OSTP nominee Arati Prabhakar (Mike Windle/Getty Images for Vanity Fair)

Biden nom­i­nates first woman to be top, Sen­ate-con­firmed sci­ence ad­vi­sor, re­plac­ing Er­ic Lan­der

More than four months af­ter Er­ic Lan­der, the fa­mous found­ing di­rec­tor of the Broad In­sti­tute of MIT and Har­vard, re­signed from his top White House spot af­ter bul­ly­ing staff, Pres­i­dent Joe Biden has nom­i­nat­ed Arati Prab­hakar to serve as the next di­rec­tor of the Of­fice of Sci­ence and Tech­nol­o­gy Pol­i­cy (OSTP), which is a Sen­ate-con­firmed po­si­tion.

Prab­hakar is the first woman, im­mi­grant, or per­son of col­or nom­i­nat­ed to serve as the di­rec­tor of OSTP, and if con­firmed, she would al­so take the role of As­sis­tant to the Pres­i­dent for Sci­ence and Tech­nol­o­gy.

Prab­hakar can im­me­di­ate­ly take up the sci­ence ad­vi­sor post, ac­cord­ing to Sci­ence, which first re­port­ed Prab­hakar’s new ap­point­ment last week. In be­tween Lan­der’s de­par­ture and yes­ter­day’s nom­i­na­tion, Biden had to scram­ble to find sci­en­tif­ic lead­er­ship, bring­ing for­mer NIH di­rec­tor Fran­cis Collins back from re­tire­ment to help. Biden still has yet to nom­i­nate Collins’ Sen­ate-con­firmed re­place­ment.

“Dr. Prab­hakar is a bril­liant and high­ly-re­spect­ed en­gi­neer and ap­plied physi­cist and will lead the Of­fice of Sci­ence and Tech­nol­o­gy Pol­i­cy to lever­age sci­ence, tech­nol­o­gy, and in­no­va­tion to ex­pand our pos­si­bil­i­ties, solve our tough­est chal­lenges, and make the im­pos­si­ble pos­si­ble,” Pres­i­dent Biden said in a state­ment. “I share Dr. Prab­hakar’s be­lief that Amer­i­ca has the most pow­er­ful in­no­va­tion ma­chine the world has ever seen. As the Sen­ate con­sid­ers her nom­i­na­tion, I am grate­ful that Dr. Alon­dra Nel­son will con­tin­ue to lead OSTP and Dr. Fran­cis Collins will con­tin­ue to serve as my act­ing Sci­ence Ad­vi­sor.”

Prab­hakar is a safe se­lec­tion for Biden as she was unan­i­mous­ly con­firmed by the Sen­ate to lead the Na­tion­al In­sti­tute of Stan­dards and Tech­nol­o­gy, which she led from 1993 to 1997. She al­so led DARPA more re­cent­ly, from 2012 to 2017.

At DARPA, ac­cord­ing to the White House, she es­tab­lished a new of­fice to spur nov­el biotech­nolo­gies and jump-start­ed the de­vel­op­ment of a rapid-re­sponse mR­NA vac­cine plat­form, mak­ing pos­si­ble the in­cred­i­bly fast roll­out of Covid-19 vac­cines. And that work may trans­late in­to help­ing out with the cre­ation of ARPA-H, which is just be­gin­ning to stand up un­der the NIH.

Born in In­dia and raised in Texas, Prab­hakar earned her PhD in ap­plied physics from the Cal­i­for­nia In­sti­tute of Tech­nol­o­gy in 1984 (where she was the first woman to earn a PhD in ap­plied physics).

“She is the right per­son at the right time to sup­port the U.S. in­no­va­tion ecosys­tem, im­prove trans­la­tion­al sci­ence, at­tract and re­tain di­verse tal­ent pools, and en­sure that in­vest­ments in re­search and de­vel­op­ment solve the re­al chal­lenges fac­ing the Amer­i­can peo­ple,” Sen. Maria Cantwell (D-WA), chair of the com­mit­tee that over­sees sci­ence pol­i­cy, said in a state­ment on the nom­i­na­tion.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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FDA commissioner Robert Califf (Jose Luis Magana/AP Images)

FDA pulls On­copep­tides' Pepax­to in­di­ca­tion, open­ing the door for dan­gling ac­cel­er­at­ed ap­proval en­force­ment

In a move all but ensured after an overwhelmingly negative adcomm vote this September, the FDA is yanking Oncopeptides’ dangling accelerated approval. And there may be more to come.

In recent months, US regulators have honed in on reforming the accelerated approval pathway and preventing drugmakers from continuing to sell their medicines in the event of a confirmatory study flop. The moves come after commissioner Rob Califf has called for companies to do more to produce post-marketing evidence quickly earlier this year.

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Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Piper Trelstad, head of CMC, Bill & Melinda Gates Medical Research Institute

Q&A with Gates leader: Women tak­ing on more roles in phar­ma man­u­fac­tur­ing, but still work to do

More and more women are driving innovation and taking leadership roles in biotech – as evidenced today in the release of Endpoints News’ list of the top 20 women in the R&D world – but those gains are beginning to extend across pharma sectors.

In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.

Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

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Mark McKenna, Prometheus Biosciences chairman & CEO

With clear PhII win in IBD, Prometheus thwarts Pfiz­er com­par­isons as it fol­lows Hu­mi­ra 'play­book'

Prometheus Biosciences reported a clear Phase II win in two inflammatory bowel disease conditions in a clinical development race with Pfizer, planting the biotech’s flag in a field of antibodies attempting to go against black box-cornered JAK inhibitors and AbbVie’s Humira.

Shares $RXDX have soared since the summer — a small dip last week notwithstanding when rival Pfizer teamed up with Roivant on a new company for their competing anti-TL1A monoclonal antibody. And they skyrocketed once again Wednesday morning, climbing from $36 apiece to more than $100 on the back of two Phase II studies: one placebo-controlled in ulcerative colitis and the other an open-label trial in patients with Crohn’s disease.

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