Pharma and Nutra

Overview

Pharmaceutical advances are improving outcomes for patients worldwide. But new inventions face a broad range of hurdles in getting to market, including rigid regulatory structures, lengthy clinical trials, and whirlwind changes in the technological landscape. Our lawyers combine a targeted business focus with proven experience to serve as trusted advisors to pharmaceutical clients. We help make the leap from laboratory to marketplace, turning bench research into protectable and usable commercial products with long-lasting value.

McKee, Voorhees & Sease partners with startups and universities in the research and development stage – including pre-human trial research and early-phase animal testing – that seek to file chemical and drug applications for pharmaceuticals and nutraceuticals. Our team helps drive research through rounds of scientific advancement and funding opportunities, then counsels clients through commercialization and FDA approval. In addition to protecting the intellectual property that underlies pharmaceutical inventions, we provide trademark, licensing, regulatory and litigation services. Our legal experience across all phases of the product development life cycle enables us to deliver cohesive, forward-thinking strategies that address problems before they arise.

The MVS team includes two attorneys with Doctor of Pharmacy degrees, lending us a scientist’s grasp on complex technical topics – such as pharmacokinetics, pharmacodynamics, and drug delivery and dosing – and a deep-rooted passion for pharmaceutical innovations. This knowledge base allows us to draft technically-sound patents with commercially meaningful claims.

We place a strong emphasis on building long-term relationships, from early-stage advising to regulatory trials and beyond. Clients involved in bench research often stipulate that we remain engaged throughout licensing of their inventions as they continue to develop the technology and proceed toward commercialization, a testament to the trust we work hard to cultivate. Our holistic approach prioritizes the client’s big picture goals, to support and enhance their strategic vision.

Clients also benefit from our wide-ranging regulatory capabilities, which span the entire product life cycle process. We advise clients from the discovery stage through post commercialization for market authorizations and regulatory requirements, engaging with stakeholders and working with federal regulatory agencies.

Services include:

  • Patentability searches and opinions
  • Freedom-to-operate analysis and opinions
  • Due diligence for mergers and acquisitions
  • Portfolio planning and management
  • Invention disclosure vetting and analysis
  • Patent procurement in U.S. and foreign jurisdictions
  • Competitive landscape audits
  • License agreement drafting and negotiation
  • Litigation enforcement and defense
  • Patent and trademark infringement
  • Trademark protection and counseling
  • Regulatory counsel
  • Labeling
  • Compliance
  • Marketing authorization
  • FDA approvals and product definition
  • Stakeholder engagement
  • GMP (good manufacturing practices)
  • GLP (good laboratory practices)

Pharma and Nutra Team

Edmund J. Sease

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Heidi S. Nebel

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Christine Lebron-Dykeman

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Cassie J. Edgar

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Jill N. Link, Pharm.D.

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Jonathan L. Kennedy

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Sarah M.D. Luth

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Oliver P. Couture, Ph.D.

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Tina G. Yin Sowatzke, Pharm.D.

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Julie L. Spieker

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Brian D. Keppler, Ph.D.

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