2024 PDA CDMO Partnership Workshop

Continental Breakfast

Room 104B

Registration Open

Promenade Lobby

P1: “The Climb”: The Start of CDMO Journey

Room 104A

• Moderator: Jackie Veivia-Panter, Chief Quality and Compliance Officer, BioCentriq

  

  Jackie Veivia-Panter, Chief Quality and Compliance Officer, BioCentriq
  

  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
  

• 09:00 – 09:10

  Welcome and Opening Remarks from Workshop Chair

  • Chair: Jackie Veivia-Panter, Chief Quality and Compliance Officer, BioCentriq

    

    Jackie Veivia-Panter, Chief Quality and Compliance Officer, BioCentriq
    

    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.

• 09:10 – 09:35

  Regulatory Perspective on Sponsor-CDMO Partnerships

  • 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.

• 09:35 – 09:55

  “Should I Stay or Should I Go?” Insourcing vs. Outsourcing

  • Presenter: Zeke Johnston, MS, Senior Director, External Manufacturing and Supply Chain, Avenge Bio

    

    Zeke Johnston, MS, Senior Director, External Manufacturing and Supply Chain, Avenge Bio
    

• 09:55 – 10:15

  "Hello, Is It Me You're Looking For": How to Determine Search Criteria and Evaluate CDMOs

  • 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 Principle 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.

• 10:15 – 10:45

  Q&A

Networking Break in the Exhibit Area

Room 104B

P2: It All Starts with Selecting the Right Collaboration Partner

Room 104A

• 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.

• 11:15 – 11:40

  CDMO Selection and Performance Management

  • 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.

• 11:40 – 12:05

  Lessons Large and Small: CDMO Interactions from the Big Pharma and Start-up Perspectives

  • 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).

• 12:05 – 12:30

  Q&A

Networking Lunch in the Exhibit Area

Room 104B

Small Group Work: CDMO Selection Exercise

Room 104A

• 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.

• 13:30 – 14:10

  Case Study Introduction
• 13:45 – 14:30

  CDMO Selection Exercise
• 14:30 – 15:00

  Report Out and Discussion

Networking Break in the Exhibit Area

Room 104B

P3: Walking the Technology Transfer Tightrope

Room 104A

• 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.

• 15:30 – 15:50

  Technology Transfer Fundamentals for Building Successful Products with CDMO Partnerships

  • 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.

• 15:50 – 16:10

  Navigating Standard and Custom Technology Transfer Workflow

  • 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

• 16:00 – 16:40

  Case Studies of Tech Transfer Challenges
• 16:40 – 17:00

  Q&A with Additional Panelist

  • 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.

Networking Reception in the Exhibit Area

Room 104B

Continental Breakfast

Room 104B

Registration Open

Promenade Lobby

P4: Strategic Alliances: A Playbook for Effective Partnerships

Room 104A

• 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.

• 09:00 – 09:20

  Execution and Governance of an Outsourcing Relationship: The Client Perspective

  • Presenter: Dimpy Gupta, MASc, PMP, CAAM, Director, Partnerships & External Supply, Johnson & Johnson Innovative Medicine

    

    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.

• 09:20 – 09:40

  Execution and Governance of an Outsourcing Relationship: The CDMO Perspective

  • 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.

• 09:40 – 10:15

  Case Studies on the Deployment of an Effective Quality Management System in an Outsourcing Relationship
• 10:15 – 10:30

  Q&A

Networking Break in the Exhibit Area

Room 104B

P5: How to Get the Most Out of a CDMO Relationship

Room 104A

• Moderator: Jennifer Cheung, MS, Vice President, Quality Assurance and Regulatory Affairs, WuXi Advanced Therapies

  

  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.

• 11:00 – 11:20

  The Good, the Bad, and the Ugly of Conflict Management

  • Presenter: Jo Anne Valentino, MS, Vice President, Quality and Regulatory Affairs, New York Blood Center Enterprises

    

    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.

  • Presenter: Salvatore DelloBuono, MBA, Director, Quality External Manufacturing, NA EXM Quality Operations, Bristol Myers Squibb

    

    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.

• 11:20 – 12:00

  Role Play: How to Resolve Conflicts Between CDMOs and a Sponsor Company

  • Presenter: Jo Anne Valentino, MS, Vice President, Quality and Regulatory Affairs, New York Blood Center Enterprises

    

    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.

  • Presenter: Salvatore DelloBuono, MBA, Director, Quality External Manufacturing, NA EXM Quality Operations, Bristol Myers Squibb

    

    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.

• 12:00 – 12:25

  Report Out and Discussion
• 12:25 – 12:30

  Closing Remarks from Workshop Chair

  • Chair: Jackie Veivia-Panter, Chief Quality and Compliance Officer, BioCentriq

    

    Jackie Veivia-Panter, Chief Quality and Compliance Officer, BioCentriq
    

    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.