By any mea­sure, mon­ey has been pour­ing in­to the bio­phar­ma R&D field for more than 5 years now, with every stage of de­vel­op­ment crowd­ed with in­vestors look­ing for the next big thing in ther­a­peu­tics.

Val­ue in­flec­tion points are the guid­ing star of that multi­bil­lion-dol­lar busi­ness.

But a busy Sam­sara Bio­Cap­i­tal, the fam­i­ly fund KCK and the big Eu­ro­pean CRO Evotec are back­ing the play of a pair of in­vestors who have staked out a field where there doesn’t seem to be quite so much den­si­ty.

Tom No­vak and Michelle Kim-Dane­ly are launch­ing a vir­tu­al in­cu­ba­tor called Au­to­bahn Labs, which is at the be­gin­ning stages of ink­ing deals with aca­d­e­m­ic labs to seed spin­out com­pa­nies for their dis­cov­er­ies. Sam­sara and KCK are pro­vid­ing up to $5 mil­lion per op­er­a­tion, with Evotec on board to lend its ex­ten­sive con­tract plat­form sup­port to the fledg­lings that sign on. And the sci­en­tists can al­so tap Au­to­bahn’s ad­vi­so­ry group as they steer their lit­tle com­pa­nies through pre­clin­i­cal de­vel­op­ment.

Tom No­vak

“Our plan,” No­vak tells me, “is to en­ter in­to part­ner­ships with ma­jor uni­ver­si­ties and find pro­grams that are at very ear­ly stage, 3 to 4 years ahead of the clin­ic.”

And the rare few that make it to launch can look to one of their in­vestors to take the lead on an A round.

To get start­ed, Au­to­bahn has signed up UCLA on kind of a mas­ter con­tract that lays out the terms cov­er­ing IP and eq­ui­ty and so on — and no, they aren’t de­tail­ing the par­tic­u­lars of the con­tract to me.

For sci­en­tists with­out se­lect VCs on speed di­al, that might look quite ap­peal­ing. And now No­vak and Kim-Dane­ly are look­ing to repli­cate the UCLA deal, pri­mar­i­ly along the West Coast but al­so back east as well as Eu­rope.

Michelle Kim-Dane­ly

Both of the prin­ci­pals at Au­to­bahn are re­al­is­tic about the like­li­hood of fail­ure. They es­ti­mate that 85% to 90% of their seed plays won’t make it to the clin­ic and that next lev­el of de­vel­op­ment. But get­ting 1 out of 10 small in­vest­ments to pay off could work out well. No­vak says they have enough mon­ey for 8 on­go­ing projects at a time.

“It’s im­por­tant to have dif­fer­ent mod­els, dif­fer­ent sweet spots,” says Kim-Dane­ly. “For uni­ver­si­ties it’s an­oth­er ar­row in their quiv­ers.”

As for dis­ease ar­eas and tech, the two say they are com­plete­ly ag­nos­tic.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.