Clinical Trial Supply West Coast 2023

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

9 - 10

May

2023
  • Hyatt Regency San Francisco Airport, Burlingame, San Francisco
  • Complimentary
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  • Agenda
  • Speakers
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Why attend?

WHAT TO EXPECT FOR 2023?

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

See What It's All About

Agenda

  • 9 May 2023
  • 10 May 2023
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Streams

Stream one

Clinical Trial Supply Operations

Stream two

Clinical Trial Supply Innovation & Technology

7:45 AM

Registration and refreshments

8:25 AM

Chair’s opening remarks

Speakers

David Larwood
CEO, Valley Fever Solutions

8:30 AM

FDA’s role in maintaining a secure and resilient supply chain

  • Supply Chain Resiliency
  • Lessons Learned
  • Government to Government Interactions
  • FDA Inspections and pre-arrival data
  • Role of CBP, FDA, and PGAs
  • 21 CCF
  • ACE 2.0
  • Communication with Import Divisions
  • Resources

Speakers

Dan Solis
Assistant Commissioner for Import Operations, FDA

9 AM

Clinical Trial Logistics: Evolving supply models and new therapies highlight emerging trends

• Decentralized trial logistics
o The role of DTP in maximizing benefits of DCT
o Overcoming DTP complexities
• Emergence of Cell and Gene Therapies
o Unique logistics considerations for CGTs
o Ensuring quality through technology solutions

Speakers

Jennifer Fenwick
Senior Manager Personalized Supply Chain, World Courier

9:30 AM

Tackling global trade compliance in clinical supply chain to meet regulations and avoid unnecessary delays

  • Valuation of clinical items moving through borders
  • HTS codes for blinded clinical shipments versus clinical supplies moving to distribution sites
  • Overall best practices to approach your clinical studies from a customs perspective
  • VAT expenses: how they apply, when and how they can be recovered
  • Sanctions and exemptions in the pharmaceutical industry

Speakers

Matt Burns
Director Global Trade Compliance, Gilead Sciences Inc

10 AM

Innovative Processes to Better Address Today’s Trial Dynamics

  • Supply chain efficiency
    • Why do extra work and spend more money than necessary?
  • Payment process efficiency
    • Leverage an existing workflow process that sites use everyday
  • Understanding the total value a vendor can provide
    • Select a vendor that can demonstrate its total value (and make you look good in the eyes of your company)

Speakers

10:30 AM

Morning refreshments and networking

11:15 AM

Fireside Chat: Forecasting effectively for clinical trials to save time and pre-plan efficiently for a small or startup company

  • Creating a strategy for small and startup companies to effectively forecast
  • Highlighting affordable forecasting alternatives for small companies to reduce time spent on manual processes
  • Considering pros and cons of using of IRT within small companies

Speakers

Margaret Pese
Associate Director, Clinical Supply Chain, Olema Oncology

11:45 AM

Negentropy in clinical trial supplies “systems”

  • Entropy Cases - What’s not getting better
  • Negentropy Cases – when we allow new objects in a closed system see what happens
  • Enough with Physics - what about biochemistry and biology?? The latest trends in comparator sourcing

Speakers

Edo Madussi
Managing Director, Euromed Pharma

12:15 PM

Contractual Obligations for Privacy in Clinical Trials – Three Pillars to Understanding New Privacy Requirements

  • What is a DPA or the SCCs
  • Standard requirements found in DPAs or SCCs
    • SCC based security measures and how to get there
    • GDPR based operational practices and how to get there
  • Why privacy laws matter beyond participant data

Speakers

Jenifer Shahan McIntosh
Attorney, Ferguson Braswell Fraser Kubasta PC
Paul Wartenberg
Vice President/vCIO, Meriplex

12:45 PM

Lunch and networking

2 PM

Modifying standard supply chain requirements and processes to incorporate cell and gene therapy clinical trials

  • Transferring clinical supply chain from traditional pharma to cell therapy pharma
  • Understanding the requirements and importance of chain of identity and chain of custody within cell and gene therapy trials
  • Challenges and considerations for cell therapy cold chain logistics
  • Identifying technology and tracking systems to assist with cell and gene therapy supply chain tracking and monitoring

Speakers

Kevin Liao
Associate Director Supply Chain, Caribou Biosciences

2:30 PM

DTP, DFP Considerations for Successful Execution of Decentralized Trials

A speaker from Yourway will be sharing case study insights into clinical trial and supply chain logistics to help your trial run smoothly

3 PM

Panel Discussion: Highlighting how clinical supplies and quality assurance teams can collaborate to ensure trials are compliant, reducing timely and costly delays

  • Aligning early phase vs late phase quality assurance considerations with supply chain protocols to minimize disruptions and backlogs in supply chain
  • Understanding importance of role and responsibility of a Qualified Person and timelines required for QP release
  • Establishing challenges and differences between UK and EU site perspectives since changes to Brexit regulations
  • Uncovering common QA compliance oversights and how to avoid them
  • Improving communication channels between clinical supplies and QA teams

Speakers

Brittney Elko
Director Technical Operations & Supply Chain, Aligos Therapeutics
Isaac Blum
Senior Clinical Supply Manager, ALX Oncology
Chidi Umeh
Director of Quality, Telios Pharma

3:45 PM

Afternoon Refreshments & Networking

4:15 PM

Evaluating and increasing use of decentralized and hybrid trials, reviewing the impact on supply chain whilst meeting patient centric demand

  • Implementing an effective DCT strategy defining which aspects can be carried out remotely and evaluating the best patient centric approach
  • Determining factors to outsource or run trials independently, assessing technology and tools to select appropriate vendors
  • Adapting trials to include more shipments, tracking multiple site delivery to overcome delays and wastage
  • Considering legal and regulatory challenges of decentralized trials to ensure safe, compliant, and successful trials
  • Analyzing the pros and cons of DCTs, lessons learned and if this remains the way forward post pandemic

Speakers

David Larwood
CEO, Valley Fever Solutions

4:45 PM

Panel Discussion: Disaster and disruption planning to prepare clinical trial industry for the unexpected and ensure contingency plans are in place

  • Discussing contingency planning to factor into your early stage trial planning to consider any form of unforeseen future disruption, learning from Brexit, Covid-19 and Russian war
  • Creating communication plans to enable a fast response to disruption
  • How to talk to clinical teams to prepare shipments and have more visibility on shipment strategies and options in face of disruption
  • Ensuring minimum impact to patients during disruption to support the ongoing clinical trial and supply

Speakers

Bonnie Bain
Global Head of Pharma and Executive Vice President of Healthcare Operations and Strategy, GlobalData
Yuyi Shen
VP Technical Operations, Abcuro
Brandon Newell
Executive Director Quality Assurance, Structure Therapeutics

5:15 PM

Chair’s Summary and Close of Day 1

5:30 PM

Drinks Reception

11:15 AM

What can we do to take advantage of high prevalence of disease in populous countries where systems are either rudimentary or non-existent?

  • Key drivers for trial enrolment and in time completion
  • Population and high prevalence of disease in developing countries
  • Barriers and hurdles to access vast pool of patients
  • Strategies and solutions to penetrate through barriers and pass hurdles

Speakers

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

11:45 AM

Reducing the impact of emerging macroeconomic pressure on trial supply

  •  Clinical trial supply management in IRT – the past, present and future
    • Why optimizing your trial supply is more critical than ever
  • Automating the optimization of clinical trial supply
    • How sponsors are saving every day, with no additional effort
  • Reducing the risk in clinical supply chain
    • How to achieve even more automation and savings

Speakers

Chris Driver
Director IT Architecture, IQVIA

12:15 PM

Utilizing IRT and understanding its essential role in decentralized clinical trials to simplify supply planning and management

  • Identifying key characteristics of IRT required for DCT or hybrid trials
  • Handling dispensing protocols, calculating dosage, predicting demand and inventory management
  • Strategies to planning for various doses, formulations, and titrating doses
  • Controlling dispensing logistics to track transit and monitor temperatures
  • Managing documentation including returns, reconciliation and accountability for drug
  • Strategies for direct-to-patients shipment

Speakers

Jennifer Banh
Senior Manager Clinical Supply Chain, Formerly of GBT / Pfizer

2 PM

Leveraging RPA (Robotic Process Automation) to automate Clinical Supply activities

  • RPA Overview
  • Case Study: Proactively Monitoring Low Site Inventory using RPA
    • Problem Statement
    • How to leverage RPA tools to address issue
    • Reviewing a solution
  • Exploring other use cases
  • Lessons Learned

Speakers

Anwar Mahmood
Director Clinical Technology Solutions, EXELIXIS
Aviral Srivastava
Senior Director, Digital Transformation, EXELIXIS

2:30 PM

Optimize your trial execution with the strategic use of an experienced IRT/RTSM technology solutions team

  • study design recommendations
  • blinding concerns
  • mid-study changes
  • supply management

Speakers

Tracy Robinson
RTSM Solution Specialist, Medidata

3 PM

Panel Discussion: Overcoming recent challenges, uncovering latest trends and driving innovation in clinical trials

  • Future supply chain considerations since the impact of challenges provoked by regulatory changes, Covid-19, Brexit and the Russia-Ukraine conflict
  • Current opportunities to enhance supply chain and processes through data driven technologies
  • New and emerging technologies and concepts for future development

Speakers

Bonnie Bain
Global Head of Pharma and Executive Vice President of Healthcare Operations and Strategy, GlobalData
Prasun Mishra
Chief Executive Officer, Agility Pharmaceuticals
Christopher Ohms
Executive Director Supply Chain, Rigel Pharmaceuticals

4:15 PM

CMO governance to support clinical supply for a virtual company

  • Regulations impacting a virtual company
  • Quality agreements
  • Vendor management
  • Change control
  • Deviations
  • Audits

Speakers

John McGinley
Senior Director Quality Assurance, Pfizer

Streams

Stream one

Clinical Trial Supply Operations

8:15 AM

Registration and Refreshments

8:50 AM

Chair’s Opening Remarks

Speakers

Bonnie Bain
Global Head of Pharma and Executive Vice President of Healthcare Operations and Strategy, GlobalData

9 AM

The State of the Biopharmaceutical Industry – 2023

• Benchmark the impact of major themes on the biopharmaceutical industry in 2023, including:
- Emerging technologies
- Regulatory trends
- Macroeconomic trends
- Industry trends
• Identify themes that will have the greatest positive or negative impact
• Explore how inflation will affect the pharmaceutical industry

Speakers

Bonnie Bain
Global Head of Pharma and Executive Vice President of Healthcare Operations and Strategy, GlobalData

9:30 AM

Industry secrets to enhance clinical trial supply chain management

  • Discover why technology is critical in achieving and maintaining visibility and traceability of the clinical trial supply chain
  • Learn how oversight and control, through technology, improve the patient and site experience
  • Tips on what to look for in a clinical trial supply chain management technology vendor/partner
    • What questions to ask?
    • What roadblocks to acknowledge and plan for

Speakers

Melanie Manrique
Associate Director, Quality Management , Endpoint Clinical

10 AM

Effective clinical distribution & label/pack vendor selection and management: creating agile relationships to ensure aligned goals and successful partnerships

  • Navigating the vendor market/how to assess vendors to find the best vendor(s) for your supply chain network needs
  • Maintaining real time conversations with vendors to monitor disruption and delays, contingency planning together through open discussions
  • Important capabilities to consider when completing your assessments
  • Overcoming challenges when working with multiple vendors to ensure aligned goals

Speakers

Brittney Elko
Director Technical Operations & Supply Chain, Aligos Therapeutics

10:30 AM

Morning refreshments and networking

11 AM

Fireside Chat: Ascertaining the advantages and challenges of packaging and labeling strategies to enhance supply chain flexibility

  • Decreasing large batch labeling to improve efficiency and reduce wastage
  • Enabling differing label requests for new countries, sites or patients within trials
  • Maximizing use of drug product with short expiration dates
  • Reviewing the impact of just in time labelling on cost, forecasting and supply chain management in intensified timeframes

Speakers

Marc Trombella
Associate Director Clinical Supply Chain Planning, BioMarin Pharmaceuticals

11:30 AM

Fireside Chat & Audience Q&A: Discussing autologous cell therapy supply chain challenges for start-ups

  • Resource considerations to solve the immediate need while considering future growth
    • Single product to multi-product
    • Demand growth
    • Clinical Site expansion
    • Gameplan for rapid expansion
  • Navigating clinical launch including onboarding and managing of clinical sites
  • Planning and scheduling considerations
  • Vetting critical partners

Speakers

Thomas Tredennick
Associate Director, Supply Chain, ArsenalBio

12 PM

Clinical supply chain responsibilities for study close out, end of trial and returns

  • Clinical Trial Master File and Data Base Lock
  • IRT compliance – expected reports, accountability logs, what auditors are looking for
  • Requirements for temperature documentation and compliance
  • How to prepare for closeout at study design to ensure reporting is maintained throughout
  • Pre-planning for supply destroys and returns to ensure compliance destroying onsite or nearby to minimize transport and customs requirements

Speakers

Anu Arora
Senior Manager Clinical Supply Chain, Agios Pharmaceuticals

12:30 PM

CEIV Pharma: Raising the standard of pharmaceutical logistics

  • Learn about risks and potential gaps in cold chain when transporting temperature-sensitive pharmaceutical products by air
  • Discover how IATA's standards and certification can improve handling of pharmaceutical cargo, ensuring compliance with regulations
  • Understand benefits of participating in IATA's CEIV Pharma program and how it can help organizations establish a complete cold chain logistical process to maintain shipment integrity
  • Engage in the process of a simplified audit solution against clear standard criteria developed by the industry and provide constructive feedback on IATA's proposed solution

Speakers

Ronald Schaefer
Consulting Head of Certification Programs (CEIV Pharma), IATA

1 PM

Lunch, networking and prize draw

2:30 PM

Evolving use of AI and Big Data in clinical trial supply chain to reduce costs and streamline processes

  • Identifying where and how data-driven technologies can be incorporated to streamline processes within clinical supply chains and decentralized trials
  • Reviewing cost savings through use of AI and big data
  • Evaluating benefits of using blockchain technologies to enhance conduction and management of trials
  • Highlighting successes of implementing AI and machine learning tools through case study examples

Speakers

Prasun Mishra
Chief Executive Officer, Agility Pharmaceuticals

3 PM

US Border Control: Hear from the Pharmaceuticals, Health & Chemicals Center

  • Overview of U.S. Customs and Border Protection’s Centers for Excellence and Expertise (CEE)
  • Focus on the Pharmaceuticals, Health, and Chemicals CEE and its role in the importation process
  • How Industry partnerships are mutually beneficial
  • Biologic import requirements

Speakers

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

3:30 PM

Speaker Hosted Round Tables

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 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 lasts for 30minutes, delegates can select up to 2 roundtables.

RT 1 - Roundtable: Feasibility issues with study protocols and clinical development plans to recognize and overcome: best practices and common mistakes to avoid

Jasmina Jankicevic, Consulting Dermatologist, Clinical Development & Medical Affairs, RAPT Therapeutics, Inc.

RT 2 - Roundtable: US Border Control: Ask the Experts

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

Gina Reneau, Biological Threat Exclusion Coordinator, U.S. Customs & Border Protection

RT 3 - Roundtable: Current challenges and issues in supply chain

Ying Cai, Director Supply Chain, Ashvattha Therapeutics, Inc

RT 4 - Roundtable: Managing expiry dates to comply with regulation and avoid wastage

Margaret Pese, Associate Director, Clinical Supply Chain, Olema Oncology

Speakers

Jasmina Jankicevic
Clinical Development, RAPT Therapeutics, Inc.
Brandy Porter
Assistant Center Director, Enforcement Pharmaceuticals, Health, and Chemicals Center of Excellence and Expertise, U.S. Customs & Border Protection
Gina Reneau
Biological Threat Exclusion Coordinator, U.S. Customs & Border Protection
Ying Cai
Director Supply Chain, Ashvattha Therapeutics, Inc
Margaret Pese
Associate Director, Clinical Supply Chain, Olema Oncology

4:30 PM

Chair’s Summary and Close of Conference

Speakers

Select a speaker to learn more

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Dan Solis
Assistant Commissioner for Import Operations, FDA

Dan Solis is a recognized expert in FDA import operations and is the Assistant Commissioner for ORA’s Office of Import Operations. Prior to this position he was the Division Director for the Division of West Coast Imports since February 9, 2018. He started his career with FDA in 1998. Prior to working in FDA, Mr. Solis worked in the Bioresearch field focusing on Medical Device and Drug Application Products after graduating from the University California of Irvine and the University of La Verne. Mr. Solis has held many positions within FDA that includes working at the FDA lab in Irvine, Ca. as a Microbiologist, HQ position within the Division of Import Operations in Rockville, MD, working as an Import Compliance Officer and working in the FDA Los Angeles District Office as a Director of Import Operations Branch.

Session Details:

FDA’s role in maintaining a secure and resilient supply chain

2023-05-09, 8:30 AM

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Matt Burns
Director Global Trade Compliance, Gilead Sciences Inc

Matt is a +20 year Trade Compliance and Transportation professional with a passion for all aspects of international trade and problem solving.  He is an US Licensed Customs broker, international tax expert and Logistician with a background in pharmaceuticals, chemicals, biotech, munitions, and cosmetics.  Whether dealing with imports or exports of controlled materials, Matt brings major bench strength to any project or workstream.

Session Details:

Tackling global trade compliance in clinical supply chain to meet regulations and avoid unnecessary delays

2023-05-09, 9:30 AM

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Anwar Mahmood
Director Clinical Technology Solutions, EXELIXIS

Anwar Mahmood has 16+ years of clinical system experience including IRT, CTMS, eCOA, and wearable device experience. He is currently a Director in the Clinical Technology Solutions Group at Exelixis where he oversees the IRT Team.

Session Details:

Leveraging RPA (Robotic Process Automation) to automate Clinical Supply activities

2023-05-09, 2:00 PM

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Aviral Srivastava
Senior Director, Digital Transformation, EXELIXIS

Aviral has 20 years of experience in Software Engineering field and has worked across Life Sciences, Banking, Utilities and Telecom industries in US, UK, and India. He is currently Senior Director within Digital Transformation group at Exelixis and oversees Business Process Automation and Quality Engineering teams.

Session Details:

Leveraging RPA (Robotic Process Automation) to automate Clinical Supply activities

2023-05-09, 2:00 PM

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Yuyi Shen
VP Technical Operations, Abcuro

Experienced and self-motivated process development scientist and team leader with specialty in process improvement, scale up, technical transfer to bioprocess manufacturing in cGMP environment. Strong subject matter experts in design robust processes for protein purification with monoclonal antibody, antigen and VLP etc, ensuring Critical Quality Attributes are achieved.

Solid trouble shooting and problem solving skills and encouraging innovation technology to achieve high efficiency and avoid repetitive work.

Strong proven track of define, design, manage and deliver projects upon all milestones, goals and cost target.

Build, develop, train and supervise team members and engage and motivate members to ensure the overall success and growth.

Session Details:

Panel Discussion: Disaster and disruption planning to prepare clinical trial industry for the unexpected and ensure contingency plans are in place

2023-05-09, 4:45 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:

What can we do to take advantage of high prevalence of disease in populous countries where systems are either rudimentary or non-existent?

2023-05-09, 11:15 AM

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Jasmina Jankicevic
Clinical Development, RAPT Therapeutics, Inc.

Dr Jasmina Jankicevic is globally recognized as an expert in dermatology drug/device development. She has led clinical development in dermatology and medical aesthetics for pharma/biotech, CROs, medical device and cosmetic companies including RAPT, Innovaderm, Premier Research, Allergan, Leo Pharma, and Murad. She has driven program strategy and planning, including implementation of 300+ clinical study protocols in 25+ indications, by leading global cross-functional teams towards successful regulatory submissions, product launches, and innovative lifecycle management. As an international key opinion leader in dermatology clinical development, Dr. Jankicevic has served as advisor to multiple companies on their path to global regulatory and commercial success. Dr Jankicevic holds Doctor of Medicine degree, Master of Medical Sciences degree, and Board-certification in Dermatology and Venereology from the University of Belgrade, Serbia. She holds medical license issued by Serbian Medical Chamber. She is also a Certified Clinical Research Professional, and a trained journalist. Dr. Jankicevic is a sought-after speaker, and author of numerous articles in peer-reviewed and trade journals.

Session Details:

Speaker Hosted Round Tables

2023-05-10, 3:30 PM

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Jennifer Banh
Senior Manager Clinical Supply Chain, Formerly of GBT / Pfizer

Jennifer Banh is an experienced clinical supply chain professional currently working in the rare disease (sickle cell disease) space. Jennifer has vast experience in end-to-end clinical supply chain from study start up to close out. She also has extensive experience with Interactive Response Systems (IRT), inventory planning and forecasting, and CMO management and oversight.

Session Details:

Utilizing IRT and understanding its essential role in decentralized clinical trials to simplify supply planning and management

2023-05-09, 12:15 PM

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Margaret Pese
Associate Director, Clinical Supply Chain, Olema Oncology

High performing, excellence-driven, end-to-end Clinical Supply Chain Professional carrying over 20 years of industry experience in pharmaceuticals and biotechnology. Over 10 years of clinical and commercial supply chain experience. Proven success in leading study teams, including external partners, to target milestones on time and on budget. Highly skilled at supply and demand planning, developing distribution strategies, scenario planning and risk mitigation, troubleshooting, streamlining processes, saving on costs, and increasing the speed to clinics and to markets without compromising product quality.

Session Details:

Fireside Chat: Forecasting effectively for clinical trials to save time and pre-plan efficiently for a small or startup company

2023-05-09, 11:15 AM

Session Details:

Speaker Hosted Round Tables

2023-05-10, 3:30 PM

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David Larwood
CEO, Valley Fever Solutions

David Larwood is a founder, the CEO, and chief chemist for Valley Fever Solutions, running the manufacturing process for a novel antifungal headed for Phase 2a trials in 2022. In his role as BD lead, he is responsible for many aspects of the company’s planning and operations.

Valley Fever Solutions is a small startup working first on a new and improved treatment for Valley Fever (coccidioidomycosis), for which NikZ will transform the standard of care. NikZ shows promise against other important fungal diseases.

Mr. Larwood co-invented his first two commercial molecules before age 30. His PhD research at UC San Francisco established the foundation for PEGylated drugs widely used today. At UCSF he co-invented suitable PEGylated lipids to make the very first PEGylated liposomes. Earlier as a bench chemist, he was the first to make Iotrolan, a CT X-ray contrast agent, generic for decades, replaced in about 2005 by newer agents.

Moving to law, in leading law firms he advised major companies on patent matters. After 3 years as a patent lawyer at Apple Computer, he took a VP role at startup FormFactor, staying in an IP role, then became the first General Counsel for startup Verisity Design, taking them public in 2001, then ultimately through successful acquisition in 2005.

Mr. Larwood is the third of his family to be involved in Valley Fever.  His father was a physician who developed an interest in the disease decades ago when the family moved to Bakersfield, California, a focal area for the disease. His mother started a foundation in 1998 and raised some $20M for research into vaccines against Valley Fever.

Session Details:

Chair’s opening remarks

2023-05-09, 8:25 AM

Session Details:

Evaluating and increasing use of decentralized and hybrid trials, reviewing the impact on supply chain whilst meeting patient centric demand

2023-05-09, 4:15 PM

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Ying Cai
Director Supply Chain, Ashvattha Therapeutics, Inc

Ying Cai is a Director of Supply Chain at Ashvattha Therapeutics with 16 years industrial experience, specializing in clinical supply chain. Ying uses that experience to ensure end to end supply chain efficiency and integrity from raw materials to patients.

Session Details:

Speaker Hosted Round Tables

2023-05-10, 3:30 PM

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Prasun Mishra
Chief Executive Officer, 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:

Panel Discussion: Overcoming recent challenges, uncovering latest trends and driving innovation in clinical trials

2023-05-09, 3:00 PM

Session Details:

Evolving use of AI and Big Data in clinical trial supply chain to reduce costs and streamline processes

2023-05-10, 2:30 PM

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Brandon Newell
Executive Director Quality Assurance, Structure Therapeutics

Well seasoned Quality Professional with a demonstrated history of working in the biotechnology industry. Strong quality assurance professional skilled in Quality Systems, CMC, QC, Regulatory, and overall GxP (GMP, GCP, GLP) Operations, including supplier oversight, investigations and CAPAs, change management, audits, vendor qualification, and Trial Master Files. Ability to navigate from Phase 1 up to and including commercialization.

Session Details:

Panel Discussion: Disaster and disruption planning to prepare clinical trial industry for the unexpected and ensure contingency plans are in place

2023-05-09, 4:45 PM

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Christopher Ohms
Executive Director Supply Chain, Rigel Pharmaceuticals

Session Details:

Panel Discussion: Overcoming recent challenges, uncovering latest trends and driving innovation in clinical trials

2023-05-09, 3:00 PM

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John McGinley
Senior Director Quality Assurance, Pfizer

Session Details:

CMO governance to support clinical supply for a virtual company

2023-05-09, 4:15 PM

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Kevin Liao
Associate Director Supply Chain, Caribou Biosciences

Kevin Liao is Associate Director of Supply Chain at Caribou Biosciences where he is responsible for the planning and logistics of raw materials and delivering investigational allogeneic products to patients. He has more than a decade of experience in Supply Chain Planning, Logistics, Procurement, and Systems. Prior to Caribou, he was Head of Supply Chain and Procurement at insitro and Vor Biopharma building the Supply Chain functions and defining processes to support manufacturing and sourcing.

Session Details:

Modifying standard supply chain requirements and processes to incorporate cell and gene therapy clinical trials

2023-05-09, 2:00 PM

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Brittney Elko
Director Technical Operations & Supply Chain, Aligos Therapeutics

Brittney is currently Director, Technical Operations & Supply Chain at Aligos where she is responsible for the supply chain department and external vendors accountable for packaging, labeling and distribution of clinical trial materials to investigational sites.

Brittney has more than 15 years of experience working in both technical development and supply chain organizations in the consumer products and pharmaceutical/biotech industries.  Prior to Aligos, she was at Tricida, Intarcia, and Genentech where she managed all aspects of supplying 40+ clinical trials across the world in over 30 countries for thousands of patients. She also managed the commercial supply chain for the Clorox Disinfecting Wipes business, dealing with un-precedented demand changes through the H1N1 flu outbreak.

Session Details:

Effective clinical distribution & label/pack vendor selection and management: creating agile relationships to ensure aligned goals and successful partnerships

2023-05-10, 10:00 AM

Session Details:

Panel Discussion: Highlighting how clinical supplies and quality assurance teams can collaborate to ensure trials are compliant, reducing timely and costly delays

2023-05-09, 3:00 PM

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Anu Arora
Senior Manager Clinical Supply Chain, Agios Pharmaceuticals

Experienced Clinical Supply Chain Professional with holistic understanding of the pharmaceutical industry and GXP requirement for clinical trials, Phase I-IV, with extensive experience in managing and leading the end to end execution of clinical trials ensure effective and efficient supply of Investigational Product (IP) across the globe. Having collaborated with several clinical service providers and cross functional groups, Anu has exhaustive experience and unique insight on managing processes related to setting up and winding down of clinical trials.

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Clinical supply chain responsibilities for study close out, end of trial and returns

2023-05-10, 12:00 PM

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Bonnie Bain
Global Head of Pharma and Executive Vice President of Healthcare Operations and Strategy, GlobalData

Bonnie Bain, PhD, is the Global Head and EVP of Healthcare Operations and Strategy. Bonnie has over 20 years’ experience in the healthcare sector and a proven track record of developing innovative solutions on both the client and agency sides of the business. Bonnie was GlobalData Healthcare’s first Western analyst, and under her leadership, the company launched a number of premium syndicated reports, analytical tools, and databases in the pharmaceuticals and medical devices space. Prior to GlobalData, Bonnie was Vice President and Global Research & Analysis Director for Informa’s Pharma Division, which includes Datamonitor Healthcare, Scrip Group, and Business Insight. Bonnie also worked for several years at Decision Resources as an Analyst and Project Manager. On the client side of the industry, Bonnie worked for several years as a Senior Manager in Marketing Strategy and Analytics at Boston Scientific, where her work contributed to the successful commercialization of the first ever Access and Visualization Platform at the company. Bonnie has a PhD in Biochemistry and Molecular Biology from Purdue University and completed a Post-Doctoral Fellowship in Molecular Pharmacology at the University Of Miami School Of Medicine. She also has a graduate certificate in Applied Management Principles from Purdue University Krannert School of Management.

Session Details:

Panel Discussion: Disaster and disruption planning to prepare clinical trial industry for the unexpected and ensure contingency plans are in place

2023-05-09, 4:45 PM

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Panel Discussion: Overcoming recent challenges, uncovering latest trends and driving innovation in clinical trials

2023-05-09, 3:00 PM

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Chair’s Opening Remarks

2023-05-10, 8:50 AM

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The State of the Biopharmaceutical Industry – 2023

2023-05-10, 9:00 AM

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Isaac Blum
Senior Clinical Supply Manager, ALX Oncology

Isaac Blum has served as Senior Manager of Clinical Supply at ALX Oncology since June 2021. Previously, Isaac served in operational roles of increasing responsibility at BioMarin Pharmaceutical, Sangamo Therapeutics and Puma Biotechnology. Isaac is excited about developing global supply strategies and systems to help advance innovative, life-saving treatments. He has used his expertise to launch multiple global oncology clinical trials, and has shared his expertise at numerous speaking events. Isaac holds a B.A. from the University of Puget Sound.

Session Details:

Panel Discussion: Highlighting how clinical supplies and quality assurance teams can collaborate to ensure trials are compliant, reducing timely and costly delays

2023-05-09, 3:00 PM

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Marc Trombella
Associate Director Clinical Supply Chain Planning, BioMarin Pharmaceuticals

Marc has 20+ years of Biopharmaceutical experience overseeing global clinical supply chain activities for oncology and rare disease clinical programs. Cold chain logistics experience in managing clinical supply inventory in the US, APAC, EU, US and AU regions.

Session Details:

Fireside Chat: Ascertaining the advantages and challenges of packaging and labeling strategies to enhance supply chain flexibility

2023-05-10, 11:00 AM

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Thomas Tredennick
Associate Director, Supply Chain, ArsenalBio

Thomas started his career at Baxter Biosciences (later Baxalta) where he worked in the External Manufacturing and Supply group managing fill/finish CMO's. Thomas took a role at Vetter Pharma as a Customer Project Manager responsible for early phase clinical tech transfers. Thomas then worked for Kite Pharma's Supply Chain group managing critical raw material suppliers. He then joined ArsenalBio where he is leading the Strategic Supply Chain group responsible for managing clinical supply and production planning.

Session Details:

Fireside Chat & Audience Q&A: Discussing autologous cell therapy supply chain challenges for start-ups

2023-05-10, 11:30 AM

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Chidi Umeh
Director of Quality, Telios Pharma

Session Details:

Panel Discussion: Highlighting how clinical supplies and quality assurance teams can collaborate to ensure trials are compliant, reducing timely and costly delays

2023-05-09, 3:00 PM

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Ronald Schaefer
Consulting Head of Certification Programs (CEIV Pharma), IATA

Ronald Schaefer is Senior Principal, Consulting. He is also the Consulting Head of the Certifications Programs (CEIV Pharma, CEIV Live Animals, CEIV Fresh, CEIV Lithium Battery, CBTA, etc.) at IATA. He was born in Hamburg, Germany, raised in Mexico and educated in the US. After long-term professional assignments in Germany, Spain, Malaysia, Kuwait, Venezuela and Canada, he has been based in Miami for the last 14 years working for IATA. Before joining IATA, Mr. Schaefer accumulated vast experience in the air transport field working as a consultant for Lufthansa Consulting GmbH, Roland Berger Strategy Consultants GmbH and Ferrostaal México. He has worked on corporate restructuring, strategy, post-merger integration, market and competitive analysis, safety, risk management initiatives among others, in the transportation industry on all continents. Throughout his career Ronald has held positions in Mexico, Stuttgart, Kuala Lumpur, Frankfurt, Cologne, New York, Montreal and Miami.

At IATA he developed in conjunction with the IATA Pharma subject matter expert the CEIV Pharma pre-assessment tools and materials to facilitate successful independent validation of organizations. He also led the initial independent assessment Proof-of-Concept for Singapore Air Terminal Services (SATS) and is now managing the program worldwide. Since its start he has managed ~450 certifications, +1000 assessments and +800 validations.

He is also jointly responsible for the development and implementation of new CEIV initiatives such as CEIV Live Animal, officially launched in April 2018 and CEIV Fresh launched in 2019. In conjunction with the IATA Live Animal and Perishable expert, he is also developing the pre-/assessment tools for validations of organizations and jointly managing the on-going pilots.

He holds a Bachelor of Science (B. Sc.) in Business Administration from California State University at Sonoma and Master of Business Administration (MBA) from Georgetown University.

Session Details:

CEIV Pharma: Raising the standard of pharmaceutical logistics

2023-05-10, 12:30 PM

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Jenifer Shahan McIntosh
Attorney, Ferguson Braswell Fraser Kubasta PC

Jenifer Shahan McIntosh counsels clients on privacy, data security, and data governance. She has significant experience with legal, operational, and reputational risk guidance, particularly as it relates to compliance initiatives, EU & UK clinical trial privacy requirements, product design, mergers, acquisitions, and tech transactions. She counsels clients on domestic and international privacy laws and regulations, including cross-border data transfers.

Jenifer has an extensive and diverse background in commercial litigation, including complex contract and licensing disputes, patent litigation, business torts and regulatory investigations defense—all of which she brings to her privacy and data security work. Her cybersecurity experience includes working with clients to stand-up security programs, helping clients establish robust privacy-by-design in product development, advising and guiding clients in the conduct of cyber and data governance due diligence during M&A transactions, and advising on vendor and licensing agreements regarding the transfer and security of data. She has advised leading pharmaceutical trials companies, private equity firms, SaaS service providers, health-tech, ad-tech, and e-commerce clients on privacy and data security issues in technology-driven transactions.

Jenifer is a Certified Information Privacy Professional for for the United States (CIPP/U) and licensed in New York, Colorado and Texas. Prior to her relocation to Dallas, she served as in-house counsel for a clinical trials company and web-based educational technology company. Jenifer has been quoted in the Law360 on legislation regarding privacy and big-tech tracking, and is a prolific writer on international and domestic privacy and data security law developments.

Session Details:

Contractual Obligations for Privacy in Clinical Trials – Three Pillars to Understanding New Privacy Requirements

2023-05-09, 12:15 PM

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Paul Wartenberg
Vice President/vCIO, Meriplex

Session Details:

Contractual Obligations for Privacy in Clinical Trials – Three Pillars to Understanding New Privacy Requirements

2023-05-09, 12:15 PM

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Chris Driver
Director IT Architecture, IQVIA

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

Session Details:

Reducing the impact of emerging macroeconomic pressure on trial supply

2023-05-09, 11:45 AM

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Edo Madussi
Managing Director, Euromed Pharma

Edo Madussi is the Managing Director, of Euromed Pharma US and Business Unit head of the Clinical Trial Division at the Petrone Group.

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

Session Details:

Negentropy in clinical trial supplies “systems”

2023-05-09, 11:45 AM

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Session Details:

Innovative Processes to Better Address Today’s Trial Dynamics

2023-05-09, 10:00 AM

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Melanie Manrique
Associate Director, Quality Management , Endpoint Clinical

Melanie has worked in Quality since starting her career in 2007 and spent six years with a pre-clinical CRO before making a switch to software and the clinical trial industry. Started working for endpoint Clinical in 2013 and has worked with the Quality leadership team in building up the quality management system. She has helped endpoint establish a robust remote client audit and inspection support program that allows the company to respond to requests and questions efficiently and in a timely manner.

Session Details:

Industry secrets to enhance clinical trial supply chain management

2023-05-10, 9:30 AM

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Jennifer Fenwick
Senior Manager Personalized Supply Chain, World Courier

Jennifer is part of World Courier's team leading the cell and gene therapy and direct-to-patient service lines, focusing on defining strategy, driving growth, and solving operational and process challenges arising from these shipments' complexity. With experience in roles on both the sponsor and vendor side for clinical and commercial pharmaceutical logistics, Jennifer has served in many leadership roles in the clinical trial supply chain, project management, vendor and alliance management before joining World Courier in 2022. Jennifer is helping the health tech sector integrate and grow within the continuously shifting landscape.

Session Details:

Clinical Trial Logistics: Evolving supply models and new therapies highlight emerging trends

2023-05-09, 9:00 AM

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Tracy Robinson
RTSM Solution Specialist, Medidata

Tracy is an RTSM Solutions Specialist at Medidata with 26+ years of experience in the Life Sciences Industry including 25 years specializing in Interactive Response Technology (IRT)/Randomization and Trial Supply Management (RTSM) for large and small study systems for both US based and global projects in multiple trial phases and indications. Prior to joining Medidata, Tracy was a Client Oversight Manager at PPD whose responsibilities included ensuring project/study activities were in compliance with company and sponsor requirements; meeting with internal teams to coordinate efforts, providing recommendations and risks, and serving as an escalation contact with clinical project management teams and sponsors for PPD’s proprietary IRT platform as well as Medidata Rave RTSM at PPD (as an accredited Medidata partner). With her years of experience and knowledge in the pharmaceutical industry and the clinical trial space, she has a great understanding of what it takes to work with CROs and Sponsors and to help them navigate and troubleshoot their varying system needs.

Session Details:

Optimize your trial execution with the strategic use of an experienced IRT/RTSM technology solutions team

2023-05-09, 2:30 PM

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

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

Session Details:

US Border Control: Hear from the Pharmaceuticals, Health & Chemicals Center

2023-05-10, 3:00 PM

Session Details:

Speaker Hosted Round Tables

2023-05-10, 3:30 PM

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Gina Reneau
Biological Threat Exclusion Coordinator, U.S. Customs & Border Protection

Gina Reneau is a Biological Threat Exclusion Coordinator (BTEC) for U.S. Customs and Border Protection (CBP) in the Office of Field Operations

Agriculture Programs and Trade Liaison/ Biological Threat Exclusion.  As a BTEC, Ms. Reneau is charged with supporting and developing CBP operational capacity and capability in preventing tools of agro/bio-terrorism from entering the U.S.  Ms. Reneau has more than 27 years of public service with CBP, and has worked in a variety of environments, including in air passenger, cargo, maritime, and express consignment locations.

Session Details:

Speaker Hosted Round Tables

2023-05-10, 3:30 PM

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The 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.

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+44 (0) 207 9472755

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Jaz Sidhu

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To enquire about speaking opportunities for the conference, please contact:

 

Ruth Atterbury

Portfolio Manager


+44 (0) 20 4540 7796