Drug repurposing is a priorityThe rapid spread of COVID-19 has triggered a global effort for accelerating the development of diagnostics, vaccines, and therapeutics. The threat of a possible recurring wave, as experienced with the 1918 Spanish flu pandemic [1], has added to the time pressure for identifying and offering therapeutic options. The anticipated 12 to 18 months timeframe required for making a vaccine available to patients [2], or the even longer time required for new drug development are challenged by the urgency of the situation. The repurposing of approved drugs and the accelerati ..read more

Model-Informed Drug Development (MIDD) has become an important quantitative tool in drug development to characterize drug disposition and effects across a broad range of therapeutic areas including infectious diseases. MIDD approaches for infectious disease therapeutics have been used in the development of Palivizumab, a monoclonal antibody used for the prevention of Respiratory Syncytial Virus (RSV) in infants at high risk of RSV infection, Rilpivirine and Raltegravir (HIV), Simeprivir (Hepatitis C Virus), Letemovir (Cytomegalovirus), Pretomanid (Tuberculosis), Botulism Toxin Heptavalent (bio ..read more

If you work in pharma, you may have heard the following acronyms: CDISC, SDTM, ADaM. They sound much like alphabet soup. But, in reality, they relate to data standards for drug development. So, what are data standards, and why were they created in the first place? And, how should pharmaceutical companies use them? In this blog, I’ll discuss the development of common pharmacokinetic (PK) CDISC data standards and the impact of building them for electronic regulatory submissions to the Food and Drug Administration (FDA).   Definitions Before we begin, here’s a short list of abbreviations for your ..read more

Demonstrating bioequivalence (BE) remains the key regulatory hurdle for generic drug approval.  However, this is a challenging process for today’s complex drugs and alternative delivery methods.  Consequently, patients lack availability of thousands of generics. This problem is especially vexing for topical drugs and trans-dermal patches. Regulatory Support for Expediting the Development of Dermal Generics The high cost of running clinical BE trials has diminished companies’ appetite to develop generic versions of topical drugs. As a result, many branded topical drugs remain on the market wel ..read more

“Come senators, congressmen Please heed the call Don’t stand in the doorway Don’t block up the hall For he that gets hurt Will be he who has stalled” Bob Dylan recorded his iconic “The Times They Are a Changin’” in 1963; the song was released on the 1964 album by the same name. One of Dylan’s favorite tracks and the saying that it has coined could not ring more true with respect to the healthcare policy debate on the cost of biopharmaceuticals. Not a day goes by without the words “drug pricing” in the headlines of a major international newspaper. In the 2020 campaign for the U.S. White House ..read more

Model-based Meta-analysis (MBMA) is a quantitative framework that uses pharmacokinetic/pharmacodynamic (PK/PD) and statistical modeling for leveraging external clinical trial efficacy, tolerability, and safety data to inform drug development decisions. MBMA has been used extensively to support developing therapeutic agents for treating a range of diseases including diabetes, autoimmune diseases, osteoporosis, and others. Last year, we presented our findings at the Population Approach Group in Europe meeting (PAGE) and American Conference on Pharmacometrics (ACOP) on the development of a MBMA c ..read more

Natural history studies follow a group of people over time who have or are at risk of developing a specific disease. This type of study is an important tool in modern drug development and in assessing new health technologies by payers. This is especially true for rare diseases or diseases with high, unmet medical need where thousands of diseases still lack safe and effective treatments, and the populations available for clinical study could be small and heterogeneous. The term “natural history of disease” theoretically restricts the population to one that has not been exposed to any interventi ..read more

The concept of evaluating the value of pharmaceutical products is not new though the changing dynamics of the healthcare system have brought it to center stage. The days of simply determining the market demand as a function of price and choosing the revenue or profit optimizing point are gone.  An explicit rationale, also known as the “value-based price”, has become a prerequisite for enabling conversations with payers. In this context, the discipline of value demonstration becomes central to the ability to price, and the success of a new technology depends not just on clinical trial-based res ..read more

Model-based Meta-analysis (MBMA) is a quantitative framework that uses PK/PD and statistical modeling for leveraging external clinical trial efficacy, tolerability, and safety data to inform drug development decisions. MBMA augments proprietary in-house clinical trial data by systematically searching and tabulating summary results from public sources. These data are then analyzed to characterize the impacts of drug class, drug, dose, and time on the response(s) of interest, plus the potential influence of study population characteristics or the trial conduct. Most important, MBMA provides a qu ..read more

“Wherever the art of Medicine is loved, there is also a love of Humanity.” – Hippocrates I cannot think of this quote from Hippocrates, the father of medicine, without also thinking of my Certara colleague, Dr. Mayumi Hasegawa, Senior Director, Integrated Drug Development. She has over 15 years of drug development experience focused on the areas of clinical pharmacology and pharmacometrics. Mayumi specializes in supporting clients in the Asia Pacific regions (APAC; Japan-Korea-Taiwan). So, her love for helping develop innovative medicines that benefit patients is evident. But in talking to May ..read more