M&A, FDA Top List of 2017 Happenings

Well, that year went surprisingly fast. A cursory glance at the industry activity that occurred in 2017 included a continuance of the WIRB-Copernicus buying spree of Medavante, ProPhase, and ThreeWire; the transfer of Parexel to private equity firm Pampoloma; Chesapeake IRB scooping up two additional IRBs, then merging with Schulman IRB to become new entity Advarra; and the big event of INC Research acquiring inVentiv Health, which is yet to be renamed. Keeping in mind the Quintiles-IMS Health merger of May 2016 resulted in

QuintilesIMS and the November 2017 renaming to IQVIA. 

There were other notable acquisitions-ERT’s purchase of Biomedical Systems, ICON’s acquisition of Mapi Group and LabCorp of Chiltern. All this is to say that the industry is shifting again. The impact of the M&As, besides rebranding and renaming, includes concern on the sponsor side. As Applied Clinical Trials’ Editorial Advisory Board (EAB) member Townsend Barnett, Vice President and Global Head of Pre-Clinical and Clinical QA for UCB Pharma, said, “Consolidation in the CRO space is a problem for sponsors. It takes time to sort out….from SOPs to the varying vendor connections.”

For 2018, the EAB members identified a number of trends outside the aforementioned business machinations. They pointed out a number of upcoming regulatory guidances scheduled for release, including ICH E6 R2; implementation of ICH E9, R1 (which hasn’t been updated in 20 years and is “the bible” of statistical principles in trials, said member Stephen Senn, PhD, Head of Competence Center for Methodology and Statistics for Luxembourg Institute of Health); and also on the ICH side, ICH E19 is a new topic on when targeted collection of safety data could replace “full” collection.

Looking at the FDA, a guidance on digital health is expected this month or in Q1 2018. With the appointment of Scott Gottlieb as commissioner in May 2017, there is a more positive vibe in the pharma world that regulatory is serious about shortening trial timelines and moving them forward, either with technology acceptance or accelerated pathways or trial designs. 

Late last month, we found out the EMA will be relocating to Amsterdam, which means 2018 will feature a series of building, moving, and integrating to bring the EMA to its new home by March 30, 2019.

While Applied Clinical Trials focuses on articles and information professionals can use in their trials today, the Board members and contributions from Ken Getz based on research from Tufts CSDD and CISCRP, highlight where industry can improve. EAB member and HL7 CTO Wayne Kubick says, “How do we implement the clinical trial of the future? There are a lot of dramatic changes that need to happen so that we can shorten timelines, take the waste out, and get things done.” Last year, we did tackle that in my favorite article to date, “The Clinical Trial of Tomorrow” (http://bit.ly/2l8SIsb), which is a good roadmap to how technology will grow to improve drug development; however, holistically it will occur in fits and starts. In 2018, the hope is that industry can continue its improvements to move forward faster and more effectively.

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at lisa.henderson@ubm.com. Follow Lisa on Twitter: @trialsonline