Rakesh joined the Bionical Emas Early Access Program division in October 2019 and brought with him extensive experience in Medical Affairs and Market Access. He started in the role of Global Market Access Lead (EAP), quickly promoted to Head of Real World Data and Market Access on reflection of his work with our Sponsors in formulating their RWD strategy through EAP.
Although the primary goal of an EAP is to provide access to treatment, there has been a trend towards capturing Real World Data (RWD) & generating associated Real World Evidence (RWE). Standardization of EAP mechanisms for treatment provision, provide an enhanced opportunity for publications utilizing RWD. With appropriate design, consent, ethical & regulatory consideration, RWD is increasingly being used to yield vital intelligence, including the potential to support marketing authorization & reimbursement dossiers.
Here at Bionical Emas, our RWD team are driven by the opportunity to generate data and bring therapies to patients with unmet clinical need faster, through providing Sponsors with innovative RWD solutions. Utilizing available sources, including study protocols, gap analysis, workshops & systematic literature searches, data collection is seamlessly integrated into our wider EAP offering – a service committed to bringing life-changing medicines to patients around the world.
Rakesh and the team are constantly looking for initiatives aligned to their aspirational goal of improving access to innovative treatments. An example of this was Rakesh’s involvement with the Institute of Cancer Research (ICR) consensus statement released late last year. It brought together experts from academia, industry, the charity sector and policymakers to accelerate the delivery of innovative new drugs to patients and make big leaps forward in cancer survival, particularly in cancers of unmet need. As well as The Lancet Oncology and BMJ, it was extensively covered in specialist media, including STAT news and Drug Discovery World.
To read the full statement or to find out more about the ICR, please click here.
Head of Real World Data and Market Access