David Shlaes

Dr. Shlaes, author of Antibiotics, The Perfect Storm (Springer) and The Drug Makers (Lulu), has had a thirty year career in anti-infectives spanning academia and industry with a long-standing scientific interest in antimicrobial resistance. He trained in infectious diseases at Case Western Reserve University in Cleveland. He then joined the faculty and ultimately became a Professor of Medicine there. Dr. Shlaes left academia to become Vice President for Infectious Diseases at Wyeth Pharmaceuticals in 1996. There he was an important leader in the development of tigecycline. In 1998, he was the cover feature in the April issue of Business Week dedicated to antibiotics research. He also was a member of the Forum for Emerging Infections of the National Academy of Sciences for seven years. In 2002, Dr. Shlaes became Executive Vice President, Research and Development for Idenix, Pharmaceuticals, a company located in Cambridge, MA focused on the discovery and development of antivirals. In 2005, he established a consulting company. During his consulting years he contributed in significant ways to the development of avibactam, eravacycline and lefamulin. During his working career, he lived in Paris, France for several years. Dr. Shlaes has since retired from Anti-infectives Consulting. He remains an Editor for Antimicrobial Agents and Chemotherapy, writes a blog – Antibiotics the Perfect Storm – and he continues to be active in antibiotic policy areas.

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Clinical Trials Novel Therapeutics

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Articles from David

FDA Analysis of Antibiotic Development - with Hubris!

(This post originally appeared on David Shlaes's personal blog)

The US FDA just published an analysis of antibiotic development looking back over the last 40 years. The paper was accompanied by an editorial by Rex and Outterson. These papers are well worth reading and I highly recommend them for everyone whether they are familiar with antibiotic development or not. I must say that the hubris of the FDA analysis is astounding (see below).

Coronavirus - My Secret Hope

Coronaviruses are a large family of viruses that cause disease in animals and humans. They were discovered as a cause of the common cold more than 50 years ago. In some studies, up to 30% of colds in children and adults were caused by these viruses. Coronavirus colds, in temperate climes, have a clear seasonality with a preference for the winter months (Figure below). They occur more sporadically in tropical climates, but there they seem to prefer spring and fall.

CF = complement-fixing antibody

Antibiotic Research and Development - Public vs. Private Funding

Over the past decade, pull incentives as a solution to the broken antibiotic market have been proposed to entice companies into antibiotic research and development. These incentives would essentially provide a market, and therefore a return on investment for pharmaceutical companies. Almost all of today’s inadequate antibiotic pipeline is provided by biotech and small pharma. All are threatened with loss of investor interest because of the failed marketplace and many are experiencing difficulty in raising funds either from public or private markets. One alternative to providing money to the “evil” pharmaceutical industry via a substantial pull incentive is to create publicly funded non-profit organizations or public-private ventures that would essentially replace the industry in antibiotic research, development and commercialization. Two proponents of this approach are Lord Jim O’Neill (of the O’Neill Commission or Antimicrobial Resistance Review fame) and Ramanan Laxminarayan of the Center for Disease Dynamics, Economics and Policy and of GARDP. Both, clearly, are key thought leaders in the area.

Will 2019 Bring Positive Signals for the Declining Antibiotics R&D Market?

Antibiotic R&D has had a particularly bad year starting with The Medicines Company who abandoned their antibiotic R&D efforts and sold their antibiotic assets to Melinta late last year right after getting approval for vabomere. This year both Sanofi and Novartis abandoned their antibiotic R&D efforts and divested their clinical and preclinical assets. Allergan, holder of the North American rights to ceftaroline, dalbavancin and ceftazidime-avibactam, also announced that they would divest their antibiotic assets. I have not heard that they were successful. Achaogen has now undergone two efforts at “restructuring” involving virtually eliminating all R&D and has essentially put up the “for sale” sign just after achieving approval for plazomicin. Finally, Melinta abandoned their antibiotic R&D efforts in the face of miserable sales of their recently launched antibiotics including delafloxacin and vabomere.