From The Editor | December 9, 2016

Clinical News Roundup: Almac And inVentiv Health Partner On IRT

Ed Miseta

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


Almac Clinical Technologies has announced a strategic partnership with inVentiv Health. The partnership will provide clients of both companies with streamlined access to clinical trial Interactive Response Technology (IRT) solutions. Through the partnership, Almac will provide IRT solutions to inVentiv clients. inVentiv’s IRT specialists will also join Almac’s consulting team of more than 500 individuals.

“We’re committed to accelerating clinical trials and see tremendous value in applying leading technology solutions to streamline the process,” says Greg Skalicky, chief commercial officer for the inVentiv Health clinical division.”

Skalicky notes inVentiv selected Almac as a partner based on the company’s dedication to customer focus, expertise, and innovation, commitments that align well with inVentiv’s dedication to accelerating client success.

Matt Cocking, director of marketing for clinical technologies at Almac, told Clinical Leader that customers have been expanding their use of IRT. Although historically designed to accommodate the randomization of patients in trials and allocate investigational treatments accordingly, the systems now capture broader features emerging in the market. Those features include electronic-reported outcomes, titration/dosing calculations, blinding of patient labs or results, supply accountability, reconciliation, and returns.

“IRT ensures the drug is in the right place, at the right time, in the right quantities, and with the ability to respond to changes throughout the course of the trial,” says Cocking. “It also gives sponsors visibility into how sites are performing. For that reason, the FDA expects it to be used as a way to provide oversight of a trial to identify and remediate issues in a timely manner.”

Cocking believes the future looks bright for IRT. Sponsors continue to expand their use of IRT to include new functionality, indicating they see the intrinsic value these systems can provide. “IRT is quickly becoming the ‘brains’ of a clinical trial,” he says. “We’re seeing the complexity profile of clinical trials continuing to increase, and IRT is playing a central role in making real-time decisions and very complex calculations like titration, dosing, and enrollment based on third-party data from central labs or companion diagnostics.”

ERT Acquires Exco In Touch

ERT, a provider of patient data collection solutions in clinical development, has announced the acquisition of Exco In Touch, a provider of patient engagement, data capture, and digital health solutions. ERT will now enable sponsors to turn to one partner for support of the full clinical development-to-commercialization spectrum.

“With this acquisition, we have combined our science-driven solutions that are delivered across every modality with patient-driven solutions that open up the BYOD (bring your own device) market to create a seamless approach to eCOA (electronic clinical outcome assessments), patient engagement, and digital health,” said James Corrigan, president and CEO of ERT. “Exco InTouch has a great history of innovation, and since its inception has made significant contributions to the eClinical landscape. We are delighted to welcome them to the ERT team, and look forward to working together to deliver market-leading offerings that solve our clients’ most complex challenges.”

Tim Davis, founder and CEO of Exco In Touch, notes ERT is the eCOA industry leader with a strong history in developing novel eClinical products and technologies to minimize risk and uncertainty in clinical research. “They were an obvious choice when we were assessing our strategic business development options. Now biopharmaceutical companies can turn to one company for all of their eCOA, patient engagement and commercialization needs, with confidence that their programs will have the right level of experience and expertise, anticipatory oversight, and adaptive problem solving required to ensure the most reliable results,” says Davis.

Financial terms of the transaction were not disclosed.

Senate Passes 21st Century Cures Bill

Congress has passed sweeping legislation that boosts funding for medical research and eases the development and approval of experimental treatments.  The Senate voted 94 to 5 in favor of approval, following a similarly lopsided 392 to 26 vote in the House. Democrat Senators Elizabeth Warren (D-MA) and Bernie Sanders (I-VT) criticized Big Pharma’s involvement in the bill, while republican Mike Lee (R-UT) questioned the cost. All three were among the five who voted against it.

The $6.3 billion bill will now move to President Obama’s desk. The President has praised the bill and vowed to sign it. The bill pays for some of his projects, including the precision medicine initiative and the Joe Biden-led cancer moonshot. "This bill will make a big difference, and I look forward to signing it as soon as it reaches my desk," the President said in a statement. “We are now one step closer to ending cancer as we know it, unlocking cures for diseases like Alzheimer's, and helping people seeking treatment for opioid addiction finally get the help they need."

The 21st Century Cures Act has been two years in the making since it was first introduced by Rep. Fred Upton (R-MI) and Rep. Diana DeGette (D-CO). It has been one of the most heavily lobbied pieces of legislation in recent history. The bill pays for cancer research and the fight against opioid abuse, funds mental health treatment, helps the FDA speed up drug approvals, and pushes for better use of technology in medicine.

The bill provides for $4.8 billion in new funding for the National Institutes of Health, of which $1.8 billion is reserved for the cancer moonshot to accelerate research in the field of oncology. Another $1.6 billion is earmarked for brain diseases including Alzheimer’s, and there is $500 million in new funding for the Food and Drug Administration. $1 billion in grants will be provided to help states deal with the current opioid epidemic.

A statement released by The Healthcare Supply Chain Association (HSCA) and its group purchasing organization (GPO) applauded Congress for bipartisan efforts to pass 21st Century Cures legislation and its commitment to improving patient outcomes and reducing costs. HSCA urges the president to swiftly sign the legislation.

“The 21st Century Cures legislation passed today by the Senate includes critical health information technology (HIT) interoperability requirements that will help healthcare stakeholders safely exchange data and collaborate across different IT systems,” said the statement. “Advances in HIT, including data interoperability and electronic health records (EHR), are driving a revolution in patient care. For healthcare providers to administer first-class patient care – and for patients to effectively engage in their own care – they must have access to vital patient and device data that are currently locked in system silos across the healthcare supply chain. Comprehensive EHRs with data that are accessible and interoperable across systems – and operating under appropriate privacy safeguards – will allow providers and patients to see a complete patient health picture and have access to all applicable information when making critical care decisions.”