PDA Week 2024

2024 PDA CDMO Partnership Workshop

Long Beach, CA
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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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Early Bird Pricing

Register before 28 January 2024

Early Bird Member Price

$1,595

GovernmentMember Only

$895

Health AuthorityMember Only

$895

Early Career ProfessionalMember Only

$1,395

StudentMember Only

$595

AcademicMember Only

$895

Non-Member

$1,995

Standard Pricing

Register after 28 January 2024

Standard Member Price

$2,095

GovernmentMember Only

$995

Health AuthorityMember Only

$995

Early Career ProfessionalMember Only

$1,495

StudentMember Only

$695

AcademicMember Only

$995

Non-Member

$2,495

See Qualifying Criteria for Member Types.

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 registration@pda.org.

Thursday, 28 March PDT

  • 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

    The 2024 PDA CDMO Partnership Workshop will cover various aspects of the sponsor-CDMO journey, spanning decisions from outsourcing and relationship management to regulatory insights and technology transfer. The opening plenary will begin with a presentation from the U.S. FDA regarding the regulatory landscape of CDMO relationships. Next, strategies for making insourcing vs. outsourcing decisions will be reviewed. Upon choosing outsourcing, the intricacies of CDMO selection, including search criteria, evaluation metrics, and best practices will be explored.
    • Welcome and Opening Remarks from Workshop Chair

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

    • Regulatory Perspective on Sponsor-CDMO Partnerships

      • Presenter: Steven S. Oh, PhD, Deputy Office Director, OCTHT, CBER, U.S. FDA

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

    • "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

    • 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

    Outsourcing of a pharmaceutical project is a strategic decision that has a huge influence on the success of the project for years to come. This session will introduce the critical step following the decision to outsource: selecting the right partner for the project.
    • Lessons Large and Small: CDMO Interactions from the Big Pharma and Start-up Perspectives

    • CDMO Selection and Performance Management

      • Presenter: Firelli Alonso, PhD, Senior Director, External Supply (Retired), Pfizer

    • 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

    This session will give participants hands-on experience with the CDMO selection process. With the support of experienced instructors, small groups will work together on a project case study, which will include: an RFP, a list of selection criteria, detailed responses from a number of different types of CDMOs, and a tool to compare and score the different criteria. Utilizing this scoring tool, teams will assess and compare CDMOs to determine the most cost-effective and reliable option.
    • Case Study Introduction

    • CDMO Selection Exercise

    • Report Out and Discussion

  • Networking Break in the Exhibit Area

    Room 104B

  • P3: Walking the Technology Transfer Tightrope

    Room 104A

    • Moderator: Grace Lee, PhD, Independent Consultant, Elevalue Consulting LLC

    Technology transfer (TT) is not only an integral piece of CDMO partnership but is an art in crafting collaboration. In this session, the presenters will use case studies to review the fundamentals of TT throughout the product lifecycle including common pitfalls, regulatory considerations, and the importance of contracts and the quality agreement.
    • Technology Transfer Fundamentals for Building Successful Products with CDMO Partnerships

      • Presenter: Beth J. Haas, MChE, Owner/Consultant, Haas Pharma Consulting

    • Navigating Standard and Custom Technology Transfer Workflow

      • Presenter: Brandon Haigh, Associate Director, Cell Therapy Process Development, WuXi Advanced Therapies

    • Case Studies of Tech Transfer Challenges

    • Q&A with Additional Panelist

      • Panelist: Steven S. Oh, PhD, Deputy Office Director, OCTHT, CBER, U.S. FDA

  • Networking Reception in the Exhibit Area

    Room 104B

Friday, 29 March PDT

  • 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

    There are several key elements essential for successful CDMO collaborations, including crafting effective quality agreements, comprehensive documentation, aligned expectations, ensuring regulatory compliance, and fostering a transparent relationship. Following the presentations, participants will explore the practical dynamics of managing deviations and implementing corrective and preventive actions (CAPAs) using a case study. This real-world scenario will serve as a focal point for discussion, offering valuable insights into how transparency plays a pivotal role in navigating challenges and fostering successful collaborations.
    • Execution and Governance of an Outsourcing Relationship: The Client Perspective

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

    • Execution and Governance of an Outsourcing Relationship: The CDMO Perspective

      • Presenter: Morten Munk, Director, Global Alliance Management, FUJIFILM Diosynth Biotechnologies

    • Case Studies on the Deployment of an Effective Quality Management System in an Outsourcing Relationship

    • 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

    Effectively navigating a sponsor-CDMO partnership is a complex task with a mutually beneficial outcome. The chosen CDMO significantly impacts business success and maintaining a strong relationship hinges on recognizing each partner’s strengths and capabilities. This session will delve into potential partnership conflicts and the importance of working through short-term tensions to achieve long-term goals. Participants will apply the insights acquired from our presenters to navigate a sponsor-CDMO conflict, discovering effective ways to address the disagreement with respect, even in the face of unforeseen challenges.
    • 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

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

    • 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

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

    • Report Out and Discussion

    • Closing Remarks from Workshop Chair

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

Presenters

  • Firelli Alonso, PhD

    Senior Director, External Supply (Retired), Pfizer

    Presenter
    Read Bio
  • Maria Amaya, PhD

    Lead External Advocacy North America (Quality Policy), Genentech

    Committee Member
    Moderator
    Read Bio
  • Jennifer Cheung, MS

    Vice President, Quality Assurance and Regulatory Affairs, WuXi Advanced Therapies

    Committee Member
    Moderator
    Read Bio
  • Salvatore DelloBuono, MBA

    Director, Quality External Manufacturing, NA EXM Quality Operations, Bristol Myers Squibb

    Presenter
    Read Bio
  • Dimpy Gupta, MASc, PMP, CAAM

    Director, Partnerships & External Supply, Johnson & Johnson Innovative Medicine

    Presenter
    Read Bio
  • Beth J. Haas, MChE

    Owner/Consultant, Haas Pharma Consulting

    Presenter
    Read Bio
  • Brandon Haigh

    Associate Director, Cell Therapy Process Development, WuXi Advanced Therapies

    Presenter
    Read Bio
  • Apneet Hayer

    Principal Quality Site Mgr GxP Supplier Quality, Roche Genentech

    Presenter
    Read Bio
  • Jay Howlett, MSc, PEng

    Director, External Manufacturing, Vir Biotechnology, Inc.

    Presenter
  • Zeke Johnston, MS

    Senior Director, External Manufacturing and Supply Chain, Avenge Bio

    Presenter
  • Grace Lee, PhD

    Independent Consultant, Elevalue Consulting LLC

    Committee Member
    Moderator
    Read Bio
  • Morten Munk

    Director, Global Alliance Management, FUJIFILM Diosynth Biotechnologies

    Committee Member
    Moderator
    Presenter
    Read Bio
  • Steven S. Oh, PhD

    Deputy Office Director, OCTHT, CBER, U.S. FDA

    Panelist
    Presenter
    Read Bio
  • Jo Anne Valentino, MS

    Vice President, Quality and Regulatory Affairs, New York Blood Center Enterprises

    Presenter
    Read Bio
  • Jackie Veivia-Panter

    Chief Quality and Compliance Officer, BioCentriq

    Chair
    Moderator
    Read Bio

PLEASE 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 Blvd
Long 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

How to Get Here
By Air The three airports closest to the Long Beach Convention and Entertainment Center (LBCEC) are the Los Angeles International Airport (LAX - approx. 22 miles/35 km), the Long Beach Airport (LGB - approx. 10 miles/17 km), and the John Wayne (Orange County) Airport (SNA - approx. 32 miles/52 km).
By Car The Long Beach Convention and Entertainment Center (LBCEC) is located at 300 E Ocean Boulevard, Long Beach, CA 90802. The LBCEC has 4,000+ parking spaces around the Center in three parking garages and one ground level parking lot. Rates vary and are in effect seven days a week.
By Other Options PDA’s recommended hotels, the Renaissance Long Beach and the Westin Long Beach, are within walking distance of the Long Beach Convention and Entertainment Center (LBCEC). Ride shares (e.g., Uber, Lyft, etc.) and bike shares are readily available around the hotels and LBCEC.