Fiscal Year 2005

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

• COX-2 Inhibitors Under Fire – COX-2 inhibitors went under the microscope this year in a 3-day FDA Advisory Committee meeting. CCA helped prepare a pharmaceutical safety team to present data addressing the potential for cardiovascular events.
• Witness Performance Punishes Company – Witnesses for a Canadian utility were blasted by regulators for not being prepared or forthcoming, resulting in a sizeable disallowance of legal fees. CCA helped the company change its approach to build a more positive relationship with regulators.
• Starting Early Bolsters Arguments and Builds Team Confidence – New medical treatments must pass rigorous management reviews beginning early in drug development. This client utilized the CCA process to defend study protocols with management as well as the FDA.
• New Exec Under Fire – Provided high-risk communication skills and strategy for new HR Vice President. Her challenge: taking the helm during a complete overhaul of the company, including severe staffing cuts and unionization efforts.
• Diabetes Treatments Win Approval – Over a period of several years, CCA assisted the developer of two novel diabetes therapies. We are pleased to announce both received FDA approval this year.
• Unfair Advantage – The losing bidder of an RFP to supply power to a major utility filed a complaint alleging the contract was wrongly awarded to another bidder. Defending witnesses were prepared with CCA’s system of skills and strategy.
• Caught Between Owners and Regulators – When a US company found itself caught between its foreign owner’s demands for earnings and its promises made to state regulators, their witnesses used CCA’s models to help them tell their story, defend their actions, and reconcile the opposing directives.
• New Hope for Lupus Patients – The developer of a treatment addressing an unmet need in lupus patients used CCA’s issue-driven process to prepare for drug-approval meetings with the FDA.
• Deficiency Recovery – With three quarters of a billion dollars deficient in fuel expenses, a utility’s witnesses were challenged to explain the severe under-collection to the state regulators, and defend prudent management. CCA prepared the witness team to account for their actions.
• Oncology R&D Team Faces Challenging Advisory Committee – CCA prepared the team to field a broad spectrum of questioning by isolating and analyzing potential issues, developing a preemptive sponsor’s presentation, and providing extensive Q&A coaching.
• Protecting Financial Health – After CCA’s preparation of several panels of witnesses, our client felt ready to defend its request for an increase in rates and a very healthy return on equity, even in light of poor economic indicators. The company achieved the positive outcome it sought.
• Making a Case to FDA & DEA – The agencies were expected to designate a new pain treatment as a strictly controlled substance. CCA assisted the pharmaceutical firm in developing compelling arguments supporting a more appropriate “scheduling” for the drug.
• Multi-Jurisdictional Team – A team of key personnel was faced with several legal proceedings in three different jurisdictions. The company called in CCA to provide the team with a set of skills for handling tough cross-examination in all jurisdictions.
• Homeland Security Experts Talk to the Media – Financial and news media interest in a defense contractor’s novel Homeland Security mega-projects prompted the company to retain CCA to prepare top level executives to deal with challenging questions in numerous future interviews.
• Prep for Label Negotiations – CCA offers a preparation process for label negotiations. This year, a Japanese pharmaceutical utilized the process to successfully negotiate a drug label and FDA approval for a sleep medication.
• Regulator Turned Witness – When a former federal regulator was asked to testify in front of a state commission on behalf of an electric utility, CCA was asked to prepare the witness for this new challenge.
• Building a Scientific Defense – CCA provided the developer of a treatment for malignant brain tumors a methodology to rank issues on the basis of risk to approval and adequacy of evidence to defend against FDA concerns.
• Screening Top Execs – To help a major corporation decide who to promote to its top executive team, leading candidates were put through CCA’s grueling witness development program. The company used the opportunity to screen candidates’ abilities to effectively communicate under pressure.
• Colorectal Cancer Treatment Approved – CCA utilizes a novel methodology to assist clients in identifying, analyzing, and ranking drug-approval issues. Medical researchers used this process to help win approval for a new colorectal cancer treatment.
• Class Action – Energy company witnesses faced a class action case charging systematic violation of regulations regarding usage/bill estimation and meter reading. Our team worked with counsel to help prepare the defense.
• Keeping the Lid on Volatility – We readied the operations and management teams of a major service company to handle potential crises (internal and external) during a complete restructuring of their operations. Focus was on preempting emotional eruptions and operational disruptions during a three-year initiative.
• Treatment for Chronic Severe Pain – The developer of a drug indicated for severe pain was required to run a third Phase 3 trial at lower doses. CCA provided a process to help the client analyze potential issues associated with study outcomes.
• Pioneering Rate Design – A Midwestern gas company wanted to propose an innovative rate design which would increase rates outside of the normal regulatory climate and make them stable. Our team prepared the witnesses to explain and defend the most controversial aspects of the case.
• Medical Device Requires More Study – A medical device client received a “Non-Approvable Letter” from the FDA for a therapy to treat severe pain. CCA helped ready a team to negotiate a path forward with the FDA.
• CCA’s Skills Accommodate Multiple Applications – The developer of a hepatitis-C therapy for HIV-infected patients utilized CCA’s issue-oriented skill set to prepare for an advisory committee. When FDA decided a committee meeting was not required, the client used the same skill set for label negotiations.
• FDA’s Dermatology and Risk Management Committees Consider New Drug – CCA prepared research physicians and scientists to present to the agency study findings and a Risk Management Plan for a new skin disorder treatment.

Note: In 2004-2005 our officers and consultants spoke at trade and professional conferences, and authored various articles.