Clinical Supply Chain Round Table
Theme: “KNOWING WHAT YOU DO NOT KNOW
& PITFALLS IN CLINICAL TRIALS”
Thursday, October 21, 2021; 5:30 pm – 8:30 pm
San Mateo Marriott San Francisco Airport, 1770 South Amphlett, San Mateo, CA
A drug development initiative is a multi-billion-dollar investment spread over 3 to 10 years and has a success rate of less than 7%. 56% of products made for Clinical Trials are wasted. There is something fundamentally wrong with this reality which we must change. The success achieved with Operation Warp Speed with COVID-19 vaccinations demonstrates that we must continue to transform Clinical Trials at an accelerated speed.
|This social network event with drinks, appetizers, mingling with peers and two short panel discussions will address some of the following critical issues:|
Executive Director and Co-Founder, BSMA
Devendra Mishra, The Co-Founder of BSMA and the former adjunct professor of Supply Chain Management at the Graziadio School of Business has been the president LIVE Entertainment, VCL-Carolco (Germany), Lieberman Enterprises and Technicolor, Strawberries Records and Tapes, and CEO of VSA (a subsidiary of International Multifoods). At RCA Records as the Vice President of worldwide operations. He is renowned as an international expert on supply chain management.
Vice President, Supply Chain, Orchard Therapeutics
Aileen Baquiran is the Vice President of Global Supply Chain and Business Operations for Orchard Therapeutics. Orchard is a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative hematopoietic stem cell gene therapies. In her role as head of supply chain, she is responsible for Sales and Operations Planning (S&OP), clinical and commercial site qualification, and global distribution. Aileen has over 20 years of experience in the life sciences industry. Prior to Orchard, Aileen held supply chain management and project management roles at Dermira, Jazz Pharmaceuticals and Johnson & Johnson. Aileen holds a bachelor’s degree in Industrial Engineering from Cal Poly, San Luis Obispo and MBA from the University of San Francisco.
President, PACT Pharma
Timothy Moore, the President and Chief Operating Officer at PACT Pharma, has more than three decades of leadership experience in biopharmaceutical manufacturing and operations. Prior to joining PACT, he served as Executive Vice President, Technical Operations at Kite, a Gilead Company, since March of 2016. Mr. Moore was responsible for overseeing the process development, manufacturing, quality and supply chain for the launch of Yescarta®, one of the first CAR T therapies to be developed, manufactured and commercialized, as well as advancement of the Kite pipeline. He globally expanded the biopharmaceutical operations to serve and support the US, EU, as well as key partners in Asia. Prior to Kite, Mr. Moore served as the Senior Vice President, Head of Global Technical Operations – Biologics of Genentech. As its member of the Genentech Executive Committee, he provided global leadership for more than 7,500 professionals across 10 internal sites and over 37 contract manufacturing organizations, as well as global manufacturing and end-to-end quality supply performance of more than 20 biological product families. Prior to that, he was Genentech’s Senior Vice President, Global Supply Chain and Global Engineering from 2007 to 2010; and, Vice President, Operations at ZLB Behring (formerly Aventis Behring). Mr. Moore received a B.S. in Chemical Engineering from Tulsa University and a M.S. in Engineering Management from Northwestern University.
Vice President, Supply Chain, Bayer
Proven leader in the Biopharmaceutical and Life Sciences industries, with broad experience leading teams responsible for Global Supply Chain, Product Launches, Manufacturing, Strategic Planning, Process Engineering, Project Management, Inventory Controlling/Reporting and Risk Management
Leadership experience in Global Supply Chain practices of global S&OP/Integrated Business Planning, Long Term Capacity Planning, Back-up / Risk Strategy, Demand/Supply Planning, Launch Planning
Leadership experience across the Biologics/Life Sciences platforms of Mammalian Cell Culture Drug Substance Manufacturing, Bacterial Fermentation, Precipitation, Solids Handling/Filling/Packaging
Leading organizations through strong Change Management during organizational startups and redesigns
Directly responsible for framing critical Strategic Supply Decisions with major capital investments
Over 24 years of experience in manufacturing and supply chain with progressively senior roles, including Biotech Divisional Head of Global Supply Chain
Diverse multicultural experience through international assignment in Europe
Senior Technical Program Manager, Standards Coordinating Body (SCB)
Dawn currently leads and oversees the technical projects and facilitates standards development for SCB. Dawn holds a PhD in Genetics and Genomic Sciences from University of Alabama at Birmingham.
Prior to joining SCB, she worked as a post-doctoral fellow at the National Institutes of Health in the National Eye Institute performing stem cell research developing retinal organoids for testing and therapeutic purposes from stem cells.
President, Modality Solutions
Gary Hutchinson is President of Modality Solutions, a biopharmaceutical cold chain engineering firm specializing in the global cold chain validation for biologics, pharmaceuticals, cell and gene therapies, and combination medical devices. Over the last two decades, he has developed life sciences supply chain logistics and designed and managed biopharmaceutical cold chains for best-in-class organizations. His professional focus is on environmentally-controlled logistics management: shock, vibration, pressure, humidity and temperature-sensitive biologics, medical devices, including tissue heart valves and perfusion systems, and pharmaceuticals.
He is a member of the Forbes Technology Council, speaker for various pharmaceutical conferences and has successfully developed cold chain transport validation data for more than 75 new drug product filings and other regulatory interactions with multiple regulatory agencies around the globe in the last 3 years alone.
Senior Client Engagement Manager, Be The Match BioTherapies
Gregg Bodnar leads the Client Engagement and Account Management team for Be The Match BioTherapies where he is responsible for overall client satisfaction and retention. He fulfills the role of account manager for several clients, overseeing proposals and contracts to ensure our services meet expectations of both exemplary quality and timeliness. Gregg joined the National Marrow Donor Program® (NMDP)/Be The Match® in 2015, helping to launch Be The Match BioTherapies by defining the original product/service offerings and pricing structure.
Gregg has worked with many organizations looking to develop standards and best practices in the industry. Gregg has over 20 years of experience in client engagement and project management. Prior to joining NMDP/Be The Match, he worked in information technology managing multi-million dollar software development portfolios for both healthcare and retail clients. Gregg started his career as a freelance business writer specializing in communications for healthcare and human services organizations.
VP of Quality at ArsenalBio
Peter Holman is VP of Quality at ArsenalBio. He was a Senior Director in Novartis Technical Operations Supply Chain, with global functional responsibility for all incoming cells and tissue for cell therapy product manufacturing, including both clinical-phase products and commercial-phase Kymriah (tisagenleclucel). Originally trained as a microbiologist, Peter has over 30 years of domestic and international pharmaceutical experience in cell & gene therapy, biologics, small molecule, and medical device combination products. Peter’s career focus has been on organizational development, strategic operations, quality/compliance, supply chain, and development of external partnerships.
Director, Procurement & Sourcing, Bluebird Bio
David joined bluebird bio in April 2019 as Head of Global Procurement & Sourcing (GPS) and is responsible for driving procurement operational excellence, robust strategic sourcing strategy, and effective supplier relationship management for the nest (company). Before joining bluebird, David worked at VCA Animal Hospitals, a part of Mars, where he lead the implementation of Coupa across ~800 hospitals throughout the United States. Prior to VCA, David worked within Kite Pharma’s Supply Chain organization where he led the roll-out of the company’s ERP and chain of custody technology platform to ensure a successful launch of Yescarta®. David firmly believes that people and technology, when used together, can transform how company’s manage their supply chain and supplier relationships.
Senior Director. Process Sciences and Engineering, Instil Bio
Kenny Choi has 11 years of industry and academic experience, with a focus on cell and gene therapies. He was one of the first engineers hired at Kite Pharma in 2014, and supported the initial knowledge transfer from NCI to support the organization’s first clinical trial. In addition, Kenny was the technical lead in the development of the Tecartus manufacturing process, and was the head of technology development, where he drove the manufacturing automation strategy for Yescarta. Kenny was also the head of process development and manufacturing at Mustang Bio, where he successfully grew the organization, executed the initial technology transfers and site build-out; all leading to the initiation of the company’s first clinical trial. Outside of industry, Kenny has also been involved in the academic space as a visiting faculty member at City of Hope, and has received training at Fred Hutchinson Cancer Research Center and National Cancer Institute.
Senior Vice President and General Manager, 3PL, AmerisourceBergen (ICS)
Albert Cooksey is Senior Vice President of Business Development and Sales for ICS. Mr. Cooksey supports pharmaceutical manufacturers launching commercial medications, including cell and gene therapies, by providing consultation throughout the sales process. He manages all aspects of business development activities to ensure RFPs meet the needs of each pharmaceutical manufacturer, while also working with clients on logistics solutions and new product introductions into the ICS 3PL support model.
THEME: “KNOWING WHAT YOU DO NOT KNOW
& PITFALLS IN CLINICAL TRIALS”
5:30 pm – 8:30 pm Event (PST)
05:30 – 6:15 am | MEET & GREET—Drinks, Appetizers, Networking
06:15 – 06:30 pm | WELCOME ADDRESS
Clinical Supply Optimization – Devendra Mishra, Executive Director, BSMA
The Services Available for Innovation – Dr. Gregory Theyel, Director, Biomedical Manufacturing Network
Challenges of Clinical Trials Research – Dr. Prasun Mishra, Founder, American Association of Precision Medicine
06:30 – 07:15 pm | First Panel: Avoid Pitfalls When Using IRT andAchieve Clinical Drug Accountability and Reconciliation
Dr. Ravi Kiron, Bio Pharma External Innovation, Head, EMD Serono
Stacy Anderson, Director, Almac
Dan Silva, Partner, Tenthpin Management Consultants
Jon Paras, Vice President, Strategic Solutions, YPrime
Moderator: Bill Coakley, Executive Vice President of Clinical and Com-mercial Supply Chain Management, BSMA
07:15 – 07:30 pm | NETWORK BREAK
07:30 – 08:15 pm | Second Panel: Optimal Site Selection of Country or Region-specific Depots for Clinical Drug Distribution and JIT La-beling & Packaging
Emily Calimquim, Manager, Clinical Supply Chain, BioMarin
Bill Coakley, Executive Vice President of Clinical and Commercial Supply Chain Management, BSMA
Scott Bailey, Senior Director, Clinical Supply Chain, BeiGene
Moderator: Dan Silva, Partner, Tenthpin Management Consultants
White Paper: “How to Industrialize Strategic Sourcing of Raw Materials and Supplies?”
08:15 – 08:30 pm | WRAP UP & NETWORKING