Galien week of innovation

THURSDAY NOV. 07

ALEXANDRIA CENTER FOR LIFE SCIENCE, NEW YORK CITY

The Galien Forum, held every autumn at New York’s Alexandria Center for Life Science, offers a full day of spirited discussions with Nobel Laureates, top policy makers, and leading industry executives who offer perspectives on the most significant health challenges of our time while highlighting the latest research and clinical pathways toward diagnosis, treatment, and cure.
 

The 2024 edition promises a rich program of critical and emerging topics at the heart of the life science research, regulation and access. With a record number of participants expected for this edition, space is limited. Register early to take part.

2024 Program


Mike Rosenblatt
OPENING REMARKS
Mike Rosenblatt

7:55 AM - 8:00 AM

Chair

Michael Rosenblatt
Co-Chair, Galien Forum; Advisory Partner, Ascenta; and Senior Partner, Bain Capital Life Sciences and Flagship Pioneering

 

Phillip Sharp
1993 Nobel Laureate for Physiology or Medicine; Institute Professor and Professor of Biology Emeritus, Koch Institute for Integrative Cancer Research, MIT; Co-Chair of the Galien Forum

Womens_Health
PANEL 1
Womens_Health

8:00 AM - 9:00 AM

Women’s Health/Generational Health

Chair

Julie Gerberding

President and CEO, Foundation for the National Institutes of Health

PANELISTS
Diana Bianchi
Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development
 
 
Mary-Ann Etiebet
Associate Vice President, Health Equity & Partnerships, Human Health International, Merck

Elizabeth Garner
Board Chair NUA SURGICAL

 

Sandra Milligan
Director, Gossamer Bio and Former Head of Research & Development, Organon

Background and Topics for Discussion

 

Decades of institutional neglect and cultural indifference have left a glaring gap in the breadth of knowledge and data on the health of women as compared to men. Improving women’s health is, at its core, an issue of health equity and inclusivity, and would raise the quality of life for women. Such advances would also benefit the global economy and the health of future generations. The McKinsey Health Institute recently published a comprehensive analysis of the impact that a greater investment in women’s health would have on the global economy, along with addressing a significant societal moral benefit. Specifically, an investment to improve women’s health would provide a $1 trillion benefit to the global economy by 2040.

 

Evidence suggests the value contributions added by women at home, at work, and in the neighborhood increases when their disease burden decreases. A lower incidence of the many health challenges facing women before, during, and beyond their reproductive years could have multiple beneficial effects, including raising economic growth and social resiliency.

 

As the science behind regenerative medicine improves, gender-specific innovations allow more women to live longer, healthier lives and promise to leave a better genetic footprint for future generations. Such contributions are only now being acknowledged, prioritizing women’s health around a holistic, cross-disciplinary construct called “generational health.” The aim is to emphasize identifying and treating the gender-specific needs of women throughout their life span, beyond their reproductive years.

 

Prioritizing women’s health remains a work in progress. The good news is many initiatives are being launched to redress the imbalance in women’s health, not only in the levels of public research funding but also in developing new technologies and tools, such as large datasets to allow evaluation of sex and gender differences to treatment response for various diseases. Yet other institutional barriers remain, such as the biopharma industry’s struggle to find a sustainable, long-term commercial business model centered on women’s health. Addressing ingrained, gender-driven resource inequities and recognizing the impact that a greater investment in women’s health would have on the global economy and society is a step forward.

 

Topics the panel will address include:

 

  • Investment gaps in women’s health: What is the relationship between the prioritization of the social drivers of women’s health and what health systems actually invest in? What is being done to address the scarcity of data on women’s health that perpetuates gender bias and prolongs the underfunding of gender-specific research? Where are we still falling short?
  • Addressing “full spectrum” of women’s health needs: Women’s health traditionally has focused on reproductive health. Has this emphasis led to a neglect of the full spectrum of women’s health needs? Can better health outcomes for women worldwide be secured without an accompanying transformation of the “gender gap” between men and women? Is changing the cultural and socio-economic status of women a public health challenge?
  • Reset of business model to solely focus on women’s health: Are life sciences companies and venture capital funders more –or less– engaged in women’s health now that a reset of the biopharma business model is underway after the pandemic? Is it possible to build a profitable, stand-alone business focused on women’s health?
Global_Warming_Air_Pollution
PANEL 2A
Global_Warming_Air_Pollution

9:05 AM - 10:05 AM

Climate Change & Health

Opening Remarks & Chair

Rohit Aggarwala
Commissioner for Climate Change, City of New York

PANELISTS
John Balbus
Deputy Assistant Secretary for Climate Change and Health Equity and Director, Office of Climate Change and Health Equity, U.S. Department of Health and Human Services
 
Awa Marie Coll-Seck
Galien Africa Chair, Former Senior Minister to the President of the Republic of Senegal, Former Minister of Health and Social Welfare
Ruxandra Draghia-Akli
Executive Leader in Life Sciences Innovation and Global Health; Chair of the Scientific Advisory Board, INTREPID Alliance 
 
Jodi Sherman
Associate Professor of Epidemiology in Environmental Health Sciences, Yale 
BPMs
PANEL 2B
BPMs

9:05 AM - 10:05 AM

PBMs, Pricing, Shortages, and Access

Chair

Zeke Emanuel
Vice Provost for Global Initiatives and chair of the Department of Medical Ethics and Health Policy, University of Pennsylvania

PANELISTS
Daniel Mendelson
CEO, Morgan Health, JPMorgan Chase & Co. 
 
Scott White
Chief Operations Office, North America, Johnson & Johnson Innovative Medicine

 

Janet Woodcock
Former Principal Deputy Commissioner, U.S. Food & Drug Administration

COFFEE BREAK

10:05 AM - 10:15 AM

Chair
Mental_Health-2
PANEL 3
Mental_Health-2

10:15 AM - 11:15 AM

Mental Health/Alzheimer’s

Co-Chairs

Joel S. Marcus
Executive Chairman & Founder, Alexandria Real Estate Equities, Inc./Alexandria Venture Investments; Co-Founder, Alexandria Summit; Board Director, Navy SEAL Foundation and National Medal of Honor Museum; Co-Founder, OneFifteen


Lynne ZydowskY
Chief of Science, Alexandria Real Estate Equities, Inc./ Alexandria Venture Investments; President & Co-Founder, Alexandria Summit

PANELISTS
Panelists TBC
Noubar Afeyan-1
FIRESIDE CHAT
Noubar Afeyan-1

11:15 AM - 11:45 AM

Exclusive fireside chat featuring Noubar Afeyan, CEO of Flagship Pioneering

MODERATOR

Michael Rosenblatt
Co-Chair, Galien Forum; Advisory Partner, Ascenta; and Senior Partner, Bain Capital Life Sciences and Flagship Pioneering

PANELIST

Noubar Afeyan
CEO of Flagship Pioneering

Bernard Poussot
PRIX GALIEN AWARDS CEREMONY
Bernard Poussot

11:45 PM - 12:30 PM

Tribute to Bernard Poussot followed by awards ceremony for the categories: Best Medical Technology, Best Digital Health Solution, Best Incubator/Accelerator/Equity and Best StartUp

Chair

Kenneth C. Frazier
Prix Galien USA Committee Chair for Medical Technology, Digital Health Solution, Incubators/Accelerators/Equity and Start-Up Categories; Former Executive Chairman, Board of Directors, Merck & Co., Inc

LUNCH BREAK

12:30 PM - 1:00 PM

Chair
Big_Biotech
PANEL 4A
Big_Biotech

1:00 PM - 2:00 PM

Big BioTech - Where Is It Going?

Chair

Phillip Sharp
1993 Nobel Laureate for Physiology or Medicine; Institute Professor and Professor of Biology Emeritus, Koch Institute for Integrative Cancer Research, MIT; Co-Chair of the Galien Forum

PANELISTS
Jay Bradner
Executive Vice President, Research & Development and Chief Scientific Officer, Amgen
 
Pushkal Garg
Chief Medical Officer and Executive Vice President, Development & Medical Affairs, Alnylam Pharmaceuticals
Jane Grogan
Executive Vice President and Head of Research, Biogen
 
George Yancopoulos
Board Co-Chair, President and Chief Scientific Officer, Regeneron Pharmaceuticals

 

Background and Topics for Discussion
 
One of the most important strategic shifts in the global medicines market is the significant role biotech companies now play through the entire cycle of new drug development, from initial target discovery to end-to-end commercialization and marketing. Small entrepreneurial enterprises launched by physician- scientists in the late 20th century aftermath of the DNA revolution have thrived. Today, these homegrown advocates of foundational science account for a major share of FDA approvals, particularly in emerging areas like regenerative medicine. As an example, just the four companies represented on this panel have within the past two decades brought to market no less than 15 world-class breakthrough-designated products; 14 of these each posted global “blockbuster” sales of more than $1 billion in 2023.

 

However, what has worked well to date is no guarantee against the uncertainties exposed by a pandemic that no one predicted, eroded what used to be the consensus on the positive role of science in society, and revealed major shortcomings in public health and institutions that support innovation. Responses in the form of a tougher pricing environment will force a significant realignment of priorities toward reimbursements where payers have the momentum. The most innovative gene-based therapies will need to work harder to earn a predicable rate of return, balancing the promise of a cure against the enormous up-front overhead risks assumed by the originator company in safely delivering the therapy to what is often a very small cohort of patients. Building in the technology to make these cost manageable is crucial to the future of patients benefiting from gene-based interventions. A focus on raising operational efficiencies include risk-based capital allocation, financial resilience, talent retention as well as the distractions of replacing legacy data systems with a radical, more strategic approach to information management. An agenda like this sounds much like the path forced over the past few years on an over-bureaucratized “big Pharma:” it raises the question, can the two players – big bio and big pharma – be that far apart?

 

Panelists will address these and other issues, including:

  • Evolution of the biotech business model since the founding of Genentech in 1976 to commercialize the nascent promise of recombinant DNA technology. Fifty years on, is drug biotech still an emerging industry in search of a sustainable revenue base? Is size, scale and reach the only feasible path to success in today’s era of expensive new science and growing payer consolidation?
  • Looking ahead to the end of this decade, what areas of biologic science applied to drug discovery offer the greatest potential in outcomes that are meaningful to patients and payers?
  • Can we expect AI-leveraged computation and large-scale data sets to serve as the cure-all to persistently high attrition rates in drug development? Or is it just one element in a larger scenario of progress?
  • Is VC and other investor funding streams aligned to the unpredictable payout cycles likely to occur in a fast-evolving therapeutic space? Is the government/regulatory community ready with the expertise, resources and policy commitments to incentivize private-sector risk in taking ground-breaking technologies to timely market approval, and beyond?
  • Managing the operational challenges of making breakthroughs in science more cost-effective, particularly in key areas like biologic drug manufacture and how novel platform therapies like Crispr can be delivered to patients in vivo. How soon will we move gene-editing and CAR-T cell therapy “over the finish line,” as the reliable standard of care for heritable diseases as well as for more common conditions?
  • Message to the next US Administration: what “big biotech” needs to keep succeeding for patients.
MASH-NASH
PANEL 4B
MASH-NASH

1:00 PM - 2:00 PM

From NASH to MASH

Chair

Alan Moses
Member, Board of Trustees, Joslin Diabetes Center, Beth Israel Lahey Health

PANELISTS

Stephen Gough
Global Chief Medical Officer and Senior Vice-President, Novo Nordisk A/S


Anthony Hollenberg
John Wade Professor of Medicine, Boston University School of Medicine


Daniel Skovronsky
Chief Scientific Officer and Executive Vice-President for Science and Technology; President, Lilly Research Laboratories and President, Lilly Immunology, Eli Lilly & Company

Ira Tabas
Richard J. Stock Professor and Vice-Chair of Research, Department of Medicine, Columbia University Irving Medical Center


Søren Tullin
Senior Vice President and Global Head of Cardio/Metabolic Diseases Research,
Boehringer Ingelheim

Background and Topics for Discussion 

Research to understand the complex biologic and lifestyle factors that contribute to chronic disease is opening new doors for medicines linked to the human condition known as metabolic syndrome. The syndrome underlies or contributes to numerous debilitating diseases which often appear in patients simultaneously, making research, diagnosis and treatment more challenging. 

A prominent example of clinical progress in this area is a new generation of incretin hormones (GLP-1 receptor agonists, dual (GLP-1 and GIP) agonists, and other combinations) medicines originally developed to improve glucose control in diabetes that now show much broader efficacy as pharmacologic approaches to overweight and obesity. The fact that obesity is a foundational condition associated with diverse health risks beyond diabetes (as many as 200, according to some estimates) means these new drug classes – and potentially others on the horizon – will add to our therapeutic armamentarium against metabolic syndrome. Even modest research breakthroughs in this area not only will contribute to improved health for individual patients but have the potential to contribute to improvements in population-wide health outcomes as well as easing the burden metabolic diseases place on scarce health resources.

Today’s panel focuses on a proliferating but still “under the radar” liver disorder, Metabolic Dysfunction-Associated Steatohepatitis (MASH). It’s a new name (replaceing the term NASH) for an existing condition that is both deadly and largely asymptomatic. Patients with MASH experience a progressive metabolically driven build-up of excess fat in the liver, resulting in inflammation and cell death that progresses to fibrosis and scarring that can lead to cirrhosis. Advanced cirrhosis may eventually necessitate a transplant as the only option remaining to prevent death. Today, an estimated 22 million US adults are living with MASH and its related stages and co-morbidities. A large proportion of victims have yet to be formally diagnosed or are not receiving treatment. Awareness of MASH as a mortality risk and public health threat remains low, an unfortunate situation because the disease can often be prevented entirely through lifestyle changes and behaviors before the need for pharmacologic intervention. 

With such statistics in mind, clinicians are working to clarify the nomenclature for diagnosing and managing this disease. In 2023, a joint collaboration between hepatology clinicians and patient groups proposed that the disease’s existing name, Non-Alcoholic Steatohepatitis (NASH) be dropped, on grounds that the “non-alcoholic” label failed to accurately define the disease as the “hepatic manifestation of metabolic syndrome.” MASH (and its accompanying label for less severe forms of the disease, Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) also removes the “stigmatization” linked to the previous label’s indirect reference to excess consumption of alcohol. Likewise, the existing shorthand characterizing a milder version of this disease, Non-Alcoholic “Fatty Liver” Disease (NAFLD) was abandoned for seemingly targeting obese patients to the exclusion of others who might benefit from treatment. 

The new designations mark a turning point in securing greater awareness among patients, clinicians and the public about the many dangers of MASH and the burden it imposes on the health system. MASH is the leading cause of the steep rise in costly liver transplants in the US: more than 10,000 were performed in 2023 alone. More important, seemingly unrelated co-morbidities from MASH ranging from heart disease, type 2 diabetes, solid tumor cancers and even neurocognitive decline also can result in death. In fact, patients with MASH/MASLD are twice as likely to die of cardiovascular diseases (CVD) than from liver failure. 

In recent years, the complexity of MASH as a research target and the challenges of clinical development programs persuaded a number of leading drugmakers to abandon development programs in this disease area, with numerous candidates failing in early development. This situation now is changing as the insights around metabolic signaling derived from the GLP-1 agonist class bear fruit. 

In March, the FDA granted the small biotech Madrigal Pharmaceuticals conditional approval to Rezdiffra (resmetirom), a thyroid hormone beta receptor agonist for adults with noncirrhotic non-alcoholic steatohepatitis characterized by moderate to advanced liver scarring (fibrosis). The first treatment that directly addresses the liver damage that can lead to liver failure and death, Rezdiffra bears a requirement for use only in conjunction with a lifestyle regimen of diet and exercise; clinical benefit must also be reaffirmed on completion of another 54-month clinical trial. Multiple other biotechnology and biopharmaceutical companies including three represented on this panel (Boehringer-Ingelheim, Eli Lilly & Co. and Novo-Nordisk A/S) have MASH candidates in development , all of which build on the potential of their vastly successful GLP-1 weight loss molecules. 

Topics our six-member expert panel may address include: 

  • Identify and assess the most promising biologic pathways toward treating and curing MASH/MASLD. Is big pharma and biotech on course to “crack the code” on metabolic syndrome? 
  • Define the principal barriers to the approval of novel drug therapies for MASH/MASLD from a discovery, development, regulatory and patient access perspective. Do the potential financial returns justify the investments in R&D? 
  • Identify the challenges in providing better diagnostics to screen, identify and track MASH/MASLD. Are current clinical practice guidelines adequate to the task of differentiating among the many facets of this condition?
  • What strategies are necessary to build awareness of MASH/MASLD and assure patient behavior changes are introduced early enough to prevent liver failure as the ultimate end point of disease? Is losing weight the single best response to reversing the course of disease? 
CEO_Panel-2
PANEL 5
CEO_Panel-2

2:00 PM - 3:00 PM

CEO Panel

Co-Chairs

Petra Jantzer
Senior Managing Director, Global Industry Sector Lead – Life Sciences, Accenture

 

Michael Rosenblatt
Galien Forum Co-Chair; Advisory Partner, Ascenta; and Senior Partner, Bain Capital Life Sciences and Flagship Pioneering

PANELISTS

John F. Crowley
President & CEO, The Biotechnology Innovation Organization 

 

Chris Viehbacher
CEO, Biogen

Other panelists TBC

MRNA
PANEL 6A
MRNA

3:05 PM - 4:05 PM

mRNA vs. Gene Therapy

Co-Chairs

Mikael Dolsten
Chief Scientific Officer & President, Worldwide Research, Development and Medical, Pfizer

PANELISTS

Katherine High
Board Director, CRISPR Therapeutics

 

Zhen Li
CEO, ADARx 

 

Rose Loughlin
Senior Vice President, Research & Early Development. Moderna

Other panelists TBC

AI
PANEL 6B
AI

3:05 PM - 4:05 PM

Artificial Intelligence

Chair

Zak Kohane
Chair of the Department of Biomedical Informatics, Harvard Medical School

PANELISTS

Michelle Longmire
Co-founder & CEO, Medable

 

Chris Mansi
CEO and Co-Founder of Viz.ai

Other panelists TBC

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