Expert Details
FDA, FTC, regulatory, fraud and abuse, e-discovery, OTC, pharma, sunshine act, social media
ID: 729311
New Jersey, USA
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Pharmaceutical online advertisingInteractions between pharma and physiciansCompliance at pharma companies, global regulatory affairs - best practicesE-discovery service providers and industry trendsLegal offshoring and outsourcing
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 2007 | Degree: JD | Subject: Law | Institution: Fordham University School of Law |
| Year: 2004 | Degree: BA | Subject: Political Science | Institution: University of Pennsylvania |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2015 to Present | Employer: Undisclosed | Title: Regulatory Counsel | Department: Legal |
Responsibilities:(Undisclosed) |
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| Years | Employer | Title | Department |
| Years: 2013 to Present | Employer: Undisclosed | Title: Counsel | Department: Law and Patents |
Responsibilities:(Undisclosed) |
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| Years | Employer | Title | Department |
| Years: 2013 to 2013 | Employer: (Undisclosed) | Title: Regulatory Attorney | Department: (Undisclosed) |
Responsibilities:Provided proactive legal support as member of advertising and promotional review committee for commercialized pharmaceutical productCounseled business functions in broad range of legal matters, including regulatory compliance, anti-kickback, and fraud and abuse laws |
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| Years | Employer | Title | Department |
| Years: 2011 to 2013 | Employer: (Undisclosed) | Title: Associate Director, U.S. Legal Department | Department: (Undisclosed) |
Responsibilities:Operationalized legal and regulatory requirements, partnering with business to achieve objectives by providing proactive legal counsel across organization on broad range of matters, including sales and marketing, research and development, federal Anti-Kickback statute, fraudand abuse laws, FDA regulations, Sunshine Act, medical grants, employment, samples, co-pay cards, sales training, intellectual property, pharmacovigilance, aggregate spend, licensing, insurance, social media, and corporate governance • Served as lead counsel and vital contributor on two Legal, Medical and Regulatory (LMR) review committees, reviewing all advertising and promotional materials and initiatives; obtained OPDP approval and launched new product formulation; optimized LMR review process, decreasing live meeting times while retaining highest quality review standards by establishing well-defined processes and roles • Collaborated with international colleagues, training on U.S. legal/compliance considerations, sharing best practices, and fostering strong working relationships, enabling increased compliance and establishment of innovative synergies across global organization • Drafted, reviewed, interpreted, negotiated, and counseled business on agreements and relationships with vendors, consultants, suppliers, and HCPs; developed, implemented and trained on enhanced contract process and templates, streamlining review of company agreements • Managed value-based relationships with outside counsel on litigation matters and legal issues, such as case strategy development, negotiation with potential indemnifying parties, drafting and administration of litigation holds, company risk assessment, record retention and discovery preparation, and vetting of litigation support vendors • Assisted in establishment of critical infrastructure for internal compliance with federal and state law and reporting requirements, providing indepth analysis of Sunshine Act, aggregate spend system, and source systems for reporting data • Managed and reconciled $1.7M budget for Legal and Compliance departments • Provided lively and engaging legal and compliance training to home office, field force, and international colleagues and clients on internal policies, U.S. state and federal regulatory landscape, pre-convention considerations, fifty-six affiliates’ interactions with U.S. healthcare practitioners, learnings from International Best Practices Forum, legally sensitive documents, and multi-national clinical research |
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| Years | Employer | Title | Department |
| Years: 2008 to 2011 | Employer: (Undisclosed) | Title: Associate Senior Counsel | Department: U.S. Legal Department |
Responsibilities:• Provide comprehensive guidance as lead counsel for four commercialized primary care and oncology products representing over $3.5B in revenue and nine client groups across organization• Counsel clinical teams on legal issues relating to research and development of three experimental compounds • Review and approve advertising and promotion materials, medical communications, and FDA correspondence as member of cross-functional team, which successfully obtained FDA-approval and launched new drug formulation • Negotiate consents to assignment and reviewed technical, quality, manufacturing, supply, and development agreements relating to $3.9B acquisition of privately-held biopharmaceutical company • Conduct over 80 client training sessions on diverse legal and compliance matters as top trainee-rated presenter • Protect company interests in broad range of legal matters, including contracts, regulatory compliance, risk assessment, records management, safety issues, packaging, labeling, social media and e-Discovery initiatives • Develop and implement sound operational policies through analysis and interpretation of relevant state and federal statutes and regulations |
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| Years | Employer | Title | Department |
| Years: 2006 to 2008 | Employer: (Undisclosed) | Title: Corporate Associate | Department: Corporate |
Responsibilities:• Represented clients in mergers, acquisitions, corporate governance and bankruptcy matters• Drafted corporate governance and organizational documents, and various agreements, including subordinated grid promissory notes, membership interest and stock purchase agreements, employment and confidentiality agreements, and services agreements • Researched federal statutes relating to foreign acquisition of assets of U.S. business enterprise, drafted closing documents, and co-drafted legal opinion in representation of high-tech Japanese public company in $37 million asset purchase • Managed multi-state closing and facilitated assignment of 150 vehicles in representation of privately-held national manufacturer and distributor in $160 million asset sale |
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| Years | Employer | Title | Department |
| Years: 2005 to 2005 | Employer: (Undisclosed) | Title: Summer Intern | Department: (Undisclosed) |
Responsibilities:• Researched and drafted motions in real estate litigation and generated arguments in support of variance requests and land use applications before Planning Board |
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International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 1915 to 1915 | Country / Region: Zurich, Switzerland | Summary: Presented at the 3rd Corporate Compliance & Transparency in Pharma The U.S. Sunshine Act: Shedding Light on HCP Payments • Gain insight into the requirements of the U.S. Sunshine Act; analyze the complexities of the regulations • Explore common threads between the U.S. Sunshine Act and transparency regulations, guidelines and codes across the globe • Understand the debate between supporters of transparency legislation and those advocating for industry self-regulation |
| Years: 1915 to 1915 | Country / Region: Barcelona, Spain | Summary: Presented at eyeforpharma Barcelona The Future is Now: Strategies for Engaging Patients via Social Media in Compliance with Current International Guidance and Regulation • Understanding jurisdictional restrictions on patient engagement via social media • Determining and mitigating risks associated with responsibility for user-generated content and the lack of detailed regulatory guidance • Navigating considerations, including pharmacovigilance, monitoring, content solicitation, access to information, and data security |
| Years: 1915 to 1915 | Country / Region: Rome, Italy | Summary: Presented at Digital Pharma Europe Welcome to the New Age: Navigating the Complexities and Uncertainty of Compliantly Engaging Patients via Social Media • Understand factors contributing to the international pharma community’s hesitance to utilize social media • Compliantly engage patients via social media and mitigate associated risks • Develop internal procedures to address social media considerations such as PV monitoring/reporting, access to information, and data security • Gain insight into FDA’s most recent thinking on social media |
Career Accomplishments
| Associations / Societies |
|---|
| Association of Corporate Counsel |
| Licenses / Certifications |
|---|
| J.D. |
Additional Experience
| Expert Witness Experience |
|---|
| Expert has argued before the NAD. |
| Training / Seminars |
|---|
| He has conducted over 80 live and web-based client training sessions as top trainee-rated presenter on diverse legal and compliance matters, including aggregate spend, state law, legally sensitive documents, IND law and pre-commercialization activities, pre-convention, and contract process. |
| Vendor Selection |
|---|
| He has led or played an integral role in two extensive and comprehensive RFP processes for vetting and choosing e-discovery vendors. I can provide in-depth analysis of the current landscape of the industry, trends in competition and business models, new technologies, differentiators, niche markets (such as various language recognition), pros and cons of specific approaches, pricing, judicial acceptance of predictive coding and the future of the industry. |
| Marketing Experience |
|---|
| He is a consultant who provides comprehensive consultations to clients and customers on a wide variety of topics, including, but not limited to, pharmaceutical online advertising, interactions between pharma and physicians, compliance at pharma companies, global regulatory affairs - best practices, legal process offshoring, legal information service providers, legal research platforms, and pre-settlement funding. |
Language Skills
| Language | Proficiency |
|---|---|
| Hebrew | He is proficient in the Hebrew language. |
Fields of Expertise
advertising, advertising claim substantiation, drug, drug labeling requirement, drug regulation, false claims act, Federal Food, Drug, and Cosmetic Act, Food and Drug Administration, Food and Drug Administration compliance, Food and Drug Administration regulation, law, pharmaceutical launch, pharmaceutical manufacturer, pharmaceutical marketing, product approval, statute, Internet advertising, over-the-counter drug regulation, prescription drug, product regulation, central nervous system agent, adverse drug reaction, health care provider, regulatory affairs, product evaluation, compliance, e-discovery, 21 CFR Part 11, investigational drug procedures, false advertising, over-the-counter market, drug label comprehension research, market development, market positioning, over-the-counter drug packaging, new consumer product development, drug container, over-the-counter topical drug product development, over-the-counter drug product development, Current Good Manufacturing Practice, pharmaceutical research and development, FDA food labeling regulation, Cooperative Research and Development Agreement, consumer product packaging, pharmaceutical product development, allergy medication, drug safety testing, drug development, pharmaceutical industry, Food and Drug Administration drug packaging regulation, packaging development, product, new drug, health care marketing, marketing, package, pharmaceutical drug, over-the-counter drug, investigational drug, Good Manufacturing Practice, expectorant drug