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
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Featured Speakers

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Kalpesh Patel​

Associate Director, QA, BeiGene USA

B.S in Engineering with over 25 years of professional experience.
• M.B.A in Operations Management with over 20 years of Management/Leadership experience.
• ASQ and RABQSA (ISO 13485) Certified Quality Auditor with over 5+ years of auditing experience.
• 18+ years Computer System Validation experience.
• 10+ years of Project management experience with in Pharmaceutical Industry.
• Strong understanding of Quality Systems like CAPA, SPC, LEAN and Six Sigma.
• Strong knowledge of GXP, 21 CFR Part 11 regulations, GAMP 5 and Computer System Validation.
• 10+ years of hands on PLC, SCADA, DCS, Building Automation Systems programming experience.
• 10+ years of experience in QO Laboratory Information Management systems such as LIMS, MIMS, EMSS, and Agilent CDA system for HPLC and GC systems.
• 18+ years of on-site Manufacturing plant experience, familiar with plant safety, OSHA regulations.
• 15+ years of hands-on Manufacturing Process Improvement experience.

Solutions-focused Validation leader with a solid track record leading complex Validation and Regulatory Compliance projects, building and rebuilding high performance teams, and executing company-wide strategies. Able to instill “big picture” perspective throughout organization and drive long-term outcomes within technical groups. Skilled in aligning technology with business goals, pinpointing areas to achieve improved performance and successful turnaround efforts.

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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.

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Charisse Eary​

Senior Director, Head of Quality, Aligos Therapeutics

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Horacio Enriquez​

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

• Technology evangelist & adoption: Developed supply chain analytics and master data management Centers of Excellence to streamline data creation/maintenance/retirement, KPI dashboards, and data-driven decision-making.

• Organizational design: Implemented global supply chain, analytics, supplier quality, New Product Introduction (NPI), warehousing, e-Commerce, & Facilities teams to improve operational efficiencies and customer service.

• Supplier/supply chain performance, risk, compliance, and quality management: Lead adoption of ISO 13485:2016 and MDSAP in supply management (supplier lifecycle management, global audit program, CAPA, change management, quality agreements, CMO/OEM collaboration).

• Process development: Designed and deployed global supplier/supply chain risk assessment program focused on supplier risk profile, mitigation, and governance. Developed global standard supplier audit program and leveraged regional/in-country Lead Auditors. Designed CD/S&OP processes focused on balancing customer service, inventory, and operations efficiencies within FDA 21CFR Parts 820 & 210 regulated organizations.

• Strategic sourcing: Managed and lead various commodity-focused procurement teams including electro & electro- mechanical (instrument), biological & chemical (reagent and laboratory consumables), plastics & resin (injection molding), indirect (travel, fleet, facilities management, HR, IT, equipment, MRO, JanSan, critical Space) and partner/alliance operations (CMO/OEM) towards improved quality, cost, and total value.

• Entrepreneur: Principal and founder of the Biotech Supply Chain Academy (BSCA), which is dedicated to the education of professionals who serve the needs of patients, point-of-care healthcare organizations, and the Life Sciences industry. CEO and Founder of Mission City Consulting, which provides end-to-end supply chain and quality operations consulting, education, and advocacy in private industry, higher learning, and government.

• Educator and Mentor: Undergraduate and graduate school adjunct lecturer and faculty advisor at UC Davis Graduate School of Management, CSU Sacramento College of Business, Santa Clara University Leavey School of Business, the University of San Francisco School of Management, and Golden Gate University E.S. Ageno School of Business. Course work: Operations management & information systems, supply chain management, sustainable operations management, and MBA capstone integrated management operations.

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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

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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.

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    Sponsors Include:

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    Company Information

    PCI is a leading global CDMO, providing integrated end-to-end drug development, manufacturing and packaging solutions to increase product speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the delivery of supply chain healthcare services.  With 30 sites across Australia, Canada, North America, the UK and Europe and over 4,300 dedicated employees, our mission is to bring life-changing therapies to patients. Leading technology and continued investment enable us to deliver development to commercialization solutions throughout the product lifecycle, collaborating with our clients to improve the lives of patients globally.

    Company Website

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

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    Company Information

    The Inceptua Group Group is a dynamic, enterprising, and future-oriented service provider operating within the clinical trial and unlicensed medicines supply chain at an international level.

    Our multinational team provide connections to an extensive global network, offering our clients customized solutions ranging from strategic planning and sourcing, clinical manufacturing and global depot solutions, right through to early access to unlicensed medicines.

    We are committed to safety, and reliably supporting our clients every step of the way, leaving them safe in the knowledge that every potential obstacle has been considered, and every eventuality planned for.

    Our worldwide presence enables us to fulfil these services for the duration of trials, and our expert team work closely with our customers to ensure they receive full support throughout the lifecycle of their project.

    Company Website

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

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    Company Information

    Acnos Pharma is privately-owned, specialized pharmaceutical company operating globally in the clinical trial supply landscape. The headquarter is in Germany, Aachen. We offer flexible, cost efficient and quality sensitive customized solutions for individual trial requirements. We offer a broad range of clinical trial services supply chain management, clinical trial procurement and logistics.

    Th combination of passion and expertise leverages our global reach and maximizes customer satisfaction.

    Company Website

    To learn more , please visit our website - http://acnospharma.de/

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    Company Information

    Simply sourcing comparators – we offer a unique blend of small company flexibility and speed, backed with the large-scale buying power of the Orifarm Group, which is one of the largest pharmaceutical suppliers in Europe. With over €1.4B products sold in 2021 and more than 4,000 unique product lines sourced on a monthly basis, we have unparalleled access to “out of market” and manufacturer direct buying capability, both in the US and Europe.

    Company website: www.Orifarm-CTS.com

    Company Website

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

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    Company Information

    BMclinical, your global clinical trial supply partner. We offer worldwide commercial medicine supply, from analytical samples to bulk comparators, through to the supply of co-meds and pre-meds.  We can pack and label your IMP/commercial medicines from our GMP facility, where we also offer storage and distribution services. BMclinical is uniquely positioned to offer solutions for overage and unused clinical trial stock.

    Company Website

    To learn more , please visit our website - https://www.bmclinical.com

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    Company Information

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

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

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

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

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

    Company Website

    To learn more , please visit our website - https://www.almacgroup.com

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    Company Information

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

    Company Website

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

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    Company Information

    Since 1997, Clinigen has offered market-leading clinical trial supplies and biological sample management services to meet the most complex clinical supply challenges. Part of Clinigen Group’s global supply chain facility and depot network, we deliver tailored solutions for clients to ensure their clinical trials are a success, regardless of size or scope, from Phase I to Phase IV projects.

    Company Website

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

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    Company Information

    Bionical Emas is a global Contract Research Organization (CRO) combining Clinical Development, Clinical Trial Supply (CTS) and Early Access Programs (EAP) bringing life-changing medicines to patients around the world. Our Clinical Trial Supply Division has a global vendor network of manufacturers, wholesaler distributors and optimized sourcing strategies to support your study. Whether you require products locally sourced in emerging markets and distributed directly to trial sites, global sourcing of high-value commercial drug products, or a demand-driven sourcing approach, we have the right solution for you.

    Company Website

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

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    Company Information

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

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

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

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

    Company Website

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

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    Company Website

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

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      Why attend?

      The 2024 programme of the Clinical Trial Supply West Coast will offer a fresh insight into the latest regulatory updates, global clinical supply chains, advanced technologies such as remote and hybrid trials, Artificial Intelligence, and more. With presentations, roundtables, and panel discussions on all the hottest industry trends and supply chain challenges, the 2-day event promises to provide the industry an unmissable opportunity to learn and network to help them succeed post-Covid.

      Get in touch now and secure your place!

      WHAT TO EXPECT FOR 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

      Testimonials

      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

      Registration and refreshments

      8:25 AM

      Chair’s opening remarks

      Speakers

      Paul Hingst
      Supply Chain Consultant, Crinetics Pharmaceuticals

      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

      Reserved for Myonex

      10:30 AM

      Morning refreshments and networking

      11:15 AM

      Managing clinical supplies in a global study and the associated challenges

      Speakers

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

      11:45 AM

      Reserved for event sponsor

      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

      1:45 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

      2:15 PM

      Reserved for event sponsor

      2:45 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

      3:15 PM

      Afternoon refreshments and networking

      3:35 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

      4:15 PM

      Reserved for event sponsor

      4:45 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: Mariam Iqbal, Director, Clinical Business Operations, Intercept Pharmaceuticals

      Speakers

      Kalpesh Patel
      Associate Director, QA, BeiGene USA
      Tom Schiavon
      Manager, Clinical Systems and Technology, Insmed Incorporated
      Prashanth Chakravartula
      Senior Director, Warehouse & Logistics Bayer

      5:30 PM

      Chair’s closing remarks

      END OF DAY 1 AND NETWORKING DRINKS

      11:15 AM

      How to innovate in a small biotech with a limited budget

      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

      1:45 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

      2:15 PM

      Reserved for event sponsor

      2:45 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

      3:15 PM

      Afternoon refreshments and networking

      3:45 PM

      Looking at shipping and logistics from another angle: Finding an all-encompassing approach that allows us to truly confront transportation challenges

      • Investing in reliable transportation partners to improve transportation challenges, especially in remote areas with poor infrastructure
      • 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
      Director Technical Operations & Supply Chain, Aligos Therapeutics

      4:15 PM

      Reserved for event sponsor

      Streams

      Stream one

      Clinical Trial Supply Operations

      Stream two

      Clinical Trial Supply Innovation & Technology

      8:15 AM

      Registration and refreshments

      8:50 AM

      Chair’s opening remarks

      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 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

      10:30 AM

      Morning refreshments and networking

      11 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: Paul Hingst, Associate Director, Crinetics

      Speakers

      Paul Hingst
      Supply Chain Consultant, Crinetics Pharmaceuticals
      Yuyi Shen
      VP Technical Operations, Abcuro
      Charisse Eary
      Senior Director, Head of Quality, Aligos Therapeutics
      Supada Sritanyaratana
      Value Chain Portfolio Manager, Cell and Gene Therapy, Genentech

      11:45 AM

      Reserved for event sponsor

      12:15 PM

      Lunch and networking

      1:15 PM

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

      Speakers

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

      1:45 PM

      Session reserved for event sponsor

      2:15 PM

      Afternoon refreshments, networking and prize draw

      2:45 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
      Hosted by 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?
      Hosted by Amy Mou, Vendor Outsourcing Management, 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

       

       

      Speakers

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

      3:45 PM

      Chair’s closing remarks and end of conference

      8:50 AM

      Chair’s opening remarks

      9 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 with innovative new technologies

      Speakers

      Frank Leu
      CEO, Novapeutics,

      9:30 AM

      Reserved for event sponsor

      10 AM

      Striving for agile planning and forecasting strategies in an era of supply chain technology innovation

      • Phase-appropriate clinical supply planning and how to best manage this alignment
      • Overcoming financial obstacles for smaller biotechs by having more smaller software vendors to suit their budgets for planning
      • The call for standard software: Ensuring adequate training and consistency to allow the staff to mature in the operational work and handover efficiently when they leave
      • Reducing the impact on trial timelines and costs buy working with the right forecasting vendor

      Session available

       

      10:30 AM

      Morning refreshments and networking

      11 AM

      Panel Discussion: Harnessing the power of AI to respond to the complexities of clinical trial supply: Ways in which automation will shape the future

      • How AI-driven analytics can enhance inventory management, reduce transportation costs and contribute to timely supply deliveries
      • Evaluating clinical demand, mitigating risk and adapting supply chain strategy as necessary in a smart and dynamic way with AI
      • Implementing AI-powered logistics to accelerate drug development pipelines by reducing supply waste and site burden
      • Ensuring we have the skills, people and systems in place to successfully onboard AI tools
      • Optimizing shipping lanes and manufacturing work flows with AI

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

      Speakers

      Fiona Barry
      Editor-in-Chief and Director of PharmSource, GlobalData
      Frank Leu
      CEO, Novapeutics,

      11:45 AM

      Reserved for event sponsor

      Speakers

      Select a speaker to learn more

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      Kalpesh Patel
      Associate Director, QA, BeiGene USA

      B.S in Engineering with over 25 years of professional experience.
      • M.B.A in Operations Management with over 20 years of Management/Leadership experience.
      • ASQ and RABQSA (ISO 13485) Certified Quality Auditor with over 5+ years of auditing experience.
      • 18+ years Computer System Validation experience.
      • 10+ years of Project management experience with in Pharmaceutical Industry.
      • Strong understanding of Quality Systems like CAPA, SPC, LEAN and Six Sigma.
      • Strong knowledge of GXP, 21 CFR Part 11 regulations, GAMP 5 and Computer System Validation.
      • 10+ years of hands on PLC, SCADA, DCS, Building Automation Systems programming experience.
      • 10+ years of experience in QO Laboratory Information Management systems such as LIMS, MIMS, EMSS, and Agilent CDA system for HPLC and GC systems.
      • 18+ years of on-site Manufacturing plant experience, familiar with plant safety, OSHA regulations.
      • 15+ years of hands-on Manufacturing Process Improvement experience.

      Solutions-focused Validation leader with a solid track record leading complex Validation and Regulatory Compliance projects, building and rebuilding high performance teams, and executing company-wide strategies. Able to instill “big picture” perspective throughout organization and drive long-term outcomes within technical groups. Skilled in aligning technology with business goals, pinpointing areas to achieve improved performance and successful turnaround efforts.

      Session Details:

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

      2024-09-17, 4:45 PM

      Session Details:

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

      2024-09-18, 9:00 AM

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

      • Technology evangelist & adoption: Developed supply chain analytics and master data management Centers of Excellence to streamline data creation/maintenance/retirement, KPI dashboards, and data-driven decision-making.

      • Organizational design: Implemented global supply chain, analytics, supplier quality, New Product Introduction (NPI), warehousing, e-Commerce, & Facilities teams to improve operational efficiencies and customer service.

      • Supplier/supply chain performance, risk, compliance, and quality management: Lead adoption of ISO 13485:2016 and MDSAP in supply management (supplier lifecycle management, global audit program, CAPA, change management, quality agreements, CMO/OEM collaboration).

      • Process development: Designed and deployed global supplier/supply chain risk assessment program focused on supplier risk profile, mitigation, and governance. Developed global standard supplier audit program and leveraged regional/in-country Lead Auditors. Designed CD/S&OP processes focused on balancing customer service, inventory, and operations efficiencies within FDA 21CFR Parts 820 & 210 regulated organizations.

      • Strategic sourcing: Managed and lead various commodity-focused procurement teams including electro & electro- mechanical (instrument), biological & chemical (reagent and laboratory consumables), plastics & resin (injection molding), indirect (travel, fleet, facilities management, HR, IT, equipment, MRO, JanSan, critical Space) and partner/alliance operations (CMO/OEM) towards improved quality, cost, and total value.

      • Entrepreneur: Principal and founder of the Biotech Supply Chain Academy (BSCA), which is dedicated to the education of professionals who serve the needs of patients, point-of-care healthcare organizations, and the Life Sciences industry. CEO and Founder of Mission City Consulting, which provides end-to-end supply chain and quality operations consulting, education, and advocacy in private industry, higher learning, and government.

      • Educator and Mentor: Undergraduate and graduate school adjunct lecturer and faculty advisor at UC Davis Graduate School of Management, CSU Sacramento College of Business, Santa Clara University Leavey School of Business, the University of San Francisco School of Management, and Golden Gate University E.S. Ageno School of Business. Course work: Operations management & information systems, supply chain management, sustainable operations management, and MBA capstone integrated management operations.

      Session Details:

      Managing clinical supplies in a global study and the associated challenges

      2024-09-17, 11:15 AM

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      Victoria Vargo
      Director, Clinical Supply, Karyopharm Therapeutics

      Session Details:

      How to innovate in a small biotech with a limited budget

      2024-09-17, 11:15 AM

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      Charisse Eary
      Senior Director, Head of Quality, Aligos Therapeutics

      Session Details:

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

      2024-09-18, 11:00 AM

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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, 1:45 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:

      Looking at shipping and logistics from another angle: Finding an all-encompassing approach that allows us to truly confront transportation challenges

      2024-09-17, 3:45 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: 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:

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

      2024-09-18, 11:00 AM

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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, 3:35 PM

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      Mariam Iqbal
      Director, Clinical Business Operations, Intercept Pharmaceuticals
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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, 1:45 PM

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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, 10:00 AM

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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:

      Chair’s opening remarks

      2024-09-17, 8:25 AM

      Session Details:

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

      2024-09-18, 11:00 AM

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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, 11:00 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.

      Session Details:

      Innovative processes to propel clinical studies into the future

      2024-09-18, 9:00 AM

      Session Details:

      Panel Discussion: Harnessing the power of AI to respond to the complexities of clinical trial supply: Ways in which automation will shape the future

      2024-09-18, 11:00 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, 2:45 PM

      Session Details:

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

      2024-09-17, 4:45 PM

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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:

      Panel Discussion: Harnessing the power of AI to respond to the complexities of clinical trial supply: Ways in which automation will shape the future

      2024-09-18, 11:00 AM

      Session Details:

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

      2024-09-18, 1:15 PM

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

      Session Details:

      Case Study: Optimizing clinical supply chain with advanced technology

      2024-09-17, 11:45 AM

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