CPD AND LEARNING

Applied BioMath, LLC Announces Partnership with Antengene for Systems Pharmacology Modeling in Oncology

Applied BioMath | December 09, 2020

Applied BioMath, the business chief in applying frameworks pharmacology and unthinking demonstrating, reproduction, and examination to de-hazard drug innovative work, today reported a joint effort with Antengene Corporation for the advancement of a frameworks pharmacology displaying in immuno-oncology. Applied BioMath will build up a frameworks pharmacology model for a PDL1/41BB bispecific immunizer, ATG-101, in immuno-oncology signs. The model will be utilized to anticipate clinical beginning and useful portions for first-in-quite a while. "Antengene Corporation is devoted to growing first-in-class as well as top tier treatments in oncology," said Dirk Hoenemann, M.D., VP, Head of Medical Affairs for Asia Pacific Region (APAC) and Early Clinical Development. "We chose to work together with Applied BioMath with an end goal to give ourselves the most noteworthy probability conceivable of anticipating exact beginning and effectual dosages which is a basic piece of our first-in-quite a while."

Applied BioMath utilizes a thorough fit-for-reason model advancement measure which quantitatively coordinates information about therapeutics with a comprehension of its component of activity with regards to human sickness systems. Their methodology utilizes exclusive calculations and programming that were planned explicitly for frameworks pharmacology model turn of events, reenactment, and examination. "Foreseeing beginning and effectual portions for first-in-quite a while is non-paltry for complex therapeutics, for example, Antengene's bispecific restorative," said Dr. John Burke, Ph.D., Co-Founder, President, and CEO of Applied BioMath. "We have created calculations and devices explicitly for this reason that have a demonstrated history of foreseeing such portions. We anticipate working together with Antengene to help them in this venture."

About Applied BioMath

Founded in 2013, Applied BioMath's mission is to revolutionize drug invention. Applied BioMath uses mathematical modeling and simulation to provide quantitative and predictive guidance to biotechnology and pharmaceutical companies to help accelerate and de-risk drug research and development. Their approach employs proprietary algorithms and software to support groups worldwide in decision-making from early research through clinical trials. The Applied BioMath team leverages their decades of expertise in biology, mathematical modeling and analysis, high-performance computing, and industry experience to help groups better understand their candidate, its best-in-class parameters, competitive advantages, patients, and the best path forward into and in the clinic. For more information about Applied BioMath and its services, visit www.appliedbiomath.com.

About Antengene

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a biopharmaceutical company with an integrated drug discovery and clinical development approach, anchored in Asia Pacific with a global footprint. Antengene aims to provide the most advanced anti-cancer drugs to patients in China, the Asia Pacific Region and around the world. Since official operation in April 2017, Antengene has built a pipeline of 12 clinical and pre-clinical stage assets, obtained 10 IND approvals and has 9 ongoing cross-regional clinical trials in Asia Pacific. At Antengene, we focus on developing drug candidates with novel MoAs and first-in-class/best-in-class potential to address significant unmet medical needs. The vision of Antengene is to "Treat Patients Beyond Borders" through discovery, development and commercialization of first-in-class/best-in-class therapeutics.

Spotlight

Biopharmaceutical drug development has been experiencing one of its most productive periods in recent history. During the past decade, the total number of new chemical and biologic entities in the R&D pipeline has been rising 6% each year and now exceeds 10,000 active drug candidates targeting unmet and under-served medical needs.

Spotlight

Biopharmaceutical drug development has been experiencing one of its most productive periods in recent history. During the past decade, the total number of new chemical and biologic entities in the R&D pipeline has been rising 6% each year and now exceeds 10,000 active drug candidates targeting unmet and under-served medical needs.

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PHARMA TECH

Alimentiv, Satisfai Health, and Virgo Announce Partnership to use AI-driven technology to Enhance Clinical Trials in IBD and other GI Diseases

Alimentiv Inc. | October 06, 2022

Alimentiv Inc. Satisfai Health, Inc and Virgo Surgical Video Solutions, Inc. announced a strategic partnership to revolutionize central reading, data capture, decision support, and patient recruitment in the clinical trial domain for Inflammatory Bowel Disease and allied GI conditions. Satisfai, a global leader in developing artificial intelligence solutions for gastroenterology, and Virgo, an industry leader in endoscopy video capture technology, will leverage their combined strengths to work in partnership with Alimentiv, a leading CRO in gastroenterology, to realize the full potential of AI-powered precision imaging in the GI clinical trials space. "This synergy of Satisfai and Virgo with Alimentiv is a positive development for patients with IBD and the drug development space. Clinical trials have many pain points, and this strategic partnership will enable advances in improving the efficiency of clinical trials and make some significant changes to how trials are run. We are delighted to enter this arrangement to bring the next generation of imaging technology to clinical trials in gastroenterology." Jeff Smith, CEO of Alimentiv "Artificial Intelligence in medicine is being increasingly adopted across various clinical specialties, with gastroenterology being one key field of use, particularly endoscopy," said Dr. Michael Byrne, CEO and founder of Satisfai Health, Clinical Professor of Medicine and gastroenterologist in Vancouver. "Working with Virgo, we are excited to bring AI-driven solutions to the IBD clinical trials arena. To be able to do so with Alimentiv — a leading Gastroenterology and imaging CRO—is a great opportunity. Our clear ambition is to change the clinical trial paradigm for IBD and other disease states such as Eosinophilic Esophagitis. As three groups working together, we are confident we can do so." "Combining Satisfai's marquis AI solutions with Virgo's HIPAA and SOC 2 compliant automated cloud video capture technology and Alimentiv's 21CFR11 compliant solutions, expansive site community, and imaging expertise is very powerful. We truly look forward to realizing this vision and bringing real-time, in-line AI solutions to GI clinical trials worldwide," said Matthew Schwartz, CEO and co-founder at Virgo. This partnership will facilitate Alimentiv's continued leadership in GI Clinical Trials through exclusive access to Satisfai's SmartScore Central Reading tool and Virgo's fully integrated, hands-free, cloud-based high-definition video-capture fleet. In addition, this will provide pharmaceutical and biotech sponsors with access to the ongoing development of novel endpoints, scoring methodologies, and scalable solutions geared toward bringing novel therapies to market faster. About Alimentiv Inc. Alimentiv is a global contract research organization (CRO) providing clinical trials, central image management, precision medicine, and real-world evidence services to the pharmaceutical and biotechnology industries. Headquartered in London, Ontario, Alimentiv employs more than 500 people across its operations in Canada, the United States, Europe, Asia-Pacific, and Latin America. The organization's unique model combines the efforts of internationally recognized academic researchers and operational experts to offer integrated solutions to customers. Over the past 20 years, Alimentiv has become a recognized expert in clinical trial design, central image management solutions, outcome measure development, and precision medicine for drug development in IBD. Today, Alimentiv provides services in more than 50 countries worldwide, collaborates with leading universities and academic institutions across the globe, and partners with many leading pharmaceutical and biotechnology organizations to bring new and improved treatment options to patients. Alimentiv is committed to investment in medical research and development, focusing on identifying barriers to drug development and pursuing solutions that advance IBD research. The research findings are operationalized into an efficient clinical trial methodology for clients that aligns with emerging regulatory standards. In collaboration with leading experts, Alimentiv has pioneered the development, validation, and standardization of outcome measures and technology, shaping the evolving clinical trial landscape for multiple indications and providing meaningful long-term consequences for patients, their treatment, and society. About Satisfai Health Satisfai is a leading medical solutions provider specializing in AI applications applied to large addressable markets in gastroenterology. Satisfai's solutions deliver real-time medical imagery analysis, providing clinicians with decision support intelligence that dramatically improves patient outcomes. Satisfai is supported by a highly respected board of medical clinicians and key opinion leaders who operate at the top of their fields in the many areas of gastroenterology. Satisfai enjoys a strong voice on academic panels, leading GI societies, and direct access to prominent industry players seeking to adopt new AI technologies in gastroenterology. About Virgo Virgo provides the leading cloud video capture, management, and artificial intelligence analysis platform for endoscopic medicine. Academic, integrated, and private practice healthcare providers use the Virgo platform to advance patient care through video-based research and training initiatives. Since launching, Virgo has helped physicians capture over 400,000 endoscopy procedures using industry-leading HIPAA, HITRUST, and SOC 2-compliant cloud service providers. Virgo also supports integration with all leading electronic health records systems. In 2021, Virgo launched a suite of tools called VirgoTrials, which help pharmaceutical trial sponsors and their participating trial sites accelerate patient recruitment and shorten the overall enrollment period for trials.

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PHARMACY MARKET

Baseball Legend John Smoltz Featured on PLx Pharma’s Social Channels

PLx Pharma Inc. | September 13, 2022

PLx Pharma Inc. is a commercial-stage drug delivery platform technology company focused on its clinically-validated and patent-protected PLxGuard™ that has the potential to improve the absorption of many drugs currently on the market and to reduce the risk of stomach injury associated with certain drugs. The Company, with its lead products VAZALORE 81 mg and VAZALORE 325 mg liquid-filled aspirin capsules has launched a new VAZALORE 325 mg advertising campaign on Facebook featuring legendary professional baseball pitcher and avid golfer John Smoltz. “From baseball to golf, I don’t want aches and pains to slow me down,” said Smoltz. “VAZALORE is the only pain reliever I have found that works quickly on my aches and pains and doesn’t upset my stomach.” “September is Pain Awareness Month, a time dedicated to raising awareness of pain and pain management options, like aspirin. We are very excited to launch our new Facebook campaign with John, a current VAZALORE user and believer in its many benefits. Millions of people rely on aspirin for the temporary relief of minor aches and pains. The unique complex inside VAZALORE capsules allows for targeted release of aspirin to temporarily relieve minor aches and pains and is specially designed to help protect the stomach.” Natasha Giordano, President & CEO of PLx Pharma PLx Pharma’s VAZALORE is the first and only U.S. Food and Drug Administration (FDA)-approved liquid-filled aspirin capsule. The product was launched in August 2021 and is available over the counter in more than 30,000 drugstores, supermarkets, mass merchandisers and e-commerce sites nationwide. About VAZALORE VAZALORE is an FDA-approved liquid-filled aspirin capsule, available in 81 mg and 325 mg doses. VAZALORE delivers aspirin differently from plain and enteric coated aspirin products. The special complex inside the capsule is designed for targeted release of aspirin, limiting its direct contact with the stomach. VAZALORE delivers fast, reliable absorption for pain relief plus the lifesaving benefits of aspirin. About PLx Pharma Inc. PLx Pharma Inc. is a commercial-stage drug delivery platform technology company focused on improving how and where active pharmaceutical ingredients (APIs) are absorbed in the gastrointestinal (GI) tract via its clinically validated and patent protected PLxGuard™ technology. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach injury associated with certain drugs.

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PHARMA TECH

Porton Advanced and Royaltech Announce Strategic Collaboration to Accelerate the Development of Bacterial Drugs and mRNA Drugs

Porton Advanced Solutions | August 29, 2022

Porton Advanced Solutions.announced a strategic cooperation with Suzhou Royaltech Med Co., Ltd. This strategic collaboration will further integrate the resources and capabilities of both parties, jointly promote the establishment of microbial vectors used for gene therapy and mRNA drug platform technology, and accelerate the R&D process of bioinnovative drugs. Porton Advanced provides an end-to-end gene and cell therapy CDMO service platform covering plasmids, cell therapy, gene therapy, oncolytic virus, nucleic acid therapy and viable bacteria therapy. Suzhou Royaltech focuses on the development of vaccines for tumor immunotherapy with its proprietary technologies, and fast transition from clinical to market . Its R&D pipeline covers the attenuated non-integrated Listeria platform, mRNA platform, and cell therapy platform. All these platforms are in the leading position not only in China but also abroad, and have a complete layout of invention patents. "We are very pleased to enter into this strategic collaboration with Royaltech. The core management team of Royaltech is from the top pharmaceutical companies, with an average of 15 years of R&D and management experience and is advancing an internationally competitive R&D pipeline. Porton Advanced's end-to-end gene and cell therapy CDMO platform with rich project experience and comprehensive quality system will help Royaltech the development of Listeria and mRNA drugs, push its R&D pipeline in a quick, efficient manner, and accelerate the development and implementation of innovative drugs, so that good medicines can benefit the public earlier." Dr. Yangzhou Wang, CEO of Porton Advanced Dr. Chun Xu, Chairman of Royaltech, said: "As a Biotech company, we are grateful to work with Porton Advanced, a very professional CDMO company, to jointly build a unique Listeria and mRNA tumor vaccine platform technology, and constantly develop leading tumor immunotherapeutic biological drugs in China and abroad." About Porton Advanced Solutions Established in Suzhou Industrial Park in December 2018, by its parent company Porton Pharma Solutions Ltd. Porton Advanced has built a CDMO platform integrating plasmid, cell therapy, gene therapy, oncolytic virus, nucleic acid therapy and microbial vectors used for gene therapy providing end-to-end services from cell banking, process development and analytical development, cGMP production to final Fill and Finish , investigator-initiated clinical trials (IIT), investigational new drugs (IND), clinical trials to commercial production. Porton Advanced is dedicated to support sponsors advance their GCT drug development and market launches. Porton Advanced focuses solely on gene and cell therapy services. Built on the professional experience of its cohort of world-class professionals, as well as on the successes of its parent company, Porton Advanced insists on "Customer First" and the tenet of "Compliance, Expertise, Focus, Open Collaboration". With its key focus on protecting IP for its sponsors, through its comprehensive project management and quality systems, Porton Advanced strives to bring gene and cell therapy products to the clinic and the market through its quality CDMO services, and help bring the best medicine to the public sooner. About Royaltech Headquartered in Suzhou Industrial Park, Suzhou Royaltech Med Co., Ltd. was founded in July 2016. In July 2017, a wholly-owned subsidiary, Shanghai Royaltech Co., Ltd. was set up in Shanghai International Medical Zone. As a high-standard innovation center of biological drugs, Shanghai Royaltech focuses on CMC development of innovative tumor vaccine, and fast clinical application of up-to-date cell immunotherapy. Since establishment, Royaltech has submitted several patents for invention to the State Intellectual Property Office. It focuses on the development of innovative tumor vaccine, and fast clinical application of up-to-date cell immunotherapy. Its R&D pipeline covers mRNA, oncolytic virus, bacteria, AAV, cell therapy platform and so on. Its core management team is from top universities in US and top 10 big pharma, with an average of 15 years of R&D and management experience. Our scientists have excellent capability on molecular biological engineering, target discovery and verification, pre-clinical R&D, quality control and assurance, and clinical trials of cell immunotherapy. On the strength of our rich experience on target biomarker, target discovery and verification, and global multicenter clinical trials, we are advancing an internationally competitive R&D pipeline.

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