Top JP­Mor­gan in­vest­ment banker brings his tal­ents — and con­nec­tions — to the biotech start­up crew on board Flag­ship

Stephen Beren­son had a 33-year run at JP­Mor­gan be­fore he stepped out as vice chair­man of in­vest­ment bank­ing at the be­gin­ning of the year. By his own ac­count, the 57-year-old had tak­en any num­ber of com­pa­nies pub­lic, worked any num­ber of M&A deals.

But he want­ed to do “some­thing com­plete­ly new and com­plete­ly trans­for­ma­tive.”

So to­day you can wel­come him to the biotech world.

Beren­son is Noubar Afeyan’s lat­est top re­cruit at Flag­ship Pi­o­neer­ing, the start­up ven­ture group that likes to launch 7 or 8 or 9 new plat­form com­pa­nies a year, all of which are look­ing to do some­thing new and com­plete­ly trans­for­ma­tive in biotech.

Flag­ship founder and CEO Noubar Afeyan

The new ex­ec­u­tive part­ner at Flag­ship joins a list of re­cent se­nior part­ner picks with decades of ex­pe­ri­ence: David Ep­stein, the se­nior No­var­tis phar­ma ex­ec who took the first ex­ec­u­tive part­ner po­si­tion at Flag­ship in Jan­u­ary; se­nior part­ner Jim Gilbert joined last year af­ter stints at Bain and Boston Sci­en­tif­ic; and Michael Rosen­blatt, Mer­ck’s chief med­ical of­fi­cer, joined up a year ago as CMO.

“There’s a the­o­ry out there,” says Beren­son, “that biotech­nol­o­gy will be to this cen­tu­ry what in­for­ma­tion tech­nol­o­gy was to the last cen­tu­ry. Flag­ship is at the epi­cen­ter of so many fas­ci­nat­ing things.”

These things in­clude mes­sen­ger RNA at biotech uni­corn Mod­er­na and new can­cer meds at Agios.

And that all sounds like “tremen­dous fun” to Beren­son, who as the new ex­ec­u­tive part­ner will now start tak­ing a lead role in the art of cap­i­tal for­ma­tion, biotech style — for Flag­ship as well as its grow­ing list of port­fo­lio biotechs, where you can ex­pect him to start tak­ing board roles and men­tor­ing start­up CEOs.

“What’s in­trigu­ing is how do we take this ecosys­tem with 7 to 9 projects a year and have it be a 10-, 20-, 30-year in­sti­tu­tion,” Afeyan tells me. Get­ting some­one with Beren­son’s ex­pe­ri­ence in the tech in­dus­try fits right in­to that, giv­en the way Flag­ship op­er­ates.

In 80% of the com­pa­nies spawned by Flag­ship, in­clud­ing 35 they’re work­ing with now, adds Afeyan, “we are founders or co-founders and we are de­ploy­ing the first $40 to $50 mil­lion of cap­i­tal. Our role is not buy­ing and sell­ing shares. We own the shares, large­ly cap­i­tal­iz­ing these com­pa­nies like J&J cap­i­tal­izes di­vi­sions, or Mer­ck cap­i­tal­izes a new pro­gram. The re­la­tion­ship doesn’t stay at a board­room lev­el. It fits a long-term part­ner­ship, to help them grow and reach their po­ten­tial.”

That’s why he’s been adding these vet­er­ans from fi­nance and Big Phar­ma, with a dif­fer­ent set of skills and a long-term view of things. When I first queried Afeyan, I not­ed that this didn’t look like your typ­i­cal new ven­ture part­ner hire. His re­sponse:

“Very lit­tle of what we do is what any VC would do or does.”

Afeyan isn’t just pi­o­neer­ing. He’s al­so set­tling new ter­ri­to­ry for what he al­ways hopes will be the long haul. He wants Flag­ship to be a play­er for decades to come, fos­tered by pro­fes­sion­als who have spent decades to get to the top of their pro­fes­sions.

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.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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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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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

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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Mark Womack, BioCina CEO

Q&A: BioCi­na’s new CEO Mark Wom­ack on the CD­MO he says is 'worth trav­el­ing over'

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.

Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

Genen­tech to halt com­mer­cial man­u­fac­tur­ing in Cal­i­for­nia HQ, with lay­offs at­tached

Genentech is halting commercial manufacturing at its California headquarters — and laying off several hundred employees.

The move is the result of a decision Genentech made in 2007 to relocate its commercial manufacturing operations from its South San Francisco headquarters said Andi Goddard, Genentech’s SVP of quality and compliance for pharmaceutical technical operations, in an interview with Endpoints News. Genentech will produce medicines at its new clinical supply center, which opened in South San Francisco last year while many of its commercial products will be made at other production sites or by contract manufacturers.

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