18th Annual Clinical Trial Supply West Coast 2025

Developing best practices and incorporating novel technologies to meet the demands of a more complex, international clinical trial supply chain

9 - 10

September

2025
  • Hyatt Regency San Francisco Airport, Burlingame, USA
  • Complimentary
  • Why attend?
  • Agenda
  • Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • 2025 Sponsors
  • Media Centre
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  • Contact Us
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2025 Sponsors Include:

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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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Company Information

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

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

Sharp is a global leader in clinical supply trial services and pharmaceutical packaging. For 70 years, we’ve provided solutions to pharma and biotech clients from phase I trials through to commercial launch and lifecycle management.

Company Website

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

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Company Information

Bionical Emas is a global leader in Clinical Trial Supply (CTS) and Early Access Programs (EAP), committed to delivering life-changing medicines to patients worldwide. We partner with leading pharmaceutical and biotech companies to offer tailored solutions for their clinical trial needs.

Our CTS division provides unmatched global access to medicines and ancillaries, leveraging a vast network of manufacturers and distributors, supported by an in-house Quality and Regulatory team. From local sourcing in emerging markets to global distribution of high-value commercial drugs, we deliver customized, end-to-end supply solutions.

Our interactive CTS Sourcing Portal enables clients to manage and monitor their supply chain in real time, enhancing transparency and efficiency.
With strategically located distribution centers across Europe, North America, LATAM, APAC, and Africa, we ensure timely delivery while meeting regulatory standards. Bionical Emas is dedicated to ethical, flexible, and reliable support for clinical trials worldwide.

Company Website

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

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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 Website

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

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    Why attend?

    The 2025 programme of the Clinical Trial Supply West Coast will offer a fresh insight into the latest regulatory updates, global clinical supply chains, advanced technologies such as remote and hybrid trials, Artificial Intelligence, and more. With presentations, roundtables, and panel discussions on all the hottest industry trends and supply chain challenges, the 2-day event promises to provide the industry an unmissable opportunity to learn and network to help them succeed post-Covid.

    Get in touch now and secure your place!

    WHAT TO EXPECT FOR 2025?

    CTS West Coast is the meeting place for pharmaceutical and biotech experts to discuss key themes and opportunities to take control and optimize clinical supply chains.

    200+

    Attendees

    		25+

    Exhibitors

    		20+

    Speakers
    200+

    Attendees

    		25+

    Exhibitors
    20+

    Speakers

    Testimonials

    See What It's All About

    Agenda

    • 9 Sep 2025
    • 10 Sep 2025
    Expand All

    Streams

    Stream one

    STREAM A: CLINICAL SUPPLY LOGISTICS AND OPERATIONS

    Stream two

    STREAM B: CLINICAL SUPPLY TECHNOLOGY AND INNOVATION

    11:30 AM

    PANEL: Clinical supply chain innovation: insights into new technology and strategy

    • Cutting edge technologies and incorporating these into your clinical supply chain
    • Sustainability and incorporating eco-friendly initiatives in clinical supply chain management
    • Collaborative platforms: improving communication and efficiency among stakeholders
    • Success stories, transformative case studies and key takeaways

    MODERATOR: Luiz Barberini, Head of External Manufacturing, Latin America, Bayer

    Speakers

    Prasun Mishra
    Founding Director, Chairman of the Board, Agility Pharmaceuticals
    Luiz Barberini
    Head of External Manufacturing, Latin America, Bayer
    Tom Gottschalk
    Vice President Business Development, Mercalis

    12 PM

    Biotech speed, biopharma scale: powered by clinical trial innovation

    • Strategies for reducing clinical supply waste while ensuring patient needs are met
    • Digital tools that enhance real-time visibility into supply shipments and their status
    • Operational innovations that enable faster timelines without increasing risk
    • Practical approaches to aligning supply chain efficiency with clinical trial demand

    Speakers

    Kirk Bray
    Senior Manager, Commercial Operations, Thermo Fisher Scientific

    12:30 PM

    Innovation in comparator sourcing processes for your clinical trial

    • Designing your comparator sourcing strategy: key factors to consider for your clinical trial
    • Exploring strategies for reliable and cost-effective sourcing: what solutions are available?
    • Addressing regulatory considerations and compliance challenges for comparator sourcing both in the US and from overseas
    • Leveraging technology and data analytics to streamline comparator sourcing processes

    Speakers

    Brenda Nguyen
    Director, Clinical Supply, BridgeBio Oncology Therapeutics

    1 PM

    Lunch and networking

    2:15 PM

    Assessing clinical materials risk: ensuring supply continuity and compliance

    • Evaluating sourcing, shelf-life and regulatory constraints for high risk items
    • Mapping global supply chain dependencies and transit vulnerabilities
    • Implementing strategies to mitigate against supply chain risk
    • Collaborating cross-functionally to align risk assessment with trial timelines and priorities

    Speakers

    Horacio Enriquez
    Former Senior Director, Supply Chain, Amgen

    2:45 PM

    Support as Strategy: Turning Technical Expertise into Operational Wins

    Support teams are often seen as reactive problem-solvers—but what happens when they’re embedded early in the trial lifecycle? This session explores how technical support can play a proactive role in study success. We’ll discuss how early involvement in processes like the Study Maintenance Plan and Go-Live allows support teams to anticipate challenges, prepare sponsors and sites, and respond more effectively when issues arise. Join us for a practical conversation on how collaboration and foresight can make support a strategic asset in clinical trial delivery.

    Speakers

    Lauren Skinner
    Technical Support Lead, Endpoint Clinical

    3:15 PM

    Afternoon refreshments and networking

    8 AM

    Registration and refreshments

    8:50 AM

    Chairperson’s opening remarks

    Speakers

    Paul Hingst
    Supply Chain Consultant, Crinetics Pharmaceuticals

    9 AM

    OPENING PANEL: The current landscape for clinical supply chains on the West Coast

    • New regulations and guidance around clinical trial supply in the US: what do you need to know?
    • AI and machine learning in clinical supply: what’s working, what isn’t and where are there new opportunities?
    • Navigating change and unforeseen circumstances: how can you reduce impact to your supply chains?
    • Assessing the clinical trial supply industry’s success in meeting sustainability targets

    MODERATOR: Paul Hingst, Supply Chain Consultant, Crinetics

    Speakers

    Prasun Mishra
    Founding Director, Chairman of the Board, Agility Pharmaceuticals
    Paul Hingst
    Supply Chain Consultant, Crinetics Pharmaceuticals
    Naymisha (Isha) Patel
    Senior Vice President, Quality, Tenaya Therapeutics

    9:45 AM

    Reducing risk and complexity in cell and gene therapy trials with IRT

    Cell and Gene Therapy (CGT) pioneers require supply chain partnerships that deliver experience in mitigating trial risk and complexity, along with a consultative approach to protocol execution. In this presentation, we’ll explore how integrated response technologies can be leveraged to:

    • Optimize pre-trial and pre-screening activities for greater trial efficiency
    • Overcome logistical challenges and ensure quality in the management of CGT trials
    • Reduce trial costs and support sustainable CGT success

    Speakers

    Cara Woodruff
    Director Product Management, IT Design and Development, IQVIA IRT

    10:15 AM

    Global virtual clinical trial supplies: the benefits of implementing a virtual supply strategy for commercially available medications and ancillary supplies

    • Optimize employ effort
    • Minimize waste and risk
    • Appreciate significant savings
    • Sustainably friendly

    Speakers

    Tom Gottschalk
    Vice President Business Development, Mercalis

    10:45 AM

    Morning refreshments and networking

    11:30 AM

    Mitigating risk and planning for unforeseen circumstances: protecting your clinical supply chain

    • Preparing for the unexpected: building contingency protocols in from the start of a trial
    • Planning for unforeseen events and incorporating this into your risk management strategy
    • Incorporating risk assessment into project management plans in order to be better prepared for every eventuality
    • How to reduce risk caused by supply chain delays

    Speakers

    Umar Hayat
    Vice President, CMC and Supply Chain, Union Therapeutics

    12 PM

    Best practice in planning and forecasting: ensuring accuracy and efficiency

    • Data-driven insights: utilizing data analytics for informed forecasting decisions
    • The importance of remaining flexible to adapt to changing trial dynamics and demands
    • Proactive risk management: identifying and mitigating potential obstacles to streamline forecasting processes
    • Effective forecasting in order to reduce waste, cost and carbon footprint

    Speakers

    Rachael Pierce
    Senior Manager Clinical Supply, Arrowhead Pharmaceuticals

    12:30 PM

    Collaboration between supply planning, process development and production to enable clinical trial supplies

    • The basics of drug substance manufacturing and what drives uncertainty in yields, especially in early phase production
    • Recommendations and tactics for how supply chain planners should coordinate early and often with counterparts in CMC and manufacturing to stay abreast of expected yields, lead times, sampling requirements
    • Understanding risks

    Speakers

    Leah Frautschy
    Vice President, Clinical Manufacturing, Denali Therapeutics

    1 PM

    Lunch and networking

    2:15 PM

    T-cell immunotherapy: trends and insights shaping clinical development

    • Overview of the T-cell immunotherapy landscape
    • Trends in regulatory approvals and designations impacting trial timing and logistics
    • Market outlook and projected growth through 2031 and the implications for supply planning
    • Clinical trial insights, including leading countries and key challenges affecting trial execution

    Speakers

    Eleni Tokali
    Drug Intelligence Analyst, GlobalData

    2:45 PM

    Understanding duty rate and entry rates in US clinical supply chain imports

    • Classifying clinical materials correctly to avoid delays or unexpected costs
    • 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

    3:15 PM

    Afternoon refreshments and networking

    4 PM

    PANEL: Breaking down silos: fostering collaboration between clinical operations and clinical supply teams

    • Interacting earlier for supply to give input and gain information sooner so they can assist and be prepared
    • Establishing clinical team needs: what, when and where
    • Building and maintaining strong relationships between teams

    Speakers

    Christine von Raesfeld
    Patient Advocate
    Evan L. Wohl, R.Ph.
    Director, Clinical Supplies, Ionis Pharmaceuticals
    Leah Frautschy
    Vice President, Clinical Manufacturing, Denali Therapeutics
    Umar Hayat
    Vice President, CMC and Supply Chain, Union Therapeutics
    Cara Woodruff
    Director Product Management, IT Design and Development, IQVIA IRT

    4:45 PM

    Chairperson’s closing remarks

    Speakers

    Paul Hingst
    Supply Chain Consultant, Crinetics Pharmaceuticals

    5 PM

    NETWORKING DRINKS

    8 AM

    Registration and refreshments

    8:45 AM

    Chairperson’s opening remarks

    Speakers

    9 AM

    SPEAKER HOSTED ROUNDTABLE DISCUSSIONS

    Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the clinical supply chain industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each roundtable will last for 45 minutes, after which delegates will be given the opportunity to swap to a different roundtable.

    ROUNDTABLE 1: Topic TBC
    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

     

    ROUNDTABLE 2: Topic TBC
    Luiz Barberini, Head of External Manufacturing, Latin America, Bayer

     

    ROUNDTABLE 3: Data, analytics and GenAI in clinical supply chains

    Speakers

    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

    10:30 AM

    Morning refreshments and networking

    11:15 AM

    KEYNOTE CASE STUDY: Ensuring excellence: quality assurance and control in clinical trial supply

    • Understanding FDA regulations and guidelines for ensuring quality and integrity
    • Implementing GMP standards to maintain consistency and reliability in production and distribution of trial materials
    • Adopting a risk-based approach to quality management
    • Establishing robust supplier qualification processes to select reliable partners and ensure adherence to quality standards

    Speakers

    Naymisha (Isha) Patel
    Senior Vice President, Quality, Tenaya Therapeutics

    11:45 AM

    Outsourcing and working with suppliers: making a success of your vendor relationships

    • Selecting the right suppliers: criteria for evaluating and choosing temperature controlled logistics partners
    • Building strong partnerships: fostering effective communication and collaboration with suppliers
    • Best practices in drafting and managing contracts and supplier agreements
    • Feedback mechanisms and performance reviews to enhance supplier relationships and logistics processes

    Speakers

    Luiz Barberini
    Head of External Manufacturing, Latin America, Bayer

    12:15 PM

    PATIENT ADVOCACY KEYNOTE: From protocols to patients: redesigning supply chains for real world impact

    • Explore how integrating patient perspectives into clinical supply chain planning can reduce trial burden, improve retention, and build long term trust. This session will highlight best practices in collaborating with advocacy groups, designing flexible logistics, and aligning operational excellence with patient experience.

    Speakers

    Christine von Raesfeld
    Patient Advocate

    12:45 PM

    Lunch and networking

    2 PM

    PANEL: Sourcing vendors and partners for your clinical supply chain: what are the most important considerations?

    • Balancing cost alongside other considerations when selecting vendors
    • Key factors to consider when choosing vendors and partners in clinical supply
    • Advantages and disadvantages of choosing large vs small vendors
    • Working with international partners: additional challenges and how to address these

    MODERATOR: Christine Von Raesfeld, Board Member and Lived Experience Expert, The Light Collective

    Speakers

    Christine von Raesfeld
    Patient Advocate
    Umar Hayat
    Vice President, CMC and Supply Chain, Union Therapeutics
    Evan L. Wohl, R.Ph.
    Director, Clinical Supplies, Ionis Pharmaceuticals
    Christopher Ohms
    Executive Director Supply Chain, Rigel Pharmaceuticals

    2:45 PM

    Importation requirements and best practices for importing biological materials into the United States

    • Ensuring biological materials comply with CBP and multi-agency regulations
    • Understanding import requirements in the trade environment and when traveling with biological materials
    • Preventing common discrepancies to avoid delays which can be costly and impact research

    Speakers

    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

    3:15 PM

    Afternoon refreshments and networking

    3:15 PM

    PANEL: Leveraging IRT and forecasting in a complex Phase 1 trial

    • Designing flexible IRT systems to accommodate multiple dose levels and protocol adaptations
    • Forecasting clinical supply needs amid uncertainty in dosing, cohorts and timelines
    • Collaborating across functions to align IRT, supply and clinical execution
    • Applying lessons learned from a real world CNS program with high complexity and unpredictability

    MODERATOR: Luiz Barberini, Head of External Manufacturing, Latin America, Bayer

    Speakers

    Charisse Eary
    Executive Director, Head of Quality, Aligos Therapeutics
    Louie Burks
    Director, Clinical Supply, Praxis Precision Medicines
    Maryam Rafiei
    Head of Quality, Aligos Therapeutics
    Cara Woodruff
    Director Product Management, IT Design and Development, IQVIA IRT
    Luiz Barberini
    Head of External Manufacturing, Latin America, Bayer

    3:45 PM

    Afternoon refreshments and networking

    4:20 PM

    EXHIBITION APPLE PRIZE DRAW

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

    4:30 PM

    END OF CONFERENCE

    Speakers

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    Prasun Mishra
    Founding Director, Chairman of the Board, Agility Pharmaceuticals

    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:

    OPENING PANEL: The current landscape for clinical supply chains on the West Coast

    2025-09-09, 9:00 AM

    Session Details:

    PANEL: Clinical supply chain innovation: insights into new technology and strategy

    2025-09-09, 11:30 AM

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    Rachael Pierce
    Senior Manager Clinical Supply, Arrowhead Pharmaceuticals

    •Proven skill in leadership and the ability to overcome/solve any problems
    •Outstanding written and oral communication skills
    •Confident in making independent decisions
    •Personable and persuasive in communicating creatively with a variety of people from culturally diverse backgrounds and economic levels
    •Experienced in applying GMP in both a lean and batch manufacturing environment
    •More than 7 years experience in supervising, training, and teaching subordinate personnel
    •Very well organized and able to motivate others
    •Proficient in the use of computer software such as Microsoft Office, including extensive statistical analysis using Excel and Kadd add-in; experienced at creating surveys using online websites such as survey monkey, questionpro, etc.
    •Clearable to Secret level of Security Clearance

    Session Details:

    Best practice in planning and forecasting: ensuring accuracy and efficiency

    2025-09-09, 12:00 PM

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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

    Session Details:

    PANEL: Clinical supply chain innovation: insights into new technology and strategy

    2025-09-09, 11:30 AM

    Session Details:

    PANEL: Leveraging IRT and forecasting in a complex Phase 1 trial

    2025-09-10, 3:15 PM

    Session Details:

    Outsourcing and working with suppliers: making a success of your vendor relationships

    2025-09-10, 11:45 AM

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    Horacio Enriquez
    Former Senior Director, Supply Chain, Amgen
    • 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:

    Assessing clinical materials risk: ensuring supply continuity and compliance

    2025-09-09, 2:15 PM

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    Brenda Nguyen
    Director, Clinical Supply, BridgeBio Oncology Therapeutics

    Session Details:

    Innovation in comparator sourcing processes for your clinical trial

    2025-09-09, 12:30 PM

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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:

    Chairperson’s opening remarks

    2025-09-09, 8:50 AM

    Session Details:

    OPENING PANEL: The current landscape for clinical supply chains on the West Coast

    2025-09-09, 9:00 AM

    Session Details:

    Chairperson’s closing remarks

    2025-09-09, 4:45 PM

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    Leah Frautschy
    Vice President, Clinical Manufacturing, Denali Therapeutics

    After more than 25 years in the biopharmaceutical industry - I have now joined Denali as the Vice President, Clinical Manufacturing. I'm looking forward to helping Denali deliver the clinical pipeline to patients waiting for treatments.

    Session Details:

    Collaboration between supply planning, process development and production to enable clinical trial supplies

    2025-09-09, 12:30 PM

    Session Details:

    PANEL: Breaking down silos: fostering collaboration between clinical operations and clinical supply teams

    2025-09-09, 4:00 PM

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    Lauren Skinner
    Technical Support Lead, Endpoint Clinical

    Lauren Skinner is a Technical Support Lead with over 10 years of experience in Interactive Response Technology and Randomization and Trial Supply Management. After starting as a Production Support Analyst with Endpoint in 2015, she has steadily advanced within the company and now manages a global team of agents across several countries and time zones. She is passionate about delivering effective technical support solutions, specializing in improving operational efficiency by anticipating and preventing support issues before they arise. Lauren also partners closely with cross-functional teams to incorporate support insights into system implementation, ensuring smoother site interactions and end user experience. She enjoys mentoring team members and driving continuous improvement initiatives that enhance both client satisfaction and internal processes.

    Session Details:

    Support as Strategy: Turning Technical Expertise into Operational Wins

    2025-09-09, 2:45 PM

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    Evan L. Wohl, R.Ph.
    Director, Clinical Supplies, Ionis Pharmaceuticals

    Session Details:

    PANEL: Breaking down silos: fostering collaboration between clinical operations and clinical supply teams

    2025-09-09, 4:00 PM

    Session Details:

    PANEL: Sourcing vendors and partners for your clinical supply chain: what are the most important considerations?

    2025-09-10, 2:00 PM

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    Cara Woodruff
    Director Product Management, IT Design and Development, IQVIA IRT

    A highly motivated, experienced IT Product Management professional with over 26 years of experience in the biopharmaceutical service industry. Executes product strategy, defines product vision and roadmaps, develops customer-driven product requirements incorporating human-centered design, drives product release cycles using Agile methodologies, and collaborates with cross-functional teams to deliver high quality solutions on time. Prior roles include IT Product Owner, IT Business Partner, Integrated Processes and Technologies POC Project/Product Manager, Predictive Analytics Lead SAS Developer, Biostatistics Senior SAS Statistical Programmer, Statistical Programming Manager, Clinical Data Programmer, and Associate Biostatistician.

    Session Details:

    Reducing risk and complexity in cell and gene therapy trials with IRT

    2025-09-09, 9:45 AM

    Session Details:

    PANEL: Leveraging IRT and forecasting in a complex Phase 1 trial

    2025-09-10, 3:15 PM

    Session Details:

    PANEL: Breaking down silos: fostering collaboration between clinical operations and clinical supply teams

    2025-09-09, 4:00 PM

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    Tom Gottschalk
    Vice President Business Development, Mercalis

    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 Mercalis 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:

    Global virtual clinical trial supplies: the benefits of implementing a virtual supply strategy for commercially available medications and ancillary supplies

    2025-09-09, 10:15 AM

    Session Details:

    PANEL: Clinical supply chain innovation: insights into new technology and strategy

    2025-09-09, 11:30 AM

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    Christopher Ohms
    Executive Director Supply Chain, Rigel Pharmaceuticals

    Session Details:

    PANEL: Sourcing vendors and partners for your clinical supply chain: what are the most important considerations?

    2025-09-10, 2:00 PM

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    Naymisha (Isha) Patel
    Senior Vice President, Quality, Tenaya Therapeutics

    Accomplished Quality and Regulatory professional with 25 years of progressive experience in pharmaceuticals, biologics, medical devices, and combination products from early stage to late stage and commercialization.
    Proven track record of significant contributions in quality management, pre-approval inspections, commercial launch, regulatory submissions, process improvement, supplier management, regulatory compliance, and implementation of quality management systems in a wide range of organizations that previously had no/minimal quality programs in place.
    Established clinical quality assurance function in clinical trials globally. This includes QA review of clinical trial documents, data integrity assurance, GCP compliance at investigator sites, clinical vendor (CRO) qualification, management and audit, independent GCP quality audits and supporting clinical CAPA.

    Session Details:

    OPENING PANEL: The current landscape for clinical supply chains on the West Coast

    2025-09-09, 9:00 AM

    Session Details:

    KEYNOTE CASE STUDY: Ensuring excellence: quality assurance and control in clinical trial supply

    2025-09-10, 11:15 AM

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    Christine von Raesfeld
    Patient Advocate

    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:

    PANEL: Breaking down silos: fostering collaboration between clinical operations and clinical supply teams

    2025-09-09, 4:00 PM

    Session Details:

    PATIENT ADVOCACY KEYNOTE: From protocols to patients: redesigning supply chains for real world impact

    2025-09-10, 12:15 PM

    Session Details:

    PANEL: Sourcing vendors and partners for your clinical supply chain: what are the most important considerations?

    2025-09-10, 2:00 PM

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    Kirk Bray
    Senior Manager, Commercial Operations, Thermo Fisher Scientific

    Session Details:

    Biotech speed, biopharma scale: powered by clinical trial innovation

    2025-09-09, 12:00 PM

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    Umar Hayat
    Vice President, CMC and Supply Chain, Union Therapeutics

    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:

    Mitigating risk and planning for unforeseen circumstances: protecting your clinical supply chain

    2025-09-09, 11:30 AM

    Session Details:

    PANEL: Breaking down silos: fostering collaboration between clinical operations and clinical supply teams

    2025-09-09, 4:00 PM

    Session Details:

    PANEL: Sourcing vendors and partners for your clinical supply chain: what are the most important considerations?

    2025-09-10, 2:00 PM

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

    Session Details:

    SPEAKER HOSTED ROUNDTABLE DISCUSSIONS

    2025-09-10, 9:00 AM

    Session Details:

    Importation requirements and best practices for importing biological materials into the United States

    2025-09-10, 2:45 PM

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

    Session Details:

    SPEAKER HOSTED ROUNDTABLE DISCUSSIONS

    2025-09-10, 9:00 AM

    Session Details:

    Importation requirements and best practices for importing biological materials into the United States

    2025-09-10, 2:45 PM

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    Brandy Porter
    Assistant Director, Department of Homeland Security, U.S. Customs and 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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    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:

    PANEL: Leveraging IRT and forecasting in a complex Phase 1 trial

    2025-09-10, 3:15 PM

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    Maryam Rafiei
    Head of Quality, Aligos Therapeutics

    Session Details:

    PANEL: Leveraging IRT and forecasting in a complex Phase 1 trial

    2025-09-10, 3:15 PM

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    Charisse Eary
    Executive Director, Head of Quality, Aligos Therapeutics

    Session Details:

    PANEL: Leveraging IRT and forecasting in a complex Phase 1 trial

    2025-09-10, 3:15 PM

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    Eleni Tokali
    Drug Intelligence Analyst, GlobalData

    Eleni Tokali, MPharm, MPH, is a Drug Intelligence Analyst at GlobalData. Her primary responsibilities include managing and maintaining GlobalData’s Drugs Database, analyzing drug pipeline information and producing analytical market insight reports. Additionally, Eleni provides timely client support and performs database quality checks. Prior to joining GlobalData, Eleni worked as a registered pharmacist under the General Pharmaceutical Council (GPhC). Eleni has a firm knowledge of pharmaceutical industry dynamics as well as global public health perspectives. Eleni holds a Master of Pharmacy from the University of Brighton and a Master of Public Health from King's College London.

    Session Details:

    T-cell immunotherapy: trends and insights shaping clinical development

    2025-09-09, 2:15 PM

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    Advisory Board

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    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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    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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    Francesco Santo
    Director Clinical Supply Chain,
    Orano Med

    A highly experienced and passionate Director Clinical Supply Chain, Francesco has dedicated the past 17 years to ensuring the seamless execution of clinical trials by optimizing supply chain operations. His deep commitment to this field is driven by a relentless pursuit of excellence in delivering life-saving treatments to patients worldwide.  Throughout his career, he has honed a diverse skill set, encompassing:

    • Strategic Supply Chain Management
    • Regulatory Compliance
    • Cross-Functional Collaboration
    • Risk Management
    • Innovative Problem-Solving

    Francesco’s dedication to the clinical supplies industry is rooted in a profound understanding of the critical role it plays in advancing medical research and improving patient outcomes. He is committed to continuing his journey in this field, always striving to contribute to the betterment of global health.

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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

    Session Details:

    PANEL: Clinical supply chain innovation: insights into new technology and strategy

    2025-09-09, 11:30 AM

    Session Details:

    PANEL: Leveraging IRT and forecasting in a complex Phase 1 trial

    2025-09-10, 3:15 PM

    Session Details:

    Outsourcing and working with suppliers: making a success of your vendor relationships

    2025-09-10, 11:45 AM

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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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