Applied Clinical Trials Editorial Staff

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.

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, 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.

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, 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.

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).

Articles

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

News Notes (November)

Trial resumptions slow as COVID cases rise again

Clinical trials disrupted by COVID-19 are expected to resume at a much slower rate than originally anticipated, as more nations are reinforcing lockdowns due to a globally rising number of COVID-19 cases, says GlobalData.

“The general trend shows a gradual increase in the overall percentage of trials for each trial status, the biggest of which has been seen in trials that are ongoing and recruiting and those that are ongoing but not recruiting,” commented Priya Nair, trials intelligence analyst at GlobalData. “Between Aug. 17 and Sept. 21, ongoing and recruiting trials decreased from 84.7% to 82.2%, while completed trials increased from 4.5% to 6.4%.”

The number of resumed trials increased from over 600 on Aug. 17 to 741 as of Sept. 21. Out of these trials, 82.2% are currently recruiting participants, 7.9% have completed recruitment but are still ongoing, and 0.5% of trials have yet to start recruiting subjects.

GlobalData reports that there is an overall steady increase of trials resuming activity. The U.S. has the highest number of resumed trials at 70.6%, followed by France at 7.6%, the UK and Spain at 7.3% each, and Japan at 7.2%.

“As large numbers of companies shift to alternative ways to conduct trials, it is possible that the use of virtual trials may still be prominent even after the COVID-19 pandemic ends,” said Nair.

Bristol Myers Squibb and MyoKardia, Inc. have entered into a definitive merger agreement under which BMS will acquire MyoKardia for $13.1 billion, or $225 per share in cash. The transaction was unanimously approved by both the BMS and MyoKardia Boards of Directors and is anticipated to close during the fourth quarter of 2020.

MyoKardia is a clinical-stage biopharmaceutical company that discovers and develops targeted therapies for the treatment of serious cardiovascular (CV) diseases. Through the transaction, BMS gains mavacamten, a potential first-in-class CV medicine for the treatment of obstructive hypertrophic cardiomyopathy (HCM), a chronic heart disease with high morbidity and patient impact. A new drug application for mavacamten for symptomatic obstructive HCM is expected to be submitted to FDA in the first quarter of 2021. BMS expects to explore the full potential of mavacamten in additional indications, including non-obstructive HCM, as well as develop MyoKardia’s pipeline of novel compounds, including two clinical-stage therapies

Genuity Science, a genomics and data insights organization, and Ionis Pharmaceuticals, a company focused on antisense therapeutics, have struck a broad, multi-year collaboration aimed at accelerating the discovery and development of novel therapies across a range of conditions.

Genuity Science’s approach combines high-quality, whole-genome sequence and deep phenotype data resulting in better definition of the underlying disease mechanisms. This approach, when coupled with Ionis’ proprietary antisense technology, has the potential to significantly expedite the drug development process through a more direct translation of targets into drugs. Under terms of the deal, Genuity Science will receive a combination of upfront payments and development milestones, plus product royalties.

Behind its RNA-targeted antisense technology, Ionis has a pipeline of more than 40 drug candidates designed to potentially treat a broad range of disease, including neurological, cardiovascular, infectious, and pulmonary diseases.

PharmaLex Group, a provider of specialized services for pharma, biotech, and medical device industries worldwide, has completed its mergerwith Biopharma Excellence (BPE) GmbH. BPE is a consultancy based in Munich, Germany, which offers specialized biopharma consulting services, including biologicals, antibody-containing products, cell- and gene therapies/ATMPs, biosimilars, and vaccines.

Founded in 2013 by Diane Seimetz, PhD, and Gabriele Dallmann, PhD, BPE supports national and global life science companies from top 10 pharma organizations to emerging startups. The company offers integrated product development services in the EU, the US, and further territories, covering early- and late-stage scientific, regulatory, and strategic support up to submission of dossiers and lifecycle strategies.

News Notes (October)

vate today announced the release of the 2020 Centre for Medicines Research (CMR) International Pharmaceutical R&D Factbook. The factbook reveals a decrease in R&D spending for the first time since 2016. While previous predictions for 2022 expenditure exceeded $86 billion, this year, 2022 expenditure is forecasted to reach $80 billion, with new factors such as COVID-19 impacting drug development.

The Centre for Medicines Research, a subsidiary of Clarivate, has released the report to help pharma and biotech companies assess R&D productivity and provide insights into industry trends which will inform drug development efforts. It provides insights on R&D expenditures, cycle times, pipeline growth and more to allow Pharma and Biotech companies to access and analyze success rates and key activities from drug discovery through commercialization.

The 2020 CMR International Pharmaceutical R&D Factbook reveals drug development continues to be complex, challenging, and time consuming. The burden of existing diseases and the recent COVID-19 pandemic has also had an impact on drug development. While inroads have been made to tackle these complex communicable and non-communicable diseases, delivering new treatments in an accelerated and cost-efficient manner remains a significant challenge.

Pharmaceutical R&D industry report provides insights into what’s behind decline in global NME outputs and reveals implications of decreased projected expenditures.

New Centre for Medicines Research Report from Clarivate Indicates Drug Development Timelines are Shortest Since 2013 

Parexel and Pfizer enter next phase of partnership

Parexel has signed a new master service agreement (MSA) with Pfizer to continue the CRO’s decade-long partnership with the big pharma company. The agreement is for a three-year term with an option to extend for an additional two years.

The strategic focus of the new arrangement is focused on driving cycle times for Pfizer’s development efforts. Parexel will provide Pfizer clinical development services via full-service, hybrid, and functional service provider (FSP) models across all therapeutic areas, including rare diseases, oncology, inflammation, and immunology, and internal and hospital-based medicines.

Regeneron Pharmaceuticals and Roche are joining forces in the fight against COVID-19 to develop, manufacture, and distribute REGN-COV2, Regeneron’s investigational anti-viral antibody cocktail, to people around the globe. REGN-COV2 could provide a much-needed treatment option for people already experiencing symptoms of COVID-19, and also has the potential to prevent infection in people exposed to the virus, thus slowing the spread of the global pandemic. This collaboration is expected to increase supply of REGN-COV2 to at least three and a half times the current capacity, with the potential for even further expansion.

If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S. and Roche will be responsible for distribution outside the U.S.

Bayer will acquire KaNDy Therapeutics Ltd, a UK clinical-stage biotech company, to expand the pharma company’s drug development pipeline in women’s healthcare. Under the terms of the deal, Bayer will pay an upfront consideration of $425 million, potential milestone payments of up to $450 million tied to KaNDy’s lead investigational compound, followed by potential additional triple-digit million sales milestone payments.

Trialbee, a provider of patient matching and engagement technology in clinical trials, has entered into a partnership with medical data informatics company Clinerion designed to accelerate time to market by shortening patient recruitment and enrollment timelines. The deal combines Clinerion’s focus in leveraging real-time, real-patient, and real-world electronic health record data for clinical research with Trialbee’s multiple-step qualification process, which includes online qualification and nurse practitioner interviews to ensure patient matches prior to obtaining consent and enrollment.