Irwin is a consultant in Quality and regulatory compliance with an emphasis on pharmaceutical excipients. He has been a sub-contracted expert consultant where pharmaceutical companies are involved in Consent Decree with the FDA.
Title: Novel or Not? Our Inadvertent Journey Filing a Novel Excipient.
Date/Time: Wednesday, July 22, 11 AM (Eastern)
Featuring: Kara Quinn, Associate Director Engineering, Merck & Co.
Webinar Overview:
A first-hand account of the challenges to realizing, determining, and confirming the novel status of an inactive ingredient in a Phase III Clinical drug product. Quickly followed by lessons learned on the proactive characterization of inactive ingredients, whether novel or not.
The goal of the presentation is to inform the audience on the inherent complexities to effectively identifying, defining, and characterizing a novel excipient.
The presentation will review a first-hand account of:
The attendee will take away a practical example of one company’s journey in the perceived “flying blind” process of novel excipient approval and guidance for proactively navigating, if you must.
Target Audience:
Presenter Bio:
Kara Quinn has over 25 years of experience in the Biopharmaceutical industry supporting large molecule (biologics & vaccine) development, commercialization, and licensure through a range of disciplines including Quality, Regulatory, Process Technology, and Clinical. Currently at Merck & Co., Inc., Kara serves as a subject matter expert in the fit-for-use qualification of procured raw materials and excipients. Kara’s participation in industry forums have enabled her to drive alignment between biopharmaceutical manufacturers and raw material suppliers on a shared standard for risk assessments published September 2019 at www.biophorum.com.
Check your inbox for an email with the link to download the “Improving Manufacturing Efficiency & Functional Performance: Co-processed Multifunctional Excipients” presentation.
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Title: Toxicology for the 21st Century: What is in the Box for Excipients?
Date/Time: Wednesday, July 8, 11 AM (Eastern)
Featuring: Dr. Thomas Hartung, Professor, Johns Hopkins University, Bloomberg School of Public Health
Webinar Overview:
Dr. Hartung will discuss revolutionary changes in how we predict human safety by assessing biological effects of chemicals in novel ways independent from the limitations associated with traditional animal-based toxicology.
Objectives for this webinar include:
Target Audience:
People from the following areas would be interested in this webinar:
Full Webinar Description:
The limitations of animal-based toxicology to predict human health threats are widely recognized. We also are discovering more shortcomings of traditional (human) cell culture such as cell identity, differentiation, genetic stability and mycoplasma infection as well as non-homeostatic and non-physiological culture conditions. The increasing pace of technological developments of modern cell culture and their integration leads to what is called “disruptive technologies” that can lead to the development of alternatives to traditional approaches for product development and safety assessment.
Such technological advances promise to be real “game-changers”. Combined with an increased mechanistic base of reasoning (e.g. Adverse Outcome Pathway concepts), Integrated Testing Strategies and evidence-based methods of data evaluation and integration, a revolutionary change for how we assess the biological effects of substances has been set into motion.
Presenter Bio:
Thomas Hartung, MD PhD, is the Doerenkamp-Zbinden-Chair for Evidence-based Toxicology in the Department of Environmental Health and Engineering at Johns Hopkins Bloomberg School of Public Health, Baltimore, with a joint appointment at the Whiting School of Engineering. He also holds a joint appointment for Molecular Microbiology and Immunology at the Bloomberg School. In addition, he holds a joint appointment as Professor for Pharmacology and Toxicology at University of Konstanz, Germany; he also is Director of Centers for Alternatives to Animal Testing (CAAT, http://caat.jhsph.edu) of both universities. He is adjunct professor at Georgetown University, Washington D.C.
CAAT hosts the secretariat of the Evidence-based Toxicology Collaboration (http://www.ebtox.org), the Good Read-Across Practice Collaboration, the Good Cell Culture Practice Collaboration, the Green Toxicology Collaboration and the Industry Refinement Working Group. As PI, he headed the Human Toxome project funded as an NIH Transformative Research Grant. He is Chief Editor of Frontiers in Artificial Intelligence.
He is the former Head of the European Commission’s Center for the Validation of Alternative Methods (ECVAM), Ispra, Italy, and has authored more than 560 scientific publications.
Title: Vision for FDA’s Inactive Ingredient Database in 2020 and Beyond
Date/Time: Wednesday, September 16, 11 AM (Eastern)
Featuring: Susan Zuk, MS, Branch Chief, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA
Webinar Overview:
The FDA’s IID is used in drug development decisions by industry and application assessment decisions by FDA. In the year 2020 the IID will change. How will these changes affect excipient suppliers and drug product applicants? Find out what is changing in 2020 and how you can be prepared.
This webinar will cover:
Target Audience:
People from the following areas would be interested in this webinar:
Full Webinar Description:
Excipients, the inactive ingredients in pharmaceutical products, are essential drug product components that facilitate drug delivery, promote solubility, improve taste and, in general, allow active pharmaceutical ingredients to be transformed into useable dosage forms. For over 30 years, FDA has published the Inactive Ingredient Database (IID), a publicly available list of the excipients used in FDA approved drug products, as a tool for drug development. Over the years, FDA has made small gradual improvements to the IID in response to requests from industry. But the format and information provided in the IID remained basically the same.
In 2019, FDA published a draft guidance for industry on use of the IID. This guidance not only provided advice to industry on how the IID can best be used to develop drug products and prepare applications, but also identified plans for important future IID enhancements that will be made by October 2020. In 2020, the IID will change in some significant and positive ways as FDA fulfills the commitments made to industry under the 2017 reauthorization of the Generic Drug User Fee Amendments (GDUFA II). What will the IID look like when these commitments are fulfilled? How will these changes impact drug applications, especially with respect to qualification of the excipients used in those drug products? What are the advantages of the IID’s new structure? Are there still unaddressed needs?
In this presentation, FDA will identify all the changes that have occurred in preparation for fulfilling our GDUFA II commitments for the IID and changes yet to come in 2020. FDA will provide its vision for the IID as an essential tool for drug development.
Presenter Bio:
Susan holds a BS in Chemistry from Syracuse University and a MS in Biotechnology from Johns Hopkins University. During her 19 years with the FDA, she served in the Office of Generic Drugs as a Chemistry Team Leader for many years, specializing in antibiotics. She joined the Office of Policy for Pharmaceutical Quality in 2015 and is currently a Branch Chief in the Division of Regulations, Guidance and Standards. She is the lead for the FDA’s Inactive Ingredient Database (IID). In this role, she is responsible for overseeing IID improvements. Susan has served on many FDA committees and working groups related to product safety and quality. She is currently a member of the FDA’s Center for Drug Evaluation and Research (CDER) Excipient Working Group.
Title: Clinical Relevance: Why are Enteric Coatings Failing In Vivo?
Date/Time: Wednesday, June 17, 2020 11 AM (Eastern)
Featuring: Daniela Amaral Silva, PhD Candidate, University of Alberta
Webinar Overview:
Over the last 70 years many cases of in vivo failure of enteric coated (EC) formulations have been reported. This webinar is designed to help participants understand the underlying science behind the unpredictable in vivo performance of enteric coated formulations.
Objectives for this webinar include:
Target Audience:
People from the following areas would be interested in this webinar:
Full Webinar Description:
Over the last 70 years many cases of in vivo failure of enteric coated (EC) formulations have been reported. EC products present a marked slower dissolution in physiologically relevant buffer which seems to be the cause for the observed in vivo failures. There is a hidden performance problem with EC products. Upon reaching the intestinal lumen, the dosage form is exposed to an environment buffered by bicarbonate at much lower molarities than those applied in compendial methods with phosphate buffer. Thus, this presentation aims to raise awareness of this matter and to elucidate the complex interaction between bicarbonate buffer and enteric coating polymers. An in vitro study investigating the performance of drug products from the market in both compendial buffer and physiologically relevant bicarbonate buffer will be covered. The results clearly indicate that the in vitro performance of EC products is highly dependent on the ionic composition and molarity of the medium. In fact, this seems to impact the coat opening more than bulk pH. Consequently, the generally accepted concept of a dissolution pH threshold for enteric coating polymers is questionable in bicarbonate buffer. Hence, the physiological aspect of bicarbonate buffer should be taken into account during the formulation development process to avoid possible failures due to insufficient drug release. Analysis of possible approaches for a better quality control method for EC products will foster an environment for rich discussion.
Presenter Bio:
Daniela obtained her BSc in pharmacy from the University of Sao Paulo in 2017. During her undergraduate studies she was a recipient of the Science Without Borders scholarship for an exchange program at the University of Toledo, OH (2014 – 2015). During the year of 2016 she worked at Johnson & Johnson in the regulatory affairs division. Daniela was recipient of the University of Alberta Research Experience award in 2017. In 2018 she joined the PhD program at Faculty of Pharmacy and Pharmaceutical Sciences at the University of Alberta under the supervision of Dr. Raimar Loebenberg. Daniela has clear understanding of the underlying sciences responsible for the complexity of oral drug absorption and has authored and co-authored many publications in great scientific journals. Daniela’s main scientific interest is focused on formulation, delivery and quality in the drug development process.
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