Avoiding Excipient Variability

pharmtech | May 02, 2019

Excipients are essential components in drug products. Although sometimes defined as “functional” or “inert,” each has a specific role within the formulation that is necessary for the overall function of the medicine. Variability in the properties and performance of excipients may, depending on the nature of the variability and the role and quantity of the excipient, have a significant impact on the safety and/or efficacy of the final drug product. Managing—minimizing—excipient variability is, therefore, an essential part of drug product development and manufacture. Excipient variability depends on many factors. One important determiner relates to whether the excipients are prepared from natural materials or via chemical synthesis, according to Liam Cullen, an engineering specialist with Servier. For example, he points to cellulose-based materials, which are derived from wood pulp that is then chemically treated. “Natural materials, particularly those that are grown, can be subject to environmental conditions such as soil type, weather, and the use of fertilizers. Secondary processing steps can also provide further material variability,” he explains.

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Kubota Vision Announces Collaboration Agreement with Leading Diabetes Center

PBOS | September 30, 2022

Kubota Vision Inc. a clinical-stage specialty ophthalmology company and a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. announced today that the Company and Joslin Diabetes Center have entered into a material transfer and collaboration agreement for our Patient Based Ophthalmology Suite in-home optical coherence tomography device. Joslin Diabetes Center is conducting two clinical studies to evaluate the ability of PBOS to identify cases of diabetic macular edema that may need treatment compared to a commercially-available OCT device. The studies will be led by Dr. Paolo S. Silva at Joslin Diabetes Center. Dr. Silva is the Co-Chief of Telemedicine at the Beetham Eye Institute of the Joslin Diabetes Center. His work is focused on innovative and investigative work in a field at the intersection of clinical care and technology with the hope of providing an ideal model for the delivery of evidence-based, highly effective, and efficient diabetes eye care to the population that needs it the most. Joslin Diabetes Center, which is affiliated with Harvard Medical School, is a one-of-a-kind institution on the front lines of the world epidemic of diabetes — leading the battle to conquer diabetes in all of its forms through cutting-edge research and innovative approaches to clinical care and education. Dr. Silva stated, “Through these studies, we will determine if home-based in-home optical coherence tomography is useful in the evaluation of diabetic macular edema and how we monitor patients at risk for losing vision from the condition.” “Diabetic retinopathy is one of the most common diseases in the world. The use of our technology brings us great excitement as we continue to focus on the development of medical devices and explore further possibilities.” Ryo Kubota, MD, PhD, Chairman, President, and CEO of Kubota Vision Inc. About PBOS PBOS is a low cost, home-based, ophthalmic self-monitoring OCT device. This small handheld device addresses needs in mobile Health applications for self-monitoring of retina health by patients, in the home and in remote field locations. The PBOS aims to improve ophthalmic treatment outcomes in patients diagnosed with and treated for wet age-related macular degeneration, diabetic macular edema and other neovascular retinal diseases. PBOS is being designed to detect nascent disease progression and support patient re-treatment prior to irreversible vision loss due to disease progression. Key features are low cost and a patient-friendly design, to be used directly by patients at home. PBOS is being designed to capture changes in retinal anatomy. Network connectivity and cloud-based technologies are used to alert the patients and their physicians of disease progression and re-treatment needs. About Kubota Vision Inc. Kubota Vision Inc. is a wholly owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. committed to translating innovation into a diverse portfolio of drugs and devices to preserve and restore vision for millions of people worldwide. Kubota Pharmaceutical group’s pipeline includes a wearable device for myopia control using Kubota GlassTM technology and a handheld OCT device for the monitoring of neovascular retinal diseases, to be used directly by patients.

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BUSINESS INSIGHTS

AustinPx Names Elizabeth Hickman Chief Business Officer

AustinPx | September 28, 2022

AustinPx, Pharmaceutics and Manufacturing, a contract development and manufacturing organization announced the appointment of Elizabeth Hickman as Chief Business Officer. In this role, Ms. Hickman will be responsible for the Company’s CDMO business operations and strategy, including building capabilities and a team to deliver high-value solutions for pharmaceutical customers. Ms. Hickman is an accomplished business leader with over 15 years of experience with small and multi-billion-dollar CDMOs. Over her career, she has held business development and market strategy positions of increasing responsibility, most recently at West Pharmaceutical Services as Senior Director of Strategic Marketing, Services and Solutions where she was responsible for market expansion of the company’s contract development, testing and manufacturing services. Prior to joining West, Ms. Hickman led sales and marketing at Pharmatek Laboratories, where she helped grow the company’s services and revenues resulting in its successful acquisition by Catalent Pharma Solutions. Following Pharmatek’s acquisition, she continued to excel in market strategy and business development leadership roles with Catalent’s oral drug development business unit. Ms. Hickman has a BA in Microbiology from the University of Texas, Austin and an MBA from San Diego State University. "Elizabeth brings a sharp skillset and a wealth of CDMO experience to AustinPx," said Tim Scott, President and CEO for AustinPx. "She has a strong history of growing CDMOs as both a strategist and a team-builder. Elizabeth is unique in her ability to foster and create a culture that excels at providing client-centric services, and that is why she is such a tremendous asset for AustinPx. We are very fortunate to have her." As CBO at AustinPx, Ms. Hickman will focus on the strategic buildout of agile, best in class operations, systems, and teams. She will be responsible for all market strategy and communications, business development, project management, systems optimization, and data-driven processes that drive growth. "I am excited to be a part of AustinPx and join its impressive team of formulation and manufacturing scientists and operations staff. They are a true scientific powerhouse for our clients. My goal is to build on the Company’s strong foundation to develop a client-centric CDMO that consistently delivers exceptional service from initial engagement to product shipment. Ultimately, my passion is for the patients of our clients – if we can help get their drug candidates to the clinic faster, with better formulations and dosage forms, we can in turn impact more patients around the world." Elizabeth Hickman About AustinPx AustinPx, Pharmaceutics and Manufacturing is a contract development and manufacturing organization providing analytical and formulation development services and cGMP manufacturing for small molecule drugs. We specialize in phase-appropriate development strategies, speed to clinic and market strategies, and bioavailability enhancement of poorly soluble molecules - including our next generation amorphous dispersion platform, KinetiSol® Technology.

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PHARMACY MARKET

ICON selected by BARDA to conduct anthrax vaccine clinical trial

ICON plc | October 07, 2022

ICON plc. a world-leading healthcare intelligence and clinical research organisation, announces that it has been selected by the US Biomedical Advanced Research and Development Authority part of the Administration for Strategic Preparedness and Response in the Department of Health and Human Services to execute an anthrax vaccine clinical trial. BARDA is providing funding to the Government and Public Health Solutions team at ICON to develop and execute a clinical trial that will evaluate the immune response to the next-generation anthrax vaccine AV7909. The team will support the evaluation of AV7909 immunogenicity kinetics by conducting clinical trial activities including but not limited to project management, clinical operations and quality assurance. ICON has extensive experience in supporting vaccine clinical trials. It has participated in over 160 vaccine studies in the past five years. ICON’s vaccine clinical research professionals are therapeutically aligned with a leadership team that brings more than 200 years of combined experience in vaccine clinical development for commercial businesses, government, NGOs and multinational health organisations. “We are pleased to have been selected to execute this important clinical trial. The potential for an anthrax attack is still a very real and serious threat, and we are proud to be playing our part to increase the understanding of treatment options for anthrax exposure, ultimately supporting human health.” Edward Wright, President, ICON Government and Public Health Solutions This clinical study will inform operational logistics and use of AV7909 should an anthrax emergency occur. The clinical studies will not expose participants to anthrax. The trial will enrol healthy adults aged 18 and older and will be conducted in the United States starting in early 2023. BARDA, part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, is responsible for developing medical countermeasures to secure the U.S. against chemical, biological, radiological, and nuclear threats, as well as pandemic influenza and emerging infectious diseases. Since 2014, ICON has been a member of BARDA’s Medical Countermeasures Clinical Studies Network (CSN). The network is responsible for planning and executing clinical studies to support medical countermeasure development. Bacillus anthracis, the agent that causes anthrax, is a serious bioterrorism threat due to the delivery of aerosolised spores that can cause high-mortality disease through gastrointestinal, cutaneous, inhalational or injection routes. Although clinical manifestations of the disease differ by route, inhalational anthrax is the most lethal. Inhalational anthrax infection usually develops within a week after exposure but can take up to two months. Without treatment, only about 10% to 15% of patients survive after exposure to inhaled B. anthracis spores. Since 2015, BARDA has supported the late-stage development of AV7909, a next-generation anthrax vaccine which uses the U.S. Food and Drug Administration licensed anthrax vaccine Biothrax in combination with an immune system stimulant or adjuvant. The vaccine is being developed in partnership with its manufacturer Emergent Biosolutions Inc. to protect against anthrax post-exposure when used in combination with the recommended antibiotics. About ICON plc ICON is the world’s leading clinical research organisation, powered by healthcare intelligence. From molecule to medicine, we advance clinical research providing outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 40,500 employees in 119 locations in 53 countries as at June 30, 2022. About ICON Government & Public Health Solutions ICON Government & Public Health Solutions is ICON's business unit focused on direct US Government engagement, Non-Government Organisations (NGOs) and academia, providing full service and functional research solutions. In addition, ICON GPHS coordinates a Government Centre of Excellence (CoE) to lend internal federal government subject matter expertise that can be leveraged by other ICON business units when commercial clients receive federal funding on ICON awarded contracts. About BARDA’s Medical Countermeasures Clinical Studies Network (CSN) The CSN provides BARDA partners and medical countermeasure developers with essential tools and services to develop vaccines, therapeutics, diagnostics, and medical devices. The CSN provides comprehensive (Phases 1-4) clinical study services.

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BUSINESS INSIGHTS

Inversago Pharma Raises $95 million CAD in Series C Financing

Inversago Pharma Inc. | October 18, 2022

Inversago Pharma Inc. a clinical stage biotech company with a unique portfolio of peripherally-acting CB1 inverse agonists, announced the completion of a Series C funding of $95 million CAD led by New Enterprise Associates. Additional new investors Forbion’s Growth Opportunities Fund and Amgen Ventures joined current investors including Forbion’s Ventures Fund IV Fonds de solidarité FTQ, Genesys Capital, AmorChem, JDRF T1D Fund and adMare BioInnovations in the financing round. Proceeds from the Series C financing will be used to move Inversago’s lead program, INV-202, into a Phase 2 clinical trial in Diabetic Kidney Disease in Q4 2022. This follows the previously announced IND clearance from the FDA and the upcoming promising Phase 1b topline results in subjects with metabolic syndrome. Additionally, the funds will accelerate the Company’s other key programs currently in pre-clinical development, while establishing its leadership in the field of CB1 blockers. “We are privileged to have the support and commitment of such an impressive investor syndicate at this critical stage of the Company’s development. This new round of financing is a strong endorsement of the whole Inversago team, who have carried the vision to leverage the potential of the CB1 blockade in developing potent treatments for a growing number of patients suffering from metabolic conditions, such as Diabetic Kidney Diseases and other diabetes-related conditions”. François Ravenelle, PhD, Chief Executive Officer of Inversago Pharma Commenting on the investment, Ed Mathers, General Partner at NEA, said: “Inversago has demonstrated that peripherally-acting CB1 blockers have an untapped potential to create a new class of target therapies that serve diabetic patient populations. Today’s financing reflects our shared vision and collaboration with the Company’s management as they initiate a Phase 2 clinical trial with INV-202”. Nanna Lüneborg, General Partner at Forbion Growth, added: “We are delighted to join this Series C financing of Inversago, and support the Company to develop a pipeline of new therapies which promise to make a profound impact on the lives of patients with cardiometabolic diseases. We have been impressed by the terrific progress of Inversago since Forbion led the Company’s Series B round two years ago and are excited to further support the Company from both Forbion Growth and Forbion Ventures”. About NEA New Enterprise Associates, Inc. is a global venture capital firm focused on helping entrepreneurs build transformational businesses across multiple stages, sectors and geographies. With nearly $24 billion in cumulative committed capital since the firm's founding in 1977, NEA invests in technology and healthcare companies at all stages in a company's lifecycle, from seed stage through IPO. The firm's track record of investing includes more than 260 portfolio company IPOs and more than 440 mergers and acquisitions. About Forbion Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion invests in life sciences companies that are active in the (bio-) pharmaceutical space. Forbion manages well over EUR 2 billion across multiple fund strategies that cover all stages of pharmaceutical drug development. Forbion’s current team consists of over 30 life sciences investment professionals that have built an impressive performance track record since the late nineties with investments in 92 companies. Besides financial objectives, Forbion selects investments that will positively affect the health and well-being of patients. The firm is a signatory to the United Nations Principles for Responsible Investment. Forbion operates a joint venture with BGV, the manager of seed and early-stage funds, especially focused on Benelux and Germany. About Amgen Ventures Amgen Ventures is Amgen's corporate venture capital fund, dedicated to investing in emerging companies and technologies to advance promising new medicines and solutions to healthcare’s biggest challenges. About Inversago Pharma Located in Montreal, Inversago Pharma is a privately owned Canadian biotech company at clinical stage, specialized in the development of new therapies focusing on CB1 blockade, based on first-in-class, peripherally-acting CB1 inverse agonists. Inversago aims to provide new treatment options that improve the lives of patients affected by metabolic conditions such as Diabetic Kidney Disease including Diabetic Nephropathy Type 1 and Type 2 Diabetes Non-Alcoholic Steatohepatitis complications of obesity and hypertriglyceridemia as well as fibrotic indications like Progressive Fibrosis-Interstitial Lung Disease including Idiopathic Pulmonary Fibrosis and other conditions.

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