Bay­er-part­nered Dew­point Ther­a­peu­tics is adding a pair of big-name phar­ma vets as it looks to make drugs tar­get­ing bio­mol­e­c­u­lar con­den­sates a re­al­i­ty.

Jür­gen Eck­hardt

The Boston biotech will add for­mer Sanofi CEO Olivi­er Brandi­court and the head of Bay­er’s ven­ture arm, Jür­gen Eck­hardt, to its board. Though both MDs, the pair has held long ca­reers on the busi­ness side of the in­dus­try, which is where their in­sight will be need­ed most, said Dew­point CEO Amir Nashat.

“The biggest is­sue for biotechs is, you know, your busi­ness,” Nashat told End­points News.

And, giv­en the long run­times in biotech, you need that ex­pe­ri­ence ear­ly. “It’s re­al­ly a game of try­ing to pre­dict what are the things that can hap­pen in this tri­al and that pro­gram and be pre­pared and hedge, be­cause every­thing’s so slow in biotech,” he said. “If you want to re­do an ex­per­i­ment, a Phase II, it’s go­ing to take 2 years and $50 mil­lion.”

Nashat al­so not­ed that a large part of Dew­point’s work in­volves part­ner­ing with phar­ma com­pa­nies. That was on dis­play in No­vem­ber, when they signed a $100 mil­lion deal with Bay­er to com­bine the biotech’s knowl­edge of the un­der­ly­ing bi­ol­o­gy with the Ger­man phar­ma’s small mol­e­cule li­brary to find drugs for car­dio­vas­cu­lar and gy­ne­co­log­i­cal in­di­ca­tions. “So hav­ing two peo­ple with a lot of ex­pe­ri­ence in that part of the busi­ness will be great,” he said.

Amir Nashat

Launched a lit­tle over a year ago by Po­laris, where Nashat is a part­ner, the com­pa­ny is built around the re­vived bi­ol­o­gy of bio­mol­e­c­u­lar con­den­sates — mem­brane­less, liq­uid-like droplets of RNA and pro­tein that can speed or slow down re­ac­tions. Al­though sci­en­tists have known about them for over a cen­tu­ry, on­ly re­cent­ly have re­searchers un­cov­ered their links to dis­eases, such as ALS.

Eck­hardt has led Leaps since 2016, af­ter serv­ing at a dif­fer­ent ven­ture firm, and is on the board of Blue­Rock, Joyn Bio, Khlo­ris, Oerth Bio, Im­mu­ni­tas and eGe­n­e­sis. He joins the board by virtue of Bay­er’s in­vest­ment in the com­pa­ny’s Se­ries A, not Bay­er’s drug dis­cov­ery part­ner­ship, Nashat said.

The ven­ture cap­i­tal­ist praised the com­pa­ny’s po­ten­tial but not­ed it was still ear­ly.

“This is open­ing up a whole new field of po­ten­tial tar­gets,” he told End­points. “But it will take time, the com­pa­ny start­ed re­al­ly on­ly last year.”

Brandi­court re­placed Chris Viehbach­er as Sanofi CEO in 2015 and tried to shake up its long-strug­gling R&D arm, but was ul­ti­mate­ly re­placed last year with Paul Hud­son, who, along­side the board, ex­e­cut­ed his own strate­gic shift. Orig­i­nal­ly trained as an in­fec­tious and trop­i­cal dis­ease spe­cial­ist, he joined Pfiz­er’s med­ical af­fairs team in 2000 and ran Bay­er from 2013 to 2015. In Feb­ru­ary, he joined Al­ny­lam’s board.

Dew­point put lab work on hold at the start of the pan­dem­ic, but is re­cent­ly back in full swing, both in Boston and at their fa­cil­i­ties in Berlin and Dres­den, where the coro­n­avirus has been brought un­der con­trol to a far greater de­gree. The biotech isn’t look­ing to have a drug in the clin­ic in the next year, but Nashat wouldn’t com­ment fur­ther. Be­yond a year, “a biotech is kind of guess­ing,” he said.

Still, Eck­hardt and Brandi­court’s ex­pe­ri­ence may be im­por­tant for a com­pa­ny that hopes to both spin­out and have com­mer­cial am­bi­tions. The pair will al­so be part of the board that re­cruits Nashat’s re­place­ment. In keep­ing with Po­laris’ phi­los­o­phy, the biotech will find a new CEO once it’s in a po­si­tion to at­tract a top tal­ent and Nashat will re­turn to Po­laris full-time.

“We want to be in­ten­tion­al about find­ing some­one who can map the fu­ture of the com­pa­ny, all the way through,” he said. “Un­til we find some­one who can do that, I’m able to per­form.”

Once vetted by the Biden team to lead the FDA as commissioner, Luciana Borio is now compiling quite the résumé.

Borio has now been named a venture partner at Bob Nelsen’s ARCH Venture Partners, and Nelsen told Endpoints News, “She will be involved in projects across the portfolio, including ongoing projects in manufacturing, clinical trials, gene therapy and gene editing, cell therapy, and delivery. We are exploring multiple projects in infectious disease, and next generation manufacturing.”

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

House Energy & Commerce committee leaders are raising fresh questions about the FDA’s ability to conduct foreign manufacturing site inspections and bring down its growing backlog.

“While we understand that the emergence of COVID-19 required the agency to suspend in-person inspection activities temporarily, we remain concerned that more than one year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” E&C chair Frank Pallone (D-NJ) and a group of five other bipartisan leaders of the committee wrote to FDA acting commissioner Janet Woodcock.