Speakers

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Thomas Adam
Head of QA Chemical APIs
Bayer

Day Two

Thursday, June 24 2021

10:00 am | Panel Discussion: Taking Better Steps in HPAPI Development & Manufacturing

Track B - Day 1 PM

12:15 pm | Case Study: How to Handle HPAPIs in Chemical Development

Anna Kulesza
Director Pharmaceutical Development
Clovis Oncology

Day Two

Thursday, June 24 2021

11:45 am | Technology Transfer – More Than a Checklist

Qiao Bobo
Division Director
Office of Pharmaceutical Quality, CDER/FDA

Day One

Wednesday, June 23 2021

10:00 am | Panel Discussion: Future Pipelines in the HPAPI Landscape & World Regulations

Chris Regens
Associate Director & Senior Scientist
Research, Gilead Sciences

Track B - Day 1 PM 2

2:30 pm | GS-9688 for Hepatitis B: Developing a Potent Compound at Gilead Sciences

Sayantan Chattoraj
GSK Fellow, Scientific Leader
GSK

Track B - Day 1 PM

12:45 pm | Robust Control Strategy Development for Continuous Manufacturing of Low Dose Tablets

Reinhold Maeck
Associate Director Tech Transfers
Boehringer Ingelheim

Track B - Day 2 PM

1:15 pm | Cleanroom Requirements to Reflect GMP Standards & EHS Requirements

Katarzyna Wegner
Acting Chemical Process Development Manager
Ipsen

Day Two

Thursday, June 24 2021

2:15 pm | Can We Become Greener?

10:00 am | Panel Discussion: Taking Better Steps in HPAPI Development & Manufacturing

Mike Whaley
Global VP EHS
Ipsen

Day One

Wednesday, June 23 2021

10:00 am | Panel Discussion: Future Pipelines in the HPAPI Landscape & World Regulations

Day Two

Thursday, June 24 2021

2:15 pm | Can We Become Greener?

Gowri Sukumar
Director CMC & Regulatory Affairs
Iterion Therapeutics

Track B - Day 2 PM

12:45 pm | Genotoxic Impurities; Definitions, Controls & Regulatory Considerations

Jay Brown
Director Environmental, Health and Safety
Mayne Pharma

Angela Wagner
Associate Principal Scientist
Merck

Day One

Wednesday, June 23 2021

4:00 pm | Future of Flexible Manufacturing: Integrating & Adapting for High-Potency Clinical Manufacturing

Courtney Stanton
Senior Scientist, Engineering
Merck

Day One

Wednesday, June 23 2021

4:00 pm | Future of Flexible Manufacturing: Integrating & Adapting for High-Potency Clinical Manufacturing

Damien Boyd
Regional Industrial Hygiene (EMEA region)
MSD

Track A - Day 2 PM

12:45 pm | Human Behaviors Leading to Safe & Successful Potent Product Manufacturing

Craig Williams
Process Hazards Specialist
Syngenta

Day Two

Thursday, June 24 2021

4:00 pm | Process Safety in Agrochemicals: Cross-Industry Insight & Learnings

Ester Lovsin Barle
Head of Product Stewardship and Health
Takeda

Day One

Wednesday, June 23 2021

10:00 am | Panel Discussion: Future Pipelines in the HPAPI Landscape & World Regulations

Chris Sears
VP, CMC
Tarveda Therapeutics

Track A - Day 1 PM 2

2:15 pm | From R&D to First-In-Human Clinical Trials

Mark Witcher
Senior Consultant
Exyte

Bob Sussman
Managing Director
SafeBridge Consultants

Day One

Wednesday, June 23 2021

5:00 pm | Chairs Closing Remarks

9:45 am | Chairs Opening Remarks

Day Two

Thursday, June 24 2021

5:00 pm | Closing Remarks

9:45 am | Chairs Opening Remarks

Scott Patterson
Vice President Pharma/Bio Technical Support
ILC Dover

Day One

Wednesday, June 23 2021

10:45 am | HPAPI Isolator Design Methodology – The Full Life Cycle Safety Process

Day Two

Thursday, June 24 2021

10:00 am | Panel Discussion: Taking Better Steps in HPAPI Development & Manufacturing

Dean Calhoun
President/CEO
Affygility Solutions

Day One

Wednesday, June 23 2021

4:45 pm | It’s Natural - How bad can it be? Health-based Exposure Limits for - Natural Health Products

Matthias Erber
Scientist, External Cooperations
Bayer

Track A - Day 1 PM

12:15 pm | Freeze-drying of drugs containing highly potent APIs - Characterization of heat and mass transfer in protective bags

Milica Glogovac
Senior Manager Health Hazard Assessment
Novartis

Track A - Day 1 PM

12:45 pm | Default OELs for Data-Poor Small Molecule Drug Candidates

Ijaz Ahmed
Scientist II, Process Chemistry
ImmunoGen

Day Two

Thursday, June 24 2021

10:00 am | Panel Discussion: Taking Better Steps in HPAPI Development & Manufacturing

Brain Haney
Director, Global Technical
AMRI

Track A - Day 1 PM 2

2:45 pm | Partnering to Improve Patient Outcomes

Jason Korbel
Technical Services Manager
Cambrex Charles City

Track B - Day 1 PM 2

2:15 pm | Design of a Mid-Scale HPAPI Commercial Facility

Duane Smith
Associate Director of Environmental, Health & Safety
Hikma Pharmaceuticals

Day Two

Thursday, June 24 2021

4:30 pm | The Merger: EHS, Quality and Production Unite!

Susan Arnold
Assistant Professor Industrial Hygiene, Director
UMN, Exposure Science and Sustainability Institute

Christian Noti
Team Leader, API Development Services & HPAPI Lab Manufacturing
Lonza

Day One

Wednesday, June 23 2021

3:30 pm | Fast Speed Manufacturing Scale Expansion of a High Potent Product Process – from Lab Scale to Monoplant within 30 Months

Sean Diver
Director, Commercial Development
Lonza

Day One

Wednesday, June 23 2021

3:30 pm | Fast Speed Manufacturing Scale Expansion of a High Potent Product Process – from Lab Scale to Monoplant within 30 Months

Tom Van De Voorde
Safety Officer
Ajinomoto Bio-Pharma Services

Day Two

Thursday, June 24 2021

12:15 pm | SMEPAC studies in high containment facilities

Joey Gouws
Prequalification Inspection Team Lead
WHO

Day One

Wednesday, June 23 2021

10:00 am | Panel Discussion: Future Pipelines in the HPAPI Landscape & World Regulations