Why are small/virtual biotech companies attractive partners?
First, smaller companies choose to outsource drug development services. Second, they make decisions quickly, which facilitates smaller service providers like Camargo.
What are some of the challenges that arise when you are working with small and virtual pharma and biotech companies and how do you address them?
Clearly, financing is a huge issue with these companies. They usually have a very good science basis for their proposed drug product, but lack the information typically required to obtain financing. Camargo provides both a commercial analysis as well as an overall drug development plan that has received the FDA’s review. This powerful information is all that is needed to obtain early-stage funding.
Discuss what makes for a good partnership between you and small/virtual pharma and biotech companies?
A good partnership happens when each party depends on each other to get the job done. Camargo is a full-service company providing services from strategic product idealization through post-NDA approval. Camargo’s partners trust that nothing will fall between the cracks; full service means a one-stop contract. This enables both partners to focus on the science rather than contracting. Scientists working together get good things done quickly and efficiently.
Ken Phelps employed more than three decades of experience in the health science and services industry to found Camargo Pharmaceutical Services in 2003. As an expert in drug development, specifically the 505(b)(2) regulatory approval pathway, Phelps has aided in the successful FDA approval of numerous compounds.
Prior to founding Camargo, his broad background in drug development had led to a number of executive level assignments in the areas of quality control, project management and regulatory, clinical and medical affairs at Duramed Pharmaceuticals (now Barr Pharmaceuticals).
Prior to his work for Duramed, Mr. Phelps held a number of positions at Merrell National Labs, which merged to become Merrell Dow and eventually evolved into Aventis. At Merrell he had global responsibility for quality assurance, quality control and processing technology with an assignment based in Milan, Italy, and later directed IT for multinational manufacturing operations, leading to technical improvements in R&D, accounting and manufacturing operations.
He began his career synthesizing, characterizing and performing drug metabolism studies of potential carcinogens with the Eppley Center for Research in Cancer. He also gained early entrepreneurial experience by establishing a laboratory and manufacturing sterile blood collection tubes.
Mr. Phelps has a BS in Chemistry from the University of Nebraska.
Camargo is your full-service drug development partner specializing in the 505(b)(2) process; a holistic approach for developing products that offer differentiated benefits. Before development even begins, we help verify profit potential by working with your team to develop a comprehensive program and timeline complete with critical milestones and cost objectives. We manage every facet of the plan throughout your development continuum, including feasibility assessments, formulation and testing the drug product, to conducting preclinical and clinical studies, to final submission.
For more information, visit: www.camargopharma.com.