Key to Drug Product Development Success: Target Product Profile and Quality by Design

Join us for an insightful event delving into the Target Product Profile (TPP) that helps you set the path for drug product development and supports business decision making. Gain insight on how to determine your CMC development strategy based on this TPP, and apply Quality by Design (QbD) and Design of Experiments (DoE). Connect with industry experts, expand your network, and elevate your CMC strategies.

4 key learnings:

1. Understanding the drug product’s CMC development road from Target Product Profile to Quality Target Product profile into Quality by Design
2. Case studies demonstrating successful QBD implementation.
3. Leveraging DOE for process robustness and cost savings.
4. Target Product Profile not only for regulatory purposes but important tool in business decisions

Agenda:

13h30: Welcome & Registration

14h00 – 14h15: Kick-off

14h15 – 14h45: Target Product Profiles (TPP)

14h45 – 15h00: Break

15h00 – 15h30: Quality by Design (QbD)

15h30 – 16h00: Design of Experiments (DOE)

16h00 – 18h00: Networking

Guest Speakers:

Anneke Blom, Senior Consultant CMC

• Senior consultant in Chemistry Manufacturing and Control (CMC)
• Head of the CMC department
• Over 20 years in the pharmaceutical industry; held positions at CDMO’s and ‘big pharma’
• Specializes in drug product development, particularly sterile injectables
• Utilizes Quality by Design approach, including Quality Risk Management
• Good understanding of GMP, ICH guidelines, and regulatory requirements
• Managed project involving: Formulation and process development, Analytical method development and validation, GMP manufacturing, including batch record, deviation, and change control handling

Ronald Ullers, Senior Consultant RA-CMC

• Ph.D. degree in molecular microbiology with over 16 years of experience in the pharmaceutical industry in the field of regulatory affairs.
• Has thorough understanding of the regulatory demands (with focus on CMC) for new biological entities including vaccines, and new chemical entities for EU/US registrations in various indications and phases of development and market approval.
• Has key experience in preparing and developing RA-CMC strategies and CMC content of regulatory submission documents and liaising with US and EU regulatory agencies, including authoring of scientific advice/Pre-IND briefing packages and acting as Sponsor representative during scientific advice procedures.
• Provides consultancy and operational support to clients ranging from start-up companies to large pharmaceutical companies.

Azra Gholami, Consultant CMC

• Pharmacist with a Ph.D in Molecular biology
• Has over 11 years of experience in the pharmaceutical industry.
• Her experience includes process and product characterization in gene therapy
• Specialized in Quality-by-design based Analytical method development and validation for small and large molecules.
• Specialized in Biotechnology, Molecular biology, and Cell culture including genetic engineering methods.
• Experienced with process optimization by Design of expert (DOE), Technology Transfers, writing, reviewing, and approving regulatory CMC documents.