Marketing Application Development
An integrated approach to marketing application development and submission services
Our dedicated, experienced submissions team consists of PhD/MD – educated authors and program managers as well as statisticians, programmers, and data scientists who work closely to provide an integrated approach to the preparation and regulatory medical writing of marketing applications. Whether providing targeted support for a single discipline or document type, or full-service support for the marketing application preparation and submission processes across multiple regulatory regions, we keep the end goal of approval in mind and work as a cross-functional team to present data in a clear and concise way that will achieve regulatory approval.
Our wide-ranging, extensive experience and data-driven approach provides our clients with a valuable, unbiased, and independent assessment of their data and guidance for how best to present these data to regulators. We strive to prepare scientifically accurate, data-driven, thoughtful, high-quality applications as time- and cost-effectively as possible using a variety of strategies.
For each of the several full marketing application and IND projects we produce per year, our project teams provide:
Early Timeline Development and Diligent Continuous Management
Initially, we develop a full draft timeline early in the preparation process that includes all known milestones and identifiable interdependencies so that time and effort are used appropriately and efficiently throughout the program and various pieces of the submission are integrated appropriately. Then we monitor and update the timeline regularly with the goal of mitigating potential risks and delays to submission.
Early Key Message Development
We collaborate early in the preparation process to develop key messages in each discipline as well as overall risk-benefit considerations to guide drafting of documents across the application that strongly support a carefully crafted draft label. This includes taking global considerations into account if submissions will be made to multiple regulatory agencies.
Rho performs early, comprehensive gap analyses for each discipline to identify any potential challenges in the presentation of the program. If determined necessary, we immediately begin any remediation to prevent submission delays. This includes evaluating existing data packages to assure submission readiness.
Cross functional analysis planning
Statistical analyses plans for crucial clinical data analyses are discussed and reviewed by a cross functional team that includes statisticians, regulatory strategists, therapeutic experts, medical professionals, and future document authors to assure that the planned analyses will allow for effective presentation of key messages and support for proposed labeling.
Effective Presubmission Meetings
Comprehensive, carefully considered Presubmission Meeting questions are crafted and prepared within an informative, high-quality Briefing Package so that responses from the meeting can effectively guide preparation of a successful marketing application.
Staggered document preparation
We draft sections as early as possible in the marketing application preparation process so that all receive the deserved focus. This allows focus late in the preparation process to be on crucial, late-stage documents such as clinical summaries and draft label development.
Coordinated serial authorship of related documents
Rho carefully plans document authorship so that more detailed documents are prepared first, followed by related summary documents – ensuring consistent messaging with appropriate supporting data across all related documents. For example, the Integrated Summary of Safety should be prepared before the Clinical Summary of Safety (Module 2.7.4), which should be prepared before the Clinical Overview (Module 2.5).
Thorough early document review
Review at all stages of document preparation by every key stakeholders across disciplines is critical. Detailed outlines can then be used to obtain early agreement on planned content and key messages within the clinical research.
Rho can support preparation of all portions of marketing applications, including:
Module 1: Regional information for US or EU submissions
Selection of regulatory communications for inclusion, preparation of an effective Reviewer’s Guide, preparation of draft labeling (including label, Medication Guide, Patient Information, Instructions for Use, etc.), preparation of REMS/Risk Management Plan.
Module 2: Overviews and Summaries
Preparation of all summaries for all disciplines, including clinical (Clinical Overview, Summaries of Biopharmaceutics, Clinical Pharmacology, Efficacy, and Safety), nonclinical (Nonclinical Overview and Nonclinical Written and Tabulated Summaries), and CMC (Quality Overview Summary).
Module 3: Quality Data
Preparation of modules effectively describing drug substance and drug product as appropriate to the product, with experience with drugs and biologics of various types and novelty, including cell and gene therapy products, and description of device components if necessary for a combination product.
Module 4: Nonclinical Data
Compilation of nonclinical reports and SEND datasets, and assistance with selecting supportive literature for inclusion, as appropriate.
Module 5: Clinical Data
Drafting of Integrated Summaries of Safety and Efficacy, if applicable; full statistical support for integrated statistical analyses; evaluation of all clinical study packages including datasets for submission readiness, with remediation available as needed; preparation of additional narratives, if needed.
Rho has a variety of clinical research and regulatory medical writing services to develop specialized technical content for complex therapeutics and regulatory situations, including summaries of microbiologic studies, abuse potential and liability assessments, device-focused Module 3.2.P documents for drug-device combinations, and analyses using historical controls.
Rho has extensive experience supporting marketing applications through various regulatory approval pathways, including both the 505(b)(1) and 505(b)(2) pathway. The 505(b)(2) approval pathway can be an attractive option for many pharmaceutical developers. As compared to its 505(b)(1) counterpart, the 505(b)(2) pathway offers the possible advantages of abridged preclinical and clinical development programs, reduced regulatory and approval risk, and lower development costs. Whether you are assessing the suitability of a development program for the 505(b)(2) pathway, are looking to construct a 505(b)(2) development program, need help executing the requisite studies, or want to be sure you are maximizing the advantages of the pathway, expertise and experience matter. Rho’s experts have successfully supported more than 20 marketing applications through the 505(b)(2) approval pathway.
After a marketing application is submitted, Rho provides support for intensive peri-approval activities, including rapid-turnaround responses to Request for Information, preparation of amendments such as the 120 Day Safety Update, and label negotiations.
Rho experts also provide strategy, biostatistical, and scientific support for clients at 1-2 Advisory Committee meetings per year.
We have led
Last year, we submitted
David Shoemaker, Ph.D.
Senior Vice President, R&D
Kevin Barber, Ph.D.
Vice President, Regulatory Strategy & Submissions
Chief Strategist, Biostatistics & Standards for Regulatory Submissions
Chief Strategist, Biostatistics & Protocol Design
I want to express our sincere appreciation to Rho’s team for their support of the successful Quizartinib NDA, specifically for their enthusiasm, passion, and dedication to high quality and timely deliverables from the preparation of the ISS/ISE package (datasets and TLFs) for the NDA to the ad-hoc analyses for addressing requests from multiple health authorities during NDA reviews, and the requests during preparation of the ODAC and CHMP’s OE meetings. The very tight deadlines for the FDA’s requests, some of them quite technically challenging, were met with smooth collaboration and dedication, ensuring that the analyses adequately addressed the FDA’s questions. I want to specially acknowledge Karen [Wade] and her team for the dedication, and the professional, efficient, reliable, and consistent support for the project.
Yibin Wang, PhD, Director, Biostatistics, Daiichi Sanyko, Inc.
Marketing Application Planning Tool
If you’re interested in working with us on your marketing application, download and complete our planning tool to provide us with critical information about your program.
Tips for a Smooth Marketing Application Submission
This article shares tips on regulatory strategy, data integration and readiness, and electronic publishing that can help you avoid common pitfalls in the submissions process.
Understanding New Drug Applications (NDAs)
Marketing application submissions, including NDAs, BLAs, and PMAs in the US, are the culmination of years of research and the final hurdle before a product makes it to market. This webinar will help you understand what is involved in an NDA including regulatory strategy, data integration and readiness, and electronic publishing, and provide tips that can help you avoid common pitfalls in the submissions process.Watch webinar
David Shoemaker, Ph.D.
Senior Vice President, R&D