2008 Project Highlights
Executives Under Pressure
With new scrutiny, risks, and pressures on CEOs and top executives, several asked for strategic counsel and private sessions this year to prepare for litigation, investigations, media, hostility, and controversy.
Coal-Fired Plant
In today’s world of regulatory uncertainty and industry awareness of climate changes, an energy company retained CCA to help their witnesses seek approval for a baseload, coal-fired generating plant.
Hope For Those With Huntington’s Disease
The drug sponsor to treat this disorder retained CCA to help identify all possible questions which might put the drug’s approval at risk. The company received a unanimous positive vote from the FDA advisory committee.
Financial Viability
Hovering on the brink of junk bond status, a utility’s financial viability was “front and center” in a case being heard by an adversarial public service commission. CCA’s team readied their witnesses to take the heat of tough cross-examination.
Non-Regulated Nuclear Company
In a first-of-its-kind case, a major corporation sought to spin off a non-regulated nuclear company. CCA worked with the company’s sole witness to enter these uncharted waters.
Treatment for Melanoma
A pharmaceutical company is developing a form of interferon to treat Stage III melanoma. The company utilized CCA’s step-by-step preparation process to ready a team of experts for a possible FDA advisory committee.
Environmental Compliance
CCA readied a panel of witnesses to defend the company’s high cost of environmental compliance for coal-fired generating plants. In addition, CCA provided guidelines to write clear and persuasive pre-filed testimony.
Cold Relief
A pair of major pharmaceutical companies are developing an OTC combo drug to treat nasal allergic rhinitis and congestion. CCA put their R&D teams through an intense issue identification process, provided methodologies to answer FDA questions, and extensive coaching drills.
Developing Cases and Witnesses
Several utilities who had not filed a rate case for 15-20 years found themselves in a position of having to file one now, with witnesses and support teams having no experience in filing. Our team provided strategic counsel, testimony writing clinics, witness preparation, issue resolution, and guidance.
Bankruptcy and Hurricanes
An energy company pulling out of bankruptcy proposed to reduce electric rates and increase gas rates. In the midst of its tenuous financial condition, it also needed to rebuild its infrastructure substantially damaged by storms. Working with CCA’s process, the company’s witnesses put forth an honest assessment of their needs.
Crisis Readiness
A major client asked CCA to bring their new executives up to a stage of crisis-readiness the rest of the executive leadership had already attained. These executives wrestled with new issues, new skills, and new mindset.
First-of-a-Kind Technology
A multi-state energy company filed parallel applications in two states for a clean-coal generation plant with a price tag of $2+ billion. This technology had been rejected in multiple states. CCA’s job was to prepare witnesses to explain the new technology and its environmental and customer impacts.
Drug Safety Challenged
The safety of an approved anti-viral drug was challenged by FDA. The developer of the treatment found no direct link between neuropsychological events and the drug. CCA provided the company’s safety experts with a process to help develop data-based arguments to protect the drug.
Creating a “Smartbook”
Forty key individuals throughout an industry-leading company underwent a challenging CCA workshop addressing issue resolution, and developed a “Smartbook” which tackled the company’s highest risk issues.
Avoiding Birth Defects
A drug used by women of child-bearing age has been associated with birth defects. The drug developer worked with FDA to establish a pregnancy prevention and registry program. CCA drilled key responders in practice sessions to sharpen answers to questions from an Advisory Committee.
Getting Your Heart Back to Normal
Atrial fibrillation is the most common arrhythmia experienced by the adult population. CCA helped the developer of a new treatment for AF by providing a ranking methodology to identify issues which may slow FDA approval.
Leadership Team Crisis Drill
All members of the top leadership team of a high-risk company were put through a grueling 2-day Crisis Management Team drill in which each executive had his/her own unique tests to face, as well as full team and functional team tests. CCA designed and conducted the drill, and provided evaluation during and after the tests.
Relief From Rheumatoid Arthritis
A very effective biologic for the treatment of rheumatoid arthritis has been discovered by a global pharmaceutical giant. CCA assisted the client in preparing arguments successfully demonstrating the efficacy and safety of the treatment.
Educating The Regulators
With the first coal-fired generating plant permitted in the state for 30 years, the company was up against inexperienced commissioners and staff, as well as intervenors who called it politically and socially unacceptable. CCA and the witness team successfully focused on issues of the case and education of the commission, staff, and intervenors.
Breakthrough in Anesthesia
A European pharmaceutical firm developed a novel compound for speedy reversal of neuromuscular blockers (allows patients to accept breathing tube). CCA assisted in developing a presentation of clinical findings and preparation for intense questioning from scientific advisors. Note: In 2007-2008, our officers and consultants spoke at several professional conferences and authored various articles.
Note: Extensive issue research is conducted as a first step for all assignments.
