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.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, 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.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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As it ex­pands its foot­print, Mod­er­na reach­es deal to man­u­fac­ture Covid-19 vac­cine dos­es in Mid­dle East

While the UAE leads the world with the highest percentage of residents vaccinated, neighboring Saudi Arabia — home to nearly 35 million people — has lagged behind significantly. On Friday, Moderna announced that it has partnered with the Saudi pharmaceutical company Tabuk to manufacture its jab and future variant-specific boosters in the country.

Tabuk will hold marketing authorization for the vaccine in Saudi Arabia, and the agreement gives them the possibility of distributing future Moderna mRNA products.

FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

An ex­pen­sive watch, shell com­pa­nies and fake in­voic­es: How two Is­raeli traders tapped in­to a $100M glob­al biotech in­sid­er trad­ing ring

It appears that we have reached the end of the saga about the global insider trading ring that collectively reaped $100 million from placing “timely, profitable” trades in biotech stocks like Ariad, Pharmacyclics and Receptos.

Tomer Feingold and Dov Malnik — Israeli traders living in Switzerland — were the last out of eight to be charged as the SEC unraveled the scheme, which ran from 2013 through 2017. Together, according to a statement in March, the pair had pocketed more than $4 million.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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