Paving the Path for a PCSK9 Inhibitor
Sector
Pharmaceutical
Company
Global Large Pharma
Therapeutic Area
Cardiometabolic
Treatment Modality
Biologic
Product Stage
Pre-Launch
Expertise
Scientific Communications
A leading global biopharmaceutical company advanced a next-generation, PCSK9 inhibitor into late-stage development, aiming to transform lipid management by bringing the proven efficacy of PCSK9 inhibition into a long-acting, twice-yearly treatment. The program carried the potential to broaden adoption by overcoming the adherence challenges, reaching millions of patients struggling with uncontrolled LDL-C despite statins.
Situation
A leading global biopharmaceutical company advanced a next-generation, PCSK9 inhibitor into late-stage development, aiming to transform lipid management by bringing the proven efficacy of PCSK9 inhibition into a long-acting, twice-yearly treatment. The program carried the potential to broaden adoption by overcoming the adherence challenges, reaching millions of patients struggling with uncontrolled LDL-C despite statins.
Situation
Approach
Our recommendation centered on scientific positioning and medical communications to prepare the asset and its pivotal trial program for pre-launch. The team having supported every prior PCSK9 inhibitor launch, we carried forward critical lessons to ensure early clarity and differentiation. We translated complex clinical and mechanistic data into a clear narrative that underscored the advantages of twice-yearly dosing, aligned trial design with payer and guideline expectations, and shaped communications that proactively addressed historic barriers to adoption, including skepticism around outcomes relevance and long-term adherence.
Our recommendation centered on scientific positioning and medical communications to prepare the asset and its pivotal trial program for pre-launch. The team having supported every prior PCSK9 inhibitor launch, we carried forward critical lessons to ensure early clarity and differentiation. We translated complex clinical and mechanistic data into a clear narrative that underscored the advantages of twice-yearly dosing, aligned trial design with payer and guideline expectations, and shaped communications that proactively addressed historic barriers to adoption, including skepticism around outcomes relevance and long-term adherence.
Approach
Results
This approach paved the path to launch readiness. By establishing scientific clarity early, the asset entered late-stage development with a stronger positioning framework, heightened KOL alignment, and a pre-launch narrative designed to accelerate acceptance where earlier PCSK9 therapies had faced resistance.
This approach paved the path to launch readiness. By establishing scientific clarity early, the asset entered late-stage development with a stronger positioning framework, heightened KOL alignment, and a pre-launch narrative designed to accelerate acceptance where earlier PCSK9 therapies had faced resistance.
Situation
A leading global biopharmaceutical company advanced a next-generation, PCSK9 inhibitor into late-stage development, aiming to transform lipid management by bringing the proven efficacy of PCSK9 inhibition into a long-acting, twice-yearly treatment. The program carried the potential to broaden adoption by overcoming the adherence challenges, reaching millions of patients struggling with uncontrolled LDL-C despite statins.
Approach
Our recommendation centered on scientific positioning and medical communications to prepare the asset and its pivotal trial program for pre-launch. The team having supported every prior PCSK9 inhibitor launch, we carried forward critical lessons to ensure early clarity and differentiation. We translated complex clinical and mechanistic data into a clear narrative that underscored the advantages of twice-yearly dosing, aligned trial design with payer and guideline expectations, and shaped communications that proactively addressed historic barriers to adoption, including skepticism around outcomes relevance and long-term adherence.
Results
This approach paved the path to launch readiness. By establishing scientific clarity early, the asset entered late-stage development with a stronger positioning framework, heightened KOL alignment, and a pre-launch narrative designed to accelerate acceptance where earlier PCSK9 therapies had faced resistance.
*Impact studies reflect the collective experience of Biography and its partners.
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Let's Partner
Generating the
Biology Century
We help life sciences teams cut through complexity and move from biology to belief—sharper, faster, leaner.
Let's Partner
Generating the
Biology Century
We help life sciences teams cut through complexity and move from biology to belief—sharper, faster, leaner.