Edward Buthusiem is a managing director in BRG’s Health Analytics practice, and a leader of the firm’s Corporate Compliance and Risk Management practice, and a co-leader of its Pharmaceutical Valuation practice.
He has over thirty years of experience advising clients on a variety of business, regulatory, operational, intellectual property, litigation, transactional, and compliance matters, with particular emphasis in pharmaceutical and medical device product and technology licensing transactions, commercial and strategic transactions, business formation and planning, securities, mergers and acquisitions, compliance, and corporate governance. Since joining BRG in 2013, Mr. Buthusiem has provided expert testimony and support in litigation matters involving, among other things, the interpretation of licensing and development contracts relating to pharmaceutical and medical device product development, deal structures, valuation, damages calculations and pricing, matters involving fiduciary responsibilities, securities disclosure, adequacy of internal controls, and pharmaceutical pre-clinical and clinical development and commercialization.
Mr. Buthusiem has served as a government and court-appointed monitor for entities subject to post-settlement and post-acquisition mandates, including on behalf of the US Department of Justice (DOJ), Securities and Exchange Commission (SEC), and Office of Inspector General (OIG) in connection with civil and criminal actions. He has also served as a court-appointed monitor in connection with the disposition of assets in bankruptcy proceedings and as an independent third party to oversee the implementation of post-closing obligations primarily involving M&A transactions. He has advised healthcare companies and their legal counsel in implementing corporate integrity agreements (CIAs) and negotiating CIA terms with the DOJ, OIG, SEC, and other governmental agencies. Mr. Buthusiem has also developed and overseen all aspects of compliance programs, including auditing and monitoring; interactions and engagements with healthcare professionals; determining fair-market value of goods and services provided by and offered to physicians; strategic marketing and sales initiatives; transparency reporting; and clinical, research and development, and post-market surveillance.
Prior to joining BRG, Mr. Buthusiem served as general counsel, chief compliance officer, and head of Business Development for a $4 billion global dental and medical device business from 2010 to 2013. His responsibilities included heading the Business Development, Legal, Compliance, Trade Operations, and Environmental Health and Safety Departments and overseeing the provision of these services to global businesses.
Prior to that, Mr. Buthusiem was a senior executive at a $45 billion global pharmaceutical and consumer healthcare company. He served in senior capacities including Vice President Global and Strategic Transactions, Senior Vice President, Head of Deal Structuring & General Counsel of R&D and Senior Vice President, Head of Business Development & General Counsel of Vaccines and Senior Vice President & Special Counsel. Among other things, Mr. Buthusiem was responsible for structuring and managing the team that drafted and negotiated product and technology licensing agreements on a global basis as head of Business Development for the Vaccines division and head of Deal Structuring for Pharma R&D. Mr. Buthusiem also served on numerous project and product management teams that were responsible for the discovery, development, and marketing of new drugs and the lifecycle management of existing products and therapeutic franchises. He also managed the group responsible for providing governance and oversight for third-party collaborations as well as the development and dissemination of scientific marketing materials to prescribing physicians with overall responsibility for the company’s Speaker’s Program.
During his tenures at these companies, Mr. Buthusiem was responsible for directly structuring, valuing, drafting, and negotiating, as well as providing alliance management support for all global transactions, including mergers and acquisitions, joint ventures, pharmaceutical product and R&D licensing and development transactions, pharmaceutical product divestitures, investment banker and broker deals, venture capital partnerships, academic and scientific collaborations, commercial joint ventures, marketing, supply and distribution agreements, and other corporate and commercial transactions.
Altogether, Mr. Buthusiem was directly responsible for well over a thousand pharmaceutical and medical device transactions involving billions of dollars of value. His expertise includes the following types of transactions:
- Product and technology licensing and research collaboration agreements
- Research consortia agreements
- Intellectual property in-licensing, out-licensing, and cross-licensing agreements involving pharmaceutical and medical device products and projects.
- Drug, device, vaccine, and biological product research and development agreements
- Mergers and acquisitions involving businesses, pharmaceutical and medical device products.
- Early stage drug, device, vaccine, and biological product research development agreements
- Co-promotion and co-marketing agreements
- Manufacturing, supply, and distribution agreements
- Business broker and venture capital investment transactions
- Grant agreements
- Pre-clinical research agreements
- Government contracts
- CRO services agreements
- Clinical trial agreements
Mr. Buthusiem was previously an attorney in private practice with two nationally recognized law firms. During his tenure in private practice, he worked in both firms’ Corporate and Securities practices and provided legal advice in areas including M&A due diligence and transactions, as well as corporate agreement transactional drafting, guidance, and review.
Throughout his career both as a Business Development executive and general counsel, Mr. Buthusiem has advised numerous companies and institutions, their executive management, and boards of directors on corporate governance issues involving fiduciary duties and conflicts of interest. Mr. Buthusiem has rendered such advice in connection with the sale of pharmaceutical products to current and former employees and has also advised on similar situations while serving as a director on external boards. In each case, through his advice Mr. Buthusiem has sought to ensure that any conflicts of interest, whether in the context of transactions or generally, were appropriately addressed and proper safeguards implemented and followed accordingly.
Employment History
Temple University Beasley School of Law
Adjunct Professor
August 2015 – Present
Berkeley Research Group, LLC
Managing Director
January 2013 – Present
Kavo Kerr Group, a Danaher Company
General Counsel, Head of Business Development, Trade Operations and Environmental Health & Safety December 2010 – January 2013
GlaxoSmithKline plc (formerly SmithKline Beecham plc)
October 1990 – December 2010
Senior Vice President and Special Counsel
January 2009 – October 2010
Senior Vice President, General Counsel of Global R&D and Vaccines Divisions, Business Development (Vaccines) and Risk Management
January 2001 – January 2009
Vice President & Associate General Counsel, Strategic & Scientific Transactions Department
January 1995 – January 2001
Senior Counsel, Licensing and Commercial Transactions
October 1990 – December 1995
Dickstein, Shapiro & Morin
Associate
January 1987 – October 1990
Fried, Frank, Harris, Shriver & Jacobson
Associate
September 1985 – December 1987
