Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech in­dus­try has faced re­peat­ed calls to di­ver­si­fy its work­force — and in the last year, those calls got a lot loud­er. Though women ac­count for just un­der half of all biotech em­ploy­ees around the world, they oc­cu­py very few places in C-suites, and even few­er make it to the helm.

Some com­pa­nies are lis­ten­ing, ac­cord­ing to a re­cent BIO sur­vey which showed that this year’s com­pa­nies were 2.5 times more like­ly to have a di­ver­si­ty and in­clu­sion pro­gram com­pared to last year’s sam­ple. But we still have a long way to go. Women rep­re­sent just 31% of biotech ex­ec­u­tives, BIO re­port­ed. And those num­bers are even more stark for women of col­or.

Even though women are en­ter­ing the field at sim­i­lar rates as men, many still re­port be­ing held back by stereo­types, or, un­for­tu­nate­ly, fac­ing ha­rass­ment from col­leagues. This year, we’ve been close­ly fol­low­ing sex­u­al ha­rass­ment al­le­ga­tions against some of the in­dus­try’s most promi­nent fig­ures, in­clud­ing for­mer Op­er­a­tion Warp Speed head Mon­cef Slaoui, MIT sci­en­tist David Saba­ti­ni, Eli Lil­ly CFO Josh Smi­ley, and an­ti-ag­ing re­searcher Aubrey de Grey. It’s a list that is far too long — and like­ly to get longer.

At End­points News, we be­lieve it’s time for a change. And cel­e­brat­ing those who have bro­ken the glass ceil­ing is cru­cial to get­ting there.

For the third year, we’ll be shar­ing the sto­ries of 20 women who are su­per­charg­ing drug R&D and, in the process, blaz­ing new paths for oth­ers to fol­low. Last year, we homed in on those who were mak­ing strides in the fight against Covid-19 — and thanks to their ef­forts, we now have the first vac­cines and treat­ments to bat­tle the world’s largest pub­lic health cri­sis in decades.

Once again, we’ll need your help find­ing this year’s hon­orees. So hur­ry up and send us your CEOs, CMOs, CSOs, R&D di­rec­tors and lead sci­en­tists — any­one who’s leav­ing a last­ing mark on the in­dus­try. For the sec­ond year, you’ll get to hear di­rect­ly from our hon­orees at a live event on Dec. 7.

Email your nom­i­nee’s name, po­si­tion, and your rea­son for choos­ing them to nicole@end­pointsnews.com and am­ber@end­pointsnews.com. Or, use this form. Nom­i­na­tions are open through Sept. 30. We look for­ward to hear­ing from you.

Up­date: Nom­i­na­tions are now closed. Thanks for your par­tic­i­pa­tion!

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sergio Traversa, Relmada Therapeutics CEO

Rel­ma­da makes 'crit­i­cal changes' to PhI­II tri­al to try and save de­pres­sion drug

Relmada Therapeutics is making changes to its Phase III study of its lead drug for major depressive disorder, in an attempt to avoid problems with a prior trial that showed little difference between the drug and a placebo.

That failure in October wiped 80% from Relmada’s stock price, and was followed by another negative readout a few months later. In both cases, the company said that there had been trial sites that were associated with what it called surprising placebo effects that skewed the results compared with the drug, REL-1017.

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Paul Song, NKGen Biotech CEO

NK cell ther­a­py-fo­cused biotech eyes SPAC deal

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

In­cyte hit by CRL on ex­tend­ed-re­lease JAK tablets, mud­dy­ing plans for Jakafi fran­chise ex­pan­sion

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

Peter Hecht, Cyclerion Therapeutics CEO

Hard pressed for cash, Cy­cle­ri­on looks for help fund­ing rare dis­ease drug

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.

Three­'s a crowd as an­oth­er Kite ex­ec hits the ex­it; Surf­ing tough wa­ters, Celyad On­col­o­gy picks up new CEO

Kite Pharma is losing another exec, as Francesco Marincola leaves his post to join Flagship startup Sonata Therapeutics as CSO. Marincola served as Kite’s SVP and global head of cell therapy research, having joined the company in 2021 after a stint as CSO at Refuge Biotechnologies. Marincola has also served as a distinguished research fellow at AbbVie and spent more than two decades at the NIH and NCI. Marincola’s exit from Kite marks the third, following CEO Christi Shaw and Tecartus global program clinical lead Behzad Kharabi, who both left last month.

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