FDA in­spec­tion of Emer­gent’s Bal­ti­more site in 2020 rais­es new ques­tions

The FDA on Thurs­day raised fresh qual­i­ty con­cerns about Emer­gent BioSo­lu­tions’ man­u­fac­tur­ing site in Bal­ti­more, which has more re­cent­ly been tak­en over by J&J af­ter an er­ror caused the site to dis­card about 15 mil­lion dos­es of the com­pa­ny’s vac­cine last month.

Ac­cord­ing to a Form 483 is­sued to the con­tract test­ing lab last April, fol­low­ing a 7-day in­spec­tion and just re­leased by the FDA, Emer­gent’s qual­i­ty unit failed to en­sure some very ba­sic, fun­da­men­tal ac­tiv­i­ties, like that staff couldn’t just delete or ma­nip­u­late elec­tron­ic da­ta, and the re­spon­si­bil­i­ties and pro­ce­dures for the qual­i­ty unit were not in writ­ing or ful­ly fol­lowed, FDA said.

“At the time of this in­spec­tion, no in­ves­ti­ga­tions had been per­formed to as­sess the im­pact of the da­ta dele­tions, mod­i­fi­ca­tions or the fail­ure to re­view sys­tem au­dit trails on drug sub­stance and drug prod­uct an­a­lyzed un­til ap­prox­i­mate­ly, De­cem­ber 2019,” the Form 483 signed by FDA in­ves­ti­ga­tor Mar­celli­nus Dor­dunoo says.

What’s more, the 483 high­lights the site’s in­abil­i­ty to pre­vent mix-ups of in­gre­di­ents or con­t­a­m­i­na­tion. The site’s mix-up of J&J and As­traZeneca drug sub­stance is what caused the mil­lions of dos­es to be thrown out.

“Sep­a­rate or de­fined ar­eas to pre­vent con­t­a­m­i­na­tion or mix-ups are de­fi­cient re­gard­ing op­er­a­tions re­lat­ed to the hold­ing of re­ject­ed com­po­nents be­fore dis­po­si­tion,” FDA said.

The com­pa­ny’s com­put­ers al­so did not pre­vent users from chang­ing the sys­tem date and time, mean­ing they could al­ter pre­vi­ous work as though they were work­ing in re­al time.

“Dur­ing the bio­chem­istry lab­o­ra­to­ry walk-through, it was ob­served that the present time-zone and sub­se­quent­ly, the date and time was able to be mod­i­fied,” FDA notes. The agency al­so found em­ploy­ees work­ing in the site’s bio­chem­istry lab who were not doc­u­ment­ed as be­ing trained on the firm’s writ­ten pro­ce­dures or test meth­ods.

An­oth­er ob­ser­va­tion notes that sam­ple iden­ti­fi­ca­tion num­bers “were ob­served to be man­u­al­ly cor­rect­ed, mul­ti­ple days af­ter da­ta ac­qui­si­tion” and the com­pa­ny did not per­form an in­ves­ti­ga­tion.

The Form 483 of­fers a peek be­hind the cur­tain on a site that has gar­nered lots of re­cent neg­a­tive at­ten­tion. Last Sat­ur­day, As­traZeneca, un­der the di­rec­tion of the US gov­ern­ment, an­nounced that it will re­lo­cate pro­duc­tion of its vac­cine drug sub­stance from the Emer­gent fa­cil­i­ty, but has yet to an­nounce a new site. No­vavax al­so pre­vi­ous­ly re­lo­cat­ed pro­duc­tion of its vac­cine from Emer­gent to Fu­ji­film.

An­oth­er out­side re­port on the site from last June, first ex­plained in de­tail by the New York Times, not­ed the fac­to­ry’s prob­lems “will re­quire sig­nif­i­cant ef­fort,” and the com­pa­ny “will have to be mon­i­tored close­ly.”

An Emer­gent spokesper­son said in a state­ment, “We have worked and con­tin­ue to work close­ly with the fed­er­al gov­ern­ment in sup­port of the COVID re­sponse. These FDA ob­ser­va­tions were ad­dressed and re­viewed in de­tail with FDA dur­ing their re­cent site vis­its in Sep­tem­ber 2020 and Feb­ru­ary 2021.”

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Frank Pallone (Kevin Dietsch/Pool via AP Images)

House com­mit­tee seeks more from FDA on in­spec­tion back­log, when to restart work on for­eign sites

House Energy & Commerce committee leaders are raising fresh questions about the FDA’s ability to conduct foreign manufacturing site inspections and bring down its growing backlog.

“While we understand that the emergence of COVID-19 required the agency to suspend in-person inspection activities temporarily, we remain concerned that more than one year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” E&C chair Frank Pallone (D-NJ) and a group of five other bipartisan leaders of the committee wrote to FDA acting commissioner Janet Woodcock.

Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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UP­DAT­ED: Pan­el of neu­ro­science ex­perts lays out the com­pli­ca­tions with us­ing Bio­gen's new Alzheimer's drug

Treatment of early Alzheimer’s patients with Biogen’s new drug Aduhelm should closely resemble how the drug was studied in its pivotal clinical trials, according to new recommendations from a panel of neuroscience experts led by UNLV’s Jeffrey Cummings.

“Those considering aducanumab therapy should understand that the expected benefit is slowing of cognitive and functional decline; improvement of the current clinical state is not anticipated,” they wrote Tuesday in The Journal of Prevention of Alzheimer’s Disease, noting that some of their recommendations are more specific or more restrictive than the information provided in the FDA’s prescribing information.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

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If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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