5th Annual MarketsandMarkets

High Potent Medicines Virtual Conference (CET TIME ZONE)

23rd - 24th March 2021

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 5th Annual MarketsandMarkets High Potent Medicines Virtual Conference to be held on 23-24 March 2021. This conference would address the challenges in continual evolution of industry standards, technologies, and regulations. Leading experts from the industry will discuss the strategies for both in-house manufacturing and outsourcing by presenting expert keynote presentations, live case studies and breakthrough panel discussions.

WHAT TO EXPECT

  • 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

  • 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

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

CONFERENCE AGENDA

Registration

14:30 - 14:50

Welcome note from MarketsandMarkets

14:50 - 14:55

Opening Remarks from the Chairman

14:55 - 15:00

Keynote Presentation: Maintaining Effective Containment Through Scale Up in a Multi-Product, Shared Facility

Richard Arnett

Richard Arnett, Manager Industrial Hygiene and Toxicology , Pharmascience, Canada

15:00 - 15:30

PROCESS DEVELOPMENT, SCALE UP AND STRATEGIES FOR EFFECTIVE OUTSOURCING PARTNERSHIP

Process Development and Scale-up of HPAPIs and their unique Challenges

Jack Brown

Jack Brown, Consultant , Scale Up Solutions, USA

15:30 - 16:00

Large Scale HPAPI Micronization – Dec’s approach to achieve low nanogram containment levels

16:00 - 16:30

Manufacturing of Oncological Products by a CDMO

Fabio Zenobi

Fabio Zenobi, EHS Director, BSP Pharmaceuticals, Italy

16:30 - 17:00

Networking and One-on-One Meetings on the event portal

17:00 - 17:15

CONTAINMENT AND HANDLING STRATEGIES

Containment and handling of HPAPI

Clement Enault

Clement Enault , EHS Manager , EX-Sanofi, France

17:15 - 17:45

HPAPI: Containment system project life cycle

Stefano Butti

Stefano Butti , Sales Director, FPS

17:45 - 18:15

How to handle HPAPIs within Chemical Development

Thomas Adam

Thomas Adam, Head of Global Quality Assurance Chemical APIs, , Bayer, Germany

18:15 - 18:45

Trends and Development in Containment

Richard Denk

Richard Denk , Head Containment, SKAN AG, Switzerland

18:45 - 19:15

Closing Remarks from the Chairman

19:15 - 19:20

End of Day 1

19:20 - 19:20

Registration

14:30 - 14:50

Welcome note from MarketsandMarkets

14:50 - 14:55

Opening Remarks from the Chairman

14:55 - 15:00

Keynote Presentation: Cleaning Validation requirements for highly potent drugs

Andreas Schreiner

Andreas Schreiner , Head of Validation, Novartis, Switzerland

15:00 - 15:30

HAZARD ASSESSMENT CLASSIFICATIONS AND CLEANING VALIDATION

Occupational exposure limit setting for antibody-drug conjugates

Brian Schmidt

Brian Schmidt , Global Head, Industrial Hygiene , Takeda, Switzerland

15:30 - 16:00

Applying a Control Banding Approach to Control Selection for Potent API Processes

Martin Axon

Martin Axon, Senior Principal Occupational Hygienist , SafeBridge Europe

16:00 - 16:30

A simple and practical way to validate cleaning by using one single cleaning limit

Michel Crevoisier

Michel Crevoisier , Consultant, Ex-Novartis Consultant, Switzerland

16:30 - 17:00

Networking and One-on-One Meetings on the event portal

17:00 - 17:15

It’s Natural - How bad can it be? Health-based Exposure Limits for Natural Health Products”

Dean Calhoun

Dean Calhoun , President, CEO, Affygility Soultions, USA

17:15 - 17:45

Different Approaches to Cleaning Validation Limits

Fred Ohsiek

Fred Ohsiek , Senior Validation Manager, Ecolab

17:45 - 18:15

Closing remarks from the Chairman

18:15 - 18:20

End of Conference

18:20 - 18:20

CONFERENCE SPEAKERS

ADVISORS

Richard Denk

Richard Denk

Head Containment, SKAN AG, Switzerland

Brian Schmidt

Brian Schmidt

Global Head, Industrial Hygiene , Takeda, Switzerland

SPEAKERS

Richard Denk

Richard Denk

Head Containment, SKAN AG, Switzerland

Brian Schmidt

Brian Schmidt

Global Head, Industrial Hygiene , Takeda, Switzerland

Fabio Zenobi

Fabio Zenobi

EHS Director, BSP Pharmaceuticals, Italy

Stefano Butti

Stefano Butti

Sales Director, FPS

Andreas Schreiner

Andreas Schreiner

Head of Validation, Novartis, Switzerland

Martin Axon

Martin Axon

Senior Principal Occupational Hygienist , SafeBridge Europe

Michel Crevoisier

Michel Crevoisier

Consultant, Ex-Novartis Consultant, Switzerland

Dean Calhoun

Dean Calhoun

President, CEO, Affygility Soultions, USA

Jack Brown

Jack Brown

Consultant , Scale Up Solutions, USA

Richard Arnett

Richard Arnett

Manager Industrial Hygiene and Toxicology , Pharmascience, Canada

Clement Enault

Clement Enault

EHS Manager , EX-Sanofi, France

Thomas Adam

Thomas Adam

Head of Global Quality Assurance Chemical APIs, , Bayer, Germany

Fred Ohsiek

Fred Ohsiek

Senior Validation Manager, Ecolab

SPONSORS

PARTNERS