Vernal Biosciences | January 03, 2024
<p> Vernal Biosciences, a leading manufacturing and services company specializing in mRNA and lipid nanoparticle (LNP) formulation, proudly announces the additions of Sven Lee, Chief Commercial Officer, and Richard P. Hamel, Chief Financial Officer to its leadership team. Both distinguished leaders will strengthen Vernal’s position as a premier mRNA and LNP Contract Development and Manufacturing Organization (CDMO) while using their deep experience to deliver Vernal’s integrated mRNA manufacturing solutions to a growing marketplace.</p> <p> Chief Commercial Officer - Sven Lee</p> <p> Sven will lead the Commercial team, including business development, marketing, technical sales, and alliance management. His team will help customers define their manufacturing needs and provide creative solutions that leverage Vernal’s innovative technologies and manufacturing operations. Sven has a 30-year track record achieving remarkable business growth across the biotech and pharma sectors. Prior to joining Vernal, Sven was a Board Member and the Chief Commercial Officer at BioCina, an Australian based CDMO. Prior to BioCina, Sven spent six years as the Chief Business Officer of Abzena, a fully integrated, global biologics and bioconjugate CDMO. Sven has also held prominent roles in sales, marketing, and strategic planning at other CDMOs and life sciences companies including Global VP of Business Development at Catalent Biologics, Sr. Director of Global Business Development & Sales at TerumoBCT, Crucell (now Janssen), and Biogen.</p> <p> As Chief Commercial Officer, Lee says, “I am thrilled to be a part of a dynamic team specializing in high purity mRNA and LNP solutions for client partners in the rapidly advancing field of biotechnology of vaccines and therapeutic development for clinical trials and commercial use.”</p> <p> Chief Financial Officer – Richard P. Hamel</p> <p> Richard will be responsible for Vernal’s finance strategy and will lead the finance organization, including planning, treasury, tax and reporting, Richard is an accomplished financial executive with over 25 years of experience managing finance teams, improving business performance, and developing systems, processes, and procedures to streamline operations for high growth life science companies. Most recently, Richard was CFO at ReciBioPharm where he played a key role in integrating and managing several business units within ReciBioPharm. Prior to joining ReciBioPharm, he was CFO at United BioSource in Blue Bell, PA helping carve out the business from Express Scripts and building a stand-alone finance organization. Prior to joining United BioSource, Richard spent over seven years at inVentiv Health/Syneos in various financial roles of increasing responsibility including finance, shared services and treasury. Earlier in his career, Richard held a range of finance positions at ThermoFisher, AB Volvo, Kodak, Diageo and EY.</p> <p> As CFO, Richard will support Vernal Biosciences in achieving its ambitious goals and driving long-term success. “I am excited to join the Vernal team and apply my experience to further bolster the company’s already strong mRNA and LNP portfolio and further expand its unique capabilities,” said Hamel.</p> <p> CEO and Founder of Vernal Biosciences, Christian Cobaugh says, “On behalf of all Vernal employees and our investors, I am excited to welcome Sven and Rich to Vernal’s talented leadership team. Their collective experience and success that they bring to Vernal and our clients complements our expansion, including the recent addition of our GMP facilities and operations. Sven has spent most of his career helping customers find creative solutions in clinical manufacturing and Rich has successfully built and integrated several businesses in the life sciences sector, from early stage to global scale. Their additions to our team will help Vernal democratize access to high purity mRNA and LNPs for all stages of research and development.”</p> <p> <strong>About Vernal Biosciences</strong></p> <p> Vernal Biosciences is a leading CDMO specializing in mRNA and LNP manufacturing. Vernal provides comprehensive high purity platform manufacturing solutions for mRNA-based medicines and vaccines, from research to clinical development. Our dedicated team of experts, our platform solutions, and GMP facility show our commitment to our partners, enabling them to focus on accelerating their programs to clinical development to improve patient lives.</p>
Andelyn Biosciences, Inc. | January 16, 2024
Andelyn Biosciences, Inc., a pioneering and patient-focused cell and gene therapy Contract Development and Manufacturing Organization (CDMO), has partnered with Armatus Bio to accelerate manufacturing of their gene therapy treatment for Charcot-Marie-Tooth Type 1A (CMT1A), a rare genetic neurological disease associated with independence-limiting disability and risk of fatal complications that has no approved therapies today. The partnership will seek to maximize program efficiency and speed to clinical studies of this novel, precision approach.
As part of the agreement, Armatus will leverage Andelyn's extensive experience in adeno-associated virus (AAV) production and its proprietary suspension platform for development activities, plasmid manufacturing, and viral vector toxicology and GMP clinical manufacturing. The partnership strengthens the working relationship and offers great hope for patients suffering from neuromuscular disease.
Both organizations, located in the well-established and growing biotech hub of Columbus, Ohio, are aligned in their belief that the rise of gene therapies will continue to advance human health.
Matt Niloff, Chief Commercial Officer at Andelyn Biosciences said, "We are extremely moved by Armatus Bio's commitment to address the urgent unmet needs in CMT1A and are impressed by its innovative therapeutic technology for the disease. We look forward to scaling up the process in our program-specific, configurable suspension platform, and accelerating the therapy into the clinic with the highest degree of quality."
"Andelyn has demonstrated its strong capabilities in manufacturing complex genetic medicines with high quality and consistency, which will be critical to accelerating our development efforts," said Brian Price, PhD, Chief Technical Officer of Armatus. "We look forward to collaborating with Andelyn on this program as we work toward supporting this population that urgently awaits innovative solutions."
From its time-tested experience, Andelyn is proud to offer its clients exceptional development, plasmid production, and quality manufacturing at its three Columbus, Ohio facilities. Andelyn is advancing client discoveries and manufacturing life-altering cell and gene therapies for rare and prevalent diseases.
About Andelyn Biosciences, Inc.
Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on the development, characterization and production of viral vectors for gene therapy. With more than 20 years of experience, Andelyn's deep scientific expertise has resulted in the production of cGMP material for more than 450 clinical batches and 75 global clinical trials. Operating out of three Columbus, Ohio facilities, Andelyn supports its clients in developing curative cell and gene therapies from concept through plasmid development and manufacturing, process development, and cGMP clinical and commercial manufacturing. Andelyn's versatile capabilities include cGMP manufacturing capacity for both adherent and suspension processes up to a 2,000-liter capacity. An advanced digital model, quality system, full regulatory support and supply chain vertical integration help Andelyn accelerate the development and manufacturing of its clients' innovative cell and gene therapies.
About Armatus Bio
Armatus Bio is a privately held late preclinical stage biotechnology innovator leveraging vectorized RNAi to address urgent unmet medical needs in genetically-driven neurological diseases. Based in Columbus, Ohio, the company is led by a seasoned team with expertise in drug development and delivery, and partnered with world renowned experts in vector biology, genomics, and neurology. The company's lead candidate for Charcot Marie Tooth Type 1A (CMT1A) has received Orphan Drug Designation and Rare Pediatric Drug Designation, and is advancing toward IND-enabling studies. The company is also developing a preclinical vectorized RNAi asset for the rare neuromuscular disease Facioscapulohumeral Muscular Dystrophy (FSHD).
PanGIA Biotech, Inc. | January 05, 2024
PanGIA Biotech, a US based biotechnology company with a mission to develop true liquid biopsy technology that is scalable for global impact, today announced that it is finalizing its three-year, prospective, multicenter, clinical study on prostate cancer liquid biopsy. This announcement comes as the company prepares to launch additional clinical studies in multi-cancer early detection using the PanGIA® Liquid Biopsy Platform. “The PanGIA urine based true liquid biopsy technology has been developed for global impact by diagnosing, monitoring, and managing cancers earlier to save lives using urine as the sample type to create vastly improved availability and scalability in cancer diagnostics,” according to PanGIA Biotech’s CEO, Holly Magliochetti.
In 2020, the company received IRB approval and launched a novel AI integrated urine based liquid biopsy study. The company immediately began recruiting urologists in US-based academic as well as large and small group community practices to enroll men who were scheduled for prostate biopsy. Results of the study are pending publication.
“Based on the high sensitivity and high specificity of the PanGIA prostate study, PanGIA Biotech is now preparing to significantly expand the platform by launching follow-on studies in ten additional cancer types,” said Tricia Schumann, Chief Investment Officer of PanGIA Biotech. Additional cancer types in the PanGIA follow-on study will include breast, ovarian, lung, renal, bladder, colorectal, stomach, pancreas, liver, and brain. The company will begin recruiting experienced medical professionals across the United States as clinical study sites as well as listing the study on ClinicalTrials.gov.
PanGIA Biotech intends to launch the expanded study in mid-2024. Interested researchers may contact the company for additional information.
About PanGIA Biotech, Inc.
PanGIA Biotech develops novel, AI integrated, true liquid biopsy technology that is scalable for global impact. The PanGIA® platform allows rapid development of non-invasive testing for detecting, monitoring response to therapy, and managing a variety of diseases and disorders, including cancers as early as Stage 1. The company combines expertise in molecular biology with advanced computational biology and machine learning to detect disease-associated patterns using proprietary technology.