PHARMA TECH
Business Wire | October 05, 2023
OM1, a leading real-world data, AI, and technology company with a focus on chronic diseases, announced the launch of two new clinical datasets, Chronic Rhinosinusitis (CRS) and Asthma. Both datasets are derived from longitudinal follow-up of patients seen by specialists and focus on patient characteristics, symptoms, treatments, clinical outcomes and healthcare resource utilization. Rapidly growing, the CRS and Asthma datasets each follow approximately 500,000 patients in the U.S.
The research-grade, real-world data available in the OM1 Respiratory & ENT Network is built with an exclusive partnership between OM1 and the American Academy of Otolaryngology and Head and Neck Surgery Foundation (AAO-HNSF). With access to thousands of clinicians and more than 25 million patient visits across all 50 states, the data is rich with the most representative network available, including patient reported outcomes, social determinants of health, and patient subtypes and classification data.
Millions of Americans are impacted by respiratory diseases, and the number continues to rise as respiratory illnesses become more common and air quality declines. Taking a deeper look, it’s estimated that 25 million people in the United States are diagnosed with asthma and 5-12% of the global population is affected by CRS. Not only do the numbers continue to rise, it’s common for patients with respiratory diseases to have multiple illnesses. Studies show that up to 67% of people with CRS with nasal polyps, small noncancerous growths that increase the severity of the disease, also have asthma.
"Having access to deep clinical information on clinical presentation, treatments, and outcomes opens a world of incredible opportunity to improve care at both the population and individual patient level,” said Dr. Richard Gliklich, CEO, OM1.
Alongside AAO, OM1 and Dr. Gliklich will be participating and presenting at the AAO-HNSF Annual Meeting and OTO Experience in Nashville, October 1-4.
About OM1
With specialization in chronic conditions, OM1 is re-imagining real-world evidence and insights by developing large electronically connected networks of clinicians and health data in dermatology, rheumatology, gastroenterology, cardiology, metabolism, respiratory, mental health, neurology and other specialty areas. Leveraging its data automation platform, OM1 Aspen, extensive clinical networks and artificial intelligence (AI) platform, PhenOM™, OM1 offers industry-leading enriched healthcare datasets, retrospective and prospective studies, advanced analytics, and AI-driven guidelines adherence and decision-support around diagnosis, risk management, and treatment. With a focus on high-quality data and clinical outcomes, the offerings are used for accelerating research, demonstrating treatment effectiveness, supporting regulatory submissions, monitoring safety, and informing commercialization.
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PHARMACY MARKET
Business Wire | September 28, 2023
Cytel Inc., provider of quantitative insights and health data analytics to leaders in the life sciences, has acquired the Berlin-based company co.faktor GmbH with its dedicated healthcare consultancy services co.value® (market access), co.medical® (medical communications), and co.patient® (patient relations) concentrations. As a result, Cytel’s services for biopharma commercialization will gain new and complementary specialist consultancy capabilities and localized expertise for successful market access in Germany, a first wave launch country. The acquisition marks another milestone in Cytel’s strategic growth in Europe, and follows the recent acquisition of stève consultants, specialists in market access, real-world evidence (RWE), and health economics and outcomes research (HEOR) in France. Cytel now boasts a 200-person-strong access consultancy team, making it one of the only providers that offers the full fleet of advisory services, from clinical trial and real-world data and evidence analytics to global market access and local in-country Health Technology Assessment (HTA) support.
Cytel is now primed to provide global drug sponsors and their affiliate teams with advanced analytical support across the lifecycle through commercialization. Achieving favorable market access in today’s global healthcare industry is challenging and requires deep knowledge of EU national regulations. Cytel has long excelled at using proven quantitative techniques to help pharmaceutical manufacturers successfully enter new markets. To continue supporting global and local clients on their road to commercial success, Cytel has invested heavily in specialized, national capabilities in key launch markets with the recent acquisitions of stève consultants in June 2023 and SDS Life Sciences in 2022. Cytel’s most recent acquisition of the co.faktor businesses continues this investment, augmenting and extending localized regulatory support through product launch and commercialization.
“The co.faktor team is recognized as a highly specialized biopharma services provider, with a broad spectrum of services including HTA, pricing, medical communication, patient relations, and strategic consultancy in Germany. It’s no surprise they’ve shaped the field there,” said Radek Wasiak, General Manager, Real-World & Advanced Analytics at Cytel. “We look forward to welcoming them to Cytel, where they will now be supported by the full depth and breadth of our unparalleled biometrics, RWE, HEOR, and market access advisory talent.”
“Cytel and co.faktor have clear synergies, particularly when it comes to Cytel’s data know-how and co.faktor’s understanding of Germany’s uniquely complex market access and HTA requirements,” said Dr. Marc Esser, CEO, co.faktor. “By combining our deep expertise in the German HTA process with Cytel’s unique capabilities, we will be able to help our clients survive the upcoming European Health Technology Assessment (EU-HTA), a key challenge for all stakeholders in the European pharma market.”
About Cytel
Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty-five years, Cytel’s scientific rigor and operational excellence have enabled biotech and pharmaceutical companies to navigate uncertainty, prove value and make confident, evidence-based decisions. Its experts deliver industry-leading software, data-driven analytics, real-world evidence, and strategic consulting. Headquartered in Waltham, Massachusetts, Cytel has more than 1,900 resources across North America, Europe, and Asia.
About co.faktor
For more than ten years, Berlin-based co.faktor GmbH has been providing specialized consulting services with its dedicated healthcare consultancy services co.value® (market access), co.medical® (medical communications), and co.patient® (patient relations) concentrations. By synergistically combining the expertise in these areas, co.faktor offers efficient launch support with consistent messaging to all relevant stakeholders.
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PHARMACY MARKET
PR Newswire | October 19, 2023
Halozyme Therapeutics, Inc. announced positive results of a clinical study demonstrating subcutaneous administration of 10 mL of a representative biologic product co-formulated with its ENHANZE® drug delivery technology, in approximately 30 seconds. In the study, the biologic was delivered with Halozyme's proprietary high-volume auto-injector (HVAI) in healthy volunteers. The injection was delivered successfully to all 23 participants and was well tolerated.
"To our knowledge, this is the first clinical study of its kind," said Mike LaBarre, chief technical officer of Halozyme. "Traditional subcutaneous auto-injector delivery methods are typically limited to volumes less than 2 mL or require long delivery times at slow rates for higher volumes. By enabling rapid subcutaneous injection of high volumes of biologic products, our ENHANZE drug delivery technology in combination with our proprietary HVAI has the potential to improve the patient experience for multiple therapies."
In the study, a representative biologic, immunoglobulin 10%, was delivered to 23 healthy volunteers. The primary endpoint of the study was achieved with all subjects receiving the completed dose with HVAI, demonstrating that 10 mL of a representative biologic product can be rapidly delivered using Halozyme's ENHANZE® and HVAI technologies.
Data Highlights
96% of participants stated that they would be willing to receive the injection again.
90% of participants indicated feeling either no pain or mild pain immediately after injection.
Erythema, swelling, and induration were generally minimal to mild and resolved by 90 minutes or less.
Biologics delivered subcutaneously through auto-injectors are typically restricted to doses of 1-2 mL. This limitation is caused by hyaluronan, a molecule that inhibits fluid dispersion in the subcutaneous space. Halozyme's ENHANZE® drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally degrades hyaluronan in the subcutaneous space. This temporarily increases the permeability of the tissue under the skin, allowing space for the biologic to enter, enabling it to be rapidly dispersed and absorbed into the bloodstream.
"These results support our continued dedication to providing innovative drug delivery options to patients," said Helen Torley, chief executive officer of Halozyme. "Our ENHANZE drug delivery and HVAI technologies have the potential to rapidly deliver large volume therapeutics subcutaneously with the potential for meaningful clinical benefits."
Halozyme's HVAI is available to partners for clinical use.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the delivery of injected drugs and fluids in order to reduce the treatment burden to patients. Having touched more than 700,000 patient lives in post-marketing use in seven commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and Chugai Pharmaceutical.
Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technology that are designed to provide commercial or functional advantages such as improved convenience and tolerability, and enhanced patient comfort and adherence. The Company has a commercial portfolio of proprietary products including XYOSTED®, TLANDO® and NOCDURNA® and partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceutical, Pfizer and Idorsia Pharmaceuticals.
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