Fiscal Year 2006

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

• Port and Transportation Security  It took an advanced version of CCA’s News Media Lab to help prepare a defense contractor to answer pointed questions about the company’s port and transportation security plans. As a result, their arguments were well received by officials and the public.
• Post-Hurricane Restoration  After Hurricanes Katrina and Rita, an electric company went into crisis mode to restore critical power to devastated areas. In the largest US restoration operation, service was restored in miraculous time. CCA prepared witnesses to explain and defend their actions as well as the cost needing to be recovered.
• FDA End of Phase 2 Meetings  The developer of a treatment for chemotherapy-related anemia utilized CCA’s process to defend proposed plans for clinical trials in discussions with European, Canadian, and US health authorities.
• Deregulation In Canada  A Canadian utility, recently deregulated, had its first transmission filing with its provincial utility board. Both the company and its regulators were on a learning curve. CCA’s process helped ensure regulatory relations were effectively cultivated and cemented.
• Private Coaching  A medical researcher engaged CCA for private coaching to help him strengthen his communication and leadership skills for internal and external interactions.
• Business Practices Scrutinized  Rebounding from a high-profile case in which unfair business practices were alleged, a corporation needed to prove transparency and validate new RFP rules. Witnesses went through a series of CCA labs to ready themselves for tough scrutiny.
• CCA Skills Effective In Label Discussions  Initially, the owners of a treatment for a low sodium condition retained CCA in anticipation of an FDA advisory committee. After the agency announced a committee wouldn’t be necessary, the company used many of CCA’s methodologies to prep for successful label negotiations.
• Contentious Environment  In an extremely hostile regulatory case, an energy company filed for a $35 million rate increase; regulators countered with a $21 million decrease. CCA worked with company witnesses to give the case its best shot, and to begin rebuilding regulatory trust.
• Protecting A Global Reputation  Vietnam -- a rapidly developing country -- is attaining a high profile on the global horizon. One of the world’s largest oil and gas corporations with operations there retained CCA to prepare their executive team to manage a variety of high risk crises.
• Children Get Drug To Fight Flu  Amidst global concerns about bird flu, a major pharmaceutical used CCA’s services to win FDA approval of a flu therapy for pediatric patients.
• Corporate Witness Development System  In anticipation of upcoming cases, a major corporation put witness candidates and their support team through several CCA labs to improve skills in writing case petitions, responses to data requests, and Issue Cards to support corporate witnesses on the stand.
• A Risk Management Program With Teeth  CCA helped a large pharmaceutical and several generic drug companies build a united defense for a new, state of the art, risk management program for a drug with terotogenic potential.
• INPO Accreditation  Nuclear plant operations were excellent. Still, the operators had to address problems with change management, qualifications tracking, and shortage of new hires. CCA guided the team to bolster their story and address INPO’s concerns.
• Nuclear Waste Clean-up Options  CCA assisted a DOE rad-waste project in establishing a collaborative approach with a state environmental division and a prime contractor to explain clean up options to the public.
• Weapon for Bad Bugs  A company seeking approval of a new antibiotic with low resistance and a high cure rate utilized CCA’s extremely effective Issue Resolution Process to prepare scientific arguments in support of FDA approval.
• International Dispute Preparation  A forensic engineering firm used CCA to develop their expert construction witnesses – examples:
  • Rail project in Australia
  • Off shore oil project in Mexico
  • Chemical plant in South America
• Executive Prepares For Cross-Examination  A company executive in line for a top-level promotion had never been a witness. CCA conducted research to identify a myriad of upcoming case issues, then conducted a private session on cross-examination and issue resolution to prepare him to defend the company.
• High Price of Fuel  The CCA team successfully prepared witnesses for a half-billion dollar utility fuel case complicated by the merger of two companies. The case resulted from soaring natural gas and coal prices. Witnesses had to explain to a state commission why their own estimates had been so wrong.
• FDA Pre-BLA Meeting  The developer of a vaccine to combat a potential pandemic used CCA’s Q&A and briefing methodologies to demonstrate the company’s data were solid and ready for a rigorous FDA review.
• Boot Camp For Witnesses  A new financial executive went through CCA’s “boot camp” for witnesses as corporate screening for possible promotion, and to prepare for tough questioning concerning a multi-million dollar case.
• Defending Simultaneous EMEA and FDA Submissions  A biotech team needed to defend data supporting an indication in the US while defending another in the EU. The client put CCA’s Issue Card process to work to ensure synchronization of US and EU answers to questions.
• Nuclear Plant Accreditation Threatened  A nuclear plant faced accreditation probation. Plant executives put our “Silver Bullet” approach to work to address INPO issues head on. Result: no probation; lots of INPO praise.
• Label Negotiations  CCA readied a European team, accustomed to dealing with EU regulations, for FDA labeling discussions.

Note: In 2005-2006, our officers and consultants spoke at several professional conferences and authored various articles.