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2024 CDMO

2024 PDA CDMO Partnership Workshop

Mar 28 - Mar 29, 2024
Long Beach, CA

Maximizing Value for the Patient to Minimize Bench to Bedside

  • Workshop
  • The Americas
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Register by 28 January to save up to $500!

Overview

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.

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 Veinia-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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Agenda

  • Day 1
  • Day 2

  • THURSDAY, 28 MARCH

    08:00 – 18:30 | Registration Open

    08:00 – 09:00 | Continental Breakfast

    09:00 – 10:45 | P1: Should I Stay, or Should I Go? Insourcing vs. Outsourcing
    Moderator: Jackie Veivia-Panter,     Chief Quality and Compliance Officer, BioCentriq

    During this workshop, we'll cover various aspects of the Sponsor-CDMO journey, spanning decisions about outsourcing, relationship management, and regulatory insights. We'll begin by gaining insights from the U.S. FDA regarding the regulatory landscape of CDMO relationships. Following that, we'll delve into strategies for deciding between insourcing and outsourcing. Upon choosing outsourcing, we'll explore the intricacies of CDMO selection, including search criteria, evaluation metrics, and recommended practices.

    09:00 | Welcome and Opening Remarks from Workshop Chair
    Jackie Veivia-Panter,     Chief Quality and Compliance Officer, BioCentriq

    09:15 | Steven Oh, PhD, Deputy Office Director, OTP, CBER, U.S. FDA

    09:40 | Zeke Johnston, Senior Director, External Manufacturing and Supply Chain, Avenge Bio

    10:00 | Maria Amaya, Genentech

    10:20 | Q&A

    10:15 – 11:15 | Networking Break

    11:15 – 12:30 | P2: It All Starts with Selecting the Right Collaboration Partner
    Moderator: Morten Munk,     Director, Global Alliance Management, FUJIFILM Diosynth Biotechnologies

    Outsourcing of a pharmaceutical project is a strategic decision, which has the potential to have a huge influence on the success of a project for many years in the future. When the decision to outsource is made, the most important next step is to select the right partner for the project.

    11:15 | Jay Howlett, Vir Bio

    11:40 | Firelli (Fi) Alonso, PhD, Senior Director, External Supply, Pfizer

    12:05 | Q&A

    12:30 – 13:30 | Networking Lunch

    13:30 – 15:00 | Small Group Work: Hands on RFP Drafting Exercise
    Moderator: Morten Munk,     Director, Global Alliance Management, FUJIFILM Diosynth Biotechnologies

    15:00 – 15:30 | Networking Break

    15:30 – 17:00 | P3: Walking the Technology Transfer Tightrope
    Moderator: Grace Lee, PhD,     Independent Consultant, Elevalue Consulting LLC

     

    Technology transfer is an integral piece of CDMO partnership and can be an art of crafting collaboration. In this session, we will discuss fundamentals of technology transfer throughout the product lifecycle including common pitfalls, importance of contracts and quality agreement, regulatory considerations, and delve into case studies.

    15:30 | Beth J. Haas, MChE, Owner/Consultant, Haas Pharma Consulting

    15:50 | Brandon Haigh, Associate Director, Process Development Cell Therapy, WuXi Advanced Therapies, Inc.

    16:10 | Interactive Presentation

    16:40 | Q&A

    17:00 – 18:00 | Networking Reception

  • FRIDAY, 29 MARCH

    08:00 – 12:15 | Registration Open

    08:00 – 09:00 | Continental Breakfast

    09:00 – 10:30 | P4: Strategic Alliances: A Playbook for Effective Partnerships
    Moderator: Maria Amaya,     Genentech

    In this session, the focus will be on several key aspects essential for successful collaborations CDMOs. The session will open with a discussion on the art of crafting effective quality agreements with your CDMO, emphasizing the significance of clear and comprehensive documentation to align expectations, and ensuring regulatory compliance. The session will conclude with an emphasize on the imperative of building a foundation of transparency in your relationship with a CDMO to foster trust, encourage collaboration, and ultimately contribute to the overall success of your project. Participants will have an interactive discussion on transparency with CDMOs, using a case study that illustrates the practical dynamics of managing deviations and implementing corrective and preventive actions (CAPAs). 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.

    09:00 | Execution and Governance of an Outsourcing Relationship
    Dimpy Gupta, MASc, PMP,     Director, Partnerships & External Supply, Johnson & Johnson Innovative Medicines

    09:20 | Morten Munk, Director, Global Alliance Management, FUJIFILM Diosynth Biotechnologies

    09:40 | Interactive Presentation

    10:10 | Q&A

    10:30 – 11:00 | Networking Break

    11:00 – 12:15 | P5: How to Get the Most out of a CDMO Relationship
    Moderator: Jennifer Cheung, MS,     Vice President Quality and Regulatory, WuXi Advanced Therapies

    Effectively navigating a partnership between a CDMO and sponsor company is a complex task. The CDMO you choose significantly impacts your business success. Maintaining a strong relationship hinges on recognizing each other’s strengths and capabilities. Ultimately, the aim is a mutually beneficial outcome. This discussion will delve into potential conflicts between a sponsor company and CDMO, emphasizing the importance of looking past immediate tensions toward the shared goal: achieving milestones like IND or BLA approval, or sustained manufacturing success, with the collaborative support of your CDMO.

    11:00 | Conflict Management and Audience Engagement
    Jo Anne Valentino

    12:10 | Closing Remarks from Workshop Chair
    Jackie Veivia-Panter,     Chief Quality and Compliance Officer, BioCentriq

Additional Information

  • Who Should Attend

    More information coming soon.

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Travel

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

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: Coming Soon!
Cut-Off: Monday, 04 March 2024

Visit Marriott Bonvoy for more details on additional reward levels and program benefits.

Marriott Bonvoy

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.

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.

Directions

Registration Fees

Early Registration
Registration Type Early
  By 28 January
Member $1,595
Non-Member $1,995
Gov./Health Authority/Academic (Member Only) $895
Early Career Professional (Member Only) $1,395
Student (Member Only) $595
Regular Registration
Registration Type Regular
  After 28 January
Member $2,095
Non-Member $2,495
Gov./Health Authority/Academic (Member Only) $995
Early Career Professional (Member Only) $1,495
Student (Member Only) $695

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].

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Program Inquiries
  • Brooke Lustig, CMP
    Senior Manager, Programs
    Tel: +1 (301) 656-5900 ext. 111
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