2011 Project Highlights
COPD
is a chronic disease affecting middle-aged smokers by limiting airflow. CCA’s Advisory Committee Preparation Process and input from subject matter experts led to a strong performance by our client at advisory committee.
INPO
In the midst of the Fukushima nuclear crisis, CCA prepared two plants to withstand the grueling scrutiny of U.S. nuclear regulators (INPO Board). Both plants had significant team and station findings prior to the Boards.
Leadership Coaching
CCA provided ongoing private leadership coaching for several executives.
Wartime Business
A high-level military witness, testifying during a Congressional investigation into the abuse of wartime contracting, used CCA’s process to get him ready for critical, high-profile questioning and allegations.
Crisis Response
CCA responded to client crises by providing services needed for each situation. These services ranged from “boots on the ground,” to strategic advice, to issue resolution, to readying the company for tough stakeholder interactions, to prepping for Congressional investigations.
Improper Actions
A major corporation used CCA’s witness development process to ready their Senior VP to address potentially inappropriate communication between executives and regulators.
Management Decisions
Facing a harsh prudence review, a company tried the same case in two state jurisdictions with very different rules and regulatory environments. CCA helped prepare the witnesses to handle issues from multiple views.
Congressional Hearing
At the height of the Deepwater Horizon spill, CCA helped an oil industry client ready their witness for an unrelated sub-committee hearing. The witness was prepared for both the questions which should have been asked as well as what we anticipated (accurately) would be asked during a vicious attack on the safety of the industry.
EOP2 Meeting
An End-of-Phase 2 meeting is a discussion/negotiation of the makeup and design of Phase 3 clinical trials. For this very important step, CCA provided a negotiation process and series of mock negotiating meetings to help ensure a positive outcome in FDA interactions.
Regulatory Lag
A plan to eliminate excessive regulatory lag for the company and rate shock for the customers was proposed for a utility. CCA helped their witnesses develop clear, concise themes and understandable explanations.
Beating Gout
The developer of a treatment for Gouty Arthritis, a particularly difficult form of the disease, brought CCA on board to establish a 4-stage prep process to ready their team for advisory committee.
Financial Errors
A Canadian corporation experienced a software and human error incident that led to audits in which the company could not produce data or justifications. With high-risk communication tools, CCA equipped their team to explain to regulators what happened and what they were doing about it.
Bad Timing
In the current economic environment, it has been difficult for utilities to ask their regulators for necessary rate increases. Nineteen companies used our team to help them realistically vet the issues, transparently lay out a case, and forth-rightly defend it.
FDA Inspections
CCA prepares medical device manufacturers for FDA Pre-Approval Inspections (PAI). For example, the manufacturer of a medicated contact lens used our Issue Resolution Process and Q&A models to succeed in inspections.
Clear Negotiations
When regulators “invited” a company to a pre-settlement meeting, CCA helped them prepare their presentations and responses to build an administrative record of violations, risks, company’s actions, and current status. The transparency was appreciated by the regulators.
Advisory Committee: Yes or No?
A pharmaceutical company sought an indication for systemic juvenile idiopathic arthritis (sJIA). Using CCA’s issue ranking methodologies and step-by-step Q&A models helped our client make a successful case to avoid the need for an advisory committee.
Putting Expenses on Hold
In deference to the current economic plight of its customers, one energy company put its upgrades on hold and requested from its commission bare-bones, cost-of-service rates. The company utilized CCA’s witness development process to equip their team to tell the story.
Finding Holes in the Case
Vetting a case before filing is critical. Working with witnesses, our team helped probe and vet opposing allegations and case points. Major holes in clients’ cases were found in enough time to repair before filing.
Diverse State Regulators
CCA worked with a regulated holding company which covered several jurisdictions, each known for being a tough regulatory climate. The company used our tools and process to prepare for issues common to all their jurisdictions.
Exocrine Pancreatic
Insufficiency (EPI) is a common malady in cystic fibrosis patients. The sponsor of a breakthrough treatment for the disease retained CCA. Using an Issue Resolution methodology, team members developed an arsenal of solid messages and answers to questions.
Crisis Readiness
How a company communicates during a crisis can destroy or enhance its credibility/reputation. CCA’s Crisis Communication sessions and drills were used to ready our client’s executives and key personnel to respond to stakeholders before, during, and after a crisis to ensure a sterling long-term reputation.
Educating The Public
State and Federal mandates require the energy sector to invest heavily into renewables, energy efficiency initiatives, and smart technology. Two major utilities asked CCA to prepare their teams to communicate technical, economic, and social issues to multiple stakeholders with varying viewpoints.
Note: Extensive issue research is conducted as a first step for all assignments.
