Recent advancements in technology and therapeutics across the life sciences are forcing big pharma and biotech to adjust their business strategies and commercialization efforts. Cambridge Healthtech Institute's Business, Investing, and Partnering conference program at the Molecular Medicine Tri-Conference will bring together multiple stakeholders from across precision medicine including investors, pharma partners, regulators, government, and start-up companies to discuss the opportunities and challenges presented by the current market. The agenda will feature presentations from industries, such as cell & gene therapy, digital health, artificial intelligence & bio-IT, immuno-oncology, and more.

Final Agenda

Monday, March 2

10:30 Conference Program Registration Open

FEATURED PANEL DISCUSSION: STATE OF THE POINT-OF-CARE INDUSTRY

11:45 Organizer’s Opening Remarks

Kaitlin Searfoss Kelleher, Conference Producer, Cambridge Healthtech Institute

11:50 Chairperson’s Remarks

David Cavanaugh, Partner, DeciBio

11:55 Leading the Pack: The Strategic Revamp POC Dx Needs before Disrupting MDx

Clinical adoption and real-world use of point-of-care diagnostic (POC Dx) technologies have fallen short of their hype and promise. The field has become increasingly crowded, with hundreds of players narrowing the runway for each company to carve out differentiated market opportunities and strategies. Disruption of the larger MDx market will require POC Dx companies to create “winning strategies” by establishing competitive differentiation from one another, driving successful adoption and implementation, and navigating regulatory and reimbursement hurdles.

Moderator: David Cavanaugh, Partner, DeciBio

Panelists: Ester Stein, Director, Corporate Reimbursement, Government Affairs, Abbott Laboratories

Gyorgy Abel, MD, PhD, Director, Molecular Diagnostics, & Clinical Chemistry/Immunology, Division of Pathology and Laboratory Medicine, Lahey Hospital & Medical Center, Burlington, MA

Trevor Martin, PhD, Co-Founder and CEO, Mammoth Biosciences

Jenny Rooke, PhD, Managing Director, Genoa Ventures

Bryan Bothwell, Director, Strategy and Business Development, Qorvo Biotechnologies

Joseph San Filippo, PhD, Director, Business Development, Roche Molecular Solutions

12:55 pm Session Break

1:05 LUNCHEON PRESENTATION I: Karius Microbial Cell-free DNA for Non-invasive Identification & Prediction of Infections in Immunocompromised Patients

Tim Blauwkamp, PhD, CSO, Karius

Immunocompromised patients are vulnerable to a wide variety of infections. The Karius Test uses next-generation sequencing of microbial cell-free DNA in blood to help diagnose infections throughout the body, offering a non-invasive alternative with higher diagnostic yield than conventional methods.  We present current applications in clinical practice and describe potential future applications in predicting infections in high-risk immunocompromised patients.

1:35 LUNCHEON PRESENTATION II: Commercialization of an IVD in a Changing Global Environment

Lynn Stephenson, PhD, Marketing Manager, Dx Manufacturing & OEM, MilliporeSigma

Changes in international standards and regulations have created challenges and roadblocks to the commercialization of diagnostic devices. The choice of a contract manufacturing (CM) partner with the expertise to provide guidance and manufacturing capabilities is one strategy diagnostics companies can use to mitigate risk.  A well-chosen CM partner can accelerate the commercialization process by anticipating potential roadblocks.  In this session, we will discuss best practices and key considerations for vetting contract manufacturing partners.

2:05 Session Break

BUSINESS AND PARTNERSHIP STRATEGIES IN COMPANION DIAGNOSTICS

2:20 Chairperson’s Remarks

Scott Patterson, PhD, Vice President, Biomarker Sciences, Gilead Sciences

2:25 How Clinical Practice Is Shaping the Precision Medicine Ecosystem

Cecilia Schott, PharmD, MBA, Head, Precision Medicine Strategy, Oncology Business Unit, Novartis

Pharma companies continue to build and invest in targeted therapy pipeline. New diagnostic platforms are being developed to identify the patient most likely to respond to a given treatment. There is an ever-growing need to understand the precision medicine landscape through the eyes of the practicing clinician. Geographical differences in the access to various testing modalities and reimbursement must be accounted for in clinical development programs and go-to-market strategies. This presentation will provide an overview of the considerations for the global development and lifecycle management of patient diagnostic and monitoring tools.

2:55 Optimization of Biospecimen Selection and Processing for Successful NGS Outcomes

Cathie G. Miller, PhD, Director, Product Marketing, Marketing, BioIVT

FFPE tissues, drug discovery workhorses, have obstacles when used in downstream applications. For 10 years, we have selected and processed specimens from BioIVT’s ASTERAND® Repository. We present case studies representing use-case scenarios: 1) Maximizing specific annotated specimens; 2) Maximizing annotated specimens across a cohort and 3) Replicating clinical validation cohort.

3:10 Using Prototype Comp Dx IHC Assays to Guide Clinical and Business Decisions 

Frank Lynch, PhD, Executive Vice President, IHC Services, Discovery Life Sciences (legacy QualTek Molecular Laboratories)

Pursuing a Drug-Diagnostics co-development approach is a monumental decision for biopharmaceutical companies. This presentation will look at considerations to strategically leverage Prototype Companion Dx IHC assays to assist in making the decision and investment to pursue a Companion Dx or not. 

3:25 PANEL DISCUSSION: Novel Collaborative Business Models in Drug-Diagnostics Co-Development

Moderator: Scott Patterson, PhD, Vice President, Biomarker Sciences, Gilead Sciences

Panelists: Shirin Khambata Ford, PhD, Head, Clinical Biomarkers & Companion Diagnostics, Global Oncology R&D, Daiichi Sankyo Inc.

Marielena Mata, PhD, Director and Diagnostic Lead, Companion Diagnostics, Pfizer

Cecilia Schott, PharmD, MBA, Head, Precision Medicine Strategy, Oncology Business Unit, Novartis

4:25 Refreshment Break and Transition to Plenary Keynote

PLENARY KEYNOTE SESSION

(please see Keynote pages for details)

4:35 Welcome Remarks

Cindy Crowninshield, RDN, LDN, HHC, Executive Event Director, Cambridge Healthtech Institute

4:45 PLENARY KEYNOTE INTRODUCTION

Thomas Westerling-Bui, PhD, Senior Scientist, Regional Business Development, Aiforia

5:00 PLENARY KEYNOTE PRESENTATION: High-Performance Medicine

Eric Topol, MD, Founder and Director, Scripps Research Translational Institute (SRTI); Author, Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again

 

 

 

 

6:00 Grand Opening Reception in the Exhibit Hall with Poster Viewing, Speed Networking, Book Signing, and Meetup Group

7:30 End of Day

Tuesday, March 3

7:30 am Registration Open and Morning Coffee

GLOBAL STRATEGIES FOR COMPANION DIAGNOSTICS

8:00 Organizer’s Remarks

Marina Filshtinsky, MD, Executive Director, Conferences, Cambridge Healthtech Institute

8:05 Chairperson’s Remarks

Marielena Mata, PhD, Director and Diagnostic Lead, Companion Diagnostics, Pfizer

8:10 Companion Diagnostics in the Era of Consolidation and Globalization: Multiplexed Biomarkers across Therapeutic Areas and around the Globe

Omar Perez, PhD, Head, Precision Medicine and Diagnostics, GSK

This presentation will discuss the need of multiple CDx strategies based on local needs and local capabilities. Examples from Europe and Asia will be discussed.

8:40 Integrating China in Global Clinical Trials with a Companion Diagnostic: Challenges and Opportunities

Marielena Mata, PhD, Director and Diagnostic Lead, Companion Diagnostics, Pfizer

Health challenges in China offer big opportunities for pharma. While the unmet need for oncology drugs in the China market represents a large opportunity, conducting the clinical trials needed for registration presents a number of challenges, including changing regulations, restrictions for the exportation of samples, IP requirements, and availability of CROs. We will discuss these challenges and potential solutions.

9:05 The Future of Genomic Studies Must Be Globally Representative

Kari North, PhD, Professor, Department of Epidemiology, University of North Carolina at Chapel Hill

The past decade has seen a revolution in human genetics that has empowered population-level investigations into the biology of complex traits. Here I demonstrate the value of diverse, multi-ethnic participants in large-scale genomic studies by providing an overview of strategies to improve global representation in genomics research and highlighting the successes of studies and consortia that have provided unique knowledge.

9:25 Market Access Strategies for Companion Diagnostics Outside the US

Arushi Agarwal, Director, Personalized Medicine, Health Advances LLC

9:40 Refreshment Break in the Exhibit Hall with Poster Viewing, Speed Networking, Book Signing, and Meetup Group

REGULATion and personalized adoptive cell therapy

Chairperson’s Remarks

Ross Wilson, PhD, Project Scientist and Principal Investigator, UC Berkeley & the Innovative Genomics Institute

10:40 Regulatory Approaches for Development of CAR T Therapies

Elena Spanjaard, PhD, Global Head of Regulatory Affairs, Regulatory Affairs, Celyad

I will define IND requirements for genetically-modified CAR T therapies and discuss the tailored regulatory strategies to address unique program features.

11:10 Personalized Multi-Targeted Adoptive Cell Therapy

Steffen Walter, PhD, CSO, Immatics US

Despite its great potential, adoptive cellular therapy (ACT) has shown limited clinical success in solid tumors. Major challenges of ACT in solid tumors include heterogeneity of tumor antigen expression, tumor escape (e.g. after addressing only one target) and toxicities (e.g. due to expression of targets on healthy tissue). In this presentation, we will show recent data from several complementary clinical-stage approaches to treat solid tumors using personalized combinations of multiple novel targets.

 

11:40 Presentation to be Announced 

12:10 pm Session Break

12:20 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:20 Refreshment Break in the Exhibit Hall with Poster Viewing, Speed Networking, Book Signing, and Meetup Group

2:00 Breakout Discussions in the Exhibit Hall (please click here for details)

3:00 Transition to Keynote Session

KEYNOTE SESSION

3:15 Organizer’s Remarks

Christina Lingham, Executive Director, Conferences and Fellow, Cambridge Healthtech Institute

3:20 Keynote Introduction

Allison Mallory, PhD, Director, R&D Molecular Biology, Stilla Technologies

 

 

 

3:35 What Does the New Era of Genomic Medicine Look Like? Effects on Patient Care, Therapeutics, and Diagnostics

20 years after the completion of the first draft of the Human Genome Project, there is compelling evidence of genomics delivering the rich promise of precision medicine. There have been major advances in the throughput and affordability of genome sequencing, enhanced tools for genome analysis and interpretation, new paradigms for therapeutics and strong signs of clinical benefit using genome editing. But major challenges remain. In this special plenary roundtable, three established pioneers of genomic medicine – David Haussler, Stephen Kingsmore, and Liz Worthey – offer their insights on the extraordinary advances in genomic medicine over the past 1-2 decades and share their hopes and concerns for the future of our field.

Moderator: Kevin Davies, PhD, Executive Editor, The CRISPR Journal, Mary Ann Liebert, Inc.

Panelists: Stephen Kingsmore, MD, DSc, President/CEO, Rady Children’s Institute for Genomic Medicine

David Haussler, PhD, Investigator, Howard Hughes Medical Institute; Distinguished Professor, Biomolecular Engineering, University of California, Santa Cruz; Scientific Director, UC Santa Cruz Genomics Institute; Scientific Co-Director, California Institute for Quantitative Biosciences (QB3)

Elizabeth Worthey, PhD, Director, Genomic Medicine, University of Alabama, Birmingham School of Medicine

4:50 Spring Fling Celebration in the Exhibit Hall with Poster Viewing, Speed Networking, Book Signing, and Meetup Group

6:00 End of Day

Wednesday, March 4

6:45 am Registration Open

7:00 BREAKFAST PANEL DISCUSSION: The Time is NOW: Creating Meaningful Change for Women in the Workplace (Sponsorship Opportunity Available)

(please see Women in Science page for details)

Moderator: Robin Toft, Author of WE CAN, The Executive Woman’s Guide to Career Advancement; Founder and Chairman, Toft Group Executive Search

Panelists: Camille Samuels, MBA, Partner, Venrock

Paul Hastings, President and CEO, Nkarta Therapeutics, Inc

Teresa L. Wright, MD, Staff Physician, Medicine, San Francisco Veterans Administration

 

REIMBURSEMENT OF COMPANION DIAGNOSTICS: A FIRST-HAND PERSPECTIVE

8:00 Organizer’s Remarks

Marina Filshtinsky, MD, Executive Director, Conferences, Cambridge Healthtech Institute

8:05 Chairperson’s Remarks

Khosrow R. Shotorbani, President, Executive Director, Project Santa Fe Foundation

8:10 NEW: Paradigms for MolDX Coverage

Gabriel Bien-Willner, MD, PhD, Medical Director, Moldx, Palmetto GBA

This talk will address the LCD process and how this process is implemented for molecular diagnostic testing by MolDX and its partner MACs. This presentation will review the information that is required for technical assessment and how this relates to a new LCD request or to coverage under an existing LCD. We will review MolDX’s approach to evidence evaluation, including the ACCE model process and chains of evidence.

8:25 NEW: Humana’s Perspective on Personalized Medicine

Kristine Bordenave, MD, FACP, Former Corporate Medical Director, Humana

This presentation will explore the impact of coverage of genetic testing on precision medicine, and payment considerations based on these relationships.

8:40 NEW: Navigating the Reimbursement Landscape in the Era of Precision Medicine 

Shivang Doshi, Director, Boston Healthcare Associates, Inc.

The increasing complexity of cancer care and accelerated approvals of targeted and immuno-oncology therapies has shifted CDx testing from a one test-one drug approach to a next-generation sequencing (NGS)-based multi-gene approach. Despite recent improvements, coverage and reimbursement remains fragmented and challenging for NGS testing.

8:55 PANEL DISCUSSION: Coverage and Reimbursement of Advanced Diagnostics

As healthcare is transitioning from “sick” care to “well” care and shifting from fee-for-service to value-based models, it’s essential that we develop evidence to demonstrate the new value of the laboratory for optimized reimbursement.

Topics to be discussed:

• Understand how to define and measure value using appropriate KPIs to help influence reimbursement policy.
• Learn ways to survive financially as payment models shift and reimbursement is driven by outcomes and risk with potential upside depending upon the reimbursement model.
• Explore key partnership opportunities that are aligned with the changes in healthcare to help shape value.

Moderator: Khosrow R. Shotorbani, President, Executive Director, Project Santa Fe Foundation

Panelists: Gabriel Bien-Willner, MD, PhD, Medical Director, Moldx, Palmetto GBA

Kristine Bordenave, MD, FACP, Former Corporate Medical Director, Humana

Lon Castle, CMO, Molecular Genetics and Personalized Medicine, eviCore Healthcare

Shivang Doshi, Director, Boston Healthcare Associates, Inc.

 

 

 

 

 

 

9:40 Refreshment Break in the Exhibit Hall with Poster Viewing, Speed Networking, Book Signing, and Meetup Group

DATA SCIENCE STRATEGY FOR PHARMA BUSINESS AND INVESTING

10:40 Chairperson’s Remarks

Faisal Khan, PhD, Executive Director, Advanced Analytics and AI, AstraZeneca

10:45 NEW: On the Road to Genetically Validated Targets in Kidney Diseases: Computational Challenges

Thomas Tibbitts, PhD, Senior Vice President, Computational Discovery, Goldfinch Bio

Focal segmental glomerulosclerosis (FSGS) is scarring of the kidney that can lead to kidney failure. To discover genetic variants associated with FSGS, we built the Kidney Genome Atlas (KGA 1.0), which contains whole genomes (>30X) on 23000 individuals, including 2000 cases of FSGS and other proteinuric disorders. To efficiently process and analyze this large amount of genomic data we have implemented infrastructure and pipelines on AWS and launched a web portal to facilitate target discovery

L DISCUSSION: Partnering for AI Startups and Pharma

Topics to be Discussed:

• Meeting expectations, what is good for both sides?
• How can we facilitate the transformation of pharma R&D?
• Best practices

Moderator: Annastasiah Mudiwa Mhaka, PhD, Founder and Principal, Mawambo Lifesciences, Co-Founder and Convenor, Alliance for AI in Healthcare (AAIH )

Panelists: Joseph Szustakowski, PhD, Vice President of Translational Bioinformatics, Informatics & Predictive Sciences, Bristol-Myers Squibb

Representative from ATOM Consortium

Christopher Willis, PhD, Lead IT Business Partner, Precision Medicine, BMS

Gini Deshpande, PhD, Founder & CEO, NuMedii, Inc.

12:00 pm PANEL DISCUSSION: Recruiting Data Scientists

Given the massive expansion of Data Science and the consequent need for experts in this area across all industries, there is a massive competition to find and source the talent required. How can we identify, recruit, and retain the best data scientists? What are the pitfalls and challenges to avoid, and success stories we can learn from?

Moderator: Faisal Khan, PhD, Executive Director, Advanced Analytics and AI, AstraZeneca

Panelists: Mustaqhusain Kazi, Head of Personalized Healthcare, Pharma Informatics, Genetech

Zahra ‘Nasim’ Eftekhari, Senior Manager, Head of Applied AI and Data Science, City of Hope

José Duca, PhD, Global Head, Computer-Aided Drug Discovery, Novartis

 

12:40 Session Break

12:50 Bio-IT World WEST Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:20 Refreshment Break in the Exhibit Hall with Last Chance Poster Viewing, Speed Networking, Book Signing, and Meetup Group

FEATURED SESSION: STRATEGIES IN RESOURCE-LIMITED SETTINGS

2:00 Chairperson’s Remarks

Michael Loeffelholz, Senior Director, Medical Affairs, Cepheid

2:05 Challenges and Opportunities in Resource-Limited Settings for POC IVD Manufacturers

Michael Loeffelholz, Senior Director, Medical Affairs, Cepheid

The impact of point-of-care technologies in resource-limited settings is profound, but the development, funding, and implementation of these technologies is not always easy. There are several challenges and opportunities for POC IVD manufacturers in resource-poor settings: technology, development, regulatory, and cost considerations, to name a few. We’ll examine the industry and business perspective, as well as the clinical implementation and, most importantly, the impact these point-of-care technologies have on patient care.

2:50 NEW: Point-of-Care Testing: Bringing the Laboratory to the Patient in Low- and Middle-Income Country Settings

Jeffrey D. Klausner, MD, MPH, Professor of Medicine and Public Health, David Geffen School of Medicine, University of California, Los Angeles

I will review studies across three continents demonstrating the acceptability, feasibility, and value of point-of-care diagnostic testing for sexually transmitted infections in pregnant women.

3:35 Close of Conference