Asembia launches a network of retail pharmacies for specialty drug services

pharmaceutical commerce | April 29, 2019

As it kicks off its annual Specialty Pharmacy Summit (Las Vegas, Apr. 29-May 2), Asembia has announced a new offering that provides a level of patient support to drugs that typically are not budgeted for the high-touch, high-cost services of hub providers. The Asembia Managed Retail Network combines the company’s network of 25,000 affiliated pharmacies with its platform for digital communications around prescription fulfillment, benefits verification and prior authorization, thus combining a “light” hub service with patient followup care. The combination promises to improve the speed to therapy, reduce prescription abandonment, and generate positive patient reaction.

Spotlight

The social, demographic and economic context in which the pharmaceutical industry (Pharma) operates is changing dramatically, as we noted in “Pharma 2020: The vision”, the White Paper PricewaterhouseCoopers* published in June 2007 (see sidebar, Seven major trends reshaping the pharmaceutical marketplace).1 All these challenges have major ramifications for the way in which Pharma markets and sells the medicines it develops – the subject on which we shall focus here. The industry has traditionally relied on aggressive marketing to promote its products. One recent study estimates that, between 1996 and 2005, total real spending on pharmaceutical promotions rose from US$11.4 billion to US$29.9 billion in the US (the only country for which expenditure on all major marketing and sales activities is available).2 Another study suggests that the true figure (including meetings and e-promotions) is closer to US$57.5 billion in real terms.


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BUSINESS INSIGHTS

Aculys Pharma and SUSMED Have Entered into a Contract to Conduct the World's First Clinical Trial Utilizing Blockchain Technology

Aculys Pharma, Inc. | July 13, 2022

Aculys Pharma, Inc. a company focused on the development and commercialization of new innovative drugs in the fields of neurology and psychiatry, has entered into a contract with SUSMED, Inc., a company that promotes digital medicine to conduct the world's first1 corporate-sponsored clinical trial using blockchain technology. The clinical trial utilizing this blockchain technology, provided by SUSMED, will be conducted in collaboration with CMIC Co., Ltd., a pioneer in drug development support (CRO), with the cooperation of several medical institutions. With the sophistication of research and development and the increasing cost of new drug development, improving the efficiency of clinical trials is one of the challenges in the pharmaceutical industry that requires addressing. In such an environment, efficient use of resources and pursuit of efficiency are required. And improving productivity and quality of new drug development is also extremely important for society as a whole. Under these circumstances, Aculys Pharma is working to improve productivity and quality of clinical trials by utilizing AI and digital technologies for the development and commercialization of new drugs. The clinical trial system developed by SUSMED enables the reduction of data entry work and monitoring work2 by medical institutions by using the SUSMED-patented technology that binds e-worksheets and eCRF using blockchain technology. In addition to publishing multiple medical papers3, the clinical research that SUSMED conducted with the National Cancer Center has been approved by the Cabinet Office regulatory sandbox4. The result of the verification test conducted by the regulatory sandbox was published in the International Medical Journal in June 20205. With this outcome, The Ministry of Health, Labor and Welfare issued a notice on December 4, 2020 that source data verification (SDV: Source Data Verification) using blockchain technology is permitted as an alternative method under the GCP ministerial ordinance. CMIC will promote these efforts for attaining an efficient clinical trial by 1) supporting the operation of the system at the medical institution, 2) cooperating with development of the e-worksheet and eCRF, and 3) complementing the functions outside the scope of the system. This clinical trial which utilizes blockchain technology significantly reduces the number of processes around data entry at medical institutions and SDV compared to conventional methods, and also contributes to reducing the number of required CRA visits to the medical institutions. In addition, by taking advantage of blockchain technology, it is expected to have the effect of increasing the reliability of the clinical trial data itself. Through these methods, we aim to improve the efficiency of the clinical trial-related work-streams necessary for new drug development, and to optimize new drug development costs without compromising reliability. "We are delighted to be able to conduct a clinical trial utilizing blockchain technology in collaboration with SUSMED and CMIC as Aculys Pharma strives for providing new therapeutic modalities by making full use of the latest in digital technology. We expect this pioneering effort of three companies, which aim to improve the quality and efficiency of clinical trials, will realize digital transformation of clinical trial monitoring work and contribute to the optimization of new drug development costs. We will continue to actively introduce new technologies not bound by a conventional framework and aim to solve social issues surrounding Japanese healthcare by collaborating and partnering with external partners." Kazunari Tsunaba, President and CEO of Aculys Pharma, Inc Taro Ueno, President and CEO of SUSMED, Inc., stated as follows. "In the clinical trials conducted in the development of new medical technology, prevention of data tampering and cost efficiency have been issues. While developing therapeutic apps in the healthcare field, we have come to focus on the possibility of using blockchain technology in clinical development and continued research and development. This time, we are delighted to be able to collaborate with CMIC to conduct the world’s first clinical trials using blockchain technology in a corporate-sponsored clinical trial of Aculys Pharma, a company that focuses on the development and commercialization of new innovative drugs. We believe that utilization of blockchain technology enables us to realize efficient and reliable clinical development and we also can contribute for optimization and sustainability of future social security.” "CMIC was established in 1992 as Japan's first CRO and has supported a number of clinical trials of drug development. This time we are participating in the corporate-sponsored clinical trial of Aculys Pharma with SUSMED. While digitalization will furthermore drive acceleration of process efficiency, we will continue to pursue further improvement of quality and efficiency of clinical trials in monitoring work by utilizing CMIC's know-how based on numerous clinical trial experiences over the past 30 years." About Aculys Pharma, Inc. Aculys Pharma is a biopharmaceutical company focused on the development and commercialization of innovations in the fields of neurology and psychiatry. Its corporate name was created from the philosophy of "Catalyst to Access." Aimed to act as a bridge for innovative medical care in the field of neuropsychiatry, Aculys Pharma develops and commercializes novel pharmaceuticals and provides innovations for better medical care to patients, their families, healthcare professionals, and society.

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BUSINESS INSIGHTS

Global Pharmaceutical Market Drives Innovative Digitalization to Accelerate Drug Discovery

Frost & Sullivan | June 17, 2022

Frost & Sullivan's recent analysis, Global Pharmaceuticals Outlook, finds that the accelerated drug development timelines are driving digitalization and innovation across the pharmaceutical value chain. Data, the decentralization of clinical trials, supply-chain resilience, digital therapeutics, and manufacturing automation are the key areas driving digitalization. The industry also ensures that healthcare will remain precise, preventive, and outcome-based in promoting social and financial inclusion. The global pharmaceuticals market, including small molecules and biologics, is expected to register 3.8% growth, garnering $1.48 trillion by the end of 2022 from $1.43 trillion in 2021 under the aspirational scenario. "The partnerships and horizontal integration of technology companies with life science companies have laid the foundation for rapid and cost-effective drug discovery and development. Further, all major genomics technology companies are channeling their resources to digitalize genomic data for better selection of patients for clinical trials and to reduce the turnaround time for clinical studies." Surbhi Gupta, Healthcare & Life Sciences Senior Industry Analyst Gupta added: "Owing to the growing use of machine learning and artificial intelligence in personalized medicine, the pharmaceuticals industry will move from a symptom-driven treatment approach to a genetics-based approach. Additionally, precision medicine can offer in-depth information about cellular and molecular alterations, accelerating the development of targeted therapies." Digitalization and innovation in the pharmaceuticals industry will unlock new growth opportunities, including: Digital therapeutics companies must excel in areas where many pharmaceutical companies are lacking, including data analytics, interoperability, user-centric design, and flexible business models. Innovative formulation and delivery technologies that improve RNA stability at ambient temperatures will facilitate the rapid global adoption of RNA-based treatments at reduced costs. Contract development and manufacturing companies should partner with global companies to meet the required experience in clinical drug manufacturing and expand market reach in Asia-Pacific. Global Pharmaceuticals Outlook, 2022 is the latest addition to Frost & Sullivan's Healthcare & Life Sciences research and analyses available through the Frost & Sullivan Leadership Council, which helps organizations identify a continuous flow of growth opportunities to succeed in an unpredictable future. About Frost & Sullivan For six decades, Frost & Sullivan has been world-renowned for its role in helping investors, corporate leaders and governments navigate economic changes and identify disruptive technologies, Mega Trends, new business models, and companies to action, resulting in a continuous flow of growth opportunities to drive future success. Contact us: Start the discussion

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BUSINESS INSIGHTS

SCA Pharma Names Louis Pace as Chief Financial Officer and Chief Information Officer

SCA Pharma | July 15, 2022

SCA Pharma, a nationally recognized leader in the 503B compounding pharmaceuticals outsourcing industry providing quality, service, and value to hospitals nationwide, has announced today the addition of Louis Pace as Chief Financial Officer and Chief Information Officer. Pace brings over 30 years of experience serving several successful private equity backed businesses in functional and P&L leadership roles. Most recently, Mr. Pace served as Chief Financial Officer at Orchid Orthopedic Solutions where he successfully led strategy deployment efforts that focused on growth and profitability improvement. "I am extremely excited to welcome Louis to the team and to partner with him as we continue to accelerate growth at SCA Pharma. SCA Pharma is committed to providing innovative solutions for our 503B customers that help health systems manage their drug supply chain and pharmacy operations more efficiently. That evolution requires a more strategic and diversified approach, which suits Louis' background. Louis will manage our finance and accounting teams as well as our information technology strategy. He will concentrate on prioritizing internal and external business opportunities." Scott Luce, CEO of SCA Pharma "I am looking forward to working with the exceptional team at SCA Pharma. I am excited to build on SCA Pharma's current success and be a part of the company's future growth," said Louis Pace. Mr. Pace holds an AB in Economics from Harvard University and an MBA from Northwestern Kellogg Graduate School of Management. About SCA Pharma SCA Pharma is a nationally recognized leader in the FDA 503B outsourcing industry, specializing in providing the highest quality sterile admixture services and pre-filled syringes to hospital and health-care facility pharmacies. The company serves all therapeutic areas of pharmacy — including critical care, labor and delivery, anesthesia, and pain management — and maintains a wide portfolio of products, including ready-to-use and drug-shortage medications.

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PHARMA TECH

Calyx Named Medical Imaging Provider by Clinscience

Calyx | June 10, 2022

Calyx, the eClinical and Regulatory solutions and services provider relied on for solving complex data challenges in clinical research, announced it has been named an approved provider of centralized medical imaging services by Clinscience, a full service CRO offering smart, end-to-end clinical trial services to the global pharmaceutical industry. "Calyx's commitment to reliably solving the complex aligns with our focus on designing integrated, smart solutions that are tailored to our customers' needs. Clinscience and Calyx are both motivated to help global clinical trial sponsors achieve their clinical development objectives in an agile, expeditious, and smart way." Megan O'Keefe, Chief Commercial Officer at Clinscience "The Clinscience team understands what's important to pharmaceutical and biotech organizations," said Elizabeth Dalton, Vice President, Channel Partnerships Solutions, Calyx. "We're honored to work with Clinscience and to deliver the reliable imaging services their customers need to accelerate and optimize their clinical trials." Clinscience joins a long list of global pharmaceutical companies and CROs who repeatedly leverage Calyx's scientific expertise and experience to assess the safety, efficacy, and effectiveness of their compounds. To date, Calyx Medical Imaging has been used in over 2,600 clinical trials worldwide and has supported the approvals of over 270 medical treatments across a broad range of therapeutic areas. About Calyx Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. With deep expertise in clinical development and 30 years supporting trial sponsors and clinical research organizations, Calyx harnesses its intelligence and experience to solve complex problems, deliver fast insights, and get new drugs to market every day. About Clinscience Clinscience is a global CRO company offering smart CRO Services, from protocol creation to final study report development. The Company has offices in Poland, Spain, Italy, Germany, and the US and provides its services in 6 European countries. More than 150 Biotechnology companies across Europe and the US trust the Clinscience brand. The Company's procedures and Data-driven approach, harnessed with the Genius Suite™ technology, work together to give the Clients power and flexibility to address even the most unique needs. Clinscience is part of a publicly-traded parent company, Neuca Plc, an organization in the pharmaceutical wholesaling and healthcare industry that provides the structure to meet the needs of commercial and non-commercial studies.

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Spotlight

The social, demographic and economic context in which the pharmaceutical industry (Pharma) operates is changing dramatically, as we noted in “Pharma 2020: The vision”, the White Paper PricewaterhouseCoopers* published in June 2007 (see sidebar, Seven major trends reshaping the pharmaceutical marketplace).1 All these challenges have major ramifications for the way in which Pharma markets and sells the medicines it develops – the subject on which we shall focus here. The industry has traditionally relied on aggressive marketing to promote its products. One recent study estimates that, between 1996 and 2005, total real spending on pharmaceutical promotions rose from US$11.4 billion to US$29.9 billion in the US (the only country for which expenditure on all major marketing and sales activities is available).2 Another study suggests that the true figure (including meetings and e-promotions) is closer to US$57.5 billion in real terms.

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