The increasing incidence of cancer and the ever-rising demand for anticancer drugs results in significant growth for the highly potent active pharmaceutical ingredients (HPAPIs) market. The highly toxic properties of HPAPIs, however, present manufacturing and handling challenges.
Our meeting facilitates hands-on experience sharing with focus on early process development and scale up, occupational health regulations and safety standards, cross-contamination risk assessment and control, aseptic facilities and equipment maintenance and cleaning, outsourcing and technology transfer strategies.
Day 1st | Wednesday, 20 February 2019
08:30 - Registration and Welcome Coffee 08:50 - Opening Address from the Chairman
PART 1: REGULATORY LANDSCAPE
09:00 - GMP and Occupational Safety Requirements for highly potent aseptic processing.
Richard Denk, Head of Sales Containment, Skan AG, Germany
09:35 - Speed Networking
PART 2: PROCESS ROBUSTNESS, SAFETY & EFFICIENCY
10:15 - Practical Delivery of HPAPI Projects.
Jeremy Justin Mason-Home, BSc (Hons), FRSC, Director, HPAPI Project Services Limited, United Kingdom
10:50 - Morning coffee and networking break
11:10 - An Ipsen Case Study in Potent Compound Handling.
This session will describe the efforts undertaken by Ipsen to plan, design, implement and manage a highly potent compound employed in product manufacturing.
Mike Whaley, VP Global EHS, Ipsen, USA
11:55 - Risk-based handling of highly potent APIs: cross-contamination and transportation parameters.
Dr. Ildiko Ziegler, Distinguished validation expert, Gedeon Richter, Hungary
12:30 - The Importance of Involving Your People.
Risk assessment is a statutory process that has many benefits. Research shows that involving employees in job based risk assessment has many benefits for any business, not least leading to improved organisational and employee knowledge. In todays brain based economy can organisations afford not to develop the knowledge of their employees?
This session highlights the unseen benefits of listening and involving your employees.
Tim Briggs, MA CFIOSH, Course Director Health Safety and Environmental Management Courses, Past President IOSH, Leeds Beckett University, United Kingdom
13:05 - Business lunch
14:05 - PSD 3 Spray Dryer with results less than 1 ug/m3 using flexible containment.
Christopher Gomez, Health Safety and Environmental Officer - US Operations, Hovione, USA
14:40 - Novel Antibody Drug Conjugate Manufacturing - Synthesis, Conjugation, and Coordination.
Dr. Thomas Nittoli, Director, R&D Chemistry Therapeutic Proteins, Regeneron Pharmaceuticals, Inc, USA
PART 3: CLEANING VALIDATION
15:15 - Cleaning Validation as one driver to prevent cross-contamination.
Andreas Schreiner, Director of Validation, Manufacturing Science and Technology, Novartis, Switzerland
15:50 - Afternoon coffee and networking break
16:20 - Cleaning Validation for API: Reaching a Steady State.
Michel Crevoisier Consultant, Formerly Novartis Senior QA and GMP Expert, Switzerland
16:55 - Analytical Approach for Implementation of Visual Inspection.
Visual inspection following equipment cleaning is a mandatory step in the cleaning verification workflow for pharmaceutical equipment. Equipment must pass visual inspection before swab sampling for analysis can be performed. However, since a significant number of low risk compounds are visible well below established safety levels, it is possible to justify equipment as “visually clean” without performing swabbing analysis.
Internal studies performed at BMS showed that over 90% of participants could identify residual product at a level of ~2 ppm without preliminary training. The implementation of a robust visual inspection qualification program and clear “Visually Clean” inspection parameters can enable visual inspection to be used to qualify equipment in lieu of swab analysis for low risk products.
Mariann Neverovitch, Research Scientist, Bristol Myers Squibb, USA
17:30 - Roundtable Discussions
18:00 - Chairman's closing remarks and end of day one 19:00 - Business dinner
Day 2nd | Thursday, 21 February 2019
08:00 - Registration and Welcome Coffee08:40 - Opening Address from the Chairman
PART 4: OCCUPATIONAL TOXICOLOGY & INDUSTRIAL HYGIENE
08:50 - Workshop: How to identify high potency and high toxicity and what to do with it.
Ester Lovsin Barle, PhD, MScTox, ERT, Head Corporate Toxicology, Lonza AG, Switzerland
09:50 - Exposure Monitoring at the workplace - challenges due to workplaces and the new EN689.
Silke Buechl, Deputy Managing Director, Occupational hygienist, Praevena AG, Switzerland
10:25 - Morning coffee and networking break
10:55 - Understand, evaluate and mitigate Risks of occupational Exposures.
Toral Mehta, CIH, CSP, Head Industrial Hygiene and Containment, Health, Safety, Environment, Novartis, Austria
11:20 - Chemical Exposure Assessment and Control; the Bayer HPAPI approach.
Kees Hommes, Global Occupational Hygiene and Safety Manager, Bayer AG, Germany
PART 5: FACILITY DESIGN, CONTAINMENT TECHNOLOGIES & PROCESS EQUIPMENT
12:05 - To Be Announced.
Yossi Shapira, Assoc Director, MS&T S.M.E, Laboratories, Containment, Lyophilization technologies, Teva Pharmaceuticals, Israel
12:40 - Business lunch
13:40 - Analysis of containment testing.
Michael Avraam, Global Product Manager for ChargePoint PharmaSafe, ChargePoint Technology Ltd, United Kingdom
14:15 - Top ten audit findings from HPAPI facilities.
In order to have an effective potent compound safety program, auditing must be performed on a periodic basis. In this session, Dean Calhoun will share the top ten audit findings based decades of professional auditing experience throughout the world.
Dean Calhoun, CEO, Affygility Solutions, USA
PART 6: INNOVATIONS & ADVANCED TECHNOLOGIES
14:50 - Challenges and Successes in Externalization of the ADC Supply Chain.
Firelli Alonso, Ph.D., Senior Director, External Supply BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc., USA
15:25 - Afternoon coffee and networking break
15:55 - Development & Manufacturing Considerations of High Potent Drug Products – a CDMO’s perspective.
Anil Kane, Ph.D., MBA, Executive Director, Global Head of Technical & Scientific Affairs Pharma Services, Patheon, Part of Thermo Fisher Scientific, Canada
16:20 - OUTSOURCING 4.0: innovative Pharma creates the CMO net.
Enrico Bettetini, R&D Technology & Pilot Manager, Teva Pharmaceuticals, Italy
16:55 - Roundtable Discussions 17:25 - Chairman's closing remarks and end of summit
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