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.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

FDA's vac­cine ad­comm unan­i­mous­ly sup­ports Mod­er­na's boost­er in same pop­u­la­tions as Pfiz­er's boost­er

The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.

Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.