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June 19-21, 2018
The Aloft Boston Seaport, Boston

2018 Speakers

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Abizer Harianawala
Senior Director, Product Development & Technical Operations
TARIS Biomedical

Day Two

Thursday June 21, 2018

14.30 | Enhancing Communication During the Outsourcing Process & Beyond

Dean Calhoun
President & CEO
Affygility Solutions

Pre-Conference Workshop A

Tuesday June 19, 2018

08:00 | Establishing Practices to Work Effectively With & In Emerging Regions

Jacqui Van Sipe
Associate Director
EH&S, Vertex

Day One

Wednesday June 20, 2018

16.30 | Panel Discussion: Lessons Learned from Innovative Organizations in the Highly Potent Space

16.15 | Developing a Robust Occupational Toxicology Framework from Scratch in a Biotech Company Environment

Jay Brown
Senior EHSS Specialist
Alkermes

Day Two

Thursday June 21, 2018

13.30 | Best-Practise Potent Compound Training: Understanding the Unique Training Requirements for Operators Handling HPAPIs

Richard Wooster
CSO
Tarveda Therapeutics

Day One

Wednesday June 20, 2018

16.30 | Panel Discussion: Lessons Learned from Innovative Organizations in the Highly Potent Space

16.00 | Pentarin Miniature Drug Conjugates: Targeting Potent Payloads to Tumors

Samuel Baron
Associate Director, Manufacturing Science & Technology
SK biotech Ireland

Day One

Wednesday June 20, 2018

11.45 | Operation of a Fully Integrated & Versatile HPAPI Manufacturing Facility

Marc Abromovitz
Head, Industrial Hygiene
Novartis

Day Two

Thursday June 21, 2018

15.00 | Panel Discussion: How Do You Decide on the Right CMO to Work With?

13.00 | Applying a Risk Based Approach for Defining Exposure Controls in the Workplace

Andrew Brewer
Senior Principal Engineer, Global Biologics Manufacturing Science & Technology
Genentech

Day One

Wednesday June 20, 2018

08.30 | Keynote Panel Discussion: Defining the Term – What Does ‘Highly Potent’ Actually Mean & Does it Matter?

Scott Duncan
Director of Chemistry, Technical Operations
Stealth Biotherapeutics

Day One

Wednesday June 20, 2018

16.30 | Panel Discussion: Lessons Learned from Innovative Organizations in the Highly Potent Space

Shaun Larsen
Director, Global EHS & Industrial Hygiene
Mylan

Day One

Wednesday June 20, 2018

11.15 | Highly Potent Containment & Controls in a Generics World

Timothy Maher
Associate Director, API Development & Commercialization
Merck

Day Two

Thursday June 21, 2018

15.00 | Panel Discussion: How Do You Decide on the Right CMO to Work With?

Reinhold Maeck
Head of Corp EHS Regulatory Intelligence
Boehringer Ingelheim

Pre-Conference Workshop B

Tuesday June 19, 2018

11.30 | Navigating the Potent Compound Regulatory Landscape

Day Two

Thursday June 21, 2018

09.00 | Evaluating Best-Practise Containment & Navigating the High Potent Regulatory Landscape from EHS to GMP

Scott Patterson
VP, Commercial Sales
ILC Dover

Day One

Wednesday June 20, 2018

14.45 | Interactive Panel Discussion: Cross-Disciplinary Perspectives on the Relative Benefits of Flexible vs Fixed Containment

13.45 | Flexible Containment Systems for Nanogram Level Containment

Paul Richards
Principal, Process Engineering
Biogen

Day Two

Thursday June 21, 2018

15.00 | Panel Discussion: How Do You Decide on the Right CMO to Work With?

09.30 | Case Study:  Containment of a High Potency Sensitizer that Sublimes – Unique Challenges & Solutions

Bob Sussman
Managing Director
SafeBridge

Pre-Conference Workshop C

Tuesday June 19, 2018

15.00 | Comprehensive Occupational Exposure Banding: Insights For Handling Novel Potent Compounds

Day One

Wednesday June 20, 2018

17.00 | Chair’s Closing Remarks

08.30 | Keynote Panel Discussion: Defining the Term – What Does ‘Highly Potent’ Actually Mean & Does it Matter?

Day Two

Thursday June 21, 2018

15.45 | Chair’s Closing Remarks

08.50 | Chair’s Opening Remarks

Evan Thackaberry
VP, Nonclinical Development
Ra Pharmaceuticals

Day One

Wednesday June 20, 2018

16.30 | Panel Discussion: Lessons Learned from Innovative Organizations in the Highly Potent Space

John Roosa
Associate Director, New Technology Development & Industrial Hygiene Lead
Merck

Day One

Wednesday June 20, 2018

14.45 | Interactive Panel Discussion: Cross-Disciplinary Perspectives on the Relative Benefits of Flexible vs Fixed Containment

14.15 | A Hands-On Investigation of Potent Compound Handling Techniques

08.30 | Keynote Panel Discussion: Defining the Term – What Does ‘Highly Potent’ Actually Mean & Does it Matter?

Michael West
Director, Environment, Health & Safety
Pfizer

Day Two

Thursday June 21, 2018

10.30 | Continuous Processing: Unique Challenges Encountered in the Construction & Use of a Continuous Processing Suite

Speaker to be confirmed

AMRI

Day One

Wednesday June 20, 2018

09.15 | Presentation Details to be Confirmed

Adam Kujath
Global Senior Director, Manufacturing Science and Technology
Alcami