GSK R&D chief Val­lance is out as its new CEO changes di­rec­tion un­der a new crew

Im­age: Patrick Val­lance.


The R&D chief at Glax­o­SmithK­line is jump­ing ship, just as new CEO Em­ma Walm­s­ley push­es through the fi­nal changes of a top-to-bot­tom shake­up aimed at spurring a more com­mer­cial­ly ef­fec­tive strat­e­gy in drug de­vel­op­ment.

Patrick Val­lance is turn­ing in his com­pa­ny cre­den­tials in ex­change for a new job in gov­ern­ment, ac­cord­ing to sev­er­al re­ports out of Lon­don, with plans to take a job as a se­nior ad­vis­er to the gov­ern­ment on sci­ence, though the Fi­nan­cial Times says that the cur­rent oc­cu­pant of that job isn’t slat­ed to leave for some months.

Both the Fi­nan­cial Times and Reuters cit­ed sources say­ing that a change is in the off­ing, with the FT not­ing that Val­lance had been feel­ing un­der pres­sure from the new regime as in­ter­nal crit­i­cism of their track record mount­ed over the course of the year. A com­pa­ny spokesper­son de­clined com­ment when I queried GSK ear­ly Fri­day.

While it’s not im­me­di­ate­ly clear whether Val­lance had some help in de­cid­ing to leave GSK, it’s un­like­ly that Walm­s­ley made an ef­fort to re­tain him. At the end of his 6-year tenure, the UK phar­ma gi­ant has found lit­tle of block­buster im­por­tance to re­port on in the late-stage phar­ma pipeline. In­no­va­tion has been large­ly lim­it­ed to vac­cines and HIV, where they are the ma­jor­i­ty own­er of Vi­iV, with some in­cre­men­tal gains on the res­pi­ra­to­ry side.

GSK, mean­while, has the 11th largest R&D bud­get in the in­dus­try at $4.5 bil­lion, mak­ing it a top 15 play­er as the ma­jors ag­gres­sive­ly pur­sued big­ger pipelines. R&D ac­count­ed for 16% of its rev­enue last year, a re­spectable amount. But with gener­ic Ad­vair pres­sures set to grow, pa­tience has been run­ning out.

Not long af­ter tak­ing the helm af­ter An­drew Wit­ty’s de­par­ture from the top job, Walm­s­ley moved to spur a change, bring­ing in As­traZeneca’s Luke Miels at phar­ma to help de­vise a bet­ter drug strat­e­gy, woo­ing Dana-Far­ber chief Lau­rie Glim­ch­er over to the board from Bris­tol-My­ers Squibb and sug­gest­ing that now might be a great time to dive deep­er in­to on­col­o­gy.

Kick­ing loose some poor R&D prospects while re­treat­ing from Chi­na, GSK’s R&D group al­so re­cent­ly com­plet­ed pick­ing up an op­tion from Adap­ti­m­mune. Just yes­ter­day the com­pa­ny tout­ed the FDA’s de­ci­sion to lend its break­through drug des­ig­na­tion to an ear­ly-stage can­cer ther­a­py guid­ed by SVP Ax­el Hoos, which helped clar­i­fy the grow­ing in­flu­ence of can­cer R&D, where fel­low British phar­ma gi­ant As­traZeneca has been mak­ing sig­nif­i­cant ad­vances.

The ques­tion now is whether GSK will reach in­to its fad­ed R&D struc­ture in search of a new R&D star, or reach out to find an ex­pert look­ing to wran­gle one of the biggest re­search groups on the plan­et. Both Val­lance and his pre­de­ces­sor in the phar­ma group, Mon­cef Slaoui, were long­time em­ploy­ees at the com­pa­ny.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Stephen Hahn (AP Images)

As he wraps stormy FDA tenure, Hahn ad­mits 'there was a sub­stan­tial amount of pres­sure' from White House — re­port

Last summer, as drugmakers rushed to test and deliver the first Covid-19 vaccines in hopes of taming a raging pandemic, FDA commissioner Stephen Hahn repeatedly reassured the public that he will fight for science and fend off any politicization. At one point in August — just before he would appear alongside President Donald Trump in a controversial event announcing the emergency use authorization of convalescent plasma — he told a reporter that “I’ve had absolutely no pressure from anyone.”

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

CEO Stephen Yoder (Pieris)

Pieris fi­nal­ly vaults FDA hold on next-gen sol­id tu­mor hunter, clear­ing the path for mid-stage tri­al

Finally freed from the restraints of a partial FDA clinical hold on its lead HER2-positive solid tumor candidate, Pieris Pharmaceuticals is now racing toward Phase II.

The FDA slapped a partial hold on Pieris’ PRS-343 back in July, restricting the biotech from enrolling new patients in a Phase I trial. While Pieris was allowed to continue dosing patients who were already enrolled, the agency requested they conduct an additional “in-use and compatibility study” before recruiting any more.

News brief­ing: Ve­rastem CMO ex­its two weeks af­ter join­ing com­pa­ny; Ther­mo Fish­er inks $550M M&A deal

Two weeks after joining Verastem Oncology as chief medical officer, Frank Neumann is leaving the company for another job.

Neumann had joined Verastem after leaving bluebird bio, which surprisingly split into two companies last week, one in oncology and one in rare diseases. It’s not yet clear to where Neumann is headed next, but he noted in a statement that Verastem’s data and strategy were “truly exciting.”

FDA hits the brakes on His­to­gen's knee car­ti­lage ther­a­py, ask­ing for more in­fo on man­u­fac­tur­ing process

A month after filing the IND application for its human extracellular matrix designed to regenerate knee cartilage, Histogen has hit a roadblock.

The FDA on Tuesday verbally notified the San Diego-based biotech that it was placing a clinical hold on the planned Phase I/II clinical trial of HST-003 due to pending CMC information and additional questions needed to complete their review.

Histogen had planned to test the safety and efficacy of implanting hECM within microfracture interstices and related cartilage defects to regenerate that cartilage in conjunction with a microfracture procedure. The company said in a press release that it expects to receive written notice of the clinical hold from the FDA by Feb 12.

Andrew Allen, Gritstone CEO (Gritstone via website)

Grit­stone con­tin­ues Covid-19 push with deal to de­vel­op 'self-am­pli­fy­ing RNA' vac­cines, as shares con­tin­ue bal­loon­ing

Gritstone Oncology has had a big week, and it’s only Wednesday.

On Tuesday, the biotech revealed plans to start clinical testing of an experimental Covid-19 vaccine — in tandem with NIAID — that can also target other coronaviruses, with the goal of preventing future pandemics should SARS-CoV-2 prove difficult to cure with current vaccines. Then, on Wednesday morning, Gritstone licensed lipid nanoparticle technology from Genevant Sciences to develop what it’s calling “self-amplifying RNA vaccines” against Covid-19.

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,200+ biopharma pros reading Endpoints daily — and it's free.