Month: August 2017
Medical Writing Competency Model—Section 1: Functions, Tasks, and Activities
Drug Asset Evaluation: Increasing “Probability of Success” of a Deal
Certara’s due diligence/asset evaluation teams are comprised of drug development and commercialization experts who advise on acquiring or investing in emerging biopharma companies.
Integrated Asset Evaluation for Go/No Go Investment Decisions
Certara performed scientific and commercial due diligence of an investment opportunity (Rivipansel for Vaso-Occulisive Crisis in Sickle Cell Disease) for a private equity firm.
Emerging Issues for Pharma R&D: A Practical Approach for Pediatric Drug Programs
In this webinar, Dr. Barry Mangum from Paidion Research and Dr. JF Marier from Certara discussed how pediatric considerations fit into the overall drug development program. They also made recommendations for addressing issues from both a practical and scientific perspective. Anonymized case studies were presented with a review of historical issues with a focus on solutions for today (ie, licensed comparators differences in US and EU, importation issues, and endpoint selection).
The Emergence of Quantitative Systems Toxicology
Achieving a pathway-based approach to more efficient chemical risk assessment.
Investigational Drug Gap Analysis
As the process of drug development has increased in cost and complexity, Certara has developed a service offering to assess a sponsors’ development program across multiple domains, and to craft a strategy to address each.
Clinical Pharmacology—The Quarterback of Drug Development
Clinical pharmacology accounts for about 50% of a drug label. Its scope ranges from facilitating the discovery of new target molecules to determining the effects of drugs in different populations. From both industry-wide and regulatory perspectives, the levers of clinical pharmacology can address the huge challenges of late-stage attrition and increase the efficiency of drug development in the quest to bring the “ball” into the end zone.