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.
