*Timings are in EST

7:30 am Welcome Coffee & Registration

8:30 am Chair’s Opening Address

  • Bob Sussman Managing Director, SafeBridge Consultants, Inc

Regulatory Framework for HPAPI Manufacturing

8:45 am In an Increasingly Toxic Landscape, How is Regulation adapting to address this?

Synopsis

  • Recent history of PIC/S and regulatory developments on cross contamination control
  • Regulatory insight on establishing and utilizing health based exposure limits
  • Expectation of PIC/S on technical and organizational controls for facilities & equipment: CGMP requirements for highly potent and toxic compounds
  • With an increase in offshore outsourcing, what are the key regulatory differences across the globe?

9:15 am Panel Discussion: How Can We Be More Proactive in Ensuring Safe HPAPI Handling?

  • Andrew Hopkins Director, Operation Quality, QA Audit and Compliance, Abbvie
  • Bob Sussman Managing Director, SafeBridge Consultants, Inc
  • David Eherts Vice President of Global EHS, Allergan

Synopsis

  • How to align regulators’ expectations and standardize common approaches amongst API suppliers and drug manufacturers?
  • Taking responsibilities in your own hand with zero accident tolerance – from culture to driving processes in place: the difficulty between doing this in-house and outsourcing
  • Can OEL limits be unified across the industry?

9:45 am Containment Selection including Flexible / Single Use Technology

10:15 am Morning Coffee & Speed Networking

Manufacturing & Tech Transfer

Best Practice in EHS

11.15 Successfully Containing & Developing HPAPI’s at Lab Through to Pilot Plant Scale & Beyond

  • Establishing robust and scalable procedures early in development
  • Overcoming unexpected containment challenges encountered in the scale up of potent compounds
  • Case studies investigating the establishment of procedures for handling HPAPIs in early stage development work

Jack Brown, Former Senior Research Fellow, Boehringer Ingelheim

11.15 Achieving the Required Standard in
Generic Drug Handling

  • Handling the ambiguity between internal and commercial OEL limits for generic drugs
  • Controlling to the OEL from the labs to production in multi-product, shared facilities
  • Assessing containment from a cost vs risk perspective

Richard Arnett, Manager, Industrial Hygiene, Pharmascience

11.45 Design of a Mid-Scale HPAPI Commercial Facility

  • Using risk based assessment to develop occupational exposure limits
  • Challenges of design and operation of a multi-purpose HPAPI facility
  • Containment strategies utilized for maintaining flexibility

Jason Korbel, Technical Services Manager, Cambrex

11:45 Session reserved for Affygility Solutions

Dean Calhoun, President and CEO, Affygility Solutions

11.55 Key Habits to Find the Right CDMO & Transfer Technology Successfully

  • Considerations and due diligence when selecting a CDMO
  • Roles for management, CMC, quality and regulatory
  • Tech transfer and scaleup from lab to clinical manufacturing – how to work efficiently with CDMOs to manage risks
  • Looking beyond to commercial manufacturing – CDMO capabilities for your highly potent API

Christopher Sears, Senior Director, CMC, Tarveda Therapeutics

12.00 Approaches for Gaining Data for Robust OEL Calculation in Innovation vs Generics
  • Using chemical structure and similar technologies to decide banding in the absence of strong data
  • Data sources when working in innovation compared to generics and pitfalls of relying on provisional OEL limits
  • Challenges specific to generic manufacturing when working without information from original innovator in- house and way to overcome this
Martin Kohan, Senior Occupational Toxicologist, AstraZeneca

12.25 Minakem: A Fully Integrated HPAPI CDMO

  • 40+ years’ experience in development and manufacturing of highly potent ingredients
  • New state of the art R&D high containment lab for handling HPAPI with OEL below 0,1 mg/m3
  • GMP production from grams to hundreds kg per batch
  • Integrated supply chain for non-HP and non-GMP intermediates and starting material

Claudio Salvagnini, Sales Director, Minakem

12:35 pm Networking Lunch

Manufacturing & Tech Transfer

Best Practice in EHS

13.35 Communicating Novel Containment Design to Isolator Manufacturers/Plant Engineers to Optimize Your Process

  • Isolators manufacturers, or plants engineers are experts in metal, plastic and machinery processing/handling. They do not recognize your process. They need detailed input about customer’s process requirement
  • What are the requirements? Whose function is to define it? How shall we know that nothing is forgotten? URS, MOCKUP TEST, SAT, FAT

Yossi Shapira, Associate Director, MS&T S.M.E, Teva

13.35 Panel Discussion: Cost vs Risk Assessments

  • Does mitigating risk by complete containment outweigh
    the cost
  • What are the key parameters of your cost vs risk
    assessments?

Dave Eherts, Vice President Global EHS, Allergan
John Roosa,
Associate Director, New Technology Development & Industrial Hygiene Lead, Merck
Richard Arnett,
Manager, Industrial Hygiene, Pharmascience

14.05 Process Development of Structurally Complex Cytotoxic Drug-Linker Payloads: Challenges and Opportunitiesommunicating Novel Containment Design to Isolator Manufacturers/Plant Engineers to Optimize Your Process

  • Overview of the technical challenges encountered while developing scalable processes for potent drug-linkers
  • Review strategies employed to maximize data collection and scale up readiness while reducing safety risk to lab personnel
  • Approaches to monitor laboratory practices to enable flexibility in high-potency chemistry development

Omid Soltani, Principal Scientist, Seattle Genetics

14.15 Session Reserved for BSP Pharmaceuticals

14.35 Mastermind: Control of Impurities in Highly Potent Compounds to Meet Regulatory Requirements

  • Reducing Impurities in HPAPI Manufacturing
  • Are these impurities also highly potent/ more potent than the API itself?
  • Can you apply default specification for these impurities, or do they need to be controlled to a lower level as a result

14.30 Tangible Solutions for Occupational Hygiene Program Management

  • The big but simple picture of OH programs as a communication tool
  • Crucial management components for targeted success
  • Interdisciplinary exposure and control banding as a communication tool
  • Growing OH program competency with globally-recognized, industry-developed, free training materials from OHTA

Nancy McClellan, Co-Chair, Occupational Hygiene Training Association, President, Occupational Health Management

3:00 pm Networking Afternoon Tea & Poster Session

Advanced Containment & Isolator Design

4:00 pm Introducing A Fully Automated, High Containment Dispensing System for APIs

Synopsis

  •  Introduction of a fully automated API dispensing system using the latest SoliValve® technology
  • Automatically dispensing of API’s into single dose containers to within 1 gram weighing accuracy, via turnkey workstation that provides a closed powder transfer process with a simple operator interface
  •  Designed to dispense API from a wide variety of source containers into single use bags where the quantity dispensed is the weight required for the batch
  • Technology explained with case study and containment performance report
  • Discussion of the benefits with automating the dispensing process

4:30 pm Containment Technology From a Perspective of Operator Safety & Product Quality

  • John Roosa Director, New Technology Development & Industrial Hygiene Engineer, Merck

Synopsis

  • Expanding implementation of multiple containment solutions
  • Bolstering primary, secondary, and tertiary containment
  • Changing existing perceptions and organizational IH containment culture

5:00 pm Commissioning Aseptic Highly Potent Fill & Finish Production Lines

  • Tom Evans Director SH&E, Ajinomoto Bio-Pharma Services

Synopsis

  • Design & Installation Considerations
  • Best Industrial Hygiene Practices vs. Good Manufacturing Practices
  • Challenging & Verifying Isolator Performance

5:10 pm Panel Discussion: Single Use Technology vs Rigid Systems

  • Scott Patterson VP, Technical Support, ILC Dover
  • John Roosa Director, New Technology Development & Industrial Hygiene Engineer, Merck
  • Peter Marshall Associate Director – Engineering, AstraZeneca

Synopsis

  • What delivers the biggest value and are single use systems as reliable
  • Feedback from end users to containment manufacturer

5:55 pm Chair’s Closing Remarks & End of Day 1

  • Bob Sussman Managing Director, SafeBridge Consultants, Inc

6:00 pm Networking Drinks Reception