Therapeutic Specialties Archives

Case Study

Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta

Many cystic fibrosis (CF) patients take several medications at one time to manage symptoms and…

Jim GallagherJuly 14, 2021

Case Study

Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies

In November 2019, the US FDA granted accelerated approval for Oxbryta™ (voxelotor) tablets for the…

Jim GallagherJuly 14, 2021

Blog

Key Considerations to Ensure Maximal Probability of Antibody Drug Conjugate Development Success

Antibody drug conjugates (ADC) are a unique way to obliterate tumor cells and represent an…

Rajesh KrishnaJuly 8, 2021

On-Demand Webinar

Strengths and opportunities for HTAs and market access in Europe through case studies

Amongst the real world data sources in Europe, the French Healthcare database SNDS is the…

Jim GallagherMay 26, 2021

On-Demand Webinar

A Best Practice Framework for Applying PBPK Modeling to Pediatric Drug Development

Pediatric PBPK models have broad application in the drug development process and are being used…

Jim GallagherApril 20, 2021

Publication

The Landscape of Emerging Randomized Clinical Trial Evidence for COVID-19 Disease Stages: A Systematic Review of Global Trial Registries

Alison Dillman,1 Michael J Zoratti,2 Jay JH Park,3 Grace Hsu,2 Louis Dron,2 Gerald Smith,2 Ofir Harari,2 Craig R Rayner,4 Noor-E Zannat,2 Alind Gupta,2 Eric Mackay,5 Paul…

Jim GallagherDecember 22, 2020

Case Study

Galderma Achieves FDA Approval of AKLIEF® (trifarotene)

In October 2019, Galderma announced that the U.S. FDA approved AKLIEF® (trifarotene) Cream, 0.005% for the…

CertaraNovember 9, 2020

White Paper

The Effects of COVID-19 on Stakeholder Engagement & Value Communication: Preparing for the New Normal

Jim GallagherOctober 28, 2020

Publication

Clinical trials of disease stages in COVID 19: complicated and often misinterpreted

As of July 28, 2020, 1840 clinical trials were registered globally, with 1001 clinical trials…

Jieun ChoeAugust 22, 2020

Publication

Accelerating Clinical Evaluation of Repurposed Combination Therapies for COVID-19

As the global COVID-19 pandemic continues, unabated and clinical trials demonstrate limited effective pharmaceutical interventions,…

Jieun ChoeAugust 22, 2020

Therapeutic Specialties

Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta

Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies

Key Considerations to Ensure Maximal Probability of Antibody Drug Conjugate Development Success

Strengths and opportunities for HTAs and market access in Europe through case studies

A Best Practice Framework for Applying PBPK Modeling to Pediatric Drug Development

The Landscape of Emerging Randomized Clinical Trial Evidence for COVID-19 Disease Stages: A Systematic Review of Global Trial Registries

Galderma Achieves FDA Approval of AKLIEF® (trifarotene)

The Effects of COVID-19 on Stakeholder Engagement & Value Communication: Preparing for the New Normal

Clinical trials of disease stages in COVID 19: complicated and often misinterpreted

Accelerating Clinical Evaluation of Repurposed Combination Therapies for COVID-19

Newsletter sign up

Quick links

Solutions

Contact