FiveSix Pharma
Strategic consultancy and advisory services for the pharmaceutical, biotechnology, and related industries
Strategic consultancy and advisory services for the pharmaceutical, biotechnology, and related industries
From pre-candidate to NDA/BLA filing - FiveSix Pharma excels at developing program strategy to align with product concepts, development of target product profiles for commercial and clinical differentiation, and advise on preclinical and clinical and integrated development strategies for effective decision making within the lifecycle of the program.
Global New Drug Development faces many challenges, particularly working within the context of multinational, matrixed/cross-functional program teams and organizations and in an industry in which technical, medical and scientific expertise may utilize combinations of both internal and external resources (such as CROs and other vendors)
FiveSix Pharma has 25+ years of experience in the planning, conduct, and execution of clinical studies in new drug development in numerous therapeutic areas (GI/GU, oncology, immunology, rare diseases, metabolic disorders, and neurological and psychiatric conditions) and partnered with most of the major CROs and many of the support vendors in the execution of clinical trials.
Understanding and effectively communicating program or clinical trial results requires in-depth knowledge and expertise to asses the impact on the program and application of pre-defined Go/NoGo criteria. As programs progress through the phases of development, it is important to put new or emerging data into context of the clinical and commercial criteria in new drug development
Technical and scientific review and assessments for merger and acquisition, in-licensing, partnering, out-licensing, and advisement for due diligence and related activities requires extensive scientific, technical, and industry knowledge and experience. FiveSix Pharma provides services for technical and scientific evaluation, clinical development strategies, and insight to risk-based assessments.
If your program or company needs are not included or described within the primary capabilities of FiveSix Pharma - we welcome the opportunity to determine whether we can provide other solutions to specific problems or circumstances within your research and development programs, based on prior experience or referrals within FiveSix Pharma's professional network.
FiveSix Pharma LLC
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