Fiscal Year 2004

Note: Extensive issue research is conducted as a first step for all assignments.

• Drug Safety Challenged – FDA threatened to withdraw an established drug from the market because of serious side effects. CCA helped the drug maker defend a strong risk management plan to keep the treatment on the market.
• Sarbanes-Oxley Litigation – In the first whistleblower lawsuit to go to trial under the Sarbanes-Oxley Act, CCA readied witnesses for extremely tough cross-examination. At issue: did the company properly disclose financial losses and did it improperly terminate the employee who raised this issue?.
• Drug Label Negotiations – One of the last steps in the FDA’s approval process is label negotiations. In several sessions, CCA provided strategic guidance and specific negotiating skills for successful discussions with the agency.
• Challenges at Sea – Conducted workshops with tanker officers to hone their communication efforts with stakeholders including ship inspectors, environmental organizations, the U.S. Coast Guard, and management.
• Oncology Team Defends Trial Data – The developers of an adjunctive therapy to enhance radiation treatment faced FDA doubts about efficacy and trial data. Using CCA’s process, the team strengthened scientific arguments and prepared for intense questioning.
• First Stranded Cost True-up Case – With $4.5 billion at stake, an energy company seeking recovery of fixed investments and stranded costs hired CCA to assist in this bellweather case.
• High Stakes "Orals" – With $5 billion at stake, a defense contractor and their partners relied on CCA to prepare the oral proposal team for success before high level Pentagon officials. They won the contract to design and implement an Actionable Intelligence system for the warfighter, integrating branches of military and intelligence sources.
• Fractured Executive Team – The CEO of a major corporation called on CCA for strategic counsel and guidance in confronting sex discrimination at the executive level, which hindered full cohesion of a diverse team. Private coaching was also provided for the top female team member.
• Patient-Controlled Opioid Analgesia – The developer of a novel drug delivery device had CCA prepare teams for two final steps in winning FDA approval: label negotiations and pre-approval manufacturing inspections.
• Wrongful Death Litigation – An appliance manufacturer utilized CCA’s Witness Development to ready a design engineer to defend the company against multiple product liability cases. At issue: product safety vs. misuse by the homeowners.
• Nuclear Waste Clean-up – Management & technical personnel representing a DOE engineering & environmental lab faced challenging questions from regulators and the public concerning safety of nuclear waste clean-up activities. CCA prepared the team to address issues head-on.
• New Depression Treatment – A medical device company developed a product similar to a pacemaker to relieve symptoms of depression. CCA helped the firm develop a strong FDA advisory panel presentation as well as answers to anticipated questions.
• Prepped New CEO to Testify – CCA worked privately with a major corporation’s new CEO to bring him up to speed on case issues and witness communication skills in advance of testifying at upcoming hearings.
• Managing Controversy Tools – A pharmacotech company faced media reports challenging the effectiveness of their product. CCA provided the company’s top three executives with a skill set to handle high-risk questions from Wall Street, regulators, customers, and the media.
• Case Approach and Support – CCA developed an internal support team for a major energy company to be “knowledge lieutenants” for witnesses to help draft pre-filed direct and rebuttal testimony, perform analyses for evidence, and develop a strategic approach for future cases.
• Infertility Treatment – Women profoundly deficient in specific hormones cannot have children. CCA prepared a team of scientists and physicians to win approval for a treatment to restore hormone levels and give these patients hope.
• Deregulation Reversal – An energy company was caught in transition when the state halted and reversed deregulation, leaving the company with stranded costs and regulatory assets. Commission staff recommended zero compensation and a rate decrease – a situation which could cause insolvency. CCA prepared witnesses for the battle before the commission.
• Transmission Line Siting – A water and power utility asked CCA to develop key personnel and witnesses for productive dialog with landowners and to testify in siting cases. As a political sub-division of the state, the sensitivities, issues, and regulations are different than investor-owned utilities.
• Type 2 Diabetes – A pharmaceutical company developing an innovative diabetes treatment utilized CCA’s newly expanded services to prepare for a Pre-NDA (New Drug Application) meeting, a key step in winning FDA approval.
• FERC Litigation – Our team prepared witnesses for depositions in a FERC case alleging the regulated side of an energy company gave an unfair advantage to its unregulated affiliate in bidding for generating capacity.
• Crisis Response – A forensics tool, used in high-profile criminal cases, was attacked in the media by the scientific community. At stake: the company’s reputation, market, stock price, and future regulatory approval of other products in their pipeline. CCA provided strategic counsel to guide them through the crisis.
• Artificial Heart Approved – CCA helped developers of a total artificial heart prepare for an FDA Advisory Panel. This first-of-a-kind device acts as a “bridge to transplant” for patients facing imminent death while awaiting a donor heart.
• Talking to the Financial Media – An international corporation undertook the development of a branding strategy, then faced a major challenge – getting key messages to come out of the mouths of executives in financial media interviews. CCA’s role: Prepare executives to address challenging issues and weave branding messages into answers.

Note: In 2003-2004 our officers and consultants were invited to speak at various trade organizations, professional associations, and corporate retreats.