3rd Annual MarketsandMarkets

High Potent Medicines Conference

28 - 29 May 2019

Novotel Milano Linate Aeroporto Hotel, Milan, Italy

20+

Speakers

9+

Sponsors

100+

Attendees

4+

Sessions

10+

Networking Hours

Exploring comprehensive strategies on containment, robustness, scalability & safety of highly potent compounds

Drug product development for highly potent APIs (HPAPIs) can be challenging. Complications with the interface between operations in drug substance and drug product handling can result in increased program complexity and cost. The growth in this market is driven by factors such as increasing demand for oncology drugs, growing demand for antibody-drug conjugates, increasing focus of leading pharmaceutical companies on HPAPIs, advancements in HPAPI manufacturing technologies, and growing focus on precision medicine. This year’s conference will focus on case studies related to development, rapid scaling, validation and commercial production of HPAPI drug substance, as well as integrated containment requirements for particle engineering and drug product.

Tag Line
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.
Tag Line
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.
Tag Line
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

Free Workshop by FPS (Valid Only for Registered Attendees)

FPS, Italian company specialized in the production of containment and micronization systems for Pharmaceutical, Biotech and Fine Chemical companies, is proud to announce the 2nd edition of Containment Workshop in partnership with MarketsandMarkets.

If you are already registered with us, please signup for the workshop here or you can register for the conferene here.

WHAT TO EXPECT

  • Process Development and Scale-up
  • Regulatory Landscape
  • Containment and Handling
  • Cleaning Validation and Industrial Hygiene

  • Containment and safety of pharmaceutical toxic powders
  • Managing cleaning validation in biologics
  • Overcoming regulatory challenges for ADC’s

Chief executives, VP’s, Directors, Heads, Leaders, Senior Managers from Pharma and BioPharma Companies Working in R&D, Risk Assessments, Validation and Product Quality

CONFERENCE AGENDA

Registration

08:15 - 08:55

Welcome note from MarketsandMarkets

08:55 - 09:00

Opening Remarks from the Chairman

Richard Denk

Richard Denk , Head Containment, SKAN AG, Switzerland

09:00 - 09:10

Process Development and Scale up

Keynote Presentation: State of the art potent solutions, drug development and manufacture

Nicola Giubellina

Nicola Giubellina , Head, CRAMS Sales , Dishman Europe Ltd.

09:10 - 09:35

Manufacturing of Oncological Products by a CDMO

Fabio Zenobi

Fabio Zenobi, EHS Director, BSP Pharmaceuticals, Italy

09:35 - 10:05

Sharing data

Chris Seaman

Chris Seaman , Managing Toxicologist, SafeBridge, UK

10:05 - 10:35

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

10:35 - 11:15

The development and manufacture of HPAPI drug products throughout the clinical phases

David O Connell

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

11:15 - 11:45

Aseptic meets high-potent - setting the stage for next level ADC processing

Matthias Angelmaier

Matthias Angelmaier , Product Manager Isolator Technology, Bosch

11:45 - 12:15

Consolidating IH programs and Potent Compound controls to enhance Process Safety Management effectiveness

Pascal Michoux

Pascal Michoux , Vice President, TAPI and BIO Global EHS, TEVA (TAPI and BIO division)

12:15 - 12:45

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

12:45 - 13:45

HP APIs Engineering – key considerations in HP APIs facilities design

Andrea Messori

Andrea Messori , Lead Process Engineer-Project & Engineering Manager, Process Service

13:45 - 14:15

Critical Elements in the Design, Implementation and Monitoring of Handling HPAPI

Rudolf Bechter

Rudolf Bechter , Managing Director , Bechter Consulting GmbH, Switzerland

14:15 - 14:45

Regulatory Landscape

Health-Based Exposure Limits: How Do The EMA’s Q&As Compare with New and Upcoming ASTM Standards?

Andrew Walsh

Andrew Walsh , President , Centre for Pharmaceutical Cleaning Innovation, USA

14:45 - 15:45

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

15:45 - 16:35

Ten common occupational health and safety audit findings from High Potency API facilities in the developing world

Dean Calhoun

Dean Calhoun , President, CEO, Affygility Soultions, USA

16:35 - 17:05

Break out session

Richard Denk

Richard Denk , Head Containment, SKAN AG, Switzerland

17:05 - 17:45

Closing Remarks from the Chairman

17:45 - 17:50

Drinks Reception & Networking

17:50 - 19:00

Registration

08:15 - 08:55

Welcome note from MarketsandMarkets

08:55 - 09:00

Opening Remarks from the Chairman

Ester Lovsin Barle

Ester Lovsin Barle , Head, Product Stewardship and Health, Takeda, Switzerland

09:00 - 09:05

Keynote Presentation: “Selection of the right Exposure Control Banding system – a case study”

Jennifer O'Leary

Jennifer O'Leary, EHS Director , SK biotek Ireland

09:10 - 09:35

Containment and Handling

Trends in Containment and outlook

Richard Denk

Richard Denk , Head Containment, SKAN AG, Switzerland

09:35 - 10:05

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

10:05 - 10:55

HPAPI handling and processing in Aseptic condition

Stefano Butti

Stefano Butti , Sales Director, FPS

10:55 - 11:25

Laboratory Containment Case Study

Sean Codling

Sean Codling , Managing Director , CTS Europe

11:25 - 11:55

Cleaning Validation and Industrial Hygiene

Quality Risk Management in Cleaning Validation

Kenneth Farrugia

Kenneth Farrugia, Quality Assurance Manager , Natrix Sciences, Malta

11:55 - 12:25

Cleaning and Validation in API manufacturing; Challenges and Solutions

Michel Crevoisier

Michel Crevoisier , Consultant, Ex-Novartis Consultant, Switzerland

12:25 - 12:55

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

12:55 - 13:55

Cleaning Validation as one driver to prevent cross-contamination

Andreas Schreiner

Andreas Schreiner , Head of Validation, Novartis, Switzerland

13:55 - 14:25

The sky is not the limit; HBELs are

Ester Lovsin Barle

Ester Lovsin Barle , Head, Product Stewardship and Health, Takeda, Switzerland

14:25 - 14:55

Closing remarks from the Chairman

14:55 - 15:00

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

15:00 - 16:00

CONFERENCE SPEAKERS

ADVISORS

Ester Lovsin Barle

Ester Lovsin Barle

Head, Product Stewardship and Health, Takeda, Switzerland

Richard Denk

Richard Denk

Head Containment, SKAN AG, Switzerland

SPEAKERS

Dean Calhoun

Dean Calhoun

President, CEO, Affygility Soultions, USA

Kenneth Farrugia

Kenneth Farrugia

Quality Assurance Manager , Natrix Sciences, Malta

Jennifer O'Leary

Jennifer O'Leary

EHS Director , SK biotek Ireland

Matthias Angelmaier

Matthias Angelmaier

Product Manager Isolator Technology, Bosch

Sean Codling

Sean Codling

Managing Director , CTS Europe

Fabio Zenobi

Fabio Zenobi

EHS Director, BSP Pharmaceuticals, Italy

Nicola Giubellina

Nicola Giubellina

Head, CRAMS Sales , Dishman Europe Ltd.

Andrea Messori

Andrea Messori

Lead Process Engineer-Project & Engineering Manager, Process Service

Pascal Michoux

Pascal Michoux

Vice President, TAPI and BIO Global EHS, TEVA (TAPI and BIO division)

David O Connell

David O Connell

Director, Scientific Affairs, PCI Services, UK

Shailendra Singh (Shelly)

Shailendra Singh (Shelly)

Board Member, MarketsandMarkets

Rudolf Bechter

Rudolf Bechter

Managing Director , Bechter Consulting GmbH, Switzerland

Andrew Walsh

Andrew Walsh

President , Centre for Pharmaceutical Cleaning Innovation, USA

Chris Seaman

Chris Seaman

Managing Toxicologist, SafeBridge, UK

Stefano Butti

Stefano Butti

Sales Director, FPS

Michel Crevoisier

Michel Crevoisier

Consultant, Ex-Novartis Consultant, Switzerland

Andreas Schreiner

Andreas Schreiner

Head of Validation, Novartis, Switzerland

Richard Denk

Richard Denk

Head Containment, SKAN AG, Switzerland

Ester Lovsin Barle

Ester Lovsin Barle

Head, Product Stewardship and Health, Takeda, Switzerland

ENQUIRE NOW

SPONSORS

PARTNERS

LOCATION

Venue

Novotel Milano Linate Aeroporto Hotel, Milan, Italy

PAST EVENT GALLERY