Evolving role of pharmaceutical physicians in medical evidence and education.

The role of pharmaceutical physicians who are the experts working in pharmaceutical companies has progressed over the last few decades, from supervising research and development (R&D) studies and/or providing support to marketing teams to serving an independent critical function. In this review, we focus on pharmaceutical physicians serving medical affairs functions in the pharmaceutical industry. Historically, members of the medical affairs team mainly provided a bridge between commercial teams and the R&D sector and between the organization and external stakeholders.

Ataluren: first global approval.

Nonsense mutations are implicated in 5-70 % of individual cases of most inherited diseases, including Duchenne muscular dystrophy (DMD) and cystic fibrosis. Ataluren (Translarna™) is an orally available, small molecule compound that targets nonsense mutations, and is the first drug in its class. Ataluren appears to allow cellular machinery to read through premature stop codons in mRNA, enabling the translation process to produce full-length, functional proteins.

Delamanid: first global approval.

Delamanid, a nitro-dihydro-imidazooxazole derivative, has been developed by Otsuka Pharmaceutical for the treatment of multidrug-resistant tuberculosis (MDR-TB). Delamanid received its first global approval for the treatment of MDR-TB in the European Union (EU), for use in combination with optimised background therapy. It is also under review for marketing in Japan for MDR-TB, the first drug application filed in Japan for this indication.