The co-development of drugs and diagnostics, i.e. companion diagnostics development, is delivering significant patient benefits, healthcare cost savings, and revenue opportunities. Historically it carries out most technological advances both as IVD products, and as laboratory developed tests with gene panels and even whole exome sequencing playing a role of companion tests. The space of companion diagnostics is highly sensitive to the regulatory and reimbursement fluctuations, and it requires specific market access strategies. Cambridge Healthtech Institute’s Seventh Annual Companion Diagnostics: Strategy & Partnerships conference is designed to facilitate knowledge and opinion exchange between pharmaceutical and diagnostics executives, translational scientists, clinicians, business experts, regulators, international companion diagnostics leaders, and other parties involved in drug-diagnostics co-development and precision medicine. Case studies of successful collaboration between pharmaceutical and diagnostics companies’ researchers and executives will be presented.

TUESDAY, AUGUST 23

7:30 am Main Conference Registration & Morning Coffee

KEYNOTE SESSION: PHARMA VOICE

10:10 Coffee Break in the Exhibit Hall with Poster Viewing

HARNESSING THE POWER OF TECHNOLOGY

10:55 Chairperson’s Remarks

Mitch Raponi, Ph.D., Senior Director, Molecular Diagnostics, Clovis Oncology

11:00 Platforms and Bridging Studies in the Development of Companion Diagnostics

Ron Mazumder, Ph.D., MBA, Global Head, R&D and Operations, Janssen Diagnostics, Janssen Pharmaceutical Companies of Johnson & Johnson

This talk will highlight strengths and weaknesses of common platforms used in patient stratification studies and discuss how these attributes may affect bridging studies.

11:30 Clinical Utility of the Cobas® EGFR Mutation Test V2 from Liquid Biopsy Samples in Patients with NSCLC

Sid Scudder, M.D., Senior Director, Clinical Science, Genomics & Oncology, Roche Molecular Systems

Common challenges to determining EGFR mutation status in non-small cell lung cancer are insufficient tissue, biopsy exhaustion and inability to undergo biopsy. The cobas® EGFR Mutation Test v2 was developed to detect the most common mutations in exons 18-21, including T790M, in both tissue and plasma. Using different cutoffs for sample type, the detection of 42 separate mutations is now possible. While maintaining a high positive predictive value to detect EGFR mutations relative to tissue results, liquid biopsy testing could eventually enable the detection of EGFR mutations at diagnosis, while on treatment and at progression, including the development of acquired resistance mutations during treatment.

12:00 pm Development and Application of an NGS-Based Companion Diagnostic for Prospective Identification of Ovarian Cancer Patients Likely to Respond to Rucaparib

Mitch Raponi, Ph.D., Senior Director, Molecular Diagnostics, Clovis Oncology

A uniquely integrated translational-clinical program (assessment of rucaparib in ovarian cancer trials: ARIEL) is ongoing to identify endometrioid and HGSOC patients who may benefit from rucaparib treatment. A test for HRD that identifies both BRCA defects and genome-wide loss of heterozygosity (LOH), or “BRCAness”, has been developed in collaboration with Foundation Medicine and is being prospectively tested in the ARIEL2 study. The ARIEL program was developed to enable prospective validation of a novel NGS-based companion diagnostic for rucaparib in both the treatment (ARIEL2) and maintenance (ARIEL3) settings. This presentation will discuss the development of the HRD test and results from the ARIEL2 study.

12:30 NGS Assay from Ideation to Realization – Translating Ideas into Patient Benefits

Judi Smith, MS, Vice President, In Vitro Diagnostics Regulatory and Quality, Precision for Medicine

Rapid advancements in NGS techniques have led to even more rapidly advancing research into the causal genomic and somatic agents of disease and response. One hurdle is the transition from research to an FDA approved commercial product. We will break down the path to commercialization into steps from research through feasibility, investigational trials, to final FDA approval and market access, and explore strategies for the ultimate goal of the most efficient path to patient access.

1:00 Luncheon Presentation: Managing Risk: A Pragmatic Approach for the Successful Co-Development of Drugs and Diagnostics

Dan Snyder, President & CEO, MolecularMD

A greater biological understanding of disease has been catalyzed by the advent of powerful genomic applications and techniques. Over 800 candidate compounds are in clinical testing for cancer; 73% have the potential to be personalized medicines. Opportunities to improve healthcare outcomes are unprecedented but not without financial constraints and a high degree of uncertainty. Risk mitigation and a pragmatic, strategic approach to managing the clinical trial and commercialization are key to a successful drug-diagnostic approval.

1:30 Refreshment and Cookie Break in the Exhibit Hall with Poster Viewing

MASTERING PARTNERSHIP ACROSS ALL THE STAKEHOLDERS

2:00 Chairperson’s Remarks

William Pignato, Founder and Principal, W.J. Pignato & Associates, LLC

2:05 Rx/Pdx Partnering: What’s Next after the Break-Up?

Andrea H. Lauber, Ph.D., Executive Director, Business Development, Clinical Biomarkers and Pharmacodiagnostics, Bristol-Myers Squibb

Salvatore Salamone, Ph.D., President and CEO, Saladax Biomedical, Inc.

BMS works closely with external partners to co-develop diagnostic products for our pipeline therapies.Key partner capabilities considered include biomarkers, technologies, manufacturing and commercialization expertise, and up-to-date regulatory and reimbursement policies aimed at providing benefits of companion products to clinical practice. We will explore some of challenges and benefits that Rx/Dx collaborations bring to the industry.

2:25 Challenges in Co-Development for Multiple Programs – A Large Pharma Company Perspective

Patricia Carrigan, Ph.D., Global Head, Translational Assays Technologies, Bayer HealthCare Pharmaceuticals

There are challenges in picking the right technology and partner to ensure that the targeted therapy and the companion diagnostic would be co-developed starting as early in the development process as possible. I will discuss some of these challenges and some strategies in overcoming them for multiple programs in a large company.

2:45 FDA Submission of Laboratory-Developed Companion Diagnostic Tests - ARUP’s Experience with HDES Approval in Rare Disease

Karen A. Heichman, Ph.D., Director, PharmaDx Program, VP New Technology Assessment ARUP Laboratories, Adjunct Associate Professor of Pathology University of Utah School of Medicine

In December 2015, ARUP Laboratories, received FDA approval for the first companion diagnostic tests under the Humanitarian Device Exemption (HDE) program for rare diseases. As a part of this endeavor, ARUP established an augmented quality management system that meets FDA requirements for medical devices including a design control program. The discussion will focus on the challenges of integrating a CDx development strategy, within an established CLIA laboratory, to ensure successful FDA approval of companion diagnostics.

3:05 The Evolving CDx Deal Landscape: Are Progressive Deal Structures the Way of the Future?
 

Gary Gustavsen, Vice President, Personalized Medicine, Health Advances

Historically, companies developing CDx have been regarded as vendors by therapeutics companies and incentives between the two partners have been misaligned. However, multiple factors are impacting the CDx deal landscape pointing towards the need for a true partnership between the diagnostics and therapeutics companies. Through discussion of the factors impacting the deal landscape, as well as case studies, the potential for more progressive deal structures will be discussed.

3:20 Sponsored Presentation (Opportunity Available)

3:35 IncellDx: Quantitative Cellular Multiplex Technology Foundation for Lung, Breast and Head and Neck Cancer Assays

Bruce Patterson, MD, CEO, Executive, IncellDx

IncellDx’s Cellular Multiplex™, a quantitative, flow cytometric diagnostic approach, that allows multiplexing of proteins using antibodies, mRNA by in situ hybridization, and DNA cell cycle. Morphologic measurements can be determined as well providing a multi-parameter, quantitative alternative to IHC.

3:50 Driving the Development of Next-Generation Sequencing Based Companion Diagnostic through IVD Partnerships

Katarina Wikstrom, Ph.D., Operations Manager, Assay Validation, Almac Diagnostics

Almac Diagnostics and Illumina have partnered to establish a framework for the development of next-generation sequencing based companion diagnostic assays. This presentation will discuss the strategic basis of the partnership, the utility of the Illumina TST-170 onco panel, qualification of the Almac Diagnostics laboratories, and how an onco panel of this type can be validated for clinical use.

4:05 Refreshment Break in the Exhibit Hallwith Poster Viewing

4:50 Companion Diagnostics: Emerging Regulatory Issues and Opportunities

Soma Ghosh, Ph.D., Regulatory Scientist, Division of Molecular Genetics and Pathology, OIR, CDRH, FDA

Companion diagnostics are an important component of personalized medicine. They are essential for the safe and effective use of therapeutic products and promise to deliver a clearer understanding of disease development at the patient level. The companion diagnostics industry is rapidly evolving and has generated a series of unique regulatory challenges. These developments will be reviewed and the FDA regulatory review process for companion diagnostic devices will be discussed.

5:20 PANEL DISCUSSION: Matching the Evolution of Diagnostic and Therapeutic Development

Moderator: William Pignato, Founder and Principal, W.J. Pignato & Associates, LLC

Panelists: Speakers of the Session

The integration of a successful therapeutic/companion diagnostic co-development strategy begins in the early stages of therapeutic clinical development. When a diagnostic test is central to patient selection in order to establish the drug’s safety or efficacy, it is key to initiate coordination of these drug/diagnostic co-development strategies as early as technically feasible. In this session, we will have speakers from the drug and diagnostic industry that have had first-hand experience in addressing early and late stage co-development issues and challenges.

 
 5:50 Wine & Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing

6:50 Close of Day

WEDNESDAY, AUGUST 24

7:15 am Registration

CO-COMMERCIALIZATION OF DRUGS AND DIAGNOSTICS IN THE US AND BEYOND

8:25 Chairperson’s Opening Remarks

Peter Collins, CCO, Premaitha Health

8:30 Global CDx Strategy and Challenges

Marisa Dolled-Filhart, Ph.D., Director, Pathology and Companion Diagnostics, Translational Biomarkers, Merck & Co., Inc.

In developing and executing on a global CDx strategy in light of drug approval strategy, there are several important considerations and challenges. This talk will cover considerations of (a) global CDx clinical trial sample analysis strategies, (b) challenges in aligning drug and CDx submission timelines, (c) requirements that differ from U.S. submissions and (d) commercial considerations.

9:00 Creating a Partnership Ecosystem to Overcome Challenges in Co-Development

Myla Lai-Goldman, M.D., CEO, GeneCentric Diagnostics, Inc.

The path of a novel diagnostic from research tool to clinical adoption is paved with well-documented scientific and business challenges. Early development focuses on ensuring an analytically valid, clinically robust assay, while co-development overcomes the greatest barrier, the demonstration of clinical utility, in well-designed prospective pharmaceutical trials. By creating a partnership ecosystem, diagnostic innovators can concentrate efforts and funds to overcome the major obstacles between discovery and the patient.

9:30 PANEL DISCUSSION: Deploying Companion Diagnostics Beyond US

Moderator: Peter Collins, CCO, Premaitha Health

Panelists: Speakers of the Session

Joseph Ferrara, President, Boston Healthcare

Alex Parker, Ph.D., Vice President, Business Development at Foundation Medicine

Jonathan Roy, Vice President Pharma Partnerships, Leica Biosystems

Gabriel Otte, Ph.D, CEO, Co-founder Freenome Inc.

• Registration and Approvals of a CDx beyond the USA
• Strategies to endure testing for drug availability and accessibility for a global drug launch
• Building sustainable partnerships between Rx and Dx, allowing for the variation in individual country approaches to Rx and Dx reimbursement.

10:00 Changing the Paradigm for the Development of Multiple Biomarker Companion Diagnostic Tests

Brian Kelly, Global Director, Diagnostic Partnering, Thermo Fisher Scientific

Applying the advantages of next-generation technology to the development of future companion diagnostics in the era of targeted therapy and precision genomics.

10:30 Coffee Break in Exhibit Hall with Poster Viewing

12:50 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:20 Close of Companion Diagnostics: Strategy & Partnerships

1:25 Ice Cream and Cookie Break in the Exhibit Hall with Poster Viewing