Practice Area | Personalized Medicine

FDA Compliance in Personalized Medicine

Gregory Glover, MD, JD, is a leading expert in FDA regulation and IP law governing personalized medicine, precision therapies, and individualized treatment. He applies his extensive experience to the development of advantageous approaches that optimize the benefits of intellectual property protection, regulatory incentives, and lifecycle dynamics for personalized medicine researchers, sponsors, manufacturers, and investors nationwide.

As a registered patent attorney and non-practicing physician, Gregory Glover’s understanding of pharmaceutical laws and regulations offers enhanced insight and risk mitigation regarding product development, marketing, and investment in targeted treatment and prevention.

Personalized Medicine

Personalized medicine continues to lead growth in pharmaceuticals, healthcare, and biotechnology, making up over 25% of new FDA-approved drugs between 2015 and 2021, creating substantial economic incentives for investment in this field. Patients diagnosed with rare conditions or conditions for which no treatments currently exist rely on targeted, individualized therapies that use genetic or biomarker information to generate treatment products and protocols.

Personalized medicine, including precision medicine, customizes treatment products and companion diagnostics to an individual patient’s (or rare group’s) genetic characteristics or biological markers using a predicted disease risk or treatment response. Examples include:

  • Therapeutic tissue engineering products
  • Human cell and tissue products
  • Combination products
  • Antibody-drug conjugates
  • Antisense oligonucleotides (ASO)
  • Human gene therapies, including genetically modified cells
  • Biologic-device, biologic-drug, or biologic-device-drug products
  • Engineered site-specific nucleases
  • Ex vivo genetically modified human cells
  • In-vitro diagnostic assays

Regulatory And Patent Market Exclusivity

Pharmaceutical companies face numerous challenges in meeting safety, ethical, and regulatory requirements in developing individualized therapies. The central difficulties of individualized drug research, development, and manufacturing require sponsors to devise unique policies and procedures that meet FDA and IND application requirements.

Gregory Glover advises and represents drug sponsors, research institutions, investors, and other stakeholders in a wide range of high-stakes regulatory and market exclusivity matters involving all stages of the product lifecycle, including:

  • Emerging issues in personalized medicine and companion diagnostics
  • Regulatory coordination of therapeutic and companion diagnostic products
  • Unique issues arising for novel or combination products
  • Specialized regulatory incentives and market exclusivity provisions for targeted product development
  • Expedited review and approval provisions (fast track designation, breakthrough therapy designation, RMAT designation, accelerated approval, and priority review designation)
  • Regulatory implications of Orphan Drug status and treatment protocols
  • Competitive disputes

Personalized medicine drug sponsors, research institutions, investors, and other stakeholders must be prepared for unique challenges and evolving approaches to intellectual property rights, data biases, and patient privacy issues.

To Connect with Gregory Glover MD JD and Pharmaceutical Law Group

202.589.1780 or [hidden email]