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Cambridge Healthtech Institute’s 12th Annual

Clinical Biomarkers & Companion Diagnostics

Enabling Precision Medicine and Drug-Diagnostic Co-Development

February 22-23, 2022

 

The promise of precision medicine has been driven by the need to accurately predict patient response to therapy while ensuring drug efficacy and safety. Reducing costs and the time required for drug development is also a driving force in the use of biomarkers. Cambridge Healthtech Institute’s 12th Annual Clinical Biomarkers & Companion Diagnostics meeting will cover novel biomarker discovery, clinical and analytical biomarker validation, and the role of biomarkers in clinical decision making and drug-diagnostic co-development.

Tuesday, February 22

KEYNOTE LOCATION: Indigo A

PLENARY KEYNOTE SESSION: INNOVATION IN PRECISION MEDICINE: FROM DIAGNOSTICS TO DIGITAL HEALTH

1:00 pm

Chairperson's Remarks

Lisa M. Suennen, Lead/Senior Managing Director, Digital & Technology Group, Manatt Phelps & Phillips LLP
Anne Wyllie, PhD, SalivaDirect Principal Investigator, Research Scientist, Epidemiology of Microbial Diseases, Yale School of Public Health
1:15 pm

Innovating Diagnostics to End a Pandemic: The RADx Tech Experience

Steven Schachter, MD, Professor, Neurology, Harvard Medical School; Chief Academic Officer and RADx Chief, CIMIT

Rapid Acceleration of Diagnostics (RADx) Tech is an NIH-funded program launched on April 29, 2020, to accelerate development, validation, and commercialization of innovative point-of-care and home-based tests, as well as improvements to clinical laboratory tests, that can directly detect the virus that causes COVID-19 and its variants. After 15 months, the program generated 27 FDA Emergency Use Authorizations for COVID-19 diagnostic tests, including the first over-the-counter test for use at home without a prescription, and produced 500 million tests. RADx Tech has proven to be a model of academic-industry-government collaboration for translational medtech development.

1:45 pm

Innovative Tests for COVID-19, Future Pandemics, and Potential Use in Non-Pandemic Test Development

Timothy Stenzel, MD, PhD, Director, Office of in vitro Diagnostics and Radiological Health, FDA
2:15 pm PANEL DISCUSSION:

Investing in Precision Medicine: Trends in Diagnostics, HealthTech and Digital Health

Panel Moderator:
Lisa M. Suennen, Lead/Senior Managing Director, Digital & Technology Group, Manatt Phelps & Phillips LLP

Precision Medicine is driven by the innovation continuum spanning genomics and diagnostics, MedTech and HealthTech, AI and Digital Health. The panel will explore investment opportunities and growth trends in the post-pandemic era, as well as the impact of precision medicine innovation on improving health outcomes and patient experience, managing healthcare costs, and advancing health equity.

Panelists:
Tom Miller, Founder & Managing Partner, GreyBird Ventures, LLC
Mara G. Aspinall, Managing Director, BlueStone Venture Partners, LLC
Jenny Rooke, PhD, Managing Director, Genoa Ventures
Taha Jangda, Partner, HealthX Ventures
Michele Colucci, Founder & Managing Partner, DigitalDx Ventures
2:45 pm Refreshment Break in the Exhibit Hall with Poster Viewing (Indigo BFGCDH)

ROOM LOCATION: Indigo 202 B

COMPANION DIAGNOSTICS STRATEGIES

3:25 pm

Chairperson's Remarks

Marielena Mata, PhD, Senior Director and Diagnostic Lead, Oncology Program, Pfizer Inc.
3:30 pm

Global Implementation of Companion Diagnostic Solutions: A Changing Landscape

Marielena Mata, PhD, Senior Director and Diagnostic Lead, Oncology Program, Pfizer Inc.

As technologies evolve and regulatory agencies throughout the world change requirements for CDx, pharma companies have to continually adjust their global CDx strategies. In this talk, we will discuss some of the recent changes, challenges and solutions.

4:00 pm

Companion Diagnostic Strategies in Oncology Early Development

Christopher Conn, PhD, Director, Companion Diagnostics, AbbVie

Increased focus on targeted patient populations in oncology drug development has led to a rise in the requirement for fit-for-purpose assays that can select the intended patient population in early oncology programs. This creates a need to implement comprehensive strategies for CDx development early on and balance the investment approach with the biomarker complexity and probability of success. Best practices related to these challenges will be reviewed.

Frederick S. Jones, PhD, Senior Director, Life Science Medical Affairs, Sysmex Inostics

Plasma-Safe-SeqS (SafeSEQ), an ultra-sensitive NGS liquid biopsy, can aid cancer drug development, treatment guidance and monitoring, in addition to post-treatment recurrence monitoring. Dr. Fred Jones discusses the clinical value of SafeSEQ by reviewing therapy de-escalation of HPV+ HNSCC patients and monitoring PIK3CA and ESR1 low-level mutations in breast cancer.

4:45 pm Sponsored Presentation (Opportunity Available)
5:00 pm

Collaborating with a Partner to Develop a Companion Diagnostic: A Pharma Perspective from Late Phase Development

Mike Zou, PhD, Leader, Companion Diagnostics, Daiichi Sankyo, Inc.

Pharma-Diagnostic partnership has become a standard practice for most drug development programs under the Rx/Dx co-development principle. However, successful collaborations often take meticulous planning and execution with flexibility on both ends to overcome constant challenges and deliver on time with highest possible quality for the developed diagnostics. This presentation will highlight some considerations from the pharma perspective at different stages of working with a diagnostic partner.

5:30 pm Close of Day

Wednesday, February 23

7:30 am Registration Open and Morning Coffee (Indigo West Foyer AB)

KEYNOTE LOCATION: Indigo A

PLENARY KEYNOTE SESSION: PRECISION MEDICINE AT BIG PHARMA

8:05 am

Chairperson's Remarks

Edward Abrahams, PhD, President, Personalized Medicine Coalition
8:10 am

Personalized Healthcare in Big Pharma: A 2022 Perspective

Jeffrey Venstrom, MD, Chief Medical Partner, US Medical Affairs, Genentech

Realizing the promises of PHC can deliver improved outcomes for patients at a lower cost to them and to society. At Genentech, we believe the key to rapidly deploying personalized solutions and delivering optimal outcomes for patients faster is through strategic partnerships from a range of different sectors and disciplines across the healthcare system, collaborating and innovating together.

8:40 am

Increasing Access to Precision Medicine – The Next-Generation of Companion Diagnostics

Ruth E. March, PhD, Senior Vice President & Head, Precision Medicine & Biosamples, AstraZeneca

Precision medicine uses diagnostic tests to match the right drugs to patients most likely to respond. As science advances through the use of advanced analytics, artificial intelligence and integrated sources of biomarker data, we need a new generation of diagnostic tests. Following the patient journey in different treatment settings offers opportunities to all patients to be able to gain access to appropriate diagnostic solutions.

9:10 am PANEL DISCUSSION:

Implementing Precision Medicine at Big Pharma

Panel Moderator:
Edward Abrahams, PhD, President, Personalized Medicine Coalition

Over the past decade, precision medicine promised to impact drug development by targeting the right medicine to the right patient. The panel of pharma thought leaders will discuss strategies to implement precision medicine in the drug discovery and development pipeline, including biomarker and companion diagnostic development, patient stratification, precision oncology advances, and emerging molecular tools for disease characterization.

Panelists:
Jeffrey Venstrom, MD, Chief Medical Partner, US Medical Affairs, Genentech
Maria C. M. Orr, PhD, FRSB, Head of Precision Medicine, Biopharmaceuticals, AstraZeneca
Marielena Mata, PhD, Senior Director and Diagnostic Lead, Oncology Program, Pfizer Inc.
Christopher Conn, PhD, Director, Companion Diagnostics, AbbVie
Andrea L. Stevens, PhD, Director, Precision Medicine Access Strategy, Janssen Pharmaceuticals, Inc.
9:40 am Coffee Break in the Exhibit Hall with Poster Viewing (Indigo BFGCDH)

ROOM LOCATION: Indigo 202 B

BIOMARKERS FOR DRUG DEVELOPMENT AND PRECISION MEDICINE

10:20 am

Chairperson's Remarks

Amanda Oran, PhD, Genomic Development Specialist, Center for Personalized Diagnostics, University of Pennsylvania
10:25 am

Towards the Identification of Biomarkers of NASH/NAFLD Disease Progression

Vincent Mikol, PhD, Head, Translational Sciences, Sanofi R&D

Recent epidemiological data reported Nonalcoholic Fatty Liver Disease, as one of the most common causes of chronic liver disease in the developing world. Diagnosis of disease severity is an important issue as noninvasive diagnostic biomarker is currently lacking. Analysis of the ABOS cohort led to the stratification of about 800 patients in three distinct groups according to their liver status. A multi-omics analysis was performed from plasma/serum, miRNA sequencing from liver biopsies, RNAseq on a subset of samples from extreme phenotypes with unequivocal diagnosis. Predictive disease biomarker candidates have been identified which are being further validated.

10:55 am

Moving with the Crowd: Development and Validation of a Large Hybrid Capture NGS Panel Using a Shared Platform Model

Amanda Oran, PhD, Genomic Development Specialist, Center for Personalized Diagnostics, University of Pennsylvania

Hybrid capture technology confers a number of advantages over traditional amplicon-based sequencing including increased uniformity, lower error rate, and improved detection of more complex indels. Because of these benefits and the multiple assays used for specific tumor types, the Center for Personalized Diagnostics (CPD) decided to move to a single hybrid capture panel for both solid tumors and hematological malignancies. The CPD joined colleagues who are developing an academic laboratory consortium, the Genomics Organization for Academic Laboratories (GOAL), that was initially developed to improve group purchasing power for the capture probes needed for the development of a larger panel. This talk will discuss the validation parameters for this clinical panel, designed for the detection and reporting of SNVs and indels across the full coding sequence of 116 hematological malignancy-related genes and 183 solid tumor-related genes as well as CNVs in a subset of these genes. Penn plans to participate in GOAL consortium concordance studies to demonstrate laboratories using the shared resources show consistent and reproducible results.

11:25 am

The Revolution of Liquid Biopsies: A Change in Perspective

Lourdes Barrera, PhD, Executive Director, Global Medical Affairs, Merck

The analysis of tumors using biomarkers in blood is already transforming treatment selection and it may have utility at almost every stage of the management of patients with cancer, including diagnosis, minimally invasive molecular profiling, treatment monitoring, the detection of residual disease and the identification of resistance mutations. The revolution of liquid biopsies will transform the way we do diagnostic testing, but it will also bring important clinical implementation challenges. These challenges include, among others, appropriate analytical and clinical validation, trained lab personnel, multidisciplinary teams’ education and training, results interpretation regulatory approvals, or reimbursement. Machine learning or artificial intelligence may facilitate some of these processes. We will review these and other options to understand how we could accelerate this transformation based on previous learnings. We do need to change our minds; we need to think differently, and this is the necessary step to definitely bring into the clinical practice this important tool.

11:55 am Enjoy Lunch on Your Own
1:30 pm Refreshment Break in the Exhibit Hall with Last Chance Poster Viewing (Indigo BFGCDH)

CLINICAL BIOMARKERS AND PRECISION MEDICINE: BEYOND ONCOLOGY

2:00 pm

Chairperson's Remarks

Sam Hanash, MD, PhD, Director, Red & Charline McCombs Institute; Evelyn & Sol Rubenstein Distinguished Chair, Cancer Prevention; Professor, Clinical Cancer Prevention-Research, Translational Molecular Pathology, University of Texas MD Anderson Cancer Center
2:05 pm

Precision Medicine Beyond Oncology

Maria C. M. Orr, PhD, FRSB, Head of Precision Medicine, Biopharmaceuticals, AstraZeneca

Over the past two decades, precision medicine has transformed the treatment of cancer by understanding disease biology and targeting treatment appropriately. Using the same approaches we can revolutionize the way that we treat other major diseases – targeting the right medicine to the right patient. In this presentation, I will outline the progress that is being made in this field and the impact that this will have on the future.

2:35 pm

Development of Biomarkers to Assess Target Engagement in Cardiovascular, Renal and Metabolic Diseases

Pia Davidsson, PhD, Head, Biomarkers, AstraZeneca R&D

Biomarker driven decisions from preclinical research through clinical phases increase the probability of success by the ability to make accurate assessment of treatment and enable optimal clinical management of patients. When each drug discovery project enters the portfolio, a dedicated biomarker strategy is therefore developed. I will present examples on biomarker development in cardiovascular and renal diseases showing how the target engagement can change by mode-of action and modality.

3:05 pm

Breakthrough Therapies Powered by Transformative Precision Medicine Approaches

Juergen Scheuenpflug, PhD, Global Head, Clinical Biomarkers & Companion Diagnostics, Merck KGaA

Transformative precision medicine approaches perfectly integrate disease root cause identification, prediction of disease dynamics and medical interventions guided by an advanced understanding of pharmacodynamic up- and downstream effects which allows to optimize and deepen responses at individual patient level. AI/ML powered translational research generated several clinically actionable insights for new targets, early interventions/maintenance settings and combination therapies. Digital pathology, radiomics and advanced clinical genomics platform approaches are key enablers to develop precision oncology break-through therapies.

INTERACTIVE DISCUSSIONS

3:35 pm Interactive Discussions (In-person only)

Interactive Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by a facilitator who keeps the discussion on track and the group engaged. For in-person events, the facilitator will lead from the front of the room while attendees remain seated to promote social distancing. To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing. Please visit the Interactive Discussion page on the conference website for a complete listing of topics and descriptions.

4:05 pm Session Break

BIOMARKER-ENABLED PRECISION CANCER THERAPY

4:15 pm

Circulating Exosomes as a Liquid Biopsy Approach for Precision Cancer Therapy

Sam Hanash, MD, PhD, Director, Red & Charline McCombs Institute; Evelyn & Sol Rubenstein Distinguished Chair, Cancer Prevention; Professor, Clinical Cancer Prevention-Research, Translational Molecular Pathology, University of Texas MD Anderson Cancer Center

Circulating exosomes have emerged as means for a multitude of cancer applications including early detection, tumor molecular classification, prediction of therapeutic response, and monitoring of tumor progression and regression. The informative value of circulating exosomes across several types of solid tumors will be presented that are indicative of the value of circulating exosomes as a liquid biopsy approach.

4:45 pm

Biomarker Combinations to Guide Combinatorial Cancer Treatment

George Vasmatzis, PhD, Assistant Professor, Lab Medicine & Co-Director, Biomarker Discovery Program, Mayo Clinic & Foundation

We have developed a functional genomics engine that consists of a multi-interdisciplinary team of clinicians, pathologists and scientists, utilizing the latest comprehensive genomics tools and preclinical models dedicated to improving patient outcomes by tailoring therapy according to the compendium of alterations of the patient’s cancer. Knowledge that is gained by this system leads to novel biomarkers that if validated can be translated to clinical tests in a CLIA environment.

5:15 pm Close of Conference





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