Network Leader Biographies

 Megan Moynahan (Megan.Moynahan@fda.hhs.gov) is the Network Leader for the Cardiac Electrophysiology and Monitoring Devices Network. Megan is responsible for ensuring coordination of the Center’s premarket, postmarket, enforcement, science, and communication activities for pacemakers, defibrillators, cardiac ablation systems, and cardiac monitoring systems. Prior to becoming a Network Leader in 2008, Ms. Moynahan was Chief of the Pacing Defibrillators and Leads Branch in the Center’s Office of Device Evaluation from 2001-2007. She was a scientific reviewer in the Division of Cardiovascular Devices from 1996-2001. She is a biomedical engineer by training. In recent years she has been a regular speaker at the Heart Rhythm Society annual meeting, and has served as an FDA representative to both the American Heart Association Emergency Cardiovascular Care committee and the NCDR National ICD Registry.

 Dr. Francis Kalush (Francis.Kalush@fda.hhs.gov) is the Network Leader for the Diagnostics (In vivo and In Vitro) and Personalized Medicine Network. Dr. Kalush plans and manages the activities for the Network, encompassing premarket, postmarket, compliance, science and communications in order to enhance total product life safety. Before moving into this new position, Dr Kalush coordinated submission of new drugs and the in vitro diagnostic devices that are intended to guide use of those drugs in the Office of In Vitro Diagnostics, CDRH. She also prepared recommendations for mitigation of product submissions developed in accordance to the new Pharmacogenomics Guidances and FDA Critical Path Initiative.

Prior to joining the FDA, Dr Francis Kalush was the Director of Pharmacogenomics for the Celera On line Business. She directed the development of all Celera SNP databases, online support for Applera Genome Initiative and future products development in the field of pharmacogenomics/toxicogenomics and genetics for both academic and commercial markets. As the Director for Integrated Science Strategy Development, she was responsible for strategy development for systems biology and integrated science across platforms and application areas. In the Medical Affairs department of Celera, she has worked on diagnostic and prognostic discovery programs to find polymorphisms & biomarkers associated with diseases such as breast cancer.

During her graduate studies in the Department of Chemical Immunology at the Weizmann Institute of Science, Dr. Kalush directed the research of the profile and role of cytokines in the development of experimental Systemic Lupus Erythematosus in mice, and assessed the role of estrogens in the disease through long term treatment with Tamoxifen.

 Nada Hanafi (Nada.Hanafi@fda.hhs.gov) is the Network Leader for the Plastic and Reconstructive Surgery, Breast Implants Network and Acting Network Leader for General Surgery. Nada began her career with CDRH in 2004. Prior to becoming a Network Leader, she served as Lead Scientific Reviewer and Breast Implant Team Leader (2007-2008) in ODE’s Division of General, Restorative, and Neurological Devices (DGRND), in the Plastic and Reconstructive Surgery Devices Branch (PRSB), where she was the lead for a variety of complex and controversial devices, including the first of a kind more-cohesive silicone gel-filled breast implant PMA, and first of a kind drug eluting neurovascular stent IDE. Nada has an MSc in Biomaterials and a BEng in Biomedical Materials Science & Engineering from Queen Mary College, University of London. Nada is currently pursing a MPH at Johns Hopkins Bloomberg School of Public Health.

 Dr. James Saviola (James.Saviola@fda.hhs.gov) is the Network Leader for the Ophthalmics and ENT Network. Dr. Saviola, a Doctor of Optometry, has been with CDRH for over 20 years. He began his Food and Drug Administration career in 1986 as a clinical reviewer in the Division of Ophthalmic Devices. He served in that division as a branch chief from 1991 until his selection as the Ophthalmic and Ear, Nose and Throat Network Leader. As a branch chief, Dr. Saviola was responsible for pre-market review of contact lenses, lens care products and retinal devices such as tamponade retinal implant devices. He also served for a year concurrently as the acting ENT branch chief from 2000 to 2001. Dr. Saviola is a Captain in the U.S. Public Health Service and also serves as a clinical consult at the National Naval Medical Center, Bethesda, MD. He has published numerous articles and presented talks at both national and international ophthalmic meetings on the topic of contact lens regulation and the FDA.

 Lawrence “Jake” Romanell (Lawrence.Romanell@fda.hhs.gov) is the Network Leader for the Regulatory Affairs and Special Interests Network. Mr. Romanell is responsible for coordinating the Center’s responses to regulatory issues, which affect all types of medical devices. Prior to becoming a Network Leader, Mr. Romanell was a member of the Program Operations 510(k) Staff where he served as the 513(g) coordinator and the RFD (Requests for Designation) coordinator for CDRH. He is a CDRH Staff College instructor for New Scientific Reviewers. Mr. Romanell began his FDA career as a microbiologist and performed scientific reviews for the Division of Ophthalmic and Ear, Nose and Throat Devices, ODE. Prior to his employment with the agency, Mr. Romanell served 14 years as the assistant supervisor of the clinical microbiology laboratory at D.C. General Hospital in Washington D.C.

 Simon Choi (Simon.Choi@fda.hhs.gov) is the Network Leader for Radiological Products and Acting Network Leader for Neurology. As network leader, Simon’s duties include coordination of issues related to radiological products. Simon has been with CDRH since 2003. Prior to becoming a Network Leader, he served as the Deputy Director for Staff College. Before joining the agency, Simon was Director of the Master of Public Health Program at the University of Kansas Medical Center. His academic background includes imaging science and public health. Simon has a MPH and PhD in public health. His research interests include childhood obesity, Geographic Information Systems, and health communication.

 Daniel S. McGunagle (Daniel.McGunagle@fda.hhs.gov) is the Network Leader for the Orthopedics Network. Dan has been with CDRH for the last 27 years and in civil service since 1980. Previously, Dan served as an MDR Analyst in OSB’s Division of Product Surveillance (DPS), Product Evaluation Branch (PEB). He also worked in the OSB/DPS Postmarket Surveillance Studies Branch, and ODE’s Division of General, Restorative and Neurological Devices, Orthopedics Branch. Dan has a BS in Biochemistry and an MBA in Finance.

 Pamela Scott (Pamela.Scott@fda.hhs.gov) is the Network Leader for the Gastroenterology, Urology, and Renal Network and the Acting Network Leader for Anesthesia and Respiratory. As a Network Leader she coordinates and manages issues within the Network, including collaboration between premarket, postmarket, compliance, and scientific activities.

Pamela began her career with CDRH in 1990. Prior to the Network Leader position, Pamela worked in the Office of Device Evaluation (ODE) as a Scientific Reviewer and in the Office of Compliance (OC) as a Consumer Safety Officer. While in ODE, Pamela served as the Executive Secretary of the Dental Products Panel and developed expertise in bone void filler devices, dental implants, temporomandibular joint implants, resorbable bone plates and screws, and dental restorative materials. As a CSO in the Office of Compliance, Pamela developed expertise in the Quality System regulation, good manufacturing practices (GMPs), and regulatory and legal actions.

Pamela has a Bachelor's of Science from Brown University and a Master's of Science from Catholic University in Biomedical Engineering. Pamela has represented the Agency at both national and international standards meetings and has co-authored a paper on clinical trials for endosseous dental implants.

 Ann Ferriter (Ann.Ferriter@fda.hhs.gov) is the Network Leader for the Cardiothoracic and Peripheral Vascular Devices (CPVD) Network and the Acting Network Leader for Physical Medicine and OB/Gyn. Ann began her career with CDRH in 2003. Prior to the Network leader position, Ann was a reviewer in the Restorative Devices Branch (ODE/DGRND), Acting Branch Chief for Circulatory Support Branch (ODE/DCD), a reviewer in the Orthopedic Spinal Devices Branch (ODE/DGRND) and Issue Manager (OSB/IMS). She leads the Center’s Radiofrequency Identification (RFID) Working Group. Ann received her B.S. in Engineering from the Massachusetts Institute of Technology in 1987. She has previously worked as an engineer in machine design and robotics for Carco Electronics, Genus, and Foster-Miller.

 Melissa Eakle (Melissa.Eakle@fda.hhs.gov) is the Network Leader for the Infection Control, Dental, Gen Hosp and Infusion Pump Network. In 2003, Melissa joined CDRH as a Nurse Consultant for the Office of Surveillance and Biometrics (OSB), CDRH. Her position responsibilities included postmarket surveillance of adverse events involving FDA approved general hospital devices, such as infusion pumps and accessories, needles, and syringes. Melissa obtained a BSN and MSN from The University of Maryland School of Nursing and is certified as an Adult Nurse Practitioner. She also has a BA from the College of Notre Dame and MBA from the University of Baltimore. Melissa has received several FDA awards, including a special FDA recognition award for her work with large volume infusion pumps. She has previously co-authored articles on luer misconnections and power injectors as well as presented at conferences at the local and national level on post market medical device adverse events.

 Abiy Desta (Abiy.Desta@fda.hhs.gov) is the Network Leader for the Science Network. Abiy began his career with CDRH in 2001 as a Biologist in OSEL’s Division of Biology (DB). Abiy has co-authored several publications such as An Exposure System for Evaluating Possible Effects of RFID on Various Formulations of Drug Products (H. Bassen, S. Seidman, J. Rougal, A. Desta S. Wolfgang; IEEE International Conference on RFID (2007) 191 – 198); Non-Thermal Exposure to Radio Frequency Energy from Digital Wireless Phones Does Not Affect Ornithine Decarboxylase Activity in L929 Cells (Desta AB, Owen RD, Cress LW; Radiation Research (2003) 488 - 491); Ornithine Decarboxylase Activity in Tissues From Rats Exposed to 60 Hz Magnetic Fields, Including Harmonics and Transient Field Characteristics ( L. J. McDonald, J.R. Gauger, D.L. McCormick, L.I. Loberg, R.E. Savage, Jr., H. Zhu, W.G. Lotz, R. Mandeville, R.D. Owen, L.W. Cress, and A.B. Desta; Toxicol. Methods.,2003 (13 ), 31-38); Ornithine decarboxylase activity in developing chick embryos after exposure to 60-hertz magnetic fields (Desta AB, Owen RD, Cress LW; Biochem Biophys Res Commun. 1999 Nov;265(1):211-3)