SUMMARY
Perspectives on Leveraging ICH and Digitization for Success
A 60-minute panel of cross-industry experts will share their unique perspectives on implementing Quality-by-Design (QbD), specifically how to use the quality target product profile (QTPP) as the foundation for designing quality into your product.
Drug sponsors, practitioners, regulatory professionals, pharmaceutical executives, academics, and other interested parties will gain an understanding of how to apply the ICH guidelines based on real-world experiences resulting in more complete and comprehensive submissions.
PERSPECTIVES BY
Attendees will learn:
The do’s and don’t of using the QTPP
Practical tips to meet the requirements of ICH Q8, Q9, and Q10
How digitization can help in the process of organizing and accelerating your efforts
Topics Covered:
- What is the regulatory basis of the Quality Target Product Profile (QTPP)?
- Why is it important for a pharmaceutical company to draft a QTPP?
- What are the most important elements of a QTPP, given the lack of a universal template?
- Why is it important to periodically revise and control the QTPP document? How does the QTPP mature over the course of the lifecycle?
- When is the most appropriate time to draft the QTPP (Hint – not at submission)
- What are some of the most common mistakes that you see companies make when drafting their QTPP?
- Can better software tools make the use of the QTPP more ubiquitous?
BIOS
Meet the Moderator
Malia Lewin
Chief Business Officer, CherryCircle Software
Malia has over 18 years of experience in the life sciences industry as a business strategist, public policy strategist, and most recently, a technology strategy expert. As Chief Business Officer (CBO), Malia oversees business development and strategic partnerships both in the US and abroad.
BIOS
Meet the Speakers
Mark Mitchell
Principal Engineer, Pharmatech Associates
Mark primarily focuses on process engineering, facility design, statistical applications, quality remediation, and CMC preparation for NDA’s for clients with aseptic, solid oral dosage forms, biological, and combination products. He specializes in Quality by Design and implementation of the FDA Process Validation Guidance and ICH Q8/9/10 for new and legacy products.
Prior to joining Pharmatech Associates in 2009, Mark was the Associate Director of Process Engineering and Validation for Novo Nordisk Delivery Technology (NNDT). Mark began his career in the pharmaceutical and medical device industry in 1991.
Mark has authored several articles on statistical applications for process validation and technology transfer and holds a patent in aseptic mixing technology.
Greg Troiano
SVP, Technical Operations, Translate Bio
Greg serves as SVP of Technical Operations at Translate Bio. Previously, he was VP of Technology and Chief Engineer at Seer, a life sciences and health data company using nanotechnology for proteomics and biomarker discovery. Prior to Seer, Greg was VP of Nanomedicine Development and Manufacturing within Pfizer’s Pharmaceutical Sciences group, leading the development and manufacturing of novel nanoparticle drug products.
Over his 20+ year career in the drug delivery field, Greg had various roles leading the pharmaceutical development of complex formulations, including numerous nano- and microparticle based systems. This includes leading groups for Formulation Development, Process Development, Analytical Development, Supply Chain Management, Manufacturing and Facilities at companies including BIND Therapeutics, Alkermes, and Guilford Pharmaceuticals. Among the products he helped commercialize are Gliadel® Wafer, Nutropin Depot®, Risperdal Consta®, Vivitrol®, and Bydureon®. Greg received his MSE and BS in Biomedical Engineering from The Johns Hopkins University. He has more than 20 process and equipment patents/applications and over a dozen scientific publications in drug delivery.
Stephanie Gaulding
Director of Regulatory Compliance, Pharmatech Associates
Stephanie serves as Director of Regulatory Compliance, bringing 25 years of experience in quality management systems and validation program management in Pharma, Biotech, Medical Device, and related life science industries. Drawing on her extensive background, Stephanie develops and delivers efficient and sustainable quality management systems assuring compliance with global regulatory requirements and industry best practices.
Over the past five years, her consulting services have helped both start-up and industry-leading clients successfully pass regulatory inspections. Stephanie has also held Quality Management leadership positions at Mediatech, Inc. and Boehringer Ingelheim Chemicals, Inc. Ms. Gaulding is an ASQ Certified Quality Auditor and ASQ Certified Pharmaceutical GMP Professional. She holds an M.Sc. in Biotechnology from Johns Hopkins and a B.Sc. in Biology from Virginia Tech.
Yash Sabharwal
CEO and President, CherryCircle Software
Yash Sabharwal is co-founder, President, and CEO,of CherryCircle Software. He is a successful serial entrepreneur. He has over 20 years of experience in the life science industry.
He was previously co-founder and Chief Operating Officer at Xeris Pharmaceuticals. It was in this role that he crafted the vision for CherryCircle Software and the development of the QbDVision platform.
Yash has a B.S. in Optics from the University of Rochester and a M.S. and Ph.D. in Optical
Sciences from the University of Arizona.
