[
Webinar
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August 16, 2022
]

Accelerating QbD: Perspectives on Leveraging ICH and Digitization for Success

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.

Speakers

Watch the webinar

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[
Chief Business Officer
]

Malia Lewin

Malia Lewin has over 18 years of experience in the life sciences industry as a business strategist, public policy strategist, and technology strategy expert. As Chief Business Officer, she oversaw business development and go-to-market strategy for the QbDVision platform. She joined from Veeva Systems, where she served as Global Director of Oncology Strategy, and previously spent seven years as Vice President of Client Services and Head of Strategic Operations at Rivermark, now an IQVIA company. She has also served as CEO of an industry-funded nonprofit. Malia is an attorney by training.

[
Principal Engineer
]

Mark Mitchell

Mark Mitchell is a Principal Engineer at Pharmatech Associates, where he advises life science manufacturers on process validation and control strategy. He is the author of the three-part BioPharm International series Determining Criticality: Process Parameters and Quality Attributes, which sets out a practical roadmap for applying scientific knowledge, risk analysis, experimental data, and process monitoring across the stages of the process validation lifecycle, and introduces the concept of a continuum of criticality.

[
Head of cGMP Strategic Supply & Operations, mRNA Center of Excellence
]

Greg Troiano

Greg serves as Head of cGMP Strategic Supply and Operations at the mRNA Center of Excellence at Sanofi, where he is responsible for all aspects of clinical production and raw material supply chain. He joined Sanofi via acquisition of Translate Bio, where he was Chief Manufacturing Officer and responsible for Technical Operations. 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. Greg received his MSE and BS in Biomedical Engineering from The Johns Hopkins University and was elected and inducted into the American Institute for Medical and Biological Engineering (AIMBE) College of Fellows in 2020 for recognition of his accomplishments in drug delivery.

[
Director of Regulatory Compliance
]

Stephanie Gaulding

Stephanie Gaulding has over 25 years of experience with quality management systems and validation program management in the pharmaceutical, biotech, and medical device industries. She develops, redesigns, and implements quality systems that meet global regulatory requirements and industry best practices, helping start-ups and established manufacturers prepare for and pass regulatory inspections. She is an ASQ Certified Quality Auditor and ASQ Certified Pharmaceutical GMP Professional, and has held quality assurance, quality control, and validation roles at Boehringer Ingelheim, Eli Lilly and Company, and Human Genome Sciences.

[
President & CEO
]

Yash Sabharwal

Yash Sabharwal is an accomplished inventor, entrepreneur, and executive specializing in the funding and growth of early-stage technology companies focused on life science applications. He has started 3 companies and successfully exited his last two, bringing a wealth of strategic and tactical experience to the team.