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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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Samantha Du, Zai Lab CEO

Any­one still look­ing for a CD47? Zai Lab shelves PhI pro­gram af­ter re­view­ing 'com­pet­i­tive land­scape'

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.

'Messy at best': Is the US re­peat­ing the same Covid mis­steps with mon­key­pox mes­sag­ing?

When Kyle Planck first suspected he might have monkeypox in late June, he went to the CDC website and found six photos of different types of lesions. And that was about it for general public information.

Planck, who is a sixth-year PhD pharmacology researcher at Weill Cornell, kept looking though and found a separate part of the CDC website meant for healthcare professionals. There he found a medical slide deck with more pictures, professional journal articles and more details about symptoms and diagnosis.

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Andy Jassy, Amazon CEO (Isaac Brekken/AP Images for NFL, File)

Up­dat­ed: FDA slaps Ama­zon with a warn­ing let­ter for sell­ing OTC mole re­moval prod­ucts

The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its Aug. 4 warning.

Craig Thompson, Cerevance CEO

UP­DAT­ED: Mer­ck makes first big splash for Alzheimer’s drug R&D since 2017 fail, ink­ing re­search pact with Cere­vance

For the first time since discontinuing its late-stage Alzheimer’s program, Merck has found promise on the path forward in the memory-robbing disease.

After a Phase III flop of its drug verubecestat, the New Jersey Big Pharma axed the study in early 2018. More than four years later, the company is ready to sign up for another pact to test the waters of the befuddling disease.

This time, there’s $1.1 billion in biobucks on the line and a target that its partner says no other biopharma is looking at en route to finding the next treatment for Alzheimer’s, a neuroscience field that has hit hurdle after hurdle for decades.

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