A first-in-class gene therapy company asked Catalyst to support both regulatory and regulatory policy.
Challenge
Provided hands-on support, communicating with clients weekly, if not daily.
Served as an expert, action-oriented extra set of hands, eyes, and ears on the policy, political, patient advocacy, and FDA fronts.
Identified and proposed solutions for corporate, pipeline, and regulatory needs.
Engaged directly with regulators on topics of timely and critical importance.
Leveraged our extensive network inside and outside the beltway to help client better understand and influence policy and regulatory environments.
Expanded the client’s footprint among the policymakers, patient advocacy groups, and thought leaders interested in collaboration through introductions and message development.
Advised on on effective trade association engagement.
Participated in cross-functional teams to help create broader strategies that impacted the reimbursement, coverage, and access to a new technology.
Positioned leadership to play a role in shaping emerging hot topics, like user fee negotiations.
Impact
Retained by five former team members to provide continued support in their expanded positions at new companies.
Hired by five employees following their transitions to other companies.
