Rethinking Drug Solubility Enhancement? How Microparticles are Opening Doors to New Solutions for Oral Drug Delivery
April 14, 2022
10:00 – 11:00 am
More than 70 percent of all small molecule new chemical entities (NCEs) are poorly soluble. Yet these molecules could be powerful therapeutics for a wide variety of diseases including cancer, cardiovascular disease, infectious diseases, and diabetes.
There are several formulation techniques currently used by pharmaceutical scientists that aim to tackle solubility challenges. However, existing manufacturing technologies cannot overcome all formulation hurdles. Many APIs are sensitive to very high temperature processing or mechanical stress, and NCEs commonly have melting points well above 200°C. The API solubility in organic solvents is often limited, which leads to low spray solution concentrations and long processing times when using standard spray dried dispersion (SDD) techniques. Furthermore, poor particle size and distribution control, as well as poor flowability of the final powder can require additional post-processing steps, resulting in increased manufacturing time and costs.
Emulsion-based microparticles have a long and successful history in pharmaceutical dosage forms for parenteral drug delivery. Several microparticle-based drug products have been developed and marketed over the past few decades. By leveraging science and established manufacturing principles, we have developed a new process technology using emulsion-based microparticles to convert poorly soluble drugs into soluble amorphous solid dispersions (ASDs) and overcome existing process hurdles.
In this webinar we present this new manufacturing technology and support services for particle-engineered free-flowing ASDs for oral drug delivery. Our speakers will walk you through the approach and outline the benefits, including how this process technology option can be easily integrated to reduce costs, improve drug quality and consistency. Through detailed discussions of case studies, we show how solubility and pharmacokinetic performance can be enhanced.
Yiming Ma, Ph.D, Evonik
Alexander Bernhardt, Evonik
Addressing Data Challenges in Noncirrhotic Nonalcoholic Steatohepatitis (NASH) Drug Development
April 19, 2022
12:30-2:00 pm ET
Nonalcoholic steatohepatitis (NASH) can progress to cirrhosis and liver failure and is associated with an increased incidence of liver cancer. Currently, the U.S. Food and Drug Administration (FDA) has not approved any therapies for NASH patients with fibrosis. Evaluation of safety and efficacy of a new drug application for treatment of NASH with fibrosis can be challenging given the complexities in
differentiating between progression of liver disease and potential drug-induced liver injury (DILI). Therefore, to adequately support evaluation of efficacy and safety, including potential DILI assessment, technical specifications for clinical trial data and disease -specific metadata are developed.
This Webinar describes the data challenges faced in data submission for clinical trials treating NASH subjects with fibrosis and outlines recommendations that pertain to submission of the sponsor’s tabulated and analysis data sets in a standardized manner based on CDISC standards to improve reviewability. These specifications are intended to support the draft guidance for industry Noncirrhotic Nonalcoholic Steatohepatitis with Liver Fibrosis: Developing Drugs for Treatment1 (NASH Guidance) and reflect the data standards and processes described in the FDA Study Data Technical Conformance Guide2 and the FDA Data Standards Catalog3. Additionally, recommendations for DILI-related data elements outlined within this technical specification can also be applicable to potential DILI evaluation in non-liver disease clinical trials.
Paul Hayashi, MD, MPH, U.S. Food and Drug Administration (FDA)
Ruby Mehta, MD, U.S. Food and Drug Administration (FDA)
Veronica Pei, MD, MPH, U.S. Public Health Service
New Initiatives to Evaluate Cardiac Safety in Drug Development
April 28, 2022
Clinical evaluation of QTc interval prolongation potential of drugs is an integral component of drug development programs. Thorough QT studies are normally conducted to assess QT prolongation, although these studies are heavily resource- and time-intensive. In light of review of historic data regulatory agency perspectives on the necessity of thorough QT studies have recently shifted, allowing for assessment of QT prolongation potential using concentration-QT modeling of data from one or more Phase 1 studies. However, several limitations exist in these types of analyses. In this webinar, experts from industry will discuss the impact of these limitations on the interpretation of study results and will share potential solutions to improve the reliability of concentration-QT modeling to inform decision-making. Experts from the FDA will also share current regulatory opinion on the evolving landscape of QT prolongation assessments and share examples of how to perform integrated risk assessments for drugs. Each presenter will be given an allotted time to present their area of expertise, followed by a Q&A session from the audience.
Peter Bonate, Ph.D., Astellas
Christine Garnett, Pharm D., CDER, Food and Drug Administration (FDA)
Stephen Riley, Pharm. D., Ph.D., Pfizer
Impurities in mRNA Vaccines - Unwanted Immune System Activation
May, 5, 2022
This webinar will be focused on development of mRNA tools and technology. During the COVID-19 pandemic haunting us the past three years, we have realized how brilliant is the mRNA technology to the biopharmaceutical companies. During this webinar, we will be able to learn more in detail about the types of impurities that may be generated during mRNA synthesis and how we can produce a cleaner mRNA. Sergio Linares (our speaker) has completed his PhD in France and now working at Sanofi Pasteur. He has great expertise in this field and willing to share his knowledge with our scientists working in vaccines, biotechnology, and pharmaceutical field.
Speaker: Sergio Linares, Ph.D., Sanofi Pasteur