RESEARCH, BUSINESS INSIGHTS
Medidata Solutions | March 13, 2023
Medidata, a leading provider of innovative software solutions for clinical trials that streamline the clinical trial process, reduce time and cost, and accelerate the development of new treatments, recently announced that Allucent, a contract research organization (CRO) that brings innovation to biopharma firms, is expanding the global use of Medidata's Clinical Cloud to enhance its clinical trial operations offering.
This agreement extends Allucent's current usage of Medidata's technology, which includes eCOA, Rave EDC, RTSM, and Rave Imaging, supporting crucial development areas such as rare and orphan indications, oncology and cell and gene therapies. As part of the deal, Allucent's team achieved 100% Rave EDC certification, reinforcing their dedication to quality and providing clients with industry-leading technology.
Allucent is a sponsor of Medidata NEXT London and will give a presentation on data analytics for early-phase oncology trials. The presentation will cover how working with Medidata has helped them apply visualization techniques and strategies to extract the total value of information for all stakeholders.
Medidata is a Dassault Systèmes company poised to drive the digital transformation of life sciences in the age of personalized medicine with its 3DEXPERIENCE platform. This platform is the first end-to-end scientific and business solution, from research to commercialization.
Medidata's head of Global Sales, Janet Butler, commented, "Allucent is leveraging the power of the Medidata Clinical Cloud to solidify their position at the forefront of clinical technology." She further emphasized, "Their work with novel therapies requires agile, patient-centric solutions. We are proud to build on our eight-year collaboration to advance the digital transformation of life sciences and deliver clinical innovations to help reach their goals."
(Source – Business Wire)
About Medidata Solutions
Medidata Solutions is a New York-based global provider of cloud-based software solutions for clinical trials. Its platform, the Medidata Clinical Cloud, enables pharmaceutical, biotechnology, medical device companies, and academic research organizations to manage all aspects of clinical trials, including study design, data capture, management, and analysis. Medidata's platform can capture real-time data from multiple sources, including electronic health records and wearable devices, to monitor patients closely, identify potential safety issues earlier, and make informed decisions about trial design and treatment protocols. The platform also features advanced analytics tools like machine learning and artificial intelligence algorithms to help researchers analyze and interpret their data. In 2019, Dassault Systèmes, a global leader in 3D design software and simulation solutions, acquired Medidata, further enhancing its platform.
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RESEARCH, PHARMACY MARKET
Impel Pharmaceuticals | February 23, 2023
On February 22, 2023, Impel Pharmaceuticals, a pharmaceutical firm that develops innovative treatments for diseases with high unmet medical needs, announced that it will execute an operational streamlining plan to reduce employee and non-employee expenses, primarily affecting the research and development division. The company intends to divert resources to benefit from the successful response of payors and prescribers to Trudhesa® (dihydroergotamine mesylate) nasal spray (0.725 mg per spray).
Impel Pharmaceuticals will stop research and development activities on INP105, a drug to treat agitation and aggression in autism spectrum disorder. The reduction in expenses is expected to come from lower non-employee-related general and administrative and research and development expenses, as well as a reduction of 16 percent in headcount.
Additionally, the company announced that its Chief Medical Officer, Stephen Shrewsbury, M.D., will leave the company on March 31, 2023.
The company projects that these measures, along with others, will provide sufficient capital to fund operations through Q3 2023, allowing it to focus on maximizing the commercial opportunity and positive momentum of Trudhesa® in the huge and rapidly expanding acute migraine market.
Trudhesa® has experienced a strong launch trajectory, with 58,424 prescriptions at the end of 2022, accounting for 4.3% of branded acute migraine prescriptions (nTRx) among prescribers after a full-year launch. Impel expanded its sales force by 50%, from 60 to 90 sales professionals, in July 2022 to capitalize on this positive momentum, resulting in a 58% increase in new quarterly prescriptions from Q2 to Q4 2022. Reimbursement of all shipments finished the year at over 60%, and refill rates remained high, with an average of 63% at the end of 2022.
The company plans to increase its efforts to commercialize Trudhesa® while also exploring strategic and financing initiatives and opportunities to fully leverage the potential of its proprietary Precision Olfactory Delivery (POD®) technology and expertise with small and large molecules in various disease areas.
About Impel Pharmaceuticals
Impel Pharmaceuticals is a commercial-stage pharmaceutical firm that focuses on developing and providing treatments for patients suffering from diseases with high unmet needs. The company employs a novel approach to drug delivery by utilizing its proprietary Precision Olfactory Delivery (POD®) technology in conjunction with established therapeutics to develop and offer treatments. In September 2021, it received approval from the U.S. FDA for its first product, Trudhesa® nasal spray, which is used to treat acute migraine with or without aura in adults. Along with Trudhesa, the company continues to address patient needs through licensing and partnerships.
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PHARMA TECH
Douglas Pharmaceuticals | January 27, 2023
A clinical advisory board has been established to support Douglas Pharmaceuticals' lead program R-107, an oral extended-release dose of racemic ketamine being developed as an adjunctive or stand-alone therapy for treatment-resistant depression.
Douglas Pharmaceuticals is a New Zealand-based pharmaceutical company specializing in the development of specialty generic and repurposed medications (TRD).
Peter Surman, Chief Scientific Officer expressed, "We are very excited to bring together a group of world-class experts in the field of psychiatry, to help guide our late-stage development of R-107." "We believe their deep knowledge in the field, insights and contributions will be instrumental in charting an efficient course through pivotal clinical studies in TRD," he added.
(Source – Cision PR Newswire)
Some of the members of the clinical advisory board are as follows:
• Prof. Paul Glue [MB, ChB (Otago), MD (Bristol), FRCPsych]
• Prof. Alan F. Schatzberg, [MD] • Prof. Sanjay J. Mathew [MD]
• Prof. Allan Young [MB, ChB, MPhil, Ph.D., FRCP (Edin.), FRCPC, FRCPsych]
• Prof. Wiesław J. Cubała, [MD, PhD]
• Prof. Colleen Loo [MBBS (Hons), FRANZCP, MD]
About Douglas Pharmaceuticals
New Zealand's largest private pharmaceutical and healthcare firm, Douglas Pharmaceuticals, employs over 700 people and exports to over 40 countries. The company provides creative, competitive, and high-quality healthcare solutions to 'improve lives'. It designs, manufactures, and distributes unique and generic products, preferring those with significant intellectual property and technological complexity in high-unmet need sectors. The company's presence in international markets continues to grow, exposing New Zealand to the world. It is dedicated to improving people's health all around the globe. Some of the products that the company works with cutting-edge partners to develop, make, market, and distribute are pharmaceuticals, nutraceuticals, automated compliance systems, and consumer healthcare items.
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