Conference Agenda

Single Nanogram & Below in the Future of HPAPI

8:45 am Welcome & Chairs Opening Remarks

  • Robert Sussman Managing Director, SafeBridge Regulatory & Life Sciences Group

9:00 am Utilizing Advanced Technologies for the Ultra High Potent Facility of the Future

  • John Roosa Director of Engineering, MRL New Technology Development & Potent Containment, Merck & Co.

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

  • Robert Sussman Managing Director, SafeBridge Regulatory & Life Sciences Group
  • John Roosa Director of Engineering, MRL New Technology Development & Potent Containment, Merck & Co.
  • Douglas Kiehl Senior Director Bioproduct Research & Development, Eli Lilly & Company
  • Rajyalakshmi Vathyam Cleaning & Sterilization Sr. Validation Engineer, Takeda

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

5:00 pm Close of Day 1 Conference Program

5:15 pm
Evening Drinks Reception