2010 Project Highlights
Unconventional Hearing
When a jurisdiction decided to hear a petitioner’s case in discreet issues, and have witnesses from all parties involved appear on the same panel, with the ability to tag on any other witness’ responses, the company asked CCA to prepare their witnesses for this novel environment
Chronic Heart Failure
A developer of a new CHF treatment utilized CCA’s full advisory committee preparation process. This included issue identification, strategy, development of a sponsor presentation, extensive Q&A coaching with slide retrieval practice, and mock AC hearings.
Affordable Energy
Financial health of a utility is critical to affordable energy. In today’s economy, CCA has helped several clients explain and defend innovative programs for the benefit of customers and utilities such as formula-based rates, environmental riders, fuel cost clauses, etc.
Leadership Coaching
Several companies requiring preparation and grooming of future executives, asked CCA to provide private leadership coaching. The sessions are always as unique as the individual and the company’s needs.
Prudence Audit
The company’s witnesses had to defend years of management’s actions and decisions in construction and improvements of two plants. CCA was hired to ready the witnesses to respond to a troublesome prudence audit.
Controversial Compound
A pharmaceutical giant developed a treatment for asthma that included a component the FDA disliked for safety reasons. CCA’s step-by-step Issue Resolution Process and exhaustive Q&A drills helped the client formulate positions for their interactions with the agency.
Strategic Advice
Trying to determine whether to file a case or not, CCA was brought in as an objective third party for opinion, strategic advice, and potential persuasive themes.
European Medicines Agency
The developer of an adjuvant treatment for localized renal cancer utilized CCA’s issue research process and strategic counsel to develop a strategy for presenting their data to the Committee for Medicinal Products for Human Use (CHMP).
INPO Review
With more scrutiny in the nuclear industry, plants are meeting with tougher questioning at accreditation boards. CCA readied plant teams to meet that challenge – whether they were on probation or working to stay off probation. We helped them address tough issues head-on, and use pre-emptive strikes and data to succeed.
Labeling Discussions
One of the last steps in drug approval is labeling. Drug sponsors engage in labeling discussions with FDA to finalize the wording of indications, efficacy data, safety warnings and many other areas. A developer of a vaccine for childhood infections used CCA’s Negotiation Process to help strengthen their ultimate drug label.
Renewable Energy
To make renewables viable, transmission facilities must be built from the renewable source to the demand areas. CCA worked with two transmission cases in which the regulators supported the cases amid public objections.
Social Media
In late 2009, FDA held a hearing to explore the role of social media in healthcare. A major pharmaceutical company used CCA Q&A models to strengthen and focus the company’s positions on uses of health-based social media.
Unreliable Data
Substantial problems and billing errors, due to the company’s total switch to a new computer system, led to lack of trust in the data. CCA worked with the witnesses to prepare them to give solid answers to tough questions from a new regulatory board.
Crisis Readiness
CCA continued to provide crisis readiness tools to executives and management – the plan, the skills, the tests. Additionally, as strategic advisors, we helped clients pre-empt crises.
Difficult Questions
One of CCA’s greatest strengths is readying physicians and scientists to effectively answer tough questions supported by backup data slides. One pharmaceutical firm with a specialty in antibiotics brought in CCA to prepare their responders to formulate answers and locate the correct supporting backup slides in seconds.
Witness Prep
A utility that had not filed a rate case for twenty-five years asked CCA to help their witnesses prepare a case, learn to lay out complex issues succinctly, and hone witness skills to withstand intense cross-examination.
Leadership Challenge
Within two years, a client’s entire executive team will be retired. The company asked CCA to develop a three day crisis exercise for potential successors – for team-building, for skill enhancement, for crisis readiness.
Harsh Economic Environment
Going into its third rate case in three years during a dire economy, a utility was fighting to stay above junk bond status. CCA worked with its witnesses to tell the straightforward story in a troublesome climate.
Chronic Obstructive Pulmonary Disease
The pharmaceutical sponsor of a COPD treatment was soon to face an FDA expert advisory committee. They needed help. The CCA preparation process answered the question: “How will we effectively present and defend our data?”
Challenging Questions
Millions for power uprates, exploratory activities for new nuclear plants, affiliate issues, and concerns over sole-sourced contracts coalesced to provide challenges for witnesses to defend. They used CCA’s process to get ready for grueling cross-examination.
Conflicting Regulators
When a client was facing a hostile commission, it found itself in a jurisdictional fight among two commissions and its own parent company. They used CCA’s witness development process to prepare their witnesses to navigate through that environment and present their case for a Formula Rate Plan.
Mock Committees
During FY 2010 CCA conducted 20 mock advisory committees. These intense sessions provide a realistic test of a teams readiness to effectively present data to the Advisory Committee and stand up to tough questioning.
Note: Extensive issue research is conducted as a first step for all assignments.
