Fiscal Year 2002

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

• National Security Labs – When three National Labs needed help deciding a path forward to clearly articulate their operations to stakeholders with a need to know, they called on CCA’s team. Providing strategic counsel, guidance, process, and structure, we assisted the labs’ team in developing strategic and tactical plans.
• Novel Drug Approach – Our team readied the foremost expert in a novel drug-delivery method for a breakthrough cancer treatment to present the company’s case to an FDA Advisory Committee Meeting (ODAC).
• Fraud – A contractor agreed to construct a resort and casino for a certain price and by an absolute date. The contractor knew they were incapable of performing the work per contract, and coerced the owner into paying for work not performed. The owner ended in bankruptcy. In the case to recover damages, CCA worked with the expert witness who proved fraud.
• Oil CEO to Face Congress – The US CEO of one of the world’s largest oil and gas conglomerates faced a Congressional hearing to address allegations about quality and safety violations. CCA provided him a process to map responses to critical issues, coaching, and simulated Congressional hearings.
• Pursuit of EU Drug Approval – A small pharmaceutical firm credited with discovering and developing a new hormone to control Type 1 and Type 2 diabetes, utilized CCA’s preparatory services to ready their team to pursue US and European approval to market.
• Strategic Approach – The developer of a new hepatitis treatment, facing up to 70 potential drug approval issues, utilized CCA’s strategic process to consolidate, prioritize, and assign individual responsibility for content and data development.
• Reconstruction of Missing Data – One of the Italian government’s new gasification plants was significantly delayed. During an investigation, some critical data was “missing”. CCA prepared an outside expert to present and defend his reconstruction of data and calculations of damages.
• Lung Cancer Vaccine Shows Promise – Having completed early studies to confirm the viability of a novel lung cancer vaccine, a young drug company retained CCA to prepare it to take the next major step: convince FDA’s oncology division plans for Phase III clinical (human) trials were sound.
• Witness Faces Foreign Government’s Lawyers – An American based constructor sued the owner of an oil plant (Egyptian government) to recover damages as a result of delay and rework. Providing our proprietary system, CCA helped ready the forensic expert witness to go up against a foreign government’s legal team.
• Energy Crisis Fallout – In light of the California crisis, a utility client proposed to state regulators a short-and long-term plan to avoid the same fate. Issues: Divestiture of generating assets and a Purchase Power Agreement for 100% of the utility’s load.
• Oncology Team Prepped for Briefing – As part of CCA’s expanded services for the pharmaceutical industry, our team readied oncology experts to provide an FDA briefing of new supplemental data to justify full marketing approval for their AIDS-associated cancer treatment.
• Finding the High Ground – A construction contractor sued the owner of a Saudi Arabian plant for cost overruns and later adjudicated with the insurance company for errors and omissions. An outside expert wrote one forensic report which held the owner responsible; later, wrote another report which held the contractor responsible. CCA was asked to prepare the expert for the task of defending his conflicting reports.
• Managing Health Care Controversy – CCA counseled and prepared a health care CEO and key executives for a regulatory audit controversy in which an unsatisfactory quality rating of their hospital was found – at the same time a lawsuit for wrongful death was being tried.
• Witness Development for a New Climate – Realizing the electric utility regulatory environment has drastically changed in the 15 years since their last rate case, a major utility called in CCA to prepare witnesses to defend ROE and level of O&M spending.
• New CEO Faces Issues – When a new CEO took the helm of one of the nation’s most respected research organizations, a CCA team prepared him to face tough issues from media, regulators, and business groups.
• Negotiating Strategies – When a pharmaceutical client received an FDA “Approvable Letter” with strict conditions requiring additional human trials, CCA helped the client develop a negotiating strategy prior to the agency meeting discussing trial details.
• International Arbitration – A prime contractor was acquired during a major construction project of a power plant in the Netherlands. Both contractor and owner sought delay cost damages from each other through the International Arbitration process. CCA prepared a critical forensic engineering expert to testify.
• Alternative Form Of Regulation – CCA worked with a team of in-house and outside expert witnesses in an AFOR case for one of the largest utilities in the country. Controversial issue in the case: capacity cost rider – which means new plants are automatically factored into customers’ rates.
• Individual Attention – When a nationally recognized diabetes expert was unable to join with his client’s drug development team to prepare for a critical FDA meeting, our consultants traveled to his clinic for preparation.
• First-of-a-Kind CCA Lab – CCA was asked to develop and conduct a lab for a client’s support team who writes regulatory case testimony. Participants learned what makes good testimony and how to answer interrogatories using CCA’s proven method for presenting and defending solid arguments.
• INPO – When their re-certification was at stake, a nuclear power plant’s operations team called on CCA to ready them to defend the company’s training program for Licensed Nuclear Operators before the INPO Board.
• Against the Odds – Increasing gas rates 90% for customers is a tough sell in today’s regulatory environment. Our team was called upon to help the company tell its story to an unsympathetic state commission and Attorney General.
• Defending Prudent Management – Suffering one of the longest forced outages in the history of the nuclear power industry, customers were charged much higher prices. In the ensuing case, CCA prepared an expert witness testifying on the prudence of management’s decisions.
• Banking Promising Witnesses – Covering several jurisdictions, a major energy company used CCA’s system to “bank” a large team of key company witnesses. Armed with CCA’s core system of skills, these witnesses are now installing throughout the company a consistent mindset and approach to regulatory cases.
• Storm Recovery – Our consultants prepared utility witnesses for a regulatory case involving the cost of emergency response during severe storms.
• Leadership Skills Development – CCA’s no-nonsense private coaching was utilized by a major healthcare company to enhance a new executive’s leadership skills.

Note: In 2001-2002 our officers and consultants were invited to speak at various trade organizations, professional associations, and corporate retreats.