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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.

Mark Sitcoske, High Purity New England CEO

New Eng­land-based dis­trib­u­tor HP­NE looks to dou­ble its work­force to keep up with de­mand

In 2019, High Purity New England, a biopharma solutions and equipment supplier and distributor based out of Smithfield, Rhode Island, had just 60 employees. Thanks to a push in demand, largely fueled by the pandemic, it hopes it can end the year 2022 with 350.

The hiring push is all part of the company’s plan to open a new facility in December, a $10 million project that would triple its manufacturing output and bring its total square footage to more than 100,000. All three buildings will be located on the same street, and the new site will be used to create a sixth clean room for manufacturing, a distribution center, a lab and more office space.

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Henrietta Lacks (Via Johns Hopkins Medicine)

Es­tate of Hen­ri­et­ta Lacks sues Ther­mo Fish­er over the im­prop­er sale of her im­mor­tal cells

The family of a black woman whose immortal cells were unethically taken from her at Johns Hopkins hospital in 1951 is now suing Thermo Fisher Scientific for profiting from the cells for decades.

The world-famous cell line, known for Henrietta Lacks as HeLa and the subject of a bestselling book about a decade ago, have proven to be incredibly important in human history, helping scientists to make major strides, from the polio vaccine to in vitro fertilization.

FDA calls for re­peat bioe­quiv­a­lence stud­ies af­ter un­cov­er­ing 'in­valid' da­ta from two In­di­an CROs

After finding “significant instances of misconduct and violations of federal regulations,” leading two Indian CROs to submit “invalid study data to FDA,” the agency is now calling on certain unnamed generic and brand name drug companies to run bioequivalence tests again for some of their marketed products.

The FDA said that after looking into the clinical and bioanalytical studies conducted by Synchron Research Services in Gujarat, India, and Panexcell Clinical Lab in Maharashtra, India following an inspection in late Nov. 2019, data from either company are no longer acceptable to support a determination of safety or effectiveness for brand name drugs, or to show affected generic drugs are bioequivalent to their brand name counterparts.

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