Capabilities

Catalyzing impact through
strategic action

How we deliver

Each Catalyst project is unique. We don’t believe in cookie cutters. We offer varying levels of engagement and deliverables tailored to specific client needs, ranging from comprehensive support to targeted initiatives. Examples of past projects and expertise are included below.

The full range: comprehensive support

Cross-functional strategic vision development and execution

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Catalyst capacities:
  • Understand objectives  
  • Conduct research to identify challenges and opportunities
  • Produce informative environmental scans
  • Identify allies, build relationships, and seek engagement
  • Pressure test policy alternatives in the context of current environment
  • Build meeting materials
  • Host workshops (both in-person and virtual)
  • Build consensus among stakeholders
  • Negotiate win-win-win outcomes that meet regulator, sponsor, and patient needs
  • Amplify objectives through targeted outreach
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All hands on deck support

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Catalyst capacities:
  • Serve as a virtual regulatory team managing the regulatory process
  • Inform internal and external regulatory policy development
  • Implement internal and external regulatory policy
  • Expand network footprint
  • Create strategic patient engagement opportunities
  • Build consensus among stakeholders and implement policy
  • Develop messaging
  • Expand the conversation though strategic communication channels
  • Gather US and international regulatory and legislative policy intelligence
  • Inform effective trade association selection and engagement
  • Develop responses to draft guidance,  proposed rules, and other FDA requests for comments
  • Conduct regulatory precedent research to inform current development strategies
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The summit approach: targeted initiatives

Project-focused policy creation
and execution

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Catalyst capacities:
  • Produce stakeholder environmental scan
  • Pressure test policy alternatives in the context of current environment
  • Leverage network of respected experts
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Science communications

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Catalyst capacities:
  • Engage with C-suite level executives, patient advocacy groups, regulators, R & D teams, and the general public
  • Write white papers to post on websites with the goal of educating consumers on cell and gene therapy
  • Conduct surveys of patient advocates to better understand their experiences
  • Research and publish horizon scans evaluating emerging technologies and the global regulatory landscape
  • Build slide presentations to help explain complicated science in lay terms
  • Prepare abstracts and moderate panels on cutting-edge science, highlighting potential regulatory implications
  • Collaborate on drafting white papers to highlight the needs of clients and the field
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Market scans and regulatory intelligence

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Catalyst capacities:
  • Gather US and international regulatory intelligence  
  • Conduct legislative and administrative environmental scanning
  • Research best practices to advance internal regulatory team objectives
  • Build regulatory teams from the ground up
  • Supplement teams with respected experts
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Regulatory submissions and pathway strategies

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Catalyst capacities:
  • Serve as a virtual regulatory team managing regulatory process  
  • File designation and voucher requests
  • Inform and build regulatory strategy
  • Supplement teams with respected experts
  • Determine best regulatory pathway options, based on market realities
  • Support efforts for label expansion
  • Embed our core team within an existing regulatory team
  • Research best practices to advance internal regulatory team objectives
  • Build regulatory teams from the ground up
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Business development

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Catalyst capacities:
  • Anticipate impactful regulatory trends and opportunities
  • Inform corporate positioning
  • Combine insights on market access and reimbursement to hone regulatory strategy
  • Analyze the legislative and administrative environment to identify business opportunities
  • Expand network footprint through strategic introductions
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Nascent technology barrier clearance

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Catalyst capacities:
  • Identify regulatory barriers
  • Create strategies to remove barriers before nascent technology reaches FDA
  • Facilitate Agency engagement to promote win-win outcomes to meet both regulator and sponsor needs
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Industry and stakeholder consensus building

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Catalyst capacities:
  • Convene stakeholders
  • Facilitate and write collaborative white papers
  • Conduct surveys to inform patient focused drug development
  • Explore policy alternatives
  • Negotiate win-win-win outcomes that meet regulator, sponsor, and patient needs
  • Pressure test policy alternatives in the context of current environment
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Network expansion

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Catalyst capacities:
  • Identify allies and build relationships
  • Engage key decision-makers
  • Write abstracts for targeted speaking opportunities
  • Expand patient and consumer networks
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Reimbursement, coding, and
access

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Catalyst capacities:
  • Understand reimbursement and coverage environment for new and existing products
  • Create strategies to improve Medicare/Medicaid coverage
  • Determine best regulatory pathway options, based on market realities
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