Day Three - Commercialization, Co-Development & Partnerships

Recent months have seen a focus on collaboration and uniting expertise to deliver reliable tests in record-breaking speed. As we prepare for an influx of diagnostic approvals and reflect on the first half of the year, the question remains: is it possible for our teams to deliver more effectively for existing disease areas?

With insights from GSK, AstraZeneca, Novartis and many more, thought leaders are uniting to discuss
all things commercial strategy, including:

  • Co-development and go-to-market strategy to streamline delivery to the market
  • Overcoming regulatory hurdles to help you develop robust, reliable drug-Dx products
  • Establishing effective Rx-Dx partnerships in a post-COVID world of more open and collaborative industry

And much more!

Key Speakers Include:

Lourdes Barrera

Senior Director, Precision Medicine, Global Precision Medicine Strategy, Oncology Business Unit

Novartis

Jeffrey Emch

Vice President, Global Companion Diagnostics Strategy, Oncology

GSK

Sid Mathur

Regulatory Affairs Director, Companion Diagnostics

Merck & Co.

Julie Ramage

Director, Precision Medicine Quality Initiatives & Partnerships

AstraZeneca

Day 3

THURSDAY OCTOBER 1, 2020
10.00AM – 4.20PM EDT | 7.00AM – 1.20PM PDT

9.00 | 6.00 Speed Networking

Synopsis

Grab a quick coffee from the comfort of your own kitchen and jump into this 1:1 networking session to make new connections, exchange virtual business cards and maybe even see a friendly face or two!

9.30 | 6.30 Chair’s Opening Remarks

9.40 | 6.40 Keynote Presentation: Supporting Drug-Dx Commercialization with Effective Go-to-Market Strategic Framework

  • Jeffrey Emch Vice President, Global Companion Diagnostics Strategy, Oncology, GSK

10.00 | 7.00 A Novel Approach To Diagnostic Strategy: Collaborating To Drive Global Availability of Comprehensive Genomic Profiling-Based Companion Diagnostics By Combining Centralized & Distributed Approaches

  • Jessica Atkinson VP, BioPharma Business Development, Foundation Medicine
  • Jason Adams Head of CDx Partnering, Roche Molecular Solutions

10.20 | 7.20 Live Audience Q+A

11.00 | 8.00 Commercialization Strategies for CDx in Precision Medicine in the US: Pitfalls & Considerations

  • Julie Ramage Director, Precision Medicine Quality Initiatives & Partnerships, AstraZeneca

11.20 | 8.20 Future Directions for Companion Diagnostics

11.40 | 8.40 Live Audience Q+A

12.20 9.20 A Spatial Biology Approach for Biomarker Studies in Immuno-Oncology

  • Gavin Gordon Vice President, Clinical Market Development, Akoya Biosciences

12.40 | 9.40 Speed Networking

Synopsis

Grab a bite to eat from the comfort of your own kitchen and jump into this 1:1 networking session to make new connections, exchange virtual business cards and maybe even see a friendly face or two!

Developing With COVID-19

1.00 | 10.00 Panel Discussion: Adoption and implementation of liquid biopsy testing in a routine clinical setting

  • Jennifer Rose VP Sales, Pharma Services, NeoGenomics Laboratories
  • Kelli Bramlett Director of R&D, Thermo Fisher Scientific
  • Shirin Khambata Ford Head of Precision Medicine, Clinical Biomarkers and Companion Diagnostics, Daiichi Sankyo
  • Amy Carroll Director of Medical Affairs, Thermo Fisher Scientific

1.40 | 10.40 Navigating the Regulatory Pathway in Light of Covid-19

2.10 | 11.10 Live Audience Q+A

Driving Collaboration & Co-Development Strategy for Drug-Dx Development

2.20 | 11.20 A PD-L1 Regulatory Case Study Panel: Key Industry Stakeholders Perspective

  • Xiaolei Xu Director, Global Regulatory Affairs, Companion Diagnostics, Agilent Technologies
  • Erin Grath Director, Therapeutic Lead, Diagnostics & Devices, Regulatory Affairs International, Merck Research Laboratories
  • Shyam Kalavar Senior Scientific Reviewer, Molecular Pathology and Cytology Branch, Division of Molecular Genetics and Pathology, U.S. Food and Drug Administration
  • Joseph Ferrara Chief Executive Officer, Boston Healthcare

3.20 | 12.20 Establishing Effective Rx-Dx Partnerships: Conducting an Uncommon Approach to a Common Problem

3.40 | 12.40 Supporting Clinical Utility Through Rx/Dx Co-Development Strategies

  • Sid Mathur Regulatory Affairs Director, Companion Diagnostics, Merck & Co.

4.00 | 1.00 Innovative Regulatory Approaches to Co-Development

4.20 | 1.20 Live Audience Q+A

4.40 | 1.40 Circulating tumor DNA (ctDNA): Emerging role in adjuvant and metastatic settings in trials and clinical practice

  • Pashtoon Kasi Assistant Professor, College of Medicine and Oncology, University of Iowa

5.10 | 2.10 Chair’s Closing Remarks & Close of Digital Clinical Biomarkers & World CDx