Outsourcing channel feed

A CRO look­ing to build its man­u­fac­tur­ing side busi­ness has a new par­ent af­ter Keen­sight snaps up ma­jor­i­ty stake

Dutch CRO Symeres has looked to grow its manufacturing side business, recognizing the benefit of synergy in contract research and production. That dual mission caught the eye of Keensight Capital, a French investment firm who has decided to go all in and steer the ship.

Keensight on Tuesday said it would pick up a majority stake in Symeres from Gilde Healthcare. Symeres specializes in small molecules and provides R&D services from preclinical discovery to Phase I/II clinical stages of drug development alongside its manufacturing offerings. The company is growing, and Keensight will help the company grow its operation over the next few years, Keensight partner Amit Karna said.

Paul Diaz, Myriad Genetics president and CEO

A ge­net­ics test­ing out­fit is bail­ing on its CRO ser­vices, choos­ing in­stead to re­fo­cus around pre­ci­sion drugs

In the past few months, there’s been a string of consolidation in the CRO space, with big players merging together and headline names in contract manufacturing snapping up research teams. But a Texas genetics player is now going the other way, bailing on its CRO offerings to instead focus on precision medicine.

Salt Lake City-based Myriad is selling its Austin contract research lab to North Carolina’s Q2 Solutions, the company said Monday. The deal is expected to be closed in Q3 and will allow Myriad to focus efforts on women’s health, oncology and mental health, CEO Paul Diaz said in a press release.

CVS splash­es in­to clin­i­cal tri­al ser­vices, lean­ing on lo­cal roots to change the game in terms of pa­tient en­gage­ment

Imagine picking up a gallon of milk and participating in a clinical trial while you’re at it.

That’s the future that CVS Health has dreamed up, and it could soon be a possibility as the company rolls out its new clinical trial services. While not technically a CRO, CVS Health plans to partner with them and drugmakers to recruit patients, run trials, and collect real-world data.

“Our focus is to give the patient or potential research participant choice,” Owen Garrick, VP of conduct and clinical trial services, told Endpoints News. “If we look at the assets and capabilities and history of CVS Health, we have the ability to essentially meet the patient where they are.”

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UP­DAT­ED: Feds charge an­oth­er CRO staffer with fak­ing da­ta in a Glax­o­SmithK­line pe­di­atric asth­ma study

A Florida woman has been indicted as part of a clinical trial fraud scheme over a GlaxoSmithKline pediatric asthma study, the Justice Department announced Tuesday, the latest development in a case where three individuals have already pleaded guilty.

Jessica Palacio was charged with participating in a plot to falsify medical records, giving off the appearance that trial participants were making their scheduled visits to a Miami CRO and taking an experimental asthma medication as required. Palacio was also charged with lying to FDA investigators about her conduct.

Aindrea Campbell, Zymergen

Q&A: Ain­drea Camp­bell goes small, step­ping away from Ap­ple to head man­u­fac­tur­ing at Zymer­gen — where am­bi­tions are big

Over the past 22 years, Aindrea Campbell has worked with just two corporate giants, Ford Motor Company and Apple, with generations of experience between them. But in her new role as Zymergen’s chief manufacturing officer, Campbell comes to a company with years — eight — of history, not decades.

This month, Campbell joined synthetic biology player Zymergen to lead manufacturing for the company’s “biofacturing” process, which ferments genetically engineered molecules to create products that can be used in a range of potential applications, including electronics, consumer health and agriculture, just to name a few. The process, Zymergen says, obviates the need for toxic chemicals and huge infrastructure demands in traditional manufacturing, potentially cutting costs by 90% in half the time.

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Gold­man Sachs jumps aboard Bain-backed 503(b) com­pound­ing phar­ma­cy with a $275M debt loan to sup­ply hos­pi­tals

Long the bane of the FDA’s existence, compounding pharmacies have seen a minor resurgence in the past year as short-term saviors for hospital drug shortages. Now, a 503(b) company specializing in hospital meds has earned a big backer to keep expanding its 200-drug strong portfolio.

Goldman Sachs and Owl Rock Capital Partners have doled out a $275 million debt loan to QuVa Pharma, a 503(b)-certified outsourcing facility providing compounded drugs to hospitals, the company said Thursday.

Lon­za keeps adding on as it looks to beef up bi­o­log­ics of­fer­ing, tack­ing on near­ly $1B in ex­pan­sions in EU, US

Amid a flurry of expansion activity, CDMO Lonza is continuing to beef up its manufacturing plants both in its native Switzerland and in the US. The newest plan? A $935 million outlay to build new sites in Visp and Portsmouth, NH, to help grow the company’s biologics portfolio.

The Swiss plant — which will absorb the vast majority of the new funds — will house six 20,000-liter bioreactors as part of a 90,000-plus-square-foot footprint. The site will be designed to optimize energy and water efficiency and cost about $714 million, Lonza said.

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John Chiminski, Catalent (JPM20)

Catal­ent snaps up Promether­a's cell ther­a­py sub­sidiary, com­plete with a Bel­gian plant to help scale plas­mid DNA ef­forts

Riding a wave from its work on the Covid-19 response, CDMO giant Catalent has been expanding rapidly in next-gen cell therapies as it gets prepped for a future boom. After a couple of snap expansions at its Belgian campus, Catalent is now adding another facility at the site as part of its plan to bolster its EU hub.

Catalent has acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium, part of the New Jersey drugmaker’s continued expansion plans in the country, the companies said Thursday.

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Covid-19 man­u­fac­tur­ing roundup: Freez­er kits to store vac­cines de­liv­ered to Venezuela; UN chief weighs in on IP de­bate

In an effort to support Venezuela’s vaccination efforts, the first 50 of 100 freezer kits were delivered to the country Wednesday, the United Nations Children’s Fund told Reuters.

Health minister Carlos Alvarado said earlier this week that the country has received 1.48 million vaccine doses between China’s Sinopharm and the Russian Sputnik V. Both vaccines require 2 shots.

The freezers are vital to the storage of vaccines, particularly because the country’s hospital network often lacks electricity. Venezuela has reported 201,807 infections and 2,208 deaths from Covid-19 since the pandemic started last March, but academics say the number of cases and death toll is much higher.

Sam­sung Bi­o­log­ics, TG Ther­a­peu­tics ink deal to mass pro­duce MS hope­ful ubli­tux­imab

As Samsung Biologics looks to dramatically scale its production with a $2 billion “super plant” in Incheon, South Korea, it’s signing on partners to fill its manufacturing schedule. Now, Samsung and TG Therapeutics will work together on manufacturing MS hopeful ublituximab.

“With the recent positive ULTIMATE I and II MS Phase 3 studies, we re-evaluated our supply needs and were very pleased we were able to secure the long-term capacity we believe we will need to meet the potential global demand for ublituximab,” TG CEO Michael Weiss said in a statement. “This is an important next step in our long-standing relationship with Samsung.”

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