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.

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.