With input from a diverse and well-rounded external technical advisory committee (ETAC), this project will help facilitate patient-centered acute pain drug trials and ease the burden of investment in pediatric drug development. Download a PDF of ETAC member biographies.
Robyn Bent
U.S. Food and Drug Administration (FDA)
Specialization: Regulatory
Captain Robyn Bent joined the United States Food and Drug Administration (FDA) in 2019 as the director of CDER’s Patient-Focused Drug Development (PFDD) Initiative, an effort to systematically obtain and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making. The PFDD initiative includes the recently launched CDER Standard Core Clinical Outcomes Assessments and Endpoints Pilot Grant Program, which will provide avenues to advance the use of patient input as an important part of drug development. Prior to joining FDA, Bent was a Chief Scientific Program Specialist at the National Institutes of Health. She has extensive experience in clinical trial design, conduct, and oversight. She earned her Bachelor of Science in Nursing from The Catholic University of America and her Master of Science degree from George Washington University.
Sharon Brown
Parent Advocate
Specialization: Long-term effects of pediatric pain
Sharon Brown is the mother of a child with life-threatening sickle cell beta-thalassemia disease whose significant battles with acute pain crises led to the decision to pursue bone marrow transplantation. Brown has served as an advocate for other parents and patients with sickle cell disease. She sits on the Governor's Appointed NC Council on Sickle Cell Disease and Related Blood Disorders. Her caregiver input is extraordinarily important to helping COA-APTIC develop a core set of clinical outcomes assessments.
Brown is the Department Chair of Business, Computer Technology and Information Systems and Associate Professor of Computer Information Systems at College of The Albemarle, where she has been employed for over 15 years.
Sarah Ciaccia
Parent Advocate
Specialization: Parental perceptions of acute pain
Ernest Kopecky, PhD
Teva Pharmaceutical Industries
Specialization: Industry
Dr. Ernest Kopecky specializes in pediatric and adult acute, persistent, and chronic pain research and has been a PI/Sub-PI on numerous academic and industry-sponsored clinical studies. Currently, he is the Vice President of Clinical Development and Head of Global Pain Medicine at TEVA Pharmaceutical Industries. His responsibilities include developing and maintaining the global pain therapeutic area pipeline, leading adult and pediatric development projects for drugs in Phase I-III clinical development, supporting Phase IV programs for life cycle management, supporting regulatory and medical affairs strategy, and clinical support of Pre-Clinical Development, biologics development, and business development.
He has served on the FDA ACTTION Executive Committee and is currently the TEVA representative for the opioid public-private partnership led by the NIH, a reviewer for NIH SIBR grants, and on faculty at the Pharmaceutical Education Research Institute. His research interests include pediatric pain, sickle cell disease, breakthrough pain, chronic pain, developmental pharmacology, novel analgesic targets, improving assay sensitivity in clinical studies, and pain assessment in children.
Amy Ohmer
International Children’s Advisory Network (iCAN)
Specialization: Patient advocacy and engagement
Amy Ohmer is the director of the International Children's Advisory Network (iCAN Research), a worldwide consortium of children’s advisory groups working in unison around the world to provide a voice for children and families in medicine, research, and innovation. She is the Co-Chair of the T1D Exchange Patient/Parent Advisory Board, the Parent Lead for Michigan Medicine, Pediatric Endocrinology Advisory Board, a member of the American Board of Pediatrics Patient/Parent Advisory Council, a member of the Patient Family Advisory Council of C.S. Mott Children’s Hospital, and an advocate for the American Diabetes Association and Juvenile Diabetes Research Foundation. Ohmer was selected to receive the 2018 Sally Joy Leadership Award by Diabetes Partners in Action (DPAC) and the American Diabetes Association (ADA).
In 2009, Ohmer founded the nationally recognized website, Naturally Sweet Sisters, to offer support to families beginning the journey of living with chronic health needs.
Meghan Pascal
Parent Advocate
Specialization: Parental perceptions of acute pain
Originally from Massachusetts, Meghan Pascal resides in Apex, N.C., with her husband and three children, one of whom has congenital heart disease. A graduate of Johnson & Wales University in Providence, R.I., with a bachelor’s degree in website development, Pascal raises her three children (9, 6 and 2 years) while also holding a part-time sales position at Pottery Barn Kids in Durham, N.C. Pascal and her husband Kurt discovered their youngest daughter’s condition (tricuspid valve atresia with normal great arteries and congenital pulmonary valve stenosis) early on in pregnancy. Their daughter has been a fighter from the beginning, but had a complicated postnatal course and suffered from a left MCA stroke while on ECMO. Their daughter has also undergone heart surgery including a bidirectional Glenn procedure, and receives weekly physical and occupational therapy. Pascal is honored to be part of the COA-APTIC advisory committee.
Frank Rockhold, PhD
Duke University
Specialization: Biostatistics
Dr. Frank Rockhold is a Professor of Biostatistics and Bioinformatics at Duke University Medical Center, Affiliate Professor of Biostatistics at Virginia Commonwealth University, and Managing Partner of HunterRockhold, Inc. His 40+-year career includes senior research positions at Lilly, Merck, and GlaxoSmithKline, where he retired as Chief Safety Officer and Senior Vice President of Global Clinical Safety and Pharmacovigilance. He has held faculty appointments at six different universities. Rockhold served for nine years on the board of directors of the non-profit CDISC, most recently as Chairman, and is past president of the Society for Clinical Trials and a past member of the PCORI Clinical Trials Advisory Panel. He is currently on the board of the Frontier Science and Technology Research Foundation and a technical advisor to EMA.
Rockhold has diverse research interests and consulting experience in industry and academia including clinical trials design, data monitoring, benefit/risk, safety and pharmacovigilance and has been a leader in the scientific community in promoting data disclosure and transparency in clinical research. He is widely published in major scientific journals across a wide variety of research topics.
Bonnie Stevens, PhD
University of Toronto
Specialization: Management of pain in hospitalized preterm newborn infants
Dr. Bonnie Stevens is the Principal Investigator of the Canadian Institutes of Health Research (CIHR) Foundation Grant (2016-2023) that focuses on the development, implementation and evaluation of a web-based seven-step resource for changing health care professional pain practices. She will be conducting a large international trial to determine the effectiveness of this resource in improving child outcomes.
Stevens teaches the Theories of Pain and Implementation Science Courses at the University of Toronto’s School of Nursing. She is also a professor in the university’s Faculty of Medicine and Faculty of Dentistry and the Director of the Centre for the Study of Pain. At the Hospital for Sick Children, she is the Associate Chief of Nursing Research, Co-Director of the Pain Center, and a Senior Scientist in the Research Institute. Stevens held the inaugural Signy Hildur Eaton Chair in Pediatric Nursing Research, the first pediatric nursing research chair based in Canada, until 2015. She was also the first nurse to be awarded the CIHR KT Prize in 2014.
Gary Walco, PhD, ABPP
University of Washington School of Medicine
Specialization: Co-chair of Pediatric Pain Research Consortium within ACTTION
Dr. Gary Walco is a Professor of Anesthesiology in the Department of Pediatrics and Psychiatry at the University of Washington, as well as the Director of Pain Medicine at Seattle Children’s Hospital. He has received the American Pain Society’s (APS) Jeffrey Lawson Award for Advocacy in Children’s Pain Relief, the American Psychological Association’s Lee Salk Distinguished Service Award, and a distinguished service award from the APS. Walco was the president of the special interest group on Pain in Childhood of the International Association for the Study of Pain and was elected president of the APS.
Walco previously consulted with pharmaceutical firms on analgesic trials for children, has been a special government employee serving the U.S. FDA. He is also the founder and first chair of the Pediatric Research Network for Pain (PRN-Pain).
David Warner, MD
Mayo Clinic
Specialization: Pediatric anesthesiology
Dr. David Warner is a pediatric anesthesiologist who has devoted his career to evaluating the effects of anesthesia and surgery on the development of children’s brains. His specific viewpoint on the effects of drugs is invaluable in considering “other factors” deserving of attention in the course of pain management.
Warner leads the Office of Health Disparities Research at Mayo Clinic, which supports meaningful research to identify and address health disparities and to help ensure patients reflect the diversity of our communities. In addition, he works with the Mayo Clinic Center for Clinical and Translational Sciences (CCaTS) to train the next generation of researchers who will make discoveries to improve human health.
Leanne West
International Children’s Advisory Network (iCAN)
Specialization: Patient advocacy and engagement
Leanne West is the Chief Engineer of Pediatric Technologies for the Georgia Institute of Technology and President of the International Children’s Advisory Network (iCAN Research). Her background includes sensing technologies, mobile health applications, and algorithm development. As Chief Engineer, she works closely with Children’s Healthcare of Atlanta to understand and identify problems that need a solution to allow Children’s to take better care of their patients.
West was appointed by the Georgia Speaker of the House as a board member of the Georgia Technology Authority. She has served as the twice-elected Chair of the Georgia Tech Executive Board and the Institutional Chair of the State of Georgia Charitable Campaign. She was recognized by Georgia Trend magazine as one of Georgia’s “40 Under 40” in 2004; she received Georgia Tech’s Outstanding Achievement in Research Enterprise Enhancement Award in 2014, and she was Women in Technology’s Woman of the Year in 2014. She also started her own company, Intelligent Access, to take her invention of a wireless personal captioning system to market.
To connect directly with COA-APTIC, email: DCRI-COA-APTIC@dm.duke.edu.