2014 Project Highlights
Protecting a Centuries-Old Reputation
A well-respected law firm was fighting for its life after a high-profile media exposé led to the disbarment of a partner, multiple lawsuits, and a Congressional investigation. CCA provided strategic guidance to the firm on coming clean and regaining the trust of their clients, the legal community, government leaders, the media, and the public.
A pharmaceutical company faced a Cardiovascular and Renal Drugs Advisory Committee that was skeptical of its study design and fixed-dose combinations. CCA prepared the company’s team of scientists and executives to respond to these concerns with a focused presentation of persuasive data.
Renewable Power Certification
In order to certify wind power for inclusion in its integrated resource plan, a diversified energy generation company needed to convince commissioners that wind power represents firm capacity. CCA prepared witnesses to effectively present this case – the first of its kind in the state – without revealing any trade secrets.
Individualized Leadership Coaching
To help senior leaders make the leap from managing and doing to truly leading, CCA provided highly specific leadership coaching for companies in a variety of industries, giving participants the tools to move their organizations forward with persuasive and inspiring actions and interactions.
Restoring Confidence After Controversy
Following the high-profile departure of key company executives and state regulators, CCA readied a team of witnesses to rebuild confidence in a new clean-coal generation plant by presenting a multiyear rate plan that minimizes consumer rate increases.
Cutting-Edge Medical Device
As part of its effort to obtain approval for a new approach to treating high-risk heart disease patients, a medical device developer created a critically important plan for educating surgeons on proper device placement. CCA worked with the company to develop an approach for presenting and defending this plan before the FDA’s Circulatory System Devices Panel.
Groundbreaking Transco Approval
A major power generation company needed approval for the first transaction of their new stand-alone transmission company. CCA prepared witnesses to educate regulators on this more expensive transaction and the potential long-term benefits of the delivery approach.
Handling Volatile Issues
A company developing an MCM (medical countermeasure) for a deadly biological agent faced the significant challenge of balancing security concerns with the need for stakeholder transparency. CCA prepared the company’s CEO to deal with Congress, regulatory agencies, and the public on these tough issues.
Mandated Cooperation With Competitors
An energy company wanted to maximize its future options during the transition to a new regulatory scheme that would require it to work together with competitors. CCA prepared the company’s management team to convince the state’s PUC to approve a plan that preserved flexibility and established rates and specific provisions that reflected the new complexities.
Transparent Crisis Response
When a university discovered that students in its medical program had been practicing injections on themselves using a product not intended for human or animal use, CCA worked with administrators to develop a fully transparent crisis response strategy that focused on the needs of students and emphasized doing the right thing.
Recovering Retrofit Costs
Facing the requirement that it retrofit a power-generation plant with expensive environmental controls, a utility turned to CCA to prepare its witnesses to persuasively make the point for recovering the full cost of these retrofits in its latest rate case.
Clinically Meaningful Debate
A multinational pharmaceutical company – facing a Cardiovascular and Renal Drugs Advisory Committee that believed the indication targeted by its proposed biologic was not clinically meaningful – turned to CCA for help in creating
a presentation strategy and defense that would maximize the future value of the product.
CCA worked with an integrated energy company to prepare nearly 20 witnesses for a rate case in a challenging jurisdiction. The case was complicated by numerous riders and the inclusion of costs for a regional transmission organization, which were presented as a known and measurable expense that was not in the historic test year.
Repairing Online Reputation
The principles of honesty, transparency, and accountability also apply to online reputations, and when a widely known technology reviewer was accused of inappropriate online behavior, CCA counseled him to stop attacking his accusers, acknowledge his mistakes, issue an unqualified apology, and take the significant step of leaving the Internet.
Preparing for a Critical EOP2
A biopharmaceutical company with a novel wound care product faced a make-or-break EOP2 meeting with the FDA. CCA prepared company executives to minimize the likelihood of having their EOP2 downgraded to a guidance meeting and establish the basis for successful Phase 3 trials.
Predictive Issue Resolution
CCA worked with management teams at a major pipeline company to create a mindset and process to identify stakeholder concerns before they arise, make operational changes to address these concerns when possible, and be ready with transparent, defensible responses.
For a major gas company acquisition, CCA worked with energy companies in two states to develop a strategic approach for presenting and defending a joint application for the acquisition. CCA also prepared the team to convince regulators that neither state would experience diminished reliability or harm to customers.
When a school district faced a serious crisis related to a campus sexual abuse scandal and allegations of a coverup, CCA counseled them to create a safe environment for additional victims to come forward, provide maximum transparency while still respecting victims’ privacy, and implement a rigorous corrective action plan.
Label Negotiation Preparations
Midway through Advisory Committee preparations, a pharmaceutical company learned that their anti-infection product wouldn’t require Advisory Committee guidance. All of CCA’s work to that point – including models, tools, and issue evaluation – was easily adapted to serve as the basis for label negotiation preparations.
Proving Prudent Management
A major utility relied on CCA to prepare its witnesses to defend and prove the prudence of its construction management practices on a nuclear project to the state’s Public Service Commission.
A First-in-Class Drug
A pharmaceutical company requested FDA approval for a new psoriasis treatment offering rapid onset of action, sustained efficacy, and safety for prolonged use. The developer sought CCA’s guidance to help it earn a unanimous Advisory Committee vote by effectively telling its story and defending the data.
Educating From the Stand
A Canadian power corporation with a rising cost of service and an evolving regulatory structure called on CCA to help prepare for its first rate case in 10 years. During the process, both the governing board and the corporation’s witnesses changed, requiring CCA to quickly bring the new witnesses up to speed and prepare them to educate the new board members on the specifics of the case.
Long Odds and Tough Challenges
The developer of a new platelet inhibitor saw strong clinician interest in its novel drug and sought CCA’s guidance in overcoming the challenge presented by limited clinical trial data. CCA helped the company present the best possible case to the CRDAC and obtain encouraging committee feedback that will be valuable in future discussion with the FDA.
Note: Extensive issue research is conducted as a first step for all assignments.