2nd Annual Highly Potent APIs Summit 2020

Tentative Schedule:

08:00 Registration and Welcome Coffee

08:30 Opening Address from the Chairman

08:40 Workshop: Skill of an occupational hygienist.

• How to do exposure measurement?
• How to observe processes?
• How to write a report?
• Which other skills are needed for an occupational hygienist with focus on exposure measurement?

Silke Buechl,
Deputy Managing Director, Occupational hygienist, Praevena AG, Basel, Switzerland

Dr. Ramona Labatzke,
Chemist, Praevena AG, Basel, Switzerland

09:40 Evaluating a CMO’s Overall Ability to Safely Handle Potent APIs.

• Management and resource.
• Evaluating the hazard.
• Controlling exposure risks.
• Verifying controls.
• Design of the facility from an exposure control perspective.
• Employee understanding of API safety.

Martin Axon, CFFOH, CMIOSH,
Principal Occupational Hygienist, SafeBridge Europe, Ltd., Stevenage, United Kingdom

10:20 Morning coffee and networking break

11:10 Health Based Exposure Limits 2020: Do we have 2020 vision now?

In this 20-minute presentation, Dean Calhoun, President and CEO of Affygility Solutions will discuss the brief history of health based exposure limits since its June 2015 effective team; common challenges and misunderstandings regarding HBELs; and future trends and where we are heading with HBELs.

Dean Calhoun,
CEO, Affygility Solutions, Denver, USA

11:30 Production of Highly Active Substances in Shared Facilities - A Risk for Patients?

• Cross-contamination risk in the manufacture of HPAPIs
• Risk mitigation measures according to ch. 5 of EMA’s GMP Guidelines
• Examples from oral and parenteral drug manufacture

Dr. Andreas Flueckiger,
Consultant Occupational Toxicology and Containment, Head of Occupational Health @ Roche (retired), Andreas Flueckiger Consulting, Basel, Switzerland

12:10 Business lunch

13:10 Vacuum Drum Drying For HPAPI Application Streams.

• Hebeler Process Solutions, Buflovak and PK introduction
• Applying Vacuum Drum Drying Technology to HPAPI Application Streams
• Operation, Containment, and Performance During the HPAPI Drying Process
• Laboratory to Production Scale-Up Synopsisd

Patrick Scanlon,
Global Product Director, Hebeler Process Solutions LLC, New York, USA

13:30 Antibody-Drug Conjugates – antibodies meeting HPAPIs for specific and efficient bio-pharmaceutical drugs

• ADCs - conjugation of antibodies with small molecule toxins
• The manufacture of ADCs - challenges and solutions
• Bayer’s ADC production concept using HPAPIs

Dr. Ulrich Rümenapp,
Head of Launch Preparation and Coordination, Bayer AG, Berlin, Germany

14:10 Mitigation of cross contamination risk in pharmaceutical production.

• Guidelines regarding Pharmaceutical Quality Risk Management
• Technical aspects and complexity in cross contamination risk analysis
• Case studies

Dr. Ildiko Ziegler,
Quality Assurance Manager, Vanessa Research, Hungary

14:50 Afternoon coffee and networking break

15:20 Challenges of introducing an ADC into a multi-purpose Drug Product facility.

• Cross Contamination Control Concept
• Cleaning Validation and Monitoring Strategy
• Deriving most stringent Acceptance criteria
• Challenges in production routine

Dr. Florian Grundmann,
MSAT Team Leader Cleaning Validation, F. Hoffmann-La Roche AG, CH, Basel, Switzerland

16:20 Q & A

16:50 Chairman’s closing remarks and end of day two

Tentative Schedule:

08:00 Registration and Welcome Coffee

08:30 Opening Address from the Chairman

08:40 Workshop: Financial Aspects of EHS Management.

• Dr. Eherts teaches a graduate level course at Tulane University entitled Financial Aspects of EHS Management
• It includes a number of lectures teaching students how to complete Quantitative Cost-Benefit Analysis
• The method will be presented and a number of case studies completed so that attendees leave with a solid understanding of the process and the ability to convince leadership to make all necessary capital investments

David Eherts PhD CIH,
Vice President Global EHS, Allergan plc, New York, USA

10:10 Morning coffee and networking break

10:40 Workshop: SMEPAC Monitoring.

• What is SMEPAC about?
• How to execute SMEPAC Monitoring?
• How to judge results from SMEPAC monitoring?
• What are the challenges of SMEPAC monitoring?

Silke Buechl,
Deputy Managing Director, Occupational hygienist, Praevena AG, Basel, Switzerland

Dr. Ramona Labatzke,
Chemist, Praevena AG, Basel, Switzerland

12:10 Business lunch

13:10 Workshop: A Hard Business-Focussed Approach to HPAPI Projects

• Fundamental project skills underpinning HPAPI projects.
• Key HPAPI project strategic business decisions.
• HPAPI project design elements.
• Capital facility and equipment “hardware”.
• Project revenue elements and their costs.
• Pitfalls and how to avoid them.

Jeremy Justin Mason-Home, BSc (Hons), FRSC,
Director, HPAPI Project Services Limited, Hoylake, United Kingdom

14:40 Q&A

15:10 Chairman’s closing remarks

15:20 Afternoon coffee and networking break