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.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges


Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Richard Lerner (Scott Audette/AP Images)

Richard Lern­er, an­ti­body pi­o­neer and long­time pres­i­dent of Scripps Re­search, dies at 83

Richard Lerner, the esteemed biochemist who pioneered a new way to develop monoclonal antibodies and led Scripps Research Institute to prominence, has passed away.

A spokesperson for Scripps told the San Diego Union-Tribune that Lerner died of cancer in his La Jolla home. He was 83 years old.

Among other things, Lerner’s lab was known for devising a new technique for creating antibodies — deployed as cancer treatments as well as in immunology and disease research — one that the New York Times called a “major advance in biotechnology.” It led to companies making mAbs a thousand times faster, more accurately, at a lower cost. That foundational research cemented the discovery of Humira, which went on to become the world’s best-selling treatment.

Gary Glick, Odyssey Therapeutics founder

Al­ways busy, Gary Glick re­cruits Or­biMed in a mas­sive $218M Se­ries A for enig­mat­ic da­ta sci­ence biotech

Gary Glick is back at it again, founding yet another biotech company. And by the sheer size of its first raise, this may be the biggest one yet.

Glick has assembled what he calls an all-star roster and recruited one of the biggest healthcare investors in OrbiMed to put together a massive $218 million Series A for his newest venture, Odyssey Therapeutics. The launch, announced Tuesday morning and co-led by SR One Capital Management, comes not three months after Glick sold First Wave Bio to AzurRx for $229 million.

Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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