Clarify Health Launches Next-Generation Analytics to Assist Pharmaceutical and Biotechnology Companies

Clarify Health | July 01, 2020

Clarify Health, a leading healthcare analytics company, announced that its life sciences software, Clarify Launch, now includes innovative enhancements that give brand teams a faster and more effective way to identify market opportunities to drive growth. The ability to explore over 300 million longitudinal patient care journeys using Clarify Launch offers brand teams rapid access to actionable insights within specific patient populations. Clarify brings first-of-their-kind patient segmentation, provider attribution, and provider scoring capabilities directly to end-users at pharmaceutical and biotechnology companies.

“Two-thirds of new drugs fall short of first year implementation expectations, and they rarely rebound. Comprehensive next-generation analytics are uniquely positioned to help pharma and biotech companies alter this trend by providing a lens that crosses all stakeholders— patients, providers, and payers,” said Calum MacRae, M.D., Ph.D., Professor of Medicine at Harvard Medical School, and an advisor to Clarify Health.

Spotlight

Successful execution of clinical trials requires the orchestration of multiple moving parts, with everything from protocol design and patient visit schedules, to lab kits and
biological samples needing to seamlessly line up to ensure on-time, on-budget delivery of high-quality data.

Spotlight

Successful execution of clinical trials requires the orchestration of multiple moving parts, with everything from protocol design and patient visit schedules, to lab kits and
biological samples needing to seamlessly line up to ensure on-time, on-budget delivery of high-quality data.

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BUSINESS INSIGHTS, PHARMA TECH

Lyra Completes Enrollment in LYR-220 BEACON Phase 2 Clinical Trial

Lyra Therapeutics | February 08, 2023

On February 6, 2023, Lyra Therapeutics, Inc., a leading clinical-stage biotechnology firm developing novel therapies for the localized treatment of chronic rhinosinusitis (CRS), announced that enrollment in the Phase 2 BEACON clinical trial of LYR-220 in adult patients with CRS who have previously undergone sinus surgery has been completed. LYR-220 is designed to provide continuous anti-inflammatory medicine (mometasone furoate; MF) to the sinonasal passageways for six months in order to treat CRS. Topline outcomes are expected in the fourth quarter of 2023. The Phase 2 BEACON trial is a sham-controlled, parallel-group trial designed to assess the efficacy and safety of the LYR-220 (7500g MF) matrix in symptomatic adult CRS patients who have previously had bilateral ethmoid sinus surgery during a 24-week period. The trial is divided into two parts: Part 1 was aimed to examine the feasibility and tolerability of two 7500µg MF matrix designs; in Part 2, 40 patients were randomly assigned 1:1 to receive LYR-220 or sham control. Lyra revealed positive preliminary findings from the BEACON trial's Part 1, the non-randomized portion, in September 2022, indicating the feasibility and tolerability of bilateral LYR-220 placement in this patient population. In addition, all six patients were given the medication for at least six weeks, and no significant or unexpected side effects were recorded. Although efficacy evaluation was not the goal of the trial's uncontrolled Part 1 stage, there was a mean improvement of 21 points (37%) from baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) total score at six weeks. This is more than double the minimal clinically significant difference of 8.9 points. About Lyra Therapeutics Founded in 2018, Lyra Therapeutics is a clinical-stage firm pioneering a novel therapeutic approach for the treatment of debilitating ear, nose, and throat (ENT) diseases that affect millions of people. Its mission is to change the ENT treatment paradigm by giving physicians effective front-line solutions and innovative therapy alternatives for their patients. The company is working on therapeutics for the localized treatment of chronic rhinosinusitis patients (CRS). Lyra has two investigational product candidates, LYR-210 and LYR-220, in late-stage development for CRS, which is a common inflammatory disease of the paranasal sinuses that causes debilitating symptoms and significant morbidities. It is headquartered in the Boston region and was created by academic luminaries in the disciplines of chemistry, materials science, and biotechnology, and is supported by top life science investors.

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RESEARCH, PHARMA TECH

OM1 Releases Analytic Reports, Uncovering Medication Discontinuation in Patients

OM1 | February 06, 2023

OM1, a leading real-world data, results, and technology firm focused on chronic diseases, recently announced the release of its Reasons for Discontinuation (RfD) Analytic Reports. Utilizing the OM1 Real-World Data CloudTM, Immunology Real-World Data Network, and proprietary artificial intelligence (AI) technology, the RfD reports provide difficult-to-obtain, extremely valuable discontinuation trends for cDMARDs, bDMARDs, and tsDMARDs in primary dermatologic and rheumatologic conditions. Each year, millions of Americans cease their prescriptions prematurely, costing the pharmaceutical industry in the United States an estimated $250 billion in lost income and can affect the health of these patients. Therefore, it is crucial for pharmaceutical businesses to comprehend patient discontinuation patterns so they may act on information regarding tolerability, costs, and emerging contraindications to enhance the patient experience. Prior to this point, it was extremely difficult to extract these insights due to the fact that crucial information was not reflected in claims or any other sort of structured data but was only available in clinical notes. OM1 is elevating the clinical narrative into actionable insights that pharmaceutical companies can rely on to comprehend patient adherence and clinician prescribing behavior, thanks to its data cloud built on billions of data points from over 300 million patients and unique AI and modeling capabilities. The analyses, which are conducted across multiple strata, such as demographic groups, patient characteristics, medical histories, comorbidities and care pathways, extract insights from the extensive clinical data sets available to OM1 and notes from prescribing clinicians dating back to 2013. Currently, accessible RfD reports include psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, and atopic dermatitis, with more to come, including schizophrenia, depression, and bipolar illness. About OM1 Founded in 2015, OM1 is a renowned health outcomes, and registries firm focused on treatment outcome measurement, comparison, and prediction. OM1 created the first intelligent data cloud for healthcare, leveraging big data, standardized outcomes measurement, and artificial intelligence technologies to provide more precise information and improve decision-making for stakeholders across the healthcare ecosystem. The company is reimagining real-world data and evidence in immunology, cardiometabolic, mental health and neurosciences, respiratory and ENT specialty areas by establishing vast electronically connected networks of clinicians and health data.

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Innovation Pharmaceuticals Announces BT BeaMedical Technologies Receives FDA Clearance for New Surgical Laser Family

Innovation Pharmaceuticals Inc | November 29, 2022

BT BeaMedical Technologies a private company developing a next-generation laser-based platform for epilepsy and cancer surgery, has notified Innovation Pharmaceuticals that it has received U.S. Food and Drug Administration clearance for its MANTA surgical laser family. The clearance is an important milestone for BeaMed in its development of an advanced laser technology with respect to shaping energy and matching it to patient specific anatomy, a novel concept that BeaMed is proving a reality. Innovation Pharmaceuticals made a strategic investment to acquire a minority stake in BeaMed in June 2022. BeaMed is the inventor and developer of the StingRay Laser System a novel laser-based thermal ablation technology designed for treatment of previously inoperable cases of epilepsy and for improvement of outcomes and enablement of new treatment options for oncology procedures, including those treating brain, prostate, liver, breast, and lung cancers. The StingRay Laser System will utilize the MANTA laser family as its core energy generation devices coupled to new fiber optic technology, allowing a perfect match between the exact structure of tumors and epileptic focal points and the energy delivery, while protecting vital functional areas against thermal damage. The MANTA surgical laser family was cleared by the FDA including five different wavelengths and soft tissue use in a very wide set of clinical specialties, including Neurosurgery, Spinal Surgery, Urology, Thoracic Surgery, Pulmonary Surgery, Gynecology, General Surgery, ENT/Head and Neck, Plastic Surgery, Orthopedics, Arthroscopy, Ophthalmology, Radiology, and Oral Surgery. BeaMed expects to soon make requisite submissions to the FDA for clearance of its fiber optics for use in multiple medical indications. “We are excited with the speed of progress BeaMed is making towards introduction of its new platform product with the potential to help millions of patients globally suffering from epilepsy and cancer in multiple specialties. The execution of this submission and the speed of clearance speaks volumes to the commercialization strategy and the exceptional capabilities of the regulatory team at BeaMed,” Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals “This is an exciting and important milestone for our company. This clearance gives us two key achievements. First, U.S. market access to a wide range of potential laser energy sources, each allowing us different and unique tissue interaction, an achievement which will have wide clinical implications. The second is a very wide set of intended uses covering many key potential markets for our technology. This underscores the clear regulatory strategy of BeaMed, which goes hand in hand with our broad impact business vision of revolutionizing key treatments, including brain tumors, epilepsy, lung cancer, prostate cancer, breast cancer and more,” said Gil Shapira, co-founder of BeaMed. BeaMed was founded by Moshe Eshkol and Gil Shapira, both highly experienced specialists in surgical lasers and medical devices. BeaMed and the development of the StingRay system are also supported by a special prestigious grant from the BIRD Foundation a bi-national organization supporting Israel-US collaboration. Gil Shapira brings forward 26+ years of engineering and product development and management experience, with over 17 years in the surgical laser industry. Gil owns and manages neoLaser, a company he founded in 2012, and led to revenue growth and profitability, with a 43% CAGR on its way to more than 1200 global installations and performing 50,000+ surgeries annually in over 30 countries. Previously, Gil led product development and marketing at OmniGuide, a successful high-growth laser-based medical device spin-off out of the Massachusetts Institute of Technology. About Innovation Pharmaceuticals Innovation Pharmaceuticals Inc. is a clinical stage biopharmaceutical company developing a portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, and infectious diseases. The Company is also active in evaluating other potential investment opportunities that can add value and diversify its portfolio.

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