Bob Kramer, Emergent CEO

Emer­gent tossed near­ly 400M Covid-19 vac­cine dos­es in Bal­ti­more de­ba­cle, House re­port says

The ex­act num­ber of dos­es lost in the Emer­gent BioSo­lu­tions mishap at its Bal­ti­more plant has nev­er been ex­act­ly de­ter­mined. But a re­cent re­port from the US House se­lect sub­com­mit­tee on the coro­n­avirus cri­sis says that the com­pa­ny might have de­stroyed near­ly 400 mil­lion dos­es of Covid-19 vac­cines af­ter fail­ures to meet qual­i­ty stan­dards.

The re­port came to the de­ter­mi­na­tion via re­quests for in­ter­nal com­mu­ni­ca­tions be­tween Emer­gent ex­ec­u­tives, which the sub­com­mit­tee al­leges in­clud­ed ef­forts to hide ev­i­dence of con­t­a­m­i­na­tion in “an at­tempt to evade over­sight from gov­ern­ment reg­u­la­tors.”

“De­spite ma­jor red flags at its vac­cine man­u­fac­tur­ing fa­cil­i­ty, Emer­gent’s ex­ec­u­tives swept these prob­lems un­der the rug and con­tin­ued to rake in tax­pay­er dol­lars,” Rep. Car­olyn Mal­oney (D-NY) said in a state­ment. “Ul­ti­mate­ly, our re­port shows that Emer­gent’s man­u­fac­tur­ing fail­ures and de­cep­tive tac­tics led to the de­struc­tion of mil­lions of dos­es of des­per­ate­ly need­ed vac­cines. Emer­gent’s busi­ness prac­tices are sim­ply un­ac­cept­able, and I urge the fed­er­al gov­ern­ment to care­ful­ly con­sid­er fu­ture con­tracts in light of Emer­gent’s fail­ures.”

Orig­i­nal­ly, it was said that be­tween 75 mil­lion and 85 mil­lion dos­es of drug sub­stance was de­stroyed af­ter con­t­a­m­i­na­tion. The re­port finds that 400 mil­lion dos­es were de­stroyed be­tween April 2021 and Au­gust 2021. Emer­gent hid the ev­i­dence, the re­port al­leges, by re­mov­ing qual­i­ty-as­sur­ance hold tags from J&J batch­es that in­di­cat­ed that the con­tain­ers had qual­i­ty is­sues, in an ef­fort to avoid draw­ing at­ten­tion from FDA in­spec­tors. Emer­gent em­ploy­ees were wor­ried that the De­part­ment of Health and Hu­man Ser­vices was get­ting too in­volved in its op­er­a­tions af­ter the As­traZeneca-J&J mix­up.

The re­port al­so says that Emer­gent en­tered con­tracts with the two phar­mas de­spite its aware­ness that tech­ni­cal op­er­a­tions were not up to snuff for at least a few years.

“Our risk is high!” A note from a se­nior di­rec­tor of qual­i­ty said at one point. “We lack com­mer­cial GMP com­pli­ance ma­tu­ri­ty.”

The team at Emer­gent main­tains that there is noth­ing new in­clud­ed in the re­port, how­ev­er, and dis­putes the state­ment that 400 mil­lion dos­es of the vac­cine were de­ter­mined to me un­us­able, cit­ing the dif­fi­cul­ty that comes with es­ti­mat­ing the dosage equiv­a­lent of drug sub­stance that has not com­plet­ed the man­u­fac­tur­ing process.

“To equate these qual­i­ty con­trol ac­tions with a ‘dis­card­ed dose’ fig­ure dis­plays a lack of un­der­stand­ing re­gard­ing the bio­man­u­fac­tur­ing process,” the state­ment said.

The CD­MO main­tains that it nev­er know­ing­ly mis­led the FDA or any of the part­ners in­volved in the man­u­fac­tur­ing process. It al­so said that the first it heard of the sub­com­mit­tee’s re­port was through the me­dia.

“While it’s im­por­tant to an­a­lyze past de­ci­sions to in­form fu­ture plans – we must do so in the prop­er con­text and avoid the temp­ta­tion to Mon­day morn­ing quar­ter­back with the ben­e­fit of what we know to­day,” the state­ment says. “Emer­gent and our gov­ern­ment part­ners were at­tempt­ing to com­press in­to a few months the de­vel­op­ment and scale up of drug sub­stance man­u­fac­tur­ing process­es that nor­mal­ly take years. We were al­ways trans­par­ent with our pub­lic and pri­vate part­ners about our process and ca­pa­bil­i­ties and of­ten wel­comed BAR­DA, J&J and As­traZeneca per­son­nel on­site dai­ly.”

The re­port says the Pres­i­dent Don­ald Trump’s ad­min­is­tra­tion was aware of de­fi­cien­cies that the com­pa­ny had high­light­ed at the Bayview site when it was award­ed $628 mil­lion in fund­ing back in May 2020. As­traZeneca per­son­nel raised con­cerns to Emer­gent in Ju­ly of 2020, not­ing that the site wasn’t pre­pared for com­mer­cial man­u­fac­tur­ing, and in­ter­nal J&J com­mu­ni­ca­tions said that the phar­ma was un­clear if Emer­gent would be good-to-go come game time.

“I am stat­ing very loud­ly that this work is NON-CGMP com­pli­ant. And a di­rect reg­u­la­to­ry risk,” an out­side con­sul­tant told Emer­gent in No­vem­ber 2020.

The re­port al­so found that in­ex­pe­ri­enced staff and high turnover led to vac­cine con­t­a­m­i­na­tion, as the staff that was work­ing wasn’t trained prop­er­ly, and had lit­tle pre­vi­ous phar­ma ex­pe­ri­ence.

In Feb­ru­ary, Emer­gent an­nounced that its trou­bled Bayview plant would get a $100 mil­lion up­grade, as it start­ed mak­ing sched­uled up­grades ear­ly, and ex­pect­ed to be back in op­er­a­tion in Q2 2022. The work will al­low for “ad­di­tion­al non-pan­dem­ic work be­ing done in Bayview down the road,” CEO Bob Kramer said, and help sup­port the strength­en­ing of J&J’s sup­ply chain.

Right now, Emer­gent has a sup­ply agree­ment for San­doz’s gener­ic Nar­can, and plans to launch a live ty­phoid vac­cine and cholera vac­cine. It al­so has a sup­ply deal with the US gov­ern­ment for its an­thrax vac­cine, the drug that kicked off the com­pa­ny’s re­la­tion­ship with the gov­ern­ment years ago.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; 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.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

Mark Womack, BioCina CEO

Q&A: BioCi­na’s new CEO Mark Wom­ack on the CD­MO he says is 'worth trav­el­ing over'

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.

Drug short­age so­lu­tions brought be­fore Sen­ate Home­land Se­cu­ri­ty com­mit­tee

With more than 300 active drug shortages, the Senate Committee on Homeland Security and Governmental Affairs had its hands full on Wednesday with multiple experts testifying on drug shortages and possible solutions.

A picture of the shortage situation. presented by Erin Fox, an adjunct professor at the College of Pharmacy at the University of Utah, explained how some patients have died due to drug shortages, including with medication errors when substitutes were dosed incorrectly or when an emergency product was not available.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.