John Neal

Pipelines and Patients

By January 30, 2019 No Comments

The clinical research industry continued its rapid evolution during 2018, coming off of a year of major activity and changes in 2017. It is no time for the faint of heart, or those resistant to change. As I first predicted in 2016 in my “Change is in the Air” series, the clinical research industry continues to change quickly. Since then we have seen major consolidation of pharmaceutical, CRO, IRB, and Site companies, and the pace continues at what may seem like breakneck speed for an industry that is slow to change.

Following very busy years in 2016 and 2017, 2018 was a very active year for acquisitions and consolidations, with GlaxoSmithKline (GSK) closing out the year with an agreement to acquire Tesaroi, broadening its reach into oncology, and GSK and Pfizer partnering to combine their consumer health businesses into a new world-leading Joint Ventureii. Already in 2019 Bristol-Meyers Squibb acquired Celgeneiii, which significantly expands its Phase III pipeline of drugs nearing completion of clinical trials, Lilly acquired Loxo Oncologyiv, which broadens the scope of Lilly’s oncology portfolio into precision medicines, and we’re still in January.

Pharma companies are not the only ones who have been busily acquiring companies to accelerate their growth and position them for future success. Coming off of a very busy 2016 and 2017, during which INC Research and InVentiv Health merged to form Syneosv Health, Quintiles Transnational merged with IMS Healthvi to form IQVIA, and PAREXEL was acquired and taken private by Pamplona Capital Managementvii, 2018 saw its own share of activity. LabCorp, which acquired Covance in 2015, went on to acquire Chiltern in 2017, and continued to build its CRO business in 2018. Many other mergers and acquisitions of smaller CRO’s continued at a rapid pace.

IRBs were also busy with M&A activity. WIRB-Copernicus has been very active in this area for yearsviii, completing multiple acquisitions in 2017 and 2018. Another major event in the IRB world was the merger in late 2017 of Chesapeake IRB and Schulman IRB, creating Advarraix. Many others are active, consolidating smaller, niche IRB’s to extend their reach and appeal to sponsors, CROs and Sites.

Throughout this time, Sites have been a target for acquisition by many CROs, SMO’s, and private equity investors intent on shoring up their project pipelines by getting closer to the key to completing clinical trials: quicker access to patients likely to volunteer to participate in clinical trials. After all, when it comes to competing for studies from sponsors (both drug and device), often the single biggest hurdle to completing the complex process of achieving approval for a drug or device is enrolling a sufficient number of patients to complete the study and submit the results to the FDA. CROs and Sites that can demonstrate that they have ready access, not just to patients, but to patients meeting the increasingly difficult inclusion and exclusion criteria, and open to participating in studies, will be awarded more studies, edging out competitors that cannot demonstrate their ability to deliver above average performance consistently.

At the bottom of the industry food chain, Sites found in 2018 that it is more difficult to attract attention and be awarded studies than in previous years. 2019 will continue down the same path. Some sites are thriving in this environment, developing niche access to hard to deliver patients, leveraging past relationships, and adopting technologies and processes to become more efficient. Many though are struggling on their own. For some of those, participating in a network may help them access studies to stay competitive and keep their pipelines full. For others, being acquired by an SMO may be the answer, as the larger, better capitalized SMO organizations hold the promise of economies of scale, and provide the opportunity to become part of a larger fish in the perilous waters of a changing industry.

All players in the clinical research enterprise will continue to face the challenge of evolving in 2019. For all involved, success ultimately depends on keeping their pipelines full, and maximizing access to the right patients.

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PCRS supports sponsors and CROs by putting our proven, successful feasibility processes to work, and supports Sites by providing access to more studies more consistently, with easy centralized negotiations for all.

i https://www.gsk.com/en-gb/media/press-releases/gsk-reaches-agreement-to-acquire-tesaro-an-oncology-focused-biopharmaceutical-company/

ii https://www.gsk.com/en-gb/media/press-releases/glaxosmithkline-plc-and-pfizer-inc-to-form-new-world-leading-consumer-healthcare-joint-venture/

iii https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-acquire-celgene-create-premier-innovative

iv https://investor.lilly.com/news-releases/news-release-details/lilly-announces-agreement-acquire-loxo-oncology

v https://www.businessinsider.com/r-contract-medical-research-firm-inc-to-buy-inventiv-in-46-bln-deal-2017-5#

vi https://ir.iqvia.com/investors/press-releases/press-release-details/2016/IMS-Health-and-Quintiles-to-Merge/default.aspx

vii https://www.parexel.com/company/news-events/press-releases/2017/pamplona-capital-management-completes-acquisition-parexel-international

viii https://www.wcgclinical.com/about/history/

ix https://www.advarra.com/about-advarra/news/chesapeake-irb-and-schulman-irb-merge-to-establish-premier-independent-institutional-review-board-for-research/

 

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