By Karen Taylor, Director, Centre for Health Solutions
Our November 2018 report - A bold future for life sciences regulation: Predictions 2025 - highlighted some of the challenges presented by today’s complex and fragmented life sciences regulatory landscape and the difficulties facing regulators and industry in ensuring efficacy and patient safety while keeping pace with changes in medicine, science and technology.1 Since publication, we have had insightful discussions with clients around our predictions and last week held an interactive webinar, where we explored how industry, regulators and patients can succeed together. The webinar included three guest speakers, representing each of these perspectives, and the discussion comprised an overview of the prediction followed by a polling question and the discussion among the panellists. This week’s blog shares the highlights of the webinar.2
About the webinar
The discussion was chaired by our Life Sciences and Health Care partner, Hanno Ronte, in addition to myself, our guest participants were:
- Emma Kinloch – upcoming chair of the National Cancer Research Institute (NCRI) Consumer Forum
- Julie O’Brien – Director of European and International Regulatory Policy at Pfizer
- Vada R. Perkins – Regulatory Intelligence Director at Bayer Pharmaceuticals and former FDA Senior Advisor for Regulatory Science.
Prediction 1: regulators will be globally aligned and coordinated. By 2025, we predict that regulation will be aligned at a national and international level, benefiting from a more collaborative approach, including co-regulation and self-regulation. Key features in 2025 include: international agreements on rapid data sharing; harmonised standards and guidelines to improve signal detection and reduce time to approval; and collaboration with regional agencies and academia helping to address skills shortages. Today we are seeing increasing levels of harmonisation between regulatory agencies, from Mutual Recognition Agreements to full integration, including the streamlining of regulation between Canada and the US, and harmonisation initiatives in Africa, South East Asia and Australia.
Polling question 1:
The results showed a mixed but positive response. In the discussion that followed, panellists made a distinction between convergence and harmonisation, noting that convergence means fully aligning the standards and technical guidance. While harmonisation is more evident today, if the different regulators can reach agreement on regulatory end points they could move towards convergence. One disadvantage is that achieving consensus can take longer and unintentionally stifle innovation. Moreover, harmonisation can be limited by the individual registration requirements in each country, with differences in the evidence required and by different considerations. For example, key considerations in different countries include cost to the NHS (UK), the size of societal benefit (Sweden) and clinical benefit (Germany). Harmonised regulatory goals reduce duplication thereby enhancing global development and approval of medicines and increasing coalition between mid-size regulatory authorities with a shared vision and ambition on access to innovative medicines.
Prediction 2: regulatory relationships are based on a ‘win-win’ data driven approach. In 2025, industry and regulators are working more closely, sharing ‘real-time’ data. Regulators have created digital platforms to enable self-regulation and encourage the use of accelerators and ‘sandboxes’ to promote innovation. Industry sees their regulatory function as an agile, integrated strategic asset, deploying an outcome-based, data-driven and segmented approach. Automation has proved a game changer, with more efficient, effective reporting helping bring products to market more quickly. Developments today include the FDA’s Pre-certification pilot programme to assess the safety and effectiveness of software technologies without inhibiting patient access to the technologies, and the EMA portal that allows developers to consult with health technology assessment (HTA) bodies and regulators simultaneously, improving reimbursement decisions.
Polling question 2
Our panellists were encouraged by the vote. They suggested that for industry and regulators to work more effectively together, data integrity and veracity are key drivers, enabled by expansion in RWE. Furthermore, they are seeing an increase in public-private partnerships, with collaboration and co-development between academia and technology companies leading to an increase in proof of concepts and pilots, which in turn is improving the development of drugs. ‘Regulatory science’ is helping industry build scientific capability and capacity, with new regulatory paradigms emerging to address innovations like gene therapy. Panellists identified a need for regulators to see patients as partners, informing the whole regulatory process from strategy to approval. This requires genuine consumer involvement, which is not the same as patient centricity, but involves co-production and partnership working to develop and validate new evaluation measures.
Prediction 3: regulators successfully balance rapid innovation with real time regulation. In 2025, data collected outside of clinical trials has led to the creation of new evidence frameworks. Similarly, new sensors, software and automation are used to track, monitor and verify products throughout the supply chain, with blockchain-like technology harnessed to verify the origin of data submissions. Today, the FDA is encouraging such innovation through agreement on new biomarkers, the increased use of modelling and simulation and its 2018 guidelines on modernising oncology trials.
Polling question 3
While the response was seen as encouraging, panellists felt that adoption of technological innovation is currently relatively slow, but it is increasing and most companies are getting there. They want to be more predictive and recognise the need for agility and that risk profiling of the quality of new approaches can help monitoring. However, they also felt there is a lot of hype on what technology can do without substantive evidence.
Prediction 4: a technology-enabled approach is driving the productivity and quality of regulation. In 2025, this has allowed vast amounts of data to be processed, and processes to be streamlined and standardised across global sites. AI, RPA and natural language generation are now commonplace in clinical trials, allowing regulators to undertake faster review and feedback. The evidence today includes: FDA’s new pilot programme to simplify and speed up pre-market reviews; use of blockchain to track and trace the security of drugs in the supply chain; and use of RPA for adverse event follow-up helping companies free up resources and improve response rates.
Polling question 4
With over three quarters of respondents answering very positively, panellists nevertheless stressed that a strong IT infrastructure is key to advancing regulatory science and leveraging insight and regulatory knowledge to enable faster reviews. The acceptance of electronic common document submissions is proving a game changer, ensuring consistency of submissions that meet regulatory standards effectively. Likewise, patient generated data and patient networks are helping to build confidence in data security and trust while improving collaboration with researchers. However, in deploying data analytics and technology, industry will find it hard to compete with Big Tech companies – so should focus on data quality, data management and data sharing tools. Moreover, while technology has its uses, the industry is still a people business – with technology simply helping to optimise their performance.
The webinar ended with a view of what regulators and industry need to do to achieving this more positive vision of the future and deliver better outcomes for patients:
- standardise operations to facilitate regulatory convergence
- increase transparency of operations and data to showcase the benefits of partnerships and improve public trust
- take a proactive approach to recruitment and retention of new skills and talent
- transform culture processes and operating models to embrace interconnectivity of regulation
- embrace wide-scale adoption of new digital and cognitive technologies
- implement streamlined and agile regulatory processes.
To learn more, please access the webinar recording.
Please note the polling results presented in the blog are the final results and vary from the ones in recording for polling question 1 and 2 due to lapse in the reflection of responses at the time of webinar.
2 https://www2.deloitte.com/uk/en/pages/life-sciences-and-healthcare/events/future-of-life-sciences-regulation-webinar.html 025.htm