| Name | Title | Contact Details |
|---|---|---|
Ashley Preston |
SVP Global Regulatory Affairs & Quality Assurance | Profile |
Harmony Biosciences, LLC, is a private biopharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to develop and commercialize novel treatment options for people living with rare diseases. With a focus on the central nervous system, including disorders of sleep and wakefulness, Harmony Biosciences is currently working to advance the understanding of narcolepsy and provide information and resources to people who live with, and healthcare professionals who treat, this chronic, debilitating neurologic disorder.
Arch Therapeutics, Inc. is a biotechnology company developing a novel approach to stop bleeding (hemostasis), control leaking (sealant) and manage wounds during surgery, trauma and interventional care. Arch is developing products based on an innovative self-assembling barrier technology platform with the goal of making care faster and safer for patients. Arch has received regulatory authorization to market AC5 Advanced Wound System and AC5 Topical Hemostat as medical devices in the United States and Europe, respectively. Arch`s development stage product candidates include AC5-G, AC5-V and AC5 Surgical Hemostat, among others.1,2
INVO Bioscience is a medical device company focused on creating simplified, lower cost treatments for patients diagnosed with infertility. Our INVOcell® Culture Device is a patented medical device used in the treatment of infertility that enables egg fertilization and early embryo development to take place in the woman`s body, in vivo. This revolutionary device promotes in vivo conception. It is an FDA cleared Intravaginal Culture (IVC) device that is a safe, effective and economical fertility treatment.
As a pioneer in the development of automated validation software solutions, ValGenesis leads the way with a unique paperless validation process that tracks the validation status of any GxP system in real time. With years of development and refinement in place, ValGenesis is the first to offer users real-time paperless validation via electronic execution thereby minimizing ineffectiveness and maximizing efficiency. ValGenesis automates and manages the validation life cycle and provides real time validation status of any system corporate wide.
We are dedicated to developing and commercializing effective and broadly applicable interventions for food allergy. Food allergy is a disease of the immune system that is triggered by an exceptionally broad range of commonly allergenic foods such as cow’s milk, eggs, tree nuts, peanuts, shellfish and even sesame. In a perfect world, the human immune system would adapt to all foods. However, in tens of millions of people, the immune system wrongly recognizes some food proteins as harmful and does not adapt. We envision a world where, with help from oral immunotherapy, the immune system can adapt to nearly all food allergens. And we built our inspiration into our name—Alladapt. Alladapt was co-founded in 2018 in Palo Alto, California, by allergist and protein biochemist Kari Nadeau, MD, PhD, and biotechnology entrepreneur, Ashley Dombkowski, PhD. Academic clinical research conducted by Dr. Nadeau has demonstrated that a food allergic immune system in an individual person can be receptive to remodeling by gradually increasing exposure, under tightly controlled clinical supervision, to the proteins that activate the inappropriate cascade of reactions. This work, combined with research illuminating disease mechanisms and pathways, led the founders to envision a biopharmaceutical intervention capable of addressing food allergy provoked by a wide-ranging set of antigens. Food allergy is a serious disease, with potentially life-threatening consequences. The disease has grown dramatically in recent years and now affects more than 6 million children¹ and 26 million adults² in the United States alone. Importantly, about half of people with food allergy are reactive to multiple foods, which further increases the risk of anaphylaxis due to accidental ingestion. The chronic, unpredictable components of this disease can elevate anxiety in patients and their families, and place extreme limitations on their lives. It is our goal to help patients experience more of life’s magical moments with less fear and greater confidence.