Single Nanogram & Below in the Future of HPAPI
8:45 am Welcome & Chairs Opening Remarks
9:00 am Utilizing Advanced Technologies for the Ultra High Potent Facility of the Future
Synopsis
• Creating and Utilizing an Interactive Virtual Reality Environment
• Creating and implementing layers of protection to ensure both reduction of personnel exposure and facility migration of potent compounds
• Utilizing innovative approaches to ensure success despite global COVID compliance
• The convergence of ultra-potent and “modality agnostic” compounds
9:30 am The Time has Come: Flexible Containment Solutions Outperform Durable Equipment
Synopsis
• Data driven case study on containment performance
• Risk analysis to speak to the false pretense that flexible products have more risk
• Disposal vs. Cleaning
• Modifications and repurposing capability of flexible solutions
• Total Cost of Ownership
10:00 am Panel Discussion: The Future of HPAPIs, Cost/Risk Analysis & Advanced Manufacturing
Synopsis
As pipelines become more potent, for which indications is costly single nanogram containment cost beneficial for? Contrasting rare disease and wide-spread indications
How can we better target drugs to efficaciously apply HPAPI’s for patient benefit?
• How are analytical cleaning methods affected, given very low (single particle like) concentrations won’t be distributed like a gas
• How can we leverage pharma 4.0 to digitalize HPAPI manufacturing, though augmented reality, digital twins and modular mobile manufacturing
10:30 am
Structured Networking and Morning Coffee Break
Safety Stream
Production Stream
Hazardous New Modalities
Scale Up & Tech Transfer
11.30 Data Poor Molecules & New Modality Classification: Industry Challenge
• Personalized Medicine: Balancing Patient Safety vs Worker Safety
• Applying expertise to classify new molecules & data poor modalities
• Adjuvants: New modality or old friend?
Michelle Hernandez, Associate Director Occupational Toxicology, Merck & Co., Inc.
11.30 Tech Transfer & Scale-up of Potent Drug-Linkers & ADCs – Internal vs External Manufacturing
• Key considerations in tech transfer and cGMP scale up of potent Drug-Linkers and ADCs
• Ensuring supply chain continuity and worker safety at production sites
• Decision process and consideration to outsource production
• Evaluating supplier’s competency and engineering controls, to ensure process and
employee safety and product quality is maintained
Subramanya Nayak, Associate Director, Development Sciences, AbbVie
12.00 Hazard Assessment of ADCs to PDCs & Beyond – the Next Frontier
• What are the key considerations for assessing the hazards of antibody drug conjugates
(ADCs) and newer peptide drug conjugates (PDCs)?
• Modern technologies – what are the newest conjugates in town? How “safe” are they,
and what are the impacts from a Tox perspective (in patients vs. workers)?
• Drug conjugate case study – an assessment walk-through
Elizabeth Vancza, Associate Director, Occupational & Environmental Toxicology, Merck & Co., Inc.
12.00 Contrasting Best Case Scenario vs Real World Evidence in Scale Up & Outsourcing
• The best laid plans.. this talk will explore reactive and real-world examples of process
scale up into GMP commercial manufacturing
• Common pitfalls and potential ways of combating foreseeable pain points
• Combined risk management to protect worker safety, prevent cross contamination, and ensure audit compliance
Richard Arnett, Manager, Industrial Hygiene, Pharmascience
12.30 Networking Lunch & Exhibition
13.30 Toxicology Aspects in Worker & Patient Safety – Basic Concepts & Regulatory Implications
• Understanding potency and toxicity
• Calculation of OELs and PDEs/ADEs
• Considerations & implementation
• Who should do it?
• Regulatory implications
Martin Kohan, Senior Occupational Toxicologist, AstraZeneca
13.30 Panel Discussion: Smoothing Scale up & Tech Transfer Mid Phase Development vs Commercial Scale
• Contrasting priorities at small and large scale
• Maximizing yield at smaller scale to support batch size, overcoming challenging logistics
of high containment at early phases and focus on time to market
• Ensuring cGMP Quality at larger scale; how to continue to optimize
manufacturing processes
Richard Arnett, Manager, Industrial Hygiene, Pharmascience
Subramanya Nayak, Associate Director, Development Sciences, AbbVie
14.00 Panel Discussion: Exposure Risk Vs Potency
• Evaluating the risk of high cytotoxicity or high potency drugs but with a low exposure risk
• With the rise of biologic drugs, and RNA based materials, how does the exposure risk
differ from that of a small molecule?
• Should we adjust our view of ‘potency’ based on these new modalities?
Panellists include:
Martin Kohan, Senior Occupational Toxicologist, AstraZeneca
Elizabeth Vancza, Associate Director, Occupational & Environmental Toxicology,Merck & Co., Inc.
Michelle Hernandez, Associate Director, Occupational Toxicology, Merck & Co., Inc.
14.30 A Virtual World - The future of risk assessments
• What is a virtual risk assessment?
• Typical technical areas covered
• Beneifits and limitations of virtual risk assessments
Dean Calhoun, President & CEO, Affygility Solutions
14.15 Platform Approach to Manage Risk in Early Development
Senior Representative, AstraZeneca
14.45 Afternoon Networking Break
Next Generation Facility & Isolator Design
3:30 pm Balancing Safety and Speed to Accelerate Patients’ Access to Life-Saving Treatments
Synopsis
• Increasing complexity of high potency drugs and drug conjugates
• Ensuring safety and vigilance in designing facilities and training
• Case studies discussing how we strike the right balance for our partners
4:00 pm Fireside chat: Safe Working Space for OEB5 Materials – R&D vs GMP
Synopsis
• Equipment selection and facility start up for OEB5 facility
• Mindset change for scientists moving from R&D to GMP set up
• How to maintain equipment for GMP validation
4:30 pm Facility, Containment & Project Design for a BSL3+ Facility
Synopsis
• Design of BSL3 facility from architectural & biosafety point of view
• Special considerations and containment for working with pathogens; how these can impact R&D programs
• Important safety and environmental regulations to adhere to