Craig Lipset
- Co-Chair of the Decentralized Trials and Research Alliance;
- Head of Clinical Innovation at Pfizer (2010-2019)
Travels From
New York
Decentralized Clinical Trials - Craig Lipset - Founder of Clinical Innovation Partners
Craig Lipset Speaker Biography
Craig Lipset has been at the forefront of innovation in clinical trials and medicine development. For over 20 years Lipset has been leading the transformation of clinical trials, pioneering new approaches to bring research closer to patients and accelerate new cures with leading-edge technology. Audiences come away both energized and informed – excited by the potential for accelerating medical breakthroughs while aware of what it will take for us to get there.
Lipset currently serves as Co-Chair of the Decentralized Trials & Research Alliance (DTRA), a new non-profit collaboration he launched in 2020. DTRA is the world’s leading initiative to ease the burden of research participation, advancing the adoption of new technologies and approaches to enable patients to engage in research in more flexible and accessible ways. DTRA members include 85 organizations including regulatory agencies, pharmaceutical and healthcare companies, technology and service providers, research sites and advocacy groups. This has become a remarkable group with membership spanning FDA, Pfizer, United HealthCare, CVS, Amazon, IQVIA, StandUp2Cancer and beyond.
For nearly a decade he was the Head of Clinical Innovation at Pfizer, leading digital initiatives, patient engagement and collaborations across all therapeutic areas around the globe. During that tenure he launched multiple “industry firsts” — from the first fully remote/virtual clinical trial for a new medicine to the first returning of results and data to research participants.
Lipset brings 360 degrees of perspective to the future of medicine development – as an industry insider, a trial innovator, a technologist, and as a patient advocate. He blends these experiences to bring audiences on a journey spanning patient empowerment, digital development, remote/in-home clinical trials and the future of data ownership. He reveals who will be disrupted and displaced along the way to these various futures.
The digital future is humanized with Lipset’s personal experience as a patient with a rare pulmonary disease, and how his own journey as a patient has defined and informed his vision for the future. He is the Managing Partner of Clinical Innovation Partners, a growth advisory with clients spanning technology and biopharmaceutical companies, leading universities, and the venture community, and has been listed among the PharmaVOICE most inspiring people in the life sciences (Red Jacket hall-of-fame), Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials, and the AlleyWatch Who’s Who in eHealth.
Who Owns My Health Data?
In 1951, a tumor was biopsied from Henrietta Lacks. Without her knowledge or consent cells from that biopsy were culture and immortalized as the HeLa cell line, and used by well-intentioned researchers to drive new cures albeit without respect and transparent to the patient who serve as the source.
Nearly 70 years later we are now poised to repeat the error of the past in the digital age, as patient data is accessed, shared, and monetized among researchers. Despite being used by well-intentioned researchers, the patients serving as source for these data have no more awareness or respect than did Henrietta Lacks. How do we redirect our efforts to ensure patients are included and engaged when their data is being used for good?
Trials on the Other Side of the Curve: Drawing from the COVID-19 Experience to Define a New Future
The COVID-19 pandemic has created urgency for clinical trials to modernize and transform. As the pandemic emerged, research teams scrambled to continue to support patients in need of access to investigational new medicines. As we emerge from the pandemic, how do we take the best of the change and embed it to become the “new normal”? How will clinical research in 2021 and beyond be faster and smarted as we get to the other side of the curve?
Bringing It Home: The New Normal for Virtual and Remote Clinical Trials
Craig Lipset pioneered the industry’s first fully in-home clinical trial for an investigational new drug over a decade ago. Fueled by the urgency of a pandemic and powered by digital with the patient at the center, virtual and remote clinical trials are poised to become the “new normal”. What will push this future over the finish line, and how will clinical research participation continue to evolve?
The Impatient Patient at the Center of Medicine Development
The history of clinical trials and medicine development has been defined by researchers and pharmaceutical companies, with patients relegated to the role of ‘subject’ (a term with roots based in “owing obedience” at worst and someone “being discussed” at best). Patients were required to have patience, waiting for researchers to prioritize their unmet medical needs and invest in research and development for new treatments.
This presentation explores how today’s digitally-empowered and socially-organized patient is able to seize control over medical research and development, no longer needing to wait to be noticed. From crowdfunding of research and venture philanthropy, to do-it-yourself biohacking online data sharing – today’s patients are positioned to own the research process. What is the 21st century role of the patient in medical R&D, and who may be displaced in the journey to this new future?
Digital Transformation in Clinical Trials
Clinical trials are essential to bring cutting-edge medical breakthroughs into the hands of physicians and patients. Yet the tools being used for these trials have seen little evolution, shifting incrementally from “pen and paper” to “manual entry into web forms”. With the proliferation and accessibility of digital tools – from social media to electronic health records, and mobile phones to wearable tech – clinical trials are on the cusp of a digital revolution. How is digital shaping medicine development and what lies ahead?
