12-15 November, 2018
Marriott Marquis & Marina, San Diego, CA

Analytical & Bioanalytical Day

 

08.00 Chair’s Opening Remarks

Leo Kirkovsky, Director, Clinical Assay Group, Pfizer

08.10

 

 

 

Keynote: Bioanalytical & Regulatory Lessons Learned from Mylotarg

  • Exploring the key bioanalytical lessons learned from Mylotarg
  • Understanding of the regulatory pathway involved
  • Looking into the future
Leo Kirkovsky, Director, Clinical Assay Group, Pfizer

08.40

 

 

 

 

 

Keynote: Continuity of Strategy & Technology in ADC Bioanalysis from Discovery to Submission & Bioanalytical Strategies for New Conjugate Modalities

  • Stage specific and continuity of bioanalytical approaches, platforms and strategies at different phases of ADC development
  • Recommended strategy in choosing ADC analytes, assay platforms and assay DAR characteristics
  • Discussion on regulatory requirements
  • Challenges and strategies of bioanalysis for new conjugate modalities
Jian Wang, Senior Principal Scientist, Bioanalytical Sciences, Bristol Myers Squibb

Novel ADCs: Analytical & Bioanalytical Considerations for Diversifying & More Complex ADC Technologies

09.10  

 

 

                                                  

Exposure Assessment of a Probody™ Drug Conjugate

  • Focus on Probody therapeutics, which are masked antibody prodrugs designed to be activated in the tumor microenvironment
  • A multi-analyte HPLC-MS/MS approach enables simultaneous quantification of the masked antibody, functional antibody and conjugated payload in plasma
  • Discussion of approaches to the assessment of tumor exposure
Jennifer Richardson, Vice President, Pharmacology & Toxicology, CytomX
09.40 Speed Networking
10.15 Morning Refreshments

Novel ADCs: Analytical & Bioanalytical Considerations for Diversifying & More Complex ADC Technologies

10:45 Session Reserved for SCIEX

11.15

 

 

 

 

 

 

Developing Analytical Strategies that Account for Product Variability

  • Review how antibody variants can impact the quality attributes of ADCs e.g. trisulfide variants and unpaired cysteine residues present in antibodies can impact the free drug profile of the ADCs
  • Discussion of how the conjugation process can change several quality attributes of the antibodies and creates product variants e.g. variants with different masses and charge profiles
  • Appropriate analytical strategies are needed to monitor the variants of antibodies and their corresponding immunoconjugates in order to assure consistent product quality
Alex Lazar, Director Analytical & Pharmaceutical Sciences, ImmunoGen

11.45

 

 

 

 

Analytical Characterization of Dolaflexin ADCs

  • Review of the use of Dolaflexin, a polymer-drug platform, which enables the generation of ADCs with drug-to-antibody ratios up to 15 while maintaining acceptable pharmacokinetics and drug-like properties
  • Address the complex structure of Dolaflexin ADCs
  • Describe selected innovative analytical approaches used to characterize these antibody-polymer-drug systems
David Lee, Senior Director, Analytical Chemistry, Mersana Therapeutics

12.15

 

 

Exploring ADC Heterogeneity Characterization & Conjugation Dynamics Analysis

  • Analyze ADC conjugation heterogeneity
  • Focus on conjugation dynamics
Dengfeng Liu, Associate Director, MedImmune
 12.45 Lunch & Networking

Analytical & Bioanalytical Requirements for ADC Development & Commercialization

 

13.45

 

 

 

 

 

Critical Factors for a Successful Potency Assay

  • Cell selection and maintenance
  • Data analysis and statistical treatment
  • Control of critical reagents
  • Phase appropriate validation
  • Bioassay life cycle management
Glenn Petrie, Senior Scientific Advisor, EAG Laboratories

14.00

 

 

 

 

Integration of Key Bioanalytical Measurements into Systems Pharmacokinetic Models to Characterize Translational PK-PD Relationships for ADCs

  • Development of systems PK-PD model for ADCs
  • Quantitative characterization of Bystander effect of ADCs
  • Preclinical to Clinical translation of ADCs
Aman Singh, PKPD Scientist, Janssen Pharmaceuticals

14.30

 

 

 

 

 

Exploring the Ever-Evolving Bioanalytical Strategy for ADCs from Discovery to the Clinic

  • Choosing what is appropriate to support decision making at the various stages of a project and how does one approach this by balancing speed, quality and available reagents
  • Key questions to answer during drug discovery (ADC optimization), versus late stage development are usually very different, therefore the analytes and assays appropriate to answer those questions could also be different
  • Presenting case studies and a bioanalytical decision tree
Edit Tarcsa, Director, DMPK-BA, AbbVie

15.00

 

 

 

Think Tank Roundtable Sessions

More practical and highly interactive breakout roundtables where attendees can crowd-source solutions and share opinions around pre-assigned topic areas. A valuable chance for attendees to unite around hot topics and debate best practice. No more sitting quietly, this is a dedicated opportunity for you to voice your experiences and identify unique solutions.

15.30 Afternoon Refreshments & Networking

16.00

 

 

Moderator Feedback & Audience Debate

Moderators will be assigned to each roundtable to facilitate discussion and collate the findings. Following the roundtables, they will present back to the entire delegation as part of a panel discussion for information dissemination.

Integrating a Robust Bioanalytical Support Strategy


15.30

Afternoon Refreshments & Networking

 16.30

 

 

 

 

 

Bioanalysis on a Budget: ADC Discovery in a Budget-Constrained Environment

  • Describe bioanalytical workflows and methodology employed in our labs for the study of ADC stability, metabolism, and identity
  • These methods, while perhaps not “state of the art”, allow for ADC discovery using relatively inexpensive instruments that are commonly found in chemistry labs throughout the country
  • The utility of these methods will be illustrated using examples of ADCs being developed in our lab for oncology and autoimmune applications
Nathan Tumey, Professor, Pharmacy & Pharmaceutical Sciences, Binghamton University

17.00

 

 

 

 

 Panel Discussion: ADC Analysis & Bioanalysis

This session will be a chaired panel interview in which experts from leading ADC analytical and bioanalytical companies will give their perspectives on how we are to overcome the challenges to robustly characterize your ADC programme and then tailor for bioanalytical purposes.

Sponsored by PPD

5.30 Chair’s Closing Remarks
Leo Kirkovsky, Director, Clinical Assay Group, Pfizer