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Charles Fisher, Unlearn CEO

Rid­ing on wave of clin­i­cal tri­al re­forms, ma­chine learn­ing start­up bags $50M to cre­ate 'dig­i­tal twin­s'

As drug developers and regulators alike increasingly warm to creative ideas for running clinical trials, a machine learning platform created by three physicists is drawing in $50 million from tech VCs.

Unlearn bills itself as the only company that can generate “digital twins” of patients for use in clinical trials, so that biopharma companies can test their drugs with fewer real patients than they would need to in traditional trials, but get similarly, if not even more, reliable results.

Fu­ji­film ex­pands C&G ther­a­py op­tions with ac­qui­si­tion of re­com­bi­nant pro­tein mak­er

Fujifilm is expanding its footprint within the US yet again, this time with another East Coast acquisition within driving distance of its new $2 billion headquarters.

Fujifilm Irvine Scientific has acquired recombinant protein maker Shenandoah Biotechnology. The Pennsylvania manufacturer makes cytokines and growth factors and recently launched a CTG grade line that was made in its new facility. This acquisition will allow Fujifilm to easily transition between preclinical and clinical phases of trials.

Michael Egholm, Standard BioTools president and CEO (IsoPlexis)

Eli Cas­din co-leads $250M in­fu­sion in­to mi­croflu­idics play­er that land­ed NIH fund­ing for Covid-19 test­ing

In about 17 months, Fluidigm has gone from working with sharks to Vikings.

The South San Francisco-based company, which landed NIH money in a Shark Tank-style program for Covid-19 testing, announced that it will take on an investment worth $250 million from Casdin Capital and Viking Global Investors. It will also rebrand, and call itself Standard BioTools. The investment will help the company focus on the highest growth areas of discovery and development and expand its CRO and CMO service providers. Right now, the company’s customer reach is limited to basic research, it said.

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Flori­da man con­vict­ed of fal­si­fy­ing clin­i­cal tri­al re­sults sen­tenced to over 2 years in prison

A Florida man who falsified medical records in connection to clinical trials was sentenced to 30 months in prison in federal court Thursday.

Daniel Tejeda, 35, of Clewiston, was also ordered to pay $2.1 million in restitution. Tejeda was a project manager and study manager for the CRO Tellus Clinical Research, and made it appear that subjects were participating in trials when they weren’t. Two other research workers from Florida were sentenced in the same case in August for 46 and 30 months, respectively.

CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Wel­come to CPhI week: The drug man­u­fac­tur­ing in­dus­try's pre­mier con­fer­ence kicks off with the winds of change blow­ing

Welcome to CPhI week!

Tuesday marked the opening of this year’s CPhI Global conference in Milan, Italy, in what marks its return to an onsite event for the first time since 2019.

In many ways, this year’s CPhI is different for us here at Endpoints News. We aren’t on site — as we certainly plan to be next year — so we can’t give you the inside scoop you can expect in the future. However, our team has been closely following the biggest trends from the past year and are staying abreast of what CPhI’s stable of experts are saying about the future of the industry.

CPhI: The time of the CMO is up­on us as mas­sive in­dus­try growth dri­ves surge in out­sourc­ing ca­pac­i­ty

Contract manufacturers are having a moment, and it hasn’t gone unnoticed by the folks at CPhI.

The organization’s annual report found that CMOs will account for four of the five top companies by manufacturing capacity in 2025. Dawn Ecker, a CPhI expert, predicts that the biologics manufacturing volume will grow 8% a year to that deadline, expanding from 2,700kL in 2020 to 3,900kL in 2025.

Nearly half of all capacity will shift from in-house manufacturing to CMOs and hybrid companies, her findings revealed, and if trends stay consistent, the big-dog contractors will have the largest capacity volume. Those four are Korea’s Samsung Biologics, Switzerland’s Lonza, WuXi Biologics, and Fujifilm Diosynth Biotechnologies.

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CPhI: As pan­dem­ic reach­es its fi­nal stages, an in­dus­try busier than ever re­flects on lessons learned

CPhI week is always a time each year to reflect on the manufacturing world writ large, and this year’s event is no different.

Normally, Endpoints News would be on site this week in Milan — we hired dedicated manufacturing reporter Josh Sullivan to cover events exactly like this, after all — but ongoing concerns over the pandemic have kept us homebound for now. But this week still holds a special place for us, and I thought one way to reflect on where biopharma manufacturing has gone in the past 12 months would be to hit on a few of the biggest trends and events we’ve reported on.

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Catalent CEO John Chiminski (Jeff Rumans)

Catal­ent wraps up San Diego site build­out as it con­tin­ues to make waves with glob­al ac­qui­si­tions

Just weeks after Catalent opened a newly acquired site in Shiga, Japan, the CDMO giant announced the opening of a new facility in San Diego to up its clinical packaging and distribution solutions on the West Coast.

The facility is 24,000 square feet and located within a mile of the company’s early-phase oral drug product center of excellence. It supports clinical studies for Phases I through III, and end-to-end services.

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Charles Riv­er Lab­o­ra­to­ries has been on an ac­qui­si­tion spree. But Tues­day, it of­floaded two as­sets

Following a summer filled with mergers and acquisitions, Charles River Laboratories has divested its research operations in Japan and a CDMO site in Sweden, engineering two separate deals expected to cut down $20 million in revenue.

Tuesday, Charles River sold its gene therapy CDMO site to a private investor group for about $52 million in cash, with the potential for contingent payments up to $25 million. The site was in the company’s possession for only a few months, as it was acquired from Cognate BioServices on March 29.