Vice President, IRB Compliance
David Borasky Jr. serves as Vice President of IRB Compliance for the WIRB-Copernicus Group (WCG). In this role, he is responsible for leading the quality and compliance activities for all of the WCG institutional review boards (IRBs). David has 20 years of experience in managing IRBs in global public health organizations, large academic medical centers and independent IRBs. He has facilitated training activities on basic research ethics and IRB operations and management for IRB staff and members for institutions and IRBs throughout the U.S. and abroad. He has served as a consultant for the Office for Human Research Protections, the U.S. Department of Energy, the World Health Organization, and numerous other institutions. David currently serves as co-chair of the subpart A subcommittee of the HHS Secretary’s Advisory Committee on Human Research Protections. Borasky is a Certified IRB Professional and former member of the board of directors of Public Responsibility in Medicine and Research (PRIM&R). In 2018, he was named a distinguished leader of PRIM&R. David received his undergraduate education at Le Moyne College and his master’s degree in public health leadership from the University of North Carolina at Chapel Hill.
Principal, Director of Inspection Readiness
Julie Larsen is a Principal Consultant and Director of Inspection Readiness Services at BioTeknica, Inc., a quality and regulatory compliance and engineering consulting firm in Coral Gables, Florida. She is a Certified Quality Manager (CQM), a Medical Technologist (MTASCP) and has more than 25 years’ experience in quality assurance and compliance in the medical device and pharmaceutical industries. Ms. Larsen has extensive experience in quality systems remediation for compliance improvement and constructing responses and corrective action plans for consent decree, warning letter and form 483 responses as well as development of quality systems.
Lead Quality Systems and Compliance Consultant
King & Spalding LLP
Former FDA Deputy Associate Commissioner for Regulatory Operations, CDRH, FDA
Steve Niedelman serves as lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, specializing in regulatory, enforcement and policy matters. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure FDA compliance. Mr. Niedelman retired from the FDA in 2006 after a 34-year distinguished career, serving as the Deputy Associate Commissioner for Regulatory Affairs and as chief operating officer of the Office of Regulatory Affairs. He also assisted in the day-to-day management of the FDA’s nearly 3,400 field staff responsible for investigative and laboratory operations. Mr. Niedelman’s prior FDA service included the roles of director and deputy director of the FDA’s Office of Enforcement, where he was responsible for oversight and consistency of compliance policy, enforcement and recall activities.
Executive Vice President, Regulatory Compliance
Former Director of CDER’s Office of Compliance
With more than 25 years of experience as an expert in compliance issues – including more than 20 years in leadership positions in the government – Cynthia Schnedar adds to Greenleaf Health’s prestige as executive vice president, regulatory compliance. Cynthia was formerly Director of the Office of Compliance for CDER, where she led a staff of more than 300 doctors, scientists, manufacturing experts, pharmacologists, attorneys and administrative staff. During her time at the FDA, she spearheaded efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety. Among her many duties, Cynthia advised the FDA commissioner, the CDER director and other senior FDA officials on significant enforcement issues. Before joining the FDA in 2014, Cynthia spent more than two decades at the DOJ, where she specialized in compliance and enforcement issues. Her most recent position was as deputy inspector general and acting inspector general, where she led a nationwide staff in investigating allegations of corruption and misconduct concerning DOJ’s employees and in conducting independent audits of the department’s operations and programs. She communicated significant findings from the investigations and reviews to the attorney general and to Congress. Cynthia’s other positions at DOJ also provided her with an extensive background in criminal and civil enforcement work. They included counselor to the Inspector General, deputy chief of the Sex Offense and Domestic Violence Section in the U S Attorney’s Office for the District of Columbia, assistant U.S. attorney, and trial attorney in the Civil Fraud Section of the civil division. Previously, Cynthia clerked for a federal judge on the Ninth Circuit and worked as a television reporter in New Mexico and Texas. Cynthia earned a B.A., with distinction, from the University of New Mexico and a J.D., with honors, from the University of Texas School of Law.
Director, Office of Compliance
As Director of CDER’s Office of Compliance, Donald D. Ashley, J.D., leads efforts to protect the American public from unsafe, ineffective and low-quality drug products through measures designed to assist industry-wide compliance with federal standards for quality and safety, as well as regulatory and enforcement measures to address violations of those same standards.
Mr. Ashley joined FDA after more than 18 years of criminal enforcement and investigation experience with the Department of Justice (DOJ). His many positions with DOJ included serving as a Trial Attorney in the Office of Consumer Litigation (now the Consumer Protection Branch), where he prosecuted consumer fraud offenses and violations of the Food Drug and Cosmetic Act (FD&C Act), and as Associate Director of the Office of International Affairs, where he managed international criminal law enforcement cooperation with countries throughout the world, represented DOJ’s interests within the United Nations, and negotiated law enforcement cooperation treaties.
Assistant Commissioner Medical Products & Tobacco Operation, Office of Regulatory Affairs
Dr. Elizabeth Miller recently rejoined the US FDA in March 2020. In her role as the Assistant Commissioner for Medical Products and Tobacco Operations, Dr. Miller provides leadership and managerial direction to ORA’s Office of Biologics Products Operations, Office of Pharmaceutical Quality Operations, Office of Medical Device and Radiological Health Operations, Office of Bioresearch Monitoring Operations, and the Tobacco Operations Staff.
Dr. Miller comes returns from the U.S. Pharmacopeia (USP) where she helped guide USP’s working relationship with the FDA. At USP, Dr. Miller was vice president, US Public Policy & Regulatory Affairs, with responsibility to deliver executive leadership for developing and achieving USP’s US regulatory science and intelligence, government affairs, and public policy programs’ goals. She also created strategic change focused on impacts and results resulting from engagement with federal, state, and international regulators, as well as senior leadership in industry, academia, and patient-focused alliances.
Before rejoining USP in 2016, Dr. Miller began her federal career with FDA’s Center for Drug Evaluation and Research (CDER) in 2007 in the Office of Unapproved Drugs and Labeling Compliance (OUDLC). She began her CDER career working on online pharmacy and health fraud issues, and ultimately served as the director for OUDLC’s Division of Nonprescription Drugs & Health Fraud.
Prior to federal service, Dr. Miller worked at USP as a scientific liaison on medication safety standards for nomenclature, labelling, and packaging, and as the director of drug information for the USP Drug Information publication. She started her pharmacy career working as a clinical pharmacist at MedStar Washington Hospital Center in Washington D.C.
Dr. Miller holds a bachelor’s degree in biology from The Johns Hopkins University and received her Doctor of Pharmacy degree from the University of Maryland.
Program Manager for the Case for Quality, Office of Compliance
Francisco (Cisco) Vicenty is Program Manager for the Case for Quality (CfQ), Office of Compliance. This effort is part of the CDRH Surveillance and Biometrics strategic priorities. This strategic priority will improve access and outcomes for patients by engaging industry, payers, providers, and patients to increase focus on the quality and performance of medical devices. Cisco began his career at FDA as a Compliance Officer, Cardiac Rhythm/Electrophysiology Branch, Office of Compliance at CDRH. He then worked as a project manager, FDA’s Case for Quality initiative. Prior to his current role, Cisco was Branch Chief, Respiratory, E/N/T, General Hospital, &Ophthalmic Devices Branch in the Div. of Mfg. and Quality, Office of Compliance. Prior to working with FDA, Cisco Vicenty was a Quality and Reliability Engineer with Micro-Electronics Business Unit at IBM responsible for emerging server technology lines and network systems along with high volume gaming systems from Nintendo, Sony, and Microsoft
Senior Vice President, Regulatory Compliance and Deputy General Counsel
Former Deputy Chief of Staff for two FDA Commissioners
Kalah Auchincloss has more than a decade of food and drug legal, policy and regulatory experience at the FDA, on Capitol Hill and in the private sector. She spent six years at the FDA, most recently as Deputy Chief of Staff for two FDA Commissioners: Dr. Robert Califf and Dr. Scott Gottlieb. As Deputy Chief of Staff, Kalah worked with senior FDA leadership to manage crises, develop policy decisions, implement communications strategies and liaise with the Department of Health and Human Services, the White House, and other agencies. Kalah was also a primary point of contact in the immediate Office of the Commissioner for the six FDA centers and other components of the Commissioner’s Office.
Prior to that role, Kalah spent time on Capitol Hill as the FDA detailee to the Senate Committee on Health, Education, Labor and Pensions, working on the 21st Century Cures Act and other FDA-related legislation. She has also served in the FDA’s Center for Drug Evaluation and Research (CDER) as a regulatory counsel in the Office of Regulatory Policy, and as Director of CDER’s Office of Unapproved Drugs and Labeling Compliance in the Office of Compliance, leading a team of more than 50 staff working on pharmacy compounding, unapproved drugs, over-the-counter drugs and other enforcement issues.
Before joining the FDA, Kalah was an associate at the law firm Foley Hoag LLP in the firm’s healthcare practice group. Kalah holds a B.A. with honors from Williams College, a J.D. with honors from Georgetown University Law Center, and an M.P.H. from Harvard University.
Lead GxP External Engagement
Bristol Myers Squibb
Former Lead Consumer Safety Officer and Acting Director, Manufacturing Quality Guidance and Policy Staff, CDER, FDA
Sarah Barkow, PhD is the Lead for GxP External Engagement with Bristol-Myers Squibb Company, where she plays a key role in supporting and contributing to the execution of the GxP external engagement strategy. This includes working closely with PhRMA, BIO, IFPMA and other trade organizations and tracking regulatory and policy developments across the GxP realm. Sarah is former Lead Consumer Safety Officer and Acting Director, Manufacturing Quality Guidance and Policy Staff in FDA CDER’s Office of Compliance. At FDA, she also served as a Special Assistant to Donald Ashley in the Office of Compliance, and as Senior Policy Advisor in Compounding. Sarah was instrumental in drafting multiple guidance and policy documents including the guidance for industry on Data Integrity and Compliance with CGMP and in developing internal processes and aids.
Vice President, Regulatory Strategy
Former Cybersecurity Program Manager, CDRH, FDA
Seth Carmody is a regulatory strategist for MedCrypt. Most recently he was the Cybersecurity Program Manager for the Center for Devices and Radiological Health, served as co-chair of CDRH’s Cybersecurity Working Group. The Cybersecurity Working Group is an interdisciplinary team responsible for the FDA’s final pre- and post- market cybersecurity guidances. Seth joined CDRH in 2011 as a medical device reviewer.
Principal and General Manager
DL Chesney Consulting, LLC
Former FDA District Director in San Francisco
David L. Chesney, MSJ, is the Principal and General Manager for DL Chesney Consulting, LLC, providing GMP and GCP compliance consulting and training services to clients worldwide. He served for over 20 years as Vice President, Strategic Compliance Services for PAREXEL Consulting. Prior to joining PAREXEL Consulting, he served 23 years with the FDA, serving as an Investigator, Supervisory Investigator, Director of Investigations and ultimately as District Director in San Francisco, managing all FDA operations in Northern California, Nevada and Hawaii. He also served as an Evidence Development instructor for FDA at the national level.
Mr. Chesney has a Bachelor's degree in Biology from California State University, Northridge, plus three years of graduate study in Biology at CSU Northridge and CSU San Diego, and an MS in Jurisprudence, concentrating in Pharmaceutical and Medical Device Law from Seton Hall University School of Law. Mr. Chesney is a member of PDA, where he serves on the faculty of the Training and Research Institute. He is also an active member of the Food and Drug Law Institute and RAPS.
Executive Vice President
Former Director, Office of Regional Operations, FDA
David Elder brings more than 30-years of extensive regulatory experience to his role as Executive Vice President for Regulatory Compliance at Greenleaf Health. A 23-year veteran of the U.S. Food and Drug Administration (FDA) and U.S. Public Health Service (USPHS), David served as a senior FDA official with prominent roles in domestic and foreign inspections, recalls and emergencies, and compliance actions involving hundreds of situations. He has testified in federal court and before Congress, initiated and approved enforcement actions, and represented the FDA during national media events. Additionally, David has received numerous honors, including the Distinguished Service Medal. David began his FDA career as an investigator in the Boston District Office where he conducted domestic and foreign inspections and investigations in various program areas. He was selected as a compliance officer and later as the director of the compliance branch with responsibility for assessment of inspection reports, initiation of compliance actions and evaluation of compliance action effectiveness. David transferred to FDA headquarters when he was selected as the director of the FDA Office of Enforcement in 2003, a position he held for the next six years. In this senior executive service position, David led the Office with responsibility for agency enforcement policy, agency recall policy and operations, and enforcement strategy and case review
Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice
King & Spalding LLP
Eric Henry is a Senior Quality Systems and Compliance Advisor in the FDA and Life Sciences practice of King & Spalding. Eric has 30 years of experience in global quality and compliance roles (18 years in medical device and health systems leadership), with a specialization in software quality (including cybersecurity), medical device design controls, risk management, audit management, management controls, and QMS remediation.
Eric came to King & Spalding from Philips, where he was the Global Head of Quality Assurance / Quality Engineering for the Diagnostic Imaging Business Group and had responsibility for design controls, risk management, and a variety of other interim management system elements in seven business units spanning 14 sites globally. Prior to Philips, Eric led design quality assurance at Medtronic’s Diabetes Business Unit, was responsible for software design controls and general design controls effectiveness for GE Healthcare for all GE businesses worldwide, and had software quality and software design leadership responsibility at Boston Scientific and Hologic.
Hoy & Associates Regulatory Consulting, LLC
Connie Hoy, founder of Hoy & Associates Regulatory Consulting, has over three decades’ experience in the medical device industry. Time and again she and Hoy & Associates have helped companies obtain important global regulatory approvals and pass foreign and domestic audits. She and the firm are well-versed in the workings of the FDA, helping companies of all sizes with presubmission meetings and submission preparation. The firm offers internal auditing and gap analysis for quality management systems and provides full-scope audits including FDA 21 CFR, ISO 13485:2016, Medical Device Single Audit Program (MDSAP) and Electronic Product Reporting, providing audit reports for regulatory agencies that will withstand the most rigorous scrutiny. Ms. Hoy is intimately familiar with the day-to-day challenges of developing strategies and obtaining approvals, developing and maintaining quality management systems and encouraging a culture of compliance. Before forming Hoy & Associates, Ms. Hoy was Executive Vice President of Regulatory, Quality and Clinical Development at Cynosure, a division of Hologic. Prior to that, she served as Senior Vice President of Global Regulatory Affairs and Quality Assurance at Cynosure, Inc. and Vice President, Regulatory Affairs and Quality Assurance, Cutera, Inc.
Covington & Burling LLP
Former Director of Guidance and Policy for the OMPQ, CDER, FDA
Paula Katz advises clients on pharmaceutical compliance and enforcement. She joined the firm after serving as Director of Guidance and Policy for the Office of Manufacturing Quality in the CDER at FDA. While at the FDA, Ms. Katz focused on cGMP enforcement and drug quality policy issues. She advised CDER and FDA leadership regarding manufacturing supply chain controls, contract manufacturing, data and application integrity, administrative law and procedure, and regulatory policy development and enforcement strategy.
Advisor & Founder
Clinical Innovation Partners
Craig Lipset is an advisor to technology and biopharmaceutical companies, leading universities, and the venture community, bringing vision and driving action at the intersection of research, digital solutions, and patient engagement. Previously, Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures.
Senior Medical & Policy Advisor, FDA & Life Sciences Practice
King & Spalding LLP
Beverly Lorell, MD is the Senior Medical and Policy Advisor with the King & Spalding’s FDA and Life Sciences Practice in Washington, D.C. Dr. Lorell specializes in the areas of clinical trial design of studies for drugs, devices and biologics; review of pre-market submissions; recalls; and assessment of matters involving a risk to health. She also specializes in the area of physician and industry relations and the development of independent scientific panels to advise health industries.
Executive Vice President, Pharmaceuticals, REGULATORY COMPLIANCE ASSOCIATES® INC.,
Former Director OMPQ, CDER, FDA
Steve Lynn has over 20 years of quality and regulatory compliance related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma and tissue industries. He served in executive leadership roles with global accountability in both the private sector, as well as at the FDA. Steve is an expert in cGMP compliance related matters and has significant experience with other GxP quality compliance and regulatory issues. Steve is currently the principal consultant/owner for Lynn Consulting, LLC, which provides expert GxP consulting services to the life sciences industry. Prior to this role, he was the global head of group (corporate) compliance and audit at Novartis AG. In this role, Steve led the corporate compliance and audit functions for Novartis. Prior to joining Novartis, Steve was the inaugural vice president of global quality compliance at Mylan, Inc. in Canonsburg, PA.
Prior to Mylan, he was the director of the CDER Office of Manufacturing and Product Quality within the Office of Compliance. In this role he was responsible for the global cGMP oversight of all drugs manufactured and/or imported into the U.S. to assure compliance with cGMPs. In addition, in his last year at the FDA he served in a dual position as the Operations Transition Lead for CDER’s new Office of Pharmaceutical Quality reporting to CDER’s Center Director where he was responsible for setting up OPQ operations.
Steve received his bachelor’s of science degree in Biology from Bethany College in Bethany, WV, and his master’s of Science Degree in quality systems management from the National Graduate School in Falmouth, MA. He is an Eagle Scout, senior member of the American Society for Quality (ASQ) and an Excellence in Government Program Senior Fellow.
Associate Director of Decentralized Trial Operations
Melanie Morris is an Associate Director of Decentralized Clinical Trials at Covance. Melanie began her career in early phase research, moving into roles of increasing responsibility at large CROs thereafter. She joined Covance in 2013 where she held leadership roles within Clinical Operations and successfully expanded the Covance FSP business with a leading pharma client. Melanie spent a brief period an Associate Director of Clinical Operations with a large pharma organization.
Senior Vice President of Quality
Melanie Power-Burns has an accomplished 30-year career in the Pharmaceutical Industry. Entering the industry as a quality control chemist, she gained a plethora of experience in Manufacturing and Quality working in areas such as manufacturing quality assurance, annual product review, change control, critical systems, QA software validation, product release, GMP training, product recalls and internal & supplier auditing. As a QA Compliance Professional, Melanie hosted several FDA, GMP and Pre-Approval Regulatory Inspections for both drugs and biologics and has a strong working knowledge of US and EU regulations. Over the past 10 years Melanie successfully collaborated with the FDA CDER Drug Shortage team on several regulatory discretions to address severe shortages within the US. Having gained this experience with several pharmaceutical companies including, SoloPak Pharmaceuticals, CSL Behring (a.k.a Centeon and Aventis Behring) and APP Pharmaceuticals, Melanie has achieved progressive leadership roles in quality assurance. In 2019, Melanie was promoted to Senior Vice President, Quality Assurance for North America at Fresenius Kabi USA, LLC. Melanie is passionate about inspiring, encouraging, and empowering children and women to have better lives. She enjoys serving in various humanitarian organizations and introducing young people to STEM careers within the pharmaceutical industry. Melanie was inducted into the National Association of Professional Women’s “VIP Woman of the Year Circle” for excellence, leadership and commitment to her profession, while encouraging the achievement of Professional Women. She is also an active member of the Parenteral Drug Association and the International Society for Pharmaceutical Engineering (ISPE); as well as other pharmaceutical industry organizations. Melanie L. Power-Burns is a graduate of Tennessee State University where she earned her Bachelor of Science Degree in Biology. In 2019, she completed an Executive Scholar Program in Leadership at Northwestern University.
Meridian Bioscience, Inc.
Alyson Roeding is the Director of Clinical Research at St. Elizabeth Healthcare. She has received her Master’s in Business Administration and B.S. in Information Systems, several certifications, including CLSSBB and CRCP, and is currently pursuing her Doctorate in Healthcare Management. Above all else, Alyson is the mother of two and takes a very committed role in her children’s' lives. Alyson is actively involved in her community and enjoys spending time with her family, running, and hiking.
former FDA Chemist ACNA and Former FDA Investigator Atlanta District Office Drug Cadre
Vicky Stoakes, President, has over 18 years combined consulting, FDA, and industry experience, including hands-on execution of laboratory responsibilities.
Vicky has been a consultant to FDA regulated industry since 2002. In this capacity, she has performed cGMP and Mock Pre-Approval Inspections of international and domestic firms and identified critical and major deficiencies. Her responsibilities have included management and coordination of extensive consulting projects to assure the quality work products and timely completion of requested services. She has assisted in guiding and developing Corrective Action Plans, Validation Plans, formal responses and correspondence with FDA, and procedures that comply with FDA expectations. She has also presented formal and informal training seminars covering FDA expectations on a variety of topics.
Previously, Vicky was employed by the U.S. Food and Drug Administration where she served as a Chemist and later as an Investigator for the Atlanta District Drug Cadre. In both roles, she conducted numerous cGMP and NDA/ANDA Pre-Approval Inspections at major pharmaceutical facilities, including compliance audits of Active Pharmaceutical Ingredients and major dosage forms. As the Acting NDA/ANDA Pre-Approval Manager for the Atlanta District Office, she facilitated high priority Pre-Approval assignments, performed technical review of applications, and provided assessment of pending NDAs/ANDAs. Vicky prepared industry seminars, meetings, and conferences addressing regulatory compliance issues and addressed pharmaceutical management on topics of mutual concern. She trained other FDA Investigators, Analysts, and Regional employees in the procedures and methods of evaluating compliance during drug inspections to ensure consistency with Agency policy.
Vicky began her career in the pharmaceutical industry with Merck & Company, where she provided technical support for the production of Active Pharmaceutical Ingredients (APIs) in accordance with cGMP requirements. Her responsibilities included performing multi-step organic synthesis, purification, and isolation of process optimization experiments, use tests, and front runs, and subsequently evaluating compliance to yield and quality specifications. She also resolved manufacturing abnormalities, provided analytical support to assist the achievement of production goals and to aid process changes, and validated analytical methods. Vicky holds a Bachelor of Science in Chemistry.
Qualified Data Systems, Inc.
Armin Torres has more than 20 years of management and engineering experience in the areas of quality assurance manufacturing, technical support, statistics, validation, in-vitro diagnostics quality and regulatory compliance, and software development within the pharmaceutical and medical device industries. Armin is also a Certified Software Quality Engineer (CQE) and certified instructor of Statistical Process Control and Design of Experiments.
Executive Vice President & Chief Scientific Officer
PRA Health Sciences
Kent Thoelke is Executive Vice President and Chief Scientific Officer. Mr. Thoelke provides corporate oversight and strategy for Scientific & Medical Affairs, Pharmacovigilance & Patient Safety, Therapeutic Centers of Excellence, Real World Data, Patient Access & Experience, Digital Health & Virtual Trials, and their integration into operational delivery. Mr Thoelke is an industry pioneer in the application of mobile first strategies, which integrate clinical trials and provide access directly to patients in both virtual and hybrid-virtual models. He emphasizes leveraging real world data, social insights, and patient connectivity to advance global drug development. With more than 25 years of experience in the global drug development, diagnostic, and device industry and experience in 40+ countries, he understands the global drug development environment and maintains established relationships with international therapeutic experts in several indications. Mr. Thoelke has lectured on his experience in the current landscape of clinical trial recruitment and drug development timelines. He actively pursues novel technologies and strategies to drive a more evidence-based clinical drug development paradigm. A leader in the field of medical informatics, Mr Thoelke leverages data to maximize patient engagement by selecting high-performing sites to minimize overall drug development timelines.
Wool Consulting Group, Inc.
Liz Wool has 28 years of clinical research experience and is a recognized industry subject matter expert, trainer, and international speaker with a focus on solutions and added value results for clients. Liz’s expertise is in the areas of clinical research, trial management, monitoring, clinical quality management systems, vendor management and oversight, compliance, operations, personnel training and development, and, performance management methods. Liz's expertise produces results in both organizational effectiveness and efficiencies (design, re-design, modifications for growing companies, and post-mergers and acquisitions) in support of the organization’s goals. She has provided consulting services to six of the TransCelerate Biopharma, Inc. companies during her consulting tenure in the areas of department level strategic support, SOPs and performance management (post-merger/acquisitions), vendor program gap analyses, enterprise wide training strategy, and framework gap analyses, training course design, development and delivery, and metrics.