Gita brings more than 20 years of experience at the FDA, with deep expertise in pharmacovigilance, global risk management, and patient-centered benefit risk assessment across the product lifecycle. Her work has helped shape how Risk Evaluation and Mitigation Strategies are designed, evaluated, and implemented in practice, including leading the development of the FDA’s REMS Logic Model.

Throughout her career, Gita has partnered with global regulators, academic institutions, and cross-functional teams to advance regulatory science and improve real-world safety outcomes.

At PPV, Gita leads regulatory strategy for clients, bringing an ex-regulator perspective to complex safety, risk management, and benefit-risk challenges.

Kisha Bush is an accomplished clinical operations leader with over 24 years of experience advancing clinical research. As Director of Patient and Site Engagement at Boehringer Ingelheim, she drives strategies that strengthen relationships with investigators and enhance the experience of patients participating in U.S. clinical trials. Her work includes designing engagement initiatives, promoting health literacy, reducing patient burden, and ensuring diverse population representation across clinical programs.

Throughout her career, Kisha has led cross‑functional teams focused on patient recruitment and retention, overseen regulatory and informed‑consent processes to safeguard participant rights, and implemented community outreach models that build trust with underrepresented groups. She has guided major clinical programs in cardiovascular, In Vitro diagnostics, and medical devices, always with a commitment to operational excellence and patient inclusion.

Kisha holds an Executive MBA from Howard University and is a member of Zeta Phi Beta Sorority, Inc.

Leah Sorini is a fundraising and external affairs leader with experience advancing mission-driven organizations through strategic donor engagement, corporate partnerships, and stewardship. At the PFF, she supports research activities and PFF patient and healthcare provider programs that serve the pulmonary fibrosis and interstitial lung disease community through the execution and management of sponsorship agreements, grants, and collaborations.

Prior to joining PFF, Leah Sorini worked for a market research firm, managing marketing initiatives to build relationships with health technology vendors. Previously, she worked as a communication specialist for a federal benefits program, USAC’s Lifeline, which helps participants get access to more affordable phone and internet services.

Dr. Catherine Leigh Higgins is a dedicated scientific executive with more than two decades of experience leading clinical research operations, developing scientific strategies, and making transformative progress in oncology and translational medicine. She currently serves as the Senior Vice President of Science Programs at Stand Up To Cancer (SU2C), where she has progressed through various leadership roles since 2016.

During her tenure, Dr. Higgins has overseen a $1.5 billion research portfolio spanning 16 countries, supporting more than 280 clinical trials, and helping advance over 11 scientific breakthroughs in cancer detection, prevention, and treatment.

Before SU2C, Dr. Higgins directed the Human Research Protection Program at Texas A&M University. She also served as an adjunct faculty member in public health where she instructed graduate-level courses in clinical research methodology.

Dr. Higgins earned her Ph.D. in biophysical chemistry from Tulane University and completed a NIH Postdoctoral Fellowship in atherosclerosis research at Baylor College of Medicine.

Jamie Brown is a Senior Director at Eli Lilly and Company, where she leads global digital strategy for clinical trial awareness and patient engagement. Her career pivot from retail to healthcare was sparked by a deeply personal experience, becoming an around-the-clock advocate for her son, following his diagnosis with a rare cardiac condition—giving her first-hand insight into how difficult it can be for patients and families to navigate the healthcare system to get the best possible care. That perspective fuels her work today as she helps expand Lilly’s clinical trial platform and reimagine how people discover, understand, and connect with research opportunities. Jamie holds a B.S. in Marketing from Indiana University and is a certified PMP, Lean Six Sigma Green Belt, and Prosci Change Management practitioner.

Karen Whonder is a clinical development leader with 23+ years in life sciences, currently at AstraZeneca as Director, Global Site and Patient Partnership Lead. She specializes in patient outreach and engagement, building collaborations with sites, advocacy groups, and community organizations to co-create outreach strategies that enhance diversity, feasibility, and retention. Karen brings sponsor-side expertise in digital patient recruitment, leveraging data-driven audience segmentation, and omni-channel campaigns to accelerate enrollment while supporting the patient journey.

Previously, she spent 15 years at Bristol-Myers Squibb in Wallingford, CT; led sponsor and government-funded clinical research at Yale University; and held roles at biotech firms before serving as Director of Therapeutic Strategy, Immunology and Internal Medicine at IQVIA. Her therapeutic focus spans immunology and internal medicine, including autoimmune and systemic inflammatory conditions. She holds a B.S. from Quinnipiac University (2015) and post-graduate studies at Harvard Extension School.

Pavel Khrimian, MBA is a strategic healthcare entrepreneur specializing in developing external collaborations focused on biotechnology, precision medicine, digital health, and diagnostics within the life sciences industry. His 18 years of experience has included roles at OriGene, Suburban Hospital, BioReliance by SAFC, and MedImmune/AstraZeneca.

Vic Stone, M.D. (Ishii Yoshihide) is Head of Cell Therapies and Japan, and General Partner and President of 82VS Venture Studios Dallas. His career in finance spans a broad range of investments including Incubation, VC, PE and PIPEs. He has raised numerous biotech funds, built numerous therapeutics and platform companies. Notable exits include Shattuck labs (NASDAQ: STTK) and ARTham Therapeutics (M&A, Kaken Pharma); signature builds include Axcelead Drug Discovery Partners, for which he continues to serve as External Director.

Dr. Stone started his career as a Naval Flight Surgeon in the Marine Corps, serving multiple combat deployments to Afghanistan, Iraq and Somalia. He received his MBA from the Harvard Business School and MD from Jefferson Medical College.

His ecosystem activities include Co-Chairman of a Consortia of Japanese Pharma and Lifescience VCs, and entrepreneurship programs in Dallas and Osaka.