Health (Pharmaceuticals)

 

• Experience with regulatory and transactional issues for corporate entities involved in life sciences, managed care, medical devices, medical equipment, medical technology and pharmaceutical manufacturers.

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• Legal support and advocacy for the use of Six Sigma methodologies – such as the define, measure, analyze, improve and control (DMAIC) improvement cycle – to decrease waste, enhance productivity and reduce costs in the various processing operations (such as raw material storage, raw material treatment, unit operations, packing and shipping).

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• Consultation for the legal aspects of product safety, such as how to initiate a product recall, interacting with government investigators, outsourcing, possible remedial protocols, retaining subject matter experts (SMEs) in various product-related disciplines, testing protocols, and the timing of when to report product issues.

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• Consultation for various services, such as adverse events, clinical hotline, co-pay, coupon program, distribution, group purchasing, manufacturing, reimbursement hub, Section 340B drug discount program, and wholesale.

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• Analysis of the legal issues involved in payment and reimbursement for various distribution channels.

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• Consultation regarding the complexities of price reporting to Federal agencies.

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• Consultation for achieving drug approvals, labeling, non-patent exclusivity provisions and patent certifications.

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• Experience with biologics and biosimilar products.

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• Experience with academic medical center (AMC) and academic research organization (ARO) operations.

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• Collaboration with various pharmaceutical business units, such as contracting operations, market access, marketing, sales, strategic pricing and trade relations.

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• Experience with regulatory and transactional issues for corporate entities involved in life sciences, managed care, medical devices, medical equipment, medical technology, pharmaceutical manufacturers, and various types of pharmacy-related organizations, such as pharmacies, pharmacy benefit management and pharmacy benefit management (PBMs), such as academic medical centers (AMCs), academic research organizations (AROs), anti-kickback, antitrust, business development, clinical research organizations (CROs), clinical trial organizations (CTOs), clinical trials, collaborations, communications, compliance, conflicts of interest, consumer protection, corporate governance, critical partnering, data licensing, data transfer, distribution, divestitures, Drug Enforcement Agency (DEA) investigations, due diligence, employment issues (such as agreement templates, conduct, corporate policies, disability, discipline, handbooks, immigration, leaves of absence, offer letters, performance criteria, and terminations), ethics, False Claims Act (FCA), Food and Drug Administration (FDA) guidelines, formularies, fraud and abuse, health care delivery systems, hospitals, incentives, insurance, intellectual property, investments, joint ventures, litigation, logistics, manufacturing, marketing, Medicaid "best price", medical research and development (R&D), National Institutes of Health (NIH) requirements, outsourcing, Pharmaceutical Research and Manufacturers of America (PhRMA) marketing code, pharmacovigilance, physician group practices, pre-clinical operations, pricing structures, procurement, privacy, rebates, regulatory, risk management, sales training, salesforce compensation structures, Section 340B pricing, social media, sourcing, speaker bureaus, statutory pricing guidelines, supply chain, taxes, teaching institutions, treasury, universities, venture investing, whistleblowers.

 

• Experience with complex financial transactions relating to entities involved in the health industry, such as business formation, cooperative marketing agreements, corporate securities, cross-border agreements, debt and equity financing, disease management programs, divestitures, domestic and international distribution agreements, incentive arrangements, initial public offerings (IPOs), joint ventures, mergers and acquisitions (M&A) – such as the purchase and sale of mail service pharmacies, specialty pharmacies, PBMs and similar distributing entities –rebate arrangements, scientific research funding arrangements, and wholesaler joint ventures.

 

​    Last updated 210509_1456