02.02.17
Cocoon Biotech, a company focused on using its silk protein-based drug delivery technology for the development of formulations to treat osteoarthritis and other conditions, has entered into service agreements with Camargo Pharmaceutical Services to provide regulatory consulting and strategic development services for Cocoon's pipeline of products. The first joint program will involve biocompatible silk fibroin loaded with a small molecule therapeutic, and will include pre-Investigational New Drug (pre-IND) meeting planning and preparations through to New Drug Application (NDA) submissions.
Camargo specializes in drug and combination device product development and approval utilizing the regulatory pathway provided for in Section 505(b)(2) of the U.S. Federal Food, Drug, and Cosmetic Act. Over the last decade, Camargo has participated in more than 1,100 FDA meetings and more than 200 FDA, NDA and ANDA approvals.
"We are pleased to be partnering with Camargo, as they will be an important part of the team which will help execute our pre-IND and overall regulatory strategy in an effort to expedite our products into the clinic and ultimately into the hands of physicians who can help the many osteoarthritis patients in need of more effective medicines," said Ailis Tweed-Kent, M.D., founder and chief executive officer of Cocoon Biotech. "We believe that the vast experience that Camargo has in navigating regulatory agencies worldwide will be very beneficial to Cocoon both in the near-term and in years to come."
"Our goal at Camargo is to guide our clients with the most cost- and time-effective strategy to navigate the 505(b)(2) regulatory pathway, while driving commercial success for our client-partners," said Ken Phelps, president and chief executive officer of Camargo Pharmaceutical Services. "Cocoon's vision of enabling healthy, productive lives for patients worldwide by utilizing silk protein technology excites all of us at Camargo."
Camargo specializes in drug and combination device product development and approval utilizing the regulatory pathway provided for in Section 505(b)(2) of the U.S. Federal Food, Drug, and Cosmetic Act. Over the last decade, Camargo has participated in more than 1,100 FDA meetings and more than 200 FDA, NDA and ANDA approvals.
"We are pleased to be partnering with Camargo, as they will be an important part of the team which will help execute our pre-IND and overall regulatory strategy in an effort to expedite our products into the clinic and ultimately into the hands of physicians who can help the many osteoarthritis patients in need of more effective medicines," said Ailis Tweed-Kent, M.D., founder and chief executive officer of Cocoon Biotech. "We believe that the vast experience that Camargo has in navigating regulatory agencies worldwide will be very beneficial to Cocoon both in the near-term and in years to come."
"Our goal at Camargo is to guide our clients with the most cost- and time-effective strategy to navigate the 505(b)(2) regulatory pathway, while driving commercial success for our client-partners," said Ken Phelps, president and chief executive officer of Camargo Pharmaceutical Services. "Cocoon's vision of enabling healthy, productive lives for patients worldwide by utilizing silk protein technology excites all of us at Camargo."