06 Abr Clinical Research Translation News April (CRO Special)

IMPORTANT LAW CHANGES AFFECTING CROs

• From 11 May, 2017, significant changes for drug development in China are taking place encouraging a new era for device, drug development and medical translation for CROs.

CRO TENDENCIES

As competition within the drug development landscape intensifies and clinical trial protocols become more complex, the industry is refocusing the needs and experience of clinical research patients developing best practices, including translation for CROs, to both ensuring trial success and making sure patients remain the center of the processes.

Contract Research Organizations (CROs) and clinical investigative sites are increasingly adopting a patient-centric approach to trial design to address some of the challenges inherent in clinical research. This should be specially taken into consideration as regards clinical trials of rare diseases, where the eligible patient population is limited.

CROs  MERGERS & ACQUISITIONS

CRO industry has been consolidating for years now, partially with the help of private equity. This consolidation includes new service offerings, new Translation for CROs needs, formal strategic partnerships and manufacturing deals.

However, mergers and acquisitions have been very active lately.

Some CRO MERGERS data

• Merger agreement between Fagron & Humco for up to $70 million.
• Syneos Health aims to establish new industry standards to improve clinical trial collaboration and execution by joining Align Clinical CRO.
• Leadership award winner PPD expands GMP Biologics Testing Capacity.
• Merger between 2 CROs, Linical and Accelovance to boost their oncology expertise. Probably new translation for CROs services might be required.

Some CRO ACQUISITIONS data

• George Clinical expands its operational expertise throughout the United States. A leading full-service CRO in the Asia-Pacific region, George Clinical, is acquired the CRO Division of the Memphis-based leader in oncology research and data analytics, Vector Oncology.
• The Sale of Parexel appears to be good news for the CRO industry, which is seen as attractive because drug companies increasingly are outsourcing their clinical trial efforts as well as translation requirements.
• ICON plc, will rebrand their acquired ClinicalRM division into ICON Government and Public Health Solutions, which demonstrates ICON’s commitment to solving global health issues through enhancing capabilities in vaccines and infectious diseases.
• Tergus Pharma has acquired a Dermatology-centric CRO based in Kannapolis, NC, EnDev Laboratories,which will add extensive early-phase drug development capabilities from lead compound selection to skin biology. New translation for CROs services might also be demanded.
• Roche acquires Flatiron Health, a market leader in oncology-specific electronic health record software and a privately held healthcare technology and services company headquartered in New York City, US. It will be essential to contract the adequate translation for CROs services.
• Concord Biosciences acquired by Frontage Laboratories.

CRO PROJECT SELECTION

• NurOwn has selected Leadership award winner Worldwide Clinical Trials CRO to run a Phase 3 study for the treatment of amyotrophic lateral sclerosis based on the investigational stem-cell therapy. The study will be carried out in US and Israel. If translation for CROs services are not already commited, we recomend Okomeds’.
• Incyte, Merck and KEYTRUDA, working for patients with Metastatic or unresectable Melanoma.

CRO POSITIONING AND EXPANSION

• ZEINCRO has been reinforcing, during the last years its leading position in Central- and South- Eastern Europe following a need to establish local presence strategy.
• George Clinical, has not only been reinforcing its position in the Asia-Pacific region, but spanding to the United States.
• The Venture capital firm ShangPharma wants to stretch out by 40% in the Bay Area, with extra lab infrastructure and conferencing space.
• Okomeds is expanding and currently incresing its translation for CROs services.

CROs & COST REDUCTION

• How to make clinical trials more efficient and to drive down drug development costs is Mitsubishi Tanabe’s motto and aim while applying Hitachi’s artificial intelligence technology.

CRO AWARDS

• Domainex was awarded £118,000 from the UK’s innovation agency to develop a new biophysical screening method for G-protein coupled receptors.
• 2017 CRO Leadership awards winners are: Algorithme Pharma, Celerion, Chiltern, Covance Inc., DaVita Clinical Research (DCR), Duke Clinical Research Institute, Eurofins Scientific, INC Research, inVentiv Health, NAMSA, Pharm-Olam International, PPD, QPS Holdings, Rho, SGS Life Sciences, UBC, Vince & Associates Clinical Research, Worldwide Clinical Trials.

CRO MARKET DATA

1.- Key CRO players

IQVIA, PAREXEL, LabCorp, Syneos Health, Charles River Laboratories, PRA Health Sciences, WuXi Pharmatech, ICON plc, Development of pharmaceutical products, MedPace Holdings, Chiltern International Ltd. and Clintract, Inc. Some of which are already Okomeds’ clients.

2.-  Main geographic regions

US, China, EU, Southeast Asia and India.

3.- CROs Market segments

Academic institutes, pharmaceutical and biopharmaceutical companies and medical device companies.

4.- CROs Market services

Laboratory services, early phase development services, toxicology tests, pharmacokinetics, pharmacodynamics, clinical research services and others.