Diane Alexander, Associate Director for Regulatory Policy, CBER, FDA (invited)
Ms. Alexander serves as the Associate Director for Regulatory Policy with the Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, where she is responsible for policy development and review. She began her service with FDA in 1995 and worked as a compliance officer for 10 years, and then six years as a Branch Chief where she was responsible for the review and evaluation of administrative and legal actions for biological drugs and devices regulated by CBER. Prior to joining the FDA, Ms. Alexander was employed as a medical technologist in the Washington Hospital Center’s blood bank.
Diane Amador Toro, District Director, ORA, FDA, Parsippany District
Ms. Amador-Toro currently serves as the New Jersey District Director in the FDA’s Office of Regulatory Affairs. As the district director, she provides executive leadership in directing and managing all FDA programs within the state of New Jersey and has operational and administrative responsibility for a professional and technical field staff. Prior to assuming her current position in November 2008, Ms. Amador-Toro served six years as the Director of Investigations, providing leadership in directing and managing the district’s inspectional activities in New Jersey. She also served four years as the Science Branch Director in the San Juan, Puerto Rico District Office.
John Avellanet, Managing Director, Principal Consultant, Cerulean Associates
John Avellanet is the author of Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine (2010, Logos Press) and founder of the FDA compliance consulting firm, Cerulean Associates LLC. Prior to founding Cerulean, Mr. Avellanet was a Fortune 500 combination device C-level executive who created, developed and ran his company’s compliance programs to achieve ISO, FDA, DEA and HIPAA compliance. During his career, he had to defend decisions to inspectors, auditors and litigators alike. He now brings that real-world experience and practical advice to his consulting clients, his articles and his speeches.
Leslie Ball, M.D., Assistant Commissioner for International Programs, Deputy Director, Office of International Programs, Office of Global Regulatory Operations and Policy, ORA, FDA (invited)
Dr. Ball is the Assistant Commissioner for International Programs and Deputy Director of the Office of International Programs and Office of Global Regulatory Operations and Policy in the Office of Regulatoy Affairs. Prior to these positions Dr. Ball has served as Director, Division of Scientific Investigations (DSI), Office of Compliance, and CDER. While in DSI, she was active in developing a risk model for selecting clinical trial sites for inspection, collaborating with the EMA and other international regulatory authorities, developing approaches to inspecting electronic data and instituting process improvements for enforcement actions. Previously, she served as branch chief of the DSI’s Good Clinical Practice Branch II, beginning in 2003. Dr. Ball joined the FDA in 1996 as a medical officer in the CBER Office of Vaccines Research and Review. From 2001 to 2003, she worked at the Office for Human Research Protections, DHHS, where she coordinated compliance investigations, participated in inspections of institutions and IRBs, and worked on children’s research issues. Dr. Ball graduated cum laude with a B.S. in Biology from Georgetown University. She received her M.D from Georgetown University School of Medicine, where she also completed a residency in Pediatrics. She completed a fellowship in Pediatric Infectious Diseases at the Walter Reed Army Medical Center. Dr. Ball is currently on staff in the Department of Pediatrics at the National Naval Medical Center, Bethesda.
Frederick Branding, Principal Attorney, Olson Frank Weeda
Mr. Branding, is a Principal Attorney with the Washington, DC OFW law firm. He is a registered pharmacist with extensive experience in pharmaceutical, food, drug, medical device and cosmetic regulatory compliance and enforcement issues. His experience includes assisting medical products manufacturers in responding to government inspections, warning letters, investigations and litigation. He has represented individuals and corporations in various government enforcement actions, including seizures, injunctions and prosecutions, as well as private litigation between businesses. Prior to joining OFW Law, Mr. Branding served in private practice with firms in Chicago. He also served as a Chief of the Civil Division of the US Attorney’s Office for the Northern District of Illinois and Chief of the Psychotropic Drugs Unit of the United Nations International Narcotics Control Board in Vienna, Austria. While at the Department of Justice, Mr. Branding twice received the FDA Commissioner’s Special Citation for outstanding contributions in the field of food and drug law enforcement. He is the author of several publications and has been a speaker and presenter at numerous meetings and conferences. For 20 years, he was Adjunct Professor of Law at John Marshall and Northwestern Law Schools. Mr. Branding received his pharmacy and biology degrees from Drake University and his JD from Illinois Institute of Technology Chicago-Kent College of Law.
David Chesney, Vice President of Strategic Compliance Services, PAREXEL Consulting
Mr. Chesney is Vice President, Quality and Compliance Management Services, for PAREXEL Consulting (formerly known as KMI/PAREXEL). Prior to joining the firm in 1995, he served 23 years with the FDA. He began his FDA career in 1972 at the Boston District Office as an Investigator. Between 1977 and 1991, he served in the Boston, Seattle and Philadelphia FDA districts in positions of increasing responsibility. He entered the Office of Regulatory Affairs’ Executive Development Program in 1990, and in 1991 was appointed District Director, San Francisco District Office. Mr. Chesney also served as an FDA Evidence Development Instructor at the national level for more than 10 years. Since joining PAREXEL Consulting, he has provided GMP and FDA inspection readiness consulting, auditing and training services to clients worldwide.
Gilda D’Incerti, CEO, Pharma Quality Europe
Ms. D'Incerti, has worked in the area of information technology for national and international companies such as Siemens Data (Milan) and Edicon (Montreal). Before the founding of PQE in 1998, she held the positions of IT manager for the Spanish affiliate in Barcelona of the Menarini Group, Operations Manager for F&J Systems Italy, and Validation Executive Consultant for M.I.S. She is a recognized international expert in the field of computer system validation due to the numerous validation projects performed and the training activities executed for regulatory bodies. She is also a certified Tick-IT and PDA auditor and has participated in several training meetings on auditing and FDA inspections. Ms. D’Incerti graduated with a degree in economic statistics. She is currently CEO of Pharma Quality Europe.
Elizabeth Dickinson, Chief Counsel, OC, FDA (invited)
Ms. Dickinson, has most recently been Senior Counsel in the Food and Drug Division of the Office of the General Counsel, DHHS’s. Her areas of expertise include innovator and generic drug approvals, exclusivity, orphan drugs, pediatrics and biosimilars. Ms. Dickinson received her B.A. in Economics from the University of Massachusetts and her JD from Northeastern University.
Rick Friedman, Associate Director, Office of Manufacturing and Product Quality, CDER, FDA (invited)
Mr. Friedman is the Associate Director, Office of Manufacturing and Product Quality, CDER. In this position, he is responsible for oversight of CGMP and drug quality programs to assure scientific and risk-based decisions. Mr. Friedman also co-chairs two multi-center workgroups (Quality Systems and Pharmaceutical Quality Standards). Mr. Friedman joined the FDA in 1990, and his prior positions have included New Jersey District Drug Specialist, CDER Senior Compliance Officer, Team Leader of Guidance and Policy, and Division Director. Mr. Friedman has authored several publications on topics including sterile drugs, quality systems and recall root causes, and was awarded The 2005 George M. Sykes Award by the Parenteral Society for outstanding journal paper. Mr. Friedman is an adjunct faculty member at Temple University School of Pharmacy in their QA/RA graduate program. Prior to joining the FDA, Mr. Friedman worked in the toxicology research division of an innovator pharmaceutical company. Mr. Friedman received his B.S. in Biology from Montclair State University in 1989 and his M.S. in Microbiology from Georgetown University School of Medicine in 2001.
David Glasgow, Director, Division of Domestic Field Investigations, ORA, FDA (invited)
Mr. Glasgow has been with the FDA for more than 25 years, serving as investigator, supervisor and manager. He has been in six district offices throughout the country and two ORA headquarters offices. He has conducted inspections across all program areas, with a primary focus on bioresearch and medical devices, and also worked import operations. He was a Bioresearch Monitoring Specialist and continues to occasionally conduct foreign inspections. He has managed across all program areas as a first-line supervisor, Director of the Investigations Branch and currently as the director of Domestic Field Investigations.
Brian Hasselbalch, Acting Associate Director, Policy and Communication, OMPQ, CDER, FDA (invited)
Mr. Hasselbalch has been with the FDA for 21 years. He began his service as an investigator and performed primarily drug process inspections and related investigations in California and overseas. Mr. Hasselbalch transferred to a compliance officer position in FDA’s CDER in the mid-1990s, where he reviewed regulatory cases in the area of drug CGMPs and drafted guidance, policy and regulations defining CGMP for drugs. Mr. Hasselbalch is now the acting Associate Director for Policy and Communications in CDER’s Office of Compliance, Office of Manufacturing and Product Quality.
Connie Hoy, Vice President, Global Regulatory Affairs, Palomar Medical Technologies
Ms. Hoy has more than 25 years of experience in medical devices including class III sterile implantable, radiation oncology and lasers. Currently she is the VP of Global RA with Palomar Medical Technologies. Prior to this role, she was the VP of RA and corporate compliance with Cutera, Inc. Previously Ms. Hoy was the VP of RA and QA at Xoft, Inc., and VP of RA and QA at Lumenis. She has extensive international submission experience to include Japan and China. Ms. Hoy regularly teaches international regulatory and complaint handling classes for ASQ..
Barbara Immel, President, Immel Resources LLC (Chairperson)
Ms. Immel is president of Immel Resources LLC, a firm serving companies in the pharmaceutical, biotechnology and medical device industries in quality assurance, quality systems, regulatory compliance, GXP systems and training. She has 30 years of industry experience. Before starting the firm in 1996, she served as compliance manager for a rapidly growing biotechnology firm and as an administrator in corporate quality assurance for a global pharmaceutical and medical device company. She assists clients in internal and supplier audits, gap analyses, corrective and preventive action plans, inspection preparation, and returning to compliance after FDA enforcement action.
She has served as conference chairperson of the FDAnews annual FDA Inspections Summit since it began in 2006. She was a compliance columnist for an industry trade journal for more than 10 years. She has taught courses on corrective and preventive action, investigations, root cause analysis and writing investigations for more than a decade, and she routinely presents executive briefings and GXP classes for her clients. She received her bachelor’s degree from the University of California, Santa Barbara, and is a graduate of the Stanford Professional Course.
Lori Lawless, SCSO, Medical Device Specialist, ORA, FDA, Baltimore District
Ms. Lawless graduated from State University of New York (SUNY) Albany with a BS in Biology and from SUNY Binghamton with an MA in Biology. She started with the FDA as an entomologist in the Baltimore District Laboratory in 1990. With the closure of the laboratory, Ms. Lawless became a Consumer Safety Officer in 1998. She received her Level II Medical Device Certification in July 2002; then became a performance auditor in December 2003. She performed domestic and international drug and medical device inspections. Ms. Lawless was the Baltimore District's Medical Device Specialist until changing to her present position in 2009. Ms. Lawless is currently a Supervisory Consumer Safety Officer with the FDA’s Baltimore District Investigation Branch.
Marie McDonald, Senior Director, Quality and Compliance Consulting, Quintiles
Ms. McDonald has 15 years of experience in the life sciences industry, primarily as a consulting business partner for biopharmaceutical and medical device companies. Her experience spans program and project planning, strategy, process design, training and change management. She has led or facilitated a wide range of projects, including quality systems evaluation, process improvement and technology implementation, as well as regulatory remediation and compliance improvement. She has partnered with global clients, and spent two years working and living in Ireland. As a Senior Director within the Regulatory and Quality area of Quintiles Consulting, Ms. McDonald is responsible for project delivery and expanding Quintiles’ rescue and remediation practice. Ms. McDonald earned a bachelor’s degree in Business Marketing at Shippensburg University in Pennsylvania and a Master’s degree in Career and Technical Education from Virginia Polytechnic Institute and State University. She serves on the Board of Directors of the Greater Philadelphia Chapter of the Healthcare Businesswomen’s Association.
Grace McNally, Senior Policy Advisor, OC, CDER, FDA (invited)
Ms. McNally is a Senior Policy Advisor in CDER’s Office of Compliance, Division of Manufacturing and Product Quality, Guidance and Policy Team. She is active on several working groups dealing with process validation, combination products and revisions of the CGMPs, as well as developing training for FDA and industry. She has served as compliance officer handling CGMP cases and as a field investigator specializing in drug and medical device inspections. Prior to coming to CDER, she worked in the FDA’s Denver District and Philadelphia District. She graduated from Boston College.
Elaine Messa, Executive Vice President of the Medical Device Practice, Becker & Associates Consulting, Inc.
Ms. Messa is Executive Vice President at Becker & Associates Consulting, Inc. Ms. Messa began her career at the FDA, where she worked for 30 years. Her most recent position at the agency was as Director of the Los Angeles District, which is responsible for the largest import operations and medical device workload in the US. During her FDA tenure, she successfully established an industry grassroots group, developed technical training efforts with local regulatory associations, and participated in the development and implementation of regulations, guidance, policy and compliance programs. As a result of this work, she received two FDA awards. Ms. Messa now works with clients in the medical device, pharmaceutical and biotechnology industries to develop quality assurance, manufacturing and regulatory strategies for compliance with FDA regulations.
Dan O'Leary, President, Ombu Enterprises
Mr. O’Leary has more than 30 years’ experience in quality, operations and program management in regulated industries including aviation, defense, medical devices and clinical labs. He is now President of Ombu Enterprises, LLC, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. He has a Master’s degree in Mathematics; is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management.
Larry Spears, Director, Deloitte and Touche LLP
Mr. Spears is a Director at Deloitte and Touche. Prior to retiring from the FDA in 2011, he was the Deputy Director, Office of Compliance, CDRH, since January 2003. Prior to that, he served as the Director, Division of Enforcement III, Office of Compliance, for six years. While with CDRH, he gained experience in processing regulatory cases and in managing the following activities: regulatory case processing, GMP reviews, PMA review support, recall classifications, regulatory guidance and labeling review activities. He also has 11 years’ experience as an FDA field investigator, where he gained considerable experience in the device, drug and bioresearch monitoring areas.
Ibim Tariah, Ph.D. Technical Director, BSI Healthcare Solutions
Dr. Tariah is the Technical Director for BSI Healthcare, with more than 23 years of experience in the medical device industry. In the past 14 years, since coming to BSI, Dr. Tariah has been providing regulatory expertise in the area of long-term implantable devices for clients needing technical documentation assessment and reviews in compliance with the European Medical Device Directive. He also acts as a liaison with regulatory authorities including MHRA (UK), EMA, Medical Products Agency (Sweden), FDA, Health Canada and Therapeutic Goods Administration (Australia).
John Taylor III, JD, Counselor to the Commissioner and Acting Deputy Commissioner for Global Regulatory Operations and Policy, OC, FDA
Mr. Taylor is the Counselor to the Commissioner in the Office of the Commissioner at the FDA. As of May 18, 2013, he is serving as Acting Deputy Commissioner for Global Regulatory Operations and Policy. Mr. Taylor advises the commissioner on a broad range of policy and regulatory issues. He advocates for and advances the commissioner’s priorities related to agency policies and programs. He leads the development and management of FDA emergency and crisis management policies and programs. In addition, he oversees FDA participation in counterterrorism and emergency exercises, and the coordination of the agency’s evaluation of emergency and crisis situations. Mr. Taylor received his law degree in 1991 from the College of William and Mary. In 2007, Mr. Taylor joined the Biotechnology Industry Organization as the executive vice president for health. From 2005 to 2007, he was divisional vice president for federal government affairs at Abbott Laboratories.
Kimberly Trautman, Associate Director, International Affairs, Medical Device International Quality Systems Expert, Office of the Center Director, CDRH, FDA
Ms. Trautman is Associate Director for International Affairs, Officer of the Center Director and is the FDA’s Medical Device International Quality Systems Expert. Ms. Trautman is responsible for the international efforts and initiatives within CDRH. She coordinates and oversees the CDRH’s Medical Device Single-Audit Program, the Harmonization by Doing Initiatives, CDRH Bilateral and Multilateral programs and exchanges with foreign regulators and many other international activities. Ms. Trautman is currently serving on the International Medical Device Regulators Forum Management Committee and the Global Harmonization Task Force (GHTF) Steering Committee, while continuing her work in GHTF Study Group 3. She was the GHTF Study Group 3 chairperson from 1996 - 2005, and has been a member of GHTF since 1993. Ms. Trautman was responsible for writing the final Quality System regulation and preamble published in 1996. Ms. Trautman was also responsible for the development and implementation of the extensive Quality System regulation roll out and training programs. In addition, she is responsible for the continuing harmonization efforts with ISO 13485. Ms. Trautman received her Bachelor of Science degree in Molecular and Cell Biology from Pennsylvania State University and a Masters of Science degree in Biomedical Engineering from the University of Virginia.
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