CMC Readiness Challenge in Case of Expedited Programs for Biotechnological Products

Course Description

Expedited development does not lower the bar on quality. Companies pursuing an accelerated pathway still need to deliver a complete Chemistry, Manufacturing and Controls (CMC) package, but on a fraction of the usual timeline. This creates real tension between the pace of clinical development and the depth of process, analytical and stability data typically expected at filing.

This masterclass looks at how CMC teams can build a readiness strategy that keeps pace with an accelerated clinical program, covering how to engage regulators early, where a risk based approach can safely defer certain components and how to keep the Pharmaceutical Quality System aligned throughout. Delegates will work through practical exercises to apply the concepts to their own programs.

Key Topics

●       Overview of accelerated development pathways and their CMC implications

●       Specific CMC and GMP relationships in the case of expedited programs

●       Engaging Regulatory Authorities on CMC data and building a Manufacturing Readiness Plan

●       Prime, Conditional Marketing Authorization, Accelerated Assessment and Exceptional Circumstances

●       Stability data considerations under compressed timelines

●       Pharmaceutical Quality System alignment

●       Strategies and tactics to accelerate CMC development

●       Minimizing the risk of deferring certain CMC components

About Your Trainers

Herve Broly

lifescend.events

Trainer

Hervé is an internationally recognized bioprocess expert with over 42 years of experience in the development, manufacture and validation of biotech processes. He is credited with 21 patents and has authored 69 scientific papers. Over his 35-year career at Merck-Serono, he served as Vice-President of the Process Development Department. Hervé's expertise spans all CMC aspects of biotechnological products for IND/CTA and BLA/MAA applications, leading to the approval of several BLA/MAA submissions. He has extensive experience in creating high-quality, compliant CMC regulatory documents and developing strategies for complex CMC challenges. Hervé has also played a crucial role in health authority interactions and inspections at company sites.

Mylène Talabardon

lifescend.events

Trainer

Mylène brings 25 years of extensive experience in the biotechnology industry, having worked with renowned companies such as BiogenIdec, Sanofi, and Merck-Serono. She has demonstrated exceptional leadership in CMC, contributing directly to multiple clinical and commercial drug substance and drug product manufacturing facilities in both technical and management roles. Prior to transitioning to consultancy, Mylène led a multi-disciplinary CMC team to successfully achieve commercial approval for a biosimilar. Her expertise encompasses process development and validation, innovative technologies, process technology transfer and scale-up, manufacturing operations and investigations, CRO/CMO management, continuous improvement, regulatory requirements, and product launches.

Who Should Attend

●       CMC Regulatory Specialists

●       Quality Assurance Specialists

●       Analytical, Pharmaceutical and Process Development Scientists and Managers

●       CMC Project Managers

●       Biotech leaders preparing for an accelerated regulatory pathway

Key Takeaways

Understand:

●       The different accelerated development programs and the CMC readiness challenge they create

Learn:

●       Regulatory expectations on CMC components for expedited programs

●       Strategies and tactics to accelerate CMC development

Gain:

●       A practical approach to minimizing the risk of deferring certain CMC components

Online Training Experience

●       Live interactive format

●       Direct interaction with the trainers

●       Q&As, case studies and breakout exercises

●       Access to recorded sessions for 30 days

●       Training materials provided in digital form

●       Certificate of attendance

Program

Session 1: Understanding Expedited Pathways and CMC Regulatory Expectations

[12th November] | [2:00 pm-5:30pm CET]

14:00–14:15 - Connect, Welcome and Introductions

14:15–15:15 - Overview of Accelerated Development Programs

●       US pathways: Fast Track, Breakthrough Therapy, Priority Review, Accelerated Approval

●       EU pathways: PRIME, Conditional Marketing Authorization, Accelerated Assessment, Exceptional Circumstances

●       How each pathway reshapes the CMC timeline

15:15–15:30

Break

15:30–16:30

CMC and GMP Relationship in Expedited Programs

●       GMP considerations specific to accelerated timelines

●       Regulatory expectations on CMC components

●       Breakout session: mapping your program against the accelerated pathways

16:30–16:40

Break

16:40–17:20

Engaging Regulatory Authorities on CMC Data

●       Building a Manufacturing Readiness Plan

●       Types of CMC-focused regulatory interactions

●       Common pitfalls in early engagement

17:20–17:30

Q&A and wrap up.

Session 2: Building a CMC Readiness Strategy

[13th November] | [2:00 to 17:30 CET]

14:00–14:15

Recap and Objectives for the Day

14:15–15:15

Adapting the Traditional CMC Development Approach

●       Product characterization and specification setting under compressed timelines

●       Process validation strategy

●       Stability data considerations

15:15–15:30

Break

15:30–16:30

Pharmaceutical Quality System Alignment

●       Aligning the PQS with an accelerated program

●       Managing change control and deviations under pressure

●       Breakout session: gap analysis exercise

16:30–16:40

Break

16:40–17:20

Minimizing the Risk of Deferring CMC Components

●       Risk based prioritization of CMC data packages

●       Strategies and tactics to accelerate CMC development

●       Case study discussion

17:20–17:30

Q&A and Wrap Up