| Name | Title | Contact Details |
|---|---|---|
Mike Berry |
Chief Technology Officer | Profile |
Momenta is a biotechnology company with a product pipeline of both complex mixture generic and novel drugs. Our complex mixture generics and follow-on biologics effort is focused on building a thorough understanding of the structure-process-activity of complex mixture drugs to develop generic versions of marketed products. While we use a similar analytical and development approach across all of our product candidates, we tailor that approach for each specific product candidate. Our first objective is to apply our core analytical technology to thoroughly characterize the structure of the marketed product. By defining the chemical composition of multiple batches of a marketed product, we are able to develop an equivalence window which captures the inherent variability of the innovator`s manufacturing process. Using this information, we then build an extensive understanding of the structure-process relationship to design and control our manufacturing process to manufacture reproducibly an equivalent version of the marketed product. Where necessary, and as required by the U.S. Food and Drug Administration, or FDA, we will supplement an application with additional supportive structure-activity data (e.g., immunogenicity, pharmacodynamics). Our goal is to obtain FDA approval for and commercialize generic or follow-on versions of complex mixture products, thereby providing high quality, safe and affordable medicines to patients in need.
LeafLine Labs was founded by practicing physicians who see the unnecessary suffering patients endure every day. We are, first and foremost, caregivers who exist to give our patients the quality of life they deserve.
Ionetix Corporation is a pioneering radiopharmaceutical end to end solutions provider for cardiac PET. Cardiac PET with Ammonia N-13.
Creating precisely tuned medicines so patients can breathe freely, we are pioneering a new therapeutic approach to treat debilitating ear, nose and throat diseases that impact the lives of millions of people. Lyra Therapeutics is a clinical-stage company pioneering a new therapeutic approach to treat debilitating ear, nose and throat (ENT) diseases that impact the lives of millions of people. Our goal is to transform the ENT treatment paradigm by providing effective front-line solutions for physicians and new treatment options for their patients. Lyra`s transmucosal therapeutic system, now being evaluated in a clinical study, directly targets tissues that are difficult or impossible to access with existing therapies. Building on expertise in materials science, drug development and formulation, the Lyra team has developed a proprietary platform that enables sustained, local delivery of medications over an extended period of time. Based on clinical results, this new therapeutic approach has the potential to provide significantly improved patient outcomes beyond the limited treatment and surgical options currently available for ENT diseases. Headquartered in the Boston area, Lyra Therapeutics was founded by George Whitesides and Robert Langer, academic luminaries in the fields of chemistry, materials science and biotechnology, and is backed by leading life science investors.
Sun BioPharma Inc. is a next-generation biopharmaceutical company developing disruptive therapeutics for serious unmet medical needs. The company`s initial programs are aimed at diseases of the pancreas, including pancreatitis and pancreatic cancer. Sun BioPharma has scientific collaborations with pancreatic disease experts at The Ohio State University, the Fred Hutchinson Cancer Center in Seattle, Translational Genomics (TGen) in Scottsdale, AZ, Cedars Sinai Medical Center in Los Angeles, the University of Minnesota, the Austin Health Cancer Trials Centre and the Box Hill Hospital in Melbourne, Australia and the Ashford Cancer Centre in Adelaide, Australia.