Rules of the Road: Staying Compliant Through Product & Promotional Development
Thursday, January 30 2014
8:00 am – 10:00 am
Location: MassBio, 300 Technology Square, 8th Floor, Cambridge, MA
Please join us for a lively discussion of compliance-related issues ranging from early product to promotional development for small to mid-sized (SME) life science companies. The discussion will touch upon current regulatory and compliance trends and how a SME can take those trends/issues into consideration during their product development and commercialization processes.
We have assembled a panel of legal, compliance, and regulatory experts to share their insights and experiences.
- Matthew DAmbrosio, Senior Vice President and Chief Compliance and Ethics Officer, Sunovion
- Luba Greenwood, Senior Corporate Counsel, Mergers and Acquisitions, Corporate Compliance, Pfizer Inc.
- Michael Loucks, Partner, Skadden, Arps, Slate, Meagher & Flom
- Tammy Phinney, Senior Director, Regulatory Affairs, Advertising, Labeling & Promotion, Biogen Idec
- Aditi Taylor, Principal, Governance, Regulatory & Risk Strategies, Deloitte & Touche LLP
- Jeremy Perisho, CPA, Partner, Forensic & Dispute Services, Deloitte Financial Advisory Services LLP
Who should attend? Anyone involved with or interested in:
- Regulatory & Medical Affairs
- Clinical trials
- Marketing and Labeling
- Commercial Operations
- Legal and Compliance issues
- R&D and Product Development
- Publications & Data Recording
This Forum is presented by the Legal & Regulatory Forum Working Group.
Matthew DAmbrosio, Senior Vice President and Chief Compliance and Ethics Officer, Sunovion
Matthew joined Sunovion in 2010 as Senior Vice President and Chief Compliance and Ethics Officer where he oversees the company corporate compliance and ethics program as well as the Internal Audit function. He has over 17 years of industry experience in legal, corporate compliance and government contracts and pricing roles.
Prior to joining Sunovion Matthew served as Vice President, US Legal Affairs and Chief Compliance Officer at Prostrakan, Inc. prior to their acquisition by Kyowa Hakko Kirin. He served for three years as Chief Compliance Officer at Reliant Pharmaceuticals, Inc. one of the nation's largest privately held pharmaceutical companies which was acquired by GSK in 2007.
Matthew started his career with Johnson & Johnson where he held several roles over 11 years in positions of increasing responsibility including being appointed as one of the first J&J operating company Compliance Officers and later spent six years running compliance programs in each of J&J's three sectors (Pharmaceutical, Device & Diagnostics and Consumer). He previously held an adjunct faculty position at Seton Hall Law in the Health Law Program where he developed and taught a course on Corporate Compliance.
Matthew holds a BS in Commerce from Rider University; MBA from Rutgers University Graduate School of Management; JD from Seton Hall Law.
Luba Greenwood, Senior Corporate Counsel, Mergers and Acquisitions, Corporate Compliance, Pfizer Inc.
Luba Greenwood is the Senior Mergers & Acquisitions Corporate Counsel at Pfizer Inc. Luba has extensive experience as a transactional lawyer, strategic advisor, and compliance and litigation counsel, representing clients, including pharmaceutical, biotechnology, and medical device companies, in connection with mergers and acquisitions, joint-ventures, venture capital financing, intellectual property, securities, and litigation matters.
Prior to joining Pfizer, Luba was at WilmerHale where she represented clients in criminal and civil investigations, and litigation involving FCPA and anti-kickback statute violations, healthcare and securities fraud, insider trading, money laundering, and financial reporting and disclosure improprieties. Luba specializes in emerging markets including Eastern Europe, India, Middle East, and China.
Luba is a frequent lecturer at Bentley University and participated on numerous panels on topics relating to innovation, global expansion strategies, assessment and management of legal and compliance risks, white collar criminal matters, intellectual property protections and litigation, deal structuring, and early stage and venture capital investments. She is also a legal mentor for the MIT Entrepreneurship Competition and on the Steering Committee for the Boston Bar Association.
Michael Loucks, Partner, Skadden, Arps, Slate, Meagher & Flom
Michael K. Loucks, a nationally recognized health care fraud prosecutor, joined the firm as a litigation partner in the Boston office in July 2010. With 25 years in public service, Mr. Loucks most recently served as acting U.S. attorney and first assistant U.S. attorney for the District of Massachusetts, where he led major criminal and civil investigations, as well as many of the most high-profile health care fraud prosecutions of the past two decades.
Since joining Skadden, Mr. Loucks’ practice has focused on representing companies in government criminal investigations, in False Claims Act and other civil litigation, in regulatory matters with the Food and Drug Administration and the Office of Inspector General, and in Foreign Corrupt Practices Act investigations. He has represented, among others, U.S. and international pharmaceutical and biotech companies; medical device companies; health maintenance organizations; physician-owned hospitals; an ambulance provider; a seafood processing plant; a publishing company; a genetic testing laboratory and its owners; and a United States senator. He has done work on matters in Brazil, the Ukraine, Serbia and Germany, in addition to his work in the United States. His government investigation work has involved off-label promotion and anti-kickback issues; alleged violations of the Clean Air Act; and FCPA issues. He and his Boston team have successfully achieved the termination, without either prosecution, the pursuit of a civil action, or the execution of a settlement agreement, of numerous government investigations. Mr. Loucks and his team also have assisted in due diligence reviews in mergers and acquisitions involving nursing homes, pharmaceutical benefit managers and retail pharmacies, and hospitals.
While acting U.S. attorney and first assistant, he reviewed and approved all major prosecutions and civil matters, including all health and defense False Claims Act matters, all environmental prosecutions (including Clean Water Act discharge cases), all Armed Export and Control Act (AECA) and major export and embargo-related criminal prosecutions, and all major public corruption prosecutions. The AECA investigative matters that he supervised and the cases in which he authorized prosecutions included alleged export of prohibited weapons and nuclear reactor components; alleged export of weapons and missile systems components; and alleged export of combat aircraft components (tachometers used in C-130 military flight simulators). He also closely supervised an undercover operation that lasted multiple years, culminating in the arrest of two Chinese nationals and the indictment of their company (the defendants were convicted in 2010).
Before serving as acting U.S. attorney, Mr. Loucks had a long history in the Massachusetts U.S. Attorney’s Office. He was first assistant U.S. attorney (2005-2009); white collar crime section chief (2005); health care fraud unit chief (1997-2004); and health care fraud coordinator (1992-2004), where he established the office’s health care fraud practice and was involved in major prosecutions, including those involving pharmaceutical and medical devices. He was lead counsel in more than 25 trials and has argued numerous appeals in the First Circuit Court of Appeals. He joined the U.S. Attorney’s Office in 1985, after five years in private practice.
Mr. Loucks speaks frequently at seminars and symposia on prosecutions, corporate compliance and litigation-related issues associated with the health care, pharmaceutical and medical devices sectors. He also writes extensively on these topics and is the co-author of Prosecuting and Defending Health Care Cases, the leading treatise in the area.
Mr. Loucks has been recognized for his achievements by several government agencies, including receiving multiple awards or citations from the Department of Justice, the Food and Drug Administration, the Department of Health and Human Services, the U.S. Attorney’s Office for the District of Massachusetts and the Federal Bureau of Investigation.
Mr. Loucks was selected for inclusion in Chambers USA: America’s Leading Lawyers for Business 2013 and The Best Lawyers in America 2013 and 2014. In 2011, he received the Burton Award for Legal Achievement, which recognizes excellence in legal scholarship. Mr. Loucks also was selected in the Boston Business Journal’s inaugural “Who’s Who in Legal Services” (March 11, 2011).
Jeremy Perisho, CPA, Partner, Forensic & Dispute Services, Deloitte Financial Advisory Services LLP
Jeremy Perisho is the Life Science & Health Sciences Leader for Deloitte Financial Advisory Services (FAS) with a focus on the Life Science Sector. Jeremy has more than 20 years of experience with Deloitte and has served as client service and engagement partner on Financial Advisory Services projects for some of the leading global companies in the life sciences industry. In particular, she has wide-ranging experience in handling both internal and government investigations, supporting life science companies with Office of Inspector General / Department of Justice / State Attorney General investigations into matters involving the Anti-kickback statute, allegations of off-label promotion and other types of health care fraud and Foreign Corrupt Practice Act violations. Jeremy’s professional affiliations include the American Institute of Certified Public Accountants. Jeremy is also an active leader in several professional industry organizations and is a frequent speaker at industry conferences in the United States and abroad
Tammy Phinney, Senior Director, Regulatory Affairs, Advertising, Labeling & Promotion, Biogen Idec
Tammy has over 20 years of experience in Regulatory Affairs including more than 14 years in the advertising, promotion and labeling area. Tammy’s background includes significant experience in drafting and negotiating product labels including more than 20 label changes for Biogen Idec’s commercial drug, Tysabri. In addition to drafting and revising labels, she has extensive experience with REMS programs and requirements. Tammy has worked on the launch of BiogenIdec’s 3 MS products which involved working with commercial teams on the development, review and approval of launch campaigns and subsequent revisions to those campaigns. She has broad based experience in the review of communication materials across a wide spectrum including press releases, investor materials, promotional materials as well as training materials for internal teams. In addition to promotional materials, Tammy has worked with medical affairs teams in developing compliant materials for field based medical teams. She has experience working with OPDP and has established successful working strategies with OPDP reviewers.
Aditi Taylor, Principal, Deloitte & Touche LLP
Aditi Taylor is a Principal in our Life Sciences’ Governance, Regulatory and Risk Strategies practice. She is based in Boston, MA and has 14 years of experience in compliance and control assessments. Aditi manages engagements related to risk assessments, program implementation and advisory services interacting with various functions within the legal, compliance, commercial operations and regulatory affairs departments at her clients. She has led several engagements to assist clients evaluate their risks; enhance their business processes and operations through use of efficient and effective processing procedures and sophisticated technology solutions. She has constantly demonstrated the ability to successfully manage projects given the ambiguity inherent in a complex and dynamic regulatory and enforcement environment by drawing from a diverse set of experiences, training, and skills.
Her primary focus is on advising life sciences companies on numerous regulatory risk and commercial compliance activities, including but not limited to, assessing product advertising and promotional materials, speaker programs, compliance programs, PhRMA code compliance, designing aggregate spend and transparency processes for Sunshine and other state regulations, publications, medical science liaison activities, third party compliance, developing auditing and monitoring programs, and creation of policies and SOP documents. She has worked with clients under Corporate Integrity Agreements (CIA) leading CIA implementation, remediation and global audits and assessments of commercial compliance activities. She has also assisted clients implementing programs and processes to monitor the external regulatory and compliance environment and to develop scenarios to assess the impact of identified global changes and trends and targeted products.
Aditi has a B.A. in Economics from the University of Mumbai, India, a MBA from Bentley University, Waltham, MA and a Graduate Certificate in Pharmaceutical and Medical Device Law and Compliance, Seton Hall Law School, Newark, NJ.