2021 Virtual Mini-Conference
Theme: “COMMERCIALIZATION OF CELL & GENE THERAPY: ADVANCING TECHNOLOGY AND INNOVATION”
BSMA is bringing together the stakeholders of the embryonic Cell and Gene Therapy to confront its formidable challenge of commercialization. Under the leadership of supply chain management heads of the major Cell and Gene Therapy companies on its Steering Committee – Atara Biotherapeutics, Allogene, Bayer, Bluebird Bio, Bristol-Myers Squibb, Celgene, Gritstone Oncology, Gilead Sciences, Instil Bio, Johnson and Johnson, Kite Pharma, Novartis, Orchard Therapeutics, PACT Pharma, Sangamo, and Ultragenyx), BSMA is organizing the Conference.
The innovative therapy of Cell and Gene Therapy has imposed Draconian demands on the supply chain in terms of production batch of one, sixteen-day vein to vein lead time, cryogenic preservation and cold-chain logistics, chain of custody, real-time patient care, and prohibitive cost of treatment. Executives of CGT companies and service providers will address the “Issues and Answers” of raw material supply, supplier QA, apheresis, scale out of clinical and manufacturing operations, distribution and logistics, information systems, governmental compliance and efficacy of treatment.

Devendra Mishra
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.

Aileen Baquiran
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.

Timothy Moore
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.

Chris Bogart
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

Dawn Henke
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.

Gary Hutchinson
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.

Gregg Bodnar
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.

Peter Holman
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.

David Karakas
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.

Kenny Choi
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.

Albert Cooksey
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.

Olive J. Sturtevant
Sr. Administrative Director of the Connell & O'Reilly Families, Cell Manipulation Core Facility, Dana Farber Cancer Institute
Olive is the Sr. Administrative Director of the Connell & O’Reilly Families, Cell Manipulation Core Facility at Dana Farber Cancer Institute in Boston Massachusetts. CMCF is a cellular product manufacturing facility that specializes in developing and manufacturing human cell and tissue-based products for research and clinical trials within the Harvard-affiliated programs, with industry sponsors as well as the Bone Marrow Transplant programs at DFCI, Brigham and Women’s Hospital and Boston Children’s Hospital.
Olive has 30 plus years in blood banking, clinical laboratory management and cellular manufacturing. In her current role she is directly responsible for the Financial and Administrative oversight, Quality Control and Quality Assurance, Materials Management and Information Systems. In addition, Olive works with investigators and facilitates the technology transfer of projects works to maintain project timelines, tracking progress against goals, coordinates with Quality Assurance and technical experts to fulfill program’s contracts.
Olive is actively involved in several professional organizations; FACT, ISCT, MABB and AABB and serves on a variety of quality and regulatory committees and boards. She also serves a regulatory consultant for both clinical laboratories and other cellular therapy and tissue related programs.

Matthew J Yedwabnick
VP Global Supply Chain, Atara Biotherapeutics
Matt Yedwabnick joined Atara Biotherapeutics in September 2017 and serves as the VP of Global Supply Chain. Matt is an accomplished biotech operations professional with 15 years of industry experience in Supply Chain including operations risk management, strategic planning, and clinical/commercial supply chain.
Prior to joining Atara as Director, Operations Strategic Planning, Matt held various leadership roles across Amgen’s Global Supply Chain. His experience includes leading cross functional initiatives across Drug Product Manufacturing Strategy and Risk Quantification. Prior to Amgen, Matt served in various operational roles in product management and supply chain in the chemical industry at Bayer MaterialScience, LLC.
Matt received his bachelor’s degree in chemical engineering at Michigan State University and earned his M.B.A. from UCLA Anderson School of Management.

Kevin Cast
Partner, Archbow Consulting
Kevin Cast’s career in the pharmaceutical and biotech industry includes experience in pharma companies, PBMs, service providers, and specialty pharmacies over three decades. Today, as a founding partner of Archbow Consulting, an Entrée Health network company, Kevin helps pharma and biotech companies develop and deliver effective and efficient product distribution and patient access strategies. He holds a Bachelor of Liberal Arts in Biology from Illinois Wesleyan University and a Master’s Degree in Botany from Oklahoma State University.

Devendra Mishra
Executive Director and Co-Founder, BSMA

Timothy Moore
President, PACT Pharma

Aileen Baquiran
Vice President, Supply Chain, Orchard Therapeutics

Chris Bogart
Vice President, Supply Chain, Bayer

Dawn Henke
Senior Technical Program Manager, Standards Coordinating Body (SCB)

Matt Yedwabnick
VP, Global Supply Chain Atara Biotherapeutics

Gary Hutchinson
President, Modality Solutions

Olive Sturtevant
Sr. Administrative Director, Connell & O'Reilly Families, Cell Manipulation Core Facility, Dana-Farber Cancer Institute

Gregg Bodnar
Senior Client Engagement Manager, Be The Match BioTherapies

Peter Holman
VP of Quality , ArsenalBio

David Karakas
Director, Procurement & Sourcing, Bluebird Bio

Albert Cooksey
Senior Vice President and General Manager, 3PL, ICS

Kevin Cast
Partner, Archbow Consulting

Kenny Choi
Senior Director. Process Sciences and Engineering, Instil Bio
INTERIM PROGRAM FOR THE GLOBAL VIRTUAL CONFERENCE, BSMA, August 5, 2021
THEME: “COMMERCIALIZATION OF CELL & GENE THERAPY: ADVANCING TECHNOLOGY AND INNOVATION”
9:00 am – 1:15 pm Event (PST)
9:00 am – 9:10 am
“Welcome To The Revolution in Healthcare”
Devendra Mishra,
Executive Director, BSMA
Sponsorship:
Contact Pamela Gardner,
VP, Sponsor Sales, (P: 858-349-8375)
09:10 – 9:40 am | KEYNOTE: “PACT Unique CGT Technology Platform: Eradication of Cancerous Tumors”
Presentation will be about tackling these solid tumor cancer challenges with pioneering technologies in a clinical stage with the goal to treat each patient with personalized neoTCR-based therapies across a broad range of tumor mutational burdens and solid tumor cancer types. The technology platform provides the differentiated ability to identify these neoantigens, as well as validate them as targets specific to the person’s cancer. Once validated, individualized, cancer-targeted neoTCR-T cell therapy products are manufactured for each person with cancer. It is now broadly accepted that cancer is a profoundly patient-specific disease, where no two tumors are alike.
Keynote Speaker: Timothy Moore, President, PACT Pharma
09:40 – 10:40 am | PANEL: “Overcoming the Challenges of Cell and Gene Therapy: The Lifeline of the Healthcare Revolution”
The pipeline of Cell and Gene Therapies has been growing rapidly since the first one, Kymriah of Novartis, was approved in 2019. Research suggests that by 2030, up to 60 new cell and gene therapies could be launched, treating upwards of 350,000 patients How do you incorporate the technology, processes and insights necessary to ensure your clinical trial needs are met fully? How can scientific and operational expertise simplify and streamline complex trial design? Today’s drug development environment was largely designed around small molecules and biologics such as proteins and monoclonal antibodies, a constrained system that has not significantly changed in 50 years. The executives will discuss their challenges and solutions.
Panelists:
Aileen Baquiran, Vice President, Supply Chain, Orchard Therapeutics
Chris Bogart, Vice President, Supply Chain, Bayer
Matt Yedwabnick, VP, Global Supply Chain, Atara Biotherapeutics
Kevin Cast, Partner, Archbow Consulting
Moderator: Devendra Mishra, Executive Director, BSMA
White Paper: “Overcoming the Challenges of Cell and Gene Therapy: The Lifeline of the Healthcare Revolution”
10:40 – 11:40 am | PANEL: “Harmonizing Best Supply Chain Practices for Apheresis”
Several Apheresis-related organizations are formulating standards for various aspects of the critical function of Apheresis in the evolving Cell and Gene Therapy. SMEs will explore how to simplify and improve the interface with Apheresis centers in areas of operations, systems, packaging, storage and logistics (particularly cold chain). Issues of compliance with regulatory standards will also be addressed. Listening to the Voice of the Customer and taking innovative, remedial steps will be the guiding principle for the exchange. Representatives from Standards Bodies (FACT and SCB) will present progress made and the challenges ahead.
Panelists:
Dawn Henke, Senior Technical Program Manager, Standards Coordinating Body (SCB)
Gary Hutchinson, President, Modality Solutions
Olive Sturtevant, Sr. Administrative Director, Connell & O’Reilly Families, Cell Manipulation Core Facility, Dana-Farber Cancer Institute)
Gregg Bodnar, Senior Client Engagement Manager, Be The Match BioTherapies
Moderator: Peter Holman, VP of Quality, ArsenalBio
Peter Holman PPT (pdf version)
White paper on “Harmonizing Best Supply Chain Practices for Apheresis”
11:40 am- 12:05 pm | “Navigating the Process Development Challenges of Cell & Gene Therapy”
Presentation will identify the unique challenges of developing and scaling out manufacturing processes of autologous cell therapies. Manufacturing for Cell and Gene Therapy has three intrinsic challenges, namely 1. The starting material, the blood or tumor cells of the patient to be cured, is always different and unique, 2. There is no buffer inventory for the production batch of one, and 3. Enabling technologies have not caught up to the needs of the industry. These systems-level challenges must be addressed early in development, where the direction of the organization’s strategy can be molded appropriately.
Speaker: Kenny Choi, Senior Director. Process Sciences and Engineering, Instil Bio
12:05 – 12:30 pm | FIRESIDE CHAT: “How to Industrialize Strategic Sourcing of Raw Materials and Supplies?”
Challenges faced by the nascent industry to qualify suppliers who understand the stringent requirements and forge a business relationship will be addressed. The just in time nature of the therapy imposes an unprecedented demand on suppliers. A robust and resilient supply chain requires manufacturers to strategically source raw materials and identify backup suppliers where possible, and where backup options do not exist, work with suppliers to de-risk their supply chain. Manufacturers are also working with CMOs for certain critical raw materials and processes that are capacity constrained which impact both pricing and availability to service market demands. Industry approach to audit suppliers will be discussed.
Speaker: David Karakas, Director, Procurement & Sourcing, Bluebird Bio
Moderator: Devendra Mishra, Executive Director, BSMA
12:30 – 12:55 pm | “Labeling, Packaging & Logistics – The Achilles Heel of the CGT Delivery”
Just-in-time packaging and labeling is critical to meeting the critical need of the patient. Labeling at the ultracold temperatures adds significant complexity in the primary and secondary packaging and labeling. The labels selected must be validated to perform at these ultracold temperatures. Subsequently, the design and documentation of temperature and the identity and security chains of custody in a 21 CFR part 11 environments have to be assured in the cold chain delivery network.
Speaker: Albert Cooksey, Senior Vice President and General Manager, 3PL, AmerisourceBergen (ICS)
12:55 – 01:00 pm | Wrap Up: “Where do we go from here?”
Devendra Mishra, Executive Director, BSMA
2021 BSMA Mini-Conference Parade of Sponsors
Panelist Sponsors