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
  • Speakers
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  • Event Gallery
  • Sponsors
  • Media Centre
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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

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.

9 AM

Reserved for event sponsor

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

Luiz Alberto Barberini
Head of External Manufacturing, Latin America, Bayer

10 AM

Reserved for event sponsor

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
Panelists: Ryan Mills, Director, Supply Chain, Denali Therapeutics
Yuyi Shen, Senior Director of PD, Manufacturing and Supply Chain, Abcuro

Seats available

Speakers

Bei Li
Director, Clinical Supply Management
RYAN MILLS
Director, Supply Chain, Denali Therapeutics
Yuyi Shen
VP Technical Operations, Abcuro

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?

2:15 PM

Reserved for event sponsor

2:45 PM

Session reserved for Brittney Elko, Director, Technical Operations & Supply Chain, Aligos Therapeutics

3:15 PM

Afternoon refreshments and networking

3:35 PM

Session reserved for 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

Speakers

Mariam Iqbal
Director Clinical Contracts and Outsourcing, Intercept Pharmaceuticals
Kalpesh Patel
Associate Director, QA, BeiGene USA
Luiz Alberto Barberini
Head of External Manufacturing, Latin America, Bayer
Tom Schiavon
Manager, Clinical Systems and Technology, Insmed Incorporated
RYAN MILLS
Director, Supply Chain, Denali Therapeutics

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

Reserved for event sponsor

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, Associate Director, Clinical Contracts, Intercept Pharmaceuticals
Panelists: Amy Finnigan, Senior Director, IT R&D, Ultragenyx
Louie Burks, Director, Clinical Supply, Antiva Biosciences

Seats available

Speakers

Mariam Iqbal
Director Clinical Contracts and Outsourcing, Intercept Pharmaceuticals
Amy Finnigan
Head of IT R&D, Ultragenyx Pharmaceutical
Louie Burks
Associate Director Clinical Supply, Allakos

12:45 PM

Lunch and networking

1:45 PM

Session reserved for Ted Chun, Director, Global Clinical Shared Services, 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

Translating technology into tangible outcomes and what are the latest ways in which it’s disrupting the supply chain industry

  • Are we playing technology catch-up: What can we learn and adapt from other industries, and how can we implement this on scale despite increased regulation?
  • Lots of inventory management systems are generic but do we have ones that are clinically focused: Are you reaching the right audience in the right way and how can CROs get recognized by biotechs?
  • Recognizing the impact of technology solutions on the patients journey and ways to progress this even further
  • How do smaller biotechs prepare their supply chains for IRT adoption and compliance?

Session available

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

Exploring new strategies for flexible, on-demand clinical trial supply manufacturing

• Delving deeper into the opportunities of continuous manufacturing, is your supply chain ready for modernization?
• How decentralized manufacturing is driving clinical trial supply and maximizing upstream and downstream clinical supply efficiency through this framework
• Don’t compromise on expertise: Avoid process shortcomings that jeopardize product safety and know exactly what to look for in selecting the right CDMO to serve your specific needs best
• Maintaining open communication with manufacturers to address precise trial needs and perfect demand planning

Session available

10:30 AM

Morning refreshments and networking

11 AM

Session reserved for Margaret Pese, Associate Director, Clinical Supply Chain, Olema Oncology

11:30 AM

Reserved for event sponsor

12 PM

China’s emergence onto the market due to increased demand for low-cost medical supplies and commercial pressures: how will this impact you?

• Understanding China’s role as a key player in the clinical drug supply space
• Building a trusted supply route in unfamiliar countries and how can we best manage this?
• Choosing a supplier who has a GMP License Accreditation in China, how can you be reassured of the integrity of the production standards and differences?
• Assuring integrity in supplies and logistics

 

Session available

12:30 PM

Lunch, networking and prize draw

1:30 PM

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

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

2 PM

Session reserved for event sponsor

2:30 PM

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

3 PM

Afternoon refreshments and networking

3:30 PM

Speaker Hosted Round Tables

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each roundtable lasts for 30minutes, delegates can select up to 2 roundtables.

RT 1 Adapting to change in an evolving industry Hosted by Luiz Alberto Barberini, Head of External Manufacturing, Latin America, Bayer

RT 2 Future-proofing your supply chain to maximize success, how are you doing it?

RT 3 The power of the patient voice and the patient-centric future of clinical trial supply

RT 4 The impact of direct-to-patient shipping on the future of clinical trial supply chains

4:30 PM

Chair’s closing remarks and end of conference

Additional Available Sessions:

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

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

Incorporating a flexible trial supply distribution strategy for decentralized trials to reduce burden on clinical supplies and move drug development forward
• Working in tandem across the trial ecosystem to better manage demands for increasingly complex clinical supply logistics in DCTs
• Ensuring timing alignment of home care practitioners and drug shipments to reduce impact on patients’ schedules and costs for biotechs
• Can we ever be appropriately equipped for adverse effects with off-site testing?
• New ways to maintain temperature integrity throughout the entirety of shipments for DCTs
• How do you control things when they’re out of your control and what can experience teach us in regards to trial supply?

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
• Implications of global privacy laws, such as GDPR, on supply chain data extraction

Designing trials to demonstrate clinical efficacies and to allow for a solid and comprehensive CTS strategy to be put in place
• Marrying supply chain design and innovation: Explore how to bring together transparency and resilience to boost the effectiveness of your CTS strategy
• Promoting cross-functional synchronization when it comes to designing study
• Customizing trial designs in a more advanced way to ensure cost-effective methods for supplies manufacturing and shipping
• How to interpret preliminary data in order to choose an appropriate trial design
• Properly projecting the clinical needs and building the overage to progress your study

Confronting the complexities of personalized supplies in cell and gene therapy clinical trials and how to best manage the multifaceted process
• How can we ensure we have a robust seamless supply chain in place and have the right sort of capabilities to champion cell and gene therapy?
• What challenges do these therapies present to the supply chain and what are the key considerations for sites to be able to host them?
• Ensuring a solid raw material sourcing and selection process is in place and that your suppliers offer scalability to match growing demands
• Selecting the appropriate cold chain service providers for you: Considering storage locations, reliability of supply and online trackability

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

Navigating the import-export landscape for clinical trial supply: Managing the regulatory requirements, Hear from the Pharmaceuticals, Health & Chemicals Center, U.S. Customs & Border Control
• Overview of U.S. Customs and Border Protection’s Centers for Excellence and Expertise (CEE)
• Focus on the Pharmaceuticals, Health, and Chemicals CEE and its role in the importation process
• How industry partnerships are mutually beneficial
• Biologic import requirements
• Why is your international clinical trial shipment in customs being held?
• Developing and maintaining robust relationships with transport partners
• Knowing how to protect your drug supply chain by avoiding a surplus of unneeded drugs during the IND
• Early identification of potential logistical hurdles such as country-specific documentation needs

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

Mastering effective budgeting and management for clinical materials in a financially tight environment
• Effectively weighing up outcome of study vs cost of study to give an accurate expectation of results and pricing
• Why stricter European price controls are affecting sponsors’ willingness to invest and in turn how can the industry tackle the sharp reduction of drugs outputted
• Knowing what you don’t know: Improved strategies for predicting and calculating hidden costs as early as possible
• Aligning milestone payments with project progress and streamlining the invoicing process

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

Seats available

Speakers

Paul Hingst
Supply Chain Consultant, Crinetics Pharmaceuticals

11:30 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

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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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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, 1:30 PM

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Luiz Alberto 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 skillsStrong knowledge , as well as Customer Service relationship and management
• Teacher for major Post Graduation Schools - Demand Planning and Procurement/Negotiation areas

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

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

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

Session Details:

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

2024-09-17, 9:30 AM

Session Details:

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

2024-09-17, 4:45 PM

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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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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, 1:30 PM

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Amy Finnigan
Senior Director IT R&D, Ultragenyx Pharmaceutical

Amy is the Sr. Director and lead for Information Technology (IT) Research and Development (R&D) at Ultragenyx Pharmaceutical. Amy leads teams as they build IT strategies, develop innovative and efficient technology portfolios, implement best in class and emerging technologies, and enable business capabilities through technology enablement. She has promoted technology advancements across the Life Sciences, from building the nation’s most successful private health insurance exchange platforms, to improving state Medicare & Medicaid technology solutions, and growing the technology portfolios of both biotechnology and pharmaceutical companies. Amy promotes strong partnership and collaboration across IT and functional stakeholders, as it has proven to promote speed and efficiency in pre-clinical drug development and clinical trial execution. With experience in IT consulting at the nation’s leading strategy consulting firm, as well as a background in International Public Health, Amy combines deep analytical approaches with a desire to save the world one patient at a time. Amy spends her free time learning about new cultures as she travels across the globe, with her knitting needles always along for the ride.

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Shubhra Kochar
Global Strategy Lead Comparator Management, Clinical Supply Planning, Genentech
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Mariam Iqbal
Director Clinical Contracts and Outsourcing, Intercept Pharmaceuticals

Session Details:

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

2024-09-17, 12:15 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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Ted Chun
Director, Global Clinical Shared Services at Stryker Neurovascular
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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, Clinical Supply Chain, Olema Oncology

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

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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: 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:

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

2024-09-18, 1:30 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, 1:30 PM

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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

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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
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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.

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

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+44 (0) 207 9472755

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Sponsorship Enquiries

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

 

Jaz Sidhu

Senior Sponsorship Manager


+44 (0) 20 7947 2755

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

 

Ruth Atterbury

Portfolio Manager


+44 (0) 20 4540 7796