Stephen Hahn speaks at an FDA and AACR workshop, February 2018 [via the American Association for Cancer Research]

As clock ticks, Trump will nom­i­nate Stephen Hahn as FDA com­mis­sion­er next week — re­port

Stephen Hahn is set to be nom­i­nat­ed as the next FDA com­mis­sion­er next week, the Wall Street Jour­nal has re­port­ed.

With the clock tick­ing to­ward the No­vem­ber 1 dead­line, Pres­i­dent Don­ald Trump is cut­ting it close. But Hahn, the chief med­ical ex­ec­u­tive at Hous­ton’s MD An­der­son Can­cer Cen­ter, has emerged as the fron­trun­ner to fill Scott Got­tlieb’s seat — which Ned Sharp­less has been serv­ing in an in­ter­im ca­pac­i­ty — as ear­ly as Sep­tem­ber. From pre­vi­ous re­ports, it ap­peared that Hahn was just one FBI back­ground check away from the nom­i­na­tion.

In do­ing so Trump and his HHS sec­re­tary, Alex Azar, is go­ing against the opin­ion of sev­er­al pa­tient ad­vo­ca­cy groups, four oth­er for­mer agency lead­ers as well as Got­tlieb him­self, af­ter they came out in sup­port of Sharp­less in let­ters and tweets.

As act­ing com­mis­sion­er, the Na­tion­al Can­cer In­sti­tute di­rec­tor preached con­ti­nu­ity rather than change, vow­ing to up­hold the rig­or­ous reg­u­la­to­ry stan­dards he in­her­it­ed from Got­tlieb while step­ping the gas on as­sess­ments of new treat­ments.

In a speech to the NORD Con­fer­ence on Rare Dis­eases ear­li­er this week, Sharp­less said that his time in fed­er­al ser­vice, be that at the NCI or FDA, has taught him that these agen­cies “are not tasked with mak­ing life bet­ter for some Amer­i­cans, or most Amer­i­cans, but for ALL Amer­i­cans.”

“There­fore, we have the du­ty to find new and bet­ter ways of ap­proach­ing the chal­lenge of rare dis­eases,” he said. “We can­not leave any pa­tient be­hind, which means we can­not leave re­search in­to any dis­ease be­hind.”

The most high pro­file con­tro­ver­sy dur­ing his tenure has noth­ing to do with drugs, or food for that mat­ter. Rather, he presided over an erup­tion of scan­dals re­lat­ed to va­p­ing as politi­cians ques­tioned why the FDA didn’t start reg­u­lat­ing e-cig­a­rettes ear­li­er and deaths tied to THC con­t­a­m­i­nants in these prod­ucts trig­gered a na­tion­wide pan­ic.

Hahn will have to hit the ground run­ning on the is­sue — pend­ing a Sen­ate con­fir­ma­tion. De­spite not hav­ing any po­lit­i­cal back­ground (oth­er than be­ing a long­time Re­pub­li­can donor), he’s been cred­it­ed for lead­ing in­sti­tu­tions out of dif­fi­cult sit­u­a­tions. One of the most telling episodes took place just a few years ago at MD An­der­son, where sound­ed the alarm on steep fi­nan­cial loss­es at the can­cer cen­ter. Af­ter the then-pres­i­dent, Ron De­pin­ho, re­signed amid a di­vi­sive tenure, Hahn found him­self in the spot­light as the bridge be­tween ad­min­is­tra­tors, fac­ul­ty, and the out­side world look­ing on with great ex­pec­ta­tion. That was March 2017, and Hahn, who came to MD An­der­son orig­i­nal­ly to lead the ra­di­a­tion on­col­o­gy di­vi­sion, had just been tapped as COO a month pri­or.

At that point, two years in­to his MD An­der­son ca­reer, he had ap­par­ent­ly built up rap­port with staff. Julie Iz­zo, chair of the fac­ul­ty sen­ate, praised him for un­der­stand­ing what it’s like to be on the front lines and for walk­ing the walk: “If he says he’s go­ing to do some­thing, he does it,” she said to the Hous­ton Chron­i­cle.

Hahn over­saw day-to-day op­er­a­tions dur­ing the tran­si­tion and played a role in ul­ti­mate­ly turn­ing the fi­nances around be­fore cur­rent pres­i­dent Pe­ter Pis­ters took charge in De­cem­ber.

Be­fore that there’s the time when he re­built a qual­i­ty re­view process at the Uni­ver­si­ty of Penn­syl­va­nia’s ra­di­a­tion on­col­o­gy de­part­ment af­ter a doc­tor was al­leged­ly found to have im­prop­er­ly plant­ed ra­dioac­tive seeds in prostate can­cer pa­tients.

“Clear­ly, you don’t work in these dif­fi­cult aca­d­e­m­ic en­vi­ron­ments with­out hav­ing a lot of po­lit­i­cal savvy,” Karen Bird, the ex­ec­u­tive di­rec­tor of the Al­liance of Ded­i­cat­ed Can­cer Cen­ters, told STAT. “It’s not a straight­for­ward job at all. Aca­d­e­m­ic med­ical cen­ters have lots of stake­hold­ers with­in them, and you’ve got lots of peo­ple with very large egos.”

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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Ed­i­tas and Cel­gene sub Juno are tack­ling hottest im­munother­a­py cells

As the first CRISPR-edited cancer patients watch their treatments unfold, one of the first CRISPR companies is rejigging a major oncology deal.

Editas Medicine is amending its long-running collaboration with Celgene and their subsidiary Juno Therapeutics. The new deal will expand the focus of their work to cover a subset of immune cells that have become an increasingly hot target for immunotherapy: gamma-delta cells.

Prakash Raman. Flagship

Flag­ship woos No­var­tis top deal­mak­er Prakash Ra­man in move to get the BD ball rolling ear­ly

Flagship Pioneering likes to be ahead of its times — so far ahead, perhaps, that it is often challenging to find partners for their startups while the scientific scaffolding is underway. But Prakash Raman is here to change that.

Raman, who most recently headed up business development at the Novartis Institutes for BioMedical Research, became Flagship’s first chief business development officer two weeks ago. By acting as a “central resource” for the 100 companies in the venture fund’s portfolio, he hopes to help entrepreneurs and management teams strategize about dealmaking to capture value beyond the near-term validation of their platform technologies, Raman told Endpoints News.

FDA Vas­cepa re­view spot­lights new safe­ty sig­nals, pos­si­ble min­er­al oil spoil­er as Amarin hunts a block­buster ap­proval

An in-house FDA review of Amarin’s Vascepa raises a set of hurdles the biotech will have to clear if the biotech expects to get the long-awaited FDA approval that could set it on a path to superstar status. But it appears that Amarin has survived another potential setback without introducing a major new threat to its prospects.
The stakes don’t get much higher, with analysts saying a win this week for Amarin could lead to billions in new sales — provided the agency stamps it with an OK. And investors liked what they say in the FDA review this morning, bumping the stock $AMRN 17%.
The insider take at the agency includes a note on two new safety signals seen in the big cardio outcomes study of the omega-3 fatty acid drug that shocked many analysts with a solid set of efficacy data. There’s a key concern over whether the use of mineral oil in the placebo skewed LDL levels in such a way that tilted the data in Amarin’s favor.
The FDA overview was written by John Sharretts, the acting deputy director in the Division of Metabolism and Endocrinology Products. 
On the safety side, the internal review focused on a 3.1% versus 2.1% rate of adjudicated events of atrial fibrillation or atrial flutter requiring hospitalization. But they also say a-fib shouldn’t confound the benefit-safety of the drug — given the improvement on MACE — or prevent its use. And then there was also a higher rate of bleeding events in the drug arm.

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FDA puts Sol­id Bio’s lead gene ther­a­py pro­gram on hold — again — af­ter an­oth­er pa­tient is hurt by SGT-001

Solid Biosciences continues to be plagued by safety issues.

Close to 18 months after the gene therapy biotech was able to quickly shed an FDA hold on their lead Duchenne muscular dystrophy program for SGT-001, regulators have stepped back in to force another halt after another patient was hit hard by a set of serious adverse events remarkably similar to the first set.

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Bill Haney, Skyhawk

Cel­gene ex­ecs shell out $92M cash for a pair of R&D deals that will fit per­fect­ly in their new home at Bris­tol-My­ers

With Bristol-Myers Squibb’s Celgene buyout all but complete, the BD teams are working in perfect synchrony now. The Celgene side is going back to Skyhawk, a darling of the crowd that set out to drug RNA, and they’re adding a suite of new programs that mesh perfectly with the new regime in charge.

Celgene is shelling out $80 million in a cash upfront to add oncology, immuno-oncology and autoimmune diseases to the initial roundup of neurological targets mapped early in Skyhawk’s existence.

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Reata's bar­dox­olone of­fers promise in pa­tients with rare kid­ney dis­or­der

After surprising Wall Street with positive data on its drug, omaveloxolone, in patients suffering from a notoriously hard-to-treat degenerative neuromuscular disorder last month, Reata Pharma on Monday unveiled pivotal results from a trial testing another drug, bardoxolone, in patients with a rare, genetic form of chronic kidney disease for which there exist no approved therapies.

Bardoxolone, like Reata’s other lead drug — omaveloxolone — is a small molecule engineered to bind to a gene called Keap1 to enhance the activity of the protein Nrf2 in order to defuse inflammation.

Kad­mon wax­es rhap­sod­ic on cGVHD re­sults as race with Jakafi heats up

A year ago, Kadmon piqued cautious interest and sent its stock up 20% when it announced positive results from a tiny proof-of-concept study on a new, chronic graft-versus-host-disease treatment. Now interim results are out on the pivotal, and not just the biotech’s executives are gushing about it.

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