2007 Project Highlights
Winning in the Court of Public Opinion
A large hotel/resort corporation, sued by an architect for non-payment of fees, became a high profile case, sparking rumors of cash-flow problems. Winning the PR war was vital. Our strategic counsel was called on to guide the architectural and legal firms.
End-of-Phase-2 Meeting; Clinical Trial Plan
One of the 10 largest pharmaceuticals retained CCA to provide the client’s clinical and statistical experts with proprietary Q&A models to defend proposed human trials. The drug is expected to reduce cardiovascular diseases including heart failure and stroke.
Withstanding a Prudence Audit
CCA was retained to help company witnesses defend their activities and management decisions in light of results of a prudency audit. Major outages at their nuclear plant caused customers to pay high replacement power costs.
Testimony Writing
Pre-filed Direct Testimony becomes the company’s case, making careful wording paramount. CCA conducted a testimony writing clinic for a utility facing several regulatory cases.
Readying Crisis Management Team
A top executive team needed a tough workout on issues and crisis skills. CCA designed a communication lab which gave them both.
Communicating in the World of Science
Scientists, wrestling with designing and proving a one-million-year safety profile of a potential repository for high level waste, worked with CCA to prepare answers to difficult questions from public policy makers in vetting and oversight committee meetings.
Cancer Treatment Gets Intense Scrutiny
The treatment developed by a small biotech enhances apoptosis of cancer cells (cell death) targeted to a killer form of leukemia. The developer of the novel treatment was required by the FDA and the EMEA to appear before expert committees in the US and Europe. CCA readied the teams for a broad spectrum of scientific questioning.
Discovery Learning
To understand what witnesses go through, a forward-looking corporation put its regulatory organization through the first phase of CCA’s witness development. As they struggled to defend the company’s positions, they learned what their witnesses needed from them.
400 Cases Consolidated
A large distribution company, after acquiring a competitor, filed simultaneous rate cases in over 400 cities it serves. The regulators consolidated it into one case. The company put its witnesses through CCA’s cross-examination labs.
Saving a Drug’s Reputation
Part of our work is helping pharmaceuticals protect approved drugs and biologics. Some drugs get a bad reputation, many times undeserved. This year, for example, CCA helped a client protect the reputation of two well-established drugs.
Environmental Compliance; Fuel Costs; Nuclear Power
CCA readied three teams of witnesses for a major energy company: one for a rate increase case spurred by high environmental compliance costs; one for a fuel reconciliation case with $750m under-forecasted; and one for an integrated resource plan with a new nuclear generation component.
Defending Management Actions
With a new top management team at the helm, a nuclear plant was facing an uncertain accreditation from INPO. We helped isolate the toughest issues, develop a strong case, prepare “silver bullets,” and increase confidence to handle tough questions from the INPO board.
Congressional Investigation
When the oil pipeline industry had a crisis, Congress immediately called in CEOs to answer for it. CCA prepared a top pipeline CEO to explain complex integrity issues under demanding questioning from congressional sub-committees and media.
Effective Labeling: A Drug’s Success or Failure
Labeling negotiation is sometimes a make- or-break interaction with health authorities. CCA has a successful proprietary labeling negotiation process, resulting in a strong label this year for an Alzheimers treatment.
Public Meetings/Public Hearings
Three large transmission expansion projects required hearings for approval. CCA prepared the utility’s witness team for public meetings as well as cross-examination and appearance before an Administrative Law Judge in a series of public hearings.
Multi-Jurisdictional Re-Structuring
A multi-national corporation planned to divest its major US utility; the utility desired to be a publicly-traded company. It necessitated a complex, unique case as it petitioned each state in which they operate for divestiture and an IPO. CCA helped the team of witnesses defend their case in nineteen jurisdictions.
Innovative Regulation
To stabilize customer rates and reduce risk for the company, an energy company proposed a Formula-Based Rate, which is the first-of-its-kind in its province. CCA’s team helped them isolate the issues, explain the process, outline the benefits, and prepare for cross-examination.
Aggressive RMAP to Protect Patients
Several generics, plus the originator of a treatment for a skin disorder associated with a serious side-effect, built one of the most rigorous Risk Minimization Action Plans to date to protect patients. CCA led an effort to prepare company experts to defend and explain the benefits of the new plan.
Developer Encounters Outrage
A billionaire land developer wanted to turn desert land into a master planned community. His proposal drew outcry from vocal state regulators. Before he took the stand, CCA and his legal team prepared him for the frenzy of regulatory questioning in a hearing room full of media.
Diabetes Treatment Faces Manufacturing Issues
For a number of years, CCA has assisted the developer of a glycemic control treatment. When the company decided to propose a long-acting version, CCA prepared the team for CMC questioning. Note: In 2006-2007, 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.
