PHARMA TECH

assisTek Announces New Partnership with Medical Device Technology Creator, Strados Labs

assisTek Inc | June 21, 2022

assisTek Announces
assisTek, based in Doylestown, PA, has announced its latest partnership with Philadelphia based Strados Labs. Strados Labs is known for their creation of cutting-edge smart technology medical devices for respiratory illnesses.

assisTek, has been a longtime leader in the eSource industry across various therapeutic areas, over 900+ Global clinical Trials and offers an array of services for the electronic collection of clinical data. Their technology offerings include eCOA, ePRO, eConsent, BYOD modules and an extensive reputation for their custom solutions to support clinical trial teams worldwide. "We are very excited to announce this partnership and are looking forward to working together with Strados to provide another way for clinicians and patients to gather novel information during their trials. By making the integration seamless into our current eDiary offerings, this paired technology will allow for better patient engagement and more efficient information gathering, with the ultimate goal of improved data for cures and treatment of these conditions," explains Richard Gastineau, CEO of assisTek.

Strados Labs is a medical technology company developing smart sensor platforms that utilize machine learning and proprietary algorithms to detect and predict compounding conditions associated with serious, chronic respiratory diseases to improve the lives of patients globally. "We are grateful and proud to solidify our partnership with assisTek.  They have been a leader in integrating technology and data collection in clinical trials for over 20 years," said Strados Labs Director of Business Development, Shane Krauss.  "We look forward to working with their experienced and knowledgeable team in clinical trials by helping them scale their digital therapeutics using our clinically validated measures for wheeze, cough, and other adventitious breath sounds, or CABS—which is something no other cleared device can measure." The Company developed a first-of-its-kind smart sensor platform for respiratory health, RESP®. Strados recently received FDA Class II 510(k) clearance for home use of its first product, RESP®, its second FDA clearance in less than 18 months. RESP® was also granted a CE Mark late last year. The Company is developing a robust pipeline algorithm to support and address other chronic diseases, as well as chronic disease management pathways. Strados will continue to target asthma, COPD and infectious respiratory diseases (COVID, RSV, and more)—with plans to add heart failure and pediatrics later this year. The Company is based in Philadelphia and is a privately held company.

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Ropack Pharma Solutions supports solid oral dosage projects from early-stage formulation through clinical manufacturing, packaging, distribution, and commercial manufacturing and packaging. Ropack Pharma Solutions, a Contract Development and Manufacturing Organization (CDMO) providing pharmaceutical drug development for solid oral dosage. As a full-service pharmaceutical drug developer, Ropack can assist at any stage of the drug development process from Formulation to Market: R&D, formulation, analytics, clinical manufacturing, commercial manufacturing, clinical pharmaceutical packaging, commercial packaging, clinical trial management, and clinical distribution. Ropack Pharma Solutions is cGMP-compliant, FDA-inspected and Health Canada-certified. Facilities in Montreal, Canada, and Long Island, NY, total more than 340,000 square feet, are licensed for controlled substance management, offer level 9 security vaults with biometric access and ample cold-storage locations. Ropack Inc. – Pharmaceutical Contract Manufacturing Organization​, Pharma ​Contract Development and Manufacturing Organization for ​Solid Oral Dosage.

Spotlight

Ropack Pharma Solutions supports solid oral dosage projects from early-stage formulation through clinical manufacturing, packaging, distribution, and commercial manufacturing and packaging. Ropack Pharma Solutions, a Contract Development and Manufacturing Organization (CDMO) providing pharmaceutical drug development for solid oral dosage. As a full-service pharmaceutical drug developer, Ropack can assist at any stage of the drug development process from Formulation to Market: R&D, formulation, analytics, clinical manufacturing, commercial manufacturing, clinical pharmaceutical packaging, commercial packaging, clinical trial management, and clinical distribution. Ropack Pharma Solutions is cGMP-compliant, FDA-inspected and Health Canada-certified. Facilities in Montreal, Canada, and Long Island, NY, total more than 340,000 square feet, are licensed for controlled substance management, offer level 9 security vaults with biometric access and ample cold-storage locations. Ropack Inc. – Pharmaceutical Contract Manufacturing Organization​, Pharma ​Contract Development and Manufacturing Organization for ​Solid Oral Dosage.

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BUSINESS INSIGHTS

Accord BioPharma Partners with StoryMD to Deliver Advanced Prostate Cancer Educational Content to Clinicians and Patients

Accord BioPharma | September 21, 2022

Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on development of oncology, immunology, and critical care therapies, announced today a partnership with StoryMD. The StoryMD platform is a single, unified, personalized digital health information portfolio that curates the most relevant, visually rich content based on a patient's condition. Accord BioPharma has signed on as StoryMD's very first corporate partner, to support StoryMD's advanced prostate cancer content, allowing Accord BioPharma to provide a comprehensive, user-friendly tool to help patients and their caregivers navigate advanced prostate cancer, just in time for prostate cancer awareness month this September. "At Accord BioPharma, we recognize the need to go beyond biology – and beyond our responsibility of drug development – to help change the clinician and patient experience at all touchpoints in the care continuum where we can," said Chrys Kokino, President of U.S. BioPharma at Accord BioPharma. "StoryMD exemplifies that mission by providing clinicians with clear, easy-to-understand visuals, videos, and health information that help their patients understand their disease journey. Partnering with StoryMD on their advanced prostate cancer content felt like a natural fit given our recent drug launch." In March of this year, Accord BioPharma announced the U.S. launch of CAMCEVI® (leuprolide) 42mg injection emulsion for the treatment of advanced prostate cancer in adults. CAMCEVI should not be used in patients with hypersensitivity to GnRN, GnRH agonist analogs as anaphylactic reactions to these drugs have been reported in the medical literature. Accord BioPharma is heading all commercial initiatives in the U.S. and Canada. The U.S. Food and Drug Administration approved the New Drug Application (NDA) of CAMCEVI from Foresee Pharmaceuticals on May 25, 2021. Through a vast library of curated, clinically accurate disease-state information, graphics, and videos, StoryMD enables physicians to share an easy-to-understand disease journey with patients at the point of care, which can help increase patient retention of information and engagement, improve physician efficiency, and reduce the amount of misinformation patients may seek out on their own. "Accord BioPharma is making efforts to provide important patient and provider education in pursuit of our aim to offer latest treatment options to patients of advanced prostate cancer and we look forward to our collaboration with StoryMD to provide comprehensive and user-friendly tools for patients and care givers" said Binish Chudgar, Vice Chairman and Managing Director of Intas Pharmaceuticals Ltd, which is the parent company of Accord BioPharma. "Every once in a while, you meet a person and a partner who has a vision. Chrys Kokino has that vision to go beyond drug development and sees the value in advancing technology rather than being afraid of it. And that's exactly what we want – partners who recognize the gap in communication between physicians and patients and who want to work together to close that gap and fill an unmet need." Alexander Tsiaras, CEO and Founder at StoryMD On the importance of prostate cancer awareness, Tsiaras said, "I have a family member who works in the medical field, and when he was diagnosed with prostate cancer, it was amazing how little he knew. Cancer is such a confusing and overwhelming disease – 'Do I wait and watch? Should I be aggressive in treatment?' So, even for the most educated among us, it is a scary moment. Accord BioPharma and StoryMD are working together to go beyond offering patients drug options to impart knowledge and serve as a trusted resource." About Accord BioPharma Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient's experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patient's perspective and develop high-quality therapies that impact patient's lives. The founders of Accord BioPharma have dedicated their time, passion, and resources to focusing on specialty care and treatments, proactively developing better ways of working, and delivering enhanced therapies. About CAMCEVI® CAMCEVI® injection emulsion is the first-ever ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection that comes in a pre-filled syringe with no mixing required. In an open-label, single-arm study of 137 adults who received 42mg of CAMCEVI on Day 0 and Week 24, CAMCEVI offered consistent testosterone suppression to castrate levels (less than or equal to 50ng/dL) after the initial injection, from Week 4 to Week 48.1 CAMCEVI should not be used in patients with hypersensitivity to GnRH or GnRH analogs due to possible anaphylactic reactions.

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PHARMA TECH

Armata Pharmaceuticals Announces Clearance of IND for Prosthetic Joint Infections

Armata Pharmaceuticals, Inc | August 02, 2022

Armata Pharmaceuticals, Inc. a biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced that the U.S. Food and Drug Administration has cleared Armata's Investigational New Drug application for AP-SA02 in prosthetic joint infection. The company is initiating start-up activities for the Phase 1b/2a trial that will explore the safety, tolerability, and pharmacokinetics of intravenous and intra-articular doses of AP-SA02 as an adjunct to standard of care antibiotics in subjects with PJI. "Prosthetic joint infection is one of the most serious complications of prosthetic joint implantation. Staphylococcus aureus is a dominant pathogen that drives the need for surgical intervention and prolonged courses of antibiotic therapy. The ability of S. aureus to create biofilms that are refractory to standard of care antibiotics highlights the need for a novel therapy. Phage therapy may fill this need for PJI patients as phage have demonstrated the ability to disrupt biofilm and work synergistically with antibiotics." Dr. Mina Pastagia, Armata's Senior Vice President of Clinical Development "Armata is excited to explore AP-PA02 in patients who suffer from complicated joint infections that don't respond adequately to standard of care antibiotics. PJI is a logical extension of our diSArm trial which is targeting complicated S. aureus bacteremia," said Brian Varnum, Chief Executive Officer of Armata. "With this IND approval, Armata now has four active clinical programs. Today marks an important development milestone for Armata and its investors who set a course three years ago to transform phage therapy from a promising new technology to one that is explored in rigorous clinical settings." In addition to evaluating AP-SA02 in PJI and bacteremia due to S. aureus, Armata has advanced AP-PA02 into the Phase 2a component of the SWARM-P.a. study which targets chronic Pseudomonas aeruginosa infections in people with cystic fibrosis (CF). In February, the company gained IND clearance for AP-PA02 in a second indication, non-cystic fibrosis bronchiectasis targeting patients with chronic P. aeruginosa infections in a Phase 2 trial. About Armata Pharmaceuticals, Inc. Armata is a clinical-stage biotechnology company focused on the development of precisely targeted bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. In addition, in collaboration with Merck, known as MSD outside of the United States and Canada, Armata is developing proprietary synthetic phage candidates to target an undisclosed infectious disease agent. Armata is committed to advancing phage with drug development expertise that spans bench to clinic including in-house phage specific GMP manufacturing.

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BUSINESS INSIGHTS

Astellas and MBC BioLabs Announce Astellas Future Innovator Prize to Help Biotech Start-ups Accelerate Early Drug Discovery and Research Efforts

Astellas Pharma Inc. | September 20, 2022

Astellas Venture Management LLC a wholly-owned venture capital subsidiary of Astellas Pharma Inc. and Mission Bay Capital BioLabs a life-science incubator, today announced their collaboration on the "Astellas Future Innovator Prize" formerly known as the Astellas Golden Ticket competition. Building on over three successful years, the competition offers entrepreneurial scientists or emerging biotechnology start-ups one year's priority usage of MBC BioLabs' state-of-the-art lab facility and access to Astellas' research and development (R&D) capabilities and business leaders. With a shared commitment to discovering and advancing innovative science for the potential future benefit of patients worldwide, AVM and MBC BioLabs are continuing their partnership to support scientists and early-stage companies to accelerate their novel therapeutic programs, modalities or platforms. The 2022 competition will prioritize innovative research that compliment Astellas' Focus Area Approach and pipeline. "We are truly thrilled to host the Astellas Future Innovator Prize again this year. Through our long-term collaboration with MBC BioLabs, we aim to create an environment that encourages innovation to thrive. The Astellas Future Innovator Prize enables us to provide biotech companies with expertise and capabilities to turn an innovative idea into a real solution, which could transform the lives of patients in need around the world." William Watt, President, AVM "We are pleased to continue our partnership with Astellas to uncover the innovators of tomorrow," said Douglas Crawford, MBC BioLabs General Manager. "The past winners of the Astellas Future Innovator Prize show what can be achieved by combining Astellas' support, advice and expertise with our laboratory incubator, and we are excited to see the result of our ongoing collaboration." Entrepreneurial scientists, emerging life-science and biotechnology start-ups have until November 4, 2022 to enter the Astellas Future Innovator Prize. About the Astellas Future Innovator Prize at MBC BioLabs Astellas is offering up to two prizes for pioneering scientists with innovative research that complements Astellas' areas of interest in alignment with its Focus Area Approach and pipeline, including Blindness & Regeneration, Mitochondria, Genetic Regulation, Immuno-Oncology, Cell Therapy, and other areas. The 2021 Astellas Future Innovator Prize winners were Vcreate and Weatherwax Biotechnologies, chosen for the potential of their innovations to deliver therapeutic advances for unmet medical needs and their potential synergy with Astellas' Focus Area Approach. About Astellas Venture Management LLC AVM is the wholly-owned venture capital organization within Astellas, dedicated to supporting pre-clinical, cutting-edge science that can bring VALUE to patients. For over 15 years, AVM has provided equity investments to private, early-stage companies developing therapeutic programs and platform technologies, helping them to advance their innovations faster. AVM is a strategic investor, making investments in science that will enhance the current Astellas R&D pipeline or that could catalyze new directions in discovery research. About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. About MBC BioLabs MBC BioLabs is dedicated to helping life-science startups succeed. By renting space as small as a single bench and providing these entrepreneurial scientists with access to millions of dollars of equipment, MBC BioLabs allows companies to be fast, focused, and frugal. It has three sites: one in the Dogpatch neighborhood in San Francisco and two campuses in San Carlos, California. Each site has a complete molecular biology core facility that allows companies to do experiments on day one. MBC BioLabs has partnerships with leading pharmaceutical and life-science companies as well as a built-in venture capital firm, Mission BioCapital. These partnerships provide entrepreneurs with valuable insights about where to focus their efforts and accelerates the innovation pipeline. Since opening in 2013, MBC BioLabs has helped launch and grow 290 companies. These companies have brought 58 programs to the clinic, produced 13 approved diagnostics, and raised over $14 billion.

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