September 20 – 22, 2017 | San Diego, CA
Sheraton San Diego Marina

 

Workshops

 

Wednesday September 20

09.00- 16.00

Workshop C: Introduction to the Discovery, Design & Development of ADCs

FULL DAY

This workshop will offer a one day intense learning environment to establish core skills and understanding in the critical areas of ADC research and development.

Designed for new entrants to the ADC field it will deliver critical knowledge in a number of
the key problem areas that hinder antibody drug conjugate programs. Covering essential elements in ADC discovery and early development, this workshop will enable you to:

  • Gain an overview of the development process for ADCs
  • Improve payload and linker design chemistry
  • Understand the impact of conjugation site selection on your ADC
  • Choose/choice of optimum “antibody” format
  • Select the most appropriate ADC target which is easily accessible
  • Learn about cellular assays
  • Review the advantages and disadvantages of different preclinical animal models
  • Develop early stage assays and learn how to effectively interpret the data

Workshop Leader: David Bramhill, Consultant, Bramhill Biological Consulting

09.00-12.00

Workshop D: Explore Advances in Next Generation Antibody-Drug Conjugate Technologies, with a specific focus on Site-Specific Conjugation

MORNING WORKSHOP

The rapid expansion and refinement of ADC modalities hold great promise for improving care of diverse human diseases. This workshop will discuss the key technology innovations that have shown preclinical promise and appear poised for translation into the clinic.

Attend this workshop to gain a comprehensive overview of next-generation ADC technologies. Join this workshop to:

  • Hear a case study on novel, site-specific, chemical conjugation to natural and unnatural amino acids
  • Review novel cytotoxic payloads and linkers
  • Explore tailoring antibodies for the use as ADCs and alternative formats and masked
    antibodies
  • Discuss the potential and application of ADCs beyond oncology

Workshop Leaders: Amy Han, Director, Chemistry, Regeneron Pharmaceuticals
Christoph Rader, Associate Professor, The Scripps Research Institute

09.00-12.00

Workshop E: Nonclinical Pharmacology & Mechanistic
Modeling of Antibody Drug Conjugates in Support of Human Clinical Trials

MORNING WORKSHOP

This workshop will discuss the nonclinical methods and strategies to evaluate ADC
pharmacology and mitigate the risk to success in the clinic. You’ll learn the tools and insight to successfully submit an investigational new drug (IND) application by robustly demonstrating both reasonable safety for initial use in humans and exhibiting pharmacological activity.This workshop will also share insight from non-clinical pharmacology studies that have demonstrated utility to identify combination therapies. Attend this workshop to:

  • Improve understanding of antigen density and ADC internalization
  • Consider tumor tissue transport and subcellular trafficking
  • Enhance pharmacokinetic modelling to robustly predict ADC pharmacology
  • Decipher ADC efficacious dose range
  • Improve understanding target-mediated toxicity
  • Explore considerations for nonclinical testing beyond antibody-drug conjugate monotherapies

Workshop Leaders: Greg Thurber, Assistant Professor, University of Michigan
Pina Cadarelli, Vice President, Cell Biology & Pharmacology, Bristol-Myers Squibb

9.00-
16.00

Workshop F: ADC Manufacturing: ADC Outsourcing, Technology Transfer and CMO-Client Relationships

FULL DAY

Wear the “Hat” of a big pharma sponsor in a safe, educational and entertaining environment, allowing you to explore key outsourcing situations in one day, which normally takes years to develop.

Experience how applying Risk Assessment tools supports the different elements of the process, including how to: choose the right CMO, guide you through the contractual agreement, perform technology transfer and produce a clinical batch of monoclonal antibody to be used as a drug substance intermediate for ADC manufacture, while keeping within budget and time constraints. Attend this workshop to:

  • Discuss the lessons learned from a broad range of biopharmaceutical projects developed successfully by the workshop instructors, who represent both the client and the CMO sides.
  • Understand the key elements to develop a partnership between the parties, covering
    all phases, from the CMO selection activity, technology transfer of processes and test
    methods, to production, testing, and delivery of Clinical Trial Materials (CTM).

Workshop Leaders: Firelli Alonso, Senior Director, External Supply, Pfizer
Jon Crate, Chief Technical Officer, FAI Testing Services
Morten Munk, Global Technology Partner, NNE

13.00-16.00

Workshop G: The Power of Synergy: Optimizing Payload & Linker Combinations

AFTERNOON WORKSHOP

This workshop will focus on the range of chemical and biological payloads currently available for attaching to antibodies, and those in the discovery and/or development phase. Discussion will focus on how payload-linker combinations can affect ADC clinical activity and toxicities when attached to antibodies, and how the most appropriate payload-linker combination can be chosen for a particular antibody and/or cancer type.

Attend this workshop to explore the scientific biological rationale for maximizing the synergy of ADC payload- linker combinations. Join your peers at this workshop to:

  • Improve understanding of the most desirable properties of payloads and linkers
  • Review current payload-linker combinations which are enhancing the therapeutic window
  • Explore payload and linker combinations currently at the discovery or development
    stages
  • Learnt to develop linker-payloads that will not release prematurely
  • Discover important considerations for designing the optimum payload-linker

Workshop Leaders: Ed Ha, Business Development, Solstice Bio

13.00-16.00

Workshop H: GMP & Containment (Occupational Safety) Requirements for Fill Finished Product from Clinical Batches to Commercial Production

AFTERNOON WORKSHOP

Attend this workshop to:

  • Review GMP and Containment Requirements for highly potent ADCs
  • Scale up production from clinical batches to commercial production with modular
    technology
  • Focus on lyophilisation and their requirements for ADCs

Workshop Leaders: Richard Denk, Head of Sales Containment, SKAN,
Armin Storz, Area Sales Manager, Bausch+Stroebel Ilshofen