Troy Tazbaz, FDA's newly-named director of the Digital Health Center of Excellence (Oracle via YouTube)

Or­a­cle ex­ec­u­tive Troy Tazbaz named new FDA di­rec­tor of dig­i­tal health

The FDA has found a brand new di­rec­tor of the Dig­i­tal Health Cen­ter of Ex­cel­lence in Troy Tazbaz, a for­mer se­nior vice pres­i­dent at Or­a­cle.

Ac­cord­ing to Tazbaz’s LinkedIn, he took a five-month break af­ter leav­ing an 11-year ca­reer at Or­a­cle be­fore join­ing the FDA in Jan­u­ary. Stat News first re­port­ed the hire. Tazbaz al­so said on his LinkedIn that he biked all the way from Chesa­peake Bay to the San Fran­cis­co Bay over 58 days dur­ing his ca­reer break.

Tazbaz is the third leader of the de­part­ment since Bakul Pa­tel left nine months ago to join Google as se­nior di­rec­tor of the gi­ant’s dig­i­tal health strat­e­gy and reg­u­la­to­ry team. Deputy Di­rec­tor Bren­dan O’Leary then took over as act­ing di­rec­tor un­til Tazbaz joined.

In an emailed state­ment to End­points News, the FDA said Tazbaz will lead the pro­gram as dig­i­tal health tech­nolo­gies be­come more sig­nif­i­cant, and as Con­gress has called on the FDA to pro­vide more guid­ance in this space.

“In his role, Troy will lead the Dig­i­tal Health Cen­ter of Ex­cel­lence in its next phase, which is fo­cused on con­tin­ued growth and im­prove­ment of build­ing and sus­tain­ing ca­pac­i­ty for strate­gic part­ner­ships, in­no­vat­ing reg­u­la­to­ry frame­works for dig­i­tal health and con­tin­ued har­mo­niza­tion with oth­er reg­u­la­tors,” an FDA spokesper­son wrote.

At Or­a­cle, Tazbaz start­ed out as se­nior di­rec­tor of the com­pa­ny’s cloud da­ta cen­ter strat­e­gy and plan­ning, then moved to VP of cor­po­rate op­er­a­tions be­fore end­ing as SVP of the in­dus­tries busi­ness unit strat­e­gy and op­er­a­tions.

The Dig­i­tal Health Cen­ter of Ex­cel­lence opened its doors in 2020, housed with­in the Cen­ter for De­vices and Ra­di­o­log­i­cal Health as a way to ad­vance tech­nol­o­gy with­in health­care, via mo­bile health de­vices, soft­ware as a med­ical de­vice, wear­able med­ical de­vices and tech­nolo­gies used to study med­ical prod­ucts.

Tazbaz isn’t the on­ly one to flip-flop be­tween big tech and the FDA. Cur­rent FDA Com­mis­sion­er Robert Califf went to Al­pha­bet to take a full-time role as head of med­ical strat­e­gy and pol­i­cy across the Google Health and Ver­i­ly units in 2019 be­fore be­ing con­firmed again as com­mis­sion­er in 2022.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Ribbon cutting ceremony for Thermo Fisher's new cell therapy manufacturing site in San Francisco

Ther­mo Fish­er moves on cam­pus with new cell man­u­fac­tur­ing site in San Fran­cis­co

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Ivana Magovčević-Liebisch, Vigil Neuroscience CEO

FDA lifts par­tial clin­i­cal hold on Vig­il Neu­ro­science's TREM2 an­ti­body, re­mov­ing dos­ing cap

When Vigil Neuroscience filed its IPO papers in late 2021, the biotech revealed that the FDA had just cleared its Phase I trial — but with a partial clinical hold that limited dosing to under a certain level.

More than a year later, the FDA has lifted the hold.

Vigil is now free to dose VGL101, an antibody targeting TREM2, at levels higher than 20 mg/kg in its ongoing and future clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), an inherited condition that affects the brain and spinal cord.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Man­u­fac­tur­ing roundup: Catal­ent to pro­duce low-cost ver­sion of nalox­one; CSL opens R&D site

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

As­pen looks to re­bound in pro­duc­tion and rev­enue af­ter Covid-19

Last year, South African-based vaccine manufacturer Aspen Pharmacare was facing reports that it had not received a single order for its manufactured Covid-19 shots and that manufacturing lines were sitting idle. But now the vaccine producer is looking to turn things around.

Aspen’s disclosure of its financial results in March unveiled that manufacturing revenue had decreased by 12% to R 603 million ($33.8 million), which Lorraine Hill, Aspen Group’s COO, said is attributable to lower Covid vaccine sales.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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