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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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Winselow Tucker, Eli Lilly's new Loxo unit chief commercial officer

Eli Lil­ly plucks a new com­mer­cial chief from Bris­tol My­ers in man­age­ment shuf­fle as HR chief re­tires

Eli Lilly has found a new chief commercial officer from among the ranks at Bristol Myers Squibb, as it says farewell to its longtime head of human resources Stephen Fry.

Fry announced on Thursday his plans to retire after more than 35 years with Lilly. He’ll vacate his seat as SVP of human resources and diversity at the end of the year, and current Loxo CCO Eric Dozier is slated to take his place. As a result, BMS’ Winselow Tucker is joining the team as Loxo CCO at the end of the month.

Simba Gill, Evelo Biosciences CEO

Sim­ba Gill heads back to Flag­ship af­ter sev­en-year run as Evelo CEO

Evelo Biosciences is on the hunt for a new CEO, with its founding chief Simba Gill switching to the chairman post to free up time for his new gig at Evelo’s incubator, Flagship Pioneering.

Gill will trade in his former Flagship title of venture partner with the higher-up role of executive partner, after originally joining in 2015. He’ll serve as CEO of Evelo until his successor is chosen, and at Flagship his priorities will be counseling and supporting the venture firm’s portfolio companies.

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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.