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Are we prepared for the ‘real world’?

Published on 02/03/17 at 11:59am

Dr Dilruwan Chaminda Herath, Medical Director for Chiesi Group, discusses whether the lack of impetus to push for recruitment of individuals with good clinical trials practice could impact pharma and life sciences, especially when real world data is already beginning to change the face of the industry.

I feel that I have been fortunate in my career in the pharmaceutical industry, in that I began in Research and Development prior to moving to medical affairs. This initiation taught me how Phase III data is cleaned, how to close a global clinical trials database at a key milestone and what is required for drug filing in multiple territories, but without doubt it most importantly taught me good clinical trials practice (GCP). The acquired knowledge has been invaluable in assisting me in medical affairs and adding value to the partnership with my commercial colleagues. However, a recent recruitment drive has made me question whether we now lack key individuals in medical affairs with GCP experience or expertise and in addition if more should be done as an industry to teach and develop these skills.

In my opinion, there is a fundamental need for GCP skills and knowledge in medical affairs and now more so than before. In a resource-constrained NHS, acquiring reimbursement for high-value medicines is becoming increasingly tortuous and costly. Ultimately, certain medicines with immediate clinical benefits for patients at need are being delayed with a net result that the UK is falling behind in international treatment outcome league tables; this includes key therapy areas such as Oncology, Respiratory, Cardiovascular Disease and Diabetes. This overall lack of clinical performance is not purely down to access or an unwillingness to pay, but is very multifactorial, despite the headlines. One of those factors is the difficulty that a reimbursement authority has in translating cost-effectiveness and development clinical trial data into potential real world benefits or, to put it into commissioning language: what are the actual in-year costs and savings for a given medicine? The cost per quality adjusted life year is no longer king.

Bridging this gap from marketing authorisation to reimbursement is a key area that medical affairs, including field-based individuals, needs to contribute to from our non-promotional stance. The recent confluence around ‘real-world’ data by the many stakeholders involved in medicines delivery is where innovation in data generation is needed from medical affairs, as well as shaping the attributes that create useful real world data. Simple non-interventional data mining and convoluted market research are not solutions, despite what some agencies offering these services will tell us. The creative thinking needed to navigate this field, for me, means a deep understanding of GCP – with the appropriate scientific background and commercial acumen.

If one were to read any post on LinkedIn pertaining to medical affairs vacancies or individuals touting their services, the focus is on being a signatory for the ABPI code – an attribute that is a core skill but not the primary function of medical affairs. Good risk assessment and support of the commercial strategy around a medicine not only needs knowledge of industry working practices but the understanding mentioned above as well as the ability to implement that knowledge into medical activities.  Arguably this has waned in the industry over recent years or in some organisations has been devolved to other departments.

The deficit in GCP understanding can, and has, led to a lack of a cohesive strategy by the industry around real-world data generation and its role in reimbursement. It should be conceded that developmental data to achieve marketing authorisation or cost-effectiveness data, is not necessarily applicable, in totality, to real world settings. There are recent examples where the innovation inherent in a new medicine, after reimbursement, has led to the unmasking of, hitherto, unknown safety signals. The generation of real-world data is not only to assist reimbursement authorities but also to fulfil our duty as an industry in evolving the efficacy and safety profiles of our medicines. With better equipped individuals, real-world data generation does not need to be de novo. For example, the current pharmacovigilance reporting framework could be utilised as a tool to generate real-world performance data, but this requires a degree of experience that many medical affairs departments currently lack.

There is no quick solution to fixing the skills gap. To remedy the situation it requires organisations to examine how medical affairs partners with the business and how developmental opportunities are created for key medical affairs staff. The centralisation of the conduct of clinical trials by some industry members is a good example of how an opportunity to increase experience has been limited and squandered.  Better integration of medical affairs into the wider business is vital with a focus on developing complementary medical plans. The greatest impact though will be medical affairs themselves taking ownership and placing an emphasis on GCP knowledge and its value to the wider business, above and beyond other core skills that are currently seen as surrogates for good medical affairs operational excellence.

Dr Dilruwan Chaminda Herath has 20 years of experience working within the healthcare and pharmaceutical industry. He worked as a Medical Advisor at Roche and performed the role of Honorary Physician at St Mary’s Hospital, London, before taking the position as Medical Director, UK & Ireland, at Gilead for eight years. He currently works as Medical Director for Chiesi Group.

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