Oxford PharmaGenesis at Medical Affairs Leaders Forum – Autumn 2016
Oxford PharmaGenesis was delighted to attend the Medical Affairs Leaders Forum in London, UK on 18–20 October. This meeting brought together medical affairs professionals and related industry staff and academics from Europe and beyond for 3 days of presentations, discussions and networking.
Day 1 focused on the strategic issues of how medical affairs teams can add value to healthcare organizations and demonstrate return on investment to internal stakeholders. These teams need not only to generate robust data to support their products but also to educate thought leaders and payers on the value of those data. Medical affairs teams also play an important role in communicating the value message to physicians objectively and ethically, including provision of information on product benefits and risks. Representatives from industry presented case studies to showcase the current best practice in ‘value-added medical affairs’ and the metrics that organizations are using to assess this.
Patient-centricity in medical affairs was also a major theme of Day 1, and representatives from industry and the patient advocacy group PatientsLikeMe described approaches that facilitate patient-beneficial activities within their organizations. The importance of increased transparency in both clinical trial reporting and physician reimbursement was also discussed, as was the growing use during clinical development of real-world evidence (RWE) to complement data from randomized controlled trials.
Day 2 comprised two streams that ran in parallel; Oxford PharmaGenesis attended stream 1, which focused on best practices in late-phase research and investigator-initiated trials (IITs). The main topic for discussion was RWE, particularly its role in medical affairs and how the pharmaceutical industry can promote this and benefit from it. The issues covered were generation of RWE (including development of fit-for-purpose processes and technologies to support the generation of this evidence), the role of RWE in understanding outcomes, supporting multi-stakeholder partnerships involved in RWE generation and overcoming hurdles in RWE methodology (such as database linkage). Another interesting perspective was presented by academics, on their experiences of working with industry on IITs and of managing such working relationships. Representatives from industry shared best practice and provided insight into how their companies are adapting and evolving in order to embrace RWE and maximize the benefits that it can bring. Strong themes throughout the day included a need for greater transparency across all dimensions of evidence generation, patient engagement in all aspects of trial design and reporting, and improving efficiency of RWE generation processes. In particular, attendees were excited and refreshed by the prospect of patient engagement with the pharmaceutical industry, and they had a desire to increase their understanding of the benefits of implementing such an initiative.
On the final day of the forum, participants discussed the role of medical affairs in the area of devices and diagnostics, where there is mounting pressure to demonstrate value. This pressure has resulted in calls for more stringent regulation and a shift towards standardized health technology assessments, as well as an increasing need for robust RWE. Medical affairs teams play a key role in driving understanding of and compliance with these changing global requirements. There was consensus among participants that a successful medical affairs team will foster an internal culture grounded in science and ethics, as well as being the company’s medical and ethical voice externally. Ensuring the technical proficiency of physicians using the device is a key responsibility of the medical affairs team, and the importance of comprehensive and timely training of these physicians was a key theme of the day. Discussion also focused on the role of medical affairs teams in late-stage research into medical devices. Participants agreed that medical affairs teams are becoming involved earlier in the product life cycle, and that they need to influence the type of clinical evidence that is collected. Compliance and regulatory considerations for devices was another theme of the day and an overview of the MedTech Europe Code, which will become binding on 1 January 2017, was presented. Finally, a hospital perspective was provided by a representative from a National Health Service Trust. This gave interesting insights into the challenges of introducing devices into hospitals associated with training, continuity and assessment.
The Spring 2017 meeting of the Medical Affairs Leaders Forum will be held in Zürich, Switzerland on 28 February–2 March 2017.
