PDA CDMO Partnership Workshop 2025
Become a Sponsor and/or Exhibitor
Registration Options
Individual Registration
Group Registration
From insourcing versus outsourcing decision, creating Request for Proposal (RFP) to awarding a contract, participants will learn about CDMO and service provider selection best practices, and how to execute right-first-time technology transfer, as well as how to navigate the complex regulatory landscape to ensure the outsourced activities are staying in compliance while being able to address the ever-evolving demands of the pharmaceutical and biopharma industries.
Key Highlights
- Building Winning Partnerships: Learn how to craft standout RFPs, establish robust quality agreements, and effectively manage technology transfers.
- Select the Right CDMO: Gain insights into the evaluation process and selection criteria for CDMO by participating in an interactive simulation process.
- Product and Service Providers: Understand the technical and strategic considerations for specialized products and services like packaging solution, testing services, and assessment of contamination control strategy.
- Inspection Readiness: Prepare for regulatory inspections with a focus on role and responsibilities between sponsor and CDMO.
- Regulatory Perspective: Expert analysis of the global regulatory requirements and trends for outsourced operations.
Related Event
PDA Pharmaceutical Manufacturing & Quality Conference 2025
Learn More and RegisterHighlighted Presenters
Key Presenters
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Bettine Boltres, PhD
West Pharmaceutical Services
Director Scientific Affairs, Integrated Systems
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Workshop Chair
The Minds Behind the Insights
Agenda
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SGT Standard Time (UTC +8:00)
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Registration
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Welcome and Workshop Introduction
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Global Regulatory Requirements and Trends for Outsourced Operations
The evolving regulatory landscape in parenteral packaging impacts CDMO businesses significantly. With stricter compliance requirements and increasing quality standards, CDMOs must adapt swiftly to remain competitive. This presentation will explore these changes and emphasize the importance of collaboration between pharmaceutical companies and CDMOs. Through open communication and shared goals, these partnerships can drive innovation, ensure product safety, and accelerate time-to-market, ultimately benefiting both parties and enhancing patient care.
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Sourcing Decision: From RFP to Contract Award – What is on the Mind of Sponsor versus CDMO
Manufacturing process development for complex biologics and cell and gene therapies has significantly increased the demand of specialized talents in the industry. Sponsors often face challenges including internal skill gaps, resource and budget constraints, as well as timeline stress from research, development to manufacturing and IND application. The decision for biopharma to outsource to Contract Research Development and Manufacturing Organization (CRDMO) may reduce operational cost and supply chain limitation, shorten development timeline, and accelerate IND readiness through effective technology transfer and process optimization while maintaining regulatory compliance. Here we present the key considerations and what is on the mind of the sponsor to make the decision from request for proposal (RFP) to CRDMO contract award.
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Coffee Break
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CDMO Selection Case Study
In this small group exercise, participants will be provided a list of CDMO with varying profiles, strengths, and weaknesses. The goal is to simulate how to define selection process parameters based on your business need, so you can select the right CDMO to enable business success. This concept of this case study can be used to build you own selection tools and will help you to impact the business result in a positive manner.
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Lunch break
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How To Craft A Winning RFP: From Process, How to Select Contract Testing Laboratory and Consulting Services
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How to Effectively Manage Technology Transfer – Sponsor versus CDMO
Technology transfer (TT) from a product company (Sponsor) to a CDMO with research capability (CRDMO) requires proactive and thoughtful investment by a dedicated technical team to leverage expertise in research, process development, optimization and scale up manufacturing. This session will depict the details of CRDMO selection and collaboration, which have several key steps and considerations from the request for proposals (RFP), TT, raw material gap, facility fit to comprehensive risk assessment, and how to capture information in development and analytical reports that can lead to optimizing final lockdown process parameters in manufacturing and enable successful regulatory submission.
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Coffee Break
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It Is All About Relationship Management
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.
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Panel Discussion / Q&A
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Location and Travel
Venue Details and Accommodations
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.
Andaz Singapore, by Hyatt
Reservation Instructions
PDA recommends the reservation at the Andaz Singapore, by Hyatt.
Venue Location
From the driveway lobby on Level 2 of Andaz Singapore, please take the escalators or elevators up to Level 3, where you will find our event spaces The Glasshouse, Garden Studio, Studio I and Studio II.
Registration
Pricing Options
Standard Registration
Member Price
USD 499Non-Member
USD 499
Presenters
PDA events bring together top-notch industry experts, innovators, and practitioners who are shaping the future of pharmaceutical science and manufacturing. Our presenters are selected for their experience, insight, and commitment to elevating the global community through knowledge sharing.
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