Umen & Co. - Strategic Regulatory Consulting and Medical Writing for Pharma and Biotech


		An NDA is the Only "Form" of a Drug That Most Regulators Will Ever See. A Firm Should Look at its NDA as an Example of its Finest Work.

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Understanding the Differences and Effectively Transitioning Between the US Integrated Summaries of Effectiveness and Safety (ISE/ISS) and the CTD Summaries of Clinical Efficacy and Safety (SCE/SCS) by David N. Schwartz, BS Michael J. Umen, PhD Kathy Nomides Mary Vanderhoof, MS As printed in Drug Information Journal, Vol. Vol. 44, pp. 641-648, 2010.

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The adoption in 2000 of the Common Technical Document (CTD) format for marketing applications notwithstanding, the US regulations requiring an integrated summary of effectiveness (ISE) and an integrated summary of safety (ISS) remain in effect. Many applicants, however, have attempted to use the CTD module 2 clinical summaries, specifically the summary of clinical efficacy (SCE) and the summary of clinical safety (SCS), alone to fulfill the regulatory requirements for an ISE and ISS, arguing that it is redundant to submit a separate ISE and ISS in addition to the SCE and SCS. Consequently, the US FDA has issued numerous guidances and made podium presentations communicating the message that, except in rare circumstances, New Drug Applications should contain the ISE and ISS documents as well as the CTD summaries of clinical efficacy and safety (SCE and SCS). The core difference between the ISE/ISS and their corresponding clinical summaries is in the depth of the analyses and the amount of information needed to support the analyses. While documenting the larger integrated analyses of efficacy and safety in the ISE and ISS, applicants should develop a strategy and process for deriving the SCE and SCS. Ultimately, submitting detailed and fully comprehensive ISE and ISS documents not only enables applicants to comply with regulations, but may also facilitate quick and efficient preparation of the SCE and the SCS.

Preparing Regulatory Submissions with the FDA Reviewer in Mind: Use of the Clinical Review Template by Mary Vanderhoof, MS Michael J. Umen, PhD David N. Schwartz, BS As printed in Drug Information Journal, Vol. 42, pp. 349-357, 2008.

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Both the guidance documents issued by FDA to industry and the guidance documents intended to be used internally by FDA's own staff of medical review officers (MROs) can be effective tools to help sponsors prepare their regulatory submissions. Two recent reviewer guidance documents, the clinical review template and the corresponding guidance, "Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review," provide useful insight into the FDA review process. The review of the clinical data has always been on the critical path to market approval for new molecular entities, and the recent reauthorization of the Prescription Drug User Fee Act (PDUFA IV) has underscored both the importance of an efficient review and postmarketing safety monitoring. The more FDA and the sponsors harmonize their efforts, with sponsors providing the summaries and analyses (including comprehensive tables, figures, and listings) that MROs need to adequately assess the safety data and document their reviews, the greater the opportunity for FDA to meet the performance goals set out in PDUFA and for FDA and industry together to deliver safe and effective new therapies to US patients in a timely fashion.

Six Enduring Principals for Preparing NDAs by Michael J. Umen, Ph.D. As printed in Drug Information Journal, Vol. 34, pp. 703-707,2000.

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Six enduring principles for preparing New Drug Applications (NDAs) are advanced: Principle Number 1: An NDA is the document that supports the labeling of a drug, Principle Number 2: An NDA is the only "form" of a drug that most regulators will ever see. A firm should look at its NDA as an example of its finest work, Principle Number 3: NDAs are organized to facilitate review by the authorities, Principle Number 4: Group studies in a logical order, Principle Number 5: Standardization of format and consistency of content make for high quality applications, and Principle Number 6: Getting it submitted on time is important; but getting it right is more important if your goal is an approved application.

Winning Plays in the R&D Game
by Robert W. Keidel Ph.D. and Michael J. Umen, Ph.D.
As printed in the Pharmaceutical Executive, February 1984.

Are my medicinal chemists playing baseball but being managed like a football team? Are my new-drug application (NDA) teams playing baseball instead of basketball? These may appear to be strange questions for pharmaceutical executives to ask themselves? However, such questions can be relevant and may provide powerful insights to help managers score points in the industry. Omit the sports terms, and they become questions pharmaceutical executives frequently ask themselves....

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