Managing Legal Risks in Structuring & Conducting Clinical Trials

Washington, DC Partner Liz Gray will be presenting, “Reacting to Scrutiny of Clinical Trial Disclosures by the SEC,” at the American Conference Institute’s 7th National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials in San Francisco on July 16.

Specifically, she will discuss:

• How FDA and SEC cooperation (Referral Process and Centralized Procedures) have affected scrutiny of clinical trial disclosures
  
• Complying with SEC reporting requirements pre- and post-approval
  
• Reconciling FDA/SEC disclaimer requirements
  
• Factoring in recent enforcement activities by the SEC and FDA
  
• Lessons learned from ImClone, TKT, ICN, and NY Executive Law 63(12)
  
• Disclosing clinical trial information that has been made available to the FDA but not publicly disclosed
  
• Determining what FDA actions to disclose and how to disclose them for accurate interpretation by the securities market
  
• Alleviating securities concerns: whether databank entries constitute “forward-looking statements” for investor reliance; and
  
• Controlling and monitoring material inside information and disclosing material facts to shareholders