knowledge Center, renowned as Israel’s leading and a one-of-a-kind forum for biomedical education and training that offers practical courses, conferences on timely topics and trends, and professional development seminars. To date, Bioforum has trained more than 150,000 individuals and hosted nearly 3,500 educational events on analytical chemistry, regulatory affairs and quality assurance, among many other topics.

A decade later, in 2008, recognizing the impact of new technologies on clinical trials, Amir saw another opportunity to develop an additional knowledge base for the Israeli market, one focused on the efficient collection, standardization, and reporting of clinical research data, as well as clinical supply chain management. However, this time he took it a step further, building interdisciplinary, cross-functional teams of experts who can also provide outsourced support and scale to life-sciences organizations of all sizes.

Beginning with clinical data management, Bioforum’s core competencies quickly grew to encompass biostatistics, statistical programming, and medical writing capabilities. From established life-sciences organizations to emerging biotechs to medical device startups, Bioforum’s data masters help clients improve and innovate data processes to optimize clinical trials and, ultimately, accelerate the delivery of new medical treatments to patients.

Delivering quality and building trust are the top priorities and at the heart of every engagement at Bioforum. As Amir reminds his team: “People care about people and relationships matter. First and foremost, we’re here to serve patients. Second, partners must be a team and a real team is like a trusted family. Getting to know colleagues and clients, and what’s important to them, being in the trenches together, and providing value at every turn — whether navigating success or failure — is what enables trust and strong, long-lasting partnerships.”

This partnering philosophy has been Bioforum’s north star and what has enabled the company’s consistent growth in Israel and, more recently, around the world. Today, Bioforum has an established global footprint, serves more than 100 customers and employs more than 170 people between Israel and its subsidiaries in Australia, South Africa, and the United States.

While Bioforum has experience across therapeutic areas and as a partner to a diverse range of clients, the company’s specialty is working with small biotech companies, medical device startups, and other emerging life-sciences companies. As Amir says, these companies are playing a significant role in driving successful clinical trial innovation, responsible for much of the life-sciences industry’s R&D pipeline in recent years. “And now, more than ever, these smaller organizations are under pressure to get CRO and vendor partnerships right from the start, much more so than big pharma,” he says. “Emerging companies cannot afford missteps that cost them time and money, such as delays, out-of-scope change orders and cost overruns. For many, one poorly designed clinical trial could end their existence.”

Clients say Amir has built a company that acts as a partner in every way. He asks questions and listens carefully, thinks big and delivers bigger. As challenges come up, Amir and his team are responsive and creative, finding solutions and, when needed, connecting clients with experts throughout the industry who can help identify more options.

Colleagues also are deeply inspired by Amir’s patient-first worldview. Those who have worked with him describe Amir as a caring, collaborative, and visionary leader who does what he says he is going to do and fosters a company culture that is nurturing and empowering. He consistently challenges colleagues to self-assess and be forward-thinking, considering what Bioforum should continue to do, stop doing and start doing.

Amir is committed to developing talent and giving people opportunities to try new things, gain experience and advance their careers within the organization, encouraging company leaders to take into consideration each person’s strengths, varied professional backgrounds, and personal motivations. Colleagues say he is always the first to offer his support to aspiring executives and that Amir has been a long-term advocate for women in the workforce, dedicated to developing, mentoring and promoting women across the industry and within Bioforum, where they make up 75% of senior management.

“When you care, you do your best work, and can make a real difference, and there are so many incredibly caring and talented people in this industry,” Amir says. “I have and continue to benefit from mentors who provided guidance, encouragement, and opportunities. They made a huge difference not just in my career, but in my life. I think we have a duty to pay it forward, so that future generations can continue to carry the torch and keep making a difference, especially for the patients we’re all here, in this industry, to serve.” (PV)

Unleashing the potential of game technology

Igniting change by…
advancing neuroscience of game design

Sam Glassenberg
Title: CEO and Founder
Company: Level Ex
Education: M.S., Computer Science, Graphics, Stanford University ; B.S., Computer Engineering, University of Illinois Urbana-Champaign
Personal Awards: MM+M 40 Under 40, 2021; MM+M’s Top 40 Healthcare Transformers, 2019; PM360’s ELITE Winner in the Entrepreneurs category, 2019
Company Awards: Fast Company World’s Most Innovative Companies — Health category, 2021; Chicago Inno’s 2020 Inno on Fire list, 2020; PM360’s Most Innovative Products, 2020; Fast Company World’s Most Innovative Companies — Gaming category, 2020; One of Built In Chicago’s Best Small Places to Work, 2019; Medical Design Excellence Award for Pulm Ex game, 2019; SIGGRAPH’s Real-Time Live! audience choice awards (2018, 3rd place; 2019, 2nd place); Variety, Best Entertainment-Based Mobile Game, 2013; Webby Awards, Best Tablet Game (Academy and People’s Choice), 2013; Top 10 Most Promising Companies in Israel, 2012; Technical Emmy, National Academy of Television Arts & Sciences, accepted on behalf of the DirectX team, 2007
Community Awards: Jewish United Fund: 36 Under 36, 2015
Twitter handle: @samzg

Artist, engineer, manager, and executive — Sam Glassenberg has been all of these across multiple industries. After developing cutting-edge video game technology at LucasArts and then Microsoft, Sam began creating companies that would revolutionize how game technology and design could be leveraged by other industries. He built and sold Funtactix, which created groundbreaking movie-based games on platforms like Facebook, iOS, and Android. Then he founded Level Ex, which uses video game technology and design to improve physician skills and accelerate the adoption curve for new techniques and technologies in healthcare.

“We’ve united a team of world-renowned game developers, artists, designers, and expert physicians to take the best technology and neuroscience-based design from the video games industry and apply it to medicine,” he says.

Under Sam’s leadership, Level Ex has been able to influence many real-world outcomes by pioneering cloud gaming technology to enable collaborative virtual surgery, disseminate COVID-19 best practices, and help to improve medical skills.

Level Ex has grown from about 10 employees in 2017 to more than 130, and has more than 750,000 medical professionals playing its games.

Sam and his team work with more than a dozen of the top 20 life-sciences companies as well as medical societies and government organizations.

A forward planner and thinker, Sam kept tabs on what was going on in Asia in January 2020 and by February he had convened the IT team in preparation to work from home, before the pandemic was on anyone’s radar. He and his team found creative ways to keep employees engaged and connected.

“For example, we host ‘Game Jams,’ intense, 48-hour competitions in which we break into teams and create wildly imaginative, fully functional games from scratch,” he says. “We also have Game Days throughout the year when employees take part of their work day to play board and video games, relax, and hang out. Whether it’s themed remote happy hours or Level Ex custom memes and emojis in Slack, we use our inventive mindset and abilities to find fun ways to stay connected across departments.”

He encourages his employees to be inspired by their colleagues and to trust one another to supplement and share knowledge.

As a leader, he draws on his many experiences to ensure his employees have the tools and freedom to live up to their full potential. For example, he draws on his experience as a technologist to ensure current technology limitations don’t get in the way of what an artist is trying to achieve. “As a leader, I strive to make sure that the business enables and supports the vision and not the other way around,” he says.

Sam’s hope is that his achievements at Level Ex can help to reimagine the pharma industry’s relationship with medical professionals.

“In the games industry, I want to be remembered for doing my part to create an entirely new genre of medical games, since genre creation is the apex achievement in the field,” he says.

Mentoring matters to Sam, who also gives talks at schools to kids of all ages and socioeconomic statuses where he speaks about how games are created and about careers in the industry. (PV)

On the frontline for patients

Igniting change by…
Truly personalizing medicine — I think we’re just beginning

Amy DuRoss
Title: Co-founder and CEO
Company: Vineti
Industry Awards: San Francisco Business Times’ Most Influential Women in Bay Area Business, 2020; Aspen Institute Health Innovators Fellow, 2018
Company Awards: Technology Pioneer award from the World Economic Forum in 2019 as a company with the potential to improve society for years to come
Community Awards: Fellowships with the Coro Foundation and the Aspen Institute
Associations: Alliance for Regenerative Medicine Foundation (Board), Aspen Global Leadership Network, Americans for Cures
Twitter: @DurossAmy

Some people tackle healthcare gaps and disparities by raising awareness, starting petition drives, or conducting a study. Then there’s Amy DuRoss, who is taking on some of the biggest medical innovation challenges of our time by rolling up her sleeves and finding new ways to bring cell and gene therapies to patients.

Her activism for patients began with pushing for additional research funding for Type 1 diabetes, which led to the unanimous approval of a $1.5 billion congressional bill. By the time she was 30, Amy was leading the successful campaign for Proposition 71, which has poured billions of taxpayer-supported funds into stem cell research in California.

Today, as co-founder and CEO of Vineti, Amy is again laser-focused on patients. Vineti was established to solve the challenge of providing personalized therapeutics, such as CAR T cell therapies, at a scale to reach all in need, at a cost that the healthcare system can sustain, and with the safety required for patient and clinician confidence and trust.

“I feel most alive when I am engaged in the hard work of driving change that ultimately is geared toward reducing human suffering,” Amy says. At the same time, the mental, physical health, and safety of patients, teams, and partners does keep her up at night. “I am a chronic worrier,” she says.

A visionary leader, Amy has not let the pandemic prevent her from pushing ahead. She has secured more than $68 million in Series C funding for the company, recruited a world-class executive team, and helped to secure significant collaborations, including a partnership with Cardinal Health, to support cell and gene therapy manufacturers.

“Since patients sit at the center of our work, I rely on patients’ perspectives and try to find opportunities to reinforce that perspective among my team,” she says.

Taking a servant-leadership approach, Amy sees her job as elevating teammates with different expertise from her own and resourcing them for success. Her primary obligation, she says, is taking care of the team in all areas.

Over the past 18 months, empathy has been key to her leadership success. To stay in touch with her staff and keep people motivated during the pandemic, Amy started sending out weekly emails where she shares wins, tells stories, addresses concerns, and checks in on the well-being of her team. This communication has evolved over the last year and a half and will continue into the future. It is a communication employees look forward to reading weekly. Vineti also instituted mental health days in months when there aren’t annual holidays, which are Zoom-free and meeting-free by design.

“The lovely thing about our team is we really have managed to find a new way of communicating together, and there is a fundamental level of respect for this various domain expertise and this broad sort of hybrid team,” she says. “I have never been more challenged than in this particular role with this company. I am constantly attempting to bridge gaps and create a common understanding.”

The pandemic has introduced new pressures but created opportunities for all companies. “We must all come together to solve this challenge and keep other parts of the healthcare ecosystem moving forward at the same time, including the advanced therapies that Vineti provides,” Amy says. “I plan to keep doing all I can to help provide solutions and save lives.”

To keep the team inspired, Amy consistently reinforces the bigger picture: Vineti’s mission — a company purpose-built for personalized therapies — and why this is important to patients. “We are personalized therapy innovators who are ambitious in our aim to serve patients and transform healthcare,” she says. “The Vineti team works every day to enable those goals. Together, we will help advanced therapies reach more patients, faster.”

One of the tough lessons Amy has had to learn as a CEO is how to compartmentalize.
“Learning how to actively listen, take in all the input, and compartmentalize it appropriately is very difficult to do, but it’s absolutely crucial if you’re going to be successful with any longevity,” she says. (PV)

Move your rocks

Igniting change by…
bringing clinical trials directly to patients

Rob Bohacs
Title: Founder and Chief Solutions Officer
Company: ClinOne Inc.
Company Awards: Top Ten companies to watch, 2019; Top Ten Patient Engagement Company, 2020
Associations: Board of Directors of the American Telemedicine Association
Giving Back: American Cancer Society
Hobbies: Anything to do with his kids and travel

When Rob Bohacs’ father was diagnosed with ALS, it became clear to him just how hard it was for patients to navigate the complex clinical research landscape. His parents lived 1,000 miles away and struggled with schedule coordination, communication, and transportation. The experience prompted him to found ClinOne, a virtual trial management company in 2016. Through ClinOne, Rob has built a world-class team to rethink how to support patients and their families through the clinical trial experience.

“We have partnered with more than 40 sponsors to enact real change and deploy technology to assist patients through their journeys,” he says. “I was very pleased to see our sponsors adopt new solutions very quickly during the pandemic, including eConsent and virtual visits, to name a few.”

While creating the vision for ClinOne, Rob spent countless hours at research sites to understand the challenges they faced. He saw nurses and principal investigators inundated with so many tasks and paperwork that there was often little time or energy left for patient care. He was determined to fix it by building a single virtual trial platform that features solutions from automated physician referrals, enterprisewide eConsent, and a patient portal to Uber Health transportation, eCOA, and connected devices for activity and safety monitoring.

Rob says every study assignment has its unique set of challenges. Aligning new sponsors and deploying technology that is intended to support the patient journey using newer technologies and newer approaches tend to have slow adoption.

“But we are making progress as an industry and I am proud that ClinOne is a part of that ongoing transformation,” he says.

As a leader, he inspires by aligning everyone to a common mission and helping to align the organization, teams, and employees’ personal goals. “Beyond building a great company that has an impact, I enjoy seeing the team growing in their capabilities and challenging themselves, establishing goals, and seeing (and at times helping) our team members achieve new levels of success,” he says.

Results-oriented, he sets goals and delights in seeing progress across the organization and individuals as they continue to succeed.

As an immigrant from Hungary who escaped Soviet rule and spent a year in a refugee camp as a child, Rob realized early that nothing in life worth having is simply handed to you.

“I’ve been inspired to work hard — probably much harder than I ever anticipated — to drive success,” he says. “And it is easier to do that when you are passionate about what you do, because at the end of the day you are helping patients and their families live better lives.”

Rob believes in people — the patients in clinical trials, the caregivers, family members, site staff, and the team of world-class professionals he works with.

“My goal is to build an amazing company led by exceptional individuals who empower the patient and the caregiver through their journey,” he says. “I would like to be reflected on as a leader who brought together a team of professionals for a common good to overcome a major challenge in the industry. We must stop talking about patient-centricity and start living it.”

During the pandemic, ClinOne has continued to grow, doubling its headcount over the past 12 months.

“I still have not met in-person half the people who run ClinOne with me,” he says. “Recently, we held our first live leadership team meeting since the pandemic began, in Philadelphia. It reinforced how much I miss interacting with people, building real relationships, and aligning on our goals by throwing ideas around in a room for a couple of days. Honestly, it has been challenging engaging teams remotely, and though I am proud of how we’ve come together and grown as a company, I am excited to get back to in-person meetings so we can really thrive as a unified team.”

Rob says next-generation leaders are few and far between, but they are critical to building an amazing team. “The clinical trial industry is in need of leaders to bring innovation and drive change,” he says. “Fortunately, the next generation of leaders who are coming into their leadership prime grew up with mainstream technology adoption and they aren’t afraid of changing the status quo. I welcome the fresh air and new approaches that will only benefit patients in the future.” (PV)

Power through to the other side of cancer

Igniting change by…
challenging precedents

Philip Astley-Sparke
Title: CEO and Founder
Company: Replimune
Education: B.Sc., Bristol University, UK
Giving Back: Mental health

For the past 20 years, Philip Astley- Sparke has focused on a mission to make oncolytic immunotherapy a cornerstone of oncology treatment regimens. As CEO for BioVex, which was acquired by Amgen in 2011, he led the development of Imlygic, the first and only FDA-approved oncolytic virus. Although it has been 10 years since the completion of BioVex’s Imlygic trials, he stays in touch with the patients treated with the drug. Imlygic’s final results showed it could cure one in four patients with previsceral disease.

Philip’s belief that cancer patients, if treated with an oncolytic earlier in the course of their disease, can be cured motivated him to co-found Replimune with Imlygic’s inventor, Rob Coffin in 2015. Replimune’s oncolytic immunotherapies have the potential to redefine the cancer treatment paradigm through igniting a patient-specific anti-tumor immune response systemically throughout the body. These therapies are designed to not only treat a patient’s cancer, but to also vaccinate against future relapse. Starting from a blank sheet of paper, Replimune’s innovative platform has produced three programs that have all advanced into the clinic, dosed several hundred patients, and demonstrated clinical proof of concept in late- stage patients who have exhausted all other therapies.

However, Philip’s aim is to drive Replimune’s well-tolerated products earlier into disease courses to prevent more patients ever getting end stage disease across multiple tumor types. Under his leadership, the company has raised more than $600 million and now employs 180 people.

The company has also built a GMP manufacturing facility. Many companies elect to outsource this function to mitigate high upfront capital requirements and risk, but Philip made the strategic decision to go the other way and, where others see manufacturing as a risk, Philip saw this as an opportunity. He believed that centralizing and owning the manufacturing function would lead to core expertise that would separate and differentiate Replimune from other emerging companies in the oncolytic immunotherapy space.

A model for corporate good behavior, Philip applies integrity and rigor to every circumstance. In all business and personal relationships, he epitomizes the philosophy of “put yourself in someone shoes.”

Colleagues say this is what makes him an excellent negotiator because he always thinks about and understands what his counterparty’s interests are. He can easily understand the perspective of investors, potential partners, or employees.

Philip also serves as chairman of uniQure, a gene therapy company developing curative treatments for patients with rare genetic diseases. He was instrumental in establishing the company’s U.S. infrastructure, including the world’s largest gene therapy manufacturing facility.

With a grounded and humble management style, Philip is focused on building the right teams and enabling team members to advance transformative cancer treatments. “Each role requires different characteristics; the blend is what is important, so I don’t look for a common theme other than people who are able to get stuff done with minimum of fuss and who are concise and direct communicators,” he says.

The company culture Philip has built is one of camaraderie, support, and drive to advance the mission in every way possible. He eschews office politics and barriers that get in the way of getting things done. He expects everyone, not just the members of his C-level team, to have and express their opinions. He believes all ideas are to be entertained and as a matter of course to be robustly debated.

Philip also believes strongly in the philosophy put forward by Leo Tolstoy, which is “Many people think of changing the world but few think of changing themselves.”

“It’s a lot easier to control yourself than others, and many issues can be avoided or resolved by mastering one’s own reactions to events,” Philip notes.

As a leader he says actions speak louder than words. “I believe in delegating as much as possible,” he says. “By hiring the right person for the right job at the right time, you are more than halfway home.”

Philip takes time to informally mentor and bring along the next generation of leaders. He takes pride in the accomplishments of others and is happy to provide guidance along the way.

He is of the opinion that the best way to inspire people is to praise them, quoting the Buddhist priest Nicherin: “When praised by others, there is no hardship one cannot bear.” (PV)

Orchestrating a better way

Igniting change by…
bringing out the best in others

Steve Viviano
Title: Founder and CEO
Company: QBFox Healthcomm
Education: B.S., Pharmacy, Rutgers College of Pharmacy
Personal Awards: Agency of the Year, MedAdNews; Agency of the Year, MM&M; Agency of the Year, PharmaTimes (London); QBFox 2019 Innovative Start-up Company of the Year, PM360; QBFox 2018 Agency to Watch, MM&M; QBFox Grand Prize Convincemetovax Creative Contest, MM&M, 2019; PharmaVOICE 100 honoree, 2012
Giving Back: Kiva
Hobbies: Playing guitar

While leading QBFox Healthcomm through the pandemic, Founder and CEO Steve Viviano found his center through one of his favorite practices. “Playing guitar has always been my creative outlet and stress reliever,” Steve says. “I have several of my guitars hanging on the wall in my home office, which during the pandemic allowed me to simply turn around and grab one for a quick interlude between meetings.”

At first, Steve thought about taking the guitars down to create more of a “work environment” for video calls. “But in the end, I left them because they are part of who I am,” he says. “And everyone loved it and this made everyone feel comfortable when facets of their own lives crept into meetings.”

Steve says working from home has given people a chance to share more of their “authentic” selves with teammates and colleagues. “Whether on purpose or not, a barking dog, a child walking into a Zoom chat, or even what we have on our walls in the background — all have given others a unique glimpse into ourselves. And I say bravo! It’s important to see what makes others tick, and that includes who they are when they are not just in the office.”

In keeping with his musical passion, Steve says he views being a CEO like being the conductor of an orchestra. “I don’t play all the instruments, but I am surrounded by top-level musicians,” he says. “My job is to lead them in a beautiful concert by understanding each of their strengths and knowing them well enough to understand how to bring the best out of each of them.”

Colleagues say Steve is a master at recognizing and assembling good talent that quickly gels into a cohesive, supportive team.

Steve says he likes to work with people who are great at what they do and bring a high level of expertise to everything they touch. “I also like people who care about others and who care about the work product that they and the team put out,” he says.

Trust is also important to Steve. “I do my job and live my life in a way that I hope shows people they can always trust me and what I say,” he says. “I expect the same from people I work with as well.”

Steve is a big believer in making the work fun. “In the end, we need to enjoy what we are doing, and I like to work with people who get that having fun is super-important,” he says.

This ability to have fun and not take any one issue too seriously has proved to be one of Steve’s most powerful assets during the pandemic. “I joke around a lot in the office to keep things light, even when deadlines are upon us or issues seem crazy,” he says. “I think in the beginning of COVID there was a lot of uncertainty about a lot of things: the health of everyone and their families of course, but also concerns about job security and even whether clients would be able to get through this. By continuing to keep the same fun approach to things, even as we all shifted to working from home and away from each other, kept our entire company inspired and motivated.”

Steve’s leadership style is collaborative, and he seeks everyone’s input even if the final decision ends up being his own. “Good, talented people appreciate that their voices and expertise are always being considered, and I find that the decisions are better when all points of view are listened to and considered,” he says.

Steve has run healthcare ad agencies for more than 20 years, and his agencies have been honored with agency of the year awards, as well as scores of creative awards and recognitions for brand performance. Amid all the accolades, he says creating QBFox has definitely been a career highlight.“While I have certainly enjoyed the success from the CEO vantage point at large agencies, the favorite part of my day has always been working directly with clients and helping them successfully drive individual brand performance — getting my hands dirty, as they say,” he says. “It’s something that CEOs of agency networks don’t get to do too often.”

Many of Steve’s former clients have remained friends over the years.

“When a couple of them approached me and asked me to start my own shop, it provided a terrific opportunity for me to get back to putting my own ‘hands in the soil’ and work closely again with my senior team of Chet Moss and Stacy Patterson,” he says. “Beyond that, starting QBFox has let me create the kind of agile, client-focused agency I always envisioned.”

Steve draws on his creative spirit for team motivation. “Part of inspiring others is getting them to see or feel what it would be like to do things the way you are suggesting,” he says. “I use the guiding phrase, ‘Imagine what we can create together’ as a way to make sure I am always reaching people where they are — whether it is getting my staff to work in a new and better way, or getting clients to sign up as partners with us.” (PV)

Happy is, happy does

Blazing new trails to…
better therapies

Brian Wamhoff, Ph.D.
Title: Chief Operating Officer, Head of Innovation, Co-founder
Company: HemoShear Therapeutics
Education: B.S., Biology, Rhodes College; Ph.D., Medical Physiology, University of Missouri
Company Awards: Southeast BIO Partnering Deal of the Year, 2017; Entrepreneur of the Year, CBIC, 2016; Tibbett’s Award for Excellence in SBIR Commercialization, U.S. Small Business Administration, 2014; GLG Leadership 15 R&D Member, 2014; U.S. Congress, Testified, Subcommittee on Science and Technology, 2013; Center for Innovative Technology (CIT) GAP 50 Entrepreneur Award, 2012; Charlottesville Business Innovation Council Rocket Award, 2012; Distinguished Alumni Award, Rhodes College, 2011
Associations: Board member, director of internships for the Charlottesville Tom Sox Collegiate Summer Baseball Team — 2017 League Champions, 2017 National Champions, 2019 League Champions
Giving Back: Mentoring entrepreneurs, coaching baseball, basketball, and flag football
Hobbies: Traveling with family and friends, coaching, cooking, Disney dad
Twitter handle: @Brian_Wamhoff

Brian Wamhoff, Ph.D., has passion: passion for science, patients, his team, his partners, and living. He cares very deeply about the work he does and the patients he will ultimately serve. Colleagues and collaborators say he is the type of guy who walks in a room and lights it up. Coupled with his passion, he is also a consummate entrepreneur. He has co-founded multiple medical device and therapeutics companies, including SoundPipe Therapeutics. He has authored or co-authored more than 70 papers and has been issued more than 10 patents.

Over a decade ago, Brian co-invented the HemoShear technology and directed the successful development of human models of the vascular system, liver diseases, and the tumor microenvironment. His efforts led to the launch of HemoShear’s proprietary drug discovery programs in rare metabolic diseases. What started as a CRO service company has evolved into a drug discovery organization leveraging the technology for which it was founded. Brian has been single-minded in advancing the Reveal-Tx platform in which he has a deep belief.

As HemoShear has matured, the focus has grown more toward rare diseases. Brian led HemoShear’s efforts to validate the cutting edge, human biology platform and advance the novel therapy for methylmalonic acidemia (MMA) and propionic acidemia (PA), two fatal inborn errors of metabolism for which no current treatment alternatives exist. Recently, the company has initiated the HERO (HElp Reduce Organic acids) study, a Phase II clinical trial investigating HST5040 for the treatment of MMA and PA in patients age 2 and older. The company has enrolled the first two patients in the Phase II clinical trial.

Children with these diseases rarely live into the second quartile of life. Brian has traveled across the globe to meet with world expert physicians and scientists in these diseases. He has met with patients and knows them and their families by name. He has simultaneously led the organization to find treatments for these underserved patients. His passion and scientific vision have fueled the formation of productive partnerships with Takeda in NASH and Horizon in gout.

“As a founder of HemoShear, I have worn many hats during this journey — head of R&D, head of innovation, chief operating officer, and office coffee maker — but at the end of the day, being a great partner and improving the life of a patient with a rare disease are always goal No. 1 in everything we do,” Brian says. “Every time I turn on a light switch at the Shear, that is what I remind myself. This goal, the patient, makes decision-making and focusing much easier for me.”

The highlight of his career has been working closely with caregivers, patients, scientists, and clinicians to discover a novel experimental therapy for propionic and methylmalonic acidurias for which no treatment exists. “Working in rare diseases brings you face-to-face with parents and their children, and that is an incredible gift,” Brian says.

Drug discovery is fraught with failure, and the big challenge is to shake it off and move forward when it does happen, he says. “The first time we terminated a preclinical program because it was unlikely to change the natural history of a rare disease patient was extremely difficult for me personally and for the organization,” he says. “We regrouped quickly and through incredible companywide leadership, perseverance, and grit, we now have a clinical-stage program in those same rare diseases.”

Colleagues say Brian believes drug discovery is the ultimate team sport. “I’m adamant about working in team settings and having fun,” he says. “I want our teams to be happy — happy people feel good about themselves and produce great results.” (PV)

Mission-driven, customer-focused

Igniting change by…
empowering all patients to have control
over their reproductive lives because access
to sexual and reproductive healthcare
should be a right, not a privilege

Ronda Dean
Title: President, CEO, and Co-Founder
Company: Afaxys Inc.
Education: MBA, Fuqua School of Business, Duke University; B.S. in Medical Technology, Ohio State University
Personal Awards: Charleston Business Magazine, South Carolina Women in Business, 2021; PharmaVOICE, Women of Influence, April 2021; Charleston Business Journal, Most Influential Women in Business, 2014
Associations/Boards: The New Morning Foundation and the Coastal Community Foundation of South Carolina; previously, Johns Hopkins Medical Institutions, the Storm Eye Institute at Medical University of South Carolina, Wings for Kids
Giving Back: The Gailliard Performing Arts Center, Wings for Kids, the International African American Museum

Responding to a pressing need to solve the public healthcare crisis, Ronda Dean co-founded Afaxys, a first-of-its-kind healthcare company and a socially conscious organization. Afaxys partners with the community and public health industry to ensure safety net healthcare providers have stable pricing and reliable access to the products and services they need to serve patients seeking reproductive and sexual healthcare.

Every year, more than 31 million Americans rely on community and public health centers to get essential care. During her 25-year career in the pharmaceutical industry, she heard hundreds of stories from men and women who relied solely on public health centers to get vital care.

“I saw how without these community and public providers — most of whom depend on politically vulnerable government funding, grants, and donations to keep their doors open — many people across the United States would have nowhere else to turn for their healthcare,” she says.

Ronda also saw that many public and community health providers struggled to serve their patients because they could not reliably access the cost-effective products they needed, and often might have to change the contraceptive product they had chosen because the supplier raised the price or because supply was unpredictable. This is incredibly disruptive to women, as many contraceptives need to be taken on a stable, consistent schedule. “After identifying this need in the market, we founded Afaxys — the company’s name intersects affordable and access — to deliver a stable, affordable supply of products and services that providers need for their patients,” she says.

Today, Afaxys serves more than 10,000 health center locations across the United States, profitably launched 10 oral contraceptives, two emergency contraceptives and a birth control shot, and earned the title of leading provider of oral and emergency contraceptives in U.S. community health centers. Afaxys has additionally saved customers millions of dollars on supply purchases through its group purchasing organization.

Ronda is resourceful in her approach, and together with her business partner Susan Overly, overcame each challenge by leveraging their skills and expertise, and finding the right people to fill the gaps. By December 2012, Afaxys had its first FDA product approval.

Ronda zeroes in on the company’s mission and ignores distractions, which has enabled her to grow Afaxys from a startup to one of the largest providers of oral and emergency contraceptives in U.S. community health centers in just over a decade.

“I ensure we are attuned not just to what providers and patients need today, but also how changes in the political and industry landscape affect how healthcare is delivered and paid for, and then adjust as necessary,” she says.

Ronda shares her experience, vision, and passion with others through mentorship and engagement. She shares her knowledge with women in a variety of ways, including through a young entrepreneurs program with the Committee of 200.

“Helping others to find their place of belonging and their path forward, especially when they feel they don’t fit a particular mold, always excites me,” she says. “I recently mentored a young female entrepreneur; it gave me great pleasure to watch her grow and prepare for her next steps. I could see the future in her eyes.”

She says the pandemic underscored the critical role that the community and public health sector plays in the healthcare system and how important health centers are to ensuring that all patients have access to essential care. “As an essential business, we’ve all been motivated during these times to help our customers navigate this new normal of remote work — and remote healthcare,” she says. (PV)

Igniting change for a better world

Sparking innovation by…
enabling patient-centric clinical trials to be accessible to a broader and more diverse patient population

Veer Mehta
Title: Founder and CEO
Company: Halo Health Systems
Education: M.S., Software Engineering, University of Texas at Dallas; B.S., Computer Science, University of Texas at Dallas
Giving Back: Support organizations in the U.S. and India focused on providing food to underserved and impoverished communities
Hobbies: Big fan of Masters of Scale podcast by Reid Hoffman, co-founder of LinkedIn
Twitter: @halohealthio

After spending 15 years in product development in the medical device and pharma industry, Veer Mehta founded Halo Health Systems in 2019 with the goal to create a digital health company that is focused on elevating the patient experience in clinical trials.

As a next-generation clinical trials business, Halo Health uses digital solutions to reduce costs, provide greater operational efficiencies, and create higher patient engagement.

“The end-goal of the trials has not changed, it is to show the clinical safety and efficacy of drugs,” Veer says. “Our mission is to enable patient-centric trials that reduce the patient burden of having to go to specific locations to participate in a trial and, in turn, provide a larger and more diverse trial population to sponsors. It has been exciting to begin to see the industry and regulatory agencies embrace alternate models, including hybrid and decentralized trials that are driven by digital technologies.”

The challenge has been to influence large pharma companies, medical device companies, and contract research organizations to embrace digital transformation in their clinical trial processes.

“I’m sure there is comfort in the business-as-usual approach,” Veer says. “The difference is the world around them is going digital and there are new solutions that can greatly expand the reach, diversity, and impact of their clinical studies.”

Veer’s goal is to continually look for ways to have a positive impact on patient lives — be it through patient-centricity in clinical trials or an improved standard of care.

“To achieve this mission, I’m going to continue to develop digital systems that bring patients faster access to clinical trials, new FDA-approved therapies, and better remote care,” he says. “I know that in many situations, time is of the essence and access to care will definitely save lives.”

He draws on his inquisitive nature and willingness to listen to others to look for innovative ways to solve problems and improve on existing products, solutions, and operational procedures.

As a business leader and technologist, he takes an outside-in approach to understand what the customer is doing, what obstacles and challenges they face, how solutions can make them more efficient and productive, and how their end customer will be impacted.

Before starting Halo Health, Veer had an employee whose wife had a terminal illness, yet the family was struggling with coordination of care and access to new drug therapies.

“This led me to look into the challenges associated with drug development and the associated clinical trials,” he says, noting these included poor publicity around trials, patient journeys to specific locations, labor-intensive paper recording, and lack of real-time insights into patient data.

After evaluating all of these issues and backed by his industry experience, Veer founded Halo Health Systems. He leads the company by clearly defining the mission and making sure the why is understood.

“I believe in inspiring my organization by sharing our strategic direction, what we are trying to achieve, and how we are going to get there,” he says. “I want employees to understand our common goals and the role they play in the journey. By empowering employees, I have been able to create strong teams. I also understand the importance of situational leadership and can quickly adapt based on a given situation.”

He relies on advice provided to him early on in his career: results matter but the journey the team takes matters more.

Having had a fantastic mentor as he was moving up the ranks, Veer wants his employees to have a similar experience.

“I focus on providing accessible guidance and building trust with the employees while serving as a mentor,” he says. “With trust as the foundation of the relationship, it is amazing to see how comfortable the mentee-employee is in every interaction. They know I am open-minded and will always listen to their input and provide honest feedback. They also know that I want their feedback. You never know where the next great idea will come from.” (PV)

This you can trust

Sparking innovation by…
starting new things myself

Grant McFadden, Ph.D.
Title: Co-founder, Research Advisor, Director
Company: OncoMyx Therapeutics
Education: B.Sc., Ph.D., Biochemistry, McGill University
Personal Awards: IOVC Organizing Committee
Company Awards: Royal Society of Canada, Fellow, 2004-present; Canadian Academy of Health Sciences, Fellow, 2005-present; Howard Hughes Medical Institute International Scholarship, 2005-2008; American Academy of Microbiology, Fellow, 2007-present; Beijerinck Award Lecturer, Amsterdam, the Netherlands, 2009; Sidney E. Grossberg Lecturer, Medical College of Wisconsin, WI, 2009; Remi Amelunxen Symposium Lecturer, University of Kansas (Keynote), 2011; University of Florida Research Foundation (UFRF) Professorship Award, 2012-14; University of Florida College of Medicine Basic Science Research Award, 2013; Danny Thomas 2014 Lecturer, St Jude Children’s Research Hospital; Elected President, American Society of Virology, 2015-16; Keynote Speaker, International Union of Microbial Sciences, Singapore, 2017
Community Awards: ASU 1967 Graduates Lecture (at Biodesign), 2017; March for Science (Washington, DC), 2017; ASU/Biodesign VIP Presentation, 2018; CEM Undergraduate students’ presentation, 2019; Glendale Community College, AZ; Biotechnology Course (Invited lecturer), 2019; Wise Guise II Speaker series (Scottsdale, AZ), 2020; ASV/ASM COVID-19 Vaccination Zoom-based Public Town Halls, 2021
Associations: American Society for Virology, Member, 1982-present; American Society for Microbiology, Member, 1982-present; American Society for Leukocyte Biology, 1995-2016; American Association for the Advancement of Science, Member, 1989-2016; Who’s Who in Science and Engineering, Inductee, 1995-2016; International Cytokine Society, Member, 1997-2016; Faculty of 1000, Member, 2001-2017; American Society of Gene and Cell Therapy, Member, 2011-present; AAAS, Member, 2021-present
Giving Back: United Way
Hobbies: Biking, hiking, reading, traveling
Twitter handle: @grantmcf_grant

Grant McFadden, Ph.D., epitomizes the phenotype of the scientific genius underpinning breakthrough therapeutics for patients in need. He is the co-founder, research advisor, and director of OncoMyx Therapeutics, an oncolytic immunotherapy company. He is also the director and professor at Arizona State University’s Biodesign Center for Immunotherapy, Vaccines, and Virotherapy. A true visionary, his diligent work in the field of oncolytic viruses has inspired a generation of scientists, contributed to the scientific cannon, and led to the formation of two companies — OncoMyx and Viron Therapeutics.

Co-founding OncoMyx from scratch, along with Steve Potts and Mike Wood, was a career highlight. It also has been his most challenging assignment in terms of raising Series A funding, which still keeps him up at night.

Just this summer, OncoMyx Therapeutics extended its intellectual property portfolio to include an exclusive option to license IP rights for the use and delivery of myxoma virus to treat certain cancers from the University of Florida Research Foundation (UFRF). Dr. McFadden developed the IP with his collaborators when he was a professor at the University of Florida College of Medicine.

“In modern approaches in oncolytic viral therapy, the myxoma virus is the only platform that can be both multi-armed and systemically delivered in hematologic cancers,” Dr. McFadden says. “OncoMyx has built a leading technology platform generating multi-armed myxoma virotherapies with demonstrated ability to modulate anti-tumor immunity and be systemically delivered for broad cancer killing potential. I am pleased to see OncoMyx continue to add to our IP portfolio as the company builds a pipeline of oncolytic immunotherapies that have the potential to be new pillars in cancer care.”

Last year, OncoMyx Therapeutics unveiled preclinical data showing its engineered rabbit pox virus therapy could slow tumor growth in mouse models of melanoma and bone cancer.
Recently it unveiled more preclinical evidence, this time in non-small cell lung cancer (NSCLC). Dr. McFadden’s lab studies how poxviruses that cause immunosuppression interact with the host immune system. The McFadden lab pioneered the field of viral immune subversion, also called anti-immunology, and is credited with the discovery of a wide spectrum of virus-derived inhibitors of the immune system. His lab also investigates host-virus tropism, and the deployment of poxviruses for oncolytic virotherapy for the treatment of cancer, particularly with a rabbit-specific poxvirus called myxoma virus (MYXV). Colleagues says this platform has the potential to treat up to 75% of all solid cancers and greater than 90% of liquid tumors.

Some of the best advice he ever received was: Find what you love to do, and become the world expert in it. Time will tell, but to date few scientists have contributed as much as Dr. McFadden has to cancer care.

With a career that has exceeded his expectations, his leadership in harnessing a virus for good has been noticed by others on local, national, and international levels and has brought heightened awareness of the scientific innovation. The city of Phoenix and the Phoenix Biomedical Campus have already felt Dr. McFadden’s impact. Based on his expertise, OncoMyx is expanding its presence on the Phoenix Biomedical Campus.

Colleagues say Dr. McFadden’s passion for what he does is continually inspiring to others. When he first shares the unique story of this virus and how it can impact the future of cancer treatments, it brings hope that certain cancers can be beaten soon.

His passion and commitment have also garnered the interest of others to join him on this journey, either in the academic lab or the company’s lab developing the next generation of scientific talent. Dr. McFadden is currently a professor at Arizona State University and the director of the Biodesign Center for Immunotherapy, Vaccines, and Virotherapy (B-CIVV). He has published more than 380 scientific papers and reviews. (PV)

It’s kind of fun to do the impossible

Blazing new trails to…
a new frontier in cell therapy by pioneering a new class of fully personalized neo-antigen T cell therapies to treat cancer

Carsten Linnemann, Ph.D.
Title: CEO and Co-Founder
Company: Neogene Therapeutics Inc
Education: Diploma/MSc., Biochemistry, Bielefeld University; Ph.D., Immunotechnology, Leiden University
Personal Awards: Emerging Pharma Leader 2021 by Pharmaceutical Executive; Antoni van Leeuwenhoek Prize 2015 (NKI-AVL); Thesis Prize of the Dutch Society for Gene and Cell Therapy (NVGCT) 2014; Ph.D. awarded cum laude 2013; Diploma awarded cum laude 2007
Associations: Alumni of Boehringer Ingelheim Fonds – Foundation for Basic Biomedical Research; Alumni German National Academic Foundation (Studienstiftung des dt. Volkes)
Hobbies: Scuba diving

Taking inspiration from Walt Disney, it’s kind of fun to do the impossible, says Carsten Linnemann, Ph.D., CEO and co-founder of Neogene Therapeutics, which is pioneering a new class of fully personalized neo-antigen T cell therapies to treat cancer. Like Walt, Carsten is a visionary. One former colleague says, while it is common for scientists to dream about discovering a new breakthrough in medicine that changes the course of history, it is rare to find one who has the vision, determination, and ability to realize that dream.

Carsten launched Neogene in 2018. Before that he served as associate director at Next Generation T Cell Therapies, and managing director of Kite Pharma, a Gilead company. He has co-founded T-Cell Factory, which was acquired by Kite Pharma in 2015, and he has co-authored several publications in the field of genetic engineering of T cells, and conducted seminal work on human neo-antigen biology. And, by the way, he is 39.

His passion for science and his ability to inspire those around him ensured his success while at Kite, however, his desire to further push the boundaries of scientific innovation led him to co-found Neogene Therapeutics, a preclinical stage biotechnology company.

In only the first few months of his tenure, Carsten led the start-up biotech through its Series A financing, which raised $110 million. Since the company’s inception, he has expanded its proprietary technology platform, which identifies specific TCR genes from routine tumor samples using state-of-the-art synthetic biology tools. He built Neogene and its team from the ground up and has instilled in his team an exemplary sense of dedication to its vision of developing innovative cancer therapies and bringing them to patients.

His leadership style is equal parts vision and action. He never shies away from making bold decisions and leads and inspires his teams with passion, thoughtfulness, and an infectious spirit. With his curiosity, commitment to scientific excellence, and approach to problem-solving, he inspires others to think outside the box, while following the science. Carsten has already left an indelible mark on the field of engineered T cell therapy and will likely do so for years to come.

“There have been many enjoyable moments in my career, but arguably seeing Neogene Therapeutics grow in less than three years from a scientific idea and a small team of seven people to a global company with 58 full-time employees, offices in Amsterdam and Santa Monica, Calif., and raising $125 million to date to deliver innovative treatments to patients in need has been both an exhilarating and humbling experience for me as a leader,” Carsten says.

With both of the biotech start-ups Carsten founded, he has transformed the concepts into highly effective, thriving businesses. Regardless of his role, Carsten’s mission remains steadfast: to change how cancer is treated on behalf of patients.

“I am innovative in my approach to advancing scientific understanding, but also in my approach to leadership,” he says. “I am relentless in solving some of the toughest challenges facing the future of cancer treatment.”

Carsten’s passion and excitement about the pioneering science and staying focused on the patient-centric mission encourages his teams to do the same. His goal is to build Neogene into a fully integrated, global cell therapy company, ultimately developing practice-changing therapies for patients fighting cancer worldwide.

It was his longtime mentor, Ton Schumacher, Ph.D., who knew he would end up blazing trails in biotech, which was not part of Carsten’s plan. “He told me that I would be ideally suited to a career in the pharmaceutical industry,” he says. “At the time, I was a little shocked as I was in the midst of my research and getting my Ph.D. Looking back, Dr. Schumacher was completely right.”

Because of Dr. Schumacher’s influence on his own career, Carsten also mentors others, and feels it is an active responsibility for industry leaders. “Mentorship contributes to the sustainability of an industry and scientific advancement, and it is always an exciting relationship that goes both ways because it also ensures that I continue to grow and advance as a leader,” he says. (PV)

Bringing big ideas to life

Sparking innovation by…
evoking visionary thinking

Raj Indupuri
Title: CEO and Co-Founder
Company: eClinical Solutions
Education: MBA, Boston University
Associations: DIA, CDISC, MassBio, Biocom, CLSA

Raj Indupuri is the true definition of an entrepreneur: someone who identifies an unsolved need, takes a risk, and is steadfast in turning that opportunity into a reality. What set him apart are his vision and spark to galvanize others to enact the change he has created. A technologist with more than 23 years of industry experience, Raj is responsible for establishing eClinical Solutions’ vision and future-looking technology strategy. The CEO possesses a real-world understanding of the challenges in clinical development, ingenuity to solve those problems to benefit clinical researchers and patients, and the ability to motivate others to look beyond short-term solutions to create an end-to-end digital transformation accelerator. The inspirational leader is deeply passionate about fostering innovation to revolutionize the life-sciences industry with ground-breaking technologies that will modernize clinical trials and bring treatments to patients faster. With astute business acumen, he is looking beyond the digital future and embracing the progress and potential of data and analytics, which are at the core of the company’s innovative products and solutions.

When eClinical president and co-founder Bob Arnesen met Raj in 2008, Bob recognized Raj as a true risk-taker and someone who firmly believed in his own vision, no matter that the approach went against the tide. At that time, cloud tech was on the rise across many industries, but in life sciences, cloud was not the norm. Many organizations were still focused on the shift to EDC. Undeterred by the highly risk-averse nature of the life-sciences industry, Raj saw the need for a clinical data cloud that could aggregate information and make it accessible and actionable for stakeholders. “What was a chance beginning in the life-sciences industry, drawn by personal life experiences and the motivation to contribute to research, has now become my life’s purpose,” Raj says. “My biggest career highlight to date is the management buy-out of a services company to pursue my passion and a deep-rooted vision to build a software and tech-enabled services company that can bring treatments to patients faster.”

When eClinical Solutions was founded in 2012, the focus was always clinical research enabled by technology, with clinical data at the core. Raj saw the need to unify data and reduce the manual effort well before digital transformation in life sciences became the persistent trend that it is now. While others in the field were still trying to figure out how to transition from paper processes to using an EDC system, Raj saw early on that getting data into an electronic system is actually only the first step to gaining important insights. He knew there needed to be many more modules created to import any format of data from any source. eClinical Solutions has built those modules for its clinical data platform, elluminate, to transform, review, and analyze data to improve efficiencies in studies.

What colleagues find most impressive is that Raj knew from the very beginning that there would be many iterations of the earliest version of elluminate.

The industry had to catch-up with his ultimate vision that was so apparent to him seven and eight years ago.

Raj saw the future game changer not just for data management but for clinical development as a whole, and he set out once again to build on his vision. Raj’s passion has the power to bring these big ideas to life and bring others along with him. He convinced people in the life-sciences industry that cloud-driven technology and solutions were a critical path for clinical research.

Since 2012, elluminate has been helping companies seamlessly integrate and unify all their data sources, including EDC, eCOA, and labs, for streamlined data review, exploration, and new data insights. “We built one of the first clinical data clouds nearly a decade ago with a team of visionaries,” Raj says. “We anticipated the need, and through innovation and perseverance, we evolved elluminate to be a key enabler for digitizing the industry.”

From his early career as an EDC specialist to his current role as the CEO of eClinical Solutions, Raj understands the issues that clinical teams face and why easing the burden of manual tasks in data management is so important in speeding up the drug approval process.

Raj sees a huge opportunity ahead for clinical trials post-COVID-19 and expects to see significant adoption of technologies like AI and machine learning across the complete clinical trials value chain within three to five years.

He says more real-time data will be coming directly from patients via smart devices or apps, and generating value or gathering insights from the data will require leveraging advanced analytics and machine learning models. (PV)


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