Drug Discovery, Development and Regulatory Affairs

Dear Colleagues,

The discovery and development processes, inclusive of regulatory affairs, manufacturing, and post-market operations, are cornerstones in the commercialization of innovative pharmaceutical and biotechnology products to address unmet clinical needs. Effective drug discovery processes provide a continuous pipeline of candidates for drug development, which in turn generates approvable compounds. Novel approaches across the fields of drug discovery, drug development, and regulatory affairs are of paramount interest to multiple healthcare industry stakeholders, including patients, biopharmaceutical manufacturers, clinicians, provider institutions, and payers. Examples of such innovations include enhanced drug screening protocols, in silico methodologies, computational-based toxicology, advanced manufacturing approaches, continuous manufacturing, process analytical technology, adaptive clinical trial designs, rolling marketing application submissions, and utilization of real-world evidence. The acceleration of and improvements to the drug development continuum will yield a more efficient and cost-effective pharmaceutical and biotechnology product commercialization process, as well as safer and more effective therapies, which provide improved clinical outcomes.

This Special Issue, “Drug Discovery, Drug Development and Regulatory Affairs”, will focus on novel approaches (original research articles) as well as reviews of current practices surrounding the continuum of taking products from the beaker to the bedside. This Special Issue will present innovative research involving aspects of drug discovery, drug development, regulatory science, commercialization, and market access for both small-molecule pharmaceuticals, as well as biotechnology products.

Prof. Dr. William C. (Trey) Putnam
Prof. Dr. Stephen F. Amato
Guest Editors

Manuscript Submission Information

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