LCDR Jessica J. Lee, MPH, CHES®, serves as a Supervisory Consumer Safety Officer with the FDA's Division of West Coast Imports and leads Northern California import operations. With more than 15 years of experience in import compliance, inspections, and supply chain oversight, she specializes in the importation of pharmaceuticals, biologics, medical devices, and other FDA-regulated products. As a leader within both the FDA and the U.S. Public Health Service Commissioned Corps, she is committed to advancing public health through effective oversight of global medical product supply chains. 

Marissa Chan is a Supervisory Consumer Safety Officer with the FDA's Division of West Coast Imports, leading import operations across California, Hawaii, and Nevada. She oversees regulatory and inspectional activities involving pharmaceuticals, biologics, medical devices, foods, and other FDA-regulated products entering the United States. With experience in both import and domestic regulatory programs, she brings extensive expertise in compliance, inspections, and global supply chain oversight.

Monica Eris is a Senior Director and Head of Supply Chain & Logistics at Imugene, where she leads enterprise end-to-end supply chain strategy for a global oncology portfolio. With over 15 years of experience in biopharmaceuticals, she specializes in integrated business planning, external manufacturing strategy, and clinical-to-commercial supply execution. Monica brings deep expertise in global CDMO networks, supply risk management, and enterprise planning transformation, with a strong focus on enabling clinical-to-commercial readiness. She previously held leadership roles at BeiGene, supporting the commercialization of BRUKINSA, and at Genentech/Roche, where she led integrated planning transformation initiatives. She is recognized for building scalable operating models, leading cross-functional teams, and driving commercialization readiness in highly regulated environments. 

Experienced Senior Supply Chain with a demonstrated history of working in the biotechnology industry. Strong operations professional skilled in Business Process, Biotechnology, Management, SAP ERP, and Business Intelligence 

Jason Keveryn is Associate Director of Clinical Supply Chain at Cytokinetics, where he has supported the late-stage development of recently approved Aficamten, a next-generation cardiovascular therapy cardiovascular therapy, and continues to lead clinical supply operations supporting post-market approval studies. With expertise in clinical supply strategy, forecasting, vendor performance optimization, and global distribution, he has driven process innovations that improved forecasting accuracy, strengthened supply continuity, and mitigated patient supply risk 

Ted has decades of experience in the healthcare industry and clinical research.  He specializes in clinical operations, project management, data management, and innovative data solutions. He also possesses a diverse executive management background spanning across healthcare, life sciences, telecommunications, and aerospace.  He has provided consulting to Neurovascular, Cardiovascular and Orthopedic startup companies, and he was a strategic leader at Stryker Neurovascular managing global clinical operations team, overseeing global pre and post-market clinical studies and a clinical technical field services team, who interfaced closely with our KOLs. He possesses a deep understanding of global device regulations, clinical strategies, and new product development activities, successfully launching many AIS and Hemorrhagic products.  Ted has been a speaker or panel member for OCT and CTS events in USA and China over the last 5 years. 

Pooja Gandhi is Director of Clinical Quality Assurance at GRAIL, where she leads enterprise-wide quality and compliance efforts across global clinical trials. She oversees risk-based audit programs, drives cross-functional remediation strategies, and partners with stakeholders to ensure clinical studies meet regulatory and operational excellence standards. With over 20 years of experience in clinical research, including leadership roles at GRAIL and 23andMe, Pooja brings deep expertise in GCP, FDA regulations, and clinical trial oversight. She is passionate about advancing quality driven processes that enable efficient, compliant, and patient-focused clinical trial execution. 

Malinda Longphre is Head of Clinical Operations at Attovia Therapeutics, where she oversees the execution of early-phase clinical programs. With over 25+ years' experience in biotech and pharma (BMS, Bayer, Aerovance, Oriel, Novartis, Connect), she has led complex global studies and driven cross-functional collaboration between Clinical Operations, CMC, and supply chain teams to ensure efficient and high-quality trial execution. She is a strong advocate for streamlined processes and strategic planning to accelerate development opportunities. Malinda holds a PhD from Johns Hopkins University and trained at UCSF prior to entering industry.

Jamie Goldman is the Logistics Program Manager at Orca Bio, where she oversees the end-to-end logistics of life-saving cell therapies to ensure delivery accuracy and reliability across a growing portfolio of onboard-carried shipments. With over 10 years of experience across biotech, e-commerce, and aviation—including leadership roles at Amazon, Redbubble, and United Airlines—Jamie has built a career driving measurable operational improvements through data-driven decision-making and people-centered leadership. At Orca Bio and Thistle, she has championed integrating AI-powered tools to streamline supply chain planning, strengthen inventory management, and accelerate the adoption of continuous improvement initiatives. Whether managing 75 frontline associates on the warehouse floor, identifying a $1.5M cost-saving opportunity through deep data analysis, or developing training programs with 90%+ adoption rates, Jamie brings the same commitment to precision and people to every challenge. She is a passionate advocate for building resilient, technology-enabled supply chains that keep both operations and teams performing optimally.   

Tom is currently serving as a Senior UAT Analyst for Bristol Myers Squibb. Most recently, he worked in clinical systems role for Ultragenyx Pharmaceutical, overseeing IRT, CTMS, eCOA, eConsent, CGM, and wearables systems and processes. Previously, he worked as an IRT senior project manager at Amgen, built and managed international technical support and data management teams, and worked as an IRT project manager, both at endpoint clinical. He has managed projects in the therapeutic areas of hematology & oncology, pain, bone, cardiovascular, and dermatology, from early-phase oncology through post-marketing studies. He graduated summa cum laude with a B.A in Philosophy and History from Florida Gulf Coast University, where he also earned an M.A. in English. He has published several articles on process improvement, change management, and making IRT concepts more accessible to sponsor study management personnel.

Paul is an experienced Clinical Supply Chain Professional with a 25-year career in the BioPharmaceutical industry.  His extensive career includes roles at major companies like Amgen and Thermo Fisher Scientific, where he honed his skills and made a significant impact.  He has served in varied roles from basic research and contract manufacturing to client services and account management.  He is a Principal Consultant and Co-Founder of Beacon BioPharm Associates, a clinical supply chain consulting firm, providing variable staffing solutions to small and mid-sized BioPharm clients.  Paul is an industry veteran and respected leader known for his expertise in clinical supply chain.

Umar Hayat, Ph.D. is VP of CMC and Supply Chain at Union Therapeutics and has more than two decades of experience in pharmaceutical development, manufacturing and supply chain. He held senior level positions with Relypsa (acquired by Galenica for 1.52B US$), Anacor (acquired by Pfizer for 5.2B US$) and Transcept Pharmaceuticals (revers merger with Paratek). He played a pivotal role in the development and commercialization of Veltassa® (USA and EU), a treatment for hyperkalemia, Intermezzo® for MOTN insomnia, Kerydin® for onychomycosis, and Eucrisa® for atopic dermatitis. Dr. Hayat is managing partner of Revive Pharm USA. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. Dr. Hayat received his Ph.D. in process engineering from INP-Toulouse, France and Post-Doctoral Fellowship from Ecole Polytechnique de Montreal, Canada. He received M.Sc. Chemistry degree from Punjab University, Institute of Chemistry

Dr Mishra (Ex Genentech, Ex NCI, Ex NIH) is the founding president and CEO of the American Association for Precision Medicine ( and chair of ACT AAPM’s Coronavirus Taskforce He is leading research efforts focused on preventing curing chronic diseases not only treating the sick but also providing knowledge/tools to individuals to live longer, healthier lives 

He is also the founder and CEO of Agility Pharmaceuticals, a pharmaceutical company committed to revolutionizing drug discovery development through technology, big data, robotics, and artificial intelligence He is a serial entrepreneur who founded his first company after graduating high school, and his second company during his Ph D Since then, he has accumulated a wealth of experience by building, investing, and advising numerous other companies He is an investor, co founder/ board member of a few corporations, focused on accelerating drug discovery/ development, data analytics, robotics, mental health, and digital health He is also the founder of AAPM Angels and Investors AAi an investment group focused on investing in drug discovery, diagnostics, precision medicine, technology healthcare companies He is also the founding investor and advisor to Barcelona Ventures and serves as an advisor to a 100 M private equity fund 

Widely recognized as a thought leader in the field of ‘technology and healthcare’, Dr Mishra has keynoted, chaired, curated, and organized numerous successful international conferences He served as a Scientist and Principal Investigator at the pharma giant Genentech, Roche Where he participated in several drug discovery project teams Moreover, his passion for drug development and precision medicine has led to the identification of new drug targets, biomarkers, companion diagnostics, and several drugs/ combinations in the clinic 

His research work has been recognized globally by over 40 prestigious awards and honors Due to his unique perspective selfless service, he is a highly respected sought after mentor to many The companies that he has advised have raised multimillion dollars Notably, he serves as a mentor and advisor to several VC funds and startup accelerators, including IndieBio HIMSS/Health 2 0 ’s Project Zygote, MedLabs ZGC Capital, J&J JLabs UCSF Innovation Venture, UCSF Invent Fund, and California Life Sciences’s FAST program, to help grow California’s life sciences innovation ecosystem 

Dr. David Larwood brings a rare combination of scientific innovation and business acumen to the fight against Valley Fever, a serious and often overlooked fungal disease. While pursuing his PhD in chemistry and chemical biology at UCSF, Dr. David Larwood explored the therapeutic potential of brilacidin, an antimicrobial compound with promising activity against fungal pathogens such as coccidioides, the organism responsible for Valley Fever, which disproportionately affects immunocompromised individuals. At UCSF, he invented PEGylated lipids and with his advisor made the first ever PEGylated liposomes, which lets the “payload” content circulate much longer in the bloodstream, making new forms of delivery possible. The delivery system is integral to Doxil, a drug that treats various cancers. It also is critical to the mRNA COVID vaccines. He was also the first to synthesize Iotrolan, a widely used contrast agent in medical imaging such as X-rays and CT scans, producing more effective clinical diagnostics. His doctoral work was the foundation of a robust career at the convergence of pharmaceutical chemistry and biotech innovation.

Today, Dr. Larwood is founder, president, and CEO of Valley Fever Solutions, where he leads a team working to advance Nikkomycin Z (NikZ), a targeted antifungal therapy. With $7 million in NIH support and a collaborative research team, Dr. Larwood is driving efforts to improve treatments in the regions most affected by Valley Fever, including the Southwestern U.S., Mexico, and Central and South America. Dr. Larwood's 2020 review of NikZ therapy has been cited more than 37 times and continues to inform the field.

Brandy Porter is the Assistant Center Director for Enforcement, of CBP’s Pharmaceutical, Health, and Chemicals Center of Excellence and Expertise (PHC CEE). PHC CEE oversees imports of pharmaceuticals, healthcare, medical equipment, and chemicals into the United States. Prior to her work at PHC CEE, Ms. Porter was the Deputy Assistant Director for the Center for Intelligence, Targeting, and Enforcement, located in the New York Field Office.  She began her career with CBP in 2009, as an analyst.

Ms. Cerullo began her career in 2014 at the port of San Francisco, CA.  In the past 12 years with CBP, Ms. Cerullo has worked in a variety of pathways, including passenger operations and the maritime trade environment. 

Jolien Wychules is a Biological Threat Operations Specialist (BTOS) with U.S. Customs and Border Protection (CBP), Office of Field Operations (OFO) for the San Francisco and Portland Field Office. Ms. Wychules began her career in 2015 at San Francisco International Airport. Ms. Wychules has more than 10 years of public service with CBP and has worked in a variety of environments including maritime, air passenger, and specialized units within CBP. 

Dr. Siamak Zadeh is a Professor, Data Scientist, and serial innovator at Golden Gate University (GGU) in San Francisco, where he serves as Director of the University’s AI Initiative. Combining academic rigor with entrepreneurial drive, he leads efforts to bridge the gap between artificial intelligence research, business transformation, and real-world impact. Beyond academia and industry, Dr. Zadeh is the Co-Founder and Chief Technology Officer (CTO) at CareImpact.ai, a startup offering CareAgent360 – a platform that applies AI and agentic automation to healthcare coordination and benefit management. His entrepreneurial work focuses on using AI to address systemic inefficiencies, reduce healthcare disparities, and improve outcomes for underserved communities.

Dr. Nick Vyas is a renowned educator and a visionary leader in supply chain management. He serves as the Founding Executive Director of the USC Marshall Randall R. Kendrick Global Supply Chain  

Institute and the Academic Director of the USC Master of Science in Global Supply Chain  

Management program. Additionally, as a full-time Professor of Clinical Data Sciences and Operations at USC Marshall, he is dedicated to shaping and inspiring the next generation of global supply chain  

Leaders. Prof. Vyas's sharp insights have made him a trusted voice across major media platforms, including Reuters, MSNBC, Bloomberg, Fox News, Voice of America, CGTN, and Business Insider. Renowned for his ability to untangle the complexities of global trade and supply chains, he is frequently sought after for his clear, compelling analyses. His skill in breaking down intricate issues into accessible, enlightening commentary has solidified his reputation as a go-to expert. His notable works, including Enterprise Excellence and Blockchain and the Supply Chain, 2nd Edition, explore the transformative impact of cutting-edge technologies. These publications have become essential references for industry professionals, offering valuable insights and practical guidance. The latest book, "Supply Chain Network Design: How to Create Resilient, Agile and Sustainable Supply Chains," which he co-authored, offers insights into building agile supply chains in the face of geopolitical changes and technological advancements. It emphasizes a global outlook, ESG objectives, and the circular economy. The book explores the role of emerging technologies, such as Artificial Intelligence (AI), Machine Learning (ML), Blockchain, and automation, in providing a competitive advantage and enhancing network design with sophisticated forecasting methods. 

He was diagnosed in 2014 and has been undergoing treatment for the disease for most of the intervening years. Paul is co-leader of the San Francisco Bay Area Multiple Myeloma Support Group. He is the patient advocate on the Myeloma Committee for the South West Oncology Group providing input into clinical trial concepts and execution. Paul is also a member of the Multiple Myeloma Patient Collaborative Team with the American Society of Hematology. He serves as a patient reviewer for grant applications made to the Congressionally Directed Medical Research Program of the Department of Defense. Paul retired in 2019 after a 34-year career in pharmaceutical R&D with Pfizer, Roche and Genentech. The first half of Paul’s career was in Drug Discovery as a Research Scientist and Project Leader. The second half spanned all phases of drug development and post-marketing. He was a Global Project Manager on cross-functional drug development teams and a Director in late-stage Clinical Operations and in US Medical Affairs. 

Few people with a cause walk the talk as boldly and graciously as Christine Von Raesfeld, Lived Experience Expert/Citizen Scientist. Christine is a pillar of patient advocacy and allyship in the rare and chronic disease community. Through the lens of her own journey in healthcare, she has become a champion for patient voices, diversity and inclusion in clinical research, and equitable patient-sponsor partnerships.**

A sought-after speaker, Christine brings firsthand expertise to discussions on clinical trials, data rights, and digital health. She serves as an e-patient scholar with Stanford MedicineX and a Committee Member with the Partnership for Quality Measures (CMS), among other roles. Christine advises initiatives like Stanford's "Humanwide" Precision Medicine Program, the NIH All of Us Research Program, and the NIH HEAL Initiative. She co-authored the patient-led AI Rights Initiative with The Light Collective, focusing on ethical data use and personalized medicine.

Christine recently published a research paper analyzing her own complex medical journey[43dcd9a7-70db-4a1f-b0ae-981daa162054](https://journal.researchtothepeople.org/christine?citationMarker=43dcd9a7-70db-4a1f-b0ae-981daa162054 "1"), highlighting the value of patient-partnered genomics in understanding rare and chronic conditions. She has additional works on patient engagement and healthcare innovation forthcoming.

Recognized for her contributions, she has been named one of Silicon Valley Business Journal's Top 100 Women of Influence, a Silicon Valley Community Hero, a member of the 2021 HIMSS Future50, and one of Medika Life's 50 most influential voices in healthcare.

Tom has worked in the life sciences industry since 1997, with the first 10 years spent as a pharmaceutical representative and marketing product manager for Bertek, Merck and GSK.

Tom joined Valeris in 2008, created the RxStudy Card offering in 2009 and since then has been focused on changing the paradigm of the traditional clinical trial supply process to one of greater efficiency.

Vanloan Nguyen (she/her) is the Chief Executive Officer of Berkeley Pharma Tech and the founder of the Berkeley Pharma Tech Foundation, organizations focused on advancing innovation, entrepreneurship, and access in the life sciences industry. She has built a dynamic community that connects scientists, entrepreneurs, investors, and industry professionals through educational programs, conferences, and strategic partnerships. With expertise in biotechnology entrepreneurship, venture investing, and ecosystem development, Vanloan supports early-stage founders, researchers, and investors in translating scientific discoveries into real-world impact while actively evaluating and supporting emerging life science ventures. She holds a Master’s degree in Biotechnology Enterprise and Entrepreneurship from Johns Hopkins University and is dedicated to fostering healthcare innovation and empowering the next generation of biotechnology leaders.

Amaury Jeandrain has a Master’s Degree in Business Engineering with a specialization in supply chain optimization. He joined Clinigen in 2015, then N-SIDE in 2016 where he last  held the position of VP of Strategy for clinical supply solutions.

Over the past decade, his objective has been to make clinical trial supply chains more efficient by redefining CTS strategies and driving measurable performance improvements. His expertise also includes forecasting, planning, waste reduction, and shortage risk mitigation.

Since 2024, while accompanying his wife on humanitarian missions abroad (Niger, then Colombia), Amaury has continued his work as a CTS advisor and trainer, partnering with pharmaceutical companies worldwide to enhance clinical supply performance.