Speakers

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Andy Maitland
Director Operations and Supply Chain
Catalent

Andy Maitland
Director Operations and Supply Chain
Catalent

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

Day One

Wednesday, June 23 2021

2:45 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

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

Day One

Wednesday, June 23 2021

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 | Poison plants, snakes and toad venom – How bad can it be?

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

Jason Korbel
Technical Services Manager
Cambrex Charles City

Track B - Day 1 PM

1:15 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