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Why Attend?

Solving the Global Clinical Supply Puzzle!

As international trials grow more complex, your strategy must evolve. We're exploring how to integrate cutting-edge technology and streamlined protocols to ensure your clinical supply chain is as agile as the science it supports.

Two Days of Insight. Infinite Connections.

Immerse yourself in a high-impact program of presentations, interactive roundtables, and expert panels. From tackling global supply chain bottlenecks to adopting emerging trends, this is your unmissable opportunity to gain the tools and the network you need to lead the industry.

Get in touch now and secure your place!

WHAT TO EXPECT FOR 2026?

Master Strategy. Build Connections. Drive Success.

Join the premier gathering for the Californian pharma and biotech community.

Discover how to excel in supply chain execution while building the strategic connections your future demands.

 

 

 

200+

Attendees

25+

Exhibitors

20+

Speakers
200+

Attendees

25+

Exhibitors
20+

Speakers

Testimonials

See What It's All About

Featured Speakers

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Nick Vyas​

Professor, Clinical Data Sciences and Supply Chain Operations, Marshall School of Business

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. 

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Monica Eris​

Senior Director, Head of Supply Chain, Logistics & CMO Management, Imugene Limited

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. 

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Jason Keveryn​

Associate Director, Clinical Supply Chain, 4D Molecular Therapeutics

Jason Keveryn is Associate Director of Clinical Supply Chain at 4D Molecular Therapeutics. Previously at Cytokinetics 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.

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Pooja Gandhi​

Director, Clinical Quality Assurance, Grail

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. 

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Shubhra Kochar​

Head of Global Clinical Supply Chain Planning, Genentech

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Paul Gater​

Advocate for patients with multiple myeloma, Member of the Patient Advocate Committee SWOG Cancer Research Network (former Genentech)

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. 

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Aimee Hogue​

Director, Supply Chain, Sutro Biopharma

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Ted Chun​

VP Regulatory, Quality & Clinical, Prometheus Therapeutics

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. 

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Louie Burks​

Director, Clinical Supply, Praxis Precision Medicines

Experienced Project Manager in Product Development, Supply Chain, Business Operations and Logistics, and Change Management

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Malinda Longphre​

Head of Clinical Operations, Attovia Therapeutics

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.

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Jamie Goldman​

Logistic Program Manager, Orca Bio

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.   

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Sebastian De Beurs​

Co-Founder, Healis Therapeutics

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Joerg Wania​

Head of Clinical Trial Supply / Export, Stadpharm

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Paul Hingst​

Supply Chain Consultant, Crinetics Pharmaceuticals

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.

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Umar Hayat​

Founder, CEO, Accanito Therapeutics Inc

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

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Rabindra Shivnaraine​

Director, Aerys Biosciences

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Charisse Eary​

Executive Director, Head of Quality, Aligos Therapeutics

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Amber Bill​

Associate Director, Sangamo Therapeutics

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Burkard Kolb​

Former Executive Director, CMC Operations, 89bio (Genentech)

Burkard Kolb has 22 years of experience in the development and manufacture of biologics. Starting out at Roche Penzberg,  Singapore and at Genentech in South San Francisco, he focused on internal development and manufacturing projects in Engineering and MSAT positions. During his tenure at Coherus Oncology and 89bio, he managed external manufacturing of Drug Substance for biosimilars and novel biologic drugs, handling site selection, tech transfer, process characterization and validation activities. He has been an author of CMC sections for multiple successful BLA and IND submissions.

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Dr. Prasun Mishra​

Co-Founder & CEO, Precision BioPharma

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 

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Jin Lee​

Founding Board Member, CURE NDD

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David Larwood​

CEO, Valley Fever Solutions

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.

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Vanloan Nguyen​

President & Director, Berkeley Pharma Tech Foundation

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.

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David Kiewlich​

Founder, Tomorrow Biotech Corporation

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Brandy Porter​

Assistant Center Director, Enforcement Pharmaceuticals, Health, and Chemicals Center of Excellence and Expertise, U.S. Customs & Border Protection

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.

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Carmin Cerullo​

Agriculture Operations Manager, San Francisco and Portland Field Office, U.S. Customs and Border Protection

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. 

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Jolien Wychules​

Biological Threat Operations Specialist, San Francisco and Portland Field Office, U.S. Customs and Border Protection

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. 

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Sia Zadeh​

Chair AI Initiative and Associate Professor and Data Scientist, Golden Gate University

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.

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Christine von Raesfeld​

Patient Advocate, The Light Collective

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.

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M. David (Dave) Malenfant​

Executive Supply Chain Leader, Trainer, Mentor, TCU

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Amanda Murphy​

Head of Digital Product Management, GlobalData

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Kirk Bray​

Senior Manager Sales, West Coast Biotech, Thermo Fisher Scientific

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Tom Gottschalk​

Vice President Business Development, Valeris

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.

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Amaury Jeandrain​

CTS Strategy Advisor, N-SIDE

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.

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Dan Caramore​

Strategic Account Manager, N-SIDE

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Chris Driver​

Senior Director, Product Management AI & Technology Solutions, Patient Suite, IQVIA Technologies

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    2026 Sponsors Include:

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    Company Information

    Valeris is a trusted life sciences commercialization partner offering end-to-end solutions across the healthcare value chain. With deep industry expertise, advanced technology, and a patient-first approach, Valeris helps life sciences companies enhance access, adherence, and outcomes. Serving over 500 clients, the company delivers data insights, patient support, and provider engagement tools that drive product success. Headquartered in North Carolina and Indiana, Valeris has supported millions of patients. Learn more at www.valeris.com.

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    Company Information

    IQVIA delivers AI‑powered clinical technologies that simplify trial operations, improve patient and site experiences, and accelerate clinical development. Our secure, SaaS‑based platforms use healthcare‑grade AI to streamline workflows, reduce administrative burden, and enable smarter, faster decision‑making across the clinical trial lifecycle.

    Company Website

    To learn more, please visit our website - https://www.iqvia.com/solutions/technologies

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    Company Information

    The PPD clinical research business of Thermo Fisher Scientific enable customers to accelerate innovation and increase drug development productivity. Utilizing patient-centered strategies and data analytics, our capabilities cover multiple therapeutic areas and include early development, all phases of clinical development, peri- and post-approval, novel approaches to patient recruitment and investigator sites, and comprehensive laboratory services.

    Company Website

    To learn more, please visit our website - https://thermofisher.com/ppd

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    Company Information

    Inceptua is a global pharmaceutical services company with market-leading capabilities across multiple business areas.

    – Inceptua Clinical Trial Supply and Clinical Services provides clinical trial supply, services and logistics, including comparator sourcing of medicines, packaging, labelling, storage, and distribution services

    – Inceptua Early Access offers strategic advice, design, facilitation, and implementation of global early access programs, and distributes unlicensed and other medicines worldwide.

    Inceptua has over 25 years of experience serving life science companies of various sizes, and has global operations with offices across Europe, North America, and Asia, including China.

    Additional information is available at: www.inceptua.com

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    QuickSTAT provides 24/7/365 trusted global life science logistics and transportation solutions for companies worldwide combining industry expertise and innovative technology. Our team of logistics experts specializes in time- and temperature-sensitive shipping of clinical research samples, CGT, vaccines, investigational drugs, CTS, etc., helping bring new drugs and medical protocols to market.

    Company Website

    To learn more, please visit our website - www.quickstat.com

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    Company Information

    Almac Group is a global leader in providing a range of expert services and support across the drug development lifecycle.

    We are trusted experts in R&D, diagnostic services, API manufacture, formulation development, clinical trial supply services and technologies through to commercial-scale manufacture and distribution.

    We are recognised as an industry leader in client service, providing understanding, experience and knowledge to our clients as we work together to advance human health.

    Almac is trusted by the leading global biopharma companies to provide crucial services across their drug development projects. In the last 5 years alone, we have contributed to over 50% of all FDA approved New Molecular Entities (NMEs) and are currently supporting 30% of EU approved /pre-registered Gene therapy products.

    A privately owned organisation, Almac has grown organically over the past five decades, employing over 7,700 highly skilled employees across 18 facilities in Europe, North America, and Asia. Learn more about us at https://www.almacgroup.com/

    Company Website

    To learn more, please visit our website - https://www.almacgroup.com

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    Company Information

    YPrime’s cloud-based technology streamlines clinical trial data collection and management. Electronic clinical outcome assessments (eCOA) and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. Our consulting services help clients simplify downstream processes, while moving faster and more efficiently to their next development milestone.

    We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. We’re doing more than streamlining your processes. We’re streamlining your research, helping you get to your next milestone faster.

    Company Website

    To learn more, please visit our website - http://www.yprime.com/

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    Company Information

    Euromed Pharma deliver strategic services tailored to support companies in their quest to better healthcare. We support each industry player from drug development through the post-marketing phases. We offer solutions in CTS services, Clinical GMP Packaging, Labeling and Distribution, IMP management, Early Access and Named Patient Programs, Pharma Order to cash solutions, and Supply Chain & Logistics. We are present around the world with offices in Italy, Spain, Ireland, Germany, Singapore and the USA. Being one of the Petrone Group companies, Euromed Pharma is positioned at the forefront of innovation in pharmaceutical distribution.

    Company Website

    To learn more, please visit our website - www.euromed-pharma.com

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    Simply sourcing comparators – we offer a unique blend of small company flexibility and speed, backed with the large-scale buying power of the Orifarm Group, which is one of the largest pharmaceutical suppliers in Europe. With over €1.4B products sold in 2021 and more than 4,000 unique product lines sourced on a monthly basis, we have unparalleled access to “out of market” and manufacturer direct buying capability, both in the US and Europe.

    Company website: www.Orifarm-CTS.com

    Company Website

    To learn more, please visit our website - www.Orifarm-CTS.com

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    Company Information

    4G Clinical is a leader in randomization and trial supply management (RTSM) for the global life sciences industry, offering the only fully cloud-based, 100% configurable and flexible solution utilizing natural language processing (NLP) and integrated supply forecasting. 4G Clinical is headquartered in the Boston Biotech corridor of Wellesley, MA, with offices in Europe and Asia. For more information, please visit www.4gclinical.com

    Company Website:http://www.4gclinical.com/

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    Company Website

    To learn more, please visit our website - http://www.bappharma.com/

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    Company Information

    Catalent solves today’s clinical trial supply challenges and develops innovative solutions for the future. Catalent’s commitment to quality and service excellence is evident in its comprehensive and flexible solutions for small molecules, biologics and advanced therapy medicinal products (ATMPs). With modern global facilities, and 25+ years’ experience reliably supplying thousands of studies of all sizes and complexities around the world, services include:

    • Clinical supply management
    • Integrated formulation development, clinical manufacturing & blinding
    • Specialty handling (potent, cytotoxic, controlled)
    • Direct commercial product sourcing
    • Clinical packaging/labeling
    • Extensive clinical storage, cold chain capabilities & global distribution
    • Demand-led supply
    • Direct-to-patient solutions
    • Clinical returns, reconciliation & destruction.

    Company Website

    To learn more, please visit our website - https://clinical.catalent.com/

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    Company Information

    Jupiter Research Services is a global, one-stop solution for comprehensive clinical supply chain management.

    We specialize in Comparator Sourcing, Labeling, Secondary Packaging, and Temperature-Controlled Storage & Distribution, with regulatory compliant GxP facilities, delivering end-to-end support to the pharmaceutical, biopharma, CRO, and CMO industries.

    Our quality-focused, tailor-made services are designed to ensure the most efficient delivery of effective and accessible treatments worldwide.

    Company Website

    To learn more, please visit our website - www.jrsllc.com

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    Company Information

    The CCL Clinical Business Unit is the global specialist of CCL Industries Inc. for products and services in the clinical trials sector. Leveraging over two decades of expertise and operating across various manufacturing sites, we stand poised as your premier partner for clinical trial labeling. With a combined portfolio, worldwide reach, and dedicated local assistance, CCL Clinical emerges as your ultimate destination for excellence in clinical trial labeling services.

    Company Website

    To learn more, please visit our website - https://cclhealthcare.com/cclclinical/

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    Company Information

    N-SIDE is a deeptech company that empowers organizations in the life sciences to make better decisions and optimize the use of critical resources. We’re doing so by combining deep industry expertise with applied mathematics and artificial intelligence into easy to use and cutting-edge software that transforms uncertainty and complexity into deterministic outcomes. We are an active player in clinical trial supply chain management for over 20 years and have the majority of the top 20 pharmaceutical companies as clients.

    With our software solution, the N-SIDE Suite, and expert services, we streamline the clinical supply of pharmaceutical and biotech companies by accelerating clinical plans, mitigating risks and curbing drug waste. We empower clinical leaders to make better, faster and safer decisions for patients waiting for life-changing medications.

    Company Website

    To learn more, please visit our website - https://lifesciences.n-side.com/

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    Company Information

    Since 1997, Clinigen has offered market-leading clinical trial supplies and biological sample management services to meet the most complex clinical supply challenges. Part of Clinigen Group’s global supply chain facility and depot network, we deliver tailored solutions for clients to ensure their clinical trials are a success, regardless of size or scope, from Phase I to Phase IV projects.

    Company Website

    To learn more, please visit our website - www.clinigencsm.com

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    Company Information

    Converge Consulting, a Division of Dark Horse Consulting Group, serves the life sciences industry with strategy, operations, and execution expertise, collaborating with biotech, pharmaceutical, and CGT companies to achieve critical business objectives. Converge’s approach focuses on bridging the gap between sound strategy and reliable execution.

    Company Website

    To learn more, please visit our website - https://convergeconsulting.com/

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    Company Website

    To learn more, please visit our website - https://www.perceptive.com/rtsm-randomization-and-clinical-trial-supply-management/

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    Company Information

    Clinical Supply Consulting (CSC) is a specialized consultancy firm that streamlines clinical trial supply chain management. Our passionate, patient-focused consultants manage early through late phase development of clinical supplies, with comprehensive services including IRT system optimization, drug supply forecasting, logistics management, and study closeout support for clinical trials worldwide.

    Company Website

    To learn more, please visit our website - https://clinicalsupplyconsulting.com/

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    Company Information

    Poxy Clinical is a trusted clinical trial technology validation partner, recognized for our commitment to quality, partnership, and specialized expertise. With experience supporting 50+ Sponsors across 850+ clinical trials, we help reduce implementation risk through validation strategy, User Acceptance Testing, and implementation support across RTSM, eCOA, and adjacent clinical technologies.

    Company Website

    To learn more, please visit our website - https://www.poxyclinical.com/

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      Agenda

      • 22 Sep 2026
      • 23 Sep 2026
      Expand All

      Streams

      Stream one

      STREAM A

      Stream two

      STREAM B

      ENHANCING STRATEGIC PARTNERSHIPS

      11:15 AM

      ASK THE EXPERT PANEL: How to choose CDMOs as a true extension of your team to enable flexible, and stage-specific clinical supply needs 📊 LIVE POLL

      • How to align CDMO partnerships with phase-specific needs while staying agile
      • How to collaborate across CDMOs and ensure smooth tech transitions, especially for biologics therapies
      • How to build transparent CDMO partnerships from Day 1 to overcome challenges and save costs

      Moderator: Amanda Murphy, Head of Digital Product Management, GlobalData

      • Panelist 1: Aimee Hogue, Director Supply Chain, Sutro Biopharma
      • Panelist 2: Amber Bill, Associate Director, Sangamo Therapeutics  

      Panelist 3: Burkard Kolb, Former Executive Director, CMC Operations, 89bio  (Genentech) 

      Speakers

      Amanda Murphy
      Head of Digital Product Management, GlobalData
      Aimee Hogue
      Director of Supply Chain, Sutro Biopharma
      Amber Bill
      Associate Director, Sangamo Therapeutics
      Burkard Kolb
      Former Executive Director, CMC Operations, 89bio (Genentech)

      12 PM

      INDUSTRY CASE STUDY: Rewriting the playbook for Clinical success: Inside the CDMO and Biotech collaboration

      • How to choose partners based on shared long-term goals, not just capabilities or price
      • How to build transparent partnerships that drive open, effective problem-solving
      • How to leverage regional sourcing for stronger partnerships without compromising risk or budget

      Speakers

      Kirk Bray
      Senior Manager Sales, West Coast Biotech, Thermo Fisher Scientific
      Jason Keveryn
      Associate Director, Clinical Supply Chain, 4D Molecular Therapeutics

      12:30 PM

      CASE STUDY: Navigating the perfect storm: How trial and drug complexity is reshaping supply chain strategy 📊 LIVE POLL

      • Advanced Modalities, biomarkers, amendments, DCTs, globalization
      • How data and early signals can help anticipate shifts in supply chain needs, competitive intelligence and site selection.
      • Navigating challenges around CDMO and supply chain vendor planning and selection

      Speakers

      Amanda Murphy
      Head of Digital Product Management, GlobalData

      1:30 PM

      Lunch and networking

      END-TO-END SUPPLY EXCELLENCE

      8 AM

      Registration and refreshments

      8:50 AM

      Chairperson’s opening remarks

      NAVIGATING GEOPOLOTICS & TRANSATLANTIC ALIGNMENT

      9 AM

      OPENING REGULATORY KEYNOTE: Ensuring Clinical Trial Continuity – Navigating the Importation of Pharmaceuticals, Biologics, Medical Devices & Combination Products

      • Understand current importation requirements and regulatory considerations for pharmaceuticals, biologics, medical devices, and combination products used in clinical research.
      • Learn practical strategies and best practices to prevent shipment delays, mitigate compliance risks, and maintain continuity of clinical trial supplies across global supply chains.
      • Explore how to navigate the FDA imports process from entry submission to compliance determination

       

      Speakers

      Jessica Lee
      Supervisory Consumer Safety Officer, Division of West Coast Imports, FDA
      Marissa Chan
      Supervisory Consumer Safety Officer, Division of West Coast Imports, FDA

      CLINICAL SUPPLY TRILEMMA: BALANCING VELOCITY, PRECISION & COST

      9:25 AM

      INTERACTIVE KEYNOTE: The Forecast Is Dead: Clinical Supply’s Shift from Prediction to Continuous Orchestration

      • From forecasting to continuous supply intelligence: why the real metric is decision latency, the time between a supply signal and a supply action, and how leading sponsors are collapsing it from weeks to hours
      • The connected ecosystem in practice: how event-driven supply orchestration (IRT working in concert with eCOA, depots, couriers, and temperature data) turns thousands of small, automated decisions into fewer shipments, leaner stock, and uninterrupted patient dosing.
      • You vs. the algorithm (live)

       

      Speakers

      Chris Driver
      Senior Director, Product Management AI & Technology Solutions, Patient Suite, IQVIA Technologies

      9:55 AM

      GEO SPOTLIGHT: Shocks, Shifts, and Safeguards: New Principles for Supply Chain Stability

      • Understanding the current current supply chain shocks and trends 
      • The core pillars: Cost, speed, and resilience 
      • Three essential safeguards: Technology (Agentic AI), Geopolitical awareness,Cybersecurity and trust

      Speakers

      Nick Vyas
      Professor, Clinical Data Sciences and Supply Chain Operations, Marshall School of Business

      10:20 AM

      PRACTICAL KEYNOTE: From Concept to Clinic: Operationalizing the Pharmacy Card Model to Decentralize Supply and Accelerate Patient Access

      • Understanding the Pharmacy Card Model
      • The Program Lifecycle: From Design to Delivery
      • A day in the Life: Sponsors & Sites
      • Proof of Performance: Feedback and Case Studies

       

      Speakers

      Tom Gottschalk
      Vice President Business Development, Valeris

      10:50 AM

      Morning refreshments and networking

      END-TO-END SUPPLY EXCELLENCE

      11:30 AM

      CASE STUDY: Streamlining E2E Supply Complexity: How to implement a robust S&OP governance across the value chain

      • Aligning Manufacturing, Regulatory, and Clinical Operations to eliminate silos and enable integrated, compliant decision-making
      • Establishing governance and ownership frameworks linking supply execution with financial planning to drive transparency, accountability, and aligned decisions
      • Identifying and resolving end-to-end process bottlenecks to improve agility, reduce risk, and ensure supply continuity across clinical and commercial programs

      Speakers

      Monica Eris
      Senior Director, Head of Supply Chain, Logistics & CMO Management, Imugene Limited

      12 PM

      INDUSTRY CASE STUDY: How to make planning a successful role through people, processes and performance?

      Planning is one the most critical roles in the cynical supply chain. Planners decide how much study drugs produce, source package and distribute and when to do so. Consequently, all the clinical supply chain’s performance indicators (waste, costs, inventories, shortage risks, CO2 emissions, etc) are intimately linked to their actions. While systems help, they are not the main driver of a planning organization’s success.

      • The 4 "P" (People, Process, Product, Performance) for a successful organisation 
      • How to structure a team, including roles and responsibilities to make planning a strategic role 
      • What are the essential processes to enable a high-performing CTS planning 
      • How to make performance a priority and improve it through planning 
      • Illustration through business cases, benchmarks and good practices 

       

      Speakers

      Amaury Jeandrain
      CTS Strategy Advisor, N-SIDE
      Dan Caramore
      Strategic Account Manager, N-SIDE

      12:30 PM

      INTERACTIVE PANEL DISCUSSION: Align demand planning and execution with a unified, consistent approach to eliminate waste

      •  📊 LIVE POLL
      • The importance of deeply understanding your study parameters to develop optimized strategies that meet trial needs, ensure patient supply, and minimize waste
      • How to implement rigorous data quality checks to ensure supply models aren't forecasting "ghost demand" caused by inconsistent site-entry habits or lagging EDC updates
      • How to pivot from static to dynamic demand modelling to build a supply chain resilient to geopolitical and regulatory shifts
      • How to integrate clinical and supply teams early to shift from speculative forecasting to agile, waste-reducing models

      Moderator: Amaury Jeandrain, CTS Strategy Advisor

      Speakers

      Louie Burks
      Director, Clinical Supply, Praxis Precision Medicines
      Justin Bourret
      Clinical Demand & Supply Lead, Genentech
      Chris Driver
      Director IT Architecture, IQVIA

      1 PM

      Lunch and networking

      END-TO-END SUPPLY EXCELLENCE

      2 PM

      CASE STUDY: The Lean Clinical Supply Chain: Reducing overage and waste through early study engagement

      • Engaging supply chain teams early in protocol design to match manufacturing strategies directly to real-world patient enrollment trajectories
      • Utilizing real-time forecasting and adaptive supply models to drastically cut drug waste without risking trial stockouts or site delays
      • Aligning site selection, packaging, and shelf-life management early on to streamline logistics across complex multi-site networks

      Speakers

      Shubhra Kochar
      Head of Global Clinical Supply Chain Planning, Genentech

      2:30 PM

      INTERACTIVE FIRESIDE CHAT: “Silo Effect” – How to turn disconnected functions into a unified strategy that accelerates clinical supply and improves patient experience LIVE POLL

      • How to reposition CTS from a pure logistics function to a strategic partner and enable teams to advocate their value internally to improve ClinOps outcomes
      • Protocol vs. Reality: How to close the gap between protocol design and operational reality through early collaboration to ensure the supply chain matches the realities of patient care
      • How to establish shared goals, KPIs, and communication frameworks between CTS and ClinOps to sustain alignment and ongoing collaboration throughout the study

      Moderator: M. David (Dave) Malenfant, Executive Supply Chain Leader, Trainer, Mentor, TCU   

      • Panelist 1: Malinda Longphre, Head of Clinical Operations, Attovia Therapeutics

      Panelist 2: Horacio Enriquez, Global Senior Supply Chain Manager, BeOne Medicine

      Speakers

      Malinda Longphre
      Head of Clinical Operations, Attovia Therapeutics
      M. David (Dave) Malenfant
      Executive Supply Chain Leader, Trainer, Mentor, TCU
      Horacio Enriquez
      Global Senior Supply Chain Manager, BeOne Medicine

      3 PM

      CASE STUDY: The 72-Hour Pulse: How Orca Bio is Using AI to Erase Risk and Guarantee Patient Delivery 📊 LIVE POLL

      • How to safeguard temperature-sensitive biologics and advanced therapies during shipping delays
      • How to stay compliant with local and global regulations while maintaining chain-custody
      • How to select validated storage facilities for all temperature ranges while keeping inventory visible and minimizing loss

      Speakers

      Jamie Goldman
      Logistic Program Manager, Orca Bio

      3:30 PM

      Afternoon refreshments and networking

      END-TO-END SUPPLY EXCELLENCE

      AI with a Human Touch: Practical Strategies for Smart, Safe Adoption

      4:10 PM

      🍻INTERACTIVE BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝

      AI is powerful, but the drug and the patient come first. This boardroom explores how teams can leverage AI safely, integrate it into workflows, and maintain human control with strong processes.

      Shift from "random prompting" to building Structured Supply Chain AI Workflows that save hours while keeping human oversight and data security intact

      Outcome: Each table will collaborate to create practical strategies, and governance approaches that balance AI capabilities with human oversight, ensuring AI enhances decisions rather than replacing critical thinking.

      Sia Zadeh, Chair AI Initiative and Associate Professor and Data Scientist, Golden Gate University

      Speakers

      Sia Zadeh
      Chair AI Initiative and Associate Professor and Data Scientist, Golden Gate University

      5:15 PM

      Chair’s summary and close of day 1

      Don’t forget to leave us your feedback through our app! Your insights help us make future sessions even better.

      5:30 PM

      Drinks reception

      🍷 Drinks reception - Unwind and network while enjoying some of California’s finest wines

      🏆 PRIZE DRAW: Visit our exhibitors’ booths throughout the day and collect stamps to enter our Prize Draw and be in for a chance of winning Apple prizes or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

      8:15 AM

      Registration and refreshments

      9 AM

      Chair’s opening remarks

      Speakers

      M. David (Dave) Malenfant
      Executive Supply Chain Leader, Trainer, Mentor, TCU

      9:05 AM

      Interactive Breakfast Speaker – Hosted Roundtable Discussions

      ROUNDTABLE SESSIONS offer a valuable opportunity to connect with peers, share best practices, and collaborate on solutions to key industry challenges. These interactive discussions also help you expand your network and learn from others’ experience and expertise.

      1.How to Prepare for U.S. Biological Material Importation: Navigating Regulatory Requirements, Operational Challenges, and Best Practices
      Moderators: Carmin Cerullo, Agriculture Operations Manager, San Francisco and Portland Field Office, U.S. Customs and Border Protection; Jolien Wychules, Biological Threat Operations Specialist, San Francisco and Portland Field Office, U.S. Customs and Border Protection
      2. Small vs. Large CDMOs/CMOs: How to choose the right partner for agility, scale, and clinical supply success
      Moderators: Umar Hayat, VP, CMC and Supply Chain, Union Therapeutics; Rabindra Shivnaraine, Director, Clinical Supply Pharmacology, Aerys Biosciences
      3.How to meet big pharma standards on a startup budget: Scaling compliance with limited staff and high regulatory burdens
      Moderator: Charisse Eary, Head of Quality, Aligos Therapeutics
      4. How to start implementing AI in your day to day workflows to deliver real outcomes in your clinical supply
      Moderator: Jamie Goldman, Logistic Program Manager, Orca Bio
      5. Integrated Program Planning: Syncing CMC, Manufacturing, and Clinical Supply for Accelerated Timelines
      Moderator: Joerg Wania, Head of Clinical Trial Supply / Export, Stadpharm
      6. Real Change Demands Synergy: Unifying the People, Process, and Tech Triad
      Moderator: M. David (Dave) Malenfant, Executive Supply Chain Leader, Trainer, Mentor, TCU

      Speakers

      Jolien Wychules
      Biological Threat Operations Specialist, San Francisco and Portland Field Office, U.S. Customs and Border Protection
      Umar Hayat
      Founder, CEO, Accanito Therapeutics Inc
      Charisse Eary
      Executive Director, Head of Quality, Aligos Therapeutics
      Jamie Goldman
      Logistic Program Manager, Orca Bio
      Joerg Wania
      Head of Clinical Trial Supply / Export, Stadpharm
      M. David (Dave) Malenfant
      Executive Supply Chain Leader, Trainer, Mentor, TCU

      ENHANCING COMPLICANCE, QUALITY & PARTNERSHIPS

      10 AM

      INTERACTIVE FIRESIDE CHAT: How to stay GMP-compliant while optimizing QP resources, quality processes, and regulatory alignment

      • How to plan and allocate resources effectively across the full study lifecycle (from manufacturing to release and distribution)
      • How to prepare for audits and inspections proactively incorporating audit readiness into daily workflows to avoid last minute firefighting
      • The value of leveraging external partners and CDMOs effectively to improve quality oversight with limited internal teams

      Moderator: Paul Hingst, Supply Chain Consultant, Crinetics Pharmaceuticals 

      Panelist 1:Ted Chun, VP Regulatory, Quality & Clinical, Prometheus Therapeutics

      Panelist 2: Pooja Gandhi, Director, Clinical Quality Assurance, Grail

      Speakers

      Paul Hingst
      Supply Chain Consultant, Crinetics Pharmaceuticals
      Ted Chun
      Owner, Chun Consulting 创始人，Chun Consulting
      Pooja Gandhi
      Director, Clinical Quality Assurance, Grail

      10:30 AM

      CASE STUDY: Moving away from audit nightmares to real-time accountability and audit readiness approach

      • How to make sure you are building accountability and reconciliation practices into the study planning up front, before the first shipment is dispatched
      • How to clearly define the accountability process and primary system of record to ensure sites and CROs understand expectations for documentation, reconciliation and destruction
      • How to standardize site-level data capture while accommodating local practices to prevent mismatches and delays at study closeout
      • How to leverage electronic systems to embed audit-ready accountability into daily workflows, shifting from reactive clean-up to real-time documentation
      • How to ensure a controlled IRT closure that eliminates discrepancies and supports complete, audit-ready records that helps you to save money in the long run

      Speakers

      Paul Hingst
      Supply Chain Consultant, Crinetics Pharmaceuticals

      11 AM

      Morning Refreshments and Networking

      DESIGNED FOR THE PATIENT

      11:30 AM

      PATIENT ADVOCACY INTERVIEW: Beyond the box: How every operational decision impacts the patient experience

      • Explore how patient-centric supply planning can reduce burden, improve retention, and build trust through advocacy partnerships, flexible logistics, and aligned operations
      • Interviewer: Christine von Raesfeld, Patient Advocate, The Light Collective  

      Speaker: Paul Gater, Advocate for patients with multiple myeloma, Member of the Patient Advocate Committee SWOG Cancer Research Network (former Genentech)

      Speakers

      Christine von Raesfeld
      Patient Advocate, The Light Collective
      Paul Gater
      Advocate for patients with multiple myeloma, Member of the Patient Advocate Committee SWOG Cancer Research Network (former Genentech)

      11:55 AM

      INDUSTRY INTERACTIVE DEBATE: The road to patient-centric trials: What’s stopping us and how to move forward 📊 LIVE POLL

      What is really stopping us today: Lack of internal training, Limited digital integration, Scalability pressures, Other operational or regulatory barriers. What next practical steps can we take to overcome these hurdles?

      Speakers

      Christine von Raesfeld
      Patient Advocate, The Light Collective

      12:45 PM

      REGULATORY SPOTLIGHT: Understanding duty and entry rates in US clinical supply chain imports!

      • Optimize clinical trade compliance by ensuring precise material classification and valuation
      • Collaborating with brokers and logistics partners to ensure compliant, efficient
        importation
      • Determining duty rates and entry rates for different types of clinical trial materials and products
      • Applying for duty exemptions: are you eligible?

      Speakers

      Brandy Porter
      Assistant Center Director, Enforcement Pharmaceuticals, Health, and Chemicals Center of Excellence and Expertise, U.S. Customs & Border Protection

      1:10 PM

      LUNCH, NETWORKING AND 🏆 PRIZE DRAW 🏆

      THE BIOTECH FRONTIER: CHALLENGES, TRENDS & FUTURE STRATEGIES

      2:10 PM

      KEYNOTE: China’s Biotechnology Sector and What It Means for America

      • China’s Rise as a Clinical Trial Hub: How rapid patient accrual, cost advantages, and government support are diverting early-phase development offshore
      • The Global Regulatory Reality: Navigating FDA expectations for multi-regional data while leveraging overseas trial efficiency
      • Western CRO Competitiveness: Adapting to aggressive competition from Chinese trial scale through niche domain expertise, specialized therapeutic focus, and process automation

      Speakers

      Sebastian De Beurs
      Co-Founder, Healis Therapeutics

      2:40 PM

      BIOTECH HOT TAKES: INSIGHTS FROM INDUSTRY LEADERS 🔥

      Panelists will share their perspectives in short, dynamic talks
      Each company addresses a set of thought-provoking prompts:

      • Biggest mistake in clinical trials today
      • One thing pharma should stop doing
      • Navigating Funding Challenges
      • One prediction for 2030
      • What’s overhyped vs. what’s worth the hype
      • What vendors misunderstand
      • Where trials fail most often
      • Biggest recruitment mistake

      Speakers

      Vanloan Nguyen
      President & Director, Berkeley Pharma Tech Foundation
      David Kiewlich
      Founder, Tomorrow Biotech Corporation
      David Larwood
      CEO, Valley Fever Solutions
      Dr. Prasun Mishra
      Co-Founder & CEO, Precision BioPharma
      Jin Lee
      Founding Board Member, CURE NDD

      3:15 PM

      END OF CONFERENCE

      Don’t forget to leave us your feedback through our app! Your insights help us make future sessions even better.

      Speakers

      Select a speaker to learn more

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      Marissa Chan
      Supervisory Consumer Safety Officer, Division of West Coast Imports, FDA

      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.

      Session Details:

      OPENING REGULATORY KEYNOTE: Ensuring Clinical Trial Continuity – Navigating the Importation of Pharmaceuticals, Biologics, Medical Devices & Combination Products

      2026-09-22, 9:00 AM

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      Jessica Lee
      Supervisory Consumer Safety Officer, Division of West Coast Imports, FDA

      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. 

      Session Details:

      OPENING REGULATORY KEYNOTE: Ensuring Clinical Trial Continuity – Navigating the Importation of Pharmaceuticals, Biologics, Medical Devices & Combination Products

      2026-09-22, 9:00 AM

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      Monica Eris
      Senior Director, Head of Supply Chain, Logistics & CMO Management, Imugene Limited

      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. 

      Session Details:

      CASE STUDY: Streamlining E2E Supply Complexity: How to implement a robust S&OP governance across the value chain

      2026-09-22, 11:30 AM

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      Shubhra Kochar
      Head of Global Clinical Supply Chain Planning, Genentech

      Session Details:

      CASE STUDY: The Lean Clinical Supply Chain: Reducing overage and waste through early study engagement

      2026-09-22, 2:00 PM

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      Justin Bourret
      Clinical Demand & Supply Lead, Genentech

      Session Details:

      INTERACTIVE PANEL DISCUSSION: Align demand planning and execution with a unified, consistent approach to eliminate waste

      2026-09-22, 12:30 PM

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      Horacio Enriquez
      Global Senior Supply Chain Manager, BeOne Medicine
      • Education: BS Mechanical Engineering 1997, MS Engineering Management 2004, EdD 2027.
      • 20 years in the Life Sciences: Operations Management and Supply Chain Management leadership roles in Biotechnology, Clinical Diagnostics, Medical Device, Cell & Gene Therapy, and synthetic Biology companies (former Genentech, Bio-Rad Laboratories, Amgen).
      • Functional and Digital Supply Chain experience: Plan, Source, Make, Deliver, ERP, Master Data Management and Governance, Analytics, Supply Chain and Supplier Risk.
      • Global experience: Americas, Western Europe, and Asia-Pac.
      • Operations Management and Supply Chain Management Adjunct Lecturer and Faculty Advisor at Santa Clara University, University of San Francisco, UC Davis, and Golden Gate University.
      • Board positions and Advisory roles have included the Bio Supply Management Alliance, American Association of Precision Medicine, Santa Clara University Bronco Venture Fund.
      • Patents in Supply Chain Digital Twin and AI-based scenario analysis.

      Session Details:

      INTERACTIVE FIRESIDE CHAT: “Silo Effect” – How to turn disconnected functions into a unified strategy that accelerates clinical supply and improves patient experience LIVE POLL

      2026-09-22, 2:30 PM

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      Aimee Hogue
      Director, Supply Chain, Sutro Biopharma
      Next speaker
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      Jason Keveryn
      Associate Director, Clinical Supply Chain, 4D Molecular Therapeutics

      Jason Keveryn is Associate Director of Clinical Supply Chain at 4D Molecular Therapeutics. Previously at Cytokinetics 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.

      Session Details:

      INDUSTRY CASE STUDY: Rewriting the playbook for Clinical success: Inside the CDMO and Biotech collaboration

      2026-09-22, 12:00 PM

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      Ted Chun
      VP Regulatory, Quality & Clinical, Prometheus Therapeutics

      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. 

      Next speaker
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      Pooja Gandhi
      Director, Clinical Quality Assurance, Grail

      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. 

      Session Details:

      INTERACTIVE FIRESIDE CHAT: How to stay GMP-compliant while optimizing QP resources, quality processes, and regulatory alignment

      2026-09-23, 10:00 AM

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      Louie Burks
      Director, Clinical Supply, Praxis Precision Medicines

      Experienced Project Manager in Product Development, Supply Chain, Business Operations and Logistics, and Change Management

      Session Details:

      INTERACTIVE PANEL DISCUSSION: Align demand planning and execution with a unified, consistent approach to eliminate waste

      2026-09-22, 12:30 PM

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      Malinda Longphre
      Head of Clinical Operations, Attovia Therapeutics

      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.

      Session Details:

      INTERACTIVE FIRESIDE CHAT: “Silo Effect” – How to turn disconnected functions into a unified strategy that accelerates clinical supply and improves patient experience LIVE POLL

      2026-09-22, 2:30 PM

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      Jamie Goldman
      Logistic Program Manager, Orca Bio

      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.   

      Session Details:

      Interactive Breakfast Speaker – Hosted Roundtable Discussions

      2026-09-23, 9:05 AM

      Session Details:

      CASE STUDY: The 72-Hour Pulse: How Orca Bio is Using AI to Erase Risk and Guarantee Patient Delivery 📊 LIVE POLL

      2026-09-22, 3:00 PM

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      Sebastian De Beurs
      Co-Founder, Healis Therapeutics

      Session Details:

      KEYNOTE: China’s Biotechnology Sector and What It Means for America

      2026-09-23, 2:10 PM

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      Joerg Wania
      Head of Clinical Trial Supply / Export, Stadpharm

      Session Details:

      Interactive Breakfast Speaker – Hosted Roundtable Discussions

      2026-09-23, 9:05 AM

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      Paul Hingst
      Supply Chain Consultant, Crinetics Pharmaceuticals

      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.

      Session Details:

      CASE STUDY: Moving away from audit nightmares to real-time accountability and audit readiness approach

      2026-09-23, 10:30 AM

      Session Details:

      INTERACTIVE FIRESIDE CHAT: How to stay GMP-compliant while optimizing QP resources, quality processes, and regulatory alignment

      2026-09-23, 10:00 AM

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      Umar Hayat
      Founder, CEO, Accanito Therapeutics Inc

      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

      Session Details:

      Interactive Breakfast Speaker – Hosted Roundtable Discussions

      2026-09-23, 9:05 AM

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      Rabindra Shivnaraine
      Director, Aerys Biosciences
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      Charisse Eary
      Executive Director, Head of Quality, Aligos Therapeutics

      Session Details:

      Interactive Breakfast Speaker – Hosted Roundtable Discussions

      2026-09-23, 9:05 AM

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      Amber Bill
      Associate Director, Sangamo Therapeutics

      Session Details:

      ASK THE EXPERT PANEL: How to choose CDMOs as a true extension of your team to enable flexible, and stage-specific clinical supply needs 📊 LIVE POLL

      2026-09-22, 11:15 AM

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      Burkard Kolb
      Former Executive Director, CMC Operations, 89bio (Genentech)

      Burkard Kolb has 22 years of experience in the development and manufacture of biologics. Starting out at Roche Penzberg,  Singapore and at Genentech in South San Francisco, he focused on internal development and manufacturing projects in Engineering and MSAT positions. During his tenure at Coherus Oncology and 89bio, he managed external manufacturing of Drug Substance for biosimilars and novel biologic drugs, handling site selection, tech transfer, process characterization and validation activities. He has been an author of CMC sections for multiple successful BLA and IND submissions.

      Session Details:

      ASK THE EXPERT PANEL: How to choose CDMOs as a true extension of your team to enable flexible, and stage-specific clinical supply needs 📊 LIVE POLL

      2026-09-22, 11:15 AM

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      Dr. Prasun Mishra
      Co-Founder & CEO, Precision BioPharma

      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 

      Session Details:

      BIOTECH HOT TAKES: INSIGHTS FROM INDUSTRY LEADERS 🔥

      2026-09-23, 2:40 PM

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      Jin Lee
      Founding Board Member, CURE NDD

      Session Details:

      BIOTECH HOT TAKES: INSIGHTS FROM INDUSTRY LEADERS 🔥

      2026-09-23, 2:40 PM

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      David Larwood
      CEO, Valley Fever Solutions

      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.

      Session Details:

      BIOTECH HOT TAKES: INSIGHTS FROM INDUSTRY LEADERS 🔥

      2026-09-23, 2:40 PM

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      Vanloan Nguyen
      President & Director, Berkeley Pharma Tech Foundation

      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.

      Session Details:

      BIOTECH HOT TAKES: INSIGHTS FROM INDUSTRY LEADERS 🔥

      2026-09-23, 2:40 PM

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      David Kiewlich
      Founder, Tomorrow Biotech Corporation

      Session Details:

      BIOTECH HOT TAKES: INSIGHTS FROM INDUSTRY LEADERS 🔥

      2026-09-23, 2:40 PM

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      Brandy Porter
      Assistant Center Director, Enforcement Pharmaceuticals, Health, and Chemicals Center of Excellence and Expertise, U.S. Customs & Border Protection

      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.

      Session Details:

      REGULATORY SPOTLIGHT: Understanding duty and entry rates in US clinical supply chain imports!

      2026-09-23, 12:45 PM

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      Carmin Cerullo
      Agriculture Operations Manager, San Francisco and Portland Field Office, U.S. Customs and Border Protection

      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. 

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      Jolien Wychules
      Biological Threat Operations Specialist, San Francisco and Portland Field Office, U.S. Customs and Border Protection

      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. 

      Session Details:

      Interactive Breakfast Speaker – Hosted Roundtable Discussions

      2026-09-23, 9:05 AM

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      Sia Zadeh
      Chair AI Initiative and Associate Professor and Data Scientist, Golden Gate University

      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.

      Session Details:

      🍻INTERACTIVE BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝

      2026-09-22, 4:10 PM

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      Nick Vyas
      Professor, Clinical Data Sciences and Supply Chain Operations, Marshall School of Business

      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. 

      Session Details:

      GEO SPOTLIGHT: Shocks, Shifts, and Safeguards: New Principles for Supply Chain Stability

      2026-09-22, 9:55 AM

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      Paul Gater
      Advocate for patients with multiple myeloma, Member of the Patient Advocate Committee SWOG Cancer Research Network (former Genentech)

      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. 

      Session Details:

      PATIENT ADVOCACY INTERVIEW: Beyond the box: How every operational decision impacts the patient experience

      2026-09-23, 11:30 AM

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      Christine von Raesfeld
      Patient Advocate, The Light Collective

      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.

      Session Details:

      PATIENT ADVOCACY INTERVIEW: Beyond the box: How every operational decision impacts the patient experience

      2026-09-23, 11:30 AM

      Session Details:

      INDUSTRY INTERACTIVE DEBATE: The road to patient-centric trials: What’s stopping us and how to move forward 📊 LIVE POLL

      2026-09-23, 11:55 AM

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      M. David (Dave) Malenfant
      Executive Supply Chain Leader, Trainer, Mentor, TCU

      Session Details:

      INTERACTIVE FIRESIDE CHAT: “Silo Effect” – How to turn disconnected functions into a unified strategy that accelerates clinical supply and improves patient experience LIVE POLL

      2026-09-22, 2:30 PM

      Session Details:

      Chair’s opening remarks

      2026-09-23, 9:00 AM

      Session Details:

      Interactive Breakfast Speaker – Hosted Roundtable Discussions

      2026-09-23, 9:05 AM

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      Amanda Murphy
      Head of Digital Product Management, GlobalData

      Session Details:

      CASE STUDY: Navigating the perfect storm: How trial and drug complexity is reshaping supply chain strategy 📊 LIVE POLL

      2026-09-22, 12:30 PM

      Session Details:

      ASK THE EXPERT PANEL: How to choose CDMOs as a true extension of your team to enable flexible, and stage-specific clinical supply needs 📊 LIVE POLL

      2026-09-22, 11:15 AM

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      Kirk Bray
      Senior Manager Sales, West Coast Biotech, Thermo Fisher Scientific

      Session Details:

      INDUSTRY CASE STUDY: Rewriting the playbook for Clinical success: Inside the CDMO and Biotech collaboration

      2026-09-22, 12:00 PM

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      Tom Gottschalk
      Vice President Business Development, Valeris

      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.

      Session Details:

      PRACTICAL KEYNOTE: From Concept to Clinic: Operationalizing the Pharmacy Card Model to Decentralize Supply and Accelerate Patient Access

      2026-09-22, 10:20 AM

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      Amaury Jeandrain
      Strategy Advisor, Clinical Supply, N-SIDE

      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.

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      Dan Caramore
      Strategic Account Manager, N-SIDE

      Session Details:

      INDUSTRY CASE STUDY: How to make planning a successful role through people, processes and performance?

      2026-09-22, 12:00 PM

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      Chris Driver
      Director IT Architecture, IQVIA

      Chris Driver is currently Director, IT Architecture at IQVIA, with over 21 years of experience in the IRT and Biotechnology space, and across a number of R&D and Information Technology functions. Chris’s experience and background in infrastructure architecture, global health platforms and more recently, decentralized trial adoption through real-time integrations, drives his enthusiasm for the future state of patient-centered health care.  In his “downtime”, Chris enjoys spending time with his growing family, advocating for adoption, especially for those blessed with an extra chromosome!

      Session Details:

      INTERACTIVE PANEL DISCUSSION: Align demand planning and execution with a unified, consistent approach to eliminate waste

      2026-09-22, 12:30 PM

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      Advisory Board

      Select a member to learn more

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      Chris Wallace
      Head of Distribution EMEA, Argenx

      Chris has over 35 years’ varied supply chain experience, having worked for several blue chip companies in a number of industries including 3rd party logistics services, automotive, medical device, nuclear fuels and biotech/pharmaceuticals.

      Originally from the UK but now based in Switzerland, he has been involved in life science - biotech/pharmaceuticals & medical device - for over 20 years of his career and has latterly been SVP Global Supply Chain at Clover Biopharmaceutical before last year moving to Argenx as Head of Distribution EMEA.

      He has developed, implemented and managed global healthcare supply chain strategies and operations on 6 continents. This has included different set-ups in multiple countries, including many in the Emerging Markets as well as the developed world.

      Chris has a degree in economics from Manchester University, an MBA from Aston University and a postgraduate diploma from London University. In his spare time, he plays golf badly and loves to sample great Italian food and red wines!

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      Luiz Barberini
      Head of External Manufacturing, Latin America, Bayer
      • Over 25 years’ experience in Logistics, Supply Chain, Procurement and Demand Planning areas.
        Solid knowledge and experience in the whole S&OP process and its KPI´s inter-relationships with stakeholders
      • Demand Planning process management - pre-S&OP, with Sales, Marketing, Trade Marketing, Industrial Planning and Finance and customized tool design for such process
      • Management skills: experience with multidisciplinary and international teams (Brazil / Latin America / US).
      • Experience in S&OP, 3PL and Supply Chain Organization projects' implementation
      • Strong experience with Pharmaceutical and Consumer companies and Brazilian distribution model / 3PL contracts
      • Solid team management skills, as well as Customer Service relationship and management
      • Teacher for major Post Graduation Schools - Demand Planning and Procurement/Negotiation areas

      CSCP & CPIM APICS. Logistics & Supply Chain driven strategy. Distribution & Logistics, Demand Planning, S&OP, Procurement and Export experiences, focusing on Business necessities through effective leadership.

      Working as External Manufacturing Operations Manager Latin America at Bayer, in charge for external partners for CHC Division. Previously as Relationship Associated Director at Merck , Logistics Manager at Takeda/Nycomed Pharma, focusing on demand management, planning and distribution activities. Also has worked as Pfizer´s Logistic Manager and EFD´s Supply Chain Manager. Souza Cruz´s Procurement Manager and Rhodia's Logistic Supervisor.

      Specialties: Logistics, Supply Chain, Materials, Procurement , Services, Negotiation, 3PL contracts, S&OP, Demand Planning

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      Amanda Briceno
      Clinical Supply Management & Patient Centricity Unit Manager, Chiesi Farmaceutici

      Amanda Briceno is an experienced clinical supply professional with over 10 years in clinical research and supply chain operations. Originally from Venezuela, now based in Italy. She currently serves as Clinical Supply Manager and Head of the Patient Centricity Unit at Chiesi Farmaceutici, where she leads initiatives to design and deliver patient-focused clinical supply solutions that improve trial compliance and enhance the experience of both patients and site staff.

      Her career began as a Clinical Research Associate at IQVIA, where she gained extensive experience in global trial monitoring and operations. Since joining Chiesi, Amanda has held positions of increasing responsibility within the Clinical Supply department, before assuming her current leadership role.

      Amanda holds a Master’s degree in Drug Biotechnology from the Università degli Studi di Milano and a Bachelor’s degree in Medical Biotechnology. Amanda brings a strong blend of technical knowledge and operational leadership. Passionate about innovation in clinical supplies, she is dedicated to advancing more accessible, patient-centric clinical trials.

      Next
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      Paul Hingst
      Supply Chain Consultant, Crinetics Pharmaceuticals

      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.

      Session Details:

      CASE STUDY: Moving away from audit nightmares to real-time accountability and audit readiness approach

      2026-09-23, 10:30 AM

      Session Details:

      INTERACTIVE FIRESIDE CHAT: How to stay GMP-compliant while optimizing QP resources, quality processes, and regulatory alignment

      2026-09-23, 10:00 AM

      View In Agenda
      Next
      Back
      Amaury Jeandrain
      Strategy Advisor, Clinical Supply, N-SIDE

      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.

      Next
      Back
      Arnaud Dourlens
      Global Head of Clinical Supply Chain Operations, Sanofi

      Arnaud Dourlens is an Arts et Métiers engineer, he began his industrial career in the FMCG sector where he held growing responsibilities. Then he joined the LVMH group where he reorganized new product launches and industrial investments in the Make-up segment in order to adapt to the need for innovation and time to market, thus providing a competitive advantage. He then managed the entire portfolio of industrial launches and investments in Perfumes, Skincare and Make-up for Parfums Christian Dior Group.

      During his career Arnaud held a wide variety of industrial roles. He joined Sanofi in 2017 as Production Director of a major solid oral form production site (>2.5 billion € turnover). He has been a key player in the development of the continuous improvement mindset and in the transformation of the site through IT projects, investments and activity growth following the acquisition of Boehringer Ingelheim consumer healthcare portfolio.

      Since the beginning of 2020, he’s been the global head of Sanofi Clinical Supply Chain Operations, managing worldwide clinical supply teams involved in more than 300 clinical studies.

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      Paul Larochelle
      Senior Director Global Clinical Supply Chain,
      Takeda

      Paul Larochelle currently serves as Senior Director (Planning Team Lead) for Global Clinical Supply Chain at Takeda, where he serves as a member of the GCSC Leadership Team and is responsible for managing a team of professionals overseeing the forecasting and planning of clinical study supplies. His role encompasses the strategic and operational aspects of clinical supply chain management in therapeutic areas such as oncology, neuroscience, gastrointestinal diseases, vaccines, and rare diseases. Paul's leadership extends to cross-functional projects aimed at implementing new capabilities, conducting due diligence of potential acquisitions by the company, and improving existing processes.  

      Previously, Paul held various roles at Biogen Corporation and Genzyme, a Sanofi Company, where he honed his expertise in clinical asset planning and clinical supplies management. His contributions to these organizations included serving as a lead contact for multiple clinical programs, developing supply chain strategies, leading continuous improvement projects, and serving as Fellowship Coordinator and Student Preceptor for dozens of students.  

      Paul has a BS in Biology from Providence College, PharmD from MCPHS Boston, and an MBA from Worcester Polytechnic Institute. He also completed a Post-PharmD Industry Fellowship in Clinical Research/Investigational Product Management with MCPHS-Worcester and Genzyme Corporation. He is Chair of the Dean's Advisory Board at MCPHS School of Pharmacy – Boston,  a member of the Pharmacy Advisory Board at Western New England University, and a member of the Advisory Board for the Clinical Trial Supply global conference series.  

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      SPONSORSHIP ENQUIRIES

      Senior Sponsorship Manager

      Jaz Sidhu


      +44 (0) 207 9472755

      SPEAKING OPPORTUNITIES

      Portfolio Lead

      Gabriela Garay Villanueva


       

      MARKETING ENQUIRIES

      Head of Marketing

      Karina Gomez


       

      DELEGATE ENQUIRIES

      VIP Delegate Manager

      Sunny Saikia