Relevant Experience Prior to Forming Camden Group Direction of cross-functional research teams in the identification of novel drug candidates utilizing gene cloning, molecular modeling, large-scale chemical and natural product screening, and in vitro and in vivo testing. Development and validation of in vitro and in vivo model systems for the evaluation of drug candidates. Phase I-III clinical trial design and management for G.D. Searle's (now Pfizer's) blockbuster arthritis drug, Celebrex® Clinical program development for G.D. Searle's (now Pfizer's) second generation oral and parenteral COX-2 inhibitors, Bextra® and parecoxib, including creation of the portfolio of efficacy and safety trials and individual trial design. Overall responsibility for implementation of 50-study clinical program for Bextra®. Multi-center phase II and phase III trial management, including the largest single trial of Celebrex®. Camden Group Experience - "We lead development from bench to bedside…" Preclinical Groundwork Evaluation of preclinical data for regulatory compliance. Preclinical development planning, including required portfolio of preclinical studies with study costs and timelines, to complete an IND package. Development Feasibility Assessment Assessment of development potential for immunologic, anti-arthritic, cardiovascular, oncologic, and analgesic therapeutics. Assessment of market potential and likely regulatory requirements for protein, small molecule, and anti-sense-based therapeutics from early pre-clinical data. Evaluation of in-licensing opportunities and new product candidates. Commercial feasibility assessment (immunologics, DMARDs, DMOADs, analgesics, oncologics). Multiple scenario valuation and product portfolio analyses. Clinical Program Development Phase I-III clinical program development and trial design for oral, IV, IM, intra-articular, and transmucosal small molecule anti-inflammatories, DMARDs, analgesics (narcotic and non-narcotic), and oncologics. FDA experience, from pre-IND through Phase III. Definition of regulatory strategy for both traditional and novel indications and claims. Clinical Program Implementation Overall responsibility for implementation of clinical programs, including site selection and contract negotiation, budget planning, protocol and case report form generation, oversight of Sponsor-CRO interactions, and coordination of clinical conduct, data management, statistics, programming, and medical writing functions for: Phase I safety and tolerability studies Phase II proof-of-concept/dose ranging studies Phase III pivotal studies