Join us on Dec. 5th for a complimentary lunch seminar, entitled: “Platform Analytical Strategies that Expedite ADCs to IND and Beyond.”
This event will be taking place at BIOCOM’s SSF office in the PAC Theater in Tower 1.
A critical step in the development process for an antibody drug conjugate (ADC) is establishing scientifically sound analytical methods that measure key product quality attributes to support pre-clinical activities and downstream clinical release and stability testing. The application of platform analytical methods to support testing of early phase biologics enables expedited paths to IND by removing analytical method development from critical path. Structural conservation within commonly investigated immunoglobulin subclasses allows for the approach to be de-risked when a platform method has been previously validated with a standard of sufficient similarity to the molecule under test. Structural variability of small molecule linker payloads and their impact on the physicochemical properties of the protein intermediate post conjugation, necessitates a more involved strategic approach to enable use of platform methods for antibody drug conjugates (ADCs).
Join Abzena’s Scientific Franchise Leader, Dr Parviz Shamlou for a complimentary lunch seminar focused on analytical strategies that can help you quickly achieve your IND milestone. Learn how Abzena is leveraging its laboratory methods, development data, and method qualification results, to standardize an automated process that predicts how certain antibody molecules will behave, based on a structural assessment. Using case studies, we will demonstrate how these strategies can reduce risk, minimize costs, and accelerate your ADCs development timeline. This event will conclude with an optional facility tour.
Key topics covered include:
- Outlining the importance of platform analytical strategies
- Justification of application of platform analytical strategies to IgGs
- Challenges with the application of platform analytical strategies to ADCs
- Sharing lessons learned from IgGs and the application of platform strategies to ADCs
- Registration & Check-In: 11:30 am – 12 pm
- Presentation & Q&A: 12:00 pm – 1 pm
*lunch will be included
About the speaker:
Dr Parviz Shamlou is Scientific Franchise Leader at Abzena. Before joining Abzena, Parviz worked for five years as the Founding Vice President and Executive Director at Jefferson Institute for Bioprocessing (JIB) at Thomas Jefferson University (TJU) in Philadelphia, Pennsylvania.
Parviz is a chemical engineer with over 35 years of experience in transitioning innovative technologies and solutions from ideation to market, much of it focused in the areas of biopharmaceutical and biologics. He has worked both in industry and academia leading and managing multidisciplinary teams of scientists and engineers in process design, scale-up, technology transfer and manufacturing of clinical and licensed biopharmaceutical products including monoclonal antibodies, fusion proteins, bispecifics, and conjugated proteins, amongst others. At TJU he extended these therapies to include emerging medicine including cell and gene therapy and advanced vaccines. His technical knowledge expands across upstream and downstream operations, process scale up and modelling, process intensification, continuous bioprocessing, process analytical technology, Quality-by-Design and Design of Experiments. He has led and managed several process development facilities and projects from the ground up.
He joined Thomas Jefferson University in 2018 to lead the development of Jefferson Institute for Bioprocessing (JIB), establishing an overall vision, building strategic plans and relationships and bringing together key stakeholders to create an ecosystem for workforce development and collaboration with biomanufacturing companies in the Greater Philadelphia and beyond. Beyond, TJU, Parviz served on the Philadelphia Chamber of Commerce Sub-committee on Life Sciences Task Force leading an effort to recharge the regional economy as the area began to recover from the debilitating impact of COVID-19
Prior to TJU, Parviz held a variety of scientific and leadership roles including Deputy Head of Department of Biochemical Engineering at University College London (UCL), UK, Director of Amgen Bioprocessing Center at Keck Graduate Institute (KGI) in Claremont, CA, and Senior Technical Leader at Eli Lilly and Company in Indianapolis, Indiana where he led early and late phase development of over a dozen biologics two of which reached successful market launch. These included Dulaglutide (Trulicity), a fusion protein for use as once-a-week insulin replacement therapy, and Lxekizumab (Taltz), a full monoclonal antibody for used as an anti-inflammatory therapy for multiple indications including plaque psoriasis. Psoriatic arthritis and ankylosing spondylitis
Parviz has supervised over 25 PhD and postdoctoral researchers and published and presented scientific work widely at national and international meetings and conferences. He is the author of two books and co-authors of 150 articles.