2020 Project Highlights
During 2020, we conducted both virtual and socially distanced sessions to fit clients’ needs and timelines. We will continue to do so as long as necessary.
Nimble Response To Virtual Challenges
The COVID-19 pandemic prompted FDA to conduct virtual AdCom meetings. We, along with our client, transformed CCA’s proprietary process into a virtual platform. We ensured the sponsor team had access to a flawless, complex technical system for a multi-speaker presentation, slide retrieval, and Q&A triage in a comprehensive, four-day virtual session. Our teams worked in tandem to vet technology, pinpoint problems, and fix system bugs through multiple rehearsals. Not only did preparations stay on schedule, but additional mocks also ensured the team’s comfort and ease in using the virtual platform. The client positioned itself steps ahead of FDA and was poised to quickly adapt to a go/no-go decision on any virtual platform.
Preempting The Red Zone
When federal regulators began reviewing a multitude of potential security violations, a Fortune 500 company faced a major reputational crisis and possible substantial fines. Company executives, along with CCA, led leadership interventions, held their feet to the fire, and demanded proof of ownership and remediation. The lack of answers sparked strategic and tactical action that instilled a rigorous compliance mindset. CCA coached the team on how to use our give-to-get strategy of disclosing system pitfalls, owning root causes, and immediately implementing procedural change. We continued to grill the team on tough issues, develop Issue Cards, rehearse briefings, and provide strategic counsel as they preempted a loss of credibility. Commitment to transparency, along with improved performance, built confidence with regulators.
Prep For A Contentious Interaction
A pharmaceutical company assembled a sponsor team with varying levels of experience to prepare for an unfriendly FDA Advisory Committee. CCA helped the team anticipate show-stopping questions and identify gaps in their sponsor presentation through our Issue Resolution process. In addition, we provided essential resources for AdCom success including our Q&A system, slide retrieval, data management system, and graphic design team. In a series of labs, the team received speaker/responder coaching, triage strategy, and improved their skills in rigorous Q&A drills.
Adaptive Approach In A Lockdown
An energy client needed to combat traditional definitions of transmission in a federal regulatory case (FERC). We readied the team to make a persuasive case in a technical setting, instilling our core models and tools through our Phase I session. As preparations began for the final lab, the coronavirus pandemic prompted a nationwide travel ban. CCA quickly adapted the session to a virtual platform that included the interactive and one-on-one elements of a traditional CCA session. The team maintained momentum as outside variables prohibited in-person meetings.
Balancing Regulatory Tightrope
While battling regulatory lag, our client was ready to accelerate a major capital spending plan focused on renewable energy and grid modernization. The witness team needed to overcome resistance from the commission and justify spending without apparent need for additional capacity. CCA drilled witnesses in a Phase II session designed to help them convey complex information in a clear manner. We helped identify vital case elements to win and provided strategies to handle oppositional positions from staffers.
Overcoming A Crisis Of Trust
A CEO sparked a crisis of trust early in his tenure. Intense internal and external scrutiny deteriorated his ability to show the benefits of his decisions. CCA provided focused leadership coaching, co-constructing a crisis theme and strategy to better navigate the politicized environment. A selection of our core models and tools helped the CEO listen to his colleagues and foster trust as he collaborated with peers to execute strategic decisions during crucial moments.
Same Case, Two Jurisdictions
Seeking to recover capital spending costs, a major utility needed to prepare a team of witnesses to testify in associated cases across two jurisdictions. CCA counseled witnesses to set a case theme that united the owner/operator narrative. Participants developed Issue Cards to tackle tough allegations and practiced in Drill Downs to defend prudence of project spending. In a rigorous mock-hearing, set specifically to the first jurisdiction, our consultants coached Q&A and demeanor, building the team’s confidence to excel on the stand and set a sound precedent for the affiliate case.
Surviving A Combative Regulatory Environment
A series of missteps by a large power generation company incited a hostile relationship with regulators. CCA provided our proprietary system of communication tools that compelled the team to be truthful and helpful under fire – foundations for building trust. The witness team identified gaps in knowledge through issue resolution, “Allegator” Hunts, and multiple Q&A drills.
Repairing Reputational Damage
Our client took a credibility hit after a failed capital project almost bankrupted the enterprise. The company needed to use an upcoming case to salvage its relationship with customers and newly elected regulators. CCA helped the team identify must-have case elements and vulnerabilities, pairing case points with strategies to kill contentious allegations. Witnesses took a forthcoming approach with the commission that began to repair its fractured reputation.
Issue Resolution For Critical Encounters
Two clients familiar with our system of core models and tools needed to pinpoint and address controversial issues before facing high-stakes encounters.
- One client, an experienced pharmaceutical team, called CCA to identify issues in an NDA draft that could impact Advisory Committee success. The team also utilized a day of CCA’s proprietary Issue Resolution process strictly for the AdCom. We led the sponsor’s team through a method of identifying pitfalls and refining proof points that helped tell a more compelling clinical story. The primary team was well prepared for their first mock presentation and Q&A drill, saving time and energy for more in-depth work including preemptive strikes in the presentation and foundational issues in the NDA.
- Another client, a large electric company, was challenged to fold witnesses into the preparation process who had been through our Phase I session in previous cases. Our client saw an Issue Resolution Day as a quick, effective and economical way to gear up for a Phase II session. In one intense day, witnesses worked with subject matter experts and attorneys to dive into issues unique to the upcoming case. Together, they found their highest ground and supporting evidence, and vetted their responses in a “fly or die” peer review. Armed with a solid Smart e-Book of Issue Cards, the team had accelerated their preparation with increased confidence for their focused Phase II program.
Immediate, Intensive Coaching
An executive’s discriminatory behavior fractured key workplace relationships. Without change, the executive faced a jagged road towards termination. CCA coupled our Phase I boot camp with specialized one-on-one sessions to identify and correct damaging behaviors. Additional tools prompted the executive to intently listen to colleagues in emotional interactions and modify behavior to prevent future unacceptable communication.
Leadership Bootcamp for High-Risk Facilities
Unable to get direct answers from the leadership team, the CEO of a high-risk nuclear facility rapidly lost confidence in their knowledge of site issues. CCA developed a tailored program to coach team members to give direct answers to tough questions and deliver targeted briefings to internal and external stakeholders, including INPO. Participants infused these tools into the site’s culture, building rapport with regulators and company leadership.
Testifying Across Jurisdictions
After acquiring several operating companies, a gas and electric client needed a core team of witnesses who could testify effectively across state, federal, and regional jurisdictions. CCA conducted witness development labs across the parent and operating companies to give witnesses the foundational tools they needed to excel in each regulatory environment. Our process brought clarity to case-specific issues and helped regional teams build powerful and united narratives on the stand, paving the way for regulatory success.
Persuasive Arguments For Shifting Needs
As state regulators spearheaded a transition to carbon-free generation, an energy corporation sought to upgrade its customer information and interface systems, and mitigate regulatory lag in a frenzied environment. In addition, the company needed to shift the commission’s mindset to support a flexible approach to asset depreciation allowing for a nimble response to changing customer needs. CCA prepped witnesses to identify their tough allegations, layout persuasive arguments, and defend them on the stand. We provided tools to handle loaded questions, maintain composure under fire, and build a strong transcript.
Defending Large Complex Construction
With public opposition mounting, our client had to defend project trajectory and prudence for a large-complex construction site to uneasy regulators. CCA prepped a team of executives from both owner and constructor companies to excel in critical briefings and power through rigorous lines of questions. The skills and tools they honed helped tell a compelling public story and protected long-term credibility with regulators.
Note: Extensive issue research is conducted as a first step for all assignments.