8:00 am Morning Registration & Coffee

Single Nanogram & Below in the Future of HPAPI

8:50 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 EHS Integration in Capital Projects & Tech Transfer

  • Risk Reduction and EHS Management Elements
  • Proactive approach for EHS review and input during TT and Capital planning process
  • How to Address EHS issues early during the design phase
  • EHS deliverables during the planning, design and installation of processes, equipment and facilities to support TT Verification: FAT/SAT/PSSR

Olindo Lazzaro, Head, Global EHS by Design, CSL Behring

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 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

12.30 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 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

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:

Rosie Russell, Head of Environmental Health & Safety, Meira GTx
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.

14:00 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

Olindo Lazzaro, Head, Global EHS by Design, CSL Behring

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

14.30 Partnering to Improve Patient Outcomes

  • From drug discovery to large scale manufacturing, how can partnering progress pipelines
    faster to expedite treatments to patients
  • Transparency in data, how clear communication on OELs and other toxicological data, as well as combustible dust data, can ensure a safer environment for sponsor and partner

Brian Haney, Director, Global Technical Operations, Curia (formerly AMRI)

14.45 Afternoon Networking Break

Next Generation Facility & Isolator Design

3:30 pm Ventilation and Sustainable Laboratories – An Industrial Hygiene Perspective

Synopsis

• Historically high general ventilation requirements in laboratories offer an opportunity for reducing environmental impact
• Systems like ASHRAE Laboratory Ventilation Design Levels and Demand Based Control applications aid in this goal
• Case Study: A look at practical implementation, benefits, challenges

4:15 pm High Containment Large Scale HPAPI Micronizing Plant, CPT <25 ng

Synopsis

• Equipment selection and facility start up for OEB5 facility
• Mindset change for scientists moving from R&D to GMP set up

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
Evening Drinks Reception