7th Annual MarketsandMarkets

High Potent Medicines Conference [Time zone - (British Summer Time)]

25th and 26th May 2022

Renaissance London Heathrow Hotel - Marriott

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 7th Annual MarketsandMarkets High Potent Medicines Conference to be held on 25th -26 th May 2022. 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

08:15 - 09:00

Welcome note from MarketsandMarkets

09:00 - 09:05

Opening Remarks from the Chairman

Fred Ohsiek

Fred Ohsiek , Senior Validation Manager, Ecolab

09:05 - 09:10

Session 1: Process Development and Scale up

Keynote Presentation- Key considerations when choosing the right CDMO for the development and manufacturing of drug products containing HPAPI

David O Connell

David O Connell , Director, Scientific Affairs, PCI Services, UK

09:10 - 09:50

Past, Present and Future of HPAPI Production- Olon Global Integrated Platform

Paola Devoti

Paola Devoti, Corporate Project Engineering, Olon Spa, Italy

09:50 - 10:30

Morning Refreshments and Poster Presentation | One-to-One Networking Meetings

10:30 - 11:15

Risk considerations for the contract manufacturing for of HPAPIs

Anna Kuleza

Anna Kuleza, Director CMC Pharmaceutical Development, Clovis Oncology, Switzerland

11:15 - 11:55

HPAPI milling and micronization contained system

Stefano Butti

Stefano Butti , Sales Director, FPS

11:55 - 12:35

Manufacturing of Oncological Products

Fabio Zenobi

Fabio Zenobi, EHS Director, BSP Pharmaceuticals, Italy

12:35 - 13:15

Lunch and Poster Presentation | One-to-One Networking Meetings

13:15 - 14:15

Does your CMO have what it takes to handle HPAPI’s?

Richard Arnette

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

14:15 - 14:55

Session 2: Containment & Handling

Ultra-potent pharmaceuticals: verifying containment

Martin Axon

Martin Axon, Senior Principal Occupational Hygienist , SafeBridge Europe

14:55 - 15:35

Afternoon Refreshments and Poster Presentation | One-to-One Networking Meetings

15:35 - 16:25

How to handle HPAPIs within Chemical Development (case studies)

Thomas Adam

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

16:25 - 17:05

Closing Remarks from the Chairman

17:05 - 17:10

Drinks Reception & Networking

17:10 - 17:10

End of Day 1

17:10 - 17:10

Registration

08:15 - 09:00

Welcome note from MarketsandMarkets

09:00 - 09:05

Opening Remarks from the Chairman

Fred Ohsiek

Fred Ohsiek , Senior Validation Manager, Ecolab

09:05 - 09:10

Maintaining the Cleaning Validation Program

Fred Ohsiek

Fred Ohsiek , Senior Validation Manager, Ecolab

09:10 - 09:50

Session 3: Hazard Assessment and Cleaning Validation

Occupational Exposure Bands

William Hawkins

William Hawkins, Managing Toxicologist, SafeBridge Europe

09:50 - 10:30

Morning Refreshments and Poster Presentation | One-to-One Networking Meetings

10:30 - 11:15

Sustainable Cleaning Validation

Kenneth Farrugia

Kenneth Farrugia, Quality Assurance Manager , Natrix Sciences, Malta

11:15 - 12:15

Legacy Cleaning Validation Pitfalls and the Solution

Fred Ohsiek

Fred Ohsiek , Senior Validation Manager, Ecolab

12:15 - 12:55

Closing remarks from the Chairman

12:55 - 13:00

End of Conference

13:00 - 13:00

SPEAKERS

Fabio Zenobi

Fabio Zenobi

EHS Director, BSP Pharmaceuticals, Italy

Stefano Butti

Stefano Butti

Sales Director, FPS

Thomas Adam

Thomas Adam

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

Paola Devoti

Paola Devoti

Corporate Project Engineering, Olon Spa, Italy

Kenneth Farrugia

Kenneth Farrugia

Quality Assurance Manager , Natrix Sciences, Malta

Fred Ohsiek

Fred Ohsiek

Senior Validation Manager, Ecolab

Martin Axon

Martin Axon

Senior Principal Occupational Hygienist , SafeBridge Europe

William Hawkins

William Hawkins

Managing Toxicologist, SafeBridge Europe

Richard Arnette

Richard Arnette

Manager, Industrial Hygiene and Toxicology, Pharmascience, Canada

David O Connell

David O Connell

Director, Scientific Affairs, PCI Services, UK

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SPONSORS

PARTNERS

LOCATION

Venue

Renaissance London Heathrow Hotel - Marriott

PAST EVENT GALLERY