- Event Date: Wednesday, Oct. 14th, 2015
- Time: 2 pm Eastern Time
- Duration: 45 Minutes including Q&A
- Presenters: Dr. Julie Suman, Co-Founder of Next Breath, LLC and Dr. Oksana Olkhovyk, Sr. Application Scientist at Gateway Analytical
- Host: Paige Cohen, Sales Development Associate at Gateway Analytical
This first webinar will offer attendees insight into utilization of ISPS to support formulation development, API and excipient selection establishing qualitative and quantitative sameness (Q&Q) and minimizing risk of clinical trials failures via pre-bioequivalence studies. Additionally, stability study design including particulates analysis, techniques and methods for identification of foreign particulates, ANDAs and NDAs including lessons learned from past OINDPs submissions.
Next Breath and Gateway Analytical will present their OINDP Webinar Series for Dry powder Inhalers (DPIs), pressurized Metered Dose Inhaler (MDIs), and Nasal drug products which are complex delivery systems and their development require key specialized expertise. Next Breath and Gateway analytical are pleased to present a webinar to provide a comprehensive review of their in-house analytical technologies, GMP methods, and specialized expertise. The webinar will cover in-depth characterizations of OINDPs from R&D stage to regulatory submission of these delivery’s systems. Special attention will be given to describe collaborative expert support that both companies can provide to reduce risk of clinical trials, mitigate device failure and drive timelines to get the product to market.
Highlighted Topics Include
- Utilization of ISPS to support formulation development, API and excipient selection
- Establishing qualitative and quantitative sameness (Q&Q)
- Minimizing risk of clinical trials failures via pre-bioequivalence studies
- Stability study design including particulates analysis
- Techniques and methods for identification of foreign particulates
- ANDAs and NDAs: lessons learned from past OINDPs submissions
Specifically, the webinar will present practical use of ingredient-specific particle sizing (ISPS) and foreign particulate matter analysis in container closure screening, API/excipients selection, deformulation support, and stability studies. In addition, the webinar will clarify the most recent OINDPs regulatory guidances and their impact on NDA and ANDAs submissions. Finally, the webinar will be wrapped up by highlighting specific risk mitigating strategies for CMC required tests.
Who Should Attend?
You should attend this webinar if you are involved in guaranteeing the development, quality and safety from R&D to regulatory submission for Nasal Drug Product Development delivery systems.
Julie D. Suman, Ph.D.
Dr. Julie D. Suman is co-founder and President of Next Breath, LLC, a contract research organization dedicated to the development and analytical testing of nasal and inhalation delivery systems. Dr. Suman directs the research division that supports product development and regulatory submissions for North American and International Clients in the pharmaceutical, biotechnology and medical device markets. Dr. Suman holds a B.S. in Pharmacy from Duquesne University (1996) and a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore (2002). She is a co-editor for Respiratory Drug Delivery Proceedings, an international symposium, and an adjunct assistant professor at the University of Maryland, School of Pharmacy in Baltimore, Maryland. She is also an Affiliate Assistant Professor in the Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University. Dr. Suman is the Past-Chair of the AAPS Inhalation Technology Focus Group. She is also a licensed Maryland pharmacist. Dr. Suman has published her research in peer-reviewed journals and has been presented during podium sessions at international meetings, the FDA Visiting Professor Lecture Series and has been an invited speaker at ANVISA in Brazil. Dr. Suman’s doctoral research, which focused on the relationship between in vitro tests for nasal sprays and in vivo deposition, has been recognized for excellence by a research award presented at the International Society for Aerosols in Medicine, 2001. In 2008, Dr. Suman received an award from the Greater Baltimore Committee for Entrepreneurial Spirit.
Oksana Olkhovyk, Ph.D., Senior Scientist
Dr. Olkhovyk manages and supports analytical testing services within Gateway Analytical cGMP and ISO-based quality assurance laboratories for the pharmaceutical, materials science and forensics industries. Serves as a scientific liaison between Gateway Analytical and their customers, as well as academic and industrial collaborators.
She has 13 years experience and professional expertise in the multidisciplinary area of materials characterization, chemical imaging, pharmaceutical products analysis, analytical process development, transfer and validation. She manages direct reports and cross-functional teams (Analytical, Quality Assurance, Regulatory and Product Development Teams). She initiates and maintains collaborative and productive interactions with industry, other CROs and academic institution, with established track record of scientific achievements and innovations supported by publications, patents and presentations.
Dr. Olkhovyk received her Ph.D. degree in Chemistry and Material Science from Kent State University 2007. Her research involved synthesis, characterization and applications of nanostructured materials, surface phenomena and adsorption. Prior graduate studies, Oksana was a research assistant at Chemical Engineering Department of the University of Strathclyde, U.K. conducting research related to carbon materials. She received her B.S. Degree in Chemical Engineering and Industrial Ecology from Lviv Polytechnic University, 1999.