Birgit Girshick, Charles River

Q&A: Amid an M&A flur­ry at Charles Riv­er, long­time ex­ec Bir­git Gir­shick dis­cuss­es how Covid-19 has changed the game

Con­tract re­search and man­u­fac­tur­ing has been run­ning at a rapid clip amid the pan­dem­ic, and big play­ers in the space have looked to lever­age run­away cash flow to tur­bocharge their busi­ness. For CRO Charles Riv­er Lab­o­ra­to­ries, that means more of every­thing — in­clud­ing a big in­fu­sion in­to its man­u­fac­tur­ing arm.

In mid-May, the com­pa­ny paid $292.5 mil­lion for Vi­gene Bio­sciences and its 52,000 square feet of man­u­fac­tur­ing space in Rockville, MD. In Feb­ru­ary, the com­pa­ny bought Cog­nate and pledged to dou­ble ca­pac­i­ty in Mem­phis and Eu­rope. In ear­ly April, it teamed up with Va­lence Dis­cov­ery to ex­pand its AI plat­form for mol­e­c­u­lar prop­er­ty pre­dic­tion.

Bir­git Gir­shick has been with Charles Riv­er for more than 32 years, and is now the EVP of dis­cov­ery and safe­ty as­sess­ment. She joined the com­pa­ny’s Ger­many of­fice in 1989, where she held a num­ber of roles, in­clud­ing some ad­min­is­tra­tive du­ties. She an­swered ques­tions about the com­pa­ny’s growth and the game plan it’s laid out.

Charles Riv­er Lab­o­ra­to­ries has made a flur­ry of moves in 2021. What are some of the things the com­pa­ny is look­ing for when scout­ing pos­si­ble ac­qui­si­tions? 

Our guid­ing prin­ci­ple for ac­qui­si­tions is to ac­quire com­pa­nies with the best sci­ence and the best peo­ple. This is how we en­hance the breadth and qual­i­ty of our ser­vices as we grow.

Our M&A strat­e­gy is built with the client and pa­tient at the fore­front. We reg­u­lar­ly con­fer with our clients to un­der­stand what is of the ut­most im­por­tance to the suc­cess of their pro­grams. We al­so con­tin­ue to work with them to en­sure that an ac­qui­si­tion not on­ly bol­sters our com­pre­hen­sive port­fo­lio, but is high qual­i­ty and that the tech­nol­o­gy is rel­e­vant.

The cell and gene ther­a­py land­scape is chang­ing fast. How does a com­pa­ny nav­i­gate a sec­tor that is chang­ing so rapid­ly?

We are in­vest­ing or­gan­i­cal­ly, through M&A and part­ner­ships, to ob­tain ac­cess to new tech­nolo­gies and ex­per­tise to fur­ther ac­cel­er­ate path­ways to “go” or “no go” de­ci­sions for our clients. Just re­cent­ly, for ex­am­ple, we ac­quired Ret­ro­genix.

Ret­ro­genix is an ear­ly-stage CRO pro­vid­ing spe­cial­ized bio­an­a­lyt­i­cal ser­vices uti­liz­ing its pro­pri­etary cell mi­croar­ray tech­nol­o­gy. This tech­nol­o­gy is used for tar­get re­cep­tor iden­ti­fi­ca­tion, off-tar­get pro­fil­ing, and tar­get de­con­vo­lu­tion on a wide range of nov­el ther­a­peu­tics in­clud­ing bi­o­log­ics, cell ther­a­pies, and small mol­e­cules. It is al­so a pre­mier plat­form for off-tar­get screen­ing for pre­clin­i­cal safe­ty as­sur­ance in CAR-T ther­a­pies, pro­vid­ing our clients an­oth­er ser­vice in their com­plex C&GT de­vel­op­ment ef­forts.

Our strat­e­gy is an in­te­gral part of en­sur­ing we are the pre­ferred part­ner for C&GT in­no­va­tors world­wide. For ex­am­ple, we had a long­stand­ing part­ner­ship with Dis­trib­uted Bio, which led to our ac­qui­si­tion of them ear­li­er this year. Dis­trib­uted Bio is a next-gen­er­a­tion an­ti­body dis­cov­ery com­pa­ny … By com­bin­ing Dis­trib­uted Bio’s an­ti­body li­braries and im­muno-en­gi­neer­ing plat­form with Charles Riv­er’s ex­ten­sive drug dis­cov­ery and non-clin­i­cal de­vel­op­ment ex­per­tise to cre­ate an in­te­grat­ed, end-to-end plat­form for ther­a­peu­tic an­ti­body and cell and gene ther­a­py dis­cov­ery and de­vel­op­ment.

Ob­vi­ous­ly, cell and gene ther­a­py have been the fo­cus of many of the lat­est deals Charles Riv­er has been a part of. Can you talk about what goes in­to the con­ver­sa­tion, when mem­bers of your team sit down and say “we’re go­ing to put mon­ey to­ward this?” What is that con­ver­sa­tion like? Is it all at once, or grad­ual?

Our process is well thought out and ex­ten­sive — our an­nu­al strate­gic plan­ning process takes a deep dive in­to all ex­ist­ing and new modal­i­ties, tech­nolo­gies, and mar­kets.

Cell and gene ther­a­pies now make up around 11% of the phar­ma­ceu­ti­cal pipeline with about 2/3 of the R&D pro­grams cur­rent­ly in the pre­clin­i­cal phase. In 2020 alone, we have con­duct­ed over 900 stud­ies, dri­ving and deep­en­ing our ex­per­tise in this field. Due to this rapid growth and ad­vance­ment, we rec­og­nized our clients’ need for ex­per­tise and ca­pa­bil­i­ties.

As a part of our client jour­ney, we reg­u­lar­ly con­sult with our clients about their needs and tech­nolo­gies that would help them to be suc­cess­ful. We al­so use part­ner­ships to find and test dri­ve new tech­nolo­gies to en­sure we’re al­ways be­com­ing eas­i­er to work with and build­ing up­on our best-in-class sci­ence.

How has the pan­dem­ic af­fect­ed op­er­a­tions? 

Charles Riv­er has been able to re­main ful­ly op­er­a­tional across all sites by ad­her­ing to the on­go­ing safe­ty mea­sures en­act­ed at the start of the pan­dem­ic, in­clud­ing, but not lim­it­ed to: hav­ing em­ploy­ees work from home when pos­si­ble; en­hanced clean­ing pro­ce­dures; re­stric­tions on all non-es­sen­tial busi­ness trav­el; test­ing, track­ing, and con­tact trac­ing of COVID-19 cas­es; mod­i­fied em­ploy­ee work sched­ules to cre­ate “time and dis­tance” and sep­a­ra­tion of staff; as well as strict vis­i­tor poli­cies. We have al­so launched re­mote au­dits and vir­tu­al fa­cil­i­ty tours, and we are ac­tive­ly uti­liz­ing re­mote study mon­i­tor­ing to sup­port clients who are un­able to trav­el.

Our glob­al and site busi­ness con­ti­nu­ity plans are ac­tive, up to date, and help­ing our site-based op­er­a­tions, as well as as­so­ci­at­ed lo­gis­tics and sup­port, to con­tin­ue to meet our clients’ needs for planned and new projects, in­clud­ing work sup­port­ing COVID-19 re­search ef­forts.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; 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.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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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.

Michael Severino, AbbVie CSO

Ab­b­Vie, rid­ing the Aduhelm af­ter­glow, hand­picks be­ta amy­loid drug for fur­ther R&D as it bails on tau

Although shrouded in controversy, the FDA’s approval of Biogen’s Aduhelm for Alzheimer’s disease has opened the floodgates for other drugmakers buying in on the anti-amyloid hypothesis underscoring the drug’s success. You can now count drug giant AbbVie among them.

On an earnings call with analysts Friday, AbbVie $ABBV revealed its plans to advance a handpicked beta amyloid targeting molecule for Alzheimer’s disease while abandoning development of its Phase II tau program ABBV-8E12.

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Brazil health minister Marcelo Queiroga [DIDA SAMPAIO/ESTADAO CONTEUDO (Agencia Estado via AP Images)]

Covid-19 roundup: Brazil backs out of Sput­nik V vac­cine deal; White House im­ple­ments new mask, vac­cine man­dates

In March, Brazil’s government signed a contract with Russia for 10 million doses of the Sputnik V vaccine. Now, the country is backing out of that agreement with its health minister citing a lapsed registration deadline as the reason why.

Brazil is battling one of the toughest outbreaks in the world. There has been a recent drop in daily cases, but the country is still seeing a seven-day average of over 45,000 infections.

FDA sends 2nd non­com­pli­ance no­tice for com­pa­ny fail­ing to post tri­al re­sults as crack­down ramps up

The FDA is slowly but surely continuing its crackdown on drugmakers that fail to post their clinical trial results to a government database in a timely manner, this week going after Georgia-based Accuitis, which develops new treatments for skin disorders.

Although the agency has previously outlined how it may take enforcement action and assess $10,000 per day fines against companies that fail to report their results, the agency has only sent two letters of noncompliance so far, and no fines have been issued to date.

Gilead lands in North Car­oli­na with a plan to hire 300 for new cen­ter

Hot off its earnings report that showed a slight dip in sales connected to HIV but a steady increase in revenue from its Covid-19 treatment, Gilead is headed to North Carolina’s Research Triangle.

Gilead will open office space in Raleigh later this year, the Raleigh News & Observer reports. The California-based company will hire 300 people for its business services center, which is set to take up three floors at 305 North Hill Street. Hiring has already begun, and the jobs will be in finance, information technology and human resources, a spokesperson told the N&O.

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Gun­ning for Bio­gen’s multi­bil­lion dol­lar mar­ket, Eli Lil­ly cuts up an­oth­er batch of Alzheimer’s da­ta

Eli Lilly executives have their eyes set on Biogen’s multibillion-dollar Alzheimer’s market.

On Thursday, the Indianapolis pharma tried to bolster its case to win accelerated approval for its amyloid-clearing antibody donanemab with a pair of new presentations at the Alzheimer’s Association International Conference.

Most notably, they argued that data from their Phase II trial showed that the more patients’ amyloid levels fell, the better they did cognitively. There was, they wrote, a “direct relationship between decrease in amyloid plaque and slowing in disease progression rate.”

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To fill African man­u­fac­tur­ing void, BioN­Tech will pig­gy­back off plans for malar­ia mR­NA vac­cine with new man­u­fac­tur­ing sites

The lack of drug manufacturing in Africa has led to a need for Covid-19 vaccines, and the lack of a malaria vaccine has led to the deaths of thousands of children each year. BioNTech will now to try and take down two birds with one stone.

BioNTech is exploring possibilities to set up mRNA manufacturing facilities throughout the continent, either by partnering with other companies or through its own volition, the company announced in a press release. These facilities would have mRNA manufacturing capabilities, and will share space with technology transfer hubs that are under development by the World Health Organization that line up with the strategy created by the Africa CDC.