Conference Overview

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.

The featured talks on:

HPAPI Process Design and Project Implementation
Manufacturing of Oncological Products by a CDMO
Garment selection criteria for the safe handling of HPAPI
HPAPI manufacturing in early Chemical Development
How to handle HPAPIs within Chemical Development
What are some hidden risks associated with isolators?
Case Study: How to develop a high potent Antibody Drug Conjugate ADC production suite
A Systematic Approach to the Safe Handling of Potent Active Pharmaceutical Ingredients
Looking Beyond Pharma 4.0: Future Initiatives and Advanced Manufacturing Approaches
Sources of cross-contamination risk in solid dosage form manufacturing
Cleaning validation – Enhanced approach required for Highly Potent APIs?
EHS Integration in Capital Projects and Tech Transfer
Integrating EHS into the RFP Process for HPAPIs
Quantitative Measurement of Risk in Cleaning using ASTM Standards
Occupational Hygiene Programs and Practice Standards of Care
The Ongoing Significant Toxicological Challenges in Developing Efficacious Antibody Drug Conjugates (ADCs)
Exposure Assessment Challenges for New Modality Potent Compounds in R&D
Flexible Isolator- Occupational Hygiene Experience
Occupational Exposure Bands (OEBs)
Health-based exposure limits (HBELs) for biotechnological products
How to derive health-based exposure limits (HBEL) for ADCs
HBEL - containment and occupational hygiene monitoring
Antibody-Drug Conjugates – antibodies meeting HPAPIs for specific and efficient biopharmaceutical drugs.
Ensuring product & worker safety in multi-product GMP facilities.
Continuous Processing as a Tool for HPAPI Development and Manufacturing
Design Considerations for the Buildout of a New Small Molecule HPAPI R&D Laboratory

Who You Will Meet

By Seniority Level

C-Level, Presidents, Chairs & Members of the Board & VPs
CEOs, CMOs, CTOs, CQOs, CDOs, & CROs
Directors, & Heads
Leaders & Managers
Toxicologists, Chemists, Hygienists Physicians, & Engineers
Coaches, Consultants, Supervisors, & Advisers
Qualified Persons
Other Professionals & Specialists

By Department

API, HPAPI & Impurities
Environmental, Health & Safety
Industrial Hygiene
Occupational Toxicology
Risk Assessment, Evaluation & Mitigation
Hazard Assessments
ADE, PDE, OELs, OEBs
Quality Control & Assurance
Aseptic Processing
ADC & New Molecules
CMC
Chemical Manufacturing, Processes & Synthesis
Compounds Manufacturing
Contamination
Containment
Drug Process Development
Extraction
Isolation
Formulation Development
Laboratory Services
Manufacturing
Materials Management
New Technologies
Plant & Site Management
Facility Design & Equipment Selection
Cleanrooms
Process Chemistry
Process Development & Engineering
Raw Materials
Regulatory
Research & Development
Toxicology
Validation
Corporate & Business Development
External Supply
Marketing
Outsourcing
Partnerships & Alliances
Sales Development
Strategic Development

By Company Activity

Pharmaceutical
Biotechnology
Chemical
CDMOs
CMOs
CROs
API & HPAPI manufacturers & suppliers
Bioprocessing services and equipment
EHS consultancies
Engineering contractors
Equipment suppliers
Exposure and containment solution providers
Finance and investment institutions
Handling and containment services
Occupational and industrial health & safety advisors
PPE manufacturers
Raw materials suppliers
Safety services
Training providers

By Region

Central and Eastern Europe
North America
Middle East and Africa
Asia-Pacific
Other

Conference Programme

Day One - Wednesday 21, February 2024

Tentative Schedule:

Central European Time (CET, Prague, UTC/GMT +1 hour)

12:00

12:10 HPAPI Process Design and Project Implementation

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

12:50 To Be Announced

Dr. Thomas Adam,
Head of GQA Chemical APIs, Bayer AG, Wuppertal, Germany

13:30

13:50 EHS by Design - EHS Integrations in Capital Project and Technology Transfer

Dr. Ing. Olindo Lazzaro, PE, MSc, CSP, EMBA,
Head, Global EHS by Design, CSL Behring, Switzerland

14:30 To Be Announced

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

15:10

15:30 Case Study AVAILABLE

16:10 To Be Announced

Richard Arnett,
Manager, Industrial Hygiene & Toxicology, Pharmascience Inc., CA

16:50

17:10 AI advancements in HPAPI CDMO industry

Artificial intelligence (AI) is revolutionizing the HPAPI CDMO industry by enhancing drug discovery and development processes, improving manufacturing efficiency and quality control, optimizing supply chain management, and enabling improvements in the categorizations of HPAPIs. AI algorithms and machine learning techniques are now being employed to analyze vast amounts of compound data and make data-driven decisions regarding the classification of compounds and the setting of robust OELs and ADEs. The impact of AI on the HPAPI CDMO industry is expected to grow in the coming years, as AI continues to evolve and become more sophisticated.

This will lead to even more innovation, efficiency, and quality in the development and manufacturing of HPAPI drugs. In this presentation, we will discuss the following:

The basics of AI
AI tools currently being used in the pharmaceutical industry
A novel database of OELs/ADEs and how AI will be used to improve decisions regarding HPAPI compound categorization

Dean Calhoun,
CEO, Affygility Solutions, Denver, USA

17:50 To Be Announced

Thomas R. Evans,
Director EHS & Facilities Management, Halozyme, USA