Clinical News Roundup: As Quintiles And IMS Health Merge, Should Sponsors Reevaluate Partnerships?

By Ed Miseta, Chief Editor, Clinical Leader

IMS Health And Quintiles Agree To Merge

IMS Health and Quintiles have announced their respective boards of directors approved a merger agreement in an all-stock transaction. The combined company will be known as Quintiles IMS.

While the merger may not seem like a perfect fit at first glance, The Hindu Business Line notes the companies are matched quite well. The merger creates a mammoth CRO and data company valued at $18 billion. The combined entity will now house “research skills sharpened by analytical data on medicines, its distribution, the people consuming the medicines and those prescribing it.”

Quintiles had its start in data analysis and remains an industry leader in technology. Quintiles CEO Tom Pike notes this agreement would make the company “unparalleled.” The future of clinical research is in data and the merger positions the new company to provide a seamless platform of data and research across healthcare, according to industry veteran Shoibal Mukherjee.  

ISR Reports notes the CRO landscape is changing quickly. In addition to this announcement, there are also rumors of talks between INC Research and LabCorp/Covance. With other large CROs filing to go public (inVentiv, Medpace, and possibly PPD), ISR believes the mergers and acquisitions will continue. Midsize CROs will need to gain scale while larger CROs will need to gain complementary services.

Of course, this also makes for an interesting and uncertain time for sponsor companies. Mergers and acquisitions can affect personnel, performance, and most importantly, quality. Companies uncertain of where their relationships are going and which CROs they should be working with can use this time to reevaluate their relationships.

According to a Business Wire press release, the merger will create one of the world’s largest portfolios of healthcare information, deep therapeutic, domain, regulatory and commercial analytic expertise, as well as proprietary technology applications supported by more than 50,000 employees operating in more than 100 countries.

BMS Raises Awareness of Immuno-Oncology Research

Bristol-Myers Squibb and actor Eric Stonestreet are calling on anyone touched by cancer to share a virtual flag in support of the cancer community. Stonestreet, star of the television show Modern Family, is familiar with the disease. His mother is a two-time cancer survivor.

“My mom has survived cancer twice, so I have personal reasons for standing with ‘Ready. Raise. Rise.’ again this year –iIt gives me a chance to say how much I admire heroes like her, and at the same time it allows me to learn about promising research in the fight against cancer, like immuno-oncology (IO),” says Stonestreet. “And participating in the campaign also supports cancer advocacy groups that are helping others like my mom. So mom and I are asking you to be Ready to Raise a virtual flag and Rise in celebration of patients, caregivers and anyone else you know whose life is touched by cancer.”

The Ready. Raise. Rise. campaign encourages everyone to raise and share a flag to salute those who have been touched by cancer, especially patients and caregivers, and learn more about a rapidly evolving area of research, Immuno-Oncology. Immuno-oncology seeks to harness the body’s own immune system to fight cancer. Ready. Raise. Rise. creates a social movement to honor cancer patients and caregivers and helps provide charitable donations to advocacy organizations.

Bristol-Myers Squibb sponsors the campaign, which inspired people to raise more than 50,000 flags last year. This year 23 participating cancer support groups will receive charitable donations on behalf of flag raisers.

Are Digital Human Models The Key To Future Clinical Research?

An article on Medical Xpress notes in silico medicine, or computer simulations of the human body and its disease processes, can help improve diagnosis and prognosis of conditions like Parkinson’s and pulmonary vascular disease. The technology is expected to quickly move into clinical trials as it can enable more effective monitoring of the impact of new drugs and treatments.

In a recent study of data from 450 patients, researchers were able to use the model to diagnose pulmonary arterial hypertension (PAH) accurately. "Two-thirds of the patients we assessed could be correctly diagnosed with PAH using our model, which meant only those patients where diagnosis was unclear would have had to have the catheter test if this was in full clinical use," said Dr Andy Swift, Insigneo senior clinical research fellow. "Many clinical trials in pulmonary hypertension also use the catheter test as an outcome measure, but it could provide a significant advantage to be able to replace it with a less invasive MRI scan, as our model also provides more detailed information on physical changes to the heart itself."

In the future, digital models of diseases and the structure of organs could help diagnose conditions, understand the impact of surgical interventions, and run digital drug trials.

Cancer Genetics Provides Data For 12 IO Clinical Trials

Street Insider is reporting that Cancer Genetics, Inc. is actively testing and providing data for 12 immuno-oncology (IO) clinical trials and 3 academic collaborations. The trials focus on solid tumors including lung, ovarian, head and neck, breast, urothelial and blood cancers including lymphomas and multiple myeloma.

“We started 2016 by actively providing PDL1 and PD1 data for 3 clinical trials and we are now actively supporting 12 clinical trials that we expect to ramp throughout 2016 and into 2017,” said Panna Sharma, CEO and president of Cancer Genetics, Inc. “We invested into diversifying our capabilities and technologies so that we could provide data and technology for genome, transcriptome and immune markers for subtyping, monitoring and response characterization in an therapeutic era where IO trials are rapidly increasing and changing patient outcomes.”

Sharma adds that personalized medicine is experiencing one of its brightest moments. Progressive therapies that can identify biomarkers and improve outcomes for patients while managing costs are fueling the cancer care sector, and Cancer Genetics, Inc. is at the center of the movement.

Pan-Canadian Cancer Network Will Match Patients With Trials

Two hundred cancer patients at the Jewish General Hospital are the first to donate their tumor samples to a pan-Canadian network that will match the patients, if needed, with the correct clinical trials and new innovative treatments. The Montreal Gazette reports the initiative was largely started by Montreal oncologist Gerald Batist, scientific director of the national network and head of the Jewish General’s Segal Cancer Centre.

Historically, so-called biobanks that contain tumor samples have helped researchers learn more about cancer without directly benefiting those patients who have donated the tissue. But the idea behind the “Personalize My Treatment” network is not only to advance general knowledge about cancer, but to contact patients should they relapse following standard treatment and to offer them the chance to take part in new clinical trials for drugs that were designed to target the genetic signature of specific tumors.

“It’s very exciting,” notes Batist. “This is the first time we’re collecting samples from patients with the real promise of being able to actually help them, not just through a general increase in knowledge that we learn but by being able to study their samples and being able to recontact them personally.”

Clinical Trials Seek Greater Participation By Women

Diversity in clinical trials has been getting a lot more attention of late with law makers and regulatory agencies pressing for greater representation in trials by women and minorities. Although trials have historically tended to test new medicines on men, new treatments can affect men and women differently. For this reason, sponsors have been hoping to increase participation by women, particularly those of diverse ethnicities. Getting feedback from different groups can also help the FDA address concerns about a new test, drug, or product before moving forward with the results.

For women interested in participating in a clinical trial, the FDA’s Office of Women’s Health has issued four recommendations to help them get started.

1. Learn about the purpose of the trial and consider availability before you commit. Know the details of the trial, and the type of drugs, treatments, and tests being administered. Understand that participating will also require a time commitment.
2. Consider the possible benefits and risks. The treatment received may help with a medical condition, but may cause side effects as well.Participants receiving a placebo, you may receive no benefit at all.
3. Be aware of possible costs. While some trials are free, others may require the participant or an insurer to pay for treatments or services.
4. Don't be afraid to ask questions, particularly regarding privacy concerns, who should be contacted if there is a problem, and how to opt out after the trial has started.

Women are also encouraged to consult with their physician about possible issues, risks, and benefits before agreeing to participate.