Fiscal Year 2001

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

• National Security Labs – Readied 48 corporate and expert witnesses for a critical utility unbundling case in a contentious jurisdiction. Major issues: cost of service, affiliate transactions, and the volatile transition to deregulation.
• Mutual Recognition Process (MRP) – Helped design and facilitate a first-of-a kind, 4-day, hands-on simulation of the European drug approval process. Goal: help U.S. and European pharmaceutical teams work together more efficiently to win European drug approvals.
• Civil Litigation – Accidental Death – Prepared key witness in an accidental death case involving a major transportation company and its driver. Plaintiffs were suing for largest award ever sought in the bus transportation industry.
• Preventing Blindness in AIDS Patients – Using CCA’s 4-stage, issue-driven preparation process, a multinational drug development team won FDA approval for a novel treatment for CMV Retinitis.
• Fast-Track Executives – Provided private coaching and strategic counsel to groom subsidiary company presidents for corporate positions.
• Strategic Counsel – Best Practices – Assisted several pharmaceuticals in establishing “best practices” for the presentation of data and findings associated with new drug treatments.
• Negotiating with FDA – Neurologists, psychiatrists, and research scientists seeking approval for a new antidepressant geared up for FDA drug label discussions using CCA’s negotiating preparation process. (Negotiations ongoing)
• Energy Crisis – Developed the critical witness in a federal case regarding high-voltage transmission lines. Learning from the California energy crisis, the company plans a massive increase in capacity over the next 5 years and needs an alternative form of regulation to capture new plant costs.
• Merger Testimony – Began developing corporate witness teams slated to testify in several states’ hearings regarding a merger of two major holding companies which would have resulted in the largest utility in the nation. Merger was halted.
• New Diabetes Treatment – A synthetic hormone instrumental in controlling diabetes discovered by a small pharmaceutical company will go to an FDA Advisory Committee for approval 3rd quarter, 2001. CCA has prepared the firm’s medical/scientific team for this critical meeting. (Approval pending)
• IPO – Guided high tech startup company in its preparation for an IPO. Work included issue resolution, strategic counsel, CEO coaching, executive leadership preparations.
• Issue Resolution – Conducted CCA’s Issue Resolution Process and Witness Development for a large power company seeking to convince regulators to consider an alternative form of regulation (AFOR) in a jurisdiction opposed to deregulation.
• Nuclear Plant Avoids Penalties – Provided guidance, a preparation process, and coaching for leaders of a nuclear plant in preparation for INPO accreditation renewal. At stake: millions of dollars and possible plant probation. Team gained full renewal with no penalties, no probation.
• Fighting Glaucoma – Prepared globally respected ophthalmologists and drug development team members for FDA staff briefings concerning clinical trial results for a new first-line glaucoma treatment. (Under FDA review)
• High Stakes – Strategized, coached, and prepared a team of biotech medical experts and scientists for several meetings with FDA and ODAC in their pursuit of a new drug approval for a localized, injectable cancer therapy.
• Defending Spending Cuts – Prepared defense site personnel to explain budget cuts and uncertainties to media, community representatives, and citizens concerned about their local economy.
• Breast Cancer Treatment – A powerful combination of two drugs for treating breast cancer has completed testing in human clinical trials conducted by a major pharmaceutical. By utilizing CCA methodologies for approval-driven agency briefings, the company was able to avoid a requirement to appear before a formal Advisory Committee.
• Controversial Operations – Key oil executives were invited to speak at a seven-state regulators’ conference. CCA was called in to prepare company leaders for tough questioning from government officials, environmentalists, NGOs, and contractors.
• CBS “60 Minutes” – The chief officer of a major defense facility agreed to discuss a series of troubled projects with “60 Minutes.” Using CCA’s issue-readiness process, our senior media consultant prepared the officer for what proved to be a grueling interview.
• Does It Communicate? – CCA analyzed numerous approval driven documents for: communicability, defensible claims, believable benefits, and clarity. Work included filed testimony for utilities, FDA “briefing books” for pharmaceuticals, and Power Point presentations to oil regulators.
• Novel Cancer Treatment – Following CCA’s first stage of Advisory Committee preparation, our client was asked by the FDA for more data, possibly requiring more clinical trials. (Under FDA review)
• From Warheads to HealthCare – Dismantling of nuclear warheads is guided by sophisticated software that tracks every step. A defense contractor who adapted the software to track critical medical procedures used CCA to help define a market for the new product.
• Courtroom Simulation – Conducted mock hearings and provided strategic counsel for large, complex, unbundled utility rate case. Witnesses appeared on a 15-member panel before a state regulatory body which was predisposed against the company.

Note: In 2000-2001 our officers and consultants were invited to speak at various trade organizations, professional associations, and corporate retreats.