October 31, 2019 | October was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from FNIH, Parexel, Certara, and more.

Certara announced the launch of BaseCase Data Studio, the newest product for its BaseCase value communications platform. Certara’s BaseCase platform enables pharmaceutical and medtech clients to build interactive, data-driven mobile apps using real-world data sources, such as healthcare claims, costs, quality, outcomes, and population data to demonstrate the value of specific drugs or devices during cost discussions with payers, providers and healthcare professionals (HCPs). With the addition of BaseCase Data Studio, those clients can now also perform sophisticated statistical modeling and data analyses live on their mobile apps during those meetings. “Due to rising healthcare costs, payers, providers and healthcare professionals are increasingly turning to evidence-based medicine and are seeking to gain meaningful insights from the huge volumes of available healthcare data to enable them to make the best value-based decisions regarding new drugs and devices,” Thomas Kerbusch, President of Certara Strategic Consulting, said in a press release. “Using BaseCase Data Studio, our clients can now conduct the requisite analyses in real time and accurately predict a range of outcomes, thus supporting their value messages with evidence-based claims.” Using BaseCase Data Studio, Certara’s clients can create mobile tools that generate simulations (including Markov chains and discrete event simulation) and budget impact models; conduct meta-analyses; perform multi-criteria decision, cost-effectiveness, health-related quality of life and probabilistic sensitivity analyses. Press release

The Foundation for the National Institutes of Health (FNIH) bestowed the 2nd annual Trailblazer Prize for Clinician-Scientists (Trailblazer Prize) to James Kochenderfer, M.D., of the National Cancer Institute (NCI), at the FNIH Annual Fall Board Dinner. Dr. Kochenderfer received the Trailblazer Prize and a $10,000 honorarium for pioneering the development of immunotherapies that leverage chimeric antigen receptor (CAR) T-cells to treat blood cancers. The Trailblazer Prize recognizes the outstanding contributions of early career clinician-scientists whose work has the potential to or has led to innovations in patient care and seeks to raise awareness of the critical role the clinician-scientist plays in biomedical research and clinical care. “It is our pleasure to bestow the 2019 Trailblazer Prize to Dr. Kochenderfer for his revolutionary research and clinical work that is changing how we treat blood cancers,” Steven M. Paul, M.D., Chairman of the Board, FNIH, said in a press release. “We enjoyed celebrating his achievements along with those of Drs. Bhatt, Macosko and Traverso last night at the Fall Board Dinner and thank each of them for helping us shine a light on the critical role clinician-scientists play in translating scientific innovation from the laboratory to patient care.” Dr. Kochenderfer was selected as the winner of the Trailblazer Prize by a jury of distinguished biomedical research leaders, chaired by Michael J. Welsh, M.D., Ph.D., Director, Pappajohn Biomedical Institute, University of Iowa. Press release

Twistle announced it has secured $16 million in Series A funding. Leading healthcare enterprises use Twistle's scalable technology to manage outreach to patient populations by automating communications, information-gathering and patient education, helping them improve clinical and patient-reported outcomes while simultaneously lowering costs. The funding round was led by Health Enterprise Partners (HEP) and MemorialCare Innovation Fund (MCIF). HEP is a growth equity firm whose investors include some of the largest health systems and health plans in the United States. MCIF, the venture arm of the MemorialCare Health System, partners with leadership at the health system to vet and invest in disruptive healthcare technology. Twistle selected HEP and MCIF because of their mutual commitment to deliver large-scale intelligent transformational solutions to the healthcare industry. "We are particularly impressed with their partnerships with leading provider and payer enterprises, and their records of helping innovative healthcare technology companies succeed," Kulmeet Singh, Twistle's CEO, said in a press release. "We think they are the ideal partners to help us lead healthcare into a new era of communication effectiveness." The funding will be leveraged to advance Twistle's mission of helping care teams optimize every patient's care by automating proactive conversations that inform timely actions. Specifically, the company will accelerate expansion in the provider and life sciences markets, and fuel innovation with a focus on human-assisted automation that enables those organizations to continuously improve patient care. Press release

Biofourmis has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its machine-learning and artificial intelligence (AI)-powered Biovitals Analytics Engine as a medical device for ambulatory physiological monitoring. This regulatory approval of the Biovitals Analytics Engine is part of FDA's growing recognition of machine-learning and AI in the Software as a Medical Device category. "This milestone approval is foundational to the Biovitals ecosystem, which includes not only our most advanced solution, BiovitalsHF for heart failure—but also our range of solutions across therapeutic areas, such as pain, oncology, sleep disorders and others in development," said Kuldeep Singh Rajput, CEO and founder of Biofourmis, in a press release. "Receiving this important regulatory approval will only accelerate the development and commercialization of these innovative digital therapeutic solutions." This FDA approval is the second market authorization for Biofourmis, having earned the agency's approval in May 2019 for its Biovitals RhythmAnalytics platform, which is cloud-based software for automated interpretation of more than 15 types of cardiac arrhythmias. The newly cleared Analytics Engine is a much broader approval to process multiple physiology signals, as the technology serves as the foundation for all of Biofourmis' digital therapeutics product pipeline. Press release

Parexel and Datavant announced a multi-year strategic partnership to enable the connection of real-world data across all clinical trials conducted by Parexel. By default, Datavant’s connectivity technology will be integrated into Parexel’s standard data workflow for all studies, allowing sponsors to optimize the evidence generation process by connecting real-world data to their clinical trial data, whether in the trial protocol or retroactively after a study is complete. “Across the industry, real-world evidence is becoming an essential component to evaluating the safety and effectiveness of drug therapies and ultimately to delivering therapeutic advances. However, one of the most significant barriers to generating real-world evidence is overcoming limitations of single data sources,” Parexel CEO Jamie Macdonald said in a press release. “Partnering with Datavant has provided Parexel the ability to link disparate data sets to drive the complex analyses necessary for providing innovative scientific and clinical data strategies. We’re delighted to expand and extend our strategic partnership by using Datavant’s technology across our entire portfolio, making the ability to link data available to more customers on a broader scale.” Datavant’s technology enables linking of de-identified data across the entire patient journey, including electronic health records, claims and diagnostics, as well as emerging sources such as genomics, wearable devices, socioeconomic and behavioral data and more. Connecting these data sources yields a more holistic view of patient health than clinical trial data alone. By linking real-world data sources with other sources of study data, biopharmaceutical customers will be better equipped to generate and submit real-world evidence for regulatory assessment. Parexel will be uniquely positioned to pursue data collaborations with the hundreds of organizations that utilize the Datavant software, including academic medical centers, life sciences and medical device companies, insurers, and leading data aggregators and analytics companies. Press release

Parexel also announced a strategic partnership with HealthVerity to expand Parexel’s network of real-world data (RWD) sources to accelerate the delivery of drug development solutions for customers. Through this collaboration, Parexel will gain access to HealthVerity’s diverse data sets including claims, electronic medical records (EMR), lab data and social determinants of health, enabled through the HealthVerity suite of privacy-preserving technologies, to provide customized RWD solutions to help life sciences companies solve their most complex clinical trial demands. “Real-world, data-enabled clinical research holds great potential to transform and accelerate drug development, and is beginning to gain endorsement from regulatory agencies,” said Michelle Hoiseth, Senior Vice President and Chief Data Officer, Parexel, in a press release. “However, the traditionally available large, proprietary data sets are of limited use in conducting these studies. By partnering with HealthVerity, Parexel can source the data best suited to support the intended analysis from a variety of resources quickly. Drawing on our proven regulatory expertise, we can meet the needs of regulators to help leverage these studies to bring new therapies to market.” Through the HealthVerity partnership, Parexel customers will have access to data for more than 330 million patients collected from more than 60 healthcare and consumer data sources that are anonymized and made interoperable via HealthVerity proprietary technology. Andrew Kress, Co-founder and CEO, HealthVerity, notes, “At HealthVerity, our technology enables the foundation for a more efficient, transparent and privacy-compliant way to leverage real-world healthcare data. We’re very excited to partner with Parexel as the company continues to lead the industry discussion on how data can change how we think about clinical trials in the future and accelerate new therapies for patients.” Press release

Pharm-Olam announced that the company’s board of directors has elected Robert Davie as its new chief executive officer. Pharm-Olam provides full-service clinical development solutions for oncology-hematology, infectious disease, vaccines, and rare diseases. Davie succeeds David Grange who has served as Pharm-Olam’s CEO since April 2017. Grange will remain a director and vice chairman of the company’s board and will continue to support the organization and its work in U.S. government-funded research, which is an expanding area of Pharm-Olam’s business. “Rob Davie is a respected leader who has worked within the CRO industry for over 25 years. We look forward to his leadership and knowledge supporting the continued growth of Pharm-Olam,” Zev Munk, founder and chairman of the board, said in a press release. “We also extend our sincere thanks to David Grange for his leadership over the past two-and-a-half years, having transformed Pharm-Olam’s therapeutic focus while achieving record sales for 2018.” Davie previously held critical roles within Covance, most recently as vice president and general manager of global clinical development. “Pharm-Olam presents a unique opportunity with an organization already positioned for continued expansion, and where I can leverage my expertise in scaling a CRO to achieve its accelerated growth strategy,” Davie said in an official statement. Press release

Bionano Genomics announced that leading organizations, including PerkinElmer Genomics and the University of Iowa, have adopted Saphyr for use in their clinical genomics laboratories. PerkinElmer Genomics and the University of Iowa have developed assays based on the Bionano optical mapping technology to expand their comprehensive suite of genetic tests assessing disease-associated chromosomal abnormalities. Their lead indication is Facioscapulohumeral Muscular Dystrophy (FSHD). FSHD is one of the most prevalent forms of muscular dystrophy and affects approximately 1 in 10,000 individuals. It is caused by changes in the number of repeats in a section of chromosome 4. To correctly diagnose FSHD, an exact count of the repeat number is necessary. To date, molecular diagnoses for FSHD are generated using outdated Southern Blot techniques, which are imprecise, labor intensive and involve radioactive labeling methods which are being phased out of laboratory use for safety reasons. In contrast, the assays developed by PerkinElmer Genomics and the University of Iowa with the Bionano EnFocus FSHD Analysis tool are reproducible, safe, fast, and automated with minimal hands-on time. These assays provide an exact repeat number for the pathogenic and non-pathogenic variants, give a high-resolution view of the repeat regions and have a high sensitivity to mosaicism. Jamshid Arjomand, CSO of the FSHD Society, the leading research-focused patient organization for FSHD, said in a press release, “The FSHD community has been waiting years for an accessible and robust assay like this. The lack of timely and affordable genetic testing has been a major hurdle for the FSHD community. Thousands of patients have never received a molecular diagnosis, which limits successful recruitment into the increasing number of clinical research and clinical trial studies for this devastating disease. We are delighted that Bionano’s Saphyr system enables a more precise and higher throughput method for FSHD genetic testing and are grateful to diagnostic groups and companies that are making genetic testing more accessible to our families.” Press release

Medisafe announced the launch of the industry's first end-to-end, holistic patient journey management solution. The new solution supports patients across the full spectrum of their medication journey from onboarding, to their first prescription fill, through managing complexities across multiple medications, to refilling medications and having them delivered to their door. "We're excited to introduce, for the first time, a unique and complete suite of solutions to cover the entire patient journey from initiation through drug management to improved outcomes," said Omri Shor, founder and chief executive officer, Medisafe, in a press release. "Having a digital therapeutics solution to accompany the drug used to be a 'nice-to-have'. This is no longer the case—patients, payers and providers are all demanding a digital solution to manage the patient journey—and a digital therapeutics companion is now the table stakes in 2020." The patient journey approach designs programs to reinforce moments of impact for patients. Medisafe has experience with more than 190 reasons for non-adherence and applies real world evidence to build connected medication management programs to influence patients' behavior on therapy.  Working with global pharmaceutical companies, Medisafe delivers digital platforms to engage and support patients throughout their medication journey. Recently, Medisafe teamed up with Lash Group, a patient support services company that's part of AmerisourceBergen, to meet end-to-end medication management needs by digitally connecting patients with care support teams. Medisafe and Lash Group created a first of its kind digital platform for at-risk patient management and timely care intervention delivery. Lash clinicians now have increased visibility into their patients' daily medication management activities. Press release

OODA Health announced the launch of its first product, OODAPay. OODAPay is a cloud-based platform that directly addresses the burden of billing administration for both providers and payers. OODAPay shifts the responsibility of collecting patient payments from providers to payers so that providers can focus on delivering care and payers own the member financial experience. The OODAPay approach meaningfully improves the patient billing experience and creates opportunities for higher payment collections. OODA Health launched a pilot program at CommonSpirit Health hospitals in Arizona with Blue Cross Blue Shield of Arizona earlier this year, achieving an unprecedented 96% member satisfaction rate. More recently, OODAPay was launched at CommonSpirit Health hospitals in California with Blue Shield of California. Additional launches with payers and providers across the country are planned later this year and next. Press release

Vanessa Research recently underwent a business expansion by opening a branch office in Győr, Hungary to facilitate the ongoing development of their inventive products. With an office currently located in Budapest, Vanessa Research is also expanding their existing footprint in Hungary. Located on the campus of Széchenyi István University, the office serves as an innovation hub for Vanessa Research where their primary focus will be cultivating SOLAWARE—a complete sun safety solution that provides tools to promote UV awareness, education, and protection—including the SOLAWARE Index, a conversion of the standard UV index into the number of minutes until skin damage can be expected under local conditions without protection. The facility will be initially staffed by a team of three bright engineers lead by a senior engineer who is an alumnus of the university. Vanessa Research intends to continuously engage more and more students and experts to maintain and grow operations. Soon, SOLAWARE will be used to inform, educate, and protect the students, visitors, and staff members of the university. “This impressive facility will help to further develop our innovative products as well as provide the students with a unique opportunity to collaborate and enhance their innovative thinking by solving real challenges of real products,” stated László Dinca, Managing Director, in a press release. Press release