Archives: Speakers

David Hadden

Dave is an entrepreneur and technology innovator. He is known for pioneering the fields of A.I.-based medical decision-support, Training Analytics, and Virtual Patient Simulation (VPS).

Dave’s last company, TheraSim, launched the world’s first successful online VPS system for physicians and trained over 500,000 doctors in every country on Earth. TheraSim built the world’s largest network of computer-based clinical simulation sites in Africa in support of the USAID and the CDC’s HIV-treatment effort. TheraSim was acquired by WebMD in 2014.

Since then, he has focused his passion for technological innovation and learning systems in the field of clinical trials, helping sponsors make their studies more accurate and efficient through finding the right technology mix such as virtualization, performance management and applied behavioral sciences to produce the most effective, lasting, and engaging results for clinical trials.

Dave has always valued the interconnectedness of our vastly changing world, and has traveled to over 70 countries for his global health work and for cultural development outreach through music.

Vinaya Kapoor

Vinaya Kapoor, PhD, is currently Vice President, Regulatory Affairs at Tricida, Inc. Vinaya is an experienced regulatory leader with over two decades of experience at both small and large companies in the biotechnology/pharmaceutical sector, at West and East Coast locations. She has contributed to over 20 development programs, in small molecules, biologics, vaccines and cell therapies. Prior to Tricida, Vinaya worked for over 10 years in Global Regulatory Affairs at Janssen Pharmaceuticals (a division of Johnson and Johnson) , at Merck & Company, and Iovance Biotherapeutics, a cell therapy company. Her experience includes CMC drug development and regulatory affairs across therapeutic areas and development phases.

Vinaya has a PhD in Chemical Engineering from the University of Notre Dame. Vinaya serves as a Stanford SPARK advisor, a CASSS Associate Director and is actively involved with American Association of Pharmaceutical Scientists (AAPS). She is passionate about furthering interest in careers in science, technology, and the environment, particularly among women and youth and volunteers her time towards this.

Skip Sands

In his over 20-year career, Skip has had responsibility for formulating and executing strategies for drugs, vaccines, diagnostics and medical devices with broad global drug development knowledge including medical affairs, clinical trial design, pharmacovigilance, clinical operations, investigator site selection, patient advocacy and product commercialization.

Skip most recently served as the Chief Medical Officer for Selecta Biosciences, a life sciences start-up headquartered in Watertown, Massachusetts, where he had responsibility for all clinical activities, including clinical strategy and development of drug candidates, clinical study designs, protocols, and CRO selection.

He held a similar CMO role at Targacept, Inc. a biopharmaceutical company, and at Plasma Surgical, Inc., a medical device company.  Prior to these roles, Skip held senior leadership roles including U.S. Head of R&D for Solvay Pharmaceuticals which was incorporated into Abbott Laboratories/AbbVie, as well as Procter and Gamble Pharmaceuticals.  Skip started his career in Obstetrics/Gynecology in both the hospital and community setting and is a principal investigator himself.

Wendy Xia

Ms. Xia currently holds the position of Head of Supply Chain at Agios Pharmaceutical located in Cambridge, Massachusetts.  Her responsibility includes clinical supplies, commercial supplies, logistic/commercial distribution and supply chain planning. Wendy is a chemist by training and has spent her early years in Chemical Development as a process chemist and analytical chemist. She then spent 20 years in Quality and Supply Chain organizations in major pharmaceutical companies in New Jersey before relocating to Cambridge, Massachusetts joining Agios in 2014. In 7 years, Wendy has successfully built a complete supply chain organization supporting clinical and commercial portfolios.

Kelsey Kern

Kelsey Kern has been with CSL Behring since 2017 where she has managed global, end-to-end clinical trial supply in the Cardiovascular, Hereditary Angioedema (HAE), and Transplant therapeutic areas.

Shawn Gehen

Shawn is a Clinical Demand Planning Manager with 24 years of experience in Clinical and Commercial Supply Chain, currently under contract with Seagen Biotech.