Brian P. Sharkey

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Brian Sharkey is a Principal of Porzio, Bromberg & Newman. He is a member of the firm's Life Sciences Practice Group and is a Vice President of Porzio Life Sciences, a subsidiary of the firm. He counsels life sciences companies on a variety of compliance-related issues, most significantly those relating to ex-US marketing disclosure and gift limitation laws and industry codes. In particular, Brian focuses on helping companies understand and comply with global reporting requirements for transfers of value to healthcare professionals, healthcare organizations, and patient organizations. Brian has written and spoken extensively on the evolving global transparency landscape for disclosure requirements, including with respect to data privacy obligations. Brian also has experience performing internal company investigations.

Prior Relevant Experience
  • Justice Peter G. Verniero, New Jersey Supreme Court, Clerk, 2000–2001
  • Porzio, Bromberg & Newman, P.C., Summer Associate, 1999
  • Office of the Attorney General, Division of Law, Newark, NJ, Law Clerk, 1998
  • Durek & Harth, Attorneys at Law, Iselin, NJ, Law Clerk, 1998
  • Governor’s Office of Constituent Relations, Trenton, NJ, Aide to the Governor, 1996–1997
Honors and Awards
  • Recognized on the New Jersey Super Lawyers "Rising Stars" List, 2007, 2009-2015

Honors and Awards

Organizations/Memberships
  • New Jersey State Bar Association
  • New York State Bar Association
Speaking Engagements
  • "Global Transparency Trends & Challenges," Seton Hall's European Healthcare Compliance Certificate Program, Paris, France, June 9, 2017.
  • "EFPIA Reporting and Consent Management," CBI's 8th Annual West Coast Forum on Transparency and Aggregate Spend, San Diego, CA, May 24, 2017.
  • "Aggregate Spend – 20 Things to Know About Transparency," 13th Annual Medical Device Compliance Congress, San Diego, CA, May 22, 2017.
  • Moderator, "Impact of Self-Regulation Schemes on Industry Relationships with HCPs, HCOs and Patient Organizations," PCF International Pharmaceutical Compliance Congress, Lisbon, Portugal, May 16, 2017.
  • "World Showcase - Adhere to Global Laws and Codes in Emerging Markets," CBI's 14th Annual Pharmaceutical Compliance Congress, Washington, DC, April 27, 2017. 
  • Moderator, "Cross-Borders Transparency Reporting," CBI's 7th Annual Global Transparency Reporting Congress, London, UK, April 5, 2017.
  • Moderator, "The Evolution of Company Compliance Programs With An Eye Towards Monitoring," Porzio Compliance Forum, Newark, NJ, February 10, 2017.
  • "EFPIA Disclosure and Consent Management – Experiences from the First Round of Disclosure in 2016," qordata Webinar, February 2, 2017.
  • "The Intersection of Global Meetings and Global Transparency," CBI's 5th Annual Global Pharmaceutical and Medical Meetings Summit, Philadelphia, PA, February 1, 2017.
  • Moderator, "EFPIA Disclosure Panel," CBI's 3rd Annual Global Compliance Congress, London, UK, November 17, 2016.
  • "Optimize Global Transparency Reporting and HCP Relationship Management Strategies," CBI's 7th Annual West Coast Compliance Congress, San Francisco, CA, November 10, 2016.
  • "EFPIA Data Demonstrates the Challenges Confronting Companies," 17th Annual Pharmaceutical and Medical Device Compliance Congress, Washington, DC, October 19, 2016.
  • "The Challenges of EFPIA Reporting are Disclosed by the Data," Pharma Compliance Europe, London, UK, October 6, 2016. 
  • "First Round of EFPIA Reporting: The Data Reveals the Challenges," AHM's Life Sciences European Compliant HCP Interactions & Risk Mitigation Seminar, Windsor, UK, October 4, 2016.
  • "Transparency Disclosure Guidelines Around the World," CBI's 10th Annual Forum on Transparency and Aggregate Spend, Washington, DC, August 16, 2016.
  • "Global Transparency Trends & Challenges," Seton Hall's 2016 European Healthcare Industry Training: Compliance Certification Program, Paris, France, June 9, 2016.
  • "Tips for Moving From Domestic to International Reporting and EFPIA-U.S. Reporting Requirements," CBI's 7th Annual West Coast Forum on Transparency and Aggregate Spend, San Diego, CA, May 18, 2016.
  • "Lessons Learned from EU Sunshine Reporting Statistics and Best Practices," ACI's 10th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, New York, NY, April 28, 2016.
  • "Data Aggregation - Challenges with Managing Cross-Border Spend," CBI's 13th Annual Pharmaceutical Compliance Congress, Washington, DC, April 26, 2016.
  • Moderator, "EFPIA/Sunshine Act," The 12th Annual Meeting of ISMPP, National Harbor, MD, April 12, 2016.
  • "Data Transparency - Domestic and Abroad," The 12th Annual Meeting of ISMPP, National Harbor, MD, April 12, 2016.
  • "The Latest Transparency Disclosure Guidelines Around the World," CBI's 6th Global Transparency Reporting Congress, Frankfurt, Germany, April 8, 2016.
  • "HCP Payments Transparency Outside of the US: An Evolving Complex Environment with Implications for Medical Device Companies," Porzio Life Sciences, LLC Webinar, March 23, 2016.
  • "Transpa Going Global: How Reporting in the US Matches Up to the O-US Reporting Regime," Porzio Life Sciences, LLC Webinar, March 3, 2016.
  • "European Transparency: Lessons Learned from the American Experience," Porzio Compliance Forum, Newark, NJ, December 3, 2015.
  • "Global Transparency of HCP Data - The Current Environment and Future Direction of Disclosure Code," CBI 2nd Global Compliance Congress for Life Sciences, Munich, Germany, November 19, 2015.
  • Moderator, "HCP Relationship Management Post-Reporting - Lessons Learned from U.S. Sunshine Act," CBI 2nd Global Compliance Congress for Life Sciences, Munich, Germany, November 18, 2015.
  • "Current Environment and Future of HCP Spend Reporting Codes Globally," CBI West Coast Compliance Congress, San Francisco, CA, November 6, 2015.
  • "Implementation of EFPIA's Code on Disclosure of Transfers of Value - The Impact on Publication Strategy and Planning" at the CBI Publication and Clinical Trial Disclosure Congress, Brussels, BE, June 24, 2015.
  • "Anti-Corruption and Disclosure - How the Two Work Together to Boost Compliance Using Disclosure Obligations to Fight Corruption," ACI Inaugural Summit on International Transparency, Chicago, IL, June 11, 2015.
  • "Global Transparency Trends & Challenges," Seton Hall European Healthcare Compliance Certification Program, Paris, France, June 2, 2015.
  • Moderator, "Mini Summit IV: Advanced Issues in Global Transparency, Disclosure and Aggregate Spend Compliance," The International Pharmaceutical Compliance Congress and Best Practices Forum, Brussels, BE, May 12, 2015.
  • "The Sunshine Act and the Impact on Global Enforcement: How to Satisfy Reporting Obligations and Assess the Risks Posed by the Disclosed Data," ACI's 9th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, New York, NY, April 28, 2015.
  • "The Sunshine Act, One Year Later," Workshop, 11th Annual Meeting of ISMPP, Optimizing Scientific Value:  Smart and Systematic Approaches to Medical Publications, Arlington, VA, April 27, 2015.
  • "Around the World in 80 Days - A Tour of Various National Reporting Mandates,"  CBI's 5th Annual Global Transparency Reporting Congress, London, UK, April 15, 2015.
  • "Global Transparency of HCP Data - Current Environment and Future of HCP Spend Reporting Code," CBI's 12th Annual Pharmaceutical Compliance Congress, Washington District of Columbia, March 3, 2015.
  • "Scientific Publications and Transfer of Value Reporting," Q1 Productions, January 27, 2015.
  • "Global Transparency Trends & Challenges," European Healthcare Compliance Certification, Paris, France, November 18, 2014.
  • Moderator, "Uncharted Compliance Waters - Ex-U.S. Transparency Challenges," Porzio Compliance Forum, Seton Hall Law, Center for Health and Pharmaceutical Law and Policy, Newark, NJ, October 30, 2014.
  • "Post Conference Master Class on Setting up an International Transparency Program: Risk Mitigation Strategies for Global Spend," 6th Annual Forum on Sunshine Act, Open Payments and Aggregate Spend Compliance, American Conference Institute, New York, New York , October 22, 2014.
  • "Sunshine Abroad: Do Start Believin' - The Global Transparency Journey for the Life Sciences Industry," Porzio Life Sciences, LLC Webinar, October 2, 2014.
  • "Data Privacy in the Global Transparency Era," CBI's 8th Annual Forum on Transparency & Aggregate Spend, Washington District of Columbia, August 18, 2014.
  • "Disclosure of Financial Support – The Impact on Medical Publications," CBI Publication and Clinical Trial Disclosure Forum, Dublin, Ireland, June 10, 2014.
  • "Global Transparency Trends and Challenges," Seton Hall University School of Law European Healthcare Compliance Certification Program, Prague, Czech Republic, June 3, 2014.
  • Co-Moderator, "Mini Summit V: Advanced Issues In Global Transparency, Disclosure and Aggregate Spend Compliance," The International Pharmaceutical Compliance Congress and Best Practices Forum, May 6, 2014, Dubai, United Arab Emirates.
  • "The Sunshine Act," 10th Annual Meeting of International Society for Medical Publication Professionals, Arlington, VA, April 9, 2014.
  • "The Sunshine Act Abroad: A Global Perspective on Transparency Rules and Regulations," 10th Annual Meeting of International Society for Medical Publication Professionals, Arlington, VA, April 8, 2014.
  • "The Status of Implementation of EFPIA's Code by Member Associations and, to the Extent Countries Have Done So, Where are There Consistencies/Inconsistencies Among Codes," The National Disclosure Summit, Washington, District of Columbia, February 7, 2014.
  • Moderator on Panel, "Engaging Healthcare Professionals in the US and Overseas: Issues and Challenges," Small and Mid-Sized Life Sciences Companies Still Face Big Issues - Minimzing the Risks, Porzio Compliance Forum, Newark, NJ, October 18, 2013.
  • "Global Applications of the Sunshine Act's Reporting Requirements," Lawline Video CLE, September 2013.
  • "Sunshine Abroad: Evaluating Regulations and Transparency Trends," Porzio Life Sciences, LLC Webinar, September 2013.
  • "Sunshine Abroad: Evaluating Regulations and Transparency Trends," Porzio Life Sciences, LLC Webinar, August 2013.
  • CBI's 4th Annual West Coast Forum on Sunshine and Aggregate Spend (San Diego 4/24/2013, Speaker - "Intro Class - A Crash Course in State, Federal and Global Transparency Requirements and Aggregate Spend Solution"/"Evaluate International Regulations and Global Transparency Trends""
  • "Update on International Transparency Laws and Industry-Adopted Codes," CBI's 10th Annual Pharmaceutical Compliance Congress PCC 2013, Washington, DC., January 29- 30, 2013.
  • "The Trend Towards Global Transparency - A Challenging New World for the Life Sciences Industry," 3rd Annual West Coast Compliance Congress for Pharmaceutical, Biotech and Medical Device/Diagnostics Companies, San Francisco, CA, November 28-29, 2012.
  • "Global Transparency – Lessons Learned from U.S. Reporting," Porzio Pharmaceutical Services, LLC Webinar, May 30, 2012.
  • "Understanding the International Transparency Landscape," Q1: Pharmaceutical and Medical Device Global Transparency Initiatives Conference, Boston, MA, May 21, 2012.
  • "NJICLE Presents Recent Developments in New Jersey Law," New Jersey Law Center, New Brunswick, New Jersey, August 11, 2010.
  • New Jersey Legislature Testimony re: Citizens United v. Federal Election Commission and Its Impact on New Jersey's Pay-to-Play Laws, Assembly Judiciary Committee, Trenton, New Jersey, February 18, 2010.
  • "Electronic Documents: Avoiding the Ethical Pitfalls of Metadata," Audio Conference, Center for Competitive Management, February 24, 2009.
  • Workshop on Judicial Clerkships, Seton Hall Law School, April 1, 2008.
  • "Be on Your Best Behavior: An Ethics Update for Municipal Lawyers, Lawyer-Lobbyists, Public Officials and Those who Contribute to Them,” New Jersey State Bar Association Mid-Year Meeting, Santa Barbara, California, November 7, 2007.
  • "Building a Successful Legal Career: Gathering the Right Tools for the Job," Seton Hall University School of Law, Newark, New Jersey, November 2, 2002.
  • "Product Liability from A to Z," ICLE Seminar, June 29, 2002.
Publications
  • "A Milestone Moment (or a Dead Jellyfish) for the Global Transparency Movement," Porzio Life Sciences, LLC, by D. Jeffrey Campbell and Brian P. Sharkey, August 2016.
  • "The Sun Never Sets on Transparency," Medical Writing by the European Medical Writers Association, March 2016.
  • "Ready Or Not, Full Speed Ahead For The Global Transparency Movement," Porzio Life Sciences, LLC, by D. Jeffrey Campbell and Brian P. Sharkey, August 2015.
  • "C-O-N-S-E-N-T: Find Out What it Means to You," prepared for distribution at CBI's 12th Annual Pharmaceutical Compliance Congress, January 2015.
  • "Do Start Believin!: The Life Sciences Industry's Journey to Global Transparency," prepared for distribution at CBI's 8th Annual Forum on Transparency & Aggregate Spend, August 2014.
  • "Getting the Deal Through - Life Sciences 2014," United States Chapter, published by Getting the Deal Through, 2014.
  • "Sunshine Spreading Across the Atlantic and Over Europe," European Medical Writers Association, Vol. 22, Iss. 4, December 2013.
  • "Holland. The Original Cool.," Sunshine Abroad: International Transparency, October 2013.
  • "EFPIA Leads the Self-Regulation Charge to Try to Avoid Government-Imposed Transparency," Sunshine Abroad: International Transparency, July 2013.
  • "The Ongoing Global Transformation in Life Sciences Transparency," by D. Jeffrey Campbell, Esq. and Brian P. Sharkey, Esq. Prepared for distribution at CBI’s 7th Annual Forum on Sunshine and Aggregate Spend, August 2013.
  • "Watch The Hot Spots For Pharma Self-Regulation," Law360.com, July 12, 2013.
  • "Here Comes the Sunshine Act - This Time, In Europe," Law360.com, June 26, 2013.
  • "Australia Takes Center Stage in the Global Debate Over Life Sciences Transparency:Legislation vs. Self Regulation," Bloomberg BNA Pharmaceutical Law & Industry Report, March 2013.
  • "Getting the Deal Through - Life Sciences 2013," United States Chapter, published by Getting the Deal Through, 2013.
  • "The Trend Towards Global Transparency: A Challenging New Work for the LifeSciences Industry," D. Jeffrey Campbell, Brian P. Sharkey (August 14, 2012) –prepared for distribution at the CBI’s 6th Annual Forum on Sunshine and Aggregate Spend, August 14-16, 2012, Washington, DC.
  • "New Jersey Supreme Court Provides a Mixed Result in a Medical Device Preemption Decision," IADC Committee Newsletter, Drug, Device and Biotechnology, October 2012.
  • Attribution in article, "Win Some Lose Some," in Science of Risk, July 19, 2012
  • Co-Author, "Getting the Deal Through - Life Sciences 2012," United States Chapter, published by Getting the Deal Through, February 2012.
  • "The Federal Courts Jurisdiction and Venue Clarification Act of 2011: What it Means for Your Federal Practice," International Association of Defense Counsel's Drug, Device, and Biotech Committee Newsletter, January 13, 2012.
  • Editor, "The New Reality of Sales Force Behavior and Management," FDLI Monograph Series, Vol. 2, Num 6, June 2011.
  • Founder and Author, Porzio Appellate Law Blog, http://porzioappeallaw.pbnlaw.com/, 2010.
  • "10 Questions, and Answers, to Get You Tweeting," ABA Young Lawyers Division - the Young Lawyer Newsletter, Vol. 15, No. 1, October 2010.
  • "Governor Christie's Executive Orders Before the New Jersey Appellate Division: One Win, One Loss, and One "Draw" For the Governor," ABA Business Law Section:Government Affairs Practice Newsletter, Vol. 1, Iss. 3, Summer 2010.
  • "A Controversial Campaign Finance Decision Should Not Impact Pay-to-Play Laws," New Jersey Law Journal, May 3, 2010.
  • "Courts and Congress Respond to Citizens United v. Federal Election Commission," ABA Young Lawyers Division - the Young Lawyer Newsletter, Vol.14, No. 7, May 2010.
  • "An Examination of New Jersey's Pay-to-Play Laws," ABA Business Law: Governmental Affairs Practice Newsletter, Winter 2010.
  • "The Appellate Division Rebuffs the Attempts of Litigants to Create Appellate Jurisdiction," New Jersey Law Journal, December 14, 2009.
  • "The Uncertainty Surrounding “Design" in Design Defect Cases," IADC Defense Counsel Journal, October 2009.
  • "Recent Corruption Arrests Could Lead To More, And Tougher, Pay-To-Play Laws," Association of Corporate Counsel, Focus on the New Jersey Chapter, August 2009.
  • "State Treasurer Defines 'State Redevelopment Entities,' Pursuant to Executive Order 118," Porzio Update, June 2009.
  • Third Circuit Editor, Products Year-In-Review, DRI Product Liability Conference, April 2009.
  • "The Importance of the ‘Design’ In a Product Liability Design Defect Case," IADC Product Liability Committee Seminar, February 2009.
  • "Attorney-Client Privilege in the United States Versus Abroad and Its Effects on Multi-National Companies," IADC Product Liability Committee Webinar, January 2009.
  • "The New Jersey Supreme Court Upholds the Constitutionality of the State's Pay to Play Law and Requires Strict Adherence to Its Provisions," Porzio Update, January 2009.
  • "Two Recent New Jersey Cases Suggest Limited Liability for Defendants in Automotive Cases," ABA TIPS Products, General Liability and Consumer Law Committee Newsletter, Fall 2008.
  • "Business Beware: Political Contributions Can Cost You Government Contracts," Porzio Update, August 2008.
  • "Buyer Beware: You May Be Liable for the Defective Products of Your Predecessor" Defense Counsel Journal, Vol. 75, No. 2, April 2008.
  • "New Jersey Supreme Court’s Decision on Admissibility of Expert Testimony Could Affect Whether New Jersey Remains a Hotbed of Product Liability Litigation," IADC Product Liability Newsletter, December 2007.
  • "Asbestos Victories Buck National Trend," New Jersey Law Journal, November 5, 2007.
  • "The Product Liability Law Maze and the Consequences for Companies That Become Trapped in It," Strategies for Limiting Product Liability: Leading Lawyers on Preventing Claims, Developing Company Policies, and Mitigating Risk, Inside the Minds, October 2007.
  • "Bucking the Tort Reform Trend? Manufacturer of Non-Asbestos Product Has Duty to Warn About Asbestos Dangers," LJN’s Product Liability: Law and Strategy, Vol. 26, No. 3, September 2007.
  • "Buyer (of the Assets of a Company) Beware," LJN's Product Liability: Law and Strategy, Vol. 25, No. 7, January 2007.
  • "How the Pharmaceutical Industry is Coming Under Attack — Part II," Metropolitan Corporate Counsel, January 2007.
  • "How the Pharmaceutical Industry is Coming Under Attack — Part I," Metropolitan Corporate Counsel, December 2006.
  • "Talking To Your Client Could Get You In Trouble," New Jersey Law Journal, October 2, 2006.
  • "Are You a Governmental Affairs Agent? New Law Broadens Definition of Lobbyist, Bestows Nebulous Title," New Jersey Law Journal, May 29, 2006.
  • "Recent Developments in Products, General Liability, and Consumer Law," Tort Trial & Insurance Practice Law Journal, Winter 2006.
  • "Will Congress Follow the Lead of State Legislatures and Force the Pharmaceutical Industry to Counteract the Methamphetamine Epidemic?," American Bar Association (ABA) Trial Tort and Insurance Practice Section Products, General Liability and Consumer Law Newsletter, Winter 2006.
  • "New Jersey Supreme Court Holds That a Forklift Manufacturer’s Compliance with OSHA Regulations Preempts State Product Liability Law," Porzio Update, January 27, 2006.
  • "Will Congress Follow the Lead of State Legislatures and Force the Pharmaceutical Industry to Counteract the Methamphetamine Epidemic?," The Metropolitan Corporate Counsel, November 2005.
  • "Asbestos Premises Liability Trends," IADC Defense Counsel Journal, July 2005.
  • "The Class Action Fairness Act of 2005: Overview, Historical Perspective, and Settlement Requirements," Tort Trial & Insurance Practice Law Journal, Summer 2005.
  • "Federal Class Action Reform Legislation Enacted After Years of Failure," American Bar Association (ABA) Products, General Liability and Consumer Law Newsletter, Spring 2005.
  • "The District Court of New Jersey Predicts That the New Jersey Supreme Court Would Permit a Plaintiff to Recover Pure Economic Loss Under a Strict Product Liability Theory Despite the Economic Loss Rule," IADC Product Liability Newsletter, July 2004.
  • "Defending Against Post-Sale Warning Claims," LJN’s Product Liability Law and Strategy, June 2004.
  • "The New Jersey Supreme Court Requires the Insured in a Long-Tail Environmental Exposure Case to Satisfy the Deductible of Each Triggered Policy," IADC Toxic and Hazardous Substances Litigation Newsletter, April 2004.
  • "Will Tort Reform be the Legacy of the September 11th Victim Compensation Fund?," New Jersey Law Journal, September 8, 2003.
  • "Now Is Congress’ Window of Opportunity to Resolve the Asbestos Litigation Crisis," New Jersey Law Journal, February 3, 2003.
  • "Asbestos Litigation Is a Crisis Spiraling Out of Control," New Jersey Law Journal, January 27, 2003.
  • "Removal of a Safety Guard Could Satisfy the Intentional-Wrong Exception," New Jersey Law Journal, November 4, 2002.
  • "Crawford-El v. Britton: The Supreme Court Re-Examines the Qualified Immunity Defense Within the Confines of the Federal Rules of Civil Procedure," 29 Seton Hall L. Rev. 1122 (1999).
  • "Third Circuit Predicts that the Pennsylvania Supreme Court Would Not Apply the Doctrine of Apparent Authority to Enforce an Attorney’s Unauthorized Settlement of a Client’s Claim," 30 Seton Hall L. Rev. 409 (1999).

Practice

Industries

Related Media

Bar Admissions

  • New Jersey, 2000
  • New York, 2001

Education

Seton Hall University School of Law, Newark, New Jersey, J.D., magna cum laude, 2000

  • Seton Hall Law Review, Notes Editor, 1999–2000; Member, 1998–1999
  • Best Oralist, Appellate Advocacy, Fall 1999
  • Cybercrimes National Moot Court Competition: Champion, Best Brief, Best Oralist, 2000
  • Lexis Publishing Company Commercial Law Book Award
  • Chicago Title Insurance Company Award

The College of New Jersey, Ewing Township, New Jersey, B.A., 1997

  • Brian Stack Internship Program
  • Pi Sigma Alpha, National Political Science Honor Society

Contact Address

100 Southgate Parkway

Morristown, NJ 07962-1997

Phone: 973.538.4006

Fax: 973.538.5146

  • Sharkey, Brian