PDA Week 2024
2024 PDA CDMO Partnership Workshop
Registration Options
Individual Registration
Group Registration
Program Highlights
Whether you are a CDMO or sponsor, this workshop will equip you with the tips and tools you need to overcome CDMO-sponsor relationship challenges!
Agenda highlights:
- A hands-on CDMO selection exercise
- A role-play exercise on how to resolve CDMO-sponsor conflicts
- A comprehensive template of a Master Transfer Plan including a RACI, roles and responsibilities, and timelines
- A presentation from Steven Oh, PhD, Deputy Office Director, OTP, CBER, U.S. FDA
- Case studies on tech transfer and effective quality management systems
- Examples to take back to your organization: RFP, quality agreement, and tool to evaluate CDMOs
Unlock success in the pharmaceutical and biotech industry by attending our exclusive workshop on CDMO Relationship Management.
Did you know that a staggering 90% of CMC programs rely on a CDMO at some stage during development and commercialization? In this essential event, industry professionals will gain invaluable insights into optimizing these critical partnerships. Learn how to streamline communication, enhance project oversight, navigate regulatory complexities, and control costs effectively. Discover best practices for supplier selection and risk mitigation.
Participants will leave with tangible resources for their workplace including a CDMO evaluation and management Master Plan, a sample quality agreement, and a model Request for Proposals (RFPs) template.
Don't miss your chance to network with peers and master the art of fostering productive, long-term relationships with CDMOs. Secure your spot and stay ahead in this ever-evolving industry!
PROGRAM PLANNING COMMITTEE
- Jackie Veivia-Panter, BioCentriq (Chair)
- Maria Amaya Genentech
- Jennifer Cheung, WuXi Advanced Therapies
- Maxwell De Long, Genentech
- Grace Lee, Elevalue Consulting LLC
- Morten Munk, FUJIFILM Diosynth Biotechnologies
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Standard Registration
Member Price
$2,095GovernmentMember Only
$995
Health AuthorityMember Only
$995
Early Career ProfessionalMember Only
$1,495
StudentMember Only
$695
AcademicMember Only
$995
Non-Member
$2,495
GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.
GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.
CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].
Thursday, 28 March PDT
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Continental Breakfast
Room 104B
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Registration Open
Promenade Lobby
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Poster Presentations
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P1: “The Climb”: The Start of CDMO Journey
Room 104A
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Moderator: Jackie Veivia-Panter, Consultant
Jackie Veivia-Panter, Consultant
Jackie Veivia-Panter currently holds the role of Chief Quality and Compliance Officer at BioCentriq, a leading Contract Development and Manufacturing Organization (CDMO) specializing in Cell and Gene Therapy (CGT). Her professional journey spans from renowned corporate environments to the dynamic CDMO sphere, dedicated to elevating Quality standards across these sectors. Her extensive expertise encompasses pivotal roles, from leading Global Quality Systems to serving as Site Quality Head and Global Quality Head. Jackie excels in deciphering the nuances of Quality Systems, identifying strengths and weaknesses, and adeptly assembling teams to devise and implement resilient, compliant solutions, processes, and organizational frameworks. -
Alternate Moderator: William Rohrs, PDA
William Rohrs, PDA
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Welcome and Opening Remarks from Workshop Chair
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Chair: Jackie Veivia-Panter, Consultant
Jackie Veivia-Panter, Consultant
Jackie Veivia-Panter currently holds the role of Chief Quality and Compliance Officer at BioCentriq, a leading Contract Development and Manufacturing Organization (CDMO) specializing in Cell and Gene Therapy (CGT). Her professional journey spans from renowned corporate environments to the dynamic CDMO sphere, dedicated to elevating Quality standards across these sectors. Her extensive expertise encompasses pivotal roles, from leading Global Quality Systems to serving as Site Quality Head and Global Quality Head. Jackie excels in deciphering the nuances of Quality Systems, identifying strengths and weaknesses, and adeptly assembling teams to devise and implement resilient, compliant solutions, processes, and organizational frameworks.
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Regulatory Perspective on Sponsor-CDMO Partnerships
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Presenter: Steven S. Oh, PhD, Deputy Office Director, OCTHT, CBER, U.S. FDA
Steven S. Oh, PhD, Deputy Office Director, OCTHT, CBER, U.S. FDA
Dr. Steven Oh is Deputy Office Director, Office of Cellular Therapy and Human Tissue in CBER, FDA. He oversees product quality review and policy development programs focused on cell therapy, tissue-engineered products, and medical devices including combination products. He also heads the bioinformatics regulatory group. Dr. Oh has been with CBER for over 16 years and served in the past as Director and Deputy Director of Division of Cellular and Gene Therapies, Chief of Cell Therapy Branch, and Combination Product Team Leader. His scientific and regulatory interests include emerging novel technologies in regenerative medicine therapies and individualized medicine, standards development and use, and global regulatory convergence in advanced therapy products. Before joining FDA in 2007, Dr. Oh served on the faculty of Tufts University School of Medicine. He was trained as a cell biologist and biochemist at the University of Michigan, Johns Hopkins University School of Medicine, and Massachusetts Institute of Technology.
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“Should I Stay or Should I Go?” Insourcing vs. Outsourcing
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Presenter: Zeke Johnston, Senior Director, External Manufacturing and Supply Chain, Avenge Bio
Zeke Johnston, Senior Director, External Manufacturing and Supply Chain, Avenge Bio
Zeke Johnston is the Senior Director of External Manufacturing and Supply Chain at Avenge Bio. He has over 15 years of expirence in the pharmaceutical industry, working at several different companies of different sizes and product phase, from pre-clinical to comercial. Zeke has lead both internal and external manufacturing teams in the production of a varity of therapies including small and large molocules, diagonistic device, ADC, and ATMPs such as gene and cell therapies. Zeke recieved a BS in Biomolecular Engineering from NC State University and MS in Biotechnology from Northeastern University.
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"Hello, Is It Me You're Looking For": How to Determine Search Criteria and Evaluate CDMOs
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Presenter: Apneet Hayer, Principal Quality Site Mgr GxP Supplier Quality, Roche Genentech
Apneet Hayer, Principal Quality Site Mgr GxP Supplier Quality, Roche Genentech
Apneet Hayer is the Principal GxP Supplier Mgr, North American in External Quality at Roche. In this position, Apneet is responsible for the Quality & Compliance oversight of CDMOs. She is also supporting the Quality Maturity Area to deliver and drive outcomes on FDAs Quality Management Maturity (QMM) Program through Cultural Excellence. Apneet holds BSc in BioChemistry/Biotechnology from the University of Waterloo in Canada. She has more than 15 years of experience in the Pharmaceutical industry working with Small Molecules, Sterile, Biological and Combination products. In the past 12 years, she has been working extensively with cross-functional management teams through out the life cycle of CDMOs from site selection, implementation and decomissioning.
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Q&A
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Networking Break in the Exhibit Area
Room 104B
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P2: It All Starts with Selecting the Right Collaboration Partner
Room 104A
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Moderator: Morten Munk, Director, Global Alliance Management, FUJIFILM Diosynth Biotechnologies
Morten Munk, Director, Global Alliance Management, FUJIFILM Diosynth Biotechnologies
Morten Munk’s career is comprised of more than 35 years of experience within the global biopharmaceutical industry. One common denominator for his approach is to have a holistic and broad perspective on all aspects and steps in the production of biopharmaceuticals. He believes; collaboration, knowledge sharing, and optimal use of all relevant technologies are the key factors in ensuring the availability of the best product for the patient. Morten joined Fujifilmin in 2020 where holds a role as Director, Global Alliance Management. In 2001 he was one of the co-founders of CMC Biologics (now AGC Biologics) after he had been working 14 years at Novo Nordisk. Furthermore, Morten has authored or contributed to several technical articles and guidelines. He is frequently invited to give scientific and technical presentations at international conferences. Additionally, he is active in the biopharmaceutical community as a member of scientific committees for various international conferences as well as a volunteer in international industry organizations, where the most important naturally is PDA, but also ISPE and BPOG.
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CDMO Selection and Performance Management
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Presenter: Firelli Alonso, PhD, Consultant, ConsultFi Biologics LLC
Firelli Alonso, PhD, Consultant, ConsultFi Biologics LLC
Dr. Firelli Alonso is a retired Senior Director, External Supply at Pfizer, Inc. She headed the BioTherapeutics and Vaccines Outsourcing group in Worldwide Research and Development. Fi has 40 years of combined experience in research, development, and cGMP production of biological products and vaccines, and 20 years of experience in outsourcing, project & contract management, and technology transfer to qualified third parties. Her areas of expertise include viral vectors and viral vaccine development, recombinant proteins, vaccine process development and cGMP production, project management, technology transfer, and outsourcing. She obtained her Ph.D. in Microbiology / Virology from the University of Alabama in Birmingham, followed by postdoctoral research at the U.S. Army Medical Research Institute for Infectious Diseases, Sloan-Kettering Institute for Cancer Research, and Rutgers University’s Center for Advanced Biotechnology and Medicine. Prior to joining Wyeth / Pfizer in 1996, Fi worked at The Salk Institute-Government Services Division, a vaccine contract manufacturer for the U.S. Armed Forces. She retired from Pfizer in December 2023.
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Lessons Large and Small: CDMO Interactions from the Big Pharma and Start-up Perspectives
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Presenter: Jay Howlett, MSc, PEng, Director, External Manufacturing, Vir Biotechnology, Inc.
Jay Howlett, MSc, PEng, Director, External Manufacturing, Vir Biotechnology, Inc.
Jay Howlett is the Director of External Manufacturing for the mAb platform at Vir Biotechnology in San Francisco, CA. He has worked in the biotechnology industry for over 20 years in the small biotech, innovator company and contract manufacturing spaces. Previous to Vir, Jay spent 15 years at Genentech/Roche where for 10 years he worked on commercial product transfers (DS, DP and packaging) to support both internal and external needs world-wide and then 5 years in the development space within external manufacturing supporting CMC teams. His contract manufacturing career started at DSM Biologics in Montreal, Canada for early and late stage DS biologics manufacturing. Jay holds an undergraduate degree in chemical engineering from the University of Waterloo (ON, Canada) and a Master of Science in Biology/Biotechnology from Carleton University (ON, Canada).
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Q&A
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Networking Lunch in the Exhibit Area
Room 104B
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Poster Presentations
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Small Group Work: CDMO Selection Exercise
Room 104A
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Moderator: Morten Munk, Director, Global Alliance Management, FUJIFILM Diosynth Biotechnologies
Morten Munk, Director, Global Alliance Management, FUJIFILM Diosynth Biotechnologies
Morten Munk’s career is comprised of more than 35 years of experience within the global biopharmaceutical industry. One common denominator for his approach is to have a holistic and broad perspective on all aspects and steps in the production of biopharmaceuticals. He believes; collaboration, knowledge sharing, and optimal use of all relevant technologies are the key factors in ensuring the availability of the best product for the patient. Morten joined Fujifilmin in 2020 where holds a role as Director, Global Alliance Management. In 2001 he was one of the co-founders of CMC Biologics (now AGC Biologics) after he had been working 14 years at Novo Nordisk. Furthermore, Morten has authored or contributed to several technical articles and guidelines. He is frequently invited to give scientific and technical presentations at international conferences. Additionally, he is active in the biopharmaceutical community as a member of scientific committees for various international conferences as well as a volunteer in international industry organizations, where the most important naturally is PDA, but also ISPE and BPOG.
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Case Study Introduction
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CDMO Selection Exercise
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Report Out and Discussion
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Networking Break in the Exhibit Area
Room 104B
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P3: Walking the Technology Transfer Tightrope
Room 104A
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Moderator: Grace Lee, PhD, MBA, CQA, Independent Consultant, Elevalue Consulting LLC
Grace Lee, PhD, MBA, CQA, Independent Consultant, Elevalue Consulting LLC
Dr. Grace Lee, PhD, is a highly experienced biotech leader with 15+ years of experience with technical domain knowledge and a strategic business mindset in drug development. She has a diverse scientific background covering oncology, immunology, genome-editing, and CMC knowledge with an end-to-end business mindset for drug development.
Over her career, Dr. Lee developed in-depth analytical and CMC expertise supporting IND to BLA of diverse modalities, including monoclonal antibodies, antibody-drug conjugates, bispecific molecules, and cell and gene therapies. Her experience includes product development planning, analytical method development, qualification/validation, technical transfer, setting up laboratories, designing end-to-end control strategies, and regulatory filing.
She previously served in various positions at Kyverna Therapeutics and Genentech. Dr. Lee was a senior director of analytical development at Kyverna Therapeutics, supporting autologous and allogeneic cell therapies. At Genentech, she supported biologics and cell therapy products from pre-clinical, clinical, and commercialization for potency assay development and other QC release and characterization assays. She led multiple cross-functional analytical and CMC teams.
Dr. Lee did her postdoctoral fellowship under Professor Jennifer Doudna at UC Berkeley for regulatory RNA molecules. She holds a PhD in Chemistry from Stanford University and EMBA from Quantic School of Business.
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Technology Transfer Fundamentals for Building Successful Products with CDMO Partnerships
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Presenter: Beth J. Haas, MChE, Owner/Consultant, Haas Pharma Consulting
Beth J. Haas, MChE, Owner/Consultant, Haas Pharma Consulting
With over 30 years in the industry, Beth has versatile experience across product lifecycle phases covering product development, CMC requirements, cGMP manufacturing, and CDMO management focusing on new product introductions and technology transfers for both APIs and drug products. She enjoys partnering with CDMOs across all platforms, working closely with procurement and supply chain to ensure compliance, and establishing strong relationships between the key functional areas to achieve regulatory approval. Beth is highly skilled in global team leadership, process development and engineering, quality risk management, GMP quality systems, and CMC regulatory filings. Currently, Beth is a member of the RAQAB, co-leads the Technology Transfer interest group for PDA, was a co-leader for the recently released PDA Technology Transfer technical report (TR-65), and was an author on the ISPE Technology Transfer guide, 3rd edition.
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Navigating Standard and Custom Technology Transfer Workflow
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Presenter: Brandon Haigh, Associate Director, Cell Therapy Process Development, WuXi Advanced Therapies
Brandon Haigh, Associate Director, Cell Therapy Process Development, WuXi Advanced Therapies
Brandon J. Haigh is an Associate Director of Cell Therapy Process Development at WuXi Advanced Therapies. With more than 12 years in the biotech industry, Brandon has worked in roles with increasing responsibilities within the CDMO space, encompassing cGMP cell and gene therapy manufacturing, MSAT, process development, technology transfer operations, team development, and scale up/out operations. Simultaneously leveraging past experience with a constantly evolving cGMP landscape, Brandon has led efforts for more than 50 cell banking programs and 20 cell and gene-mediated therapies. Brandon continues to help CDMO-partnered clients navigate industry requirements, strategies, risks, and opportunities through robust collaboration and development as they work to transfer their technology from benchtop through clinical and later-stage manufacturing
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Case Studies of Tech Transfer Challenges
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Q&A with Additional Panelist
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Panelist: Steven S. Oh, PhD, Deputy Office Director, OCTHT, CBER, U.S. FDA
Steven S. Oh, PhD, Deputy Office Director, OCTHT, CBER, U.S. FDA
Dr. Steven Oh is Deputy Office Director, Office of Cellular Therapy and Human Tissue in CBER, FDA. He oversees product quality review and policy development programs focused on cell therapy, tissue-engineered products, and medical devices including combination products. He also heads the bioinformatics regulatory group. Dr. Oh has been with CBER for over 16 years and served in the past as Director and Deputy Director of Division of Cellular and Gene Therapies, Chief of Cell Therapy Branch, and Combination Product Team Leader. His scientific and regulatory interests include emerging novel technologies in regenerative medicine therapies and individualized medicine, standards development and use, and global regulatory convergence in advanced therapy products. Before joining FDA in 2007, Dr. Oh served on the faculty of Tufts University School of Medicine. He was trained as a cell biologist and biochemist at the University of Michigan, Johns Hopkins University School of Medicine, and Massachusetts Institute of Technology.
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Networking Reception in the Exhibit Area
Room 104B
Friday, 29 March PDT
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Continental Breakfast
Room 104B
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Registration Open
Promenade Lobby
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Poster Presentations
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P4: Strategic Alliances: A Playbook for Effective Partnerships
Room 104A
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Moderator: Maria Amaya, PhD, Lead External Advocacy North America (Quality Policy), Genentech
Maria Amaya, PhD, Lead External Advocacy North America (Quality Policy), Genentech
Maria Amaya, PhD, is the Lead External Advocacy, North America in Quality Policy & Advocacy at Roche. In this position, Maria works within the Roche/Genentech Global External Advocacy community to develop and deliver innovative quality and current GMP regulatory pathways and collaborate with internal and external stakeholders, including support in harmonization and streamlining of regulations. Maria has more than 15 years of experience in the pharmaceutical industry working in product development, manufacturing technology, regulatory, and quality, and compliance. Maria holds a PhD in protein chemistry, a Master of Science in protein engineering from the Paris-Sud University in France, and a Bachelor of Science in chemistry from the National University in Colombia.
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Execution and Governance of an Outsourcing Relationship: The Client Perspective
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Dimpy Gupta, MASc, PMP, CAAM, Director, Partnerships & External Supply, Johnson & Johnson Innovative Medicine
Dimpy Gupta is a Director of Partnerships and External Supply at Johnson & Johnson Innovative Medicine where she is currently leading the design and execution of strategic partnerships with contract manufacturers for large scale biologics drug substance production. Dimpy has 20 years of experience in process development, tech transfers, project management, and supply chain management for combination products, medical devices and pharmaceutical manufacturing. She has launched several new products, supported clinical manufacturing through commercial operations, managed facility expansions, as well as integrated several acquisitions. Dimpy has volunteered with local hospitals to create solutions for Health Equity initiatives. Dimpy holds a BASc in Chemical Engineering, MASc in Biomedical Engineering, and is Six Sigma Black belt, Lean Green Belt, PMP and CA-AM certified.
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Execution and Governance of an Outsourcing Relationship: The CDMO Perspective
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Presenter: Morten Munk, Director, Global Alliance Management, FUJIFILM Diosynth Biotechnologies
Morten Munk, Director, Global Alliance Management, FUJIFILM Diosynth Biotechnologies
Morten Munk’s career is comprised of more than 35 years of experience within the global biopharmaceutical industry. One common denominator for his approach is to have a holistic and broad perspective on all aspects and steps in the production of biopharmaceuticals. He believes; collaboration, knowledge sharing, and optimal use of all relevant technologies are the key factors in ensuring the availability of the best product for the patient. Morten joined Fujifilmin in 2020 where holds a role as Director, Global Alliance Management. In 2001 he was one of the co-founders of CMC Biologics (now AGC Biologics) after he had been working 14 years at Novo Nordisk. Furthermore, Morten has authored or contributed to several technical articles and guidelines. He is frequently invited to give scientific and technical presentations at international conferences. Additionally, he is active in the biopharmaceutical community as a member of scientific committees for various international conferences as well as a volunteer in international industry organizations, where the most important naturally is PDA, but also ISPE and BPOG.
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Case Studies on the Deployment of an Effective Quality Management System in an Outsourcing Relationship
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Q&A
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Networking Break in the Exhibit Area
Room 104B
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P5: How to Get the Most Out of a CDMO Relationship
Room 104A
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Jennifer Cheung, MS, Vice President, Quality Assurance and Regulatory Affairs, WuXi Advanced Therapies
Jennifer Cheung brings 27 years of quality, compliance and regulatory experience in biotechnology and pharmaceutical manufacturing prior to joining WuXi Advanced Therapies, a contract testing, development, and manufacturing organization (CTDMO) in 2020. In her current role, she is supporting many cell and gene therapy clients by interpreting and applying the phase appropriate GMP regulations and requirements to accelerate development and manufacturing timeline, focusing on client satisfaction and the right first-time performance. She is passionate in promoting GMP convergence, inspection reliance, and data driven, risk-based decision-making to maximize patients’ benefit. Jennifer held various leadership positions in United States and Singapore, spent five years on a biologics parenteral manufacturing startup project and three years to expand the biologics drug substance site overseas. Jennifer has a BS degree in Microbiology and MS degree in Manufacturing Management.
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The Good, the Bad, and the Ugly of Conflict Management
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Jo Anne Valentino, MS, Vice President, Quality and Regulatory Affairs, New York Blood Center Enterprises
Jo Anne Valentino oversees quality operations for Comprehensive Cell Solutions (CCS), the dedicated cell therapy manufacturing unit of NYBC Enterprises. As the organization’s VP of Quality and Regulatory Affairs, she brings 25 years of industry experience and leadership at major pharmaceutical companies and, most recently, a contract development and manufacturing organization (CDMO). Prior to joining CCS, Jo Anne led teams as Global Head of Quality and later, as Chief Operating Officer at Minaris Regenerative Medicine, LLC, a cell therapy CDMO. Jo Anne spent many years in roles of increasing responsibility, honing her expertise in quality operations, process, and product development at companies like Novartis, Merck, and Schering-Plough. Jo Anne earned a Master’s in management from Stevens Institute of Technology after completing her BS in chemical engineering at Manhattan College. She is based at CCS’s headquarters in New York, New York. -
Salvatore DelloBuono, MBA, Director, Quality External Manufacturing, NA EXM Quality Operations, Bristol Myers Squibb
Salvatore DelloBuono is currently Director, Quality External Manufacturing, NA EXM Quality Operations at Bristol Myers Squibb. In this role, Sal is responsible for overseeing the packaging and disposition of BMS pharma, bio, and combination products. Prior to joining BMS, Sal was responsible for Sandoz M&A Quality due diligence and was Head of the External Supply Quality Americas organization at Novartis. Sal has extensive experience in launching new products, tech transfers, and building effective partnerships with External Suppliers. Prior to Novartis, Sal worked at Fisher Clinical Services, Merck, Schering Plough, and Organon in various quality roles. Sal has a BS in Chemistry and MBA in Pharmaceutical Management.
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Role Play: How to Resolve Conflicts Between CDMOs and a Sponsor Company
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Jo Anne Valentino, MS, Vice President, Quality and Regulatory Affairs, New York Blood Center Enterprises
Jo Anne Valentino oversees quality operations for Comprehensive Cell Solutions (CCS), the dedicated cell therapy manufacturing unit of NYBC Enterprises. As the organization’s VP of Quality and Regulatory Affairs, she brings 25 years of industry experience and leadership at major pharmaceutical companies and, most recently, a contract development and manufacturing organization (CDMO). Prior to joining CCS, Jo Anne led teams as Global Head of Quality and later, as Chief Operating Officer at Minaris Regenerative Medicine, LLC, a cell therapy CDMO. Jo Anne spent many years in roles of increasing responsibility, honing her expertise in quality operations, process, and product development at companies like Novartis, Merck, and Schering-Plough. Jo Anne earned a Master’s in management from Stevens Institute of Technology after completing her BS in chemical engineering at Manhattan College. She is based at CCS’s headquarters in New York, New York. -
Salvatore DelloBuono, MBA, Director, Quality External Manufacturing, NA EXM Quality Operations, Bristol Myers Squibb
Salvatore DelloBuono is currently Director, Quality External Manufacturing, NA EXM Quality Operations at Bristol Myers Squibb. In this role, Sal is responsible for overseeing the packaging and disposition of BMS pharma, bio, and combination products. Prior to joining BMS, Sal was responsible for Sandoz M&A Quality due diligence and was Head of the External Supply Quality Americas organization at Novartis. Sal has extensive experience in launching new products, tech transfers, and building effective partnerships with External Suppliers. Prior to Novartis, Sal worked at Fisher Clinical Services, Merck, Schering Plough, and Organon in various quality roles. Sal has a BS in Chemistry and MBA in Pharmaceutical Management.
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Report Out and Discussion
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Closing Remarks from Workshop Chair
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Chair: Jackie Veivia-Panter, Consultant
Jackie Veivia-Panter, Consultant
Jackie Veivia-Panter currently holds the role of Chief Quality and Compliance Officer at BioCentriq, a leading Contract Development and Manufacturing Organization (CDMO) specializing in Cell and Gene Therapy (CGT). Her professional journey spans from renowned corporate environments to the dynamic CDMO sphere, dedicated to elevating Quality standards across these sectors. Her extensive expertise encompasses pivotal roles, from leading Global Quality Systems to serving as Site Quality Head and Global Quality Head. Jackie excels in deciphering the nuances of Quality Systems, identifying strengths and weaknesses, and adeptly assembling teams to devise and implement resilient, compliant solutions, processes, and organizational frameworks.
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Poster Presentations
Presenters
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Firelli Alonso, PhD
Consultant, ConsultFi Biologics LLC
Presenter
Read BioFirelli Alonso, PhD
ConsultFi Biologics LLC
Dr. Firelli Alonso is a retired Senior Director, External Supply at Pfizer, Inc. She headed the BioTherapeutics and Vaccines Outsourcing group in Worldwide Research and Development. Fi has 40 years of combined experience in research, development, and cGMP production of biological products and vaccines, and 20 years of experience in outsourcing, project & contract management, and technology transfer to qualified third parties. Her areas of expertise include viral vectors and viral vaccine development, recombinant proteins, vaccine process development and cGMP production, project management, technology transfer, and outsourcing. She obtained her Ph.D. in Microbiology / Virology from the University of Alabama in Birmingham, followed by postdoctoral research at the U.S. Army Medical Research Institute for Infectious Diseases, Sloan-Kettering Institute for Cancer Research, and Rutgers University’s Center for Advanced Biotechnology and Medicine. Prior to joining Wyeth / Pfizer in 1996, Fi worked at The Salk Institute-Government Services Division, a vaccine contract manufacturer for the U.S. Armed Forces. She retired from Pfizer in December 2023. -
Maria Amaya, PhD
Lead External Advocacy North America (Quality Policy), Genentech
Committee Member
Moderator
Read BioMaria Amaya, PhD
Genentech
Maria Amaya, PhD, is the Lead External Advocacy, North America in Quality Policy & Advocacy at Roche. In this position, Maria works within the Roche/Genentech Global External Advocacy community to develop and deliver innovative quality and current GMP regulatory pathways and collaborate with internal and external stakeholders, including support in harmonization and streamlining of regulations. Maria has more than 15 years of experience in the pharmaceutical industry working in product development, manufacturing technology, regulatory, and quality, and compliance. Maria holds a PhD in protein chemistry, a Master of Science in protein engineering from the Paris-Sud University in France, and a Bachelor of Science in chemistry from the National University in Colombia. -
Jennifer Cheung, MS
Vice President, Quality Assurance and Regulatory Affairs, WuXi Advanced Therapies
Committee Member
Moderator
Read BioJennifer Cheung, MS
WuXi Advanced Therapies
Jennifer Cheung brings 27 years of quality, compliance and regulatory experience in biotechnology and pharmaceutical manufacturing prior to joining WuXi Advanced Therapies, a contract testing, development, and manufacturing organization (CTDMO) in 2020. In her current role, she is supporting many cell and gene therapy clients by interpreting and applying the phase appropriate GMP regulations and requirements to accelerate development and manufacturing timeline, focusing on client satisfaction and the right first-time performance. She is passionate in promoting GMP convergence, inspection reliance, and data driven, risk-based decision-making to maximize patients’ benefit. Jennifer held various leadership positions in United States and Singapore, spent five years on a biologics parenteral manufacturing startup project and three years to expand the biologics drug substance site overseas. Jennifer has a BS degree in Microbiology and MS degree in Manufacturing Management. -
Salvatore DelloBuono, MBA
Director, Quality External Manufacturing, NA EXM Quality Operations, Bristol Myers Squibb
Presenter
Read BioSalvatore DelloBuono, MBA
Bristol Myers Squibb
Salvatore DelloBuono is currently Director, Quality External Manufacturing, NA EXM Quality Operations at Bristol Myers Squibb. In this role, Sal is responsible for overseeing the packaging and disposition of BMS pharma, bio, and combination products. Prior to joining BMS, Sal was responsible for Sandoz M&A Quality due diligence and was Head of the External Supply Quality Americas organization at Novartis. Sal has extensive experience in launching new products, tech transfers, and building effective partnerships with External Suppliers. Prior to Novartis, Sal worked at Fisher Clinical Services, Merck, Schering Plough, and Organon in various quality roles. Sal has a BS in Chemistry and MBA in Pharmaceutical Management. -
Dimpy Gupta, MASc, PMP, CAAM
Director, Partnerships & External Supply, Johnson & Johnson Innovative Medicine
Presenter
Read BioDimpy Gupta, MASc, PMP, CAAM
Johnson & Johnson Innovative Medicine
Dimpy Gupta is a Director of Partnerships and External Supply at Johnson & Johnson Innovative Medicine where she is currently leading the design and execution of strategic partnerships with contract manufacturers for large scale biologics drug substance production. Dimpy has 20 years of experience in process development, tech transfers, project management, and supply chain management for combination products, medical devices and pharmaceutical manufacturing. She has launched several new products, supported clinical manufacturing through commercial operations, managed facility expansions, as well as integrated several acquisitions. Dimpy has volunteered with local hospitals to create solutions for Health Equity initiatives. Dimpy holds a BASc in Chemical Engineering, MASc in Biomedical Engineering, and is Six Sigma Black belt, Lean Green Belt, PMP and CA-AM certified. -
Beth J. Haas, MChE
Owner/Consultant, Haas Pharma Consulting
Presenter
Read BioBeth J. Haas, MChE
Haas Pharma Consulting
With over 30 years in the industry, Beth has versatile experience across product lifecycle phases covering product development, CMC requirements, cGMP manufacturing, and CDMO management focusing on new product introductions and technology transfers for both APIs and drug products. She enjoys partnering with CDMOs across all platforms, working closely with procurement and supply chain to ensure compliance, and establishing strong relationships between the key functional areas to achieve regulatory approval. Beth is highly skilled in global team leadership, process development and engineering, quality risk management, GMP quality systems, and CMC regulatory filings. Currently, Beth is a member of the RAQAB, co-leads the Technology Transfer interest group for PDA, was a co-leader for the recently released PDA Technology Transfer technical report (TR-65), and was an author on the ISPE Technology Transfer guide, 3rd edition. -
Brandon Haigh
Associate Director, Cell Therapy Process Development, WuXi Advanced Therapies
Presenter
Read BioBrandon Haigh
WuXi Advanced Therapies
Brandon J. Haigh is an Associate Director of Cell Therapy Process Development at WuXi Advanced Therapies. With more than 12 years in the biotech industry, Brandon has worked in roles with increasing responsibilities within the CDMO space, encompassing cGMP cell and gene therapy manufacturing, MSAT, process development, technology transfer operations, team development, and scale up/out operations. Simultaneously leveraging past experience with a constantly evolving cGMP landscape, Brandon has led efforts for more than 50 cell banking programs and 20 cell and gene-mediated therapies. Brandon continues to help CDMO-partnered clients navigate industry requirements, strategies, risks, and opportunities through robust collaboration and development as they work to transfer their technology from benchtop through clinical and later-stage manufacturing -
Apneet Hayer
Principal Quality Site Mgr GxP Supplier Quality, Roche Genentech
Presenter
Read BioApneet Hayer
Roche Genentech
Apneet Hayer is the Principal GxP Supplier Mgr, North American in External Quality at Roche. In this position, Apneet is responsible for the Quality & Compliance oversight of CDMOs. She is also supporting the Quality Maturity Area to deliver and drive outcomes on FDAs Quality Management Maturity (QMM) Program through Cultural Excellence. Apneet holds BSc in BioChemistry/Biotechnology from the University of Waterloo in Canada. She has more than 15 years of experience in the Pharmaceutical industry working with Small Molecules, Sterile, Biological and Combination products. In the past 12 years, she has been working extensively with cross-functional management teams through out the life cycle of CDMOs from site selection, implementation and decomissioning. -
Jay Howlett, MSc, PEng
Director, External Manufacturing, Vir Biotechnology, Inc.
Presenter
Read BioJay Howlett, MSc, PEng
Vir Biotechnology, Inc.
Jay Howlett is the Director of External Manufacturing for the mAb platform at Vir Biotechnology in San Francisco, CA. He has worked in the biotechnology industry for over 20 years in the small biotech, innovator company and contract manufacturing spaces. Previous to Vir, Jay spent 15 years at Genentech/Roche where for 10 years he worked on commercial product transfers (DS, DP and packaging) to support both internal and external needs world-wide and then 5 years in the development space within external manufacturing supporting CMC teams. His contract manufacturing career started at DSM Biologics in Montreal, Canada for early and late stage DS biologics manufacturing. Jay holds an undergraduate degree in chemical engineering from the University of Waterloo (ON, Canada) and a Master of Science in Biology/Biotechnology from Carleton University (ON, Canada). -
Zeke Johnston
Senior Director, External Manufacturing and Supply Chain, Avenge Bio
Presenter
Read BioZeke Johnston
Avenge Bio
Zeke Johnston is the Senior Director of External Manufacturing and Supply Chain at Avenge Bio. He has over 15 years of expirence in the pharmaceutical industry, working at several different companies of different sizes and product phase, from pre-clinical to comercial. Zeke has lead both internal and external manufacturing teams in the production of a varity of therapies including small and large molocules, diagonistic device, ADC, and ATMPs such as gene and cell therapies. Zeke recieved a BS in Biomolecular Engineering from NC State University and MS in Biotechnology from Northeastern University. -
Grace Lee, PhD, MBA, CQA
Independent Consultant, Elevalue Consulting LLC
Committee Member
Moderator
Read BioGrace Lee, PhD, MBA, CQA
Elevalue Consulting LLC
Dr. Grace Lee, PhD, is a highly experienced biotech leader with 15+ years of experience with technical domain knowledge and a strategic business mindset in drug development. She has a diverse scientific background covering oncology, immunology, genome-editing, and CMC knowledge with an end-to-end business mindset for drug development.
Over her career, Dr. Lee developed in-depth analytical and CMC expertise supporting IND to BLA of diverse modalities, including monoclonal antibodies, antibody-drug conjugates, bispecific molecules, and cell and gene therapies. Her experience includes product development planning, analytical method development, qualification/validation, technical transfer, setting up laboratories, designing end-to-end control strategies, and regulatory filing.
She previously served in various positions at Kyverna Therapeutics and Genentech. Dr. Lee was a senior director of analytical development at Kyverna Therapeutics, supporting autologous and allogeneic cell therapies. At Genentech, she supported biologics and cell therapy products from pre-clinical, clinical, and commercialization for potency assay development and other QC release and characterization assays. She led multiple cross-functional analytical and CMC teams.
Dr. Lee did her postdoctoral fellowship under Professor Jennifer Doudna at UC Berkeley for regulatory RNA molecules. She holds a PhD in Chemistry from Stanford University and EMBA from Quantic School of Business. -
Morten Munk
Director, Global Alliance Management, FUJIFILM Diosynth Biotechnologies
Committee Member
Moderator
Presenter
Read BioMorten Munk
FUJIFILM Diosynth Biotechnologies
Morten Munk’s career is comprised of more than 35 years of experience within the global biopharmaceutical industry. One common denominator for his approach is to have a holistic and broad perspective on all aspects and steps in the production of biopharmaceuticals. He believes; collaboration, knowledge sharing, and optimal use of all relevant technologies are the key factors in ensuring the availability of the best product for the patient. Morten joined Fujifilmin in 2020 where holds a role as Director, Global Alliance Management. In 2001 he was one of the co-founders of CMC Biologics (now AGC Biologics) after he had been working 14 years at Novo Nordisk. Furthermore, Morten has authored or contributed to several technical articles and guidelines. He is frequently invited to give scientific and technical presentations at international conferences. Additionally, he is active in the biopharmaceutical community as a member of scientific committees for various international conferences as well as a volunteer in international industry organizations, where the most important naturally is PDA, but also ISPE and BPOG. -
Steven S. Oh, PhD
Deputy Office Director, OCTHT, CBER, U.S. FDA
Panelist
Presenter
Read BioSteven S. Oh, PhD
U.S. FDA
Dr. Steven Oh is Deputy Office Director, Office of Cellular Therapy and Human Tissue in CBER, FDA. He oversees product quality review and policy development programs focused on cell therapy, tissue-engineered products, and medical devices including combination products. He also heads the bioinformatics regulatory group. Dr. Oh has been with CBER for over 16 years and served in the past as Director and Deputy Director of Division of Cellular and Gene Therapies, Chief of Cell Therapy Branch, and Combination Product Team Leader. His scientific and regulatory interests include emerging novel technologies in regenerative medicine therapies and individualized medicine, standards development and use, and global regulatory convergence in advanced therapy products. Before joining FDA in 2007, Dr. Oh served on the faculty of Tufts University School of Medicine. He was trained as a cell biologist and biochemist at the University of Michigan, Johns Hopkins University School of Medicine, and Massachusetts Institute of Technology. -
Jo Anne Valentino, MS
Vice President, Quality and Regulatory Affairs, New York Blood Center Enterprises
Presenter
Read BioJo Anne Valentino, MS
New York Blood Center Enterprises
Jo Anne Valentino oversees quality operations for Comprehensive Cell Solutions (CCS), the dedicated cell therapy manufacturing unit of NYBC Enterprises. As the organization’s VP of Quality and Regulatory Affairs, she brings 25 years of industry experience and leadership at major pharmaceutical companies and, most recently, a contract development and manufacturing organization (CDMO). Prior to joining CCS, Jo Anne led teams as Global Head of Quality and later, as Chief Operating Officer at Minaris Regenerative Medicine, LLC, a cell therapy CDMO. Jo Anne spent many years in roles of increasing responsibility, honing her expertise in quality operations, process, and product development at companies like Novartis, Merck, and Schering-Plough. Jo Anne earned a Master’s in management from Stevens Institute of Technology after completing her BS in chemical engineering at Manhattan College. She is based at CCS’s headquarters in New York, New York. -
Jackie Veivia-Panter
Consultant
Chair
Moderator
Read BioJackie Veivia-Panter
Consultant
Jackie Veivia-Panter currently holds the role of Chief Quality and Compliance Officer at BioCentriq, a leading Contract Development and Manufacturing Organization (CDMO) specializing in Cell and Gene Therapy (CGT). Her professional journey spans from renowned corporate environments to the dynamic CDMO sphere, dedicated to elevating Quality standards across these sectors. Her extensive expertise encompasses pivotal roles, from leading Global Quality Systems to serving as Site Quality Head and Global Quality Head. Jackie excels in deciphering the nuances of Quality Systems, identifying strengths and weaknesses, and adeptly assembling teams to devise and implement resilient, compliant solutions, processes, and organizational frameworks.
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Request InformationPLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
Long Beach Convention and Entertainment Center (LBCEC)
300 E Ocean BlvdLong Beach, CA 90802, United States
Westin Long Beach
333 E Ocean Blvd, Long Beach, CA 90802
+1 (562) 436-3000
Located in the thriving downtown district, steps from the Long Beach Convention & Entertainment Center, the Westin Long Beach is designed to maximize your potential. Whether you are staying for business deals or vacation, take time to explore the area, as the Queen Mary and the Catalina Express are just moments away. Return to the hotel and maintain your health at the WestinWORKOUT® Fitness Studio or take advantage of the sunny weather with a swim in the outdoor pool. The restaurant, Navy Proof Food & Spirits, delights your palate with California Coastal cuisine and craft cocktails. Business travelers appreciate our downtown event venues, including a ballroom that seats more than 1,000 attendees. At the end of the day, settle into hotel rooms and suites featuring spacious work areas, high-speed Wi-Fi, flat-screen TVs and the Westin Heavenly® Beds. Select accommodations offer calming views of the ocean for your stay in Long Beach, CA.
Rate: $249 plus applicable taxes and fees
Reservation Link: https://book.passkey.com/e/50719719
Reservation Phone: +1
(800) 937-8461
Cut-Off: Monday, 04 March 2024
Visit Marriott Bonvoy for more details on additional reward levels and program benefits.
Renaissance Long Beach
111 E Ocean Blvd, Long Beach, CA 90802
+1 (562) 437-5900
Soak up California vibes at Renaissance Long Beach hotel – situated in the central downtown area, allowing you to immerse yourself in the neighborhood's artistic scene. From the eclectic design to our smiling team, the hotel near downtown Long Beach perfectly reflects the vibrant culture of our city. Satisfy your cravings at our on-site SIP Bar Lounge, which serves craft cocktails and California cuisine. Revel in the Pacific breezes from SIP's spacious outdoor patio or our rooftop pool with city views. At the end of the day, keep those California dreams going strong as you sink into plush bedding and surf the web with free Wi-Fi for Marriott Bonvoy members.
Rate: $269 plus applicable taxes and fees
Reservation Link: https://book.passkey.com/go/PDAMEETING2024
Reservation Phone: +1
(888) 236-2427
Cut-Off: Monday, 04 March 2024