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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.

Development Advice for Gene Therapy Products

FREE WEBINAR

Development Advice for Gene Therapy Products

It has been and big year for gene therapy.  In the past 12 months, three gene therapy products received approval from FDA, and in July 2018, FDA Commissioner Scott Gottlieb released a statement on the FDA’s efforts and commitment to advance gene therapy.  The statement included the announcement of six new or revised guidance documents related to the development of gene therapy products.  This webinar will review Commissioner Gottlieb’s statement, provide an overview of the six guidance documents, and discuss the implications for development of new gene therapy products from the perspective of regulatory strategy, clinical development, pharmacology/toxicology considerations, and CMC development.

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

Dr. David Shoemaker has more than 25 years of experience in research and pharmaceutical development.  Dr. Shoemaker has managed the regulatory strategy for programs involving multiple therapeutic areas, including hematology, oncology, cardiology, pulmonology, infectious diseases, genetic enzyme deficiencies, antitoxins, and anti-bioterrorism agents.  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.

Dana Minnick, Ph.D.
Senior Research Scientist

Dana Minnick, PhD, DABT, RAC, is a board certified toxicologist and general regulatory affairs professional with 20 years’ experience leading and supporting drug and biologics programs throughout the development lifecycle.  Dr. Minnick has extensive experience in leading multi-disciplinary drug development teams to successful regulatory filings.  She has led and contributed to many marketing authorization applications.  Dr. Minnick has extensive experience interacting with regulatory authorities and has moderated and participated in dozens of FDA meetings.  Additionally, she has designed and led nonclinical development programs for many successful drug development programs.

Scott Burian, Ph.D.
Senior Research Scientist

Scott Burian, Senior Regulatory Scientist, is a broadly-experienced regulatory affairs professional specializing in pharmaceutical development, regulatory strategy, and chemistry, manufacturing, and controls (CMC).  Dr. 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 gene therapy products. 

The Evolving Role of Clinical Data Management

FREE WEBINAR

The Evolving Role of Clinical Data Management

Technology and data sources are rapidly changing, and clinical data management has to change too in order to keep pace.  This webinar will examine the effect of technology advancements on the future responsibilities of clinical data managers and discusses the needs introduced by the application of new technologies and broader data source availability.

Derek Lawrence
Operational Service Leader, Clinical Data Management

Derek Lawrence is a Senior Clinical Data Manager and is responsible for overseeing the development and maintenance of EDC systems, establishing and executing programmatic solutions to database development and data cleaning, writing programs for analysis data sets, and validating data from external vendors. At Rho, he serves as Operational Service Leader in Clinical Data Management, an internal expert responsible for disseminating the application of new technology, best practices, and processes.

Understanding New Drug Applications (NDAs)

FREE WEBINAR

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.

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. Dr. Shoemaker has managed the regulatory strategy for programs involving multiple therapeutic areas.  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 and moderated dozens of regulatory authority meetings. 

Meagan Spychala, Dr.P.H.
Assistant Vice President, Operations

Meagan Spychala  currently serves as the co-PI for the Medical Countermeasures Clinical Studies Network (MCM-CSN), a federal contract that provides support for clinical studies relevant to the Biomedical Advanced Research and Development Authority’s (BARDA) vision to create a nation with the capability to respond quickly and effectively to deliberate, natural and emerging threats by providing a range of clinical study services.  Her experience includes consulting with protocol development and submission strategies, serving as a voting member of Data Safety Monitoring Boards (DSMBs), writing statistical analysis plans, and performing planned and exploratory statistical analyses. 

Handling Suspected Fraud and Data Fabrication in Clinical Studies

FREE WEBINAR

Handling Suspected Fraud and Data Fabrication in Clinical Studies

Fraud and fabrication is no laughing matter in the realm of clinical trials. It can be a tall task to take on, it is important that everyone involved in a clinical trial understands their role in detecting and preventing fraud and fabrication. This webinar will outline the ways in which sponsors and CROs can remain diligent by being aware of signs of possible fraud and fabricated data throughout the course of the study.

Lysa Triantafillou
Director, Quality Assurance

Lysa has more than 20 years’ experience in clinical research including 15 years’ experience in regulatory compliance and quality assurance.  As Director of Quality Assurance, Lysa ensures compliance with Rho quality standards, GCP, and regulatory requirements, and is currently involved in Rho’s implementation of ICH E6 R2 and a refresh of Rho’s CAPA program. In her previous roles, she has served as a director of regulatory and quality management systems, led a top independent IRB through the AAHRPP re- accreditation process, and acted as the head of the Human Research Protection Program.

Not Just Tiny Humans: Conducting Pediatric Clinical Trials

FREE WEBINAR

Not Just Tiny Humans: Conducting Pediatric Clinical Trials

From study design to logistics to recruitment, there are key differences between studies in pediatric populations and studies in adult populations. This webinar examines what it takes to successfully conduct a pediatric clinical trial.

Jamie Arnott, BSN, RN
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 14 years’ experience in project management and 25 years’ experience in healthcare as a practitioner and in clinical research work. Jamie has extensive experience in pediatric studies including studies in rare diseases.

Caitlin Hirschman, BSN, RN
Clinical Team Lead

Caitlin has 17 years clinical research experience across Phase 1-4 studies in a variety of therapeutic areas.  Prior to beginning her clinical research career, she practiced as a Registered Nurse in the Medical Intensive Care Unit where she built a strong base of knowledge in a large number of medical therapeutic areas including pulmonology, gastroenterology, immunology, hematology, and infectious diseases.  Caitlin has extensive experience in pediatric studies including studies in rare diseases.

Bench to Clinic: Preparing for a Successful Transition

FREE WEBINAR

Bench to Clinic: Preparing for a Successful Transition

Getting a new product from the bench into the clinic is a complex endeavor.  This webinar will provide an overview of the clinical, nonclinical, CMC, and regulatory activities necessary for a successful IND submission.

Dana Minnick, PhD, DABT, RAC
Senior Research Scientist

Dana Minnick, PhD, DABT, RAC, is a toxicologist and regulatory affairs professional with over19 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 filings.  She is skilled at regulatory strategy having led many small companies through effective FDA meetings. 

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.

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.

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.

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.