January 30, 2019 | January was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from Align Clinical CRO, ZappRx, SAP, and more.

Align Clinical CRO and Veeva Systems announced its first technology standard is available for industry review and input. The new operational data exchange standard aims to facilitate seamless information sharing during clinical trials and give sponsors greater visibility into study execution when working with CROs. Cross-functional domain experts developed the standard to improve the exchange of information between sponsors and CROs during phase II and phase III clinical trials. The standard supports operational data related to milestones and metrics for areas such as general trial information, study start-up, patient enrollment, and data management. The operational data exchange standard also provides technical considerations when developing APIs for clinical trial systems. Align Clinical CRO is dedicated to creating open technology standards, with input from across the industry, that make it easier for sponsors and CROs to work together during trials. The group is now soliciting public review and feedback on its operational data exchange standard through March 15, 2019 at AlignClinicalCRO.org. Once industry input is received, Align Clinical CRO will make the final standard available in spring 2019. Press release

LexisNexis Risk Solutions announced that in December 2018 it met the requirements to become a Certified Qualified Entity (QE) under the Centers for Medicare & Medicaid Services' (CMS) Qualified Entity Certification Program. Based on the volume of LexisNexis Risk Solutions' claims data and other requirements, LexisNexis is recognized as a QE for the 50 states of the US and the District of Columbia. The CMS Qualified Entity Program (also known as the Medicare Data Sharing for Performance Measurement Program) enables organizations to receive Medicare Parts A and B medical claims data and Part D prescription drug claims data for use in evaluating provider performance. Organizations approved as QEs are required to use the Medicare data to produce and publicly disseminate CMS-approved reports on provider performance. LexisNexis Risk Solutions offers health plans, providers, life sciences organizations, Pharmacy Benefit Management companies and pharmacies a robust suite of solutions that combine trusted provider data sources, claims data and patient insights to drive better outcomes, efficiency and compliance. The ability to integrate Medicare Parts A and B claims data and Part D prescription drug event data from CMS will help accelerate innovation to drive better provider performance and patient analytics. Press release

ZappRx announced an agreement with Bayer to provide a more efficient approach to the accessing of specialty medications and associated support programs. ZappRx will support patients living with two specific types of Pulmonary Hypertension (PH) and patients with Relapsing Remitting Multiple Sclerosis (RRMS), conditions within Bayer’s Specialty Medicines portfolio. Subsequent to the integration with ZappRx’s platform, Bayer will also gain access to unique data assets and meaningful insights around the treatment of these patient populations. “By collaborating with a global pharmaceutical company such as Bayer, we continue to build momentum around our primary goal – helping patients,” Zoë Barry, CEO and Founder of ZappRx, said in a press release. “Like ZappRx, Bayer puts the patient at the center of their world and by working together we believe the impact of both organizations can be greatly amplified. This agreement constitutes another meaningful step toward transforming how specialty medications are prescribed and accessed.” Press release

ZappRx also announced that it has entered into an agreement with Genentech. The agreement will start by seeking to improve patient access to specialty drugs in IPF, with an option to continue in allergic asthma, and chronic idiopathic urticaria. ZappRx’s goal is to develop an industry-first digital platform for specialty drugs, using a data-driven approach to solving the challenges with today’s paper-based, manual, and time-consuming processes currently associated with ordering specialty drugs. ZappRx’s specialty ordering and fulfillment platform allows for the digitization of existing paper-based and manual workflows and for the analysis of real-time, pre-fulfillment data to enable value-based health care. Clinicians using the ZappRx technology can now select the treatment of their choice from the specialty drugs indicated in a therapeutic area using a standardized workflow on one platform. This platform is capable of connecting to relevant stakeholders and can help enable patients to get access to the prescribed treatment as soon as possible. Press release

SAP announced the general availability of SAP Information Collaboration Hub for Life Sciences, option for US supply chain, a blockchain-technology hub to help eliminate counterfeit products along the pharmaceutical supply chain. The hub is designed to authenticate pharmaceutical packaging returned from hospitals and pharmacies to wholesalers before products are resold. US wholesalers encounter nearly 60 million returns annually, accounting for an estimated $7 billion. The blockchain-based solution helps customers comply with the US Drug Supply Chain Security Act (DSCSA), which requires that as of November 2019 wholesalers verify prescription drugs that are returned and intended for resale. The mandate is intended to protect consumers from fake, contaminated and stolen medication. “Blockchain is driving a new breed of enterprise applications that could drastically improve cooperation for wholesale distribution,” said Jeffery Denton, senior director, Global Secure Supply Chain, AmerisourceBergen Corporation, in a press release. “The blockchain-based solution from SAP provides the best opportunity to fully satisfy our need to be interoperable with our trading partners and their solutions as well as to remain compliant with the US DSCSA.” The new software allows customers to verify the product code, lot, expiration date and a unique serial number embedded in the barcode against manufacturers’ data stored in the blockchain. The software was developed in co-innovation with AmerisourceBergen, Boehringer Ingelheim, GlaxoSmithKline and Merck Sharp & Dohme, among others. Press release

Notable Labs announced that it has launched its first drug development program, ND-1000, which targets pediatric and adult blood cancers. In an industry first, the company has opted to donate the commercial rights to price, manufacture, and distribute ND-1000 for pediatric leukemia to global repurposing non-profit Cures Within Reach in order to provide the drug to pediatric leukemia patients at a very low cost. The partnership between Notable and Cures Within Reach is intended to further Cures Within Reach’s mission to develop and implement effective economic incentives for the repurposing of inexpensive generic drugs, devices, and other products  which is especially critical in rare diseases. This collaborative venture will be supported by philanthropy from individuals, foundations and disease non-profits, as well as investment from for-profit stakeholders. As a for-profit company, Notable Labs is able to donate ND-1000’s pediatric commercial rights to Cures Within Reach due to the drug’s eligibility for the FDA’s Pediatric Priority Review Voucher Program, which has a financial value due to an awarded voucher’s ability to be sold to another pharmaceutical company. Notable Labs will open the first clinical trial for ND-1000 at The University of Kansas Cancer Center later this year through a partnership with the University’s Institute for Advancing Medical Innovation (IAMI). Press release

Scipher announced positive outcomes of its retrospective trial for Prism, demonstrating the proprietary blood test accurately predicts non-response to anti-tumor necrosis factor (anti-TNF) therapies, including Humira, Enbrel, and Remicade. Anti-TNF therapy is the largest selling drug class in the world, yet a majority of patients prescribed such therapy does not reach treatment targets. Prism helps patients who will not respond to anti-TNF therapy gain access to alternative effective drugs. Inadequate response to therapies causes significant clinical and financial burdens on the healthcare industry. Over 65% of patients prescribed anti-TNF therapy do not respond adequately to treatment resulting in disease progression and exposure to potentially dangerous and unnecessary side effects, while payers and patients spend $20 billion annually on such ineffective drugs. By leveraging artificial intelligence and a proprietary map of all protein interactions in human cells, Scipher Medicine’s platform analyzes RNA data from a patient’s blood sample to determine the underlying molecular processes driving the disease, generating a patient’s specific disease signature. Drugs are then screened to determine which therapy targets the disease signature in order to determine most effective therapy. Prism is disease agnostic and can be applied to different disease states for a variety of clinical applications. Beyond autoimmune diseases, Scipher Medicine has also begun investigating the utility of Prism in cardiovascular, respiratory, and neurological diseases. Press release

AiCure announced NeuroBo has chosen its platform to provide behavioral insights around diabetic patients participating in a clinical trial for neuropathic pain. AiCure’s interactive platform will offer NeuroBo a single touchpoint to measure and modify patient behavior, keeping participants engaged and on treatment throughout the trial. NeuroBo will also integrate patient reported outcomes and micro-reimbursements within AiCure’s platform, providing a simplified experience for all trial participants. According to the Centers for Disease Control and Prevention, approximately 50% of the 30 million Americans with diabetes suffer from diabetic neuropathy, which results in numbness and tingling in one’s limbs. As the disease progresses, 50% of the diabetic neuropathy patients develop neuropathic pain as a result of damage to the peripheral nerves which can produce debilitating limb pain. NeuroBo’s lead candidate, NB-01, will be entering into a Phase III clinical trial to evaluate its efficacy in treating diabetic neuropathic pain. “Proper adherence and dosing are both critical to the accuracy of trial results – and it’s often quite difficult to ensure,” said John L. Brooks III, president and CEO of NeuroBo, in a press release. “AiCure offers the only platform that can accurately confirm our trial participants are taking the right medication at the right dosage, while also capturing valuable behavioral and endpoint data – helping us to advance our clinical trial for a potential treatment of diabetic neuropathic pain.” AiCure’s Interactive Medical Assistant (IMA) uses artificial intelligence (AI)-powered computer vision to recognize individual faces and medications. IMA offers patients a single platform to monitor their treatment regimen, complete ePRO questionnaires and receive micro-reimbursements. Press release