This webinar will benefit executives at Biotech and Pharmaceutical companies interested in growth through pipeline expansion or new products. With a change in indication, therapeutic area, dosage form, or other innovation, products developed via the US 505(b)(2) regulatory pathway gain the advantage of utilizing appropriate existing literature to meet safety and efficacy claims. But in order to be beneficial, 505(b)(2) product development must utilize an early heavy strategic approach to enable a lower cost, lower risk, and faster path to regulatory approval and market.

Focusing on high-level strategies, this webinar will introduce the four essential elements to successful product selection, and include other considerations:

•    Key areas for evaluation
•    Where studies should be conducted
•    Reimbursement 
•    Listed drug considerations
•    Changes and clinical impact
•    Old drug / new drug
•    Pipeline extension

Featured Speaker:

Kenneth V. Phelps
President and CEO
Camargo Pharmaceutical Services

Ken Phelps is co-founder and Chief Executive Officer of Camargo. He has over 40 years of industry experience, including a number of executive-level positions in areas such as quality control, project management and regulatory, clinical and medical affairs.


Register now for this webinar