GSK vac­cine chief heads for AIDS vac­cine ini­tia­tive; Pfiz­er en­lists Sue Desmond-Hell­mann to its board of di­rec­tors

Rip Bal­lou

Rip Bal­lou, who un­til very re­cent­ly led vac­cine re­search and de­vel­op­ment at Glax­o­SmithK­line, is join­ing the In­ter­na­tion­al AIDS Vac­cine Ini­tia­tive (IAVI) to lead its US­AID-fund­ed AD­VANCE pro­gram. The pro­gram us­es a net­work of re­searchers and in­sti­tu­tions in Africa to help de­vel­op a vac­cine for HIV. Bal­lou had worked at GSK since 2010 and has led glob­al vac­cine R&D since 2015. Pri­or to that he held posts at the Bill & Melin­da Gates Foun­da­tion, a dif­fer­ent post at GSK, Med­im­mune, and Wal­ter Reed Army In­sti­tute of Re­search.  IAVI is led by Mark Fein­berg, the for­mer CSO of Mer­ck Vac­cines. 

→ As we re­port­ed yes­ter­day, Sue Desmond-Hell­mann has been elect­ed to Pfiz­er’s board of di­rec­tors along­side a ver­i­ta­ble who’s-who that in­cludes Co­ca-Co­la CEO James Quincey and for­mer FDA chief Scott Got­tlieb. Desmond-Hell­mann was CEO of the Bill & Melin­da Gates Foun­da­tion from 2014 un­til she an­nounced her de­par­ture in De­cem­ber, and be­fore sign­ing on there, was chan­cel­lor of the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co. In her 14-year tenure at Genen­tech, she led the de­vel­op­ment of two land­mark can­cer drugs, Avastin and Her­ceptin.

Lo­cana, which con­cen­trates on an RNA-tar­get­ing gene ther­a­py plat­form, has ap­point­ed Mic­ah Mack­i­son as its CBO. Mack­i­son leaves As­sem­bly Bio­sciences, where he was SVP, cor­po­rate de­vel­op­ment & strat­e­gy since 2015. He had been at a cor­nu­copia of bio­phar­ma play­ers be­fore As­sem­bly: H. Lund­beck A/S, as head of cor­po­rate strat­e­gy and se­nior di­rec­tor, new ven­tures; Ova­tion Phar­ma­ceu­ti­cals, as di­rec­tor, cor­po­rate de­vel­op­ment and M&A; and fi­nan­cial roles at Eli Lil­ly and Pfiz­er.

Mic­ah Mack­i­son

Jesse Mc­Cool has been pro­mot­ed to CEO of Cy­to­vance Bi­o­log­ics, a CD­MO that de­vel­ops and man­u­fac­tures ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (APIs) from both mam­malian cell cul­ture and mi­cro­bial fer­men­ta­tion. He re­places Yan Wang, who is step­ping down from the in­ter­im CEO post. Mc­Cool, who was pre­vi­ous­ly chief tech­nol­o­gy of­fi­cer at Ok­la­homa City-based Cy­to­vance, al­so held po­si­tions at Lon­za and Mas­co­ma Corp.

Owl­stone Med­ical gets a breath of fresh air as it wel­comes Neil Tween as its CFO. Owl­stone is the de­vel­op­er of Breath Biop­sy, which acts as a breath­a­lyz­er to mea­sure chem­i­cals in the breath for ear­ly dis­ease de­tec­tion and pre­ci­sion med­i­cine. Tween jumps to Owl­stone from GW Phar­ma­ceu­ti­cals, where he was VP and group fi­nan­cial con­troller. He al­so spent time at Jagex and De­loitte.

Neil Tween Owl­stone

→ Seneca Bio­phar­ma has made some new changes to its lead­er­ship team. The com­pa­ny wel­comed Matthew Kalnik as pres­i­dent and COO and Dane Saglio as CFO. In ad­di­tion, Seneca pro­mot­ed Thomas Hazel — who joined the com­pa­ny in 1998 — to the new po­si­tion of SVP of re­search and de­vel­op­ment. Kalnik joins the com­pa­ny from An­ti­dote Ther­a­peu­tics and held po­si­tions at Pfiz­er and Nabi Bio­phar­ma­ceu­ti­cals. Pre­vi­ous­ly, Saglio served as the CFO of Re­gen­eRx Bio­phar­ma­ceu­ti­cals.

→ AAV gene ther­a­py de­vel­op­er Stride­Bio has added Mar­itza McIn­tyre to its ex­ec­u­tive team as chief de­vel­op­ment of­fi­cer. McIn­tyre brings more than 20 years of ex­pe­ri­ence in the in­dus­try to the Re­search Tri­an­gle-based biotech. The for­mer pres­i­dent of Ad­vanced Ther­a­pies Part­ners, she al­so held VP po­si­tions at Bam­boo Ther­a­peu­tics and Re­genxbio, and was al­so chief of the gene ther­a­py branch at the FDA.

→ Af­ter a short stint at Gy­ro­scope Ther­a­peu­tics, Lau­ra Ro­ca-Alon­so has made the leap to CBO at the AI drug dis­cov­ery biotech e-ther­a­peu­tics. She was Gy­ro­scope’s di­rec­tor of busi­ness de­vel­op­ment, and be­fore that, she had a num­ber of roles at Si­lence Ther­a­peu­tics, most re­cent­ly as VP, head of cor­po­rate de­vel­op­ment.

Mar­itza McIn­tyre

→ Chi­na-based bi­o­log­ics de­vel­op­er and man­u­fac­tur­er CMAB Bio­phar­ma has tapped Ye Shi as the head of qual­i­ty. Be­fore mak­ing the leap to CMAB, Shi served as deputy gen­er­al man­ag­er and qual­i­ty as­sur­ance di­rec­tor at QILU Phar­ma­ceu­ti­cal. In ad­di­tion, Shi held posts at the PDI Com­pa­ny and Im­munomedics.

Joseph Mc­Crack­en has hopped aboard Lu­mos Phar­ma‘s board of di­rec­tors. Mc­Crack­en brings ex­pe­ri­ence from stints at Roche, Genen­tech and Aven­tis Phar­ma­ceu­ti­cals. In ad­di­tion, the com­pa­ny has tapped its CEO Rick Hawkins as chair­man of the board.

→ For­mer pres­i­dent of Pfiz­er On­col­o­gy Gar­ry Nichol­son has joined NextCure‘s board of di­rec­tors. In ad­di­tion, board mem­ber Tim­o­thy Shan­non will be step­ping down from his po­si­tion.

Kim Popovits, for­mer CEO of Ge­nom­ic Health, is join­ing the board of di­rec­tors of se­quenc­ing com­pa­ny 10x Ge­nomics.  Popovits al­so serves on the boards of Kiniksa Phar­ma­ceu­ti­cals and MyoKar­dia.

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.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

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.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

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.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

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.

Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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