Cell and gene therapies have had a tremendous impact on the lives of patients who benefitted from them to date, but their promise is still larger: the fast-developing field of cell therapy continues to push the boundaries further in order to move cell therapies to earlier lines of treatment, to conquer solid tumor indications, branch to autoimmune diseases, and more.
These innovative strides are enabled by cellular and molecular technologies that grow in numbers and in sophistication. As cell and gene therapy approaches become more and more complex, so does the challenge of regulating them.
In these talks, our guest speakers will discuss the recent trends in FDA’s approach to cell and gene therapies, the debate around the long-term safety monitoring requirements, as well as the importance and potential benefits of cell therapy kinetics monitoring. The talks will layout and illustrate some of the different types of cell and gene therapies and also highlight typical questions or concerns in Pre-IND meetings with examples of different kinds of cell and gene therapies.
Registration Fees & Deadlines
Member $25 | Nonmember $45 | Students $10
Speakers
Monika Maleszewska, PhD
Director of Product Management and Strategy, CareDx
Monika Maleszewska is the Director of Product Management and Strategy at CareDx. In the past 2+ years she served as the Associate Director of Cell Therapy Products, leading the development and pharma partnering of NGS-based cell therapy monitoring products. Prior to that, she served as the Senior Manager, Program and Alliance Management at Arsenal Biosciences, currently a clinical-stage cell therapy company.
Monika holds an MSc degree in Biotechnology from Jagiellonian University (Cracow, Poland), a PhD degree in Cell and Molecular Biology from University of Groningen (the Netherlands), and she completed her post-doctoral training as an Alexander von Humboldt Fellowship grantee at the Max Planck Institute for Biology of Aging in Cologne, Germany.
Gregory Meyer
Vice President of Regulatory Affairs, Premier Consulting
Gregory Meyer serves as Vice President of Regulatory Affairs at Premier Consulting. Greg has been in the pharma, biopharma and medical device industry for over 30 years in both Regulatory and QA Compliance. He has gained regulatory approvals in more than 20 countries and has represented companies during numerous interactions with the FDA, European national and EU regulators, and the Australian TGA. He has worked on the development, submission, and commercialization of biologic and small molecule NMEs and 505(b)(2) products in numerous therapeutic areas including oncology, neurology, dermatology and rare diseases. His specialty areas include biologics and drug-device combination products and he currently heads up the cell and gene therapy consulting practice at Premier Consulting.
Greg studied at St. John’s University, and graduated from Reed College. He also spent several years as a Research Associate in the Department of Medicine at the University of California, San Francisco.
David Pudwill is a seasoned leader and regulatory expert who helps companies get medical devices and combination products to market. David has served in senior leadership roles at AscentX Medical and ConvaTec, and previously worked at the U.S. Food and Drug Administration (FDA), and St. Jude Medical. He is a founding member of the Kidney Health Initiative, and has helped several startups acquire funding and successfully interact with FDA and the Department of Defense. While at FDA, David worked on DARPA projects and consulted with CBER and CDER regarding regulatory submissions, including clinical studies and drug and biologic marketing submissions.
David holds a Master of Mechanical Engineering from Johns Hopkins University, a BSE in Biomedical Engineering from Case Western Reserve University, and a Certificate from HBX, now Harvard Business School Online.
Sponsor
Premier Consulting
Will be providing space, meals and non-alcoholic beverages
Location
Premier Consulting
8000 Jarvis Ave
Suite #100
Newark, CA 94560
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
RAPS@raps.org