THURSDAY 5 JUNE, 2025
SCIENCE MUSEM, LONDON
Detailed programme to be released soon. Stay tuned!
2024 Program
GALIEN FORUM CO-ChairS
Michael Rosenblatt
Galien Forum Co-Chair; Prix Galien Committee Chair (Categories: Pharma, Biotech, Rare/Orphan); Advisory Partner, Ascenta Capital; Senior Advisor to Bain Capital Life Sciences and Flagship Pioneering
Phillip A. Sharp
Nobel Laureate; Galien Forum Co-Chair; Institute Professor and Professor of Biology Emeritus, Koch Institute for Integrative Cancer Research, MIT
Chair
Julie Louise Gerberding
President and Chief Executive Officer, Foundation for the National Institutes of Health
PANELISTS
Director, Eunice Kennedy Shriver, National Institute of Child Health and Human Development, NIH
President and Chief Executive Officer, Vital Strategies
Former Chief Scientific Officer, Ferring US; Immediate Past President, American Medical Women’s Association
Sandra Milligan
President, Aspira Women's Health, Organon
Sans Thakur
Founder and Chairwoman of TOWER Capital Group and the pioneer of Generational Health
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?
Opening Remarks & Chair
Rohit Aggarwala
Chief Climate Officer, City of New York
PANELISTS
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
Chair of the Galien Africa; Former Senior Minister to the President of the Republic of Senegal; Former Minister of Health, Republic of Senegal
Executive Leader in Life Sciences Innovation and Global Health; Chair of the Scientific Advisory Board, INTREPID Alliance
Co-Chair, Lancet Commission on Sustainable Healthcare, Yale
Climate change is disrupting the contours of human health in ways that are only now being assessed and quantified. The markers of mortality and morbidity are legion, from heat-related illnesses that contribute to edema and cardiovascular failure; respiratory ailments like asthma and allergies from airborne pollutants; fatalities, injuries, mental illness and habitat loss from severe weather events; changes in vector ecology that spread malaria, dengue fever and a host of other pathogens while enhancing prospects for zoonotic disease transmission; water quality impacts, led by cholera; and increased malnutrition induced by climate pressures on the natural environment, farming and the food supply.
In May, the World Health Assembly (WHO) reiterated its position on climate change as humanity’s single biggest health threat, forecasting 250,000 additional deaths per year worldwide between 2030 and 2050. The WHO estimates that direct damages to health system infrastructure from extreme weather events alone will total $4bn annually by 2030, a trend destinated to waylay the organization’s plans to introduce a basic global platform of universal health coverage, including access to affordable essential medicines for all, the same year.
Vulnerable populations like the poor, children and the elderly will be disproportionately affected. Beyond the documented income losses, climate change undermines many of the basic social determinants of health, such as equality and access to care as well as the local community support structures that act as a hedge against economic displacement and mass migration.
Pressure is mounting on business and the private-sector to do more to address climate change. The Intergovernmental Panel on Climate Change (IPCC) has resolved that, to avert a truly catastrophic trajectory to unsustainable weather patterns, action must be taken now to limit carbon emissions and prevent further rises in global temperature by no more than 1.5 C by 2050. Accomplishing this goal depends heavily on the private-sector to help finance a global “green transition” tied to major new investments in renewable, zero-carbon energy technologies that don’t rely on fossil fuels. The IPCC now estimates $2.4 trillion a year in combined global and country financing/investment commitments will be needed well into the next decade to jump start the transition.
There is also an expectation that at least a part of this investment be earmarked for countries of the global south, with the preferred vehicle being public-private partnerships involving key multilateral lenders like the World Bank. The idea is to leverage such partnering as a way to “de-risk” the exposure for companies investing in geographies where business confidence is low.
The health impacts of climate change pose particular challenges for the pharma and biotech sector. The extensive global supply chains that big pharma companies rely on in the manufacture and distribution of medicines have led to scrutiny by climate change advocates, who are demanding a higher level of “resource stewardship” from management. There is also pressure on the shareholder front to ramp up environmental disclosures and compliance under voluntary company ESG commitments.
More important, government regulators like the US Securities and Exchange Commission (SEC) and the European Commission are moving forward with plans for even more transparency on industry actions to address climate change. The SEC rule mandates public companies to report annually on carbon emissions levels, exposure to risks from global warming and the status of strategies to address it. The EU rule is more prescriptive and calls for evidence on how the company business model and commercial strategies are compatible with the climate reduction provisions of the 2015 Paris Agreement of the UN Framework Convention on Climate Change, including impacts on atmospheric pollution; water and marine resources; and land-based biodiversity and ecosystems – at every step of the company value chain.
Overall, climate change makes for more uncertainty for big pharma in operating an essential complex business with numerous customer touchpoints, at scale and across diverse geographies. Extreme weather conditions alone promise supply bottlenecks and product shortages from the loss of manufacturing capacity around temperature-sensitive products with limited shelf life. Long term, the industry will have to confront external demands for changes in its R&D portfolio, in some cases for conditions accentuated by climate change that carry a lower profitability ratio than other disease areas. Finally, coping with these climate-related risks will require significant new investments in due diligence and hazard avoidance capabilities, extending deep into the third-party supply and support networks where compliance has always been hard to establish.
Topics for Discussion:
- Current state of academic and institutional research on the relationships between climate change and human health – what does the evidence show? Real world implications for health status, public health provision and disease spread if countries fail to meet UN Paris Convention commitments to limit growth in fossil fuel emissions by 2050.
- Scientific researchers have found a way for plant seeds to effectively fertilize themselves, a discovery with the potential to reduce reliance on fossil fuel-based fertilizers in agriculture. Are there similar impactful innovations underway to address the harmful effects of climate change on disease and other key public health parameters?
- In the US, just under 10% of our national carbon footprint can be attributed to business practices of the health care industry. Is the industry moving at an appropriate pace to lower its carbon profile? What additional actions can the pharmaceutical and biotech sector take to address the challenge? Do the standardized company reporting guidelines that allow the public to assess and compare progress on climate change act as an incentive or as a burden, in terms of doing more?
- Is the international negotiating framework now in place for addressing climate change sufficiently enabled to tackle the public health aspects of the threat? Are government negotiators sufficiently aware of the private-sector’s commitment and contributions to meeting climate-related targets?
- Africa is a relatively poor continent which contributes marginally to global warming but whose livelihoods are disproportionally damaged by its effects. What can the region’s experience tell us about what works and what doesn’t in addressing what is now an existential global challenge? Is progress simply an issue of extracting more concessional aid through a revamp of the current international financing system? What can we learn from local approaches built around community awareness and empowerment? Can the continent achieve a better balance between exploiting abundant extractive industry resources and transitioning to greener, renewable technologies?
Chair
Ezekiel J. Emanuel
Vice Provost for Global Initiatives; Co-Director, Healthcare Transformation Institute; Diane v.S. Levy and Robert M. Levy University Professor; Perelman School of Medicine and The Wharton School; University of Pennsylvania
PANELISTS
Co-founder and Chief Executive Officer, H1
Chief Executive Officer, Morgan Health, JPMorgan Chase & Co.
John M. O'Brien
President and Chief Executive Officer, National Pharmaceutical Council
Janet Woodcock
Former Principal Deputy Commissioner, U.S. Food & Drug Administration
Background and Topics for Discussion:
Health care in the US continues to adapt to the structural weaknesses exposed by the Covid-19 pandemic. Industry has responded with initiatives to consolidate market positions and test out new business models, all with the aim of mastering a moving chessboard of competitive challenges. These include reducing cost exposures, realigning business operations to achieve the long-awaited “digital transformation” and fending off inroads from adjacent players seeking a foothold in an opportunity-rich sector that now accounts for almost one-fifth of US GDP.
Also demanding industry attention is the pandemic’s effect on government involvement in health care. The Biden Administration has positioned access to health as a right, not a privilege, advancing an expansive post-Covid legislative agenda focused on lowering prescription drug costs and insurance premiums; enhancing coverage under the subsidized insurance marketplace option provided through the 2010 Affordable Care Act; more federal funding for the low-income federal-state Medicaid program; and an aggressive legal stance on anti-competitive behaviors. Still in play is a bipartisan congressional effort to impose more transparency on the business practices of the pharmacy benefit manager (PBM) segment that most private-sector employers rely on to manage drug benefit costs – and where three giant PBM companies now control 80% of the US market.
Big pharma companies are uniquely exposed to provisions enacted in the 2022 Inflation Reduction Act (IRA) which, for the first time, grants the federal government’s Medicare program for seniors authority to negotiate with individual drugmakers the price of the most profitable and widely used branded medicines prescribed to patients. This, in addition to a steep upward revision of drug manufacturers’ percentage-based cost-sharing contributions to reimbursement under Medicare, means that companies face a much more difficult (and ultimately less profitable) set of calculations in deciding whether to participate in a program that currently accounts for slightly more than half of overall prescription drug sales in the US. The concern is that the growing weight of government on the industry will “bleed” to the employer-driven commercial payer side.
Taken together, such changes carry the potential to shift US health care markets, policy and regulation in new, unanticipated directions. The big question for this moment is whether the industry playbook has changed as well.
Panelists will discuss these and other issues, including:
- Defining the new US healthcare and medicines innovation landscape in the aftermath of Covid-19. What has changed in the calculations required to deliver revenue growth and profitability to industry shareholders and meet the expectations of policy-makers and the public at large?
- Ways in which a soaring post-Covid public debt load and mounting federal spending deficits will shape the US health reform debate. What measures are needed to preserve current standards of patient care and fund new drug research and other drivers of medical innovation, where the US leads the world? Will the piercing of the $1 million per drug barrier for gene therapies lead to a more expansive interpretation of accessibility, one based on the lifetime value of a cure?
- How will the Biden Administration’s expanded government role in health care financing and delivery play out? Are the impacts of the sweeping 2022 IRA legislation on negotiated Medicare drug pricing sufficiently understood by industry and the public?
- Viewed from another perspective, can the FDA maintain its independence as industry regulator in a drastically more politicized decision-making environment in Washington?
- Most working Americans receive health care benefits through private-sector commercial insurance plans. What innovations are taking place in this sector to tackle rising employer cost contributions while maintaining the competitive benefits that workers expect? Is the PBM controlled network pharmacy and formulary model down for the count?
- There is an emerging bipartisan consensus to force more transparency on drug pricing and other, often opaque, commercial business practices within the industry overall. What impact will this year’s election have in charting the way forward – and what does it mean for the future of new drug development? Is the US longtime status as preferred first country of launch in jeopardy?
- Geopolitical risk has emerged as a top issue for the biopharma C-suite – unanticipated disruptions in the global pharma supply chain is just one threat now on the table. What role should regulators and drug companies play in reversing the sharp rise in drug shortages (which reached a record high in the last quarter of 2023) that harm vulnerable patients? What’s the next step toward joint risk management and regulatory harmonization across the entire supply chain, involving all the key country sources of medicines worldwide?
- Hazard a guess: will the US health system look more like those of western Europe in 2030? Will investing decisions on US drug innovation remain in private-sector hands or in a more dispersed “social partnership” model?
COFFEE BREAK
10:05 AM - 10:15 AM
Chair
PRIX GALIEN AWARDS CEREMONY
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
MASTER OF CEREMONY
Kenneth C. Frazier
Prix Galien Committee Chair (Categories: Medtech, Digital Health, IAE and Startup); Retired Chairman and Chief Executive Officer, Merck & Co., Inc.; Chairman, Health Assurance Initiatives, General Catalyst
LUNCH BREAK
12:30 PM - 1:00 PM
Chair
Chair
Phillip A. Sharp
Nobel Laureate; Galien Forum Co-Chair; Institute Professor and Professor of Biology Emeritus, Koch Institute for Integrative Cancer Research, MIT; Co-Chair of the Galien Forum
PANELISTS
Senior Vice President Global Research Emeritus, Amgen
Chief Medical Officer and Executive Vice President, Development & Medical Affairs, Alnylam
Executive Vice President and Head of Research, Biogen
Board Co-Chair, President and Chief Scientific Officer, Regeneron
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.
TOP SCIENTISTS & KOL
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