ADVANCED THERAPIES XCHANGE
WEST COAST
MARCH 28, 2022
Welcome to hubXchange’s Hybrid Advanced Therapies Xchange 2022, West Coast, bringing together executives from pharma and biotech to address and find solutions to the key issues faced in cell and gene therapeutics.
Discussion topics will cover Cell Tx Development, Gene Tx Development, C&G Tx Bioprocessing and C&G Tx Manufacturing.
Take advantage of this unique highly interactive meeting format designed for maximum engagement, collaboration and networking with your peers.
Please note this is a HYBRID meeting. Participants can join in-person and virtually. All Covid protocols will be adhered to.
Venue Details: DoubleTree by Hilton San Francisco Airport Hotel, 835 Airport Boulevard, Burlingame CA 94010-9949
Cell Tx Development
Opening Address & Keynote Presentation: Outsmarting Complex Diseases with Intelligent Medicines
- Discuss how complex gene circuits can be used to generate smarter cell therapies that overcome fundamental disease challenges
- Explore the use of gene circuits within cell therapies to increase efficacy and specificity
- Demonstration of gene circuit application: FLT3 OR CD33 NOT EMCN CAR-NK cell therapy for acute myeloid leukemia (AML)
Director of Research, Senti Biosciences
Brian Garrison, PhD, is Director of Research at Senti Bio, where he leads development of logic gated CAR-NK cell therapies for cancer, and is driven by the belief that introduction of logic gating into cell therapies will ultimately be transformative for cancer patients in need. Dr. Garrison has been helping develop novel technologies and therapies at Senti for over 5 years, after having completed 2 postdoctoral fellowships at Harvard University focused on stem cell biology and leukemia, and a PhD in human gene therapy from Stanford University.
Cell therapy for solid tumors: challenges and opportunities
- Finding the tumor
- Trafficking CAR T cells to the tumor site
- Overcoming hostile tumor microenvironment
- Production logistics and financial accessibility issues
Chief Cellular Therapy Officer
Nurix Therapeutics
Michael Lotze has served as Chief Cellular Therapy Officer of Nurix since June 2020. He is a leading clinician scientist with more than 30 years of experience in immunology and clinical medicine, dedicating his efforts to the advancement of translational research, particularly in immunotherapy for cancer including dendritic cell, T cell, and cytokine therapies. He is the co-inventor of multiple patents in dendritic cell vaccines and antigen discovery, and tumor infiltrating lymphocyte therapy. He previously held leadership roles at Iovance Biotherapeutics and GlaxoSmithKline. Prior to joining Nurix, Michael served as professor of surgery, immunology, and bioengineering, vice chair of research at the University of Pittsburgh Medical Center Hillman Cancer Center.
Over the course of his career, he has authored more than 500 publications and several books. Michael holds an M.D. from Northwestern University and completed his postdoctoral training at the National Cancer Institute.
- Do you use only mouse antibodies in your R&D models or do you consider other species?
- Is there an advantage to working with human antibodies raised in human biology?
- When to conduct antibody discovery vs using off-the-shelf solutions?
Director, Business Development, Rapid Novor
Anthony has been heading the business development at Rapid Novor for nearly 5 years, merging his previous 8 years of experience in the business roles with a strong passion for biomedical research, stemming from his training in biomedical engineering. His current efforts are focused on the growth of the REpAb™and NovorIg™ platforms with pharmaceutical and biotech companies globally. His partnerships are focused on using REpAb in patients or animal models to sequence monoclonal antibodies from polyclonal sera, as well as immune system profiling using NovorIg, the team’s NGS based analysis to monitor the relative quantity of specific antibodies over time. Anthony’s a maker and in his spare time takes advantage of the Toronto HackLab to do biological research and other engineering projects
Networking Lunch
Next-Generation Engineering Approaches
- What are the most promising approaches to logic-gating cell therapy responses?
- Advantages and disadvantages of building tunable cell therapies?
- What technical hurdles must be overcome to implementation of more advanced synthetic biology approaches in cell therapy?
Director of Research, Senti Biosciences
Brian Garrison, PhD, is Director of Research at Senti Bio, where he leads development of logic gated CAR-NK cell therapies for cancer, and is driven by the belief that introduction of logic gating into cell therapies will ultimately be transformative for cancer patients in need. Dr. Garrison has been helping develop novel technologies and therapies at Senti for over 5 years, after having completed 2 postdoctoral fellowships at Harvard University focused on stem cell biology and leukemia, and a PhD in human gene therapy from Stanford University.
4:20 – 5:20pm
Beyond CART: Alternative cell modalities
- What are the pros and cons of potential alternatives to T cells?
- What technical hurdles must be overcome for development of these alternatives?
- Can specific cell types be matched with given indications?
- What drives selection of the best binding moiety for a chimeric receptor?
- In vivo CAR-T cell therapies
CSO
Nkarta Therapeutics
James Trager joined Nkarta in 2016 and leads all new product discovery efforts. James is deeply versed in the development and application of cellular therapies for cancer. He previously served as Vice President of Research and Development at Dendreon, where he was responsible for product development, clinical immunology, analytical development, and process automation, supporting the late stage development of sipuleucel-T through clinical study, approval, and commercialization. Prior to Dendreon, James was a Senior Scientist at Geron, where he was part of the team that cloned human telomerase, and later established a Quality Control function to enable the manufacture and clinical development of a telomerase inhibitor.
Gene Tx Development
Opening Address & Keynote Presentation: Outsmarting Complex Diseases with Intelligent Medicines
- Discuss how complex gene circuits can be used to generate smarter cell therapies that overcome fundamental disease challenges
- Explore the use of gene circuits within cell therapies to increase efficacy and specificity
- Demonstration of gene circuit application: FLT3 OR CD33 NOT EMCN CAR-NK cell therapy for acute myeloid leukemia (AML)
Director of Research, Senti Biosciences
Brian Garrison, PhD, is Director of Research at Senti Bio, where he leads development of logic gated CAR-NK cell therapies for cancer, and is driven by the belief that introduction of logic gating into cell therapies will ultimately be transformative for cancer patients in need. Dr. Garrison has been helping develop novel technologies and therapies at Senti for over 5 years, after having completed 2 postdoctoral fellowships at Harvard University focused on stem cell biology and leukemia, and a PhD in human gene therapy from Stanford University.
Concurrently optimization of manufacturing processing with clinical development
- Coordination of clinical development with CMC
- Optimizing the CMC process via clinical data
- Functional releases assays coordinating with clinical assay
Chief Technology Officer & Executive Vice President, IASO Biotherapeutics
David He has more than 30 years of combined experiences in developing therapeutics and biomedical research with extensive experience in the process development and GMP Manufacturing of cellular immunotherapies and biological products. Currently, Serving as EVP and CTO in ISAO Biotherapeutics Inc, Prior to this, served as leadership positions in innovative biotech and global pharmaceutical companies such as Clover Biopharmaceuticals (CTO), Legend Biotech (VP of Tech Ops), and Boehringer Ingelheim (Head of CS&T) in China and the United States. David holds MD/Ph.D. from Sun Yat-Sen University and completed postdoctoral training at the University of Alabama at Birmingham.
Networking Lunch
Approaches to improving efficiency and durability of gene therapies
- Key challenges and future for viral vectors
- Recent advancement in non-viral vectors, key challenges, and prospects.
- Key considerations when selecting vectors – viral versus non-viral, for various gene therapy modalities?
Senior Director – Head of Gene Therapy (Research and Translation)
Janssen
Thomas is the head of Gene Therapy Research and Translation at Janssen in San Francisco. Prior to joining Janssen, Thomas was an Independent Gene Therapy Consultant and the VP of Research at Grace Science, LLC. Before, he rose through the scientific and leadership ranks at Sangamo Therapeutics, where he contributed to the first ever in vivo gene editing clinical trials using a nuclease-based mechanism. Thomas has earned his Ph.D. in Biology from LMU, Munich (Germany) after thesis work at UCSF and conducted his Postdoctoral Fellowships working on DNA repair at Cancer Research UK and at the Stanford School of Medicine.
C&G Tx Bioprocessing
Opening Address & Keynote Presentation: Outsmarting Complex Diseases with Intelligent Medicines
- Discuss how complex gene circuits can be used to generate smarter cell therapies that overcome fundamental disease challenges
- Explore the use of gene circuits within cell therapies to increase efficacy and specificity
- Demonstration of gene circuit application: FLT3 OR CD33 NOT EMCN CAR-NK cell therapy for acute myeloid leukemia (AML)
Director of Research, Senti Biosciences
Brian Garrison, PhD, is Director of Research at Senti Bio, where he leads development of logic gated CAR-NK cell therapies for cancer, and is driven by the belief that introduction of logic gating into cell therapies will ultimately be transformative for cancer patients in need. Dr. Garrison has been helping develop novel technologies and therapies at Senti for over 5 years, after having completed 2 postdoctoral fellowships at Harvard University focused on stem cell biology and leukemia, and a PhD in human gene therapy from Stanford University.
Building essential characterization data for bioprocesses and translation
- Overcoming manufacturing and supply chain bottlenecks throughout development
- Implementation of robust process control and standardization strategies while balancing design flexibility
- Automation as a tool to meet the needs of your customers (patients)
- Creating a comprehensive and viable business strategy to meet market demand
Vice President of Operations
Cellares
John Tomtishen is Vice President of Operations at Cellares. He has more than 10 years of experience in cell and gene therapies, biologics, and vaccines, with diverse roles in Business Operations, CMC/Technical Operations, Supply Chain, Engineering/Facilities, and Operational Excellence. John served as the Site Managing Director at Legend Biotech. He supported the clinical development and BLA filing of Ciltacabtagene autoleucel (Cilta-cel) in collaboration with Janssen Pharmaceuticals. John also worked for Novartis Pharmaceuticals within Cell and Gene Technical Development & Manufacturing. John had an integral role in the filing and approval of the first CAR-T BLA (Kymriah™-tisagenlecleucel).
- Are you currently experiencing ancillary material challenges with closed systems? If so, how are you overcoming these challenges?
- What ancillary materials are most critical to move into closed system formats?
- What are your closed systems container material requirements? Form-fit-function
- Which quality attributes are most important? For example, particulates specifications, other required tests and/or regulatory requirements
Vice President, Sales, Akron Biotech
Robert brings 14 years of business leadership and sales experience in the cell and gene therapy market, with a focus on business development and corporate strategy and execution. His experience ranges across cell therapy drug product and ancillary material manufacturing. Robert’s deep knowledge of clinical and commercial operations has driven process development, scale-up, and design and configuration of electronic systems and logistics platforms for each stage of development. Additionally, Robert played an instrumental role in the formation and growth of the Alliance for Regenerative Medicine, serving as its vice president of communications, along with launching several of the field’s preeminent conferences and events.
PD to Clinical: Data Acquisition and Analysis to Draft Critical Attributes
- Vein to ven data lake
- Packaged software for analysis
- Support for tech transfer to manufacturing
- Clinical to commercial for support continuous process improvement
Vice President and Head of Technical Operations
Senti Bio
Martin Giedlin is currently the VP, Head of Tech Ops at Senti BioSciences supporting the allogeneic NK-CAR programs. Before his joining Senti, he led the PD groups at PACT Pharma (non-viral process for generating autologous neoTcR+ T cells), Poseida (non-viral process for generating autologous CAR-T’s), and Novartis (clinical and commercial manufacturing process for Kymriah). His experience covers over 25 years of various approaches to harness the immune response to treat cancer and infectious disease, starting with Proleukin rIL-2 (aldesleukin; Chiron), Oncolytic adenovirus (Onyx), Listeria-based cancer vaccines (Cerus), and CCR5 knockout CD4+ T cells for HIV+ patients (Sangamo). In addition, he led the implementation of AAV clinical manufacturing to support the Hemophilia, LSD, and neurodegenerative disease programs.
4:20 – 5:20pm
- What is the efficient phase-appropriate approach to develop and implement C&G potency assay from a regulatory perspective?
- What is the requirement of an orthogonal potency assay for the release and characterization of C&G products?
- How to minimize the variability in cell-based potency assay for C&G products?
Senior Director Analytical Sciences
Jasper Therapeutics
Zhenyu Gu has 15+ years of experience in assay development and characterization for biotherapeutics of diverse modalities. He is currently working at Jasper therapeutics as a Senior Director of Analytical Sciences. Prior to Jasper therapeutics, he was a director of developability and preformulation at Denali therapeutics. Before Denali, he held roles of increasing responsibility at Alexion pharmaceuticals and Sanofi-Genzyme.
C&G Tx Manufacturing
Opening Address & Keynote Presentation: Outsmarting Complex Diseases with Intelligent Medicines
- Discuss how complex gene circuits can be used to generate smarter cell therapies that overcome fundamental disease challenges
- Explore the use of gene circuits within cell therapies to increase efficacy and specificity
- Demonstration of gene circuit application: FLT3 OR CD33 NOT EMCN CAR-NK cell therapy for acute myeloid leukemia (AML)
Director of Research, Senti Biosciences
Brian Garrison, PhD, is Director of Research at Senti Bio, where he leads development of logic gated CAR-NK cell therapies for cancer, and is driven by the belief that introduction of logic gating into cell therapies will ultimately be transformative for cancer patients in need. Dr. Garrison has been helping develop novel technologies and therapies at Senti for over 5 years, after having completed 2 postdoctoral fellowships at Harvard University focused on stem cell biology and leukemia, and a PhD in human gene therapy from Stanford University.
- Advantages and disadvantages of in-house manufacturing
- Selecting and successfully managing CMOs
- Strategies for transitioning from outsourced to internal manufacturing
Vice President of Technical Operations
Caribou Biosciences
Justin is responsible for developing Caribou’s CRISPR-edited cell therapies and critical materials. Justin was previously Chief Development Officer at Actym Therapeutics and served in various positions of increasing responsibility in immuno-oncology and vaccine development at Aduro Biotech, Anza Therapeutics, and Cerus Corporation. Justin has authored over 12 publications in peer-reviewed journals and is an inventor on numerous U.S. and foreign patents. Justin earned his undergraduate degree in Biology from Vassar College and his Ph.D. in Molecular and Cell Biology from the University of California, Berkeley. He did his post-doctoral fellowship at the University of California, San Francisco.
- What are the major roadblocks you face in your cell therapy QC? (especially focused on identity, purity and potency phenotyping)
- How do you manage the complexity and labor requirements associated with cell therapy analytical processes?
- How are you addressing issues associated with training, retaining, and paying highly skilled operators to perform cell analysis?
- How to scale your cell analysis processes to accommodate additional in-process checkpoints and a growing patient population?
Vice President, Sales & Marketing, Accellix
Rey joined Accellix as its Vice President Sales and Marketing in July 2019. She has served as a Product Development and Marketing leader for the prior 14 years in both hi-tech and biotech companies. Rey has a graduate degree in Medical Research and an MBA from The University of California, Berkeley and started her career in pharmaceutical sales at Merck Pharmaceuticals. She then joined a biotech startup that was acquired by Life Technologies (Thermo Fisher) as a Field Applications Scientist (FAS) increasing customer acquisition and retention and later was promoted to a Global Product Manager role at Life Technologies, where she launched and managed products in the molecular biology space. She then transitioned to a Sr. Product Marketing Manager at Illumina, where she launched and managed products in the sequencing space, and later served as the Product Marketing Director at Twist Bioscience leading the global marketing team towards commercial product launches and a successful IPO. Recently, she has been working at the Chan Zuckerberg Initiative (CZI) leading the Product Marketing efforts of free technological tools to advance medical research
Networking Lunch
- Patient-centric planning
- Strategies for sourcing and securing AMTP raw materials
- Logistics focusing on cold chain and beyond
- Building flexibility and responsiveness in the age of COVID
Vice President, Supply Chain Management and Business Operations,
Sangamo Therapeutics
Heather Erickson serves as Vice President of Supply Chain Management and Business Operations at Sangamo Therapeutics, a publicly traded, clinical-stage company with programs in gene therapy, genome editing, cell therapy, and gene regulation. She joined Sangamo in 2016 as Chief of Staff, a post she held for two years. Previous roles included serving as President and CEO of the Life Sciences Foundation and founding President of MedTech Association. Earlier in her career, she served as Senior Consultant at Edgar Dunn & Company, a boutique strategy consultancy. She currently serves on several industry and community Boards.
3:45 – 4:15pm
Poster Session: Your future cell therapy manufacturing success-story: The Lonza Cocoon® with integrated magnetic separation
The Lonza Cocoon® is a closed, automated platform for end-to-end cell therapy manufacturing. As manufacturing processes evolve, Lonza continues to upgrade the Cocoon® Platform with new functionalities. The recently released “Integrated, in-line magnetic cell separation” will allow the automated isolation of T cells as a unit operation within the system, resulting in standardized cellular input material and greater control over closed cell therapy manufacturing processes.
Associate Director, Business Development & Clinical Applications, Lonza
Peter Yates, PhD, is currently Associate Director of Business Development & Clinical Applications for Lonza’s Personalized Medicine Business Unit. His focus is on the Cocoon® Platform, a closed and automated cell therapy manufacturing solution. Peter earned a doctorate in Genetics, Molecular, and Cellular Biology – Microbiology and Molecular Immunology from University of Southern California. He has been with Lonza since early 2021.
4:20 – 5:20pm
- Rapid product development
- Phase appropriate implementation of processes
- Managing lifecycle with outsourced vs internal manufacturing
Senior Vice President, Head of Manufacturing,
Nurix Therapeutics
Michael Blackton has served as Senior Vice President of Cell Therapy Manufacturing since September 2021. Prior to joining Nurix, Michael was Vice President of Quality at Adaptimmune Therapeutics where he was responsible for the development of a multi-national quality organization supporting cell therapy and lentiviral vector manufacturing. Michael is a former Board Member of the Parenteral Drug Association, where he currently chairs the Advanced Therapy Medicinal Products Advisory Board and is a member of the Biopharmaceutical Advisory Board. Prior to 2015, Michael worked in a variety of roles at Eli Lilly and Company, ImClone Systems, Millennium Pharmaceuticals, Inhale Therapeutics, and IDEC Pharmaceuticals. Michael has extensive global regulatory inspection experience and has been directly involved in the worldwide regulatory submission, pre-approval inspection, and launch of six biologic products, two small molecule products, and one medical device. He has a B.A in Biochemistry/Cell Biology from the University of California at San Diego, and an M.B.A. with specializations in Leadership, Finance and Strategy from New York University.