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life sciences

Industries

Life Sciences

We draw on extensive industry-specific knowledge and technical background to help life sciences clients create innovative business plans. We are particularly experienced with the biotech, medical device and pharmaceutical industries and their products. Whether you are a new, privately held startup or an established public company, our practical and legal experiences can help you overcome the complex corporate, information technology, intellectual property, litigation and regulatory issues that challenge your business daily. Simply put, we can help you take your ideas to market.

Our Life Sciences group is focused on helping FDA-regulated industries translate their scientific advances to commercial success. A cascade of social, political, scientific, legal and regulatory factors combine to make the life sciences one of the most complex and dynamic business pursuits. Fostering the development of products that improve the condition of living beings also makes the life sciences one of the most rewarding endeavors.

LMG Lifesciences Recommend by

Our Life Sciences group draws from a diverse range of experience. Whether your business requires the development of a comprehensive compliance program to prevent and defend against claims of off-label promotion, the development of a tax optimization strategy in a global co-development agreement or defense of your products from product liability claims, our lawyers have the ability and experience to meet your needs.

Representative Experience

  • Counseled a pharmaceutical client in all phases of global product launch, including clinical trial development, publication plans, FDA dialogue, risk management plan development, product and disease state education, training and promotional strategy.
  • Provided advice on issues pertaining to the import and export of controlled substances and raw materials.
  • Advised a pharmaceutical client in the application of FDA regulations to product labeling, advertising, and promotional and educational activities, as well as provided advice on limiting liability exposure relating to those communications (including product liability, intellectual property, competition laws, and fraud and abuse laws).
  • Represented a pharmaceutical client in multidistrict product liability litigation.
  • Represented a pharmaceutical client on a variety of international transactions including an international licensing arrangement for a controlled substance, cost allocation for new product development, and profit sharing arrangements.
  • Provided advice on the informed consent process, clinical trial recruitment strategy and related advertising and education.
  • Provided advice on the use of coupons and vouchers for prescription drugs.
  • Advised a pharmaceutical client on the structure and operation of patient assistance programs.
  • Provided advice on DEA, PDMA and licensing restrictions pertaining to prescription drug sampling.
  • Advised a pharmaceutical client in the establishment of a compliance program, including structural formation, policy and procedure development, training and advice.
  • Established educational and research grant review process for FDA-regulated client.
  • Provided advice on issues relating to orphan drug and compassionate use programs.
  • Represented medical device, biotech and pharmaceutical clients on acquisitions and asset transfer arrangements.
  • Represent clients on acquisitions and asset transfer arrangements.

Leader

Our clients include the following life science providers:

  • Pharmaceutical companies engaged in branded and generic pharmaceuticals
  • Biotechnology innovators creating the next generation of medicines
  • Medical device companies
  • Animal health companies
  • Contract research organizations
  • Institutions responsible for medical research and development
  • Health-related e-businesses
  • Physicians, health plans and hospitals engaged in the life sciences
  • Companies engaged in the development of bioterrorism protection