What Does Brexit Mean for Health Care and Medical Research?

Panel Overview and Ecosystem Shift

• The panel highlights a paradigm shift in biomedical research from isolated silos to collaborative "end-to-end" integration across academia, industry, regulators, and patients.
• Participants note that historical secrecy and regulatory barriers have largely been replaced by pre-competitive collaboration, driven by the necessity of solving complex diseases like Alzheimer's where individual failures occurred.
• A core theme is the "externalization of innovation," where large pharmaceutical companies are shrinking internal R&D capacity to seek partnerships with academia and biotech firms globally.
• The Innovative Medicines Initiative (IMI) exemplifies this shift with a €5 billion commitment over 20 years to fund collaboration between the European Commission and private pharmaceutical industry.
• The European Lead Factory project demonstrates this new model by pooling compound libraries from seven major pharmaceutical companies and academic institutions into a €180 million shared asset for SMEs and researchers.

Panelist Perspectives and Career Trajectories

• Annalisa Jenkins (CEO, Dimension Therapeutics):
  • Transitioned from cardiologist and military medical officer to global R&D leadership roles at Bristol Myers Squibb and Merck Serono.
  • Launched a gene therapy company focusing on liver disorders and hemophilia using adeno-associated viruses, citing the convergence of genomic insights and viral vector technology as a revolutionary moment.
  • Emphasizes that risk equity and capital flow in the U.S. have accelerated the translation of basic biology into therapies for rare disorders.
• Isabel Mugon (European Medicines Agency):
  • Traced the evolution of regulatory culture from total secrecy 25 years ago to today's routine collaboration with patients and healthcare professionals.
  • Notes that 17% of new medicines originate from academia, prompting the EMA to reduce regulatory burdens on academic innovators.
  • Stresses that patient and professional input is now standard in scientific advice, product evaluation, and review of patient information leaflets.
• Aisling Vernon (Association of Medical Research Charities):
  • Observes that patient communities are reshaping research strategies, such as Arthritis Research prioritizing symptom management (pain, fatigue) alongside the pursuit of cures.
  • Highlights the rise of "patient power," driven by groups uniting around specific disease needs, forcing charities and academia to adapt their funding strategies.
  • Identifies "consumer behavior" and patient needs as the new north star, mirroring shifts in other industries like retail and consumer tech.
• Pierre Moulian (Innovative Medicines Initiative):
  • Advocates for aligning regulatory approval, health technology assessment (HTA), and reimbursement to shorten time-to-patient access.
  • Cites the failure of parallel, siloed drug development for Alzheimer's as a catalyst for shared clinical trial designs and cross-industry cooperation.
  • Argues that the industry must move from measuring scientific outcomes to measuring patient or carer outcomes to satisfy payers and regulators.

Impact of Brexit and Political Volatility

• UK Research Community: The UK life science sector was overwhelmingly in favor of remaining in the EU due to the borderless nature of medical research and collaboration.
• Government Response: The UK government has announced an additional £2 billion for research and innovation and is developing a new industry strategy to maintain the sector's global standing.
• Capital and Workforce: Annalisa Jenkins identifies three critical capitals at risk or needing protection: human capital (academic workforce), financial capital (cross-border investment), and knowledge (freedom to share data).
• Continuity of Collaboration: Pierre Moulian and Isabel Mugon state that the IMI and EMA are maintaining "business as usual," actively encouraging UK partners to continue applying for programs as the UK remains a major beneficiary.
• Future Outlook: The consensus is that while political changes create challenges, the fundamental need to cure diseases requires the UK to maintain its collaborative ecosystem with Europe and globally.

Integration with Healthcare Systems and Data

• Real-World Evidence (RWE): There is a growing push to utilize electronic health records and registries (e.g., 60 million UK records) to monitor post-market drug safety and usage patterns.
• NHS Role: The NHS is increasingly viewed as a valuable partner for clinical research, with policy shifts opening access to patient populations and academic health science networks.
• Pilot Success: The GSK trial with the National Institute for Health Research in Salford demonstrated success in using RWE to link GP, pharmacist, and hospital data to identify asthma and COPD treatment gaps.
• Technology Integration: The panel urges the inclusion of med-tech, imaging, and ICT companies in biomedical partnerships to accelerate innovation, noting that the pharmaceutical industry has historically lagged in adopting such technologies.
• Digital Disruption: A case study of "NUCO" (Mousera) illustrates how tech investors are creating fully digital vivariums, using cloud data and AI to revolutionize pre-clinical rodent testing while improving animal welfare.

The Evolving Role of Patients and Advocacy

• Regulatory Shift: The US FDA now views the absence of patient advocacy groups as a strategic disadvantage in drug development, signaling a fundamental change in regulatory culture.
• Integration Timing: Patients demand engagement at the beginning of development programs rather than as a "box-ticking" exercise at the end of the process.
• Transparency: Panelists emphasize that interactions between industry and patients must be transparent to mitigate compliance concerns and build trust.
• Advocacy Risks: A reference to the Sarepta/DMD approval in the US serves as a cautionary tale, prompting discussions on balancing patient pressure with independent regulatory assessment of risk/benefit ratios.
• European Approach: The EMA integrates patients early in the development timeline to ensure continuous understanding of the decision-making process, reportedly avoiding the extreme pressures seen in the US.
• Digital Engagement: There is a move toward "patients in the wild" rather than just "patients in a zoo," utilizing apps and citizen science to reach broader patient populations for data collection and research.

Future Outlook and Challenges

• Pace of Innovation: The current rate of scientific advancement (e.g., in immunotherapy and oncology) often outpaces the ability of healthcare systems and clinical guidelines to adapt.
• Systemic Reform: Panelists agree that while innovation is rapid, healthcare systems are slow to reform their reimbursement and delivery models to accept high-cost, life-extending therapies.
• Optimism: Despite political uncertainties and systemic friction, the consensus is that the biomedical ecosystem is stronger and more unified than ever, driven by a shared commitment to patient outcomes.
• Next Steps: The immediate priority is assembling a clear "science of patient input" to provide a consistent framework for companies, regulators, and patient organizations to follow.