Speakers

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Brian Schmidt
Global Lead, Occupational Hygiene
Takeda Pharmaceuticals

Day One

Wednesday, June 29 2022

3:30 pm | Ventilation and Sustainable Laboratories – An Industrial Hygiene Perspective

Andrea Guytingco
EHS Business Partner
Takeda Pharmaceuticals

Day One

Wednesday, June 29 2022

3:30 pm | Ventilation and Sustainable Laboratories – An Industrial Hygiene Perspective

Day Two

Thursday, June 30 2022

9:35 am | Panel Discussion: Manufacturing Quality, Operator Safety & Regulatory Considerations in Sterile HPAPI Production

Stefano Bucciero
Director, Global Quality & Risk Management
Pharma Industry

Olindo Lazzaro
Head, Global EHS by Design
CSL Behring

Youchu Wang, Ph.D.
SVP API Early Phase Changzhou
WuXi STA

Day Two

Thursday, June 30 2022

10:20 am | Balancing Safety and Speed to Accelerate Patients’ Access to Life-Saving Treatments

Rajyalakshmi Vathyam
Cleaning & Sterilization Sr. Validation Engineer
Takeda

Day One

Wednesday, June 29 2022

10:00 am | Panel Discussion: The Future of HPAPIs, Cost/Risk Analysis & Advanced Manufacturing

Fred Ohsiek
Senior Global Technical Manager
Ecolab

Day Two

Thursday, June 30 2022

12:30 pm | Cleaning Validation Risk Assessments & Setting Appropriate Cleaning Limits for HPAPI Manufacturing

Robert Sussman
Managing Director
SafeBridge Regulatory & Life Sciences Group

Day One

Wednesday, June 29 2022

10:00 am | Panel Discussion: The Future of HPAPIs, Cost/Risk Analysis & Advanced Manufacturing

8:50 am | Welcome & Chairs Opening Remarks

Day Two

Thursday, June 30 2022

3:15 pm | Chairs Closing Remarks

9:35 am | Panel Discussion: Manufacturing Quality, Operator Safety & Regulatory Considerations in Sterile HPAPI Production

9:00 am | Opening Remarks

John Roosa
Director of Engineering, MRL New Technology Development & Potent Containment
Merck & Co.

Day One

Wednesday, June 29 2022

10:00 am | Panel Discussion: The Future of HPAPIs, Cost/Risk Analysis & Advanced Manufacturing

9:00 am | Utilizing Advanced Technologies for the Ultra High Potent Facility of the Future

Michelle Hernandez, Ph.D.
Director, Occupational Toxicology
Merck & Co.

Elizabeth Vancza
Associate Director, Occupational & Environmental Toxicology
Merck & Co.

Subramanya Nayak
Associate Director, Development Sciences
AbbVie

Douglas Kiehl
Senior Director Bioproduct Research & Development
Eli Lilly & Company

Day One

Wednesday, June 29 2022

10:00 am | Panel Discussion: The Future of HPAPIs, Cost/Risk Analysis & Advanced Manufacturing

Matthias Erber
Scientist External CMC 2
Bayer

Day Two

Thursday, June 30 2022

9:35 am | Panel Discussion: Manufacturing Quality, Operator Safety & Regulatory Considerations in Sterile HPAPI Production

Naiffer Romero
Scientific Affairs Sr. Manager
United State Pharmacopeia

Amanda Guiraldelli
Scientific Affairs Manager
United State Pharmacopeia

Rosie Russell
Head of Environmental Health & Safety
Meira GTx

Day Two

Thursday, June 30 2022

2:15 pm | Weaving EHS Culture into the Fabric of Gene Therapy R&D Environment

Martin Kohan
Senior Occupational Toxicologist
AstraZeneca

Preeti Bharaj
BSL3 Director
Rutgers University

Day One

Wednesday, June 29 2022

4:30 pm | Facility, Containment & Project Design for a BSL3+ Facility

Tomasz Rychlik
Engineering Manager
PolPharma

Richard Arnett
Manager, Industrial Hygiene & Toxicology
Pharmascience

Morcos Loka
Training Manager & GMP Advisor
Minapharm

Scott Patterson
Vice President Pharma/ Bio Technical Support
ILC Dover

Day One

Wednesday, June 29 2022

9:30 am | The Time has Come: Flexible Containment Solutions Outperform Durable Equipment

Dean Calhoun
President & CEO
Affygility Solutions

Vimal Sachdeva
Technical Officer (Senior GMP Inspector)
WHO

Day Two

Thursday, June 30 2022

9:05 am | GMP Inspection Excellence for Highly Potent API Manufacturing

9:35 am | Panel Discussion: Manufacturing Quality, Operator Safety & Regulatory Considerations in Sterile HPAPI Production

Frederic Pasche
Business Developer North America
Dec Group

Day One

Wednesday, June 29 2022

4:15 pm | High Containment Large Scale HPAPI Micronizing Plant, CPT <25 ng