Robust and Targeted Publication Planning for Novel CAR T Therapies: A Case Study on a Strategic Startup Biotech-Agency Partnership

• Objective: To develop and implement robust publication plans supporting rapid communication of data on a novel CAR T cell therapy in a startup company setting • Challenge/Problem: While CAR T cell therapy has generated great excitement, there was an overall low awareness of key attributes and differentiators of CAR T cell therapies as recently as 2015. Constructs, manufacturing processes, mechanisms of action, and patient populations were identified as key knowledge gaps. This new sponsor company also had limited internal resources in a very competitive landscape • Solution: Publication planning strategy focused on increasing scientific share of voice (SSOV) and awareness of identified knowledge gaps. A collaborative agency-sponsor relationship was forged early to ensure scalability, facilitate compliant publication development, and build subject-matterexpert medical writer partners. Elements for effective implementation included: (1) tailored encores of key presentations to maximize impact of limited clinical datasets, (2) leveraging academicsponsor partnerships to disseminate data from non-sponsor studies, (3) supporting review articles addressing gaps not requiring clinical datasets (eg, manufacturing process), and (4) capitalizing on internal experts and external study investigators through invited lectures at scientific meetings • Outcome: SSOV increased 12.25-fold during the 4 years prior to initial market approval of the sponsor’s CAR T cell therapy. Awareness of the sponsor’s CAR T cell therapy improved from 35% in 2016 to 69% in 2017 in clinician surveys because of this increase in SSOV and other educational tactics • Benefits: Effective agency-sponsor partnerships can enable startups to establish a presence, educate through scientific publications, and differentiate from more established competitors

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CC BY 4.0