6th Annual MarketsandMarkets High Potent Medicines Virtual Conference

One of the major challenges faced by the players in this market, especially CMOs that offer HPAPI manufacturing services, is the continual evolution of industry standards, technologies, and regulations.

Owing to their target release characteristics, HPAPIs find major applications in target therapies for cancer. Globally, there is a significant growth in the incidence of cancer. Diseases like musculoskeletal diseases, glaucoma, and specifically cancer have a significant impact on the health status of people worldwide, with comparatively higher growth rates in developing countries.

The 2-day event will share the latest industry trends, 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.

Discussing strategies for effective management of high potent medicines supply chain, sessions on how to do a competent toxicological evaluation of HPAPI and Overview of the new ASTM E3106 Cleaning Standard

Expert keynote presentations, live case studies, and breakthrough panel sessions on Solutions to the challenges with regards to cleaning and validation in API Manufacturing and procedures to avoid cross-contamination.

Process Development and scale up of HPAPI’s
Strategies for effective outsourcing partnership
Containment and Handling Strategies
Validation of cleaning procedures to avoid cross contamination
Regulatory Landscape
Hazard Assessment Classifications

From pharmaceutical and Biopharmaceutical manufacturing:

Chief executives, VP’s, Directors, Heads, Leaders, Senior Managers, Principal Scientists, Principal Toxicologists, Toxicologists, Fellows, Investigators working in:

Research & Development
Manufacturing/Operations/Production
Maintenance
Engineering
Risk Assessments
Laboratory Services/Analytical
New Technologies
Process Development/Technical transfer

Utilizing the best practices to ensure safe and efficient production of high potent medicines
Training sessions on complex high potent compounds handling and containment issues
Understanding the updated regulatory guidelines in the HPAPI process
Implementing response plans to react to an unplanned event
Knowing the outsourcing strategies to effectively build a reliable supply chain

CONFERENCE AGENDA

Registration	14:30 - 14:50
Welcome note from MarketsandMarkets	14:50 - 14:55
Opening Remarks from the Chairman Martin Kohan, Senior Occupational Toxicologist, SafeBridge	14:55 - 15:00
Keynote Presentation: 2021 HPAPI Trends Dean Calhoun , President, CEO, Affygility Soultions, USA	15:00 - 15:30
PROCESS DEVELOPMENT AND SCALE UP OF HPAPI’S
Co-manufacturability and cross-contamination risk: pharmaceutical and cosmetic semi-solids Ildiko Ziegler, Quality Assurance Manager, Vanessa Research	15:30 - 16:00
Potency of new therapeutic modalities Ester Lovsin Barle , Head, Product Stewardship and Health, Takeda, Switzerland	16:00 - 16:30
Process equipment special design for HPAPI containment system integration Stefano Butti , Sales Director, FPS	16:30 - 17:00
Development of HPAPIs process, Challenges and Opportunities Jack Brown, Consultant , Scale Up Solutions, USA	17:00 - 17:30
Considerations for optimizing a multi-product, shared facility for HPAPI OSD products Richard Arnett, Manager Industrial Hygiene and Toxicology , Pharmascience, Canada	17:30 - 18:00
Closing Remarks from the Chairman	18:00 - 18:00

Registration	14:30 - 14:50
Welcome note from MarketsandMarkets	14:50 - 14:55
Opening Remarks from the Chairman Martin Kohan, Senior Occupational Toxicologist, SafeBridge	14:55 - 15:00
Keynote Presentation: Manufacturing of Oncological Products by a CDMO Fabio Zenobi, EHS Director, BSP Pharmaceuticals, Italy	15:00 - 15:30
IDENTIFICATION OF RISKS DURING CLEANING HPAPI’S AND REGULATORY UPDATES
How to achieve & maintain high containment in a multi-purpose plant	15:30 - 16:00
Worker and patient safety in the production of highly potent APIs Claudia Sehner , Principal Scientist, Toxicology , Boehringer Ingelheim, Germany	16:00 - 16:30
Occupational Exposure Bands (OEBs) Martin Kohan, Senior Occupational Toxicologist, SafeBridge	16:30 - 17:00
Closing remarks from the Chairman	17:00 - 17:00