Paul R. DeMuro
Retired Partner
Latham & Watkins LLP
Paul DeMuro retired from Partnership on September 30, 2012. Also a CPA, his practice focused on corporate, healthcare law and technology. Mr. DeMuro is currently pursuing his PhD in Biomedical Informatics at Oregon Health and Science University School of Medicine.
Mr. DeMuro is a member of the American Institute of Certified Public Accountants, the American Medical Informatics Association, the Medical Group Management Association, and a Fellow in The American College of Medical Practice Executives, the Healthcare Financial Management Association, the Health Care Compliance Association, the American College of Healthcare Executives and the American Health Lawyers Association. Chambers USA has listed Mr. DeMuro as a leading California Healthcare lawyer from 2007 to 2011.
Mr. DeMuro has authored more than 100 publications on various topics, such as: accountable care organizations, biomedical informatics, clinical integration, mergers and acquisitions, capital finance, corporate governance, Medicare reimbursement, fraud and abuse and various healthcare issues.
James Burgess
CEO
American Biomedical Group, Inc.
James Burgess is the CEO of The American Biomedical Group.
Gerald P. Schneeweis
Member
Clark Hill PLC
For over 35 years, Gerald Schneeweis has represented clients in state and federal trial and appellate courts. These include pharmaceutical, medical device, and other manufacturers in product liability litigation asserting claims of design and manufacturing defect, failure to warn and off-label promotion. He has acted as coordinating, regional and local counsel in federal and state-wide coordinated proceedings, asserting product liability claims against life sciences manufacturers and research entities. He served as lead coordinating counsel in multi-plaintiff product liability litigation on behalf of a dermal filler manufacturer/clinical trial sponsor and several of its former executives, officers and directors. He has also counseled manufacturers and insurers on various product liability issues, including adequacy of warnings, marketing, and FDA rules on promotion of off-label use.
In addition, Gerry has represented industrial, consumer and agricultural research companies in product liability, breach of warranty and breach of contract litigation. His experience also includes the representation of clients in design and engineering firms and retailers in commercial disputes, unfair competition and business torts, as well as IP litigation.
He is a member of the American Bar Association, Defense Research Institute and the American Board of Trial Advocates.
Cynthia M. Stamer
Attorney
Cynthia Marcotte Stamer PC
A nationally recognized workforce and health care management attorney, strategist, author, and advocate, Cynthia Marcotte Stamer is Martindale-Hubble AV-Preeminent (highest/top 1%) attorney Board Certified in Labor & Employment Law by Texas Board of Legal Specialization and American College of Employee Benefit Counsel Fellow, recognized as a "Top Woman Lawyer," "Top Rated Lawyer,” and "LEGAL LEADER™" in Health Care Law and Labor and Employment Law; among the “Best Lawyers In Dallas” in “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law, and with numerous other accolades for deploying her extensive legal and business knowledge with an insightful and pragmatic solutions orientation to provide client centric performance, compliance, risk, crisis and change management, health and employee benefit design and innovation, public policy and regulatory affairs advice, representation and advocacy, litigation and other enforcement defense representation, strategy, consulting counsel and expert witness services other operations critical legal and operations management advice, representation, coaching and training, regulatory affairs and other advocacy, and support for health care, employee benefits, insurance and financial, technology and other services, manufacturing, construction, government and other performance and compliance sensitive organizations and their leaders.
Cynthia helps organizations and leaders understand and use the law and processes to design, implement, administer, enforce and defend pragmatic, legally defensible policies, regulations and laws, practices, internal and external controls, insurance and risk management, and other tools to manage people, workforce and operational performance, regulatory and operational compliance, confidential information and other legal and operational requirements in crisis, change and other times on an ongoing and special project basis.
Carolina M. Wirth
Of Counsel
Arnall Golden Gretory LLP
Carolina is of counsel in the firm’s Food & Drug practice and is a member of the Dietary Supplements and Pharmaceuticals & Biologics industry teams. She provides clients with FDA regulatory guidance related to food, dietary supplements, drugs, cosmetics, and medical device products.
Carolina’s prior experience as regulatory counsel in CDER’s Office of Regulatory Policy at the FDA and as an in-house lawyer at a biotechnology company has aided her work with domestic and international clients on regulatory issues associated with the marketing, labeling, packaging, and advertising of conventional foods, prescription and over-the- counter (OTC) drugs, cosmetics, and dietary supplements. She also assists clients with Federal Trade Commission (FTC) and Better Business Bureau National Advertising Division inquiries. In addition, Carolina counsels clients on the clinical trial issues, including reviewing informed consent documents and master clinical trial agreements.
Prior to joining AGG, Carolina served as a food and drug regulatory attorney in private practice, including at Am Law 100 and 200 ?rms. She also served as Senior Vice President for Regulatory Affairs at a veterinary regenerative medicine company, where she was responsible for its overall strategy for obtaining FDA approval of veterinary stem cell products for various species and indications.
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