Featured Experts

Rho's experts are some of the best and brightest in the industry

Let our team of experts be your go-to team for your next clinical trial

Our multifunctional teams work side by side with you throughout the course of your trial. This unique 360º approach eliminates hand-off confusion and empowers you to make more informed decisions. Learn more about some of the experts that could become an extension of your team. Scroll down to see all profiles.

Jack Modell, M.D.

Vice President and Senior Medical Officer

Dr. Modell is a board-certified psychiatrist with over 35 years of experience in clinical research, including 20 years conducting trials, teaching, and providing patient care in academic medicine, and 15 additional years of experience in clinical drug development (proof of concept through market support), medical affairs, successful NDA filings, medical governance, drug safety, compliance, and management within the pharmaceutical and CRO industries. His specialties and expertise include neuroscience, clinical pharmacology, drug development, clinical research, medical governance, teaching, and clinical diagnosis and treatment. Jack has authored over 50 peer-reviewed publications across numerous medical specialties, including addiction medicine, anesthesiology, neurology, nuclear medicine, and psychiatry. He has lead several successful development programs in the neurosciences. Jack is a key opinion leader in the neurosciences, has won numerous awards and honors for patient care and teaching, 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.

Back to top

David Shoemaker, Ph.D.

Senior Vice President, R&D

In the past two years, Dr. Shoemaker has served as an expert reviewer for four successful marketing applications. Dr. Shoemaker has significant experience interacting with the Divisions of Anesthetics, Analgesia, and Addiction Products (DAAARP), Gastroenterology and Inborn Error Products (DGIEP), Bone and Reproductive & Urological Products (DBRUP), Dermatology and Dental Products (DDDP), Anti-infective Products (DAIP), Oncology Products (DOP), Hematology and Oncology Products (DHOP), Cardiovascular and Renal Products (DCRP), Pulmonology, Allergy, and Rheumatology Products (DPARP), and Neural Product (DNP) at the Center for Drug Evaluation and Research, and the Divisions of Cellular & Gene Therapeutics (DCGT), and Hematology Research and Review (DHRR) within the Center for Biologics Evaluation and Research at FDA and has obtained marketing approval for products in the US, Canada and the EU. He works closely with medical, biostatistics, clinical operations, and regulatory authors to ensure Rho’s effort reflects the advantages of his over 20 years marketing application experience. David has over 25 years of experience in research and pharmaceutical development. He has served as a Program Leader or Advisor for multidisciplinary, matrix management program teams and has been involved with products at all stages of the development process. Primarily, he has managed the regulatory strategy for programs in multiple therapeutic areas including the following: hematology, oncology, cardiology, pulmonology, infectious diseases, genetic enzyme deficiencies, antitoxins, and antibioterrorism 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 over two dozen marketing applications including NDAs, BLAs, NDSs, and MAAs. He 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.

Back to top

Karl Whitney, Ph.D.

Assistant Vice President, Product Development

Dr. Whitney has almost 15 years of experience in the pharmaceutical industry, specializing in clinical and regulatory aspects of pharmaceutical development. During this time, he has led multiple integrated drug-development programs spanning the development spectrum by planning, managing, and overseeing concurrent manufacturing, nonclinical, clinical, and regulatory activities. Karl has also led the preparation of or helped prepare Investigational New Drug (IND) applications, clinical and nonclinical final study reports, pre-New Drug Application (NDA) meeting packages, annual reports, Investigator Brochures, Fast-Track and Orphan-Drug applications, NDAs in the electronic Common Technical Document (eCTD) format, and numerous other documents. He has provided strategic advice to clients on a broad array of drug development strategy issues. Karl’s therapeutic areas of expertise include CNS disorders such as pain, Huntington’s Disease, and schizophrenia, as well as hemophilia and tuberculosis. Through his doctoral and postdoctoral research, he has technical expertise in these areas as well as in neuroimmunology, nuclear hormone receptor biology, and various genomics research techniques.

Back to top

Jamie Arnott

Senior 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 more than 10 years’ experience in project management and 20 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 up to four concurrent INDs. She has broad therapeutic experience in oncology, including ovarian cancer, hematological malignancies, and advanced solid tumors; in addition, she has recent experience managing two large phase III studies.

Back to top

Brett Gordon

Senior Director, Operations

Brett Gordon has seventeen years of overall clinical development experience, including thirteen years in project management, encompassing trials of varying sizes and complexity, both domestically and internationally. He has extensive knowledge of clinical development for both drugs/biologics and medical devices, 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 and neurological experience, having managed or monitored trials in epilepsy, ADHD, bipolar disorder, alcohol dependence, spinal cord injury, and pain (acute, chronic, neuropathic, and musculoskeletal).

Back to top

Rob Woolson

Chief Strategist, Biostatistics & Standards for Regulatory Submissions

Rob Woolson is a statistical scientist with 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.

Back to top

Karen Kesler, Ph.D.

Senior Statistical Scientist Adaptive Design Expert

Dr. Kesler earned both a Masters and Doctoral degree in Biostatistics from the University of North Carolina at Chapel Hill and has over 18 years of experience in clinical research. She currently serves as the co-Primary Investigator of the Statistics and Data Management Center for a NIH sponsored coordinating center that supports 27 studies in solid organ transplant. Karen is involved in researching more efficient Phase II and III trials and is an expert in adaptive design. She has written protocols, statistical analysis plans, and performed the analyses for 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 15 publications and manuscripts to her credit.

Back to top

Ben Vaughn

Senior Statistical Scientist Specialist in Statistical Analysis of Pain Studies

Ben Vaughn is a senior statistical scientist who has participated in over 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 several chronic and acute pain products. He has authored responses to various FDA queries regarding NDAs, PMAs, IDEs, and SPAs. Additionally, he has represented sponsors in FDA teleconferences, face-to-face meetings and advisory committee meeting (back room and bullpen).

Back to top

Kevin Barber, Ph.D.

Vice President, Regulatory Strategy & Submissions

Kevin Barber, PhD, VP, Regulatory Strategy & Submissions has more than 20 years of experience in regulatory affairs and product development, working for both sponsor companies and CROs, across all stages of development from pre-clinical through product launch and post-approval life cycle management. He has lead the preparation and execution of integrated regulatory strategy and clinical development plans for drug, biologic, and medical device products in therapeutic areas including dermatology, nephrology, urology, women’s health, neurology, cardiovascular diseases, virology, oncology, immunology, infectious diseases, blood products, and gene therapy. Dr. Barber has significant experience preparing and filing regulatory submissions, including more than 40 US INDs and more than 35 marketing applications in the US, Canada, Europe, Latin America, Australia, and New Zealand.

Back to top

Matt Healy

Vice President, Clinical Operations

Matt Healy has over 23 years of clinical research experience, spanning both academia and the CRO industry.  For the last 14 years, Matt has been focused on supporting the development and management of clinical operations across a variety of global clinical programs.  He has extensive experience in the implementation of processes and procedures used by the clinical operations teams to successfully manage clinical studies across all stages of development from Phase I through Phase IV.  Matt has broad therapeutic experience which includes Alzheimer’s disease, vascular dementia, migraine, geriatric schizophrenia, traumatic brain injury, late-life depression, acute and chronic pain, dermatology, acute myeloid leukemia, NSCLC (immunotherapy) and synovial sarcoma (immunotherapy). 

Back to top