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Webinars

Rho is committed to leading and contributing to the discussion around key industry topics and trends. Our experts have conducted a variety of webinars and are happy to share their considerable knowledge and expertise drawn from years of industry experience. Each of the following free webinars is an hour-long and can be viewed on-demand. See our Events page for information about upcoming live webinars.

Understanding Common Causes of Failure in Depression Studies

FREE WEBINAR

Understanding Common Causes of Failure in Depression Studies

The failure rate of clinical studies in depression is high, and placebo response is often blamed.  In this webinar, Dr. Jack Modell, a board certified psychiatrist with more than 35 years of experience in clinical research and patient care, discusses why there is more to the story than placebo response.  Additionally, Dr. Modell addresses steps that can be taken to avoid these pitfalls.

Jack Modell, MD
Vice President and Senior Medical Officer

Dr. Modell is a board-certified psychiatrist with 35 years’ of experience in clinical research and patient care including 15 years’ experience in clinical drug development in the pharmaceutical industry.  He has led successful development programs in the neurosciences, is a key opinion leader in the neurosciences, has served on numerous advisory boards, and is nationally known for leading the first successful development of preventative pharmacotherapy for the depressive episodes of seasonal affective disorder.

Small Size, Big Plans – Product Development Advice for Small Companies

FREE WEBINAR

Small Size, Big Plans – Product Development Advice for Small Companies

Pursuing big pharma dreams on a small budget?  This webinar will discuss product development strategies for small biotechnology and pharmaceutical companies.

David Shoemaker, PhD
Senior Vice President, R&D

Dr. David Shoemaker has more than 25 years of experience in research and pharmaceutical development.  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.

Lauren Neighbours, PhD, RAC
Research Scientist

Lauren Neighbours is a regulatory program manager with experience leading cross-functional teams for clinical operations and regulatory submissions programs.  Dr. Neighbours partners with early-, mid-, and late-stage companies to develop and refine strategic development plans, design and execute clinical studies, lead regulatory submissions, and provide support for regulatory authority meetings and other consulting needs.  Dr. Neighbours has authored a variety of clinical and regulatory documents, and has contributed as an author to multiple IND/CTA and NDA dossiers.  

Sheila Bello-Irizarry, PhD, RAC
Integrated Product Development Associate

Sheila Bello-Irizarry is actively involved in  protocol development, clinical feasibility, regulatory submissions and authoring including INDs, NDAs/BLAs modules, orphan-drug designation applications, among others. Dr. Bello Irizarry was part of the Global Community Advisory Board for the NIH funded HIV Vaccine Trials Network, AIDS Clinical Trials Group, and the Pediatric HIV Program for 8 years. At the local Community Advisory Board in Rochester, NY, she was part of the Outreach Committee contributing to community education and encouraging minorities to participate in clinical trials.

Putting Patient-Centric Principles into Practice

FREE WEBINAR

Putting Patient-Centric Principles into Practice

While on the verge of becoming a moral mandate for clinical research, the concept of patient-centered research struggles to move beyond a platitude into practical application.  This webinar will explore the rationale for implementing patient-centered practices and offer guidance for initiating patient-centered approaches to research.  Presenters will review practical strategies for engaging patients in the clinical trial process without sacrificing research quality or adding untenable costs to your trials. With more than 20 years of experience successfully implementing patient-centered strategies, our experts share which factors matter to patients and how to design trials that honor their needs and desires. 

Shann Williams, PMP
Senior Director, Operations

Shann Williams is the Operations Director of the Statistical and Clinical Coordinating Center for the Division of Allergy, Immunology, and Transplantation consolidated coordinating center sponsored by the National Institute of Allergy and Infectious Disease (NIAID). She has led a variety of projects, including community-based, observational, interventional, and Phase II-IV clinical trials primarily in immunology, asthma, and transplantation. Shann also serves as Rho's project management Operational Service Leader, an internal expert sharing project management best practices, processes and training.

Ryan Bailey, MA
Senior Clinical Researcher

Ryan Bailey has over 10 years of experience conducting multi-center research projects, managing technical teams, and developing multimedia communications content. He has worked primarily in asthma, allergy, and immunology. He also coordinates Rho’s Center for Applied Data Visualization, which develops novel data visualizations and statistical graphics for use in clinical trials.

Derek Lawrence
Senior Clinical Data Manager

Derek Lawrence has 9 years of data management and analysis experience in the health care/pharmaceutical industry. He is a certified Medidata Rave Study Builder and is responsible for overseeing the development and maintenance of the EDC systems, establishing and executing metadata-driven programmatic solutions to database development/data cleaning, creating and implementing data validation plans, creating SAS programs for deriving analysis datasets, and importing/validating data from external vendors and labs. Derek also serves as Rho's Operational Service Leader in Clinical Data Management, an internal expert responsible for disseminating the application of new technology, best practices, and processes.

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. 

Get Your Development Program Started on the Right Foot

FREE WEBINAR

Get Your Development Program Started on the Right Foot

You think you have a potential pharmaceutical or biotechnology product based on animal or in vitro data—what is the next step?  Two documents you need at an early stage are the Target Product Profile (TPP) which defines expectations for your potential medicine and an Integrated Product Development Plan (IPDP) which describes the activities required through approval of your marketing application.  Why engage in these early stage activities when only 10-20% of products in clinical development make it to the market?  By providing a framework of go/no go decision points that allow you to use accumulating data to assess the likelihood of product success, these documents make it possible to make key development decisions.  This webinar will review the content of both the TPP and the IPDP, demonstrate how they are written, and provide specific examples of decisions that are made as a result of the use of these documents.

David Shoemaker, PhD
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.

Jack Modell, MD
Vice President and Senior Medical Officer

Dr. Modell is a board-certified psychiatrist with 30 years of experience in clinical research, teaching, and patient care including 10 years of experience in clinical drug development (phases 2 through 4), medical affairs, successful NDA filings, medical governance, drug safety, compliance, and management in the pharmaceutical industry.  Dr. Modell has authored over 50 peer-reviewed publications in addiction medicine, anesthesiology, psychiatry, neurology, and nuclear medicine.  Dr. Modell is a key opinion leader in the neurosciences, has served on numerous advisory and editorial boards, and is nationally known for leading the first successful development of preventative pharmacotherapy for the depressive episodes of seasonal affective disorder.

Dana Minnick, PhD
Senior Research 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.  

Scott Burian, PhD
Senior Research Scientist

Scott Burian has more than 15 years of experience in the pharmaceutical industry and has contributed to the development of a diverse range of small molecule, biologic, and nanoparticle-based products.  He has supported the development of lingual spray, solid oral, topical, parenteral, and nasal spray dosage forms.  He has participated in numerous FDA interactions, including pre-IND meetings, Type A meetings, and Advisory Committee meetings. Dr. Burian has also acted as the U.S. Agent for several European-based companies.  He is fully-versed in eCTD format and has authored a variety of CMC submissions, including numerous pre-IND meeting packages, INDs, NDAs, and IMPDs.

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. 

Optimizing Sponsor/CRO Relationships

FREE WEBINAR

Optimizing Sponsor/CRO Relationships

Join us on  Tuesday, May 10 at 1 PM ET for "Optimizing Sponsor/CRO Relationships" featuring Jamie Arnott and Kristen Snipes.  Developing and maintaining strong relationships between the Sponsor and the selected CRO can make or break a clinical study.  In this webinar, two experts with experience managing clinical programs from both a CRO and a Sponsor perspective provide tips and strategies for optimizing these relationships using real world examples.  

Jamie Arnott
Project Director

Jamie Arnott has extensive experience from her clinical nursing background as well as both the CRO and sponsor perspective in the oversight and management of clinical trial operations and outsourcing with 12 years’ experience in project management and 22 years’ experience in healthcare as a practitioner and in clinical research work. Before joining Rho, Jamie was the Director of Clinical Trial Operations for a biotechnology company where she provided oversight and management for all clinical activity for multiple concurrent INDs. 

Kristen Snipes
Project Director

Kristen Snipes has over 18 years of pharmaceutical industry experience primarily as a program manager or clinical operations lead. Before joining Rho, Kristen worked for several small pharmaceutical companies where she collaborated with scientists and thought leaders in the design, development, implementation and management of programs for lead compounds.  She has managed analytical method development, formulation, IND filings (including CMC) and Phase 1-4 clinical trials.  She is also the Clinical Operations Service Lead for Rho, her responsibilities include keeping the company current on industry trends and practices  as well as supporting training and process development. 

Clinical Research Statistics for Non-Statisticians

FREE WEBINAR

Clinical Research Statistics for Non-Statisticians

Through real-world examples, webinar participants learn strategies for choosing appropriate outcome measures, methods for analysis and randomization, and sample sizes as well as tips for collecting the right data to answer your scientific questions.

Jennifer Marcello
Senior Biostatistician

Jennifer Marcello, Senior Biostatistician, has experience in statistical planning, analysis, and reporting for Phase 1, 2 and 3 clinical trials.  Jennifer is trained in writing detailed statistical analysis plans, performing sample size computation, preparing statistical analysis specifications of analysis databases, developing summary displays including summary tables for integrated safety and efficacy data, utilizing SAS® software for programming and analysis of clinical data, and providing ongoing safety evaluations for data monitoring committees.  She also has experience in analyzing quality of life data, nutrition data and other patient reported outcomes.

Protocol Design: What You Need to Know to Ensure a Successful Study

FREE WEBINAR

Protocol Design: What You Need to Know to Ensure a Successful Study

Solid protocol design is critical to clinical development.  No matter how well executed a clinical study is, if the underlying design is flawed, it wasn’t worth doing.  In this webinar, Dr. Shoemaker and Dr. Kesler will walk through the process of developing a protocol, explain the major considerations, and point out common mistakes and challenges.

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.

Karen Kesler, Ph.D.
Assistant Vice President, Operations

Dr. Karen Kesler currently serves as the Primary Investigator of the Statistics and Data Management Center for a NIH sponsored coordinating center researching asthma, allergies, autoimmune disorders, and solid organ transplant. Dr. Kesler is deeply involved in researching more efficient Phase II and III trials and has led many adaptive studies including sample size recalculations, pruning designs, Bayesian dose escalation studies, and adaptive randomizations. She has given numerous professional presentations and has over 25 publications and manuscripts to her credit.

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.

Using ePRO with Smart Devices: A Case Study

FREE WEBINAR

Using ePRO with Smart Devices: A Case Study

Interest in using electronic patient reported outcomes (ePRO) on smart devices is on the rise. Using mobile devices or tablets in clinical trials, especially to record patient outcomes, creates a new set of challenges. Over the past 24 months, Emily Cantrell and Becky Baggett have been working on a large phase 3 pain study that utilizes ePRO on tablet devices. In this webinar, they will share a number of considerations for implementing ePRO on a smart device based on the lessons they’ve learned.

Emily Cantrell
Senior Director, Operations

While Emily has experience in many therapeutic areas, her focus has been in pain management, including successful management of five full-service Phase 2 & 3 post-operative pain trials from study start through NDA. These trials involved distribution and return of Schedule II investigational product and included sites in California, which involved submissions to the Research Advisory Panel of California. As a project advisor, Emily finds creative paths to meet aggressive timelines and help project managers solve problems and keep studies on track.

Becky Baggett
Senior Project Manager

Becky has nine years of clinical trial experience managing Phase 1 – 3b projects. She has gained diverse experience in multiple therapeutic areas including oncology, CNS, ophthalmology, dermatology, gastroenterology, organ transplantation, and allergy. Becky recently completed enrollment for a phase 3 pain study six weeks ahead of schedule.

The TMF Reference Model: It Doesn’t Have to be Scary

FREE WEBINAR

The TMF Reference Model: It Doesn’t Have to be Scary

At first glance, the trial master file (TMF) reference model seems daunting, especially for smaller companies. In this webinar, Kristen Snipes, Project Director and Missy Lavinder, Senior Project Manager share tips and tricks for making the process manageable based on their own recent experience implementing the model. The webinar will cover background on the reference model, and then walk you through the steps of implementation from assessing your current process to determining what parts of the model you will implement to managing the change in your company.

Kristen Snipes
Project Director

Kristen Snipes has 17 years of pharmaceutical industry experience primarily as a program manager or clinical operations lead. Kristen led Rho’s implementation of the TMF reference model.

Missy Lavinder
Senior Project Manager

Missy Lavinder has 15 years of clinical research experience as a research coordinator, in-house CRA, study start-up specialist, clinical operations manager, and project manager. Missy was a key contributor to Rho’s implementation of the TMF reference model.

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.

FREE WEBINAR

Improve the Inclusion & Exclusion Criteria for Your Next Clinical Trial

Adherence to inclusion and exclusion criteria is essential to the successful execution of a clinical trial. Deviations from these criteria must be avoided because they can jeopardize scientific integrity, regulatory acceptability, or the safety of subjects in the study. In this webinar, Dr. Modell will provide suggestions and advice on formulating inclusion and exclusion criteria to enhance the quality of subject selection, minimize protocol violations, and avoid protocol amendments.

Jack Modell, M.D.
Senior Medical Officer

Dr. Modell is a board-certified psychiatrist with 30 years of experience in clinical research, teaching, and patient care including 10 years of experience in clinical drug development (phases 2 through 4), medical affairs, successful NDA filings, medical governance, drug safety, compliance, and management in the pharmaceutical industry.  Dr. Modell has authored over 50 peer-reviewed publications in addiction medicine, anesthesiology, psychiatry, neurology, and nuclear medicine.  Dr. Modell is a key opinion leader in the neurosciences, has served on numerous advisory and editorial boards, and is nationally known for leading the first successful development of preventative pharmacotherapy for the depressive episodes of seasonal affective disorder.

Strategies for Analgesic Development and the New FDA Guidance for Analgesic Indications

FREE WEBINAR

Strategies for Analgesic Development and the New FDA Guidance for Analgesic Indications

CDER recently issued an updated draft guidance for Analgesic Indications. In this webinar, Brett Gordon and Ben Vaughn provide a high-level review of the agency’s guidance, offer strategies for analgesic product development and share experiences with PROs and paper vs. tablet collection.

Ben Vaughn
Senior Statistical Scientist

Ben Vaughn has twelve years of experience in clinical research. He has participated in nearly 20 regulatory submissions, coproduced the ISE for two opioid products; and provided statistical consultation, display generation and submission work for four separate products for OA knee pain. Last spring he attended an FDA advisory committee to represent the sponsor for an opioid product. 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. His analytic experience includes cross-over studies, survival analysis, non-parametrics, and extensive work with linear and non-linear repeated measure models.

Brett Gordon
Project Director

Brett Gordon has more than fifteen years of overall clinical development experience, including eleven years in project management, encompassing trials of varying sizes and complexity, both domestically and internationally. He has extensive knowledge of clinical development including initial development plan formulation, protocol writing, trial implementation, monitoring and delivery, clinical study report writing, and regulatory submission to support of marketing applications. Brett has worked across numerous therapeutic areas and in particular possesses in-depth CNS experience, including four years at an orthobiologics company supporting clinical development activities for ultrasound bone healing and two hyaluronate products for osteoarthritis.

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.

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.  

FREE WEBINAR

Using FDA’s Draft Guidance on Risk-Based Monitoring to Improve Clinical Data Quality

The Industry’s changing approach to clinical data monitoring requires the tools and team structure to effectively plan and execute risk-based monitoring. Join Lynn King and Rob Woolson as they discuss multi-disciplinary approaches to implementing alternative monitoring plans and specialized tools for successfully executing risk-based monitoring.

Rob Woolson JD, MS
Senior Biostatistician

Rob Woolson has 12 years experience in the analysis of complex data. He has conducted statistical analyses in all phases of drug development (Phase I through NDA) and has led SDTM/ADaM dataset conversion projects in multiple therapeutic areas.