Don Ashley joined Greenleaf Health after a distinguished 25-year career at the Food and Drug Administration (FDA) and the Department of Justice (DOJ), including six years as Director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research (CDER).

As Director of CDER’s Office of Compliance, Don led a staff of over 400 lawyers, scientists, consumer safety officers, pharmacists, and physicians. He oversaw development and implementation of the FDA’s entire breadth of drug compliance and enforcement measures, including for manufacturing quality, current good manufacturing practice, good clinical practice, data integrity, clinical trial oversight, pharmacovigilance, drug supply chain security, compounding, over-the-counter monograph compliance, drug import and export, and unapproved drug compliance, among other areas. Don led all drug compliance actions taken by the FDA following inspection, as well as all grants of regulatory discretion in drug shortage cases. As an executive member of CDER’s Drug Risk Management Board, Don helped guide the Agency’s approach to some of most difficult drug safety issues over the last several years, including for nitrosamine and benzene impurities. In addition, Don served as one of a small group of senior agency officials who liaised with the generic drug industry to implement the Generic Drug User Fee Act program.

Before joining the FDA, Don spent nearly two decades at DOJ in both the Civil and Criminal Divisions, prosecuting violations of the Food, Drug, and Cosmetic Act among other criminal statutes, as well as managing and directing investigations on both a national and international level. During his time with the Civil Division’s Office of Consumer Litigation (now the Consumer Protection Branch), he prosecuted complex schemes to defraud consumers and/or federal agencies such as the FDA. Later, Don served in Asia as the senior DOJ official responsible for managing international law enforcement cooperation on behalf of the United States with several countries, including the Philippines, Singapore, and Indonesia. Don also represented DOJ in Italy as the senior official responsible for facilitating closer cooperation between Italy and the United States in criminal investigations and prosecutions.

Previously, Don worked as a senior litigation associate with a major D.C. law firm, often representing clients under investigation for FDA-regulated activities. Don also served on active duty as an Army captain assigned to the Office of General Counsel, Department of the Army.

Don earned his J.D. from Harvard Law School and an A.B., magna cum laude, from John Carroll University. 

Tom Berry brings more than 20 years of extensive regulatory experience to his role as Senior Vice President, Regulatory Compliance at Greenleaf Health.

Tom is a retired Captain with 23 years in the U.S. Public Health Service (USPHS) and six years as an Army Pharmacy Officer. He was assigned to multiple positions over his 20 years with the FDA, most recently as a Pharmaceutical Program Expert in the Office of Regulatory Affairs (ORA), responsible for providing guidance to ORA field components, drafting FDA policy, reviewing proposed guidance and legislation, and representing ORA on FDA committees. He also trained “new hire” investigators and was a cadre member for courses in Food and Drug Law, Evidence and Development, and New Hire Fundamentals. Tom was an original author of “FMD-153 Investigations of Facilities engaged in the Manufacturing, Packaging, Labeling, and Testing of Medical Products that may be subject to an Emergency Use Authorization (EUA).” As the past Director of Compliance, Denver District and member of the FDA Cannabis Product Council, he is familiar with FDA cannabis oversight operations and cannabis regulatory history to include “Brownie Mary,” Charlotte Figi, Colorado Amendment 64, and the 2018 Farm Bill.

Tom began his FDA career as an investigator for eight years in the Raleigh, NC resident post, where he was a domestic and international drug, bioresearch monitoring (BIMO), and pharmacovigilance investigator. He was selected as a Compliance Officer in Denver and subsequently as the Director of the Compliance Branch, with responsibility for assessment of inspection reports, initiation of compliance actions, and evaluation of compliance action effectiveness.

After ORA Program Alignment in May 2017, Tom conducted a 180-day detail to establish the BIMO Program West Division responsible for the oversight of BIMO operations in the Western 27 States. He subsequently assumed his permanent position as Director of Compliance, Office of Pharmaceutical Quality Operations IV, with oversight of the pharmaceutical operations in the Western 13 States and global inspection regulatory assessments. At Greenleaf, Tom provides strategic guidance and support to pharmaceutical, pharmacovigilance, and cannabis companies, including: developing compliance strategies; performing due diligence activities; ensuring inspection readiness; assisting industry clients and legal counsel in developing and communicating corrective action plans that meet FDA expectations and that achieve and sustain compliance; conducting audits and mock inspections; and providing training, coaching, and mentoring. Tom continues to communicate expert advice through presentations at FDA and industry conferences and articles published in industry journals.

Tom received a B.S. in pharmacy and a Pharm.D. from Creighton University and completed an ASHP-certified residency at Fitzsimons Army Medical Center. 

Dawn Wydner joined Greenleaf Health as Senior Vice President, Regulatory Compliance, after working closely with Greenleaf’s Quality, Manufacturing, and Compliance Team as an independent consultant. Dawn has extensive FDA regulatory compliance expertise as well as quality and compliance experience within industry. During her ten years at the U.S. Food and Drug Administration (FDA), she was a Commissioned Public Health Service Medical Officer, conducting complex, thorough bioresearch monitoring (BIMO) inspections to assess good clinical practices (GCPs), good laboratory practices (GLPs), and good manufacturing practices (GMPs) under medical device and drug compliance programs domestically and internationally. She has also worked in bioresearch quality and compliance and clinical quality assurance roles for Janssen Research & Development, where she managed company-wide, global compliance activities and provided expert strategic direction and advice to senior leadership.

Dawn offers Greenleaf clients a deep understanding of all aspects of operational strategy, coordination, and conduct to ensure quality, safety, and compliance across the global pharmaceutical R&D, medical device, and consumer products industries. Her expertise covers the end-to-end lifecycle of a product and processes from GLP to GCP to GMP, including postmarketing surveillance; audits and compliance, safety, and quality monitoring; and operational risk management across all GxPs. She is frequently sought as a subject matter expert based on her proven track record of consistently establishing proactive compliance and application of quality oversight. Dawn is adept at utilizing her broad skillset to enable easy collaboration, big-picture strategic thinking, and compliance mindsets.

Prior to her career at the FDA, Dawn worked as a Registered Nurse in the hospital setting, caring for patients within transitional trauma, pediatrics, infectious diseases, and oncology. She has obtained her Ph.D. in Health Psychology and RQAP-GCP certification. 

Grace joined Greenleaf Health after a 33-year career with the FDA. Through her many agency roles and experiences, Grace developed a broad understanding of the quality requirements and initiatives intended to assure that high-quality pharmaceuticals and devices are available to patients. For 13 years Grace served as an investigator for the Office of Regulatory Affairs (ORA) in the Philadelphia and Denver district offices, where she developed expertise in quality systems and current good manufacturing practice (cGMP) for pharmaceuticals and medical devices. She conducted drug and device inspections, both domestically and abroad.

Grace later drew upon her ORA experience when she joined the Center for Drug Evaluation and Research (CDER) as a compliance officer in the Office of Compliance (OC), evaluating violative facility inspection results and initiating risk-based enforcement or other agency action. She also served as Senior Policy Advisor and helped CDER realize the goals of the Pharmaceutical Quality for the 21st Century initiative. During her tenure with OC, she developed cGMP guidance for drugs and combination products, helped craft revisions to cGMP regulations, and supported implementation of several ICH quality guidelines as well as new legislation impacting CDER’s quality program. Grace led development of the 2011 guidance, “Process Validation: General Principles and Practices,” and following its publication, provided training to FDA staff and presented on the guidance at numerous industry conferences. In the international realm, she contributed to information-sharing initiatives with EU and other regulatory counterparts designed to minimize duplication and redirect inspection resources toward higher-risk areas.

With the formation of the Office of Pharmaceutical Quality (OPQ) in 2015, Grace continued to be involved in agency initiatives aimed at modernizing the regulation of pharmaceutical manufacturing and product quality. Selected to serve as an acting branch chief in the new Office of Process and Facilities (now Office of Pharmaceutical Manufacturing Assessment), she helped establish processes to better integrate quality review and inspection and improve quality drug assessment for NDAs, ANDAs, and CDER-led BLAs. In 2016, she was selected as the Director, Division of Regulations, Guidance, and Standards within the Office of Policy for Pharmaceutical Quality (OPPQ). In that role, she oversaw the development of cGMP and CMC guidance covering the product quality lifecycle, oversaw the quality aspects of citizen petition responses, and guided OPQ staff in establishing policies and programs — e.g., emerging technology, quality metrics, and quality management maturity — to facilitate advancements in drug manufacturing and pharmaceutical quality management systems.

At Greenleaf, Grace provides strategic guidance and support to pharmaceutical and medical technology companies in areas including: strengthening corporate quality systems; developing compliance strategies; assisting industry clients and legal counsel in developing and communicating corrective action plans that meet FDA expectations and that achieve and sustain compliance; conducting audits and mock inspections; ensuring inspection readiness; and providing training, coaching, and mentoring. Grace communicates expert advice through presentations at industry conferences such as FDLI, FDANews, and ECA (European Compliance Academy) and through articles published in industry journals.

Grace holds a B.S. in physics from Boston College, Chestnut Hill, MA. She received a certificate for completing the American Course on Drug Development and Regulatory Sciences (ACDRS), University of California, San Francisco, in 2016.