From The Editor | August 26, 2016

Clinical News Roundup: Bioclinica To Be Acquired By Cinven

Source: Clinical Leader
Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

clinical news

Bioclinica, a provider of specialized technology-enabled services supporting clinical trials, has entered a definitive agreement to be acquired by Cinven, an international private equity firm. The company was previously owned by Water Street Healthcare Partners and JLL Partners. Bioclinica represents the first investment from the €7 billion Sixth Cinven Fund, which was raised to acquire targeted companies where Cinven can strategically drive revenue growth both in Europe and globally, supported by its Pan-European office network and offices in New York and Hong Kong.

Upon close of the proposed acquisition, Dr. John Hubbard will continue as president and CEO. All executive officers will remain in their current positions reporting to Dr. Hubbard. Bioclinica serves more than 400 pharmaceutical, biotechnology, and device organizations through a network of offices and research sites in the U.S., Europe, Asia, and South America.

Since going private in 2013, Bioclinica has expanded its services and products with strategic acquisitions. This strategy has led to significant growth as Bioclinica is able to leverage its internal infrastructure and expertise to offer a variety of services associated with drug development.

“We are extremely excited about this new partnership with Cinven and see great things on the horizon for Bioclinica,” says Hubbard. “We experienced tremendous growth under our prior partnership with JLL and Water Street, and look forward to leveraging the strategic leadership and investment that will come with Cinven. Bioclinica is on a quest to accelerate and bring clarity to clinical trials, and this move will help us achieve these goals.”

Finalists Announced For SCRS Eagle Award

The Society for Clinical Research Sites (SCRS) has announced the finalists for the 2016 SCRS Eagle Award. The finalists were selected from nominations provided by SCRS members. Qualifying nominees were in the 75th percentile or higher of the total nominations submitted for the Eagle Award. Voting is now open to all clinical research site professionals, regardless of their membership with SCRS. Voting closes on September 21, 2016, and winners will be honored at the Global Site Solutions Summit Award Gala on Saturday, October 15th in Boca Raton, FL.

Finalists in the sponsor category are Amgen, Eli Lilly, GlaxoSmithKline, Merck, Nektar, Novartis, Novo Nordisk, and Pfizer. Finalists in the CRO category are INC Research, Medpace, PRA, Quintiles, and Target Health.

“SCRS congratulates each Eagle Award finalist and looks forward to announcing the Sponsor and CRO recipients during the Eagle Award Gala," says Christine Pierre, president of SCRS. "These nominations signify sites' eagerness to appreciate and publicly recognize companies demonstrating a strong commitment to the site partnership, which is critical for our collective success."

The SCRS Eagle Award recognizes outstanding leadership, professionalism, integrity, and dedication to advancing the clinical research profession through a strong site partnership. SCRS Eagle Award nominees are finalized through direct site input. Clinical research site personnel can go to this website to vote.

Foundations Support Study For Kids With Brain Tumors

Solving Kids’ Cancer, a brain tumor cure foundation, and the Ty Lewis Campbell Foundation have announced joint financial support for a Phase 1 clinical trial to test the safety and efficacy of combination checkpoint inhibitors in the treatment of children with brain tumors. The collaboration will result in a total contribution of $185,000 to the clinical trial.

The study will be led by Dr. Ira Dunkel, Memorial Sloan Kettering Cancer Center (MSKCC). Enrollment is expected to open in the first quarter of 2017. The International trial will be available to children in six esteemed cancer centers to start, including MSKCC, Dana Farber/Boston Children's Hospital, Johns Hopkins/Sidney Kimmel Comprehensive Cancer Center, Great Ormond Street Hospital (UK), Institut Curie Research Centre (France) and Children's Hospital Colorado. It is also likely that this innovative study will expand to additional centers in upcoming months.

Checkpoint inhibitors are humanized antibodies that take the "brakes" off immune cancer cells to effectively and efficiently kill cancer cells. This combination treatment targets the immune system rather than the cancer itself.

Three Keys To Mitigating Risk In Adaptive Trials

About 50 percent of all Phase 3 clinical trials fail. That is an expensive problem for the pharmaceutical industry, where the estimated average cost of these trials is $20 million. In an article appearing on Life Science Leader, Sy Pretorius, CSO for PAREXEL International, notes the high failure rate is due in part to the rigid, inflexible designs of late-stage clinical trials that prevent misguided preliminary assumptions from being fixed.

“In contrast, adaptive trial designs (ATDs) allow developers to revisit initial assumptions and change course during a trial,” says Pretorius. “This can generate more and higher-quality information about a drug’s safety and efficacy (or lack thereof) in the target patient population. The result? Faster, smarter terminations, and the conservation of precious R&D resources. However, due to the complexity of the process, many companies do not design and conduct adaptive trials. However, due to the complexity of the process, many companies do not design and conduct adaptive trials.”

In order to conduct successful adaptive trials, Pretorius recommends companies do three things.

  • Choose the right compounds and conditions. A compound suitable for adaptive trials should have an effect that is known quickly, has a well-characterized relationship between the dose and expected effect, and is for treatment of a life-threatening disease. Early-stage trials also accommodate adaptive trials more easily than later-stage trials.
  • Ensure statistical validity. Unblinding data can introduce bias into a trial and skew results. This is why traditional trials do not allow interim looks at data. Therefore, the first hurdle for adaptive designs to overcome is ensuring the statistical integrity and validity of the trial data while adding flexibility.
  • Build a supportive operational infrastructure. The infrastructure required to execute an adaptive trial is more complex than that of a traditional trial. For this reason, adaptive trials require an experienced, cross-functional, and integrated operational approach. That approach should avoid delays, feature frequent communication, and have a technology infrastructure that enables real-time decision making and implementation.

BeiGene Approved To Start Clinical Trials In China

BeiGene Ltd., a clinical-stage pharmaceutical company focused on immuno oncology drugs for cancer treatment, has received Clinical Trial Application approval from the China Food and Drug Administration to initiate clinical trials in China for BGB-290, a PARP inhibitor.

BGB-290 has already obtained approval to conduct clinical trials in Australia and the U.S. Data from the Phase I proof-of-concept trial of BGB-290 were previously disclosed at last year’s AACR-NCI-EORTC conference.

“The CTA approval for BGB-290 represents the third molecule from the BeiGene portfolio to receive regulatory clearance for initiation of clinical trials in China,” says John V. Oyler, founder, CEO, and chairman of BeiGene. “We look forward to commencing the development of BGB-290 in China, in addition to continuing global development of BGB-290, both as a monotherapy and in combination with BGB-A317, our PD-1 antibody.”

Zika Vaccine Trials Advance To Humans

Researchers are seeking volunteers for clinical trials designed to test a new experimental Zika virus vaccine. If health officials approve the proposal, the clinical trials will start in December at John Hopkins Hospital, Baltimore.

"We're looking at these human challenge protocols not only as an important step in vaccine development but as a means to learn more about Zika,” says Dr. Ana Durbin, leading scientist for the trial. “We can look at things that you just can't do in someone who's naturally infected."

This is a big leap for the scientific community studying the virus. The experimental vaccines were said to be promising after tests performed on monkeys. The experimental vaccine contains DNA plasmid, which has proteins similar with the deactivated Zika virus. The conferred proteins help the immune system to build a defense mechanism against the invasion of an active Zika virus.  

Large-Scale Study Looks At Dementia

Scientists at Newcastle University in the U.K. are involved in a new multimillion pound study on volunteers which will be the most thorough test to date to detect Alzheimer’s disease. The Deep and Frequent Phenotyping study is funded by the National Institute of Health Research (NIHR) and the Medical Research Council (MRC) with the hope of dramatically improving the success rate of clinical trials for treatments of the condition.

This landmark £6.9m research project has been designed to identify measurable characteristics, known as biomarkers, which can detect the occurrence of Alzheimer’s disease very early on, when a person may have no obvious symptoms.

Currently, there is no known cure for the disease and few treatments which are available treat symptoms, rather than slow or stop its progression. “Our goal is to find treatments that can slow down or even stop the progression of Alzheimer’s disease,” says Dr. Rob Buckle, director of science programs at the MRC. “Finding biomarkers for clinical trials is crucial for fast-tracking decisions as to whether a trial should stop or continue. And the faster we can find out which drugs work and which ones don’t, the faster we can benefit patients.”