2009 Project Highlights
Pandemic Preparedness
U.S. Health Authorities (HHS, FDA, CDC, and NIH) have become very concerned about the possibility of a major pandemic. Recent H1N1, as well as H5N1, flu concerns prompted a plan to have an influenza “MedKit” at home. CCA prepared scientific and medical personnel to describe a vaccine manufacturer’s plan for U.S. distribution and home use to protect against a pandemic.
Nuclear Power – The New Generation
With three decades of baggage, the nuclear power industry is re-emerging. Having “grown up” in the nuclear industry, CCA has been using its experience to help clients through the new streamlined permitting hearings and public meetings.
Treatment of Severe Pain
A pharmaceutical company specializing in neurological treatments seeking European approval (EMEA) for a cutaneous patch for pain relief, retained CCA to prepare team members for the agency’s “Oral Explanation.”
Attacked From All Sides
As if allegations of misuse of designated funds, reregulation, corporate struggles, bankruptcy, and a change at the top weren’t enough, the company was facing a maverick approach by regulators. CCA helped the witnesses get down to core issues and address them head-on.
Schizophrenia and Bipolar Disorder
CCA prepared psychiatrists and scientists to present findings of a new treatment for schizophrenia and bipolar disorder. Members of the company team used CCA’s Q&A models to stay on top of advisory committee issues.
Oral Argument Preparations
With the entire case resting on the lead attorney’s shoulders, CCA helped him with storyboarding, message construction, and preparation of demonstrative aids for oral argument. The attorney also underwent CCA’s grueling preparation for questioning from the bench.
High Stakes
Two clients, both with plant and team findings, were facing difficult INPO Board Meetings, with probation as a definite possibility. Key nuclear plant personnel worked with CCA’s team to present clear, concise answers to complex questions.
Breakthrough for Gout Patients
CCA helped the developer of a new biologic treatment prepare a presentation addressing key clinical trial findings of the new treatment and provided preparation for extensive questioning by a FDA advisory committee.
Changing Business Structure
A new state bill required electric utilities to file and defend a business plan which would ensure power generation remained regulated by the state. One of the largest U.S. energy corporations called on CCA to prepare their team of witnesses for intense hearings.
Disgruntled Public
When activists failed to stop the construction permit of a new coal-fired plant, they intervened in the siting of its transmission lines across two states. Our team helped the company tell the courts and public of the environmental efforts taken during the siting studies to avoid ecological concerns.
Screening Potential Witnesses
In the calm before impending litigation, a client put several key personnel through CCA’s first phase of witness development, to screen potential future company witnesses.
Dupuytren’s Disease: Non-Surgical Treatment
Dupuytren’s Disease is a condition in which excessive collagen causes a formation of a cord between the skin and tendons of the palm which can result in permanent contraction of a finger. The developer of a non-surgical treatment retained CCA to help specialists explain successful findings of clinical trials.
Reliable Transmission Grid
With more wind power coming online, balancing load and capacity is necessary to maintain a reliable transmission grid. CCA readied witnesses to address an application for a natural gas plant for regulating this balance.
Fighting Melanoma
A pharmaceutical giant is developing a form of interferon to treat Stage III melanoma. The company is using CCA’s step-by-step preparation process to get ready for the Oncologic Drugs Advisory Committee.
Cost Recovery
With the current state of the economy, and facing the necessity of constructing electric generation plants with a price tag in the billions, several clients were forced to ask states to allow construction work in progress (CWIP) carrying costs recovery. Working through CCA’s witness development labs, clients met the challenge of explaining the reasons for, and benefits of, CWIP.
Leadership Skills
Moving from management to a leadership position requires enhanced communication skills. A CEO, retiring within the next three years, hired CCA as personal coaches to strengthen several of his executives’ leadership skills.
Testimony Writing Clinics
Having to draft pre-filed direct testimony for a team of corporate witnesses, each having a vital piece of the company’s case, can be daunting for inexperienced, as well as veteran, witnesses. Our Testimony Writing Clinics were used this year to help clients prioritize issues, lay out the case solidly, and test for clarity.
Oral Explanation
A firm seeking EMEA approval of a treatment for Hodgkin’s lymphoma retained CCA to ready physicians and scientists to present an “Oral Explanation” addressing outstanding issues.
Strategic Counsel
Throughout the year, clients used CCA strategic counsel during controversial situations. One example: how to handle the situation when company employees withheld information from the public – which was not in keeping with the company’s values of transparency and ethics.
Air Permit Appealed
When local landowners and environmental organizations challenged the air permit for a new coal-fired plant, the company was forced to defend its analyses. During witness preparation, CCA helped company witnesses stay non-defensive and grounded in facts.
Private Coaching
A new manager, knowing she would be responsible for testifying on behalf of the company in future proceedings, asked for personal assistance to attain core witness skills now. CCA put her through a private lab for cross-examination skills and issue resolution.
Treating Ocular Itching
An ophthalmic drug for ocular itching required preparation for an advisory committee. The firm used CCA’s preparation process to rank issues, develop answers to tough questions, and build a winning sponsor’s presentation.
Note: Extensive issue research is conducted as a first step for all assignments.
