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
  • Why partner?
  • 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

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit 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

Mercalis has a suite of Clinical Trial Support services designed to provide time and cost efficiencies.

RxStudy Card – Pharmacy provides commercially available medications and supplies through retail and specialty pharmacies. This supply strategy reduces supply process steps, requires less employee time, eliminates supply waste, and has fewer risks resulting in an 80% reduction in labor and a 50% reduction in costs.

RxStudy Card – Provider provides reimbursement for site sourced and administered medication and is essential for studies requiring biologics and oncolytics, which are more frequently being sourced directly by a provider and not through a pharmacy.

RxStudy Card – Procurement is an innovative GLOBAL clinical trial supply process that more efficiently provides commercially available medications and supplies. RxStudy Card – Procurement leverages “in country” sourcing and distribution, provides study teams and sites a simple online ordering experience for “just in time” “as needed” delivery, in quantities specific to each site and patients need with direct to site shipments and real time order and shipment status.

Company Website

To learn more, please visit our website - www.mercalis.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

    11:15 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: Amanda Murphy, Senior Director, Data Intelligence and Solutions, GlobalData

    Speakers

    Amanda Murphy
    Senior Director, Data Intelligence & Solutions,
    GlobalData
    Prasun Mishra
    Chief Executive Officer, Agility Pharmaceuticals
    Luiz Barberini
    Head of External Manufacturing Latin America, Bayer
    Tom Gottschalk
    Vice President, Business Development, Mercalis

    11:45 AM

    Reserved for ThermoFisher Scientific

    12:15 PM

    Topic TBC

    Speakers

    Brenda Nguyen
    Director, Clinical Supply, BridgeBio Oncology Therapeutics

    12:45 PM

    Lunch and networking

    2 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

    2:30 PM

    Reserved for Endpoint Clinical

    3 PM

    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

    Speakers

    Hale Davies
    Senior Supply Planner, Clinical Supply Chain, Alnylam Pharmaceuticals

    3:30 PM

    Afternoon refreshments and networking

    4:15 PM

    Available for event sponsor

    7:30 AM

    Registration and refreshments

    8:15 AM

    GlobalData opening remarks

    Speakers

    Amanda Murphy
    Senior Director, Data Intelligence & Solutions,
    GlobalData

    8:30 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

    Paul Hingst
    Supply Chain Consultant, Crinetics Pharmaceuticals
    Prasun Mishra
    Chief Executive Officer, Agility Pharmaceuticals
    Naymisha Patel
    Senior Vice President, Quality, Tenaya Therapeutics

    9 AM

    Reserved for IQVIA Tech

    9:30 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: what events such as the Baltimore Bridge collapse have taught us
    • 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

    10 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

    10:30 AM

    Morning refreshments and networking

    11:15 AM

    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

    11:45 AM

    Available for event sponsor

    12:15 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

    12:45 PM

    Lunch and networking

    2 PM

    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

    2:30 PM

    Available for event sponsor

    3 PM

    Understanding duty rate and entry rates when importing into the US

    Speakers

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

    3:30 PM

    Afternoon refreshments and networking

    4:15 PM

    Available for event sponsor

    4:45 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

    Moderator to be confirmed

     

    Speakers

    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

    5:15 PM

    Chairperson’s closing remarks

    Speakers

    Paul Hingst
    Supply Chain Consultant, Crinetics Pharmaceuticals

    5:20 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!

    5:30 PM

    NETWORKING DRINKS

    8 AM

    Registration and refreshments

    8:45 AM

    Chairperson’s opening remarks

    Speakers

    Paul Hingst
    Supply Chain Consultant, Crinetics Pharmaceuticals

    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
    Brad Graybehl, Director of Data, Analytics and AI G&A and Supply Chain, Exelixis
    Chi Truong, Clinical Supply Logistics Manager, Exelixis

    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
    Luiz Barberini
    Head of External Manufacturing Latin America, Bayer
    Brad Graybehl
    Director of Data, Analytics and AI G&A and Supply Chain, Exelixis
    Chi Truong
    Clinical Supply Logistics Manager, Exelixis

    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 Patel
    Senior Vice President, Quality, Tenaya Therapeutics

    11:45 AM

    Available for event sponsor

    12:15 PM

    PATIENT ADVOCACY KEYNOTE: Ensuring your supply chain processes are designed with patients in mind

    • Collaborating with patient advocacy groups to understand lived experience and logistical barriers
    • Considering patient burden when planning shipment schedules, visit kits and returns
    • Designing flexible supply solutions that accommodate diverse patient needs
    • Building trust by ensuring transparency, reliability and responsiveness in clinical supply logistics

    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 to be confirmed

    Speakers

    Umar Hayat
    Vice President, CMC and Supply Chain, Union Therapeutics
    Evan L. Wohl, R.Ph.
    Director, Clinical Supplies, Ionis 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

    3:50 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 PM

    The state of the biopharmaceutical industry in 2025: emerging technologies and opportunities

    • Emerging themes and technology advancements in biopharma
    • Leveraging data to predict the outlook for 2025 clinical trials
    • Trends, key players, opportunities, and threats in clinical trial outsourcing
    • Latest biopharma investor activity: venturing financing, IPOs, and grants

    Speakers

    Amanda Murphy
    Senior Director, Data Intelligence & Solutions,
    GlobalData

    4:30 PM

    INTERACTIVE DISCUSSION SESSION: Sustainability in clinical supply chains: ensuring you minimize your carbon footprint

    • Making environmentally conscious choices when selecting packaging materials: what options are available and which are the most sustainable?
    • Pros and cons of active and passive containers when it comes to sustainability in temperature control
    • Methods of lowering the carbon footprint of pharma supply chains beyond just packaging
    • Balancing cost, quality and sustainability in clinical supply chains
    • How can your supply chain logistics contribute to meeting both internal and external sustainability targets?

    5 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

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    Hale Davies
    Senior Supply Planner, Clinical Supply Chain, Alnylam Pharmaceuticals

    Session Details:

    Leveraging IRT and forecasting in a complex Phase 1 trial

    2025-09-09, 3:00 PM

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    Horacio Enriquez
    Former Senior Director, Supply Chain, Amgen
    • Technology evangelist & adoption: Developed supply chain analytics and master data management Centers of Excellence to streamline data creation/maintenance/retirement, KPI dashboards, and data-driven decision-making.
    • Organizational design: Implemented global supply chain, analytics, supplier quality, New Product Introduction (NPI), warehousing, e-Commerce, & Facilities teams to improve operational efficiencies and customer service.
    • Supplier/supply chain performance, risk, compliance, and quality management: Lead adoption of ISO 13485:2016 and MDSAP in supply management (supplier lifecycle management, global audit program, CAPA, change management, quality agreements, CMO/OEM collaboration).
    • Process development: Designed and deployed global supplier/supply chain risk assessment program focused on supplier risk profile, mitigation, and governance. Developed global standard supplier audit program and leveraged regional/in-country Lead Auditors. Designed CD/S&OP processes focused on balancing customer service, inventory, and operations efficiencies within FDA 21CFR Parts 820 & 210 regulated organizations.
    • Strategic sourcing: Managed and lead various commodity-focused procurement teams including electro & electro- mechanical (instrument), biological & chemical (reagent and laboratory consumables), plastics & resin (injection molding), indirect (travel, fleet, facilities management, HR, IT, equipment, MRO, JanSan, critical Space) and partner/alliance operations (CMO/OEM) towards improved quality, cost, and total value.
    • Entrepreneur: Principal and founder of the Biotech Supply Chain Academy (BSCA), which is dedicated to the education of professionals who serve the needs of patients, point-of-care healthcare organizations, and the Life Sciences industry. CEO and Founder of Mission City Consulting, which provides end-to-end supply chain and quality operations consulting, education, and advocacy in private industry, higher learning, and government.
    • Educator and Mentor: Undergraduate and graduate school adjunct lecturer and faculty advisor at UC Davis Graduate School of Management, CSU Sacramento College of Business, Santa Clara University Leavey School of Business, the University of San Francisco School of Management, and Golden Gate University E.S. Ageno School of Business. Course work: Operations management & information systems, supply chain management, sustainable operations management, and MBA capstone integrated management operations.

    Session Details:

    Assessing clinical materials risk: ensuring supply continuity and compliance

    2025-09-09, 2:00 PM

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    Rachael Pierce
    Senior Manager Clinical Supply, Arrowhead Pharmaceuticals

    Session Details:

    Best practice in planning and forecasting: ensuring accuracy and efficiency

    2025-09-09, 11:15 AM

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    Luiz Barberini
    Head of External Manufacturing, 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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    Brenda Nguyen
    Director, Clinical Supply, BridgeBio Oncology Therapeutics

    Session Details:

    Topic TBC

    2025-09-09, 12:15 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.

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    Leah Frautschy
    Vice President, Clinical Manufacturing, Denali Therapeutics

    Session Details:

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

    2025-09-09, 12:15 PM

    Session Details:

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

    2025-09-09, 4:45 PM

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    Brad Graybehl
    Director of Data, Analytics and AI G&A and Supply Chain, Exelixis

    Session Details:

    SPEAKER HOSTED ROUNDTABLE DISCUSSIONS

    2025-09-10, 9:00 AM

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    Chi Truong
    Clinical Supply Logistics Manager, Exelixis

    Session Details:

    SPEAKER HOSTED ROUNDTABLE DISCUSSIONS

    2025-09-10, 9:00 AM

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    Amanda Murphy
    Senior Director, Data Intelligence and Solutions,
    GlobalData
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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, 4:45 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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    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.

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    Christine von Raesfeld
    Patient Advocate

    Session Details:

    PATIENT ADVOCACY KEYNOTE: Ensuring your supply chain processes are designed with patients in mind

    2025-09-10, 12:15 PM

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

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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

    View In Agenda
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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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    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, 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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    Paul Larochelle
    Senior Director Global Clinical Supply Chain,
    Takeda

    Paul Larochelle has over 17 years of experience in a variety of positions within Clinical Supplies, including roles in clinical planning, production scheduling and planning, secondary packaging operations management, and business expert for a clinical inventory management system. Paul currently leads a team of Clinical Planning Leads at Takeda and is a member of the Global Clinical Supply Chain (GCSC) Leadership Team. He also oversees Takeda’s GCSC Post-PharmD Fellowship Program in partnership with the Massachusetts College of Pharmacy and Health Sciences (MCPHS). Paul’s prior organizations include Genzyme/Sanofi and Biogen, supporting therapies across all indications and stages of development.

    In addition to his primary responsibilities, Paul served as a coordinator of Pharmacy Industry Fellowships for the Genzyme/Sanofi MCPHS Fellowship Program (2009-2014) and precepted over 50 pharmacy students interested in a career in industry for several schools. He is currently the Chair of the Dean’s Advisory Board for MCPHS Boston School of Pharmacy and a member of the Pharmacy Advisory Board for Western New England University. He is also a member of the Clinical Trial Supply Conference Series Advisory Board.

    Paul completed a Post-PharmD Industry Fellowship in Clinical Research/Investigational Product Management with Genzyme/MCPHS, a Doctorate in Pharmacy from MCPHS, an MBA from Worcester Polytechnic Institute, and a degree in Biology from Providence College. Paul has also served previously as President of the Board of Directors for the Massachusetts Pharmacists Association (MPhA), and as President of the MCPHS Alumni Association.

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