Services -- Research & Development: The Pre-Approval Phases

Clinical Trial and Other Study Agreements

   ♦  CROs
       • Sponsor Master Services Agreements
       • Clinical trials management
   ♦  Investigators
   ♦  Contract Labs
       • Preclinical testing
   ♦  IRBs
   ♦  Active Pharmaceutical Ingredient (API) supply sourcing
   ♦  Component sourcing deals
   ♦  Consultants 


Commercial Agreements – FDA Issues

   ♦  Co-Development Agreements
   ♦  Acquisitions involving pipeline products
   ♦  Clinical data ownership 


Clinical Trial Regulatory Issues

   ♦  Clinical Trial Protocol Reviews
   ♦  Informed Consent Reviews
   ♦  Financial Disclosure Requirements – Compliance and Strategies
       • Federal:  FDA & HHS
       • Institutional (e.g., university, hospital)
       • Clinical trial design to minimize conflicts 

   ♦  Good Clinical Practice (“GCP”) Compliance & Training 

       • SOPs –
          ○ drafting
          ○ review
       • Compliance
          ○ audits
          ○ training
       • HIPAA and privacy considerations
          ○ implementing procedures in clinical trials
          ○ consents
       • State regulatory requirements 


Investigational New Drug (IND) and Device (IDE) Submissions

   ♦  Pre-IND and Pre-Submission meetings
       • preparation
       • submissions
   ♦  INDs & IDEs
       • initial filing
       • maintenance during life of the IND – changes


FDA Marketing Submissions -- NDAs, ANDAs, PMAs, 510(k)'s, BLAs

   ♦  Counseling on requirements
   ♦  Strategies to maximize approval process
   ♦  Responding to FDA deficiency letters
   ♦  Achieving binding agreements with FDA on clinical design
   ♦  FDA Liaison & Meetings
       •  End-of-Phase meetings (I, II, III)
       •  Advisory Committee preparation and meetings 

   ♦  Device Reclassification Petitions – easing the burden

       • “De Novo” requests for truly “new” technologies       
       • Traditional for pre-’76 devices

   ♦  Drug and Device User Fees


Emerging FDA Issues & Their Impact on Development Plans

   ♦  Comment preparation on FDA initiatives
   ♦  Legislative responses
   ♦  Client-generated strategic initiatives

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