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Perspectives

A bold future for life sciences regulation

Predictions 2025

A special look at how life sciences regulation is evolving to support positive and innovative outcomes for patients.

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Register today: The Future of life sciences regulation: How industry, regulators and patients can succeed together

Wednesday, March 20, 11am EST

Join us for an upcoming webinar exploring the future of life sciences regulation. We will discuss:

  • How convergence and consistency of regulation is improving the efficiency and cost-effectiveness of regulation
  • Regulatory functions as a strategic asset and approaches to optimize collaboration with regulators
  • How new data-driven approaches are enabling faster regulatory approvals, better sharing of risk and value to patients
  • How advances in technologies and robotics are driving productivity and quality of regulation.

Panelists

  • Emma Kinloch, Upcoming chair of National Cancer Research Institute (NCRI) Consumer Forum, Member of Head and Neck EURACAN
  • Julie O’Brien, Director Europe & International Regulatory Policy, Worldwide Regulatory Affairs at Pfizer
  • Vada R. Perkins, Head, Regulatory Intelligence Director, Regulatory Policy & Intelligence, Bayer Pharmaceuticals

A bold future for regulation in the life sciences industry

Today, there is an increasingly complex and fragmented life sciences regulatory landscape, which is struggling to keep pace with the exponential changes in medicine, science, and technology while protecting patient safety.

However, this latest predictions report from the Deloitte UK Centre for Health Solutions shows a bold future for regulation in the life sciences industry. One in which collaboration between regulators and life sciences organizations, enabled by developing technologies, supports positive, and innovative outcomes for patients.

Our four key predictions for life sciences regulation in 2025 are brought to life by imagining how regulators, industry players, and patients might behave in this new world. We purposefully present an optimistic view of the future, designed to enable industry leaders to grasp the disruption and transformation opportunities that lie ahead.

Four predictions for life sciences regulation in 2025

  1. Regulators will be globally aligned and coordinated: We have already seen streamlining of regulation between Canada and the United States, as well as moves from bodies across South East Asia, Australia, and APAC in harmonizing regulation across their regions. By 2025, we foresee that regulation will be aligned at a national and international level, benefiting from a more collaborative approach using co-regulation and self-regulation, and regulators will have robust data sharing arrangements in place.
  2. Industry and regulatory bodies will collaborate effectively to mutual benefit: The industry and regulators will work closely and share real-time data. The regulatory approach will become outcome-based, data-driven, and segmented, with automation becoming a game changer in enabling significant proportions of reporting to be automated. The FDA has already implemented a program to assess the safety and effectiveness of software technologies without inhibiting patient access. And the EMA has introduced a portal that allows developers to consult with health technology assessment bodies and regulators simultaneously.
  3. New data-driven approaches will enable regulators to make faster approvals and balance risk: Data collected outside of clinical trials will lead to the creation of new evidence frameworks. Similarly, blockchain technology could be harnessed to verify the origin of data submissions. The FDA has already supported innovation of this kind with its use of bio markers and its 2018 guidelines on modernizing oncology trials.
  4. Productivity will be revolutionised by technology: Technologies such as AI, robotic process automation, and natural language generation will become commonplace in clinical trials and streamline processes, allowing regulators to undertake faster review and feedback and focus more on decisions and action where needed.

Robot Ai

Bottom line: Ambitious but achievable

Achieving this more positive vision of the future and delivering better outcomes for patients will require regulators and the industry to:

  • Develop more efficient and effective systems and processes;
  • Acquire new skills and talent;
  • And deploy new generation technologies more effectively.

Indeed, the skillset and engagement strategies of regulators will look quite different from today. And life sciences companies will need to re-program their regulation mind-set to create a new, more collaborative environment that drives a culture change across the industry. This is a future in which patients are fully engaged in designing regulations, companies are truly patient-centric, and the regulatory function of each life sciences company has moved from being a back-office enabler to a strategic business partner.

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Digital transformation meets 'Regulation 4.0'

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