Speakers

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Brian Schmidt
Global Lead, Occupational Hygiene
Takeda Pharmaceuticals

Day Two

Thursday, June 30 2022

10:00 am | Ventilation and Sustainable Laboratories – An Industrial Hygiene Perspective

Andrea Guytingco
EHS Business Partner
Takeda Pharmaceuticals

Day Two

Thursday, June 30 2022

10:00 am | Ventilation and Sustainable Laboratories – An Industrial Hygiene Perspective

Stefano Bucciero
Director, Global Quality & Risk Management
Pharma Industry

Day Two

Thursday, June 30 2022

1:00 pm | 360 Degree Analysis of High Containment Environments Risk Management

Olindo Lazzaro
Head, Global EHS by Design
CSL Behring

Day Two

Thursday, June 30 2022

10:30 am | EHS Integration in Capital Projects & Tech Transfer

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

Day One

Wednesday, June 29 2022

3:30 pm | 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

8:45 am | Welcome & Chairs Opening Remarks

Day Two

Thursday, June 30 2022

4:00 pm | Chairs Closing Remarks

8:45 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.
Associate 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

2:30 pm | Radiopharmaceuticals – Containment and Development Considerations

9:30 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

3:00 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

Day One

Wednesday, June 29 2022

4:00 pm | Fireside chat: Safe Working Space for OEB5 Materials – R&D vs GMP

Day Two

Thursday, June 30 2022

9:30 am | Panel Discussion: Manufacturing Quality, Operator Safety & Regulatory Considerations in Sterile HPAPI Production

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

9:00 am | GMP Inspection Excellence for Highly Potent API Manufacturing

10:00 am | Ventilation and Sustainable Laboratories – An Industrial Hygiene Perspective