17th Annual Clinical Trial Supply West Coast 2024

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

17 - 18

September

2024
  • Hyatt Regency San Francisco Airport, California, USA
  • Complimentary
  • Why attend?
  • Agenda
  • Advisory Board
  • Speakers
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  • Event Gallery
  • Sponsors
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Why attend?

WHAT TO EXPECT FOR 2024?

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

  • 17 Sep 2024
  • 18 Sep 2024
Expand All

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

Fiona Barry
Editor-in-Chief and Director of PharmSource, GlobalData

8:30 AM

Opening Keynote: FDA importation overview and how to resolve issues with import entries being held for examination

  • Correcting common errors when importing drugs and devices into the United States.
  • How to communicate with FDA when your shipments are on hold?
  • Understanding the complexity of filing an FDA electronic entry.
  • Getting to know your FDA management staff when importing through the West Coast.

Speakers

Gordon Chu
Director of Investigations Branch, FDA
Sylvia Thomas
Supervisory Consumer Safety Officer, Division of West Coast Import, FDA

9 AM

Aligning clinical supply strategies with sustainability goals

Increasingly pharmaceutical companies are committing to reduce their carbon footprints in the execution of clinical trials. This session will cover how implementing innovative clinical trial supply technologies and sustainable processes can:

  • result in a more efficient use of human resources
  • reduce the number of logistical resources required
  • reduce waste
  • save money
  • lower the carbon footprint impact

Speakers

Robbie Hill
Director, Business Development, Mercalis

9:30 AM

Optimizing cold chain logistics and improving green credentials to ensure the integrity of your products end-to-end

• What are the latest technological advances and innovative systems adopted by the industry that can enhance cold chain distribution: What should be on your radar?
• Hot topic in cold chain logistics: Sustainability - Aligning market growth with responsible practices to ensure businesses are making smarter decisions regarding the planet
• Efficiently and effectively outsourcing management of temperature-sensitive materials to ensure your cold chain is never compromised
• Expanding capacity on cold chain resources and enhancing end-to-end management to keep up with increasing demand and limited supplies

Speakers

Prashanth Chakravartula
Senior Director, Warehouse & Logistics Bayer

10 AM

Fostering patient centricity and diversity equity & inclusion with your supply chain decisions

  • Discuss how patient insurance in the United States can impact a clinical trial patient’s experience in accessing therapies (i.e. SOC, comparators)
  • Discuss how companies are currently addressing improving Diversity Equity and Inclusion (DEI) in clinical trials and how appropriate medication access can support DEI
  • Supply chain considerations and optimizing the patient experience
  • FDA guidance on DEI plans for clinical trials

Speakers

Samit Bhatt
Vice President, Clinical Trial Patient Solutions, Myonex

10:30 AM

Morning refreshments and networking

11:15 AM

Managing clinical supplies in a global study and the associated challenges with CMOs, CROs, suppliers, global regulatory directives, quality compliance, and risk

Speakers

Horacio Enriquez
Director of Clinical Supplies and Supply Chain Management, Kezar Life Sciences

11:45 AM

Reserved for Inceptua

12:15 PM

Panel Discussion: How labelling technologies and strategies are redefining what is possible concerning fast and accurate clinical trial supply

  • Latest advancements with sourcing, labelling, and filing strategies for auxiliary medicinal product
  • Identifying the right packaging and storage solutions based on your bespoke needs to accelerate your drug supply
  • Improved expiry date predictions to avoid relabeling and reduce wastage
  • Recognizing different labelling requirements globally and how to ensure total adherence: What are the implications of the revised Annex 13 on labelling of IMPs
  • Enhancing label management with cloud-based technology to improve quality control and avoid
    unnecessary recalls

Chair: Bei Li, Senior Director, Clinical Supply  Management, Gilead Sciences

Speakers

Bei Li
Director, Clinical Supply Management
Yuyi Shen
VP Technical Operations, Abcuro
Ryan Mills
Senior Director, Head of Supply Chain, Denali Therapeutics

12:45 PM

Lunch and networking

2 PM

A Holistic Approach to Supply Chain Planning for Clinical Trials

  • Why is supply chain planning important?
  • What are the foundational elements of successful supply chain planning for clinical trials?
  • What does the Clinical Planner need to account for within their plan?
  • What does the Clinical Planner need to effectively manage their plan?
  • Which business processes are required to ensure the Clinical Planner keeps their plan current and accurate?

Speakers

Ryan Mills
Senior Director, Head of Supply Chain, Denali Therapeutics

2:30 PM

Reserved for event sponsor

3 PM

Optimizing inventory management to reduce inefficiencies in clinical supply chain

  • Ensuring readiness for unexpected disruptions: Contingency planning for failed batches to maintain supply chain resilience
  • Phase-appropriate inventory planning and how to best manage this alignment
  • Implementing the right tools and making data-driven decisions to modernize your inventory management strategy
  • Key considerations and solutions for improved tracking, managing, and purchasing supplies

Speakers

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

3:30 PM

Afternoon refreshments and networking

4 PM

How has your comparator sourcing strategy updated to keep up with changes in the industry and regulatory revisions?

  • Developing a risk-driven demand plan that can aptly accommodate changes in the quantity of comparators
  • Finding the right provider with a global comparator network who can provide timely and accurate product assessments and insight on how long they take to source
  • Single sourcing vs. decentralized sourcing to ease the demands on internal supply and logistics whilst being regulation compliant
  • Appropriately weighing risk vs reward with comparator sourcing to lead to successful outcomes

Speakers

Shubhra Kochar
Global Strategy Lead Comparator Management, Clinical Supply Planning, Genentech

4:30 PM

Reserved for event sponsor

5 PM

Closing Panel Discussion: Levelling up vendor partnerships so that both sides win

  • Being more strategic with vendor partnerships and knowing what it means to be a true partner
  • Collaborating with all parts of the supply chain ecosystem to foster supplier relationships based on trust and mutual benefit
  • Why vendor flexibility and ability to customize is mission critical for sponsors
  • Ensuring alignment of incentives to avoid delays in supply shipments

Chair: Paul Hingst, Associate Director, Crinetics

Speakers

Kalpesh Patel
Associate Director, QA, BeiGene USA
Tom Schiavon
Manager, Clinical Systems and Technology, Insmed Incorporated
Prashanth Chakravartula
Senior Director, Warehouse & Logistics Bayer
Paul Hingst
Supply Chain Consultant, Crinetics Pharmaceuticals

5:45 PM

Chair’s closing remarks

END OF DAY 1 AND NETWORKING DRINKS

11:15 AM

Innovative processes to propel clinical studies into the future

  • Transitioning from existing capabilities  and architecture to integrating powerful new solutions to optimize trial supply
  • Technology to determine next actions in preventing supply disruption, detect temperature excursions earlier and ensure patient safety
  • Obtaining increased data points to validate or adjust predetermined excursion criteria
  • Minimize discarding of potentially viable drug supply wi

Speakers

Victoria Vargo
Director, Clinical Supply, Karyopharm Therapeutics

11:45 AM

Case Study: Optimizing clinical supply chain with advanced technology

  • Advanced technology in clinical supply chain
  • Case study – isolating objectives and delivering results through technology
  • Emerging technologies, risks and regulatory considerations – identifying trial supply use cases for AI/ML

 

Speakers

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

12:15 PM

Panel Discussion: Where does innovation fit in the highly regulated world of clinical trials?

  • Gaining enough traction for smallersoftware solutions companies with promising products to sustain their presence in the clinical ecosystem
  • How to best implement innovative vendor services to ensure they work within the pre-existing CRO universe
  • When CROs have too much power, how can we ensure innovation isn’t stifled?
  • What are the best ways to balance risk mitigation and innovation in a traditionally slow-paced industry?

Chair: Mariam Iqbal, Director, Clinical Business Operations, Intercept Pharmaceuticals

 

Speakers

Louie Burks
Associate Director Clinical Supply, Allakos
Umar Hayat
Vice President, CMC and Supply Chain, Union Therapeutics

12:45 PM

Lunch and networking

2 PM

Reducing the impact of increased data privacy requirements under data privacy laws on biotechs

  • Managing all considerable factors when it comes to data handling
  • Do the sites or vendors have a Data Privacy Officer or SOPs around data handling?
  • How to review data in an efficient way

Speakers

Ted Chun
Director, Global Clinical Shared Services at Stryker Neurovascular

2:30 PM

Unlocking the Future: Real-World AI Integration in IRT

  • Introduction to AI in IRT - Understand the foundational concepts of machine learning, natural language processing, and data analytics.
  • Advanced Techniques with ChatGPT Plus - Explore pre-designed flows, customization, data visualization, and automation within IRT.
  • Next-Level AI Integration - Discover how AI can streamline core and auxiliary functions in clinical trials, from patient engagement to data analysis.
  • Enterprise Adoption of LLMs - Gain insights into strategic planning for large-scale AI adoption and future roadmaps for integrating AI into your enterprise.
    Senior Representative, Endpoint Clinical

Speakers

Chris Varner
Senior Director of Solutions Consulting, Endpoint Clinical

3 PM

Transforming IRT implementation to improve the accuracy of CTS management: What’s new for 2024?

  • Capitalizing off the prominent role IRTs play in the decentralized approach of
    direct-to-patient drug deliveries Strategies for mid-study changes and how to best prepare for these
  • Achieving the greatest amount of visibility and control possible with IRT usage
  • Knowing when to justify the costs of customized IRT for the nature of your study

Speakers

Tom Schiavon
Manager, Clinical Systems and Technology, Insmed Incorporated

3:30 PM

Afternoon refreshments and networking

4 PM

Looking at shipping and logistics from another angle: exploring watchouts & lessons learned in order to find an all-encompassing approach to proactively anticipate challenges

 

  • Explore best practice in close monitoring of transportation activities to guarantee timely supply delivery and minimize risk of loss or damage
  • Tackling inconsistent import and export regulations for transporting clinical supplies globally and optimizing your shipping process to ensure regulatory compliance
  • Effective strategies in mitigating shipping risks and reducing supply transportation costs

Speakers

Brittney Elko
Senior Director, Technical Operations and Supply Chain, Aligos Therapeutics

4:30 PM

Reserved for event sponsor

Streams

Stream one

Clinical Trial Supply Operations

8:15 AM

Registration and refreshments

8:50 AM

Chair’s opening remarks

Speakers

Fiona Barry
Editor-in-Chief and Director of PharmSource, GlobalData

9 AM

Plan for success and prepare for adversity: How can we transform contingency planning to help anticipate unforeseen circumstances and budget appropriately

• A macroeconomic perspective on clinical supplies – Managing supply distribution, resource shortages and transportation constraints to and in areas of conflict
• Forecasting to optimize clinical trial supply management and better-informed decision making in dynamic trials
• Key considerations for minimizing impact on patients during unprecedented situations
• Collaborating cross-functionality to respond to trial disruptors to allow the trial to progress

Speakers

Kalpesh Patel
Associate Director, QA, BeiGene USA

9:30 AM

Reserved for event sponsor

10 AM

How are you honing your data in the supply chain to make you more efficient and achieve actionable results?

  • Leveraging data to predictively build products in time to render your inventory better and less static
  • Rethinking your supply strategy through data-driven decision-making capabilities
  • How can we intelligently incorporate and optimize the true potential of the supply chain data?
  • Adapting to an age of decentralization with live and predictive analytics

Speakers

Charisse Eary
Executive Director, Head of Quality, Aligos Therapeutics

10:30 AM

Morning refreshments and networking

11:15 AM

Panel Discussion: Benchmarking success and assessing efficacy in avoiding dangerous pitfalls in clinical trial supply

• Take control of supply chain chaos: Preventing drug shortages through robust end-to-end visibility and streamlined workflows
• Fulfilling moral obligations to do better by patients and win the war on counterfeit products
• Why a secure network must remain mission critical: Prioritizing cybersecurity concerns throughout the supply chain to protect patients and healthcare providers
• Maintaining a resilient supply chain strategy amid macroeconomic volatility

Chair: Fiona Barry, Editor-in-Chief and Director of PharmSource, GlobalData

Speakers

Yuyi Shen
VP Technical Operations, Abcuro
Charisse Eary
Executive Director, Head of Quality, Aligos Therapeutics
Supada Sritanyaratana
Value Chain Portfolio Manager, Cell and Gene Therapy, Genentech
Fiona Barry
Editor-in-Chief and Director of PharmSource, GlobalData

12 PM

How supply chain sustainability will empower and optimize the way CTS strategies are planned to improve productivity and minimize costs

  • Future-proofing supply chains to endure greater long-term sustainability responsibilities
  • Sharing best practice for circular supply chain strategies and creating win-win business opportunities
  • Adhering to sustainable practices without adding cost and risk to the supply chain
  • Operational implications of striving for more sustainable shipping logistics

Speakers

Margaret Pese
Associate Director, Supply Chain, 89Bio

12:30 PM

Session reserved for Fiona Barry, Editor-in-Chief and Director of PharmSource, GlobalData

1 PM

Networking and prize draw

2:15 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 Adapting to change in an evolving industry
Prashanth Chakravartula, Senior Director, Warehouse & Logistics, Bayer

RT 2 How does clinical trial supplies strategy differ between small studies, IST, R-CRC and large phase II and phase III?
Amy Mou, Vendor Strategy Manager – FSP, Pfizer

RT 3 Future-proofing your supply chain to maximize success, how are you doing it? RT 4
The power of the patient voice and the patient-centric future of clinical trial supply

RT 4 The power of the patient voice and the patient-centric future of clinical trial supply

Speakers

Amy Mou
Vendor Strategy Manager – FSP, Pfizer
Prashanth Chakravartula
Senior Director, Warehouse & Logistics Bayer

3:15 PM

Chair’s closing remarks and end of conference

Speakers

Select a speaker to learn more

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Gordon Chu
Director of Investigations Branch, FDA

Gordon Chu is the Director of Investigations Branch at the Food and Drug Administration (FDA) Division of West Coast Imports (DWCI) within the Office of Enforcement and Import Operations (OEIO).

In this role, Mr. Chu develops, manages, and evaluates inspectional matters for DWCI covering all FDA import activities associated with air and sea port operations in the States of Hawaii, California, Nevada, Oregon, and Washington. The Investigations Branch handles: importer inspection, import sample collection, field examination, entry review, investigation, and inspection of imported FDA regulated products. He works cooperatively and collaborates with Federal, State, and local agencies to ensure appropriate consumer protection.

Mr. Chu began his FDA career in 2002 as a Consumer Safety Officer (CSO). As a CSO, he conducted domestic food inspection, consumer compliant investigation, recall traceback investigation, and inspection of imported FDA regulated products. In 2010, he became a Supervisor Consumer Safety Officer (SCSO). As a supervisor, he had the opportunity to manage an Import Field Operation Team, an FDA team in the Centralized Examination Stations (CES), and the Los Angeles International Mail Facility. Mr. Chu was also the Import Program Manager (IPM) for the FDA Los Angeles District. As the IPM, he is the District liaison to FDA Headquarter handling import related issues and concerns. Mr. Chu was selected to be the Director of Investigations Branch (DIB) for DWCI in June 2018.

Mr. Chu has served as a mentor for the Federal Executive Board in Los Angeles, CA. He also served on multiple FDA Headquarter working group and committee related to Food Safety Modernization Act (FSMA), import process improvement, strategic framework, rapid screening technology, and partnership agreements. He also been instrumental in enhancing FDA relationship with U.S. Customs and Border Protection (CBP) and other Partnering Government Agencies. Mr. Chu holds a Bachelor of Science in Applied Ecology from the University California of Irvine.

Session Details:

Opening Keynote: FDA importation overview and how to resolve issues with import entries being held for examination

2024-09-17, 8:30 AM

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Bei Li
Director, Clinical Supply Management

Bei Li has a Ph.D. in Pharmaceutical Chemistry with 10+ years of experience in pharmaceutical industry and hands-on experience in a wide spectrum of drug development stages ranging from discovery support, preformulation, to phase III formulation and process development. She has extensive experience in formulation development with expertise in a variety of dosage forms including solid and liquid oral formulation and parenteral (i.v., topical, subcutaneous, transdermal) formulations.

She also has an-depth experience in GMP manufacturing of tablets, capsules, and iv solutions and managing contract research and manufacturing organizations, IND and CTA filings, and dealing with a wide range of drug delivery techniques including supersaturation, amorphous formulation, liposomes, and nanoparticles.

Session Details:

Panel Discussion: How labelling technologies and strategies are redefining what is possible concerning fast and accurate clinical trial supply

2024-09-17, 12:15 PM

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Charisse Eary
Executive Director, Head of Quality, Aligos Therapeutics

Session Details:

How are you honing your data in the supply chain to make you more efficient and achieve actionable results?

2024-09-18, 10:00 AM

Session Details:

Panel Discussion: Benchmarking success and assessing efficacy in avoiding dangerous pitfalls in clinical trial supply

2024-09-18, 11:15 AM

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Reid Tonik
Senior Director, Clinical Supply Chain, Eikon Therapeutics

Global clinical supply chain expert with over 20 years of industry experience and a proven track record of successfully managing multiple clinical trial programs and teams from initial design through study close-out. Experience includes a 2-year international assignment, team and budget management, and optimizing departmental productivity by identifying opportunities for greater efficiencies and quality.

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Ryan Mills
Senior Director, Head of Supply Chain, Denali Therapeutics

Ryan is a versatile, results-oriented Supply Chain professional with 15+ years experience across multiple industries and roles.

His top skills include: Supply Chain Strategy; Forecasting and Demand Management; Supply and Capacity Planning; Risk Management; Data Analytics; Business Process Design and Optimization; ERP Implementation; Team Leadership; Program and Project Management; Career Development

Session Details:

Panel Discussion: How labelling technologies and strategies are redefining what is possible concerning fast and accurate clinical trial supply

2024-09-17, 12:15 PM

Session Details:

A Holistic Approach to Supply Chain Planning for Clinical Trials

2024-09-17, 2:00 PM

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Brittney Elko
Senior Director, Technical Operations and Supply Chain, Aligos Therapeutics

Brittney is currently Senior 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:

Looking at shipping and logistics from another angle: exploring watchouts & lessons learned in order to find an all-encompassing approach to proactively anticipate challenges

2024-09-17, 4:00 PM

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Reena Patil
Vice President, Chemistry, Manufacturing and Control (CMC) Strategy, Supply Chain Logistics and Project Management, Gritstone Bio Inc

Results-oriented, motivational strategic leader with extensive experience in developing, launching, and managing global projects. Adept at managing CMC activities from initial product development stages, supporting regulatory submissions, product launch, and ensuring stable commercial supply. Capacity for communication, collaboration, and leadership, establishing relationships with multidisciplinary teams internally and externally engaging business development partners and contract manufacturing sites for outsourced work to facilitate project goals.

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Shubhra Kochar
Global Strategy Lead Comparator Management, Clinical Supply Planning, Genentech

Session Details:

How has your comparator sourcing strategy updated to keep up with changes in the industry and regulatory revisions?

2024-09-17, 4:00 PM

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Ted Chun
Director, Global Clinical Shared Services at Stryker Neurovascular

Session Details:

Reducing the impact of increased data privacy requirements under data privacy laws on biotechs

2024-09-17, 2:00 PM

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Anthony L Colenburg Sr
Senior Director & Site Head of Quality, Sutro Biopharma

Dedicated Quality Assurance Leader who excels at phase-appropriate development/redevelopment, management and strengthening of an organization's Quality Culture to ensure a constant state of Inspection Preparedness & Readiness by:

- establishing/re-aligning a current state feedback loop which utilizes close to real-time data, Quality metrics & Key Performance Indicators (KPI's);

- creating robust assessment and evaluation programs that builds sensitivity, accountability, transparency and awareness collaboratively to constantly reduce Cost of Quality;

- developing a strategic approach of continuous improvement to a Company's Quality Management System Elements which remain in a state of control.

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Louie Burks
Associate Director Clinical Supply, Allakos

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

Session Details:

Panel Discussion: Where does innovation fit in the highly regulated world of clinical trials?

2024-09-17, 12:15 PM

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Margaret Pese
Associate Director, Supply Chain, 89Bio

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:

How supply chain sustainability will empower and optimize the way CTS strategies are planned to improve productivity and minimize costs

2024-09-18, 12:00 PM

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Paul Hingst
Supply Chain Consultant, Crinetics Pharmaceuticals

Paul is an experienced Clinical Supply Chain Professional with a 25-year career in the BioPharmaceutical industry.  His extensive career includes roles at major companies like Amgen and Thermo Fisher Scientific, where he honed his skills and made a significant impact.  He has served in varied roles from basic research and contract manufacturing to client services and account management.  He is a Principal Consultant and Co-Founder of Beacon BioPharm Associates, a clinical supply chain consulting firm, providing variable staffing solutions to small and mid-sized BioPharm clients.  Paul is an industry veteran and respected leader known for his expertise in clinical supply chain.

Session Details:

Closing Panel Discussion: Levelling up vendor partnerships so that both sides win

2024-09-17, 5:00 PM

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Supada Sritanyaratana
Value Chain Portfolio Manager, Cell and Gene Therapy, Genentech

Supada manages a team of Product Leads to bring cell and gene therapies from acquisition to manufacturing readiness. They work on a growing portfolio of targeted and personalized medicines for oncology and ocular diseases that span from early clinical development to preparation for commercial launch.  Her responsibilities include due diligences, process development, system stakeholder, and contract manufacturer selection.

Session Details:

Panel Discussion: Benchmarking success and assessing efficacy in avoiding dangerous pitfalls in clinical trial supply

2024-09-18, 11:15 AM

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Tom Schiavon
Manager, Clinical Systems and Technology, Insmed Incorporated

Tom is currently serving as a Senior UAT Analyst for Bristol Myers Squibb. Most recently, he worked in clinical systems role for Ultragenyx Pharmaceutical, overseeing IRT, CTMS, eCOA, eConsent, CGM, and wearables systems and processes. Previously, he worked as an IRT senior project manager at Amgen, built and managed international technical support and data management teams, and worked as an IRT project manager, both at endpoint clinical. He has managed projects in the therapeutic areas of hematology & oncology, pain, bone, cardiovascular, and dermatology, from early-phase oncology through post-marketing studies. He graduated summa cum laude with a B.A in Philosophy and History from Florida Gulf Coast University, where he also earned an M.A. in English. He has published several articles on process improvement, change management, and making IRT concepts more accessible to sponsor study management personnel.

Session Details:

Transforming IRT implementation to improve the accuracy of CTS management: What’s new for 2024?

2024-09-17, 3:00 PM

Session Details:

Closing Panel Discussion: Levelling up vendor partnerships so that both sides win

2024-09-17, 5:00 PM

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

Umar Hayat, Ph.D. is VP of CMC and Supply Chain at Union Therapeutics and has more than two decades of experience in pharmaceutical development, manufacturing and supply chain. He held senior level positions with Relypsa (acquired by Galenica for 1.52B US$), Anacor (acquired by Pfizer for 5.2B US$) and Transcept Pharmaceuticals (revers merger with Paratek). He played a pivotal role in the development and commercialization of Veltassa® (USA and EU), a treatment for hyperkalemia, Intermezzo® for MOTN insomnia, Kerydin® for onychomycosis, and Eucrisa® for atopic dermatitis. Dr. Hayat is managing partner of Revive Pharm USA. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. Dr. Hayat received his Ph.D. in process engineering from INP-Toulouse, France and Post-Doctoral Fellowship from Ecole Polytechnique de Montreal, Canada. He received M.Sc. Chemistry degree from Punjab University, Institute of Chemistry

Session Details:

Panel Discussion: Where does innovation fit in the highly regulated world of clinical trials?

2024-09-17, 12:15 PM

Session Details:

Optimizing inventory management to reduce inefficiencies in clinical supply chain

2024-09-17, 3:00 PM

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

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

Session Details:

Case Study: Optimizing clinical supply chain with advanced technology

2024-09-17, 11:45 AM

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Chris Varner
Senior Director of Solutions Consulting, Endpoint Clinical

Chris Varner is the Senior Director of Solutions Consulting at Endpoint Clinical, where he brings over 15 years of experience in the clinical trials industry. Joining the company in May 2024, Chris has over 8 years of expertise in site and clinical project management and more than 7 years in technology supporting clinical trials. He has successfully led a global team of 30+ project managers, focusing on designing and implementing DCT and eCOA solutions across various therapeutic areas and study phases. Throughout his career, Chris has developed effective operating models and cultivated strong relationships with major pharmaceutical companies, ensuring long-term delivery partnerships. His strong operational leadership is complemented by his collaboration with the sales team, where he helps ensure that proposals feature the most effective strategies at scale.

Session Details:

Unlocking the Future: Real-World AI Integration in IRT

2024-09-17, 2:30 PM

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Frank Leu
CEO, BioPharMatrix
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Mary Zhang
National Account Manager, US Customs and Border Protection

Mary Zhang – National Account Manager since 2009, at the Center of Excellence and Expertise for the Pharmaceuticals, Health and Chemicals (PHC-CEE) with U.S Customs and Border Protection (CBP). Ms. Zhang's previous experience includes serving as a Senior Import Specialist for the Trade Operations Division in the Port of New York/Newark, and Chicago. Previously she worked for the Revenue Management at the United Airlines.

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Amy Mou
Vendor Strategy Manager – FSP, Pfizer

Session Details:

Speaker Hosted Round Tables

2024-09-18, 2:15 PM

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Robbie Hill
Director, Business Development, Mercalis

Session Details:

Aligning clinical supply strategies with sustainability goals

2024-09-17, 9:00 AM

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Samit Bhatt
Vice President, Clinical Trial Patient Solutions, Myonex

Samit manages Myonex’s growing Clinical Trial Patient Solutions (CTPS) in North America and Europe. Samit and his team are responsible for the innovation and execution of CTPS to provide value to Myonex’s clients in addition to enhancing clinical trial sites and patient experience. He brings over 12 years’ experience in managing successful formulary status and relationship management with payers, a significant understanding of healthcare contracts, and knowledge of medical and pharmacy benefits including specialized knowledge across different therapeutic areas. Samit holds both a Doctor of Pharmacy degree and an MBA from Drake University.

Session Details:

Fostering patient centricity and diversity equity & inclusion with your supply chain decisions

2024-09-17, 10:00 AM

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Jan Pieter Kappelle
VP of Clinical Services at Inceptua

Jan Pieter (JP) Kappelle, VP of Clinical Services at Inceptua, is a Supply Chain Executive with 30 years of industry experience, of which 15 years were spent leading clinical trial supplies departments in global pharmaceutical and biotech companies.

Trained as an Electronic and Quality Engineer, JP has a strong financial background and brings a methodical, analytical and process-oriented approach to his work. Coupled with his MBA and MSc in Supply Chain Management, JP has the unique ability to switch between strategic and operational discussions.

JP also serves as the Global Clinical Supplies Group (GCSG) Master of Ceremony where he connects clinical supply professionals for the purposes of education,
knowledge sharing and the development of industry best practices.

 

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Sascha Sonnenberg
Vice President Global Business Development & Country Head Germany, SanaClis

Sascha held numerous positions in business development and operations, most notably in global Commercial Operations AMERICAS & EMEA at Marken and VP Business Development at Sharp Clinical Services, where he formed a new business development team and implemented novel services. Sascha is a subject matter expert of a broad range of services along the clinical supply chain such as Direct-to-Patient, labelling & packaging, cell & gene therapies , and global distribution strategies. Sascha studied economics and holds a MBA in International Management and Leadership. He has been a long-term member of the ISPE Investigational Product community, contributed to the development of several Good Practice Guides and was a member of the European IP Steering Committee. At SanaClis Sascha is leading global business development and acts as Country Head Germany.

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Sylvia Thomas
Supervisory Consumer Safety Officer, Division of West Coast Import, FDA

Session Details:

Opening Keynote: FDA importation overview and how to resolve issues with import entries being held for examination

2024-09-17, 8:30 AM

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Fiona Barry
Editor-in-Chief and Director of PharmSource, GlobalData

Experienced healthcare editor with a demonstrated history of B2B journalism covering drug development, manufacturing, and the pharma industry. Skilled in editing, news writing, KOL interviews and financial journalism. Special focus on pharmaceutical manufacturing, clinical trials, rare disease and women's healthcare. Bilingual Glasgow/London-based English and French-speaking media professional with a Master of Arts (M.A.) in English from the University of Bristol.

Session Details:

Chair’s opening remarks

2024-09-17, 8:25 AM

Session Details:

Chair’s opening remarks

2024-09-18, 8:50 AM

Session Details:

Panel Discussion: Benchmarking success and assessing efficacy in avoiding dangerous pitfalls in clinical trial supply

2024-09-18, 11:15 AM

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Frank Leu
CEO, Novapeutics,

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

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Advisory Board

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Chris Wallace
Head of Distribution EMEA, Argenx

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

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

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

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

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

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

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

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

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Paul Hingst
Supply Chain Consultant, Crinetics Pharmaceuticals

Paul is an experienced Clinical Supply Chain Professional with a 25-year career in the BioPharmaceutical industry.  His extensive career includes roles at major companies like Amgen and Thermo Fisher Scientific, where he honed his skills and made a significant impact.  He has served in varied roles from basic research and contract manufacturing to client services and account management.  He is a Principal Consultant and Co-Founder of Beacon BioPharm Associates, a clinical supply chain consulting firm, providing variable staffing solutions to small and mid-sized BioPharm clients.  Paul is an industry veteran and respected leader known for his expertise in clinical supply chain.

Session Details:

Closing Panel Discussion: Levelling up vendor partnerships so that both sides win

2024-09-17, 5:00 PM

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Francesco Santo
Associate Director Global Clinical Supply Chain, HUYABIO

A highly experienced and passionate Clinical Supplies Project Manager, 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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Arnaud Dourlens
Head of Clinical Trial Supply, Sanofi

Arnaud Dourlens is an Arts et Métiers engineer, he began his industrial career in the FMCG sector where he held growing responsibilities. Then he joined the LVMH group where he reorganized new product launches and industrial investments in the Make-up segment in order to adapt to the need for innovation and time to market, thus providing a competitive advantage. He then managed the entire portfolio of industrial launches and investments in Perfumes, Skincare and Make-up for Parfums Christian Dior Group. During his career Arnaud held a wide variety of industrial roles. He joined Sanofi in 2017 as Production Director of a major solid oral form production site (>2.5 billion € turnover). He has been a key player in the development of the continuous improvement mindset and in the transformation of the site through IT projects, investments and activity growth following the acquisition of Boehringer Ingelheim consumer healthcare portfolio. Since the beginning of 2020, he’s been the global head of Sanofi Clinical Supply Chain Operations, managing worldwide clinical supply teams involved in more than 300 clinical studies.

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Paul Larochelle
Director Global Clinical Supply Chain Planning, 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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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) 20 7947 2755

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