If there’s one un­der­ly­ing les­son I’ve learned watch­ing bio­phar­ma in ac­tion over the past 20 years or so, it’s that no R&D or­ga­ni­za­tion can rest on its lau­rels. Es­pe­cial­ly the larg­er ones. You’ve had a big suc­cess? Great. Now how do you plan to fol­low up on that? And how soon? Hit by fail­ure? What’s Plan B, C, D and E?

Lars Fruer­gaard Jør­gensen

And that’s the cen­tral mes­sage of my up­com­ing Eu­ro­pean Bio­phar­ma Sum­mit com­ing up next week. I’ll be talk­ing to 5 top bio­phar­ma ex­ec­u­tives about their next-gen game plans.

— No­vo Nordisk CEO Lars Fruer­gaard Jør­gensen and I have had a lot to talk about. Semaglu­tide has been the kind of suc­cess sto­ry any com­pa­ny likes to tell, es­pe­cial­ly now that it looks to make block­buster re­turns in fight­ing obe­si­ty — one of the tough­est nuts to crack in drug R&D his­to­ry. But we know that al­ready. What hap­pens now in R&D? The com­pa­ny has some am­bi­tious plans for build­ing the pipeline, and a clear strat­e­gy for where it wants to head. And there are even more plans for semaglu­tide in R&D.

Su­san Gal­braith

— Su­san Gal­braith had a big role to fill when she took José Basel­ga’s job at As­traZeneca, fol­low­ing the top sci­en­tist’s trag­ic death. But com­ing from the trans­la­tion­al side of can­cer drug re­search, she’s top­ping a lengthy ca­reer in Big Phar­ma by fol­low­ing in­sights in­to the 2.0 gen­er­a­tion of can­cer drugs and com­bos. She has a lot to say, and I’m pay­ing close at­ten­tion. You should too.

John Tsai

— One of the key is­sues in any big de­vel­op­ment group is defin­ing risk. How do you em­brace the idea of a high-risk, high-re­ward pro­gram? For No­var­tis de­vel­op­ment chief John Tsai, that in­volves a “wild card” strat­e­gy we’ll be dis­cussing, where the phar­ma picks up a tough chal­lenge and goes in­to the clin­ic — know­ing that a win could de­liv­er a com­pa­ny-build­ing drug, but that suc­cess is far from se­cure. That’s one of sev­er­al things we’ll be talk­ing about No­var­tis’ de­vel­op­ment strat­e­gy.

Jean-François Tou­s­saint

— Then there’s mR­NA. You don’t even need to ex­plain it any­more. What start­ed out with a hand­ful of star­tups a decade ago has be­come the New, New Thing in bio­phar­ma now that the tech has de­liv­ered the top 2 vac­cines be­ing used to fight a pan­dem­ic. Of course, there’s a lot — and I mean a lot — that still has to be done to prove the full po­ten­tial. And there are def­i­nite­ly no guar­an­tees. I’ll be talk­ing with Jean-François Tou­s­saint, the head of glob­al R&D at Sanofi Pas­teur, which is in­vest­ing heav­i­ly in the field, and Sean Marett, a top ex­ec at BioN­Tech.

Sean Marett

One of the most in­ter­est­ing star­tups in the in­dus­try has been Centes­sa, as­sem­bled by the start­up crew at Medicxi. David Grainger played a big role in that com­pa­ny, and now he’s tak­en on the task of chief deal­mak­er as they con­tin­ue to build up the pipeline. Grainger and End­points News pub­lish­er Ar­salan Arif will be ex­plor­ing that in a one-on-one ses­sion.

David Grainger

And fi­nal­ly, my co-host for this year’s event, Sil­i­con Val­ley Bank’s Nooman Haque, will be wrap­ping up with an­oth­er look at the Eu­ro­pean biotech fi­nance land­scape with 3 top play­ers: Alex Pas­teur at F-Prime, Juli­ette Au­det from For­bion and Thomas Burt at Sofinno­va. These have been boom times in the glob­al biotech busi­ness — how is that play­ing out in Eu­rope?

It’s a packed pro­gram. If you’re in­to R&D strat­e­gy, or you’re grow­ing your own com­pa­ny, I hope you’ll join us on Oct. 12. You can look over the sched­ule and sign up here — at no cost — by hit­ting the link.

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

While calls to diversify clinical trials have grown louder in recent years — gaining support from federal agencies such as the FDA and NIH — progress has largely stalled, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Swaths of patients in racial and ethnic minority groups, as well as LGBTQIA+, pregnant and older adult populations continue to be left out of clinical trials. While some advances have been made in the last 30 years — women now account for roughly half of clinical trial participants — growth in other areas remains stagnant, according to the report, which was mandated by Congress and sponsored by the NIH.

It seems that smallpox vaccination production is weighing on the mind of the US government. And manufacturer Bavarian Nordic is the latest company to benefit.

Just a few days after Emergent, a company that has made government contracts its lifeblood, acquired the exclusive rights to Tembexa from Chimerix, with a $225 million cash payment and an expected BARDA contract, the agency has offered a contract for smallpox vaccine production.

The House Energy and Commerce Committee on Wednesday offered a rare show of bipartisan support for a bill that would provide the FDA with user fees for the next five years.

The committee voted 55-0 to advance the quinquennial user fee bill to the full House floor, which if approved, will allow the FDA to use biopharma funds to hire new reviewers, and hit new marks as outlined in the user fee deals that the FDA and biopharma companies forged over the past several years.

The Senate last week voted along party lines, 51-50, with Vice President Kamala Harris casting the tie-breaker, to make President Biden appointee Alvaro Bedoya the deciding vote on a split 2-2 Federal Trade Commission.

The addition of Bedoya to the FTC could not only spell more trouble for biopharma M&A activity, as he may align with his Democrat partners to break the FTC ties, but it may also mean that FTC Chair Lina Khan has what she needs to move forward on a study around the pharma middlemen known as pharmacy benefit managers.

The story of Henrietta Lacks’ immortal cell line and her family’s fight for justice caught the attention of national media outlets and Hollywood years ago. Now, the case faces an uncertain fate as a Baltimore federal judge considers tossing the case.

After a hearing on Tuesday, Judge Deborah Boardman is weighing Thermo Fisher’s motion to dismiss the claims against it on the grounds that the statute of limitations has passed, and the continuing harm doctrine does not apply. Boardman is grappling with the “extraordinarily unique facts” of the case, according to Maryland Matters, which first reported the news.