PHARMA IP XCHANGE XCHANGE
June 29, 2023
Welcome to hubXchange’s Pharma IP Xchange East Coast 2023, bringing together executives from pharma and biotech to address and find solutions to the key issues faced in pharmaceutical intelectual properties.
Discussion topics will cover Patent Access & Licensing, IP Rights & FDA Regulations, Protecting the Rights of Drug Manufacturers and Innovative Drugs/Generics & Biosimilars.
Take advantage of this unique highly interactive meeting format designed for maximum engagement, collaboration and networking with your peers.
Venue: Hilton Boston Woburn Hotel, 2 Forbes Road, Woburn MA 01801
SNAPSHOTS OF DISCUSSION TOPICS
- Prospects for harmonization of legislative approaches. Legal mechanisms for the development of the American intellectual property market
- Legal issues and precautions in licensing and pharmaceutical enterprises in the USA
- Reduced patent life in the US legislation: extension patent applications and regulatory approval process
- Legal mechanisms for the development of the US intellectual property market
- IP rights, legal issues and precautions in licensing and cooperative development of pharmaceutical enterprises
- Enforcement of IP Rights ensuring the development of an IP strategy to deal with possible infringers
- Ensuring a balance of interests in the prevention of defects: protecting the rights of manufacturers of innovative drugs VS timely withdrawal of generics and biosimilars
- Trials in supplementary experimental data: acceptance criteria, analysis of practical cases and trends
Full Xchange Agenda
Click on each track for detailed agenda
Implementing NGS and predictive analytics in cell therapy development
- What are the barriers to routine implementation of NGS during cell therapy development?
- How are people using NGS data in decision making, and at what stages of product development?
- What predictive analytics are being implemented to integrate internal and external data?
Director, Systems Biology, Notch Therapeutics
Dan Kirouac leads the Systems Biology department at Notch Therapeutics, integrating bioinformatics, dynamical systems modelling and machine learning to design and deliver the next generation of T cell therapies. Prior to joining Notch in 2020, he held scientific positions in large pharma (Genentech), mid-size biotech (Merrimack Pharmaceuticals) and consulting (Applied BioMath), and has been developing mathematical models of biological systems for almost 20 years. Dan did post-doctoral training at MIT and Harvard Medical School, holds a PhD in Biomedical Engineering from the University of Toronto, and Bachelors’ in both Chemical Engineering and Genetics from the University of Western Ontario.
Outsource the compliance, control the manufacturing: A different way of thinking about biomanufacturing
- Understand biomanufacturing landscape and traditional options available for clinical and commercial manufacturing
- Provide data and insights on how the industry utilizes those traditional options
- Introduce a hybrid option that minimizes compliance and capital risk while maximizing flexibility in development and production
Vice President of Client Development, Azzur Group
David Frank, VP of Client Development, leads customer-facing initiatives for Azzur Group nationwide including Azzur Cleanrooms on Demand™, consulting and advisory services, labs, and training. For the past decade, David has consulted some of the world’s largest pharmaceuticals, medical devices, technology, and financial services companies, aligning people, processes, and technology to drive sustainable business results. He has been recognized for leading award-winning teams over the past 20 years and is passionate about developing individuals into leaders. David received his Bachelor of Arts in Economics from The Pennsylvania State University and is a Lean Six Sigma Master Black Belt and PMP.
14:50 – 15:20
Optimizing T Cell Therapy Outcomes with TCR Engineering: A Path to Success in Cancer Treatment
T cell therapies have shown promising therapeutic potential in a variety of contexts, from in vitro studies to advanced clinical trials. However, the high cost and complexity of such
therapies can significantly slow down their technological development.
Our interdisciplinary team has developed a suite of computational solutions to streamline the end-to-end development of cellular therapies for cancer treatment. These services can help identify T-cell targets, predict epitope presentation, describe the dynamics of T-cell
repertoires and tumor microenvironment through NGS data analysis, and identify potential T-cell off-target toxicities. The TCR optimization module also enables us to engineer T-cell receptors (TCRs) to enhance the therapeutic potential of T-cell candidates by proposing mutations designed to lengthen the interaction time between TCRs and their targets. Such services can be extended to other therapeutic modalities targeting antigens (CAR-Ts, NKs, antibodies, nanobodies, DARPins, etc.).
Lead Scientist, Ardigen
Giovanni Mazzocco is a computational biologist expert with over a decade of experience in both academic and commercial projects. He has collaborated with a variety of institutions, including universities, scientific institutes, and medical research centers, as well as pharmaceutical and biotechnology companies. Throughout his career, Giovanni hasconducted research in various areas of bioinformatics and computational biology, including enzyme discovery, molecular modeling, protein dynamics and interactions, chromatin modeling, design of statistical learning methods for predicting protein interactions, vaccine design, NGS analysis and more.
Giovanni is currently working at Ardigen, where he is using AI to advance precision medicine in oncology. He is leading the TCR optimization project in the immunology team, and is responsible for proposing and exploring new scientific directions for the Immunology Business Unit.
Maximizing clinical benefit in solid tumor therapies: Combination therapies and other strategies
- Prevention of exhaustion: Checkpoints (PD-1 and Combos), Epigenetic Modulators and others (chemo)
- Prevention of and overcoming resistance: Drug sequencing, multiple targets, combinations
- Expanding the addressable market: Minimizing toxicity, minimizing in-patient time, cost
Chief Operations Officer, VisiCELL Medical
George Smith is the COO at VisiCELL Medical, developing cell therapy imaging diagnostics, and is an advisor to advanced therapy companies. Recently, he led strategy and development of next generation TIL therapies at Myst/Turnstone Biologics. He founded the IQVIA Cell and Gene Therapy Center, helping companies develop advanced therapies. He is a SME for clinical and preclinical development strategy, pharmacology, translational medicine and asset evaluation. He has worked for small and large biopharma companies for a wide variety of therapeutic areas and modalities from concept through Phase III, including inventing Paxlovid. Dr. Smith received his Ph.D. and MBA from UCSD.
16:30 – 17:30
Overcoming resistance to currently approved autologous engineered T cell based therapies
- ~80% ORRR, 50% CR yet in 3rd line, >60% of patients relapse from currently approved CAR T Therapy across indications
- Advanced and next generation cell therapy product development needed to meet emerging CAR refractory patient population
- Solid tumor indications remain and unmet need
Vice President, Translational Medicine, Cargo Therapeutics