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Post Covid-19: Outsourcing & Partnership to Progress HPAPI Pipelines

9:45 am Chairs Opening Remarks

  • Bob Sussman Managing Director, SafeBridge Consultants

10:00 am Panel Discussion: Taking Better Steps in HPAPI Development & Manufacturing

Synopsis

  • Spray drying, milling or tableting? What steps in your processes could be optimized to reduce cross contamination?
  • What is the barrier to a better process for these steps, knowledge, capability, equipment or available partners?

11:15 am High Potency Containment from Early Stage to Commercial Scale Micronization

Synopsis

• Learn the difference between jet milling, mechanical milling and cryogenic milling
• Understand and manage the development of the formulation process for complex HPAPI from early to late stage development
• Discover examples of product categories best fit for micronization with large scale isolators

11:15 am Speed Networking

Synopsis

An innovative 1-2-1 networking experience. Get matched with fellow conference attendees for a 5-minute introductory chat, share a virtual business card at the touch of a button and expand you HPAPI expert network!

11:45 am Technology Transfer – More Than a Checklist

  • Anna Kulesza Director Pharmaceutical Development, Clovis Oncology

Synopsis

  • Evaluating the key criteria used to assess contract development and manufacturing organizations in the highly potent space
  • Understanding of supplier processes and containment strategy as key to define the basis for the technology transfer for highly potent compounds
  • Adequate team members definition and effective collaboration for the successful know-how transfer and process understanding
  • Handling of highly potent compounds requires multiple measures during production. PAT analytical tools in help to solve some of the challenges
  • Establishing mutually-beneficial and sustainable partnerships throughout the full life cycle of potent compound development

12:15 pm SMEPAC studies in high containment facilities

Synopsis

  • Overview of Aji Bio-Pharma and OEB-5 capabilities (current and future)
  • Short introduction to SMPEAC and lessons learned
  • SMEPAC study in high containment R&D-lab

12:25 pm Morning Refreshment Break

Synopsis

Head to the informal networking room to catch up with peers over a hot drink or view the virtual exhibition hall

Embedding Human Factors & Automation to Drive Forward EHS

12:45 pm Human Behaviors Leading to Safe & Successful Potent Product Manufacturing

  • Damien Boyd Regional Industrial Hygiene (EMEA region), MSD

Synopsis

  • Examining some of the key human factors that can influence a successful approach to handling potent compounds
  • Reflection on the progressive improvements and lessons learned in potent compound containment in Pharma within the last 20 years
  • Great sharing of ‘best practice’, resulting in similar approaches across the sector
  • Addressing ‘health and safety anxiety’ when the API OELs go below 10 mcg/m3
  • Why expensive containment infrastructure is only as useful as the human capability interacting with it
  • Do we need to look at how we prepare workers handling extremely active, harmful chemical agents?

1:15 pm Round Table Discussion: Will I Be Replaced By a Robot?

Synopsis

  • What’s the lower limit that humans’ can handle safety?
  • Why is pharma behind other industries in the implementation of AI and robotics?
  • Where to apply in the product lifecycle?
    Share your voice! Round table discussion are a chance to get involved in hot HPAPI
    topics of the moment. Discuss with peers and colleagues to take away insights
    from a wide range of experiences.

Advancing cGMP Quality Control to Cross Out Contamination

12:45 pm Genotoxic Impurities; Definitions, Controls & Regulatory Considerations

  • Gowri Sukumar Director CMC & Regulatory Affairs, Iterion Therapeutics

Synopsis

  • Definitions, sources and identifications of genotoxic impurities
  • Overview current regulatory guidelines and past key regulatory milestones
  • Analytical approaches and sensitivity of analytical techniques
  • Mitigation processes though QbD, altering synthesis, adjusting conditions and more

1:15 pm Round Table Discussion: Contrasting Small Molecules vs Biologics in HPAPI Development

Synopsis

• Should we think of handling high potent biologics and small molecules differently or are the core principals the same?
• Isolating active ingredient from High Potent Biologics: What is the relative risk of purified dried product vs liquid form?
Share your voice!

Round table discussion are a chance to get involved in hot HPAPI topics of the moment. Discuss with peers and colleagues to take away insights from a wide range of experiences.

1:45 pm Networking Lunch

Synopsis

Visit the virtual exhibition hall to see the innovative solutions offered by our expert partners, download white papers, view demo videos and chat with the teams in real time

Instilling a Culture of Sustainability in EH&S

2:15 pm Can We Become Greener?

Synopsis

  • Design of processes that minimize the use and generation of hazardous substances
  • Benefits of green chemistry from a efficiency, environmental and regulatory standpoint
  • Cooperation with American Chemical Society (ACS) Green Chemistry Initiative (GCI) PR

3:00 pm Afternoon Refreshment Break

Synopsis

Visit the virtual exhibition hall to see the innovative solutions offered by our expert partners, download white papers, view demo videos and chat with the teams in real time

4:00 pm Process Safety in Agrochemicals: Cross-Industry Insight & Learnings

Synopsis

  • Process Risk and Hazard Assessment – procedure and code of practice in agrochemical industry; what similarities lie between agrochemicals and pharmaceutical sector?
  • Chemical Reaction and Fire & Explosion Hazards – testing and assessment for process
  • Training and communication to ensure safe processes are followed, reducing risk to plant, operators and environmental safety

4:30 pm The Merger: EHS, Quality and Production Unite!

  • Duane Smith Associate Director of Environmental, Health & Safety, Hikma Pharmaceuticals

Synopsis

  • Engaging critical functional areas with common linkage to reduce organizational risk.
  • Exploring the prevention of cross contamination and production uptime while decreasing employee exposure away from the HP materials.
  • Influencing the integration of additional controls when containment isn’t warranted.

5:00 pm Closing Remarks

  • Bob Sussman Managing Director, SafeBridge Consultants

5:05 pm Close of HPAPI Summit