High Potent Medicines Conference

Transcription

1 2nd Annual High Potent Medicines Conference Looking beyond scale-up, containment, regulatory aspects and safety of highly potent compounds Event Overview The HPAPI industry is expanding at a healthy rate due to development and manufacturing of drugs for anti-cancer and chronic disorders. Despite of challenges in designing multi-product facilities, robust containment, safety & toxicology issues, there are many pharmaceutical firms coming up with their new research pipeline of drugs. After our successful inaugural 2017 edition, MarketsandMarkets is proud to announce the 2nd Annual High Potent Medicines Conference to be held on 29th - 30th May 2018 Frankfurt, Germany. The focus of this year s conference would address the issues in process development, scale-up, regulatory updates, containment, handling, cleaning validation and toxicology of highly potent compounds. The conference would be discussing about the latest industry trends, technological advancements and future growth in the highly potent medicines market where leading industry experts will discuss the strategies for both pharma and CMO s by presenting expert keynote presentations, live case studies and breakthrough panel sessions. Key Highlights Scientific Advisory Panel: Aseptic processing and production of highly potent compounds Risk management and monitoring scale-up processes for hipo products Regulatory updates in GMP regulations Changes in import regulations after USA-EU mutual recognition agreement Requirements and strategies to ensure Data Integrity Managing the risk of cross contamination of HPAPI s Robust and reliable containment solutions Medical surveillance/monitoring workers programs Cleaning Validation of highly potent products Ester Lovšin Barle, Corporate Toxicologist, Lonza, Switzerland Ildiko Ziegler, Validation Expert, Gedeon Richter, Hungary Who should attend? From pharmaceutical manufacturing and Biopharmaceutical manufacturing Chief executives, VP s, Directors, Heads, Leaders, Senior Managers, Principal Scientists, Principal Toxicologists, Toxicologists, Fellows, Investigators working in the following departments; Departments: Research & Development Manufacturing/Operations/Production Maintenance Engineering Quality Regulatory Risk Assessments Laboratory Services/Analytical New Technologies Process Development/Technical transfer Environmental, Health & Safety (HSE) Occupational Toxicology Industrial Hygiene New Products Product Quality Innovations Regulatory Validation Formulation Development External Supply Juergen Knoebel, Ex- F.Hoffmann La Roche AG, Switzerland Richard Denk, Head, Sales Containment, Skan AG, Switzerland

2 Expert Speaker Panel: Ester Lovšin Barle, Corporate Toxicologist, Lonza, Switzerland Gerald Kindermann, QA and GMP Compliance Lead, F.Hoffmann La Roche AG, Switzerland Richard Denk, Head, Sales Containment, Skan AG, Switzerland Ildiko Ziegler, Validation Expert, Gedeon Richter, Hungary Andreas Schreiner, Validation Head, MS & T, Novartis, Switzerland Ulrich Scholz, Head, Scale Up and Processing, Bayer, Germany Toral Mehta, Head Industrial Hygiene and Containment, Health, Safety, Environment, Novartis, Austria Firelli Alonso, Senior Director, External Supply, Biotherapeutics, Pfizer, USA Yossi Shapira, Associate Director, MS&T S.M.E, Teva Pharmaceuticals, Israel Angela Zhou Senior Sourcing Manager Genentech, USA Michel Crevoisier, Senior QA and GMP Expert, Ex-Novartis Consultant, Switzerland Claudia Sehner, Principal Scientist, Boehringer Ingelheim Pharma, Germany David O Connell Director, Scientific Affairs PCI Services, UK Chris Seaman Managing Toxicologist SafeBridge, UK Stefano Butti Technical Sales Director Food Pharma Systems, Italy Mary Moran Director, Manufacturing Science and Technology SK Biotek, Ireland

3 Silver Sponsor Sponsor/ Exhibitors Supporting Association Media Partners

4 Day 1, 29 th May, :15 Registration 08:55 Welcome note from MarketsandMarkets 09:00 Opening Remarks from the Chairman Richard Denk, Head, Sales Containment, Skan AG, Switzerland 09:10 Keynote Presentation: Challenges and Successes in Externalization of the ADC Supply Chain Strategizing the best outsourcing practices for producing and testing ADCs for use in clinical trials Establishing guiding principles for externalization to ensure the selection of the right CMOs for ADC outsourcing and technology transfer Gaining insights into the complex technology transfer process for ADC manufacture and analytical control Firelli Alonso, Senior Director, External Supply, Biotherapeutics, Pfizer, USA Process Development and Scale up 09:45 HPAPI handling in the chemical development departments (process development, process technology, GMP kg-lab, GMP Pilot Plant) Scale-up in fast and dynamically moving development HPAPI projects which equipment needs to be in place in which facilities, what kind of training of technical staff is advisable to minimize safety issues (contamination of co-workers) as well as GMP questions (cross contamination) Risk-based assessment of cross contamination in shared (chemical process) development facilities Ulrich Scholz, Head, Scale Up and Processing, Bayer, Germany 10:20 Morning Refreshments and Poster Presentation One-to-One Networking Meetings 11:10 Operation of a Fully Integrated and versatile HPAPI manufacturing facility Effective Containment Design Strategy for handling HPAPI s from g to kg IH monitoring philosophy Purification Strategy for HPAPI s Mary Moran, Director, Manufacturing Science and Technology, SK Biotek, Ireland 11:45 Sources of uncertainty in toxicological risk assessment Background Availability of data Sources of variability and gaps in data Implications for risk assessment Chris Seaman, Managing Toxicologist, SafeBridge, UK 12:20 The development and manufacture of HPAPI drug products throughout the clinical phases The on-boarding of high potent API s to be developed and manufactured into suitable drug products The complexities for each of the clinical phases from drug in capsule to complex formulations How to guide your high potent API to commercial supplies for solid oral products, non-sterile oral liquid and semi-solids David O Connell, Director, Scientific Affairs, PCI Services, UK 12:55 Lunch and Poster Presentation One-to-One Networking Meetings 13:55 Cross contamination risk at production areas for active substances exhibiting hormonal activity Toxicological approach in cross contamination guidelines Complexity of cross contamination and containment measures Case studies in hormonal steroid API production Ildiko Ziegler, Validation Expert, Gedeon Richter, Hungary Regulatory Landscape 14:30 GMP - Cleaning and Cross Contamination Requirements for none product contact surfaces Highly Potent Products and their requirements Cleaning Limits for none product contact surfaces based on the PDE GMP and Containment how this fit together Richard Denk, Head, Sales Containment, Skan AG, Switzerland

5 15:05 Requirements on Data Integrity in the Laboratory ALCOA-principles and life time cycle of data Data Integrity problem areas Data Integrity in the focus of the health authorities Warning Letters Gerald Kindermann, QA and GMP Compliance Lead, F.Hoffmann La Roche AG, Switzerland 15:40 Afternoon Refreshments and Poster Presentation One-to-One Networking Meetings 16:30 A no-nonsense approach to Cleaning Validation Challenging a few traditional concepts of Cleaning Validation Using a single cleaning limit for a whole manufacturing unit A pragmatic way to identify contamination risks in shared facilities - how to comply to EMA Guideline of 2014 Michel Crevoisier, Senior QA and GMP Expert, Ex-Novartis Consultant, Switzerland 17:05 Dealing with Health Authorities when having a multi-functional facility supplying clinical studies and market 17:40 Closing Remarks from the Chairman 17:45 Drinks Reception & Networking End of Day 1

6 Day 2, 30 th May, :15 Registration 08:55 Welcome note from MarketsandMarkets 09:00 Opening Remarks from the Chairman 09:10 Keynote Presentation Use and abuse of occupational hazard banding What is hazard banding vs exposure banding When is hazard banding useful Why should you use OELs Ester Lovšin Barle, Corporate Toxicologist, Lonza, Switzerland Containment and Handling 09:45 Guidelines for general isolator design and construction Time required mins Yossi Shapira, Associate Director, MS&T S.M.E, Teva Pharmaceuticals, Israel 10:20 Morning Refreshments and Poster Presentation One-to-One Networking Meetings 11:10 Containment system with HPAPI integrated process equipment & Isolators with Sterile/Toxic system integration Stefano Butti, Technical Sales Director, Food Pharma Systems, Italy 11:45 Progress Made on HPAPI Handling at CMOs Outsourcing Landscape HPAPI production demand Progress made by CMOs How to work with CMOs on HPAPI manufacture Angela Zhou, Senior Sourcing Manager, Genentech, USA Cleaning Validation and Industrial Hygiene 12:20 Scientific and Inventive Occupational Hygiene in Pharmaceutical Industry Classic occupational hygiene approach to innovative risk evaluation approach Hazard based approach to risk based approach PPE dependency to containment dependency Over engineering to adequate containment HSE by design is the key! Toral Mehta, Head Industrial Hygiene and Containment, Health, Safety, Environment, Novartis, Austria 12:55 Lunch and Poster Presentation One-to-One Networking Meetings 13:55 Hazards and risks of gene therapy How does hazard identification of gene therapy differ from standard therapy What are the risks for workers Are there carry-over risks Ester Lovšin Barle, Corporate Toxicologist, Lonza, Switzerland 14:30 Health based cleaning limits in shared facilities for highly potent actives Introduction to regulatory requirements on cleaning validation Practical Experiences and Case Studies Andreas Schreiner, Validation Head, MS & T, Novartis, Switzerland 15:05 Worker and patient safety in the production of highly potent APIs OELs and PDEs how to set scientifically defensible, health-based limits Approaches for setting health-based limits for APIs in early development What to consider in the implementation of these limits? Claudia Sehner, Principal Scientist, Boehringer Ingelheim Pharma, Germany 15:40 Closing remarks from the Chairman 15:45 End of Conference