Microneedle array patches (MAPs) are a groundbreaking technology in drug delivery, offering the potential to revolutionize how medications and vaccines are administered. MAPs could offer a more intuitive and efficient approach to drug delivery for a wide range of therapeutics. However, as with any innovative technology, the path from concept to market presents numerous challenges.
Innovators in the space need to optimize drug delivery capacity, ensure consistent performance and scale-up manufacturing processes to meet rigorous current good manufacturing practice (cGMP) standards. Overcoming these hurdles is crucial not only for realizing the full potential of intradermal technology but also for attracting the investment needed to bring these products through late-stage clinical trials to market.
This webinar will provide a comprehensive exploration of the critical characterization methods essential for advancing MAP development. The expert panel will provide an overview of microneedle types and their clinical benefits, setting the stage for an in-depth examination of characterization techniques.
Participants will be guided through a multifaceted approach to product evaluation, encompassing analytical, performance and preclinical assessments. From chemical assays and physical property analyses to sophisticated benchtop evaluations of array velocity and puncture performance, they will explore the methods required to ensure MAP efficacy and safety.
The webinar will also consider the crucial role of preclinical evaluations, highlighting techniques for assessing skin penetration and delivery efficiency that are vital for predicting clinical performance. By attending this webinar, participants will gain insights into the tools and approaches shaping the future of microneedle technology. Attendees will leave with a deeper understanding of how comprehensive characterization methods can de-risk intradermal development, potentially accelerating the path to clinical trials and commercial production.
This webinar offers a unique opportunity to stay at the forefront of this innovative field and contribute to the advancement of more accessible, patient-friendly drug delivery systems.
Register for this webinar today to gain insights into microneedle array patches and how the challenges of bringing this groundbreaking drug delivery technology to market can be overcome.
Speakers
Andrew Riso, Vice President of Dermal Delivery and Licensing, Kindeva Drug Delivery
Andrew Riso brings over a decade of expertise in strategic planning, market research, commercial analysis and financing within the biotech and drug delivery sectors to his role as Vice President of Dermal Delivery and Licensing at Kindeva Drug Delivery.
Mr. Riso leads business development efforts and licensing initiatives focused on dermal delivery systems, helping to drive growth and innovation at Kindeva. He plays a key role in shaping the company’s strategy in the competitive biotech landscape by identifying and securing strategic partnerships, facilitating market expansion and guiding the commercialization of cutting-edge dermal drug delivery technologies. Andrew earned his BA in psychology from the University of Virginia.
Message Presenter
Dr. Mahmoud Ameri, Co-Founder, Zosano Pharma
Dr. Mahmoud Ameri is Co-founder of Zosano Pharma, where he spearheaded microneedle research and operational initiatives. He brings over twenty years of expertise in drug delivery and preclinical and clinical development of combination products, playing a key role in the development of microneedle technology.
Prior to Zosano Pharma, Dr. Ameri was a key innovator at Alza/J&J, where he co-invented the microneedle transdermal system. He holds a PhD from the University of Manchester, School of Pharmacy, in the United Kingdom.
Message Presenter
Ben Newton, R&D Engineering Manager, Kindeva Drug Delivery
Ben Newton has over 15 years of experience in design engineering and medical device product development. He has specialized in designing and developing various drug delivery devices from early conceptual and clinical stage through commercial production. Prior to his current position at Kindeva, Mr. Newton worked in engineering roles at Antares Pharma, Vertebral Technologies and Boston Scientific. Ben has a BS in Biomedical Engineering from the University of Minnesota.
Message Presenter
Dr. Scott Burton, R&D Principal Scientist, Kindeva Drug Delivery
Dr. Scott Burton is a Principal Scientist in R&D at Kindeva Drug Delivery. He focuses on preclinical studies with hollow and solid microneedle arrays, contributing to the development of microneedle drug delivery technologies. He has 33 years of experience researching transdermal drug delivery technology, developing chronic wound dressings and advancing microneedle drug delivery technology.
He holds an MS in Physical Chemistry from Brigham Young University and a PhD in Pharmacology from the University of Utah.
Message Presenter
Vinh Hua, Lab Manager, Kindeva Drug Delivery
Vinh Hua is a Lab Manager at Kindeva Drug Delivery’s Woodbury, MN, facility. He is a technical team leader on the Microstructured Transdermal System teams for both hollow and solid microneedles from the technical and lab perspective.
In this role, he leads teams of analytical chemists in the development of coated microneedle drug products and hollow microneedle-based drug products. In his 30 years with Kindeva, Mr. Hua has contributed to the development of inhalation and transdermal drug products from early-phase feasibility through launch and marketed product support.
He has extensive experience with drug product development, analytical method development, quality, FDA audits and regulatory filings. Mr. Hua received his BS in Chemistry from the University of Minnesota.
Message PresenterWho Should Attend?
This webinar will appeal to senior professionals from pharma/biotech/medical device organizations involved in:
- Manufacturing process and development
- VP of External Manufacturing
- Manufacturing and/or Process Engineering Manager (Director, Head, or VP)
- Formulation Scientists
- VP/Heads/Managers of R&D
- Pharmaceutical Scientist
- Biomedical Engineer
- Regulatory professionals
What You Will Learn
Attendees will learn about:
- Microneedle product types and their benefits in drug and vaccine delivery
- Analytical characterization methods for ensuring product quality and safety
- Understanding performance characterization techniques from benchtop to preclinical evaluations
- Strategies for addressing manufacturing challenges and optimizing microneedle product development
Xtalks Partner
Kindeva Drug Delivery
Kindeva Drug Delivery is a leading global combination product CDMO for sterile injectable, pulmonary, nasal, transdermal, and intradermal finished dose. We deliver unrivaled expertise across development, manufacturing, and comprehensive analytical services. Through strategic investments, we are expanding aseptic injectable fill-finish capabilities and leading the way in green propellants. Combining forces with a diverse global client base, Kindeva operates state-of-the-art facilities across the U.S. and U.K.
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