This year, Ropes & Gray had the pleasure of sponsoring the FT's Global Pharma and Biotech Summit. The summit featured presentations, panel discussions and CEO interviews centred around three main themes: investment, innovation and leadership. The summit touched on certain trends highlighted during last year's conference (please see our earlier post) such as collaboration and environmental, social and governance (ESG) strategies, whilst also addressing more recent developments including the exponential rise of artificial intelligence (AI) and navigating geopolitical uncertainty.
For those who were unable to attend, the following ten trends appeared to be of particular importance:
1. Collaboration: In a similar vein to the 2022 summit, collaboration and strategic partnerships were commonly highlighted throughout the conference. With the current macroeconomic and geopolitical environment making it particularly challenging for businesses to raise funds, M&A activity has significantly slowed down. Therefore, as an alternative, many early stage companies are choosing to partner with more established, resource-rich companies. However, such strategies can attract the attention of regulators who may be concerned about competition issues.
2. Use of AI: In almost every session, the discussion turned to the increasing importance of AI and machine learning for advancing progress in the industry. Similar points were recently discussed at the UK's AI Safety Summit. Crucial for innovation, AI is also used to optimise routine processes in clinical trials, patient monitoring, manufacturing etc, as AI presents the unique opportunity to process high volumes of data in short spaces of time. However when AI is used, experts emphasised the importance of eliminating bias from the datasets used to train the algorithms to ensure accuracy and reliability of the results.
3. Increasing importance of ESG and health equity: Discussions around the impact the industry is having on the environment and health equity are becoming increasingly prominent. Companies are aware of the need to integrate ESG and health equity strategies into their global philosophy. One speaker even suggested that the carbon footprint of individual medicinal products should be considered as part of the marketing authorisation application process. Many companies are making great progress with improving global access to medicinal products, but more needs to be done to address other environmental and social challenges, and to ensure that the discussions of these measures go beyond the boardroom.
4. Patient engagement: There is a growing focus within the industry on patient engagement to ensure their voices are heard and needs addressed. In the UK and Europe, where direct interactions of the industry with patients are limited, there is a rise in the prominence of patient organisations, which are able to bring together diverse perspectives around healthcare challenges. Additionally, there seems to be a growing recognition by regulators of the importance of patient engagement, with moves by the FDA and the EMA.
5. Wearables and digital medicine: As noted above, with the advances in AI, there is a newfound possibility to process large quantities of data in a short timeframe, with the aim of producing more precise and useful results. However, for this to be possible, such data also needs to be of high quality and truly representative of the patient population. For this, patient engagement and use of data gathering tools is crucial. This also presents the opportunity to use real-world evidence to assess the effects of new therapies outside of the traditional randomised controlled clinical trial setting. Overall, this trend towards the digitalisation and decentralisation of healthcare is continuing to develop rapidly in the post-pandemic climate.
6. Regulatory reform: In light of the tough macroeconomic climate, many of the conversations turned to the importance of innovation-friendly incentives. Throughout the summit, concerns were expressed over the proposed reform of the EU pharmaceutical legislation, especially in relation to regulatory data protection periods and orphan incentives. The general consensus of the speakers was that, in its current form, the proposal has not found the optimal balance between rewarding innovation and encouraging competition. Generally, there is demand for a more harmonised global regulatory environment, as challenges arise from attempting to test, manufacture and launch medicinal products across a variety of jurisdictions.
7. UK regulatory developments: Speakers from the UK's health technology assessment body, the National Institute for Health and Care Excellence, and the UK medicines and medical device regulator, the Medicines and Healthcare products Regulatory Agency, differentiated the UK's approach, showing the diverging trend of the UK post-Brexit. In order to increase its attractiveness for innovation, these regulators have launched numerous initiatives, which aim to ease the process of agreeing protocols for clinical trials, facilitate early dialogue with regulatory decision makers and ultimately shorten the time taken to place products on the market. The regulators consistently highlighted their commitment to ensuring appropriate allocation of resources to prevent the system from being overwhelmed by the demands of the industry.
8. Government-led funding initiatives: As mentioned above, many speakers commented on how the current macroeconomic environment has exacerbated difficulties around securing R&D funding. Horizon Europe, recently re-joined by the UK, was praised as a Government-led initiative which has made a real difference, especially for early-stage research. Whilst various other initiatives are also in place, such as the Chancellor's £650 million package to drive growth in British life sciences and the UK Science and Technology Framework, they are perceived by the industry as only providing funding for research that does not carry a high risk. Throughout the various sessions, calls were made for further Government-led initiatives to foster innovation.
9. Private financing: Whilst grant financing in Europe is helpful in the early stages of research, there is a consistent concern within the industry that after a certain development point, there is a tendency for companies to move away from Europe to launch the products in more favourable environments such as the US. The UK and Switzerland are facing similar challenges. In an effort to change this, the UK government and the FCA have announced a number of regulatory and policy changes, including a pension reform, which now diverts 5% of assets from public to private equity. The European Union is also looking at measures to stop a shift towards US markets.
10. US market strategy: With the US accounting for the largest portion of the global pharmaceutical market, discussion inevitably turned to strategies for successfully entering the US market. There was discussion of the need to have a particular product profile, which is adapted to the success metrics in the destination market – in this case, the US. The development of such a tailored strategy is likely to require assistance from US industry experts, such as those in our FDA and US Healthcare teams, who can advise on the complexities of the commercial landscape.
Throughout the various sessions, despite the macroeconomic, geopolitical and regulatory challenges for companies, there was a general sense of optimism about the continued development of the industry. Innovation is plentiful and there is certainly no shortage of new ideas and products. Navigating the regulatory approaches, funding and addressing one's corporate responsibilities, such as ESG targets, whilst keeping up with the speed of innovation seems to be the crucial balance to be struck by most companies.
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