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Resources for Regulatory Submissions

Regulatory submissions are the most critical milestones in your clinical research program. Quality submissions can accelerate time to market, bring the benefit of new treatments to patients sooner, maximize research investments, and conserve patent life.

White Paper: Accelerating US Regulatory Approval for Drugs and Biologics that Treat Serious Diseases

FDA’s Fast Track, Accelerated Approval, and Priority Review designations can reduce product approval timelines if pursued and implemented appropriately. Taking the time to understand the requirements and potential benefits of each acceleration mechanism will help you make informed decisions about what’s best for your product development program.

Tips for a Successful NDA Submission

FREE WEBINAR

Tips for a Successful NDA Submission

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 share tips on regulatory strategy, data integration and readiness, and electronic publishing that can help you avoid common pitfalls in the submissions process.

David Shoemaker, Ph.D.
Senior Vice President, R&D

Dr. David Shoemaker has more than 25 years of experience in research and pharmaceutical development.  He has served as a Program Leader or Advisor for multi-disciplinary program teams and has been involved with products at all stages of the development process. He has extensive experience in the preparation and filing of all types of regulatory submissions including primary responsibility for four BLAs and three NDAs.  He has managed or contributed to more than two dozen NDAs, BLAs, and MAAs.  Dr. Shoemaker has moderated dozens of regulatory authority meetings for all stages of development.  His primary areas of expertise include clinical study design and regulatory strategy for development of novel drug and biological products.

Rob Woolson, J.D., M.S.
Chief Strategist, Biostatistics and Data Standards for Regulatory Submissions

Rob Woolson has 14 years’ experience in the analysis of complex data. He has conducted statistical analyses in all phases of drug development (Phase I through IV, NDAs, and BLAs) and has led SDTM/ADaM dataset conversion projects in multiple therapeutic areas. He has held a leadership role in six CDISC-compliant regulatory submissions, having guided the creation of ISS/ISE statistical analysis plans; integrated analysis dataset design and production; integrated display design and production; and submission-related documentation development. He has authored responses to numerous FDA queries and has represented sponsors at FDA in-person meetings.

Bob Rohde
Submission Services Consultant

Bob Rohde has held a wide variety of regulatory affairs positions since 1979. He has worked exclusively with the electronic submission process since 1999. Mr. Rohde has served as the Global Director of the electronic submissions department of a multinational pharmaceutical company and a multinational clinical research organization.  Mr. Rohde has successfully managed the development and publishing of many eCTD submissions for investigational products and marketing applications to the FDA, EU and Canadian authorities. He has served on submission teams at pharmaceutical and biotech companies publishing INDs, NDAs, BLAs, NDSs and MAAs. Bob provides pharmaceutical and biotechnology companies with a wide variety of e-Sub related services, including submission planning and management, vendor management, report publishing, submission publishing, training and staff augmentation. 

Keys to Success for Your Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)

FREE WEBINAR

Keys to Success for Your Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)

The integrated summary of safety (ISS) and the integrated summary of efficacy (ISE) are critical components of your new drug application (NDA) submission. Presenting the FDA with a coherent and clear integration of the data from your product development program is imperative and requires a sound strategy and a skillful approach.

Ben Vaughn
Senior Statistical Scientist

Ben Vaughn has participated in nearly 20 regulatory submissions and is an expert on CDISC implementation and standards. His work has included serving as lead statistician to complete displays and datasets for several ISS/ISEs (as well as the associated pivotal studies); coproducing the ISE for two opioid products; and statistical consultation, display generation and submission work for four separate products for OA knee pain. He has authored responses to various FDA queries regarding NDAs, PMAs, IDEs, and SPAs. Additionally, he has represented sponsors in FDA teleconferences and face-to-face meetings for both OA knee pain products and opioid products.

Rob Woolson
Statistical Scientist

Rob Woolson has conducted statistical analyses in all phases of drug development (Phase I through IV, NDAs, and BLAs) and has led SDTM/ADaM dataset conversion projects in multiple therapeutic areas. He has held a leadership role in six CDISC-compliant regulatory submissions, having guided the creation of ISS/ISE statistical analysis plans; integrated analysis dataset design and production; integrated display design and production; and submission-related documentation development. He has authored responses to numerous FDA queries and has represented sponsors at FDA in-person meetings.

FDA’s Expedited Development and Approval Programs

FREE WEBINAR

FDA’s Expedited Development and Approval Programs

FDA’s Breakthrough Therapy, Accelerated Approval, Priority Review, and Fast Track designations can reduce product approval timelines if pursued and implemented appropriately. Taking the time to understand the requirements and potential benefits of each acceleration mechanism will help you make informed decisions about what’s best for your product development program.  In this webinar, Dr. David Shoemaker, SVP R&D, will explain the differences between these programs, describe strategies to determine which program may be right for your product, and discuss FDA expectations and requirements for each program.

David Shoemaker, Ph.D.
Senior Vice President, R&D

Dr. David Shoemaker has more than 25 years of experience in research and pharmaceutical development.  He has served as a Program Leader or Advisor for multi-disciplinary program teams and has been involved with products at all stages of the development process. He has extensive experience in the preparation and filing of all types of regulatory submissions including primary responsibility for four BLAs and three NDAs.  He has managed or contributed to more than two dozen NDAs, BLAs, and MAAs.  Dr. Shoemaker has moderated dozens of regulatory authority meetings for all stages of development.  His primary areas of expertise include clinical study design and regulatory strategy for development of novel drug and biological products.

Worried about Your Next FDA Meeting? Key Tips to Make It a Success

FREE WEBINAR

Worried about Your Next FDA Meeting? Key Tips to Make It a Success

Regulatory authority meetings require strategic preparation and effective delivery on the part of the company to ensure a successful outcome.  In this webinar, Lauren Neighbours, Clinical Research Scientist, and Dana Minnick, Regulatory Scientist, discuss how to approach formal interactions with FDA to get the most benefit for your product development program.  The webinar will cover background on the different types and requirements for FDA meetings, present steps on how to prepare for and conduct the meeting, and share best practices based on Lauren’s and Dana’s own experiences.

Dana Minnick
Regulatory Scientist

Dana Minnick, PhD, DABT, RAC, is a toxicologist and regulatory affairs professional with 16 years’ experience leading and supporting drug and biologics programs throughout the development lifecycle.  Dr. Minnick is experienced in leading multi-disciplinary drug development teams to successful regulatory meetings, including 20+ FDA meetings, and submissions and has authored and reviewed many nonclinical sections for regulatory submissions.  

Lauren Neighbours
Clinical Research Scientist

Lauren Neighbours, PhD, RAC is a regulatory project manager with experience leading cross‑functional project teams for clinical projects and regulatory submissions programs.  This experience includes coordinating and overseeing the strategy, document authorship, and electronic publishing activities associated with submissions to regulatory authorities.  Dr. Neighbours has authored a variety of regulatory documents, including FDA meeting requests and briefing packages, and has contributed as an author to multiple IND and NDA dossiers.  Dr. Neighbours recently participated in an End of Phase 2 meeting with the Division of Bone, Reproductive and Urologic Products.  

Understanding the New FDA Guidance on Data Standards

FREE WEBINAR

Understanding the New FDA Guidance on Data Standards

In December 2014, FDA released the finalized Guidance for Industry “Providing Regulatory Submissions in Electronic Format—Standardized Study Data.” In this webinar, Rob Woolson and Ben Vaughn will review key points in the guidance followed by a discussion of the implications for Sponsors currently conducting studies as well as those who will be starting new studies soon.

Rob Woolson
Chief Strategist, Biostatistics and Data Standards for Regulatory Submissions

Rob Woolson has 13 years’ experience in the analysis of complex data. He has conducted statistical analyses in all phases of drug development (Phase I through IV, NDAs, and BLAs) and has led SDTM/ADaM dataset conversion projects in multiple therapeutic areas. He has held a leadership role in six CDISC-compliant regulatory submissions, having guided the creation of ISS/ISE statistical analysis plans; integrated analysis dataset design and production; integrated display design and production; and submission-related documentation development. He has authored responses to numerous FDA queries and has represented sponsors at FDA in-person meetings.

Ben Vaughn
Senior Statistical Scientist

Ben Vaughn is a senior statistical scientist who has participated in nearly 20 regulatory submissions and is an expert on CDISC implementation and standards. His work has included serving as lead statistician to complete displays and datasets for several ISS/ISEs (as well as the associated pivotal studies); coproducing the ISE for two opioid products; and statistical consultation, display generation and submission work for four separate products for OA knee pain. He has authored responses to various FDA queries regarding NDAs, PMAs, IDEs, and SPAs. Additionally, he has represented sponsors in FDA teleconferences and face-to-face meetings for both OA knee pain products and opioid products.

Cost Effective Data Standards Implementation: How to Integrate CDISC Standards into Your Product Development Strategy

FREE WEBINAR

Cost Effective Data Standards Implementation: How to Integrate CDISC Standards into Your Product Development Strategy

Based on recent guidance from FDA, a data standards plan is now expected at the IND stage of development. Join David Shoemaker, PhD and Jeff Abolafia, MA as they discuss cost effective methods for integrating CDISC data standards into your overall product development plan.

Jeff Abolafia
Chief Strategist, Data Standards

Mr. Abolafia has more than 20 years of experience in clinical research and has successfully led multiple CTD/NDA submissions. He is the co-founder of the Research Triangle Park CDISC Users Group and a member of the CDISC ADaM and ADaM Metadata teams.

David Shoemaker, PhD
Senior Vice President, R&D

Dr. Shoemaker has 25 years of experience in pharmaceutical development and has led the regulatory strategy for programs in many therapeutic areas. He has experience with all types of regulatory submissions and has moderated dozens of FDA meetings.

Understanding FDA’s Priority Review Voucher System

FREE WEBINAR

Understanding FDA’s Priority Review Voucher System

How can one regulatory program simultaneously benefit both blockbuster drugs and rare or neglected diseases?  How can your company leverage the opportunities afforded by this program?  In this complimentary webinar, Rho’s panel of experts will walk you through the how’s and why’s of the FDA’s Priority Review Voucher program. 

Kelly Roney, PhD, RAC
Senior Research Scientist

Dr. Roney has extensive experience in research and pharmaceutical development.  She has served as a senior regulatory program leader for multiple development projects, and has experience from the pre IND through NDA stages of pharmaceutical development.  Dr. Roney has experience in CNS, oncology, pediatrics, obstetrics, pelvic floor disorders, immunology, and infectious disease products.  Her primary areas of expertise include regulatory strategy, medical writing, and clinical development.

Sheila Bello-Irizarry, PhD
Integrated Product Development Associate

Dr. Bello-Irizarry is actively involved in protocol development, orphan-drug designation applications, and regulatory submissions including INDs and NDAs/BLAs. Her therapeutic area experience includes infectious diseases, immunology, vaccines, lung biology, musculoskeletal, and antibody-mediated therapy.  She contributed to developing vaccine candidates against malaria and MRSA infections and to the understanding of inflammatory processes during lung fungal infections. 

Devin Rosenthal, PhD, RAC
Research Scientist

Dr. Rosenthal works with companies at all stages of development to help them shape their product development programs. He has experience across the full drug development spectrum through his roles in small biotech, big pharma, and at Rho, with particular focus on oncology, CNS, gastrointestinal, and respiratory indications. 

See our experience with regulatory submissions

Rho_2016_RegulatorySubmissions_FNL_web.pdf Download File ›

Submissions Capabilities

Submissions Capabilities

Our sponsors' regulatory submissions benefit from professional expertise across our entire company.

Regulatory Operations
Our experienced regulatory team understands that you get one chance at a submission and ensures that all deliverables meet regulatory guidance standards.

Data Standards
Rho is a leader in development and implementation of CDISC standards. Learn about how our professionals deliver results to the highest data standards and how we can enhance your clinical trial program.

Regulatory and Medical Writing
Rho's Medical Writers are experienced in delivering protocols, investigational brochures, clinical study reports, and documents for IND and NDA submissions.

Biostatistics and Statistical Programming
Our statisticians have vast experience with common safety endpoints and can tackle the challenges of integrated analyses (ISS and ISE) for numerous therapeutic areas. We provide documentation of statistical methods and results that will impress even the most skeptical of FDA reviewers.

Project Management
Learn about Rho’s project process and how our project management professionals will see to it that your project is completed as efficiently as possible, whether they be clinical, regulatory, or statistically focused, or interdisciplinary end to end product development programs.