Clinical Trial Program Series – MEDICAL PRODUCT DEVELOPMENT 101

Overview

This program is a series of 3 panel discussions with industry and government partners, focused on providing high-level insight into the clinical trial process. Each event will have its own specific focus while contributing to a sequential flow for the series. Experts from varying backgrounds have been selected for each discussion to help provide a more robust and complete overview of key considerations and event topics for each discussion.
Goal

This program aims to provide early-stage startups, stakeholders, and others, with expert insight and knowledge into the clinical trial process. From attending these discussions, attendees should have a better understanding of clinical trials, the necessary steps needed to develop a plan that will lead to successful study outcomes, insight into key considerations for the process, and a better understanding of what partners to engage with, and when.
Agenda

12:00pm – 12:30pm: Opening Remarks

12:05pm – 12:10pm: Panelist Introductions

12:10pm – 1:10pm: Panel Discussion

1:10pm – 1:25pm: Q&A

1:25pm – 1:30pm: Closing Remarks
Topics

Clinical Trial Basics – Understanding your product, Designing Your Study, Regulatory Requirements and EC/IRB and Informed Consent
Site selection
Medical Device vs. Therapeutic
Developing an MVP and manufacturing a product for studies
The importance of strategy and planning

Panelists

Barry Sands – President & Founder, RQMIS, Inc.

RQMIS President and Founder, Barry E. Sands, is a Biomedical Engineer (with a chemical engineering specialization) by trade with a passion for helping medical companies get their products to market. Barry has seven years’ experience as a Biomedical Engineer and Sr. Scientific Reviewer at FDA/CDRH/ODE and FDA’s Boston District. This government experience was followed with seventeen years in midlevel and executive management positions in small start-up and large multinational medical device companies. Market responsibilities included United States (including Puerto Rico), European Union, South America, Middle East, Canada, Japan and South Korea.

He has provided companies with regulatory and clinical strategic advice on bringing novel technologies for both the pediatric and adult populations specially to the United States and EU markets. The devices involved have included wearable devices, human tissue, combination products, electromechanical, PPE, ultrasonic imaging and PACS products. He has worked on various innovative medical devices including writing an FDA Presubmission for an electromechanical medical device with software that was used to diagnose radiation exposure. Barry was the primary author of the IDE for an electromechanical device with software that used irreversible electroporation used to treat Stage III Pancreatic Cancer.

Barry has managed data management services designed to make the process of designing, collecting, reconciling and reviewing clinical research data more efficient and reliable. He has extensive knowledge of clinical data and biostatistics, thus leading groups to make the use of EDC technology and the surrounding processes work to ensure the integrity of each data set. By minimizing the risks associated with EDC and clinical data management, clean and accurate clinical research data is captured while meeting aggressive key project deadlines. Being for the sponsors, less training time for each project and more time performing efficient tests. Within this point, the role played by Barry is key to the successful planning and execution of a development program.

He has worked with different companies throughout his career path to accompany new projects developments, in conjunction with the steps for having the facilities aligned to the worldwide regulations, especially in QMS, Manufacturing Operations & SupplyManagement. During these projects, Barry is deeply involved in all the manufacturing activities, managing and training people under the latest regulations. His QMS/Manufacturing experience has included the establishment of clean rooms for the packaging of sterile implants. Products manufactured in the QMS that Barry has designed/managed have included a wide range of complexity from soft bracing products to sterile active implantable products.

Barry is currently serving as the Executive Regulatory Manager for a client that is working on developing an electronically-determined test for stroke that employs both AI and Machine Learning algorithms. In this role he guides all regulatory and quality decisions in related to product development. RQMIS is also currently developing a regulatory strategy and Presubmission to the FDA for a company developing a wearable patch that will detect biomarkers in a patient’s sweat using AI and machine learning technology. Similarly, our team is working on generating a regulatory strategy for certification and testing standards required for masks for the FDA, European NB and MHRA.

He is the CAPCaT reviewer responsible for reviewing/grading medical device grant applications to support development, deployment, and testing of promising “late-stage” point of care technologies that can be rapidly deployed to enhance the diagnosis, monitoring, management, and/or treatment of heart, lung, blood or sleep disorders (NHLBI), with an additional interest in projects that incorporate complementary and integrative health approaches (NCCIH).

Barry has managed FDA inspections in R&D facilities (including clinical study files) and manufacturing facilities located in the United States, Germany and Japan. These inspections have included Level 1 (Abbreviated), Level 2 (Comprehensive), Level 3 (Compliance Follow‐up), For Cause, Sterilization processes, MDR/MedWatch, Corrections and Removals Practices, and Biomonitoring/Good Clinical Practices. Barry has designed/implemented corrective actions to resolve 483s, Warning Letters, and import detentions.

Ann Han – Clinical Research Navigator, University of Massachusetts Medical School

Ann Han is the Clinical Research Navigator at UMass Medical where she works to connect researchers to resources to improve the efficiency and quality of clinical research. She facilitates clinical trial site selection activities and assists with clinical trial feasibility and recruitment and retention. She is a UMass CCTS Point of Contact for the Trial Innovation Network and a member of the CCTS and COVID research protocol review committees. She received her Master of Science in Health Services Research from Boston University and has over 15 years’ experience in clinical research.

Melinda Hamer – Director of the Clinical Trials Center, Walter Reed Army Institute of Research

Melinda Morton Hamer MD, MPH was the Director of the Clinical Trials Center at the Walter Reed Army Institute of Research from 2017-2021, and is currently detailed to the Department of Health and Human Services, Biomedical Advanced Research and Development Authority as a Senior Medical Advisor. She has served as a principal and associate investigator for more than 20 FDA regulated and other clinical trials, to include multiple first-in-human vaccine trials, and the largest in history controlled human malaria challenge trial, and managed an annual budget of more than $10 million. She was principal investigator of the recently completed first-in-human trial of a novel Marburg virus vaccine, in collaboration with the NIH’s Vaccine Research Center, and served as an investigator on multiple COVID-19 related clinical trials. She is a U.S. Army flight surgeon and board-certified emergency physician, and an Associate Professor in the Department of Military and Emergency

Medicine at the Uniformed Services University of the Health Sciences in Bethesda, Maryland. She also holds a part-time appointment as an Assistant Professor in the Department of Emergency Medicine at the George Washington University Department of Emergency Medicine. Dr. Hamer is also the co-author of official U.S. Government and Institute of Medicine reports on health care reconstruction efforts in Iraq, and has over 40 peer-reviewed publications as well as dozens of national abstract presentations and other reports.

Meg Johnson – Senior Manager of Clinical Research Compliance, University of Massachusetts Medical School

Meg Johnson has overseen the Office of Clinical Research for UMass Medical for the past 8 years. Prior to UMass Medical she worked in IRB Operations and Research for Harvard Medical School and Ohio State University. Meg received her BS in Health Policy and Administration from Penn State and her JD in Law from Ohio State University.

Gustavo Cipolla – Associate Director of Preclinical at Ethicon, Johnson & Johnson

Interventionalist & Scientist D.V.M. with extensive experience and expertise in the areas of preclinical research, operation of preclinical research labs, IACUC, physician training, FDA submissions and GLP compliance. Excellent track record in developing and implementing target specific preclinical research studies. Proven adaptation to different working environments (academic institutions, start ups, established corporations and contract research organizations)

Specialties: Operations, Execution, Compliance, IACUC, GLP

Moderator: Eric Claude – Vice President of Product Development, MPR Associates, Inc.

Eric Claude is the Vice President of MPR’s Health and Life Science practice. Mr. Claude has a background in engineering and a broad systems perspective in product design. With more than 25 years in the medtech industry, Mr. Claude’s leadership and experience helps teams navigate the complex challenges in developing and commercializing breakthrough products. He has a passion for developing high performance multi-disciplinary teams and a focus on optimizing the new product development process to best manage risk and minimize time to market. MPR’s clients, including companies large and small, rely on Mr. Claude to be a valued senior advisor and executive sponsor for critical projects.