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New Horizon /  (Page 2)

Theresa Shalaby is Senior Regulatory Services Manager and Plain Language Summary Functional lead at Certara. Theresa has 30 years of experience in the clinical research and drug development industry and has extensive clinical writing experience. She has an MSN and Clinical Research Management from Vanderbilt University. She has expertise in the therapeutic areas of pediatrics, neonatology, pediatric cancer, hematology, gastroenterology, pulmonary and respiratory diseases, genetic diseases, cardiology, vascular diseases, critical care, and rare diseases. Theresa has also written Informed Consent Forms (ICFs) in the therapeutic areas of pediatric gastroenterology, cancer, hematology, and pulmonary and respiratory diseases, and has experience in presenting ICFs and educational materials to patients and families....

Gregory Reaman is the Associate Director for Pediatric Oncology in the FDA’s Oncology Center of Excellence, Office of the Commissioner and Associate Director for Pediatrics in the Office of Oncologic Diseases, CDER. He is the Executive Director emeritus of the Center for Cancer and Blood Disorders and senior attending physician at Children's National, Washington, D.C.. He has held numerous academic and clinical research leadership positions. He was the Inaugural Chair of the Children’s Oncology Group and previously served as the Associate Chair for New Agent Studies and Vice Chair for Scientific Affairs of the Children’s Cancer Group. He served on the national Board of Directors of the American Cancer Society and chaired its Task Force on Cancer in Children and...

Amy Ohmer specializes in creating collaboration through patient-centered programs by focusing on the needs of patients/families as partners within research and medical communities. Amy’s efforts include engaging the unique population of children living with chronic, rare, and complicated medical conditions through community building for adolescents, providers, clinicians, and caregivers. She is an active advocate for clinical research leading to better outcomes through co-design within the T1D Exchange as Co-Chair of the Patient/Family Advisory Board, C.S. Mott Children's Hospital Patient/Family Advisory Council (PFAC) at Michigan Medicine, and as a patient advocate for the American Diabetes Association Call to Congress/ Camp Midicha and JDRF Teen Central. In 2019, Amy was the recipient of the Sally Joy Award from the State of Michigan Diabetes...

Robert “Skip” Nelson, M.D., Ph.D. is Senior Director, Pediatric Drug Development in the Child Health Innovation Leadership Department at Johnson & Johnson and serves as the Strategy Lead for the Pediatric Development Team in the Janssen Immunology Therapeutic Area. Previously (2006-2017), Dr. Nelson was the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics at the U.S. Food and Drug Administration....

Lily Mulugeta is an Associate Director for Policy and Research in the Division of Pediatrics at the FDA.  She engages in scientific and regulatory review and research related to pediatric drug development.  Dr. Mulugeta serves as a representative for the Division on the FDA Pediatric Review Committee (PeRC).  Prior to joining the Division in 2017, Lily was the Scientific Lead for Pediatrics in the Division of Pharmacometrics at the FDA.  Prior to joining the FDA, Dr. Mulugeta practiced as a Critical Care Specialist at Children’s National Medical Center in Washington D.C.   She also served as a faculty member in the Department of Pediatrics at the George Washington School of Medicine and in the Department of Pharmacy at the University of...

Dr. Mangum is a leader in pediatric clinical pharmacology and drug development. He has been instrumental in developing multiple compounds for the care of children worldwide. His expertise is in neonatal pharmacology where he has excelled in understanding the pharmacology and pathophysiology of disease in the most vulnerable patients, the neonate. He also has served as an academic with appointments in the Schools of Medicine at Duke University and University of North Carolina-Chapel Hill as Associate Clinical Professor, Clinical Pharmacology and Associate Clinical Professor, Pediatrics.  He is a graduate of The Medical University of South Carolina where he received his Doctorate in Pharmacy with special thesis emphasis on neonatal/pediatric pharmacology.  Currently, Dr. Mangum is a co-founders and CEO of a...

Jing Liu, PhD, is a Sr. Director of Clinical Pharmacology at Pfizer with more than 20 years of experience in innovative model-informed drug discovery and development. Dr. Liu is currently the Chair of the IQ Clinical Pharmacology Pediatric Workgroup focusing on initiatives for more efficient pediatric drug development....

Lynne Georgopoulos, RN, MSHS, RAC, is Vice President, Regulatory Strategy, Integrated Drug Development, and Lead of the Pediatric Integrated Practice Area, at Certara. Lynne has over 30 years of diverse biopharmaceutical and CRO industry experience developing and providing strategic guidance and clinical development and regulatory advice at all stages of product development. Lynne has lead numerous successful regulatory filings and agency interactions in the US and Europe with extensive experience in developing and negotiating innovative strategies to accelerate pediatric drug development across multiple therapeutic areas including rare/orphan diseases. Additionally, Lynne has extensive experience in clinical operations and has coordinated large multinational adult and pediatric trials. Previously, Lynne was VP of Regulatory Affairs and Pediatric Strategic Development at Synteract, and Sr. VP Regulatory Affairs and Clinical Development at KinderPharm.  Lynne received a nursing degree from...

Dr Nathalie GASPAR, MD, Ph, is a paediatric oncologist at Gustave Roussy Cancer Campus (Villejuif, France), head of the adolescent and young adult (AYA) unit and chair of the AYA programme of the institute (SPIAJA programme), since 2009. She is in charge of bone sarcomas, cancers with peak incidence in the AYA population, from biology to clinical care. Dr Gaspar is also paediatric head of the French bone adult and paediatric sarcoma group, GROUPOS. She is actively involved in early new drug development in France and in Europe, through her participation to the Innovative Therapeutics for Child and adolescent with Cancer (ITCC) consortium and through her action as co-chair of the Fostering Age Inclusive Research (FAIR) trial initiative of the...

Elin Haf Davies has 20+ years paediatric drug development experience across clinical, academic and regulatory. Her PhD focused on developing biomarkers and outcome measures of ataxia in children with neuro Lysosomal Storage Disorders. She was also part of the core team at the European Medicine Agency (EMA) responsible for implementing the Paediatric Regulation (EC) No1901/2006 in Europe. Since leaving the EMA, Elin Haf has focused her efforts on supporting innovative study designs, including founding a digital health company to support decentralised clinical trials and digital biomarkers; Aparito....