Monday 15th September: Pre-Conference Day - ET (Eastern Time, GMT-05:00)
- Introduction
- Objectives and outline of course
- Main development stages and regulatory cadre
- The main streams of activity from cell line to drug product
- The CTD for Regulatory filings. Quality Module – overview of main sections
- The importance of CMC : Quality (and Safety and Efficacy)
- Supply
- The pillars of pharmaceutical development
- Criticality Assessment
- Control strategy & Validation
- QBD Principles
- Most relevant regulatory Guidance and where to find it MH
Quiz
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
- Christopher Hwang - Executive Vice President & CTO, Transcenta Therapeutics/HJB
- Shireen Goh - Associate Professor, Singapore University of Technology & Design (SUTD)
- Matthias Müllner - CEO, bespark*bio
- David Humphreys, PhD - Executive Director and Head of Antibody and Novel Therapeutics, UCB Pharma
- Giovanna Iosca - Fermentation Specialist, Department of Biotechnology and Biomedicine, Technical University of Denmark
- Nathan Crook - Assistant Professor, NC State University
- Michael Butler - Principal Investigator, Cell Technology, NIBRT
- Stefano Menegatti - Professor, Chemical and Biomolecular Engineering, North Carolina State University
- Review of the main streams and initial status
- Broad requirements for Tox and for First in Human Studies
- Cell banking
- Other Raw materials
- Drug Substance Process and Manufacture
- Minimum requirements
- Understanding your process :
- Impurities : identity, clearance, control
- First steps towards a control strategy
- Adventitious contamination and Viral Clearance Studies
- Drug formulation and Drug Product Processing
- Analytical package
- Release methods definition and development
- From method performance to method validation
- In Process Controls (else cover under process?)
- Batch data in the submission
- Product Characterisation and Reference standard
- Stability ( DS and DP)
- Forced degradation studies : necessity and importance
- Why is stability important ?
- Different type of stability studies and typical package for PhI
- Shelf life assignment
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
Round Table 1: Scaling CP: From Bench to Plant
- What breaks between lab-scale CP and full-scale implementation?
- What scale counts as “commercially viable” for CP?
- What's missing in current tech to make this easier
Round Table 2: The Business Case for Hybrid and CP Models
- How do you model ROI on continuous or hybrid investments?
- What incentives drive adoption (speed, cost of goods, flexibility)?
- When is it worth revisiting old filings to modernize an existing process?
Round Table 3: Continuous But Flexible: Connected vs Fully Continuous Systems
- Is connected processing a stepping stone or an endpoint?
- When is hybrid actually better than true CP?
- Charles Sardonini, PhD - Consultant to the Biotechnology Industry, Sardonini Consulting, LLC
- Yue Liu, PhD - CEO, Ab Studio Inc.
- Jarrod Longcor - Chief Operating Officer, Cellectar Biosciences
- Steffen Goletz, PhD - Full Professor, Head of Biotherapeutic Glycoengineering and Immunology - Institute for Biotechnology & Biomedicine, Danish Technical University
- Abraham Lenhoff - Allan P. Colburn Professor, University of Delaware
- Mark Duerkop - Chief Executive Officer, Novasign, Austria
- Review of the main streams and initial status
- Broad requirements for Tox and for First in Human Studies
- Cell banking
- Other Raw materials
- Drug Substance Process and Manufacture
- Minimum requirements
- Understanding your process :
- Impurities : identity, clearance, control
- First steps towards a control strategy
- Adventitious contamination and Viral Clearance Studies
- Drug formulation and Drug Product Processing
- Analytical package
- Release methods definition and development
- From method performance to method validation
- In Process Controls (else cover under process?)
- Batch data in the submission
- Product Characterisation and Reference standard
- Stability ( DS and DP)
- Forced degradation studies : necessity and importance
- Why is stability important ?
- Different type of stability studies and typical package for PhI
- Shelf life assignment
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
- Anticipating the needs on the work streams
- Process Understanding and Design
- Technology Transfer
- Dealing with changes and Comparability
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
- Jonathon Romero - Distinguished Scientist, BioProcess Development & Mfg, Merck
- Jaeweon Lee, MSE - Student, University of Massachusetts Lowell
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: Partners@informaconnectls.com
- Engin Ayturk - Senior Director, CMC BioConjugation, Process Development & Manufacturing, Exelixis
- Marco Lobba - CEO, CatenaBio
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: Partners@informaconnectls.com
- Stefano Menegatti - Professor, Chemical and Biomolecular Engineering, North Carolina State University
- John Woodley - Professor, Department of Chemical and Biochemical Engineering, Technical University Denmark
- Frank Riske, Ph.D. - Founder and Principal Consultant, Deep Dive Biotech Consulting
- Kevin Zen, PhD - CMC Technical Operations, Opthea
- Gap analyses of the studies available to prepare a Phase 1 submission.
- 4 teams (Analytics, DS, DP, Materials) to cover different parts of case
- 30 – 45 min work in groups : Brief :
- do the existing studies support a Phase 1 file and what are the risks involved?
- Recommendation on eventual additional or superfluous studies
- Map studies / data onto CTD modules (if time)
- 60 min debrief (15 min / group)
- General Conclusions and End of Session
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
- Christoph Herwig - Senior Scientific Advisor, Körber Pharma Austria GmbH, Austria
- Yanhuai Ding - Sr . Director, CMC DS/DP, Evolve Immune Therapeutics
- Thomas Toupy - Scientist, Takeda
- Lior Shaltiel - CEO, NurExone Biologic
- Balancing molecular potency with manufacturability from day one.
- Key trade-offs: Choosing between established platforms and bespoke processes.
- Using in silico and predictive tools to de-risk development.
- Aligning discovery and CMC teams for streamlined success.
- Applying today's lessons to the next wave of complex therapeutics.
- Krist V. Gernaey - Professor, Technical Univirtsity of Denmark
- Michael Daniele - Professor, Department of Electrical & Computer Engineering, NC State University
- Gary Gilleskie - BTEC’s Executive Director, NC State University
- Kevin Zen, PhD - CMC Technical Operations, Opthea
- Michael Butler - Principal Investigator, Cell Technology, NIBRT
- Stefano Menegatti - Professor, Chemical and Biomolecular Engineering, North Carolina State University
- Mark Duerkop - Chief Executive Officer, Novasign, Austria
- Kevin Zen, PhD - CMC Technical Operations, Opthea