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Special Issue "Drug Discovery, Development and Regulatory Affairs"
Deadline for manuscript submissions: closed (31 May 2019).
Prof. Dr. William C. (Trey) Putnam Website E-Mail
Departments of Pharmacy Practice and Pharmaceutical Sciences, School of Pharmacy, Texas Tech University Health Sciences Center, 5920 Forest Park Avenue, Dallas TX, USA
Interests: clinical pharmacology, drug discovery, drug development, drug regulatory affairs, biomarker discovery, altered metabolism of disease states, advanced analytical techniques
Prof. Dr. Stephen F. Amato Website E-Mail
Global Regulatory Affairs/Quality Assurance/Advanced Manufacturing Systems, College of Professional Studies, Northeastern University, USA
Interests: global convergence of biomedical product regulation and reimbursement/market access; regulation of gene and RNA interference-based therapies; biotechnology; biomaterials; advanced manufacturing and healthcare product quality assurance
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
Manuscript Submission Information
Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All papers will be peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.
Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. International Journal of Molecular Sciences is an international peer-reviewed open access semimonthly journal published by MDPI.
Please visit the Instructions for Authors page before submitting a manuscript. There is an Article Processing Charge (APC) for publication in this open access journal. For details about the APC please see here. Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.
- drug discovery
- drug development
- target identification
- target validation
- regulatory affairs
- regulatory sciences
- drug commercialization
- pharmaceutical market access
- drug screening
- novel nonclinical models/approaches
- advanced manufacturing
- continuous manufacturing
- process analytical technology
- adaptive clinical trials
- in silico laboratory and clinical development
- rolling submissions
- accelerated approvals
- real world evidence