Tag: Model-informed Drug Development
Systematic literature review of cross-protective effect of HPV vaccines based on data from randomized clinical trials and real-world evidence
The extent of cross-protection provided by currently licensed bivalent and quadrivalent HPV vaccines versus direct protection against HPV 31-, 33-, 45-, 52-, and 58-related disease is debated. A systematic literature review was conducted to establish the duration (…)
Can Biosimulation Provide the Key to Unlocking the Neurodegenerative Disease Development Challenge?
By Professor Piet van der Graaf, Ph.D., and Hugo Geerts, Ph.D. Neurodegenerative diseases (NDs) affect millions of people worldwide. In the US alone, five million people suffer from Alzheimer disease; 1 million from Parkinson disease; 400,000 from multiple sclerosis (MS); and 30,000 each from amyotrophic (…)
Sealing Pharma Commercialization Deals: Creating Optimal Value for Investors
It is crucial for biotech developers to engage in early commercial market assessment to generate value for Regulators, Payers, and Clinicians. This approach should be integrated with a clinical development strategy that will help drive acquisition potential, co-development prospects, and overall return on investment. Speakers: Fran Brown Dr. Fran Brown is currently the SVP of … Continued
Certara Renews Peking Union Medical College Hospital as Academic Center of Excellence for Model-Informed Drug Development
Partnership provides access to Certara’s industry-standard Phoenix™ Platform to advance drug development in China PRINCETON, N.J.—Mar 1 , 2021. Certara, a global leader in biosimulation, today announced that it has renewed Peking Union Medical College Hospital (PUMCH) as an academic Center of Excellence for model-informed drug development. Through this partnership, Certara will provide training and access … Continued
Three steps can help companies speed FDA approval of new drugs
Drug developers see Food and Drug Administration approval as a difficult uphill climb, requiring large investments of resources and time. But when it comes to new drug applications and biologics license applications, it’s usually (…)
The Year 2020 Marks the 7th Consecutive Year Certara Customers Received 90 Percent of US FDA Novel Drug and Biologic Approvals
Affirms continued regulatory and industry adoption of biosimulation and technology to bring new drugs to patients PRINCETON, N.J.—Feb. 25, 2021– Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that 2020 marked the seventh consecutive year where 90% of new drug and biologic approvals by the US Food and Drug Administration (FDA), excluding diagnostic … Continued
AAPS Webinar: Blinding in Early Clinical Development Trials
An IQ working group was founded in 2018 with the goal of revisiting blinding concepts in early clinical trials in healthy volunteers and patients. The working group developed and conducted a survey across multiple biopharmaceutical companies in early 2020 in order to gain information about design options commonly used in early clinical development trials with … Continued
Model-Informed Drug Development for Anti-Infectives: State of the Art and Future
Authors: Craig R. Rayner, Patrick F. Smith, David Andes, Kayla Andrews, Hartmut Derendorf, Lena E. Friberg, Debra Hanna, Alex Lepak, Edward Mills, Thomas M. Polasek, Jason A. Roberts, Virna Schuck, Mark J. Shelton, David Wesche, Karen Rowland‐Yeo Abstract Model‐informed drug development (MIDD) has a long and rich history in infectious diseases. This review describes foundational … Continued
Expert Tips for Pediatric Drug Development and Regulatory Success
While the pharmaceutical industry in the US and EU has made tremendous progress in pediatric drug development with over 850 products containing pediatric labeling, there is still a significant lag between attaining approval for a drug for adults and the first pediatric label information. Why is this? Conducting pediatric clinical studies has well-known challenges. From … Continued