News Notes (November)

November 18, 2020
Applied Clinical Trials Editorial Staff

Applied Clinical Trials, Applied Clinical Trials-11-01-2020, Volume 29, Issue 11

A compilation of recent notable news developments that pertain to the clinical trials industry.

Syneos Health acquires emerging-biopharma-focused CRO Synteract

Syneos Health, a fully integrated biopharmaceutical solutions company combining a contract research organization (CRO) and contract commercial organization (CCO), has agreed to acquire Synteract, a full-service CRO focused on the rapidly growing emerging biopharma segment. Synteract has built a solid reputation in this space, providing deep therapeutic expertise in oncology, rare and orphan diseases, neuroscience, dermatology, and pediatrics. The company’s client base comprises primarily pre-revenue companies, a segment in which Syneos Health has growth opportunities. Synteract’s 700 employees across North America, Europe, Asia Pacific, and Africa have supported more than 4,000 Phase I-IV clinical trials across 26,000 sites in more than 60 countries.

The acquisition will enhance Syneos’ position in the marketplace, particularly for serving customers across the small to mid-sized (SMID) category. According to industry estimates, funding to the biotech sector has shown no signs of slowing down, remaining near all-time record highs.

Biosimilars R&D pact with FDA

Health-management information company SomaLogic, Inc. has struck an agreement with FDA’s Division of Applied Regulatory Science to evaluate the use of large-scale analysis of proteins (proteomics) for the identification of biomarkers that may be useful in demonstrating biosimilarity of a proposed biosimilar to a reference biologic.

The collaborative project will use data generated on the SomaLogic SomaScan Platform, which makes 5,000 protein measurements simultaneously in small samples of blood, to compare changes in circulating proteins following treatment with FDA-approved biologics. The protein measurements from an FDA-approved reference biologic could then be compared to those generated by a candidate biosimilar drug.

Advarra buys IntegReview IRB

Advarra, a provider of institutional review board (IRB), institutional biosafety committee (IBC), quality and compliance consulting services, and research technology solutions has acquired IntegReview IRB, an AAHRPP-accredited central IRB. As a market player in early phase clinical research, the addition of IntegReview enables Advarra to continue its expansion of comprehensive review solutions capabilities in North America.

The Austin, Tex. headquarters for IntegReview will become the first Advarra office in the southern US.

Growth for DNA sequencing

According to a report by Bizwit Research & Consulting, the worldwide DNA sequencing market garnered a valuation of $4.7 billion in 2019 and is projected to record a year-over-year growth rate of 11.3% during 2020-2027. Increasing demand for DNA sequencing in biological research applications and across various medical fields such as virology, biotechnology, medical diagnosis, forensic biology, and biological systematics is expected to augment the industry growth in the upcoming years.

The rising prevalence of cancer, the report notes, serves as a major growth impetus for the global DNA sequencing industry. Nearly 18.1 million new cancer cases were recorded in 2018 and the number is expected to climb to 27.5 million by 2040, the report says, citing data from the International Agency for Research on Cancer.

eGenesis partners with Duke

eGenesis, a biotech using gene editing technologies for the development of safe and effective human-compatible organs, tissues, and cells to address the global organ shortage, has initiated a research collaboration with Duke University School of Medicine. The arrangement will encompass evaluation of gene-edited pancreatic islet cells in non-human primate recipients as a prerequisite to advancing to human clinical trials. This collaboration is in addition to an existing eGenesis partnership with Massachusetts General Hospital, established in 2017.

TMF University readies for launch

The first independently accredited Trial Master File University (TMF University) is getting ready to launch its inaugural training series on Jan. 11, 2021. TMF University engages students with a combination of high-quality virtual instruction along with standardized educational competency requirements to prepare internationally qualified TMF experts. It is being facilitated by LMK Clinical Research Consulting and has received accreditation from the International Accrediting Organization for Clinical Research (IAOCR).

— Staff and wire report

download issueDownload Issue : Applied Clinical Trials-11-01-2020