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In March, US Food and Drug Administration commissioner Scott Gottlieb surprised the industry when he announced that he would be stepping down as head of the organisation after less than two years. With his tenure now at an end, we take a look back at some of the key developments made during Gottlieb’s time at the helm of the regulatory giant.

Also, we speak to Dutch tech start-up Pharmaoffer, which has created a digital platform that connects the dots between drugmakers and qualified raw material suppliers, find out if there is still hope that GDNF could form the basis for an effective Parkinson’s therapy after disappointing trial results, and take a look at the pharmaceutical properties and indications for CBD.

Plus, we explore the potential of a powerful protein found in the blood of pregnant women to see if it could hold promise as a treatment for a range of age-related disorders, and examine the role that sanitation and hygiene play in the rise of antimicrobial resistance.

In this issue

Scott Gottlieb: achievements of the outgoing FDA commissioner
In March 2019, FDA commissioner Scott Gottlieb announced that he would be leaving his post after less than two years at the helm of the organisation. During his short tenure, Gottlieb fostered a reputation as a dedicated reformer with record numbers of novel and generic drugs approved under his watch. Allie Nawrat tracks his main achievements and milestones as commissioner.
Read the article here.

Can Pharmaoffer become the Amazon of pharma raw materials? 
Disruptions in the supply of the raw materials needed to manufacture medicines are increasingly common. Could the digitisation of the API/excipients marketplace help address the issue? To find out more, Abi Millar spoke to Ammar Badwy, co-founder of Dutch start-up Pharmaoffer, which provides a digital platform for drugmakers to connect with qualified material suppliers.
Read the article here.

Is growth factor protein the future of Parkinson’s treatment?
A major, multi-year trial of the GDNF protein as a treatment for Parkinson’s disease published its results in February. While the trial did not meet its primary endpoint, other findings were very encouraging. Is there still hope that GDNF could form the basis for an effective Parkinson’s therapy? Abi Millar finds out.
Read the article here.

CBD: the myth, the magic and the real deal drugs
The use of cannabidiol, or CBD, has surged in popularity, but is it comparable to other more established drugs for similar indications? Abi Millar takes a look at the pharmaceutical properties and indications for CBD.
Read the article here.

Could a pregnancy protein hold promise for new drugs?
Australian scientists have identified a remarkable adaptation of pregnancy in which pregnancy zone protein can stabilise the misfolding of proteins, a cause of a range of age-related and other serious diseases. Could PZP’s newly found mechanism of action represent a new therapeutic approach for these disorders? Allie Nawrat reports.
Read the article here.

Antimicrobial resistance: sewage samples reveal bad sanitation as a key driver
Sequencing genes from DNA found in sewage has led to the conclusion that AMR prevalence is related to sanitation and general health outcomes, rather than use of antibiotics. How can this discovery and the creation of a global surveillance system support the fight against the spread of AMR and disease-causing microorganisms? Allie Nawrat investigates.
Read the article here.

Next issue preview

In the next issue of Pharma Technology Focus, we take a look at the arguments for and against a national drug company in the UK after it was suggested that only a state-run drug company could be trusted to deliver timely results in the fight against superbugs, and dive into a potential treasure trove for drug manufacturers as we examine the rich bacteria source found in underwater forests.

Also, we take a look at the race to get the first nonalcoholic steatohepatitis drug approved for market as industry heavyweights such as Gilead Sciences , Pfizer and Novartis vie to take the lead and explore the therapeutic benefits, risks and market potential of Brexanolone, the world’s first treatment indicated for post-partum depression.

Plus, we find out about Innoplexus AG, an AI company in Frankfurt, which claims to be able to predict trial failures using an algorithm to analyse pharma companies’ drug pipelines, and examine the potential of discovery proteomics, a new innovation in clinical trials being introduced by Swiss pharma giant Roche and proteomics specialist Biognosys .