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    Health (Pharmaceuticals - Research and Development - R&D)

 

  • Drafting and negotiation of research and development (R&D) agreements and contracts for various specialized life sciences-related enterprises, such as for biologics vendor services, clinical trials, collaboration, compassionate use, confidentiality, consultants, distribution, expanded access, investigator-sponsored studies, licenses, master services, manufacturing, material transfer, non-compete, non-disclosure, non-solicitation, services, supply chain, technology transfer, third-party vendor.

 

  • Consultation regarding the legal implications of R&D initiatives, particularly as external research collaborations, such as with academic institutions or specialty companies.

 

  • Drafting and negotiation of agreements with cross-border and international vendors, such as in Canada, Central America, EMEA (Europe, Middle East and Africa), Japan, India, Mexico, People’s Republic of China (PRC), Republic of China (Taiwan), Russian Federation and South America.

 

  • Consultation regarding R&D-related activities, involving antitrust, clinical trials, commercial law, compliance, diversity, employee engagement, ethics, healthcare fraud and abuse, inclusion, intellectual property, pharmaceutical product discovery, pharmacovigilance, privacy, product liability.

 

  • Working knowledge of the pharmaceutical R&D life cycle for generic and branded products.

 

  • Experience with complex biotechnology and pharmaceutical R&D structures related to business development, equity investments, financing, in-licenses, mergers and acquisitions (M&A), options, out-licenses, platform-based transactions, product development alliances and therapeutics.

 

  • Tracking and reporting to stakeholders, management and relevant staff regarding current laws and regulations relating to drug commercialization and R&D.

 

  • Familiarity with current technological advancements related to R&D, such as 3D printing, artificial intelligence (AI), augmented reality (AR), deep learning (DL), digital health, distributed ledger technologies (DLTs) such as blockchain, extended reality (XR), health robotics, machine learning (ML), machine vision (MV), medical technology (Med-Tech), mixed reality (MR), natural language processing (NLP), telemedicine, virtual health services, virtual reality (VR).

 

  • Experience with domestic and international data protection and privacy laws relating to R&D, as applied to clinical trials, digital health information, patient support services, and scientific research involving patient-derived data.

 

  • Legal support for clinical development programs including R&D activities.

 

  • Consultation for pharmaceutical entities engaging in rare disease R&D, as well as specialty pharmaceuticals.

 

  • Biopharmaceutical experience regarding commercializing and R&D for therapies treating rare genetic obesity disorders.

 

    Last updated 210509_1540

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