Understanding the Food and Drug Administration

Michael Walsh is a partner in the Dallas office of Strasburger & Price and leads the firm’s Drug and Device Industry Team. He devotes most of his practice to representing clients in FDA regulated industries on issues related to labeling and compliance and is a frequent speaker on issues concerning FDA labeling and marketing. Mike is also a member of the Laws and Regulations Committee of the Association of Food and Drug Officials and DRI Drug and Device Committee.

Dr. DeWyngaert has provided operational, clinical, managerial, consulting, and litigation services to various segments of the health care industry. He trained as a molecular biologist and has been actively involved in both research and business development roles for the past 25 years. Mark specializes in assisting pharmaceutical manufacturers, biotechnology, and medical device companies with identifying and mitigating regulatory risks and valuing intellectual property.

Mark regularly leads teams in the assessment of medical affairs and clinical development activities and assists companies in the redesign of business practices to comply with applicable regulations and standards. He also serves clients and their legal counsel in fraud investigations, compliance inquiries, litigation strategy issues, and acting as an expert witness.

Brad has more than 16 years’ experience advising pharmaceutical, biotechnology, and medical device clients on issues of strategic growth, process improvement, and quality systems optimization. Brad delivers solutions focused on the transformation of core business and scientific processes from R&D, through commercial launch, with a particular emphasis on regulated clinical operations improvement.

Glenn Engelmann is Senior Counsel in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C. office. In advising clients, he leverages his 25 years of experience managing complex legal and regulatory matters in the pharmaceutical industry. As the Vice Chair of McDermott’s multi-disciplinary global Life Sciences Industry Group, Glenn is integral to the ongoing development of the growth of this important part of the firm’s practice. Prior to joining McDermott, Glenn served as a member of Astra Zeneca’s executive leadership team responsible for managing the U.S. business. In this role, he provided advice and support to company leadership in addressing a wide range of legal and regulatory matters including defending multiple Federal and State investigations and patent challenges. For the last two and a half yearsof his tenure , he was responsible for the legal support for the global sales and marketing organization as well. In 2012, Glenn was selected as a Life Science Star by LMG Life Sciences. He is a member of the D.C. bar and is also past chair of the PhRMA Law Section Executive Committee.