Clinical Trial Supply West Coast 2023

Biography: David Larwood is a founder, the CEO, and chief chemist for Valley Fever Solutions, running the manufacturing process for a novel antifungal headed for Phase 2a trials in 2022. In his role as BD lead, he is responsible for many aspects of the company’s planning and operations. Valley Fever Solutions is a small startup working first on a new and improved treatment for Valley Fever (coccidioidomycosis), for which NikZ will transform the standard of care. NikZ shows promise against other important fungal diseases. Mr. Larwood co-invented his first two commercial molecules before age 30. His PhD research at UC San Francisco established the foundation for PEGylated drugs widely used today. At UCSF he co-invented suitable PEGylated lipids to make the very first PEGylated liposomes. Earlier as a bench chemist, he was the first to make Iotrolan, a CT X-ray contrast agent, generic for decades, replaced in about 2005 by newer agents. Moving to law, in leading law firms he advised major companies on patent matters. After 3 years as a patent lawyer at Apple Computer, he took a VP role at startup FormFactor, staying in an IP role, then became the first General Counsel for startup Verisity Design, taking them public in 2001, then ultimately through successful acquisition in 2005. Mr. Larwood is the third of his family to be involved in Valley Fever.  His father was a physician who developed an interest in the disease decades ago when the family moved to Bakersfield, California, a focal area for the disease. His mother started a foundation in 1998 and raised some $20M for research into vaccines against Valley Fever.

Session Details: Chair’s Opening Remarks 14-04-2022, 8:50 am Leveraging Mobile Health Technologies to Engage Patients and Reduce Timelines 14-04-2022, 2:30 pm View In Agenda

Biography: Brittney is Director, Head of Supply Chain at Tricida where she is responsible for the clinical supply group managing investigational drug and ancillary supplies for Tricida's global 1600 patient confirmatory post marketing trial for TRC 101 as well as the commercial supply chain group preparing for the launch of TRC 101 / Veverimer in the later part of 2020. Brittney has more than 12 years of experience working in both technical development and supply chain organizations. Prior to Tricida, she was at Intarcia and Genentech where she managed all aspects of supplying clinical trials. From developing forecasts from protocols, translating these forecasts to manufacturing plans and appropriate inventory levels, assessing the supply status of clinical sites and putting in place delivery plans that take into account production, release and distribution timing to ensure no stock-out situations at clinics, Brittney has extensive experience in forecasting creation and hopes to share those tools with you today. She also managed the commercial supply chain for the Clorox Disinfecting Wipes business, dealing with un-precedented demand changes through the H1N1 flu outbreak.

Session Details: Utilizing IRT Reporting and Functionality for Demand and Supply Planning 14-04-2022, 9:00 am View In Agenda

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Session Details: Utilizing IRT Reporting and Functionality for Demand and Supply Planning 14-04-2022, 9:00 am View In Agenda

Biography: 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: KEYNOTE PANEL – Digital Transformation and Expanding on Innovation Lessons Learned through COVID-19 13-04-2022, 4:00 pm View In Agenda

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Session Details: Chair’s opening remarks 13-04-2022, 8:25 am Leaders' Panel Discussion: 2020 & 2021 – How did we do? Exploring the Impact of a Disrupted 2 Years on the Global Clinical Supply Chain 13-04-2022, 8:30 am Movement Towards Decentralized Trials 13-04-2022, 2:00 pm KEYNOTE PANEL – Digital Transformation and Expanding on Innovation Lessons Learned through COVID-19 13-04-2022, 4:00 pm View In Agenda

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Frank Leu is a Co-Founder and CEO of Novapeutics at Philadelphia, PA - a biopharma spun-out from the University of Pennsylvania, developing a first-in-class small molecule beta-cell restoration curative for type 2 diabetes. Prior, Frank was at a specialty pharma Verto Institute, developing biologic therapeutics for treating the neuroendocrine cancer. Frank graduated with a Pharmacology Ph.D. from Weill Cornell Graduate School of Medical Sciences in 2001, and then post-doc in a Howard Hughes Medical Institute laboratory at the Rockefeller University in molecular enzymology. He has served as an adjunct instructor at the Rutgers Cancer Institute of NJ, and is an adjunct professor at the pharmacology department of the Thomas Jefferson Medical University. Frank also founded BioPharMatrix developing blockchain solutions to lifescience innovations at all phases, and serves as advisor to the Pennovations center working with 1776 / Benjamins Desk. Frank is a thought leader in the blockchain architecture innovations in the life-sciences and drug development, Frank serves on multiple advisory boards and frequently served as chairman, speaker, moderator, and facilitator for many life-sciences and drug development events.

Session Details: Blockchain use in the Clinical Supply Chain Management 13-04-2022, 2:00 pm View In Agenda

Biography: Chris Driver is currently Director, IT Architecture at IQVIA, with over 20 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: Case Study Proofs: How the Implementation of Drug Supply Automation Tools Reduce Waste and Cost 13-04-2022, 11:45 am View In Agenda

Biography: Antoine Remiot has been sharing his enthusiasm and technical advice to various pharma partners, helping them tackle clinical trial supply challenges and solve drug shortage. He truly enjoys complex situations where he can use his skills to solve tricky problems. Antoine has a Master’s Degree in Mechanical Engineering with a focus on optimization. After working for various optimization software companies in the aeronautical market, he joined N-SIDE to focus on new pharma companies

Session Details: From Protocol Draft to LPO, How to Keep Your Clinical Supply Planning Under Control 13-04-2022, 9:15 am View In Agenda

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Session Details: From Protocol Draft to LPO, How to Keep Your Clinical Supply Planning Under Control 13-04-2022, 9:15 am KEYNOTE PANEL – Digital Transformation and Expanding on Innovation Lessons Learned through COVID-19 13-04-2022, 4:00 pm View In Agenda

Biography: Toby Odenheim is the former Director of Technology and Governance at the Parker Institute for Cancer Immunotherapy (PICI). He is now Senior Vice President, Research & Development Technology at ProPharma Group. Committed to accelerating the development of new medical treatments through effective technology adoption and continual process improvement.

Session Details: Cloud Migration: From Server Room to Cloud 14-04-2022, 10:00 am View In Agenda

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Session Details: Preparing for your Upcoming Clinical Trial: Avoid the Pitfalls that can Delay Study Timelines 13-04-2022, 10:15 am View In Agenda

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Session Details: Using Modern Technology to Mitigate Supply Chain Risk from Unpredictable Demand 13-04-2022, 2:30 pm View In Agenda

Biography: Toby Odenheim is the former Director of Technology and Governance at the Parker Institute for Cancer Immunotherapy (PICI). He is now Senior Vice President, Research & Development Technology at ProPharma Group. Committed to accelerating the development of new medical treatments through effective technology adoption and continual process improvement.

Session Details: Cloud Migration: From Server Room to Cloud 14-04-2022, 10:00 am View In Agenda

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Session Details: Q&A Session: Empowering Excellence in Supply Through Digital Quality Management Systems 14-04-2022, 10:00 am View In Agenda

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Session Details: ASK THE EXPERTS: How to Ensure your Clinical Supplies Pass US Border Control from the CBP Perspective 13-04-2022, 9:45 am Audience Discussion Roundtable Session: Ensuring Your Clinical Supplies Pass US Border Control 14-04-2022, 12:00 pm View In Agenda

Biography: Experienced Import Director with a demonstrated history of working in the government administration industry. Skilled in U.S. Food and Drug Administration (FDA), Good Laboratory Practice (GLP), Import, Government, and Life Sciences. Strong operations professional with a MHA focused in Health/Health Care Administration/Management from University of La Verne.

Session Details: FDA response to COVID-19 related challenges – lessons learned during the first year of the pandemic 13-04-2022, 12:15 pm View In Agenda

Biography: Dr. Ravi Kiron based in California, USA is an experienced pharma/biotech executive with decades of experience in discovery R&D through late-stage clinical development, intellectual property and regulatory, technology & business development, M&A, strategy and product commercialization, negotiating and executing partnerships by leveraging his extensive global business development networks in CVMD, Oncology, CNS, Wound Healing, Microbiome and Diagnostics. He was a tenure-track faculty member at Cornell University Medical College and adjunct faculty at University of Rhode Island. Dr. Kiron served in various operational & management roles at Pfizer Inc., and J&J/ALZA, in Cardiovascular R&D, Oncology clinical development (Tarceva), strategic business development and M&A (acquisition of WLA, PHA & other biotech).  Dr. Kiron has consulted for several dozen global biotech & pharma companies, founded and led multiple companies/new ventures, served as an Entrepreneur In Residence (EIR) at SRI Ventures, ShangPharma Innovation and advises company and non-profit boards. ​ Currently, Dr. Kiron is Head, BioPharma External Innovation at the Merck KGaA/EMD Serono’s Silicon Valley Innovation Hub in Menlo Park, California and is exploring cutting edge game changing technologies (Artificial Intelligence & Machine Learning, Microbiome, Electroceuticals etc.) to have an impact on pharma/biotech research, product development and launches.

Session Details: Leaders' Panel Discussion: 2020 & 2021 – How did we do? Exploring the Impact of a Disrupted 2 Years on the Global Clinical Supply Chain 13-04-2022, 8:30 am View In Agenda

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Session Details: Q&A Session: Preparing for a clinical trial: choosing the right CMO to manufacture your product 14-04-2022, 9:00 am View In Agenda

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

Session Details: Q&A Session: Demand Forecasting for Clinical Sites and IRT Inventory Management 13-04-2022, 3:30 pm View In Agenda

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Tom is currently serving as a Senior UAT Analyst for Bristol Myers Squibb. Most recently, he worked in clinical systems role for Ultragenyx Pharmaceutical, overseeing IRT, CTMS, eCOA, eConsent, CGM, and wearables systems and processes. Previously, he worked as an IRT senior project manager at Amgen, built and managed international technical support and data management teams, and worked as an IRT project manager, both at endpoint clinical. He has managed projects in the therapeutic areas of hematology & oncology, pain, bone, cardiovascular, and dermatology, from early-phase oncology through post-marketing studies.

He graduated summa cum laude with a B.A in Philosophy and History from Florida Gulf Coast University, where he also earned an M.A. in English. He has published several articles on process improvement, change management, and making IRT concepts more accessible to sponsor study management personnel.

Session Details: Leaders' Panel Discussion: 2020 & 2021 – How did we do? Exploring the Impact of a Disrupted 2 Years on the Global Clinical Supply Chain 13-04-2022, 8:30 am View In Agenda

Biography: Phil is a supply chain professional working exclusively in the clinical space for over 15 years.  He has managed all aspects of clinical supply, packaging and labeling and distribution, IXRS setup and management.  He has worked with the following companies:

• Rainier Therapeutics
• Aimmune Therapeutics
• Myovant Sciences
• Onyx Pharmaceuticals
• Elan Pharmaceuticals

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Biography: Tom has worked in the life sciences industry for over 20 years, initially as a pharmaceutical representative and then as a pharmaceutical product manager. Over the past 10 years Tom has become an expert in providing sponsors and CRO’s with an innovative clinical supply process that is patient centric, saves clinical operations and supply management teams time and saves sponsors money.

Session Details: One Size Does Not Fit All…..Global Diversity Requires Supply Strategy and Vendor Diversity 13-04-2022, 11:45 am View In Agenda

Biography: Edo Madussi is the Managing Director, of Euromed Pharma US and Business Unit head of the Clinical Trial Division at the Petrone Group. His business experience combined with his academic background and four spoken languages - English, German, French, and Italian - brought him to develop an extensive network within the global clinical supply chain space.  He is currently developing one of the latest ventures of the Petrone Group: a US-based integrated platform to support Clinical Trial Sponsors and other industry players around the world with a wide range of services in the R&D space.

Session Details: Behind the Scenes of Clinical Supplies and Comparators: The Latest Regulatory Perspective 13-04-2022, 2:30 pm View In Agenda

Biography: Isaac Blum is currently the Senior Manager of Clinical Supply at ALX Oncology in South San Francisco, California. Previously, Isaac oversaw clinical supply chain operations at Puma Biotechnology and Sangamo Therapeutics. Isaac is excited about optimizing drug supply operations to help advance innovative, life-saving treatments. He has used his expertise to launch multiple global oncology clinical trials, and enjoys collaborating with others in the field through speaking at conferences and workshops. In his free time, Isaac enjoys hiking, running and spending time with his family.

Session Details: Building a Clinical Supply Chain From Scratch 13-04-2022, 11:15 am View In Agenda

Biography: Ian has over 30 years of pharmaceutical industry experience, predominantly within global organisations such as Pfizer and Eli Lilly.  He built his reputation in the commercialisation of numerous brands in a variety of disease areas, and at every stage of the product lifecycle. During his career, Ian has worked closely with supply chain, ensuring accurate forecasting, and getting medicines to patients through the implementation of novel approaches. Before joining Abacus Medicine Pharma Services Ian worked in senior roles at two leading global clinical solutions companies.  He provided many leading pharmaceutical and biotechnology companies with successful comparator sourcing solutions which helped successfully deliver their pivotal late phase clinical trials.

Session Details: What’s Been Keeping Clinical Supplies Professionals Awake at Night? 14-04-2022, 9:30 am View In Agenda

Biography: Marc has spent his entire career in the eClinical technologies space, with most of that time focused in the area of IRT. Having spent years on the client services side, Marc has worked with 7 of the top 10 pharmaceutical companies and 6 of the top 7 CROs to design, implement, and maintain IRT solutions across a variety of therapeutic areas. As a Co-founder and Director of Business Development at Suvoda, Marc uses his IRT subject matter expertise to provide creative solutions to customers’ problems, all while growing Suvoda’s business globally. Marc enjoys creating long-lasting relationships with customers and colleagues and loves brokering introductions within his network. Marc is a graduate of Lafayette College with a degree in biochemistry and minor in music.

Session Details: Moving Beyond the Status Quo: Tools to Manage Your Supply Chain with Flexibility, Visibility and Control 14-04-2022, 9:30 am View In Agenda

Biography: Craig joined Calyx in 2021 as Vice President Scientific eTech Enabled Services, Craig has nearly 30 years of experience in the clinical trial arena including clinical operations, IMP packaging, labeling & logistics, with a primary focus in Interactive Response Technology (IRT). In his current role Craig’s remit is to: Leverage experience as an IRT business owner & sponsor to drive excellence in product, project management, and commercialization; Consult with clients on IRT best practices and emerging trends in the regulatory landscape; Serve as an advocate for sponsors within Calyx through expanded partnership engagements; And contribute to the industry as an evangelist for IRT and its proper role in clinical trials.

Session Details: A Practical Look at Direct-to-Patient Shipment 14-04-2022, 11:30 am View In Agenda

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Session Details: Key Randomization & Trial Supply Considerations: Starting your study on the right foot! 14-04-2022, 2:00 pm View In Agenda