Therapeutic Innovation & Regulatory Science

Therapeutic Innovation & Regulatory Science

2015 Impact Factor: 0.511
2015 Ranking: 241/253 in Pharmacology & Pharmacy | 20/20 in Medical Informatics
2016 Release of Journal Citation Reports, Source: 2015 Web of Science Data
Published in Association with Drug Information Association


eISSN: 21684804 | ISSN: 21684790 | Current volume: 50 | Current issue: 5 Frequency: Bi-monthly

Therapeutic Innovation & Regulatory Science (TIRS) is the official scientific journal of DIA that strives to advance medical product discovery, development, regulation, and use through the publication of peer-reviewed original and review articles, commentaries, and letters to the editor across the spectrum of converting biomedical science into practical solutions to advance human health.

The focus areas of the journal are as follows:

  • Biostatistics
  • Clinical Trials
  • Product Development and Innovation
  • Global Perspectives
  • Policy
  • Regulatory Science
  • Product Safety
  • Special Populations 

This journal is a member of the Committee on Publication Ethics (COPE)

Therapeutic Innovation & Regulatory Science (TIRS), previously known as The Drug Information Journal, was launched as the official journal of DIA. The scope of Therapeutic Innovation & Regulatory Science reaches beyond the focus of pharmaceuticals, and its research and development, to include innovations in drugs, devices, and diagnostics, as well as global regulatory issues. Cutting edge articles on new science issues dedicated to fostering health and wellness worldwide will be included in each issue and feature hot topics such as CER, HTA, companion diagnostics, personalized medicine and more. Finally, Commentaries on emerging healthcare issues will continue to engage readers in the ongoing conversation between industry, academia, regulators and patients.

Deputy Editor
Lisa Jenkins, PhD Virtual Regulatory Solutions, Inc. Audubon, PA, USA
Associate Editor for Review Processes
MaryAnn Foote, PhD MA Foote Associates, Westlake Village, CA, USA
Associate Editor for Novel Communications
Eric D. Perakslis, PhD Harvard Medical School, Boston, MA, USA
Managing Editor
Section Editor: Clinical Pharmacology
Richard Day St. Vincent's Hospital, Sydney, NSW, Australia
Section Editor: Compounding/Manufacturing/Quality
Lisa Jenkins, PhD Virtual Regulatory Solutions, Inc. Audubon, PA, USA
Section Editor: Ethics/Policy
Josephine Babiarz Massachusetts College of Pharmacy and Health Sciences, Boston, MA, USA
Wendy Lipworth The University of Sydney, Sydney, NSW, Australia
Section Editor: Regulatory Science–Europe
Monika Pietrek Pietrek Associates GmbH, Weinheim, Germany
Section Editor: Special Populations–Pediatrics
Ronald J. Portman, MD, FAAP, FASN Novartis Pharmaceutical Corporation, East Hanover, NJ, USA
Section Editor: Special Populations–Women's Health
Lode Dewulf, MD, Dip Pharm Med, FFPM UCB, Brussels, Belgium
Section Editor: Statistics
Richard C. Zink, PhD SAS Institute, Cary, NC, USA
Editorial Board
Theresa Allio National Institutes of Health, Bethesda, MD, USA
Joseph R. Assenzo, PhD The Critical Path Institute, Tucson, AZ, USA
Christopher P. Austin, MD National Institutes of Health, Bethesda, MD, USA
Paul A. Bleicher Optum, Cambridge, MA, USA
Leona Blustein, PharmD University of the Sciences in Philadelphia, Fort Watshington, PA, USA
David R. Bristol Statistical Consulting Services LLC, Winston Salem, NC, USA
Robert M. Califf, MD Duke Translational Medicine Institute, Durham, NC, USA
Joseph C. Cappelleri Pfizer Inc, Groton, CT, USA
Jennifer B. Christian, PharmD, MPH, PhD GlaxoSmithKline, Research Triangle Park, NC, USA
Andrzej Czarnecki Eli Lilly & Company, Windlesham, United Kingdom
Gregory Daniel, PhD, MPH, RPh Brookings Institution, Washington, DC, USA
Nikos Dedes European AIDS Treatment Group (EATG), Athens, Greece
Joseph A. DiMasi, PhD Tufts University, Boston, MA, USA
Rafe Donahue, PhD BioMimetic Therapeutics, Inc, Franklin, TN, USA
Sara Doshi Eli Lilly and Company, Libertyville, IL, USA
Todd A. Durham, MS Durham Statistical Consulting LLC, Durham, NC, USA
Ronald D. Fitzmartin, PhD, MBA Center for Drug Evaluation and Research (CDER), FDA, Silver Spring, MD, USA
Erick J. Gaussens, PhD ProductLife Group, Suresnes, France
Kenneth A. Getz Tufts University, Boston, MA, USA
Barbara Gladson, PhD Rutgers' Biopharma Educational Initiative, Short Hills, NJ, USA
Alan M. Hochberg F. Hoffmann-La Roche Ltd, Basel, Switzerland
Stuart Horowitz, PhD, MBA WIRB-Copernicus Group, Princeton, NJ, USA
Mitchell W. Krucoff, MD, FACC, FAHA, FSCAI Duke University, Durham, NC, USA
Craig H. Lipset, MPH Pfizer Inc., New York, NY, USA
David Madigan, PhD Columbia University, New York, NY, USA
Christopher-Paul Milne, DVM, MPH, JD Tufts University, Boston, MA, USA
Shunsuke Ono The University of Tokyo,Tokyo, Japan
Min Soo Park, MD, PhD Yonsei University, Seoul, Republic of Korea
Peter J. Pitts Center for Medicine in the Public Interest, New York, NY, USA
Gayatri R. Rao, MD, JD Office of Orphan Products Development, US Food and Drug Administration, Silver Spring, MD, USA
Daniel Reshef F. Hoffmann-La Roche Ltd, Nutley, NJ, USA
Ramses F. Sadek, PhD Georgia Regents University, Augusta, GA, USA
Jonathan Seltzer, MD, MBA, MA, FACC Applied Clinical Intelligence, Bala Cynwyd, PA, USA
E. Mitchell Seymour, PhD, RAC University of Michigan, Ann Arbor, MI, USA
Adil E. Shamoo University of Maryland School of Medicine, Baltimore, MD, USA
R. William Soller, PhD Soller Regulatory and Research Services, Houston, TX, USA
Amy Sun, MD, PhD, FACP Sanofi-Aventis, Bridgewater, NJ, USA
Tetsuya Tanimoto, MD Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan
J. Rick Turner, PhD Quintiles, Durham, NC, USA
Raymond L. Woosley, MD, PhD AZCERT Inc, Tucson, AZ, USA
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    To view additional information about how to publish with DIA, click here.

    Therapeutic Innovation & Regulatory Science (TIRS) is the official scientific journal of DIA that strives to advance medical product discovery, development, regulation, and use through the publication of peer-reviewed original and review articles, commentaries, and letters to the editor across the spectrum of converting biomedical science into practical solutions to advance human health.

    The 8 focus areas of the journal are as follows:

    • Biostatistics
    • Clinical Trials
    • Product Development and Innovation
    • Global Perspectives
    • Policy
    • Regulatory Science
    • Product Safety
    • Special Populations

    We welcome your submissions on any of the above subjects or related topics. Please download and follow the instructions outlined here; use the Manuscript Submission Checklist to ensure all submission requirements have been met. Failure to follow these instructions may delay manuscript processing. Please contact the editorial office with any questions:

    An overview of the process, link to the submission site, and our Editorial and Ethical Statements is listed below. Please download the PDF of the author guidelines for specific instructions on the types of papers published, manuscript preparation, and acceptable file types.  

    Submission. Manuscripts are to be submitted online at, and authors will be required to set up an account in the SAGE Track system powered by ScholarOne. Authors will be guided stepwise through the creation and uploading of all manuscript files. All correspondence, including notification of the Editor’s decision and requests for revision, will take place via email.

    Peer Review

    TIRS operates a conventional single-blind reviewing policy in which the reviewer’s name is always concealed from the submitting author.

    1. Following online submission, manuscripts are reviewed for the following:

    • Formatting
    • Submission completeness, i.e., that all necessary and cited components are included in usable formats (e.g., figures, tables, references, supplementary materials)
    • English proficiency
    • Survey standards
    • General appropriateness to journal’s scope
    • Response to reviewer comments (revised manuscripts only)

    2. Following this, the manuscripts are:

    • Rejected if the topic is outside the scope of TIRS, does not meet survey standards, is poor science, or if the manuscript contains poor formatting, or is written in poor English.
      • If the manuscript is rejected outright for poor formatting or poor English, we invite resubmission if the necessary steps are taken to improve the paper.
    • Sent to Statistics Section Editor for reviewer selection if the paper’s methodology is based on statistics.
    • Sent out for peer-review to at least two (2) reviewers, based on areas of expertise. Reviewers are asked to comment on the following:
      • Original Manuscripts
        • Are the standard components of a research paper presented clearly (abstract, introduction, methods, results, discussion)?
        • Does the abstract clearly reflect the key points of the article?
        • Is the research hypothesis clearly stated in the introduction?
        • Is the methodology sound and clearly explained?
        • Is the research question answered in the results?
        • Are the conclusions justified? Are the results convincing?
        • Are the strengths and weaknesses of the research summarized in the discussion?
        • Is the appropriate literature cited and summarized throughout?
        • The novelty of the work and the significance to the field.
      • Review Articles and Analytical Reports
        • Does the abstract clearly reflect the key points of the article? Is the main argument clearly stated in the introduction?
        • Is the literature appropriately cited and does it improve the arguments or discussion posed in the article?
        • Is the article thought-provoking and/or controversial?

    3. The Editor-in-Chief will make a decision following:

    • The receipt of two (2) independent peer-reviews for new submissions
    • The receipt of necessary additional input from an Associate Editor or original reviewers on revised manuscripts if the topic is outside his area of expertise or if major revisions were required.

    Production and Publication. Authors will be notified of editor’s decision via email. Additional instructions, including obtaining signed contributor forms, working with copyeditors to finalize the manuscript and dates of online and print publication will be provided to accepted authors. All accepted manuscripts are published on the TIRS website at in the ‘‘Online First’’ section. Online First articles are considered fully published and citable. Unless otherwise notified, the manuscript will also appear in a print issue of the journal. The exact timing of the print publication is at the discretion of the Editor-in-Chief.

    Editorial Policies

    Prior Publication. Manuscripts are accepted for consideration with the understanding that they have not been published elsewhere and are not concurrently under review elsewhere. Papers that have been presented at scientific meetings are accepted for consideration, as well as original papers developed from student and professional posters presented at conferences and meetings. Please disclose the conference or meeting where the information was first presented.

    Statement on Human and Animal Rights. All studies involving human subjects must include a statement in the Methods section that the study has been approved by the appropriate institutional review board (IRB) and/or national research ethics committee. Include the full name of the reviewing entity. Studies involving experiments on animals must include a statement indicating that the international, national, and/or institutional guidelines for the care and use of animals have been followed, and that the study has been approved by a research ethics committee.

    When reporting experiments on human subjects, authors should indicate whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964, as revised, or current local regulatory requirements, whichever affords more protection. If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach, and demonstrate that the institutional review body explicitly approved the study. When reporting experiments on animals, authors should be asked to indicate whether the institutional and national guide for the care and use of laboratory animals was followed.

    Financial Support and Conflicts of Interest. All papers must indicate the affiliation of each author and include a statement for each author whether they have any financial arrangement or connection with the sponsor of the study or the organization that provided support for the work. Any conflict of interest and funding information should appear on the title page of the submitted manuscript. In addition, authors of accepted papers will be required to fill out a conflict of interest form. Statements of funding sources and conflicts of interest will be published in the final article.

    Authorship. The journal adheres to the guidelines for authorship as established by the Uniform Requirements for Manuscripts Submitted to Biomedical Journals (http://www.icmje .org/). Authorship credit is extended to individuals who met all 3 requirements: substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; drafting the information product or revising it critically for important intellectual content; and final approval of the version to be published. All persons designated as authors should qualify for authorship, and all those who qualify should be listed. Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content. Others who contribute through acquisition of funding, general supervision of researchers/authors, or review and approval of an information product, by themselves, do not qualify for authorship but should be acknowledged appropriately.

    Ghostwriting and Guest Authorship. Ghostwriting occurs when the author of an article does not reveal contributions of other authors as coauthors to the publication nor does the contributors are listed in the acknowledgement. The use of a medical/ technical writer is not prohibited per se, but if the writer qualifies for authorship, it must be assigned, otherwise, the writer should be acknowledged for his or her assistance. Guest Manuscript Submission Guidelines and Information 3 authorship occurs when the author contribution does not meet the 3 criteria set above and the person is listed as an author. The journal does not tolerate ghostwriting or guest authorship, as both situations suggest the lack of scientific integrity and honesty.

    Informed Consent. Patients have a right to privacy that should not be infringed without informed consent. Identifying information, including patients’ names, initials, or hospital numbers, should not be published in written descriptions, photographs, and pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication. Informed consent for this purpose requires that a patient who is identifiable be shown the manuscript to be published. Authors should identify Individuals who provide writing assistance and disclose the funding source for this assistance. Identifying details should be omitted if they are not essential. Complete anonymity is difficult to achieve, however, and informed consent should be obtained if there is any doubt. For example, masking the eye region in photographs of patients is inadequate protection of anonymity. If identifying characteristics are altered to protect anonymity, such as in genetic pedigrees, authors should provide assurance that alterations do not distort scientific meaning, and editors should so note. When informed consent has been obtained it should be indicated in the published article.

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