The Galien Foundation
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2026年6月11日(木)

ロンドン・サイエンス・ミュージアム

変革される未来の医療:発見から提供まで

新興技術、AI革命、そして質の高いマルチチャネル医療データへのアクセスは、医療イノベーションを絶えず変革し続けています。2026年ガリエン・フォーラムでは、科学、技術、政策、そして患者コミュニティのリーダーたちが一堂に会し、よりパーソナライズされた、予防的で公平な医療ソリューションの推進について、未来を見据えた議論を交わしました。また、新たなアプローチが革新的な治療法やモダリティの開拓に不可欠であると同時に、規制当局、支払者、そしてイノベーターに対し、医療の未来を再考するよう促す課題についても議論されました。
今後の機会と課題の両方が浮き彫りになったものの、議論そのものが重要な転換点となりました。イノベーション、分野横断的な連携の加速、そして世間の注目が、世界の医療に対する私たちの認識を形作る上で不可欠となるでしょう。

プログラム


2024 Program


Mike Rosenblatt
OPENING REMARKS
Mike Rosenblatt

7:40 AM - 7:45 AM

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

 

Womens_Health
PANEL 1
Womens_Health

7:45 AM - 9:00 AM

Women’s Health / Generational Health

Chair

Julie Louise Gerberding
President and Chief Executive Officer, Foundation for the National Institutes of Health

PANELISTS
Diana W. Bianchi
Director, Eunice Kennedy Shriver, National Institute of Child Health and Human Development, NIH
 
Mary-Ann Etiebet
President and Chief Executive Officer, Vital Strategies
 
Elizabeth I. O. Garner
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?
Global_Warming_Air_Pollution
PANEL 2A
Global_Warming_Air_Pollution

9:05 AM - 10:05 AM

Climate Change & Health

Opening Remarks & Chair

Rohit Aggarwala
Chief Climate Officer, 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
Chair of the Galien Africa; Former Senior Minister to the President of the Republic of Senegal; Former Minister of Health, Republic of Senegal

Ruxandra Draghia-Akli
Executive Leader in Life Sciences Innovation and Global Health; Chair of the Scientific Advisory Board, INTREPID Alliance 
 
Jodi Sherman
Co-Chair, Lancet Commission on Sustainable Healthcare, Yale
Panel Background:

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?    
BPMs
PANEL 2B
BPMs

9:05 AM - 10:05 AM

BioPharma Pressure Points: PBMs, Pricing, Access, and the Global Supply Chain

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
Ariel Katz
Co-founder and Chief Executive Officer, H1 
 
Daniel Mendelson
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
Ken Frazier
PRIX GALIEN AWARDS CEREMONY
Ken Frazier

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
Big_Biotech
PANEL 4A
Big_Biotech

1:00 PM - 2:00 PM

Big BioTech - Where Is It Going?

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
Ray Dehaies
Senior Vice President Global Research Emeritus, Amgen 
 
Pushkal Garg
Chief Medical Officer and Executive Vice President, Development & Medical Affairs, Alnylam

Jane Grogan
Executive Vice President and Head of Research, Biogen
 
George D. Yancopoulos
Board Co-Chair, President and Chief Scientific Officer, Regeneron

 

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.
OPENING_REMARKS_MUNIR_PIRMOHAMED
開会の挨拶
OPENING_REMARKS_MUNIR_PIRMOHAMED

午前9時30分~午前9時40分

ガリエン賞英国委員長

ムニール・ピルモハメド教授(医学士(優等学位)、博士、英国王立内科医協会フェロー、英国王立内科医協会フェロー(イングランド)、英国王立医学会フェロー、英国王立内科医協会フェロー、英国王立医学会フェロー、英国王立医学会フェロー、王立医学博士)
リバプール大学医学部デイビッド・ウェザロール記念講座教授

Molecular_Innovation_icon
パネル1
Molecular_Innovation_icon

午前9時40分~午前10時45分

変革される「発見」:分子イノベーションの次なるフロンティア

椅子

アン・マリー・マーティン博士
GSK社 オンコロジー・トランスレーショナル・メディシン担当シニア・バイス・プレジデント

PANELISTS

カリン・コンデ=クナップ博士(PhD)
Valo Health社 最高科学責任者(CSO)

 

エリザベス・シュワルツバッハ博士(PhD)
BigHat Biosciences社 最高事業責任者(CBO)

 

ルパート・ヴェッシー博士(BM, BCh, DPhil, FRCP)
フラッグシップ・パイオニアリング社 チーフ・サイエンティスト兼エグゼクティブ・パートナー

 

ポール・ワークマン教授(OBE、PhD、FRS)
ハロップ記念薬理学教授、元がん研究所(ICR)所長兼最高経営責任者(CEO);CRUK小児脳腫瘍センター・オブ・エクセレンス(ICR・ケンブリッジ大学)共同ディレクター;ケミカル・プローブ・ポータル(Chemical Probes Portal)ディレクター

背景と議論の論点:
創薬は今、ここ数十年で最大となる手法の転換期を迎えています。AIが設計した分子が臨床試験段階に入り、空間生物学、オルガノイド、マルチオミクスといった新たなツールによって、疾患の生物学的メカニズムがかつてない解像度で解明されつつあります。治療法の選択肢も、従来の低分子医薬から、多重特異性抗体、分解誘導剤(デグレーダー)、遺伝子治療アプローチへと拡大しており、この分野はまさに重要な転換点にあります。AIに対する当初の熱狂は、単なる既存ワークフローの自動化や、多大なリソースを投じる前の計算予測の検証といった段階を超え、より本質的な課題の探求や創薬プロセスの加速へと成熟しつつあります。一方で、細胞の微小環境を可視化し、遺伝子型と表現型を極めて詳細に関連付けることが可能になった今、私たちはその複雑さを活用するのではなく、むしろその複雑さに圧倒されてしまうリスクにも直面しています。

 

  • こうした進歩は実際に成功率を向上させるのでしょうか、それとも、変わることのない確率に対して単に複雑さを加えているだけなのでしょうか。

  • 第II相試験における開発中止率は、依然として依然として高い水準にとどまっています。前臨床データからヒトでの有効性を予測するという根本的な課題は、未だ解決されていません。こうした新しいアプローチのうち、真にそのギャップを埋めつつあるのはどれでしょうか。それとも、単に変わらぬ基盤の上に、洗練された新たな層を付け加えているに過ぎないのでしょうか。

Clinical_Trials_icon
パネル2
Clinical_Trials_icon

午前11時15分~午後12時20分

変革される臨床試験:よりスマートな設計、より適切な意思決定、より迅速な実施

椅子

メル・ウォーカー博士(BPharm, PhD)
Access InVivo社 CEO

パネリスト

チンメイ・バット氏
ノバルティス グローバル・ドラッグ・デベロップメント
戦略・ポートフォリオ・プログラム・オペレーション責任者

 

ジェーン・モーズリー博士(PhD)
欧州医薬品庁(EMA)科学的助言室 上級科学担当官


マーク・ワーナー博士(PhD)
Faculty AI CEO兼共同創業者

 

サラ・ゾハール教授(PhD)
HeKAプロジェクト責任者、フランス国立保健医学研究機構(Inserm)研究ディレクター

背景および議論の論点:
臨床試験は依然として、医薬品開発において最も多額の費用と時間を要し、かつ失敗のリスクが高い段階にあります。適応型デザイン、AIを活用した最適化、分散型臨床試験(DCT)の要素、そして合成対照群(synthetic control arms)の導入は、いずれも変革をもたらす可能性を秘めていますが、試験的なイノベーションと本格的な社会実装との間には、依然として大きな隔たりがあります。重要な局面においては、構造的な要因も相まって、スポンサー(開発企業)は従来型の手法を選択する傾向にあります。

 

  • 証拠の質を落として時間を短縮するのではなく、各段階で得られる情報を最大限に活用しながら、近道に頼ることなく、どのようにプロセスを加速させるか。

  • 単にスケジュールの短縮にとどまらず、真に成功率を向上させているイノベーションはどれでしょうか。 

  • 孤立した実験の段階から、体系的な変革へと移行するには、何が必要なのでしょうか。




KEYNOTE_ARA_DARZI
KEYNOTE
KEYNOTE_ARA_DARZI

12:55 PM - 1:45 PM

Prof. Ara Darzi, Baron Darzi of Denham, Paul Hamlyn Chair of Surgery and Co-Director of the Institute of Global Health Innovation at Imperial College London

Keynote

Prof. Ara Darzi,
Baron Darzi of Denham
Paul Hamlyn Chair of Surgery and Co-Director of the Institute of Global Health Innovation at Imperial College London



Sally Davies
基調
Sally Davies

午後1時15分~午後2時00分

AMR(薬剤耐性)から学ぶ教訓:政策と「節約型イノベーション(frugal innovation)」の活用によるグローバルヘルスへの貢献

基調

サリー・デイヴィス教授(デイム・サリー・デイヴィス)
英国政府AMR(薬剤耐性)担当特使、ケンブリッジ大学トリニティ・カレッジ学寮長



Regulation_Reinvented_icon
パネル3
Regulation_Reinvented_icon

午後2時25分~午後3時20分

規制の刷新:承認の迅速化と患者の安全性の向上

椅子

ローレンス・タロン氏
医薬品・医療機器規制庁(MHRA)長官

パネリスト

アラステア・デニストン教授(MBBChir, MRCP, FRCOphth, PhD)
バーミンガム大学 規制科学・イノベーション講座 教授;保健研究局(HRA) 非業務執行取締役;Health Data Research UK AI戦略アドバイザー;AI・デジタルヘルス技術規制科学センター・オブ・エクセレンス(CERSI-AI) センター長


ペトラ・ドール博士
欧州医薬品・ヘルスケア品質理事会(EDQM)局長

 

ヨハンナ・フルヘルム博士、博士
カロリンスカ研究所 AI イノベーション センター ディレクター


ヒラリー・マローン博士(PhD)
Corrixr Therapeutics社 CEO

 

背景と議論のテーマ:
申請件数の複雑さと量は審査能力を上回るペースで増加しており、製品自体(AIを活用した診断、適応型治療、医薬品・医療機器複合プラットフォームなど)も、個別の静的な介入を想定して設計された枠組みにますます負担をかけています。規制当局は、イノベーションを促進し、危害を防止するために、より迅速に、より多くの案件を捕捉することが求められています。これに対し、様々な試みが展開されています。規制当局は、AI支援型審査ツールの試験運用、実世界データの安全性監視への統合、適応型ライセンスモデルの検討、計算評価における新たな能力の構築に取り組んでいます。国際的な調和に向けた取り組みは効率化を約束するものの、その進捗状況はまちまちです。

 

  • 規制は十分に迅速に変化し得るのか。また、その変化は意思決定を真に改善するものとなるのか、それとも単に既存の限界を助長するだけなのか。

  • 私たちは、変わらないパラダイムを最適化しているのでしょうか、それともそれを真に変革しているのでしょうか。

 
Precision_Medicine_icon
パネル4
Precision_Medicine_icon

午後3時45分~午後4時50分

精密医療の実現:ゲノム医療の可能性から患者への貢献へ

椅子

サー・ハルパル・クマール(MBA、FMedSci)
Grail社 最高科学責任者 兼 国際事業担当プレジデント

PANELISTS

アンナ・ドミニチャク教授(DBE, MD, FRCP, FAHA, FRSE, FAMSci)
スコットランド担当チーフ・サイエンティスト、グラスゴー大学レジウス医学教授

 

デビッド・ハルクープ博士(PhD)
Open Targets エグゼクティブ・ディレクター 兼 EMBL欧州バイオインフォマティクス研究所(EMBL-EBI) 産業連携部門長

 

トム・ラインズ博士(DSc)
Quercis社 CEO

 

ジュリー・マカニ教授(MD, PhD, FRCP, FTAAS)
ムヒンビリ保健・関連科学大学(MUHAS)およびSickleInAfrica臨床調整センター 教授;在英国タンザニア高等弁務官事務所および東・中央・南部アフリカ保健委員会(ECSA-HC) 科学顧問

背景および議論の論点:
プレシジョン・メディシン(精密医療)は、個人の遺伝的特性や疾患の経過に合わせた個別化治療の実現を約束するものですが、この構想を臨床の現場で現実のものとするには、新たな診断技術、規制上の承認プロセス、そして医療提供モデルが必要となります。鎌状赤血球症は、この取り組みにおける重要な試金石となっています。CRISPRを用いた遺伝子治療から、合併症リスクに応じて患者を層別化する精密診断に至るまで、鎌状赤血球症への対応は、ゲノム医療の成果を研究室から患者ケアへと応用する取り組みにおいて、最も進んだ事例の一つと言えます。

  • つい最近まで選択肢が限られていた疾患に対し、根治的治療法はどのように転帰を塗り替えつつあるのでしょうか。

  • これらの治療を安全かつ効果的に提供するためには、患者の選定やモニタリングにおいてどのような革新が必要でしょうか。

  • また、歴史的に深刻な健康格差に直面してきた、鎌状赤血球症の影響を最も受けている人々に対して、公平なアクセスをどのように確保すればよいのでしょうか。

  • この変革から得られた教訓は、他の遺伝性疾患や複雑な疾患を対象としたプレシジョン・メディシン(精密医療)への道筋を切り開いています。

CLOSING_REMARKS
閉会の辞
CLOSING_REMARKS

午後4時50分~午後5時00分

PRIX GALIEN COMMITTEE Chair

Pr Sir Munir Pirmohamed
David Weatherall Chair of Medicine, University of Liverpool

AWARDS

ガリエン英国賞授賞式

AWARDS
午後7時30分~午後10時:ロンドン自然史博物館

基調講演: ジョン・アーン・ロッティンゲン博士、MD、PhD、ウェルカム CEO。ガリエン橋賞委員会委員

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