DermDefense Vendors
Meet the vendors who provide such outstanding support to DermDefense!
Only Orphans Cote
Dr. Timothy R. Coté is a leading national regulatory expert in orphan drug development and the founder and CEO at Only Orphans Cote, which has offices in Cambridge MA and Washington DC. Dr. Coté is leading a select team of experts in rare diseases and orphan drug development.
As a former Director of the Office of Orphan Product Development (OOPD) of the Food and Drug Administration between 2007-2011, Dr. Coté led the agency’s efforts in implementing the Orphan Drug Act and personally signed decisions on 1400+ orphan drug designation applications.
Only Orphans Cote is currently offering a range of advisory services to a growing portfolio of new clients in the US and Europe, including preparing FDA orphan designation applications, regulatory strategic planning, breakthrough therapy designations, pediatric priority review vouchers, and clinical trials design and execution.
Learn more at their website: https://only-orphans-cote.com/
MRI Global
MRIGlobal improves the health and safety of people everywhere by addressing some of the world’s greatest threats and complex biological, chemical, and engineering challenges. Founded in 1944 as an independent, non-profit organization, MRIGlobal provides customized research and development services to health and defense-focused organizations in need of innovative and multidisciplinary solutions. This includes expertise in clinical research support, infectious disease and biological threat agent detection, global biological engagement, in vitro diagnostics, and laboratory management and operations. To learn more, visit mriglobal.org.
AltaSciences
AltaSciences is an integrated CRO/CDMO offering pharmaceutical and biotechnology companies a seamless solution to early-stage drug development from lead candidate selection to clinical proof of concept. They acquired Sinclair Research, a nonclinical research organization (CRO) offering animal efficacy models, IND-enabling and specialty toxicology services, and GLP-compliant research capabilities to pharma, biotech, animal health, and medical device customers.
Their research center offers clients more than 300,000 square feet of dedicated research and production facilities on a 650-acre research campus. The facility is AAALAC accredited, FDA and USDA inspected, and supports Non-GLP and GLP compliant studies. Sinclair Research also maintained the largest herds of miniature swine in the United States.
Learn more at their website: https://www.altasciences.com/
Advanced Isolation Tech
Advanced Isolation Tech has over 30 years of experience in the
pharmaceutical/biopharmaceutical industry.
Expert in services related to chemistry, manufacturing, and controls (CMC) with
emphasis on technology transfer for Drug Substance and Drug Product and
compliance to cGMP (current Good Manufacturing Practices).
Extensive experience with numerous drug substance and drug product development and commercial programs both domestical and abroad.
