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Biotech Symposium: Innovations in Cell + Gene Therapy
Cell and gene therapy innovations have capability to save and change lives around the world. More than 30 Colorado organizations are developing breakthroughs in this space, creating a fast-growing cluster in our state.
Discover recent cell and gene therapy developments, gain insight from the EY Biotechnology Report 2022, and learn more about the contract manufacturing models in cell and gene therapy, at CBSA’s Biotech Symposium: Innovations in Cell + Gene Therapy.
Symposium Keynote Speaker Terry Fry, M.D. will provide an update on the development of the Gates Institute, a $200 million investment to advance the potential of cell and gene therapies and the commercialization of novel therapies for patients.
Agenda
7:30 a.m. – Registration opens
8:00 – 8:05 a.m. – Welcome & Introductions
8:05 – 8:30 a.m. – Symposium Keynote, Gates Institute : Terry Fry, M.D. – Executive Director, Gates Institute and Director of Cancer Immunotherapy, Co-Director, Human Immunology and Immunotherapy Initiative, University of Colorado School of Medicine
Dr. Terry Fry will provide an update on the development of the Gates Institute, a $200 Million investment to advance the potential of cell and gene therapies and the commercialization of novel therapies for patients.
Dr. Fry will be joined by Matthew Seefeldt, Ph.D., Charles C. Gates Biomanufacturing Facility and Laura Borgelt, PharmD, MBA, Chief Operating Officer, Gates Institute and Associate Vice Chancellor of Strategic Initiatives, University of Colorado Anschutz Medical Campus, who will highlight the manufacturing capabilities and active Investigational New Drug Applications (INDs) on campus, as well as, the Gates Institute goals of translating cell and gene therapies into Phase I Clinical Trials.
8:30 – 9:30 a.m. – Contract Manufacturing Models in Cell + Gene Therapy
AGC Biologics, a global CDMO providing development and manufacturing services for protein-based biologics and advanced therapies, will review trends and evolving needs in the growing cell and gene therapy industry, how investments and the business climate are supporting innovation, and ways to create a strong cluster where industry experts want to live and work.
Introductory remarks & panel moderated by Maggie Chen, Sr. Director of Manufacturing, Cell & Gene Therapy, AGC Biologics:
Raghu Malapaka Ph.D., Sr. Director, Business Development – Cell & Gene Therapy, AGC Biologics
Jordan Page, Quality Control Specialist, AGC Biologics
Jeff Rosenbloom, Director, MSAT – Cell & Gene Therapy, MSAT, AGC Biologics
Whitney Sandberg, Vice President of Quality, AGC Biologics
Jeremy Howe, Sr. Mgr, Manufacturing, AGC Biologics
Tony Fraij, General Manager, AGC Biologics
9:30 – 9:45 a.m. – Break
9:45 – 10:30 a.m. – Beyond Borders: EY Biotechnology Report 2022 – Presented by EY: Ashwin Singhania – Principal, EY-Parthenon – Strategy, Life Sciences at Ernst & Young LLP
How do biotechs stay the course in uncharted waters?
10:30 – 11:30 a.m. – Panel Discussion featuring Colorado Cell + Gene Therapy Companies
Local companies will discuss opportunities and challenges in the growing cell and gene therapy sector.
Moderator
Ethan Mann, Ph.D., M.B.A. , Co-Founder and CEO of Validus Cellular Therapeutics, Inc.
Panelists
Tanya Warnecke, President, CTO and Board Member of Artisan Bio
Joe Guiles, Ph.D., Head of Development at Agilent Technologies
Corey Stone, M.B.A., President at Essent Biologics
Michael Strauss, Ph.D., Vice President of Scientific Affairs at CBR International Corp.
11:30 a.m. – 12:30 p.m. – Lunch & Networking Reception
Complimentary for CBSA Members | $25 for Non Members
Key Note
Dr. Terry Fry
Dr. Fry is a Professor of Pediatrics, Hematology and Immunology, Co-Director of the Human Immunology and Immunotherapy Initiative, Director of Cancer Immunotherapy at the University of Colorado School of Medicine and holds the Robert and Kathleen Clark Endowed Chair in Pediatric Cancer Therapeutics at the Children’s Hospital Colorado. Dr. Fry also serves as Head of T cell Therapeutics at Sana Biotechnology. He arrived at the University of Colorado Anschutz in 2018 after serving as Head of the Hematologic Malignancies Section in the Pediatric Oncology Branch at the NIH where he led efforts in Cellular Immunotherapy for pediatric leukemia. Prior to the NIH, Dr. Fry was Chief of Blood and Marrow Transplantation at Children’s National Medical Center in Washington, DC. Dr. Fry’s research focuses on the preclinical and clinical development of chimeric antigen receptor T cells for pediatric cancers. He serves on the Committee for Scientific Affairs for the American Society of Hematology, Vice Chair for Biology in the Cellular Therapy Committee of the Children’s Oncology Group and was recently elected into the American Society for Clinical Investigation
Speaker
Ashwin Singhania
Ashwin is a Partner/Principal in EY-Parthenon’s Life Sciences practice who brings with him 20 years of strategic consulting experience in life sciences. Ashwin works with biopharmaceutical companies to support corporate growth and commercial brand strategy as well as companies providing services to biopharma. Prior to joining EY, Ashwin was a Partner with Navigant Consulting (acquired by Guidehouse), and led the West Coast Commercial Strategy team for Life Sciences. He sourced and led projects across clients to develop corporate strategy, support new product launches, execute commercial due diligence, create comprehensive lifecycle plans and create strategic approaches to therapeutic and disease areas. Industry expertise: Pharmaceuticals and biotechnology in specialty, retail and hospital-based products Therapeutic expertise in oncology, immunology, rare diseases, gastroenterology, cardiology and neurology Commercial services to biopharma. Fields of expertise: Strategic planning, Opportunity sizing and assessments, Commercial due diligence, Launch management, Lifecycle planning, Portfolio planning and prioritization. Education: MBA from Columbia Business School BS in Microbiology from the University of California, Berkeley
Panel Moderator
Dr. Ethan Mann
Dr. Ethan Mann is Co-Founder and CEO of Validus Cellular Therapeutics, Inc., a cell-based antibacterial therapeutic company based in Aurora, CO. Dr. Mann is leading the translation of the stem cell therapy to first in human trials. He completed a Bachelor of Science from Chadron State College and a Ph.D. from the University of Nebraska. Dr. Mann trained as a post-doctoral fellow in infectious disease at the Ohio State University. His academic career was dedicated to understanding how bacteria cause chronic infections. That experience led to joining a startup called Sharklet Technologies, Inc. in Aurora, CO where he initially led scientific and strategic efforts to commercialize the infection preventing texture on medical devices. In 2013, Dr. Mann join Sharklet Technologies and was instrumental in the development of that technology which led to its acquisition in 2017. Following the sale of Sharklet, Dr. Mann was retained and promoted to COO to lead Sharklet US operations and complete an integration of a company holding an enabling manufacturing capability.
Following Sharklet, Dr. Mann has participated in numerous scientific advisory boards and co-founded Validus with Dr. Steven Dow at Colorado State University. Validus has been fund raising to transition from preclinical to clinical stage.
While at Sharklet Dr. Mann, completed an MBA with specialization in finance. Dr. Mann believes that promoting collaboration in the bioscience community in Colorado is critical to grow everyone’s success. He also serves on NIH review panels to evaluate small business innovation research grants which support commercialization of innovative technologies. Dr. Mann dedicates his volunteer time to the Colorado Bioscience Association and various community activities. He has been recognized as a “Distinguished Young Alumni” by his undergraduate institution. Dr. Mann has a leadership profile indicating strengths in delegation, selling, general persistence and overall management. These attributes fit well with his passion for accomplishing very challenging goals, including launch novel biotechnologies.
Panelists
Tanya Warnecke
Tanya is a seasoned executive-level professional with a unique combination of experiences including technical, operational, and business leadership. She currently serves as the President, CTO and Board Member of Artisan Bio. Ventures include cell engineering startups with a variety of applications (cell therapies, biofuels, and biochemicals) and life sciences tools including instrumentation, reagent development, and software engineering. Prior to Artisan, Tanya was the co-Founder, CTO, and VP of Applications at Inscripta and Director of Technology at OPXbio. Tanya is the inventor on 30+ patent filings and brings deep expertise in genome engineering, synthetic biology, automation and engineering novel endonucleases for CRISPR-based editing.
Joe Guiles
Joe Guiles, Pharma/biotech CMC leader with extensive experience at building and leading technical functions and sites. He currently leads the RNA products and services chemical development department at Agilent Technologies in Colorado. His past employers include Pfizer, Albany Molecular, Replidyne, Sanofi-Aventis, and Johnson & Johnson.
Corey Stone
As President, Corey is responsible for creating, communicating and implementing the vision, mission and overall direction. He leads the development and execution of the company’s strategy, building a strong team to execute on goals and objectives.
With over 15 years of experience in the medical device and biotech industry, Corey has held several leadership positions. Most recently, Corey served as Senior Vice President, Innovation for AlloSource, managing research and development initiatives. Prior to that, Corey was Vice President, Marketing and Strategic Planning, as well as Head of Strategy, Corporate Development and Portfolio Planning. Corey came to AlloSource from Terumo BCT’s Strategic Marketing and Communications team.
Dr. Michael Strauss
Dr. Michael Strauss is the Senior Director of Technical Consulting at Novotech Drug Development Consulting, formerly CBR International, a full-service product, clinical, quality, and global regulatory development group. Dr. Strauss leads a team of scientists at Novotech DDC who build value into client programs through critical scientific review and strategic program development. His consulting specialties span medical devices and combination products, drugs, biologics, and biosimilar product development, with a primary focus on CMC/Regulatory. In his sixteen+ years at CBR, now Novotech, Dr. Strauss has assisted clients in preparing their CMC and quality systems for further steps in development, which includes inspection preparation, due diligence, CMO qualification and oversight, and process and analytical validation. Dr. Strauss has led teams in drafting numerous INDs and BLAs, both for biosimilar and innovator products, which includes overseeing the electronic assembly of numerous large dossiers for marketing approval. Along with his team, he has provided technical writing support for the preparation of BLAs, CTAs, INDs, NDAs, IMPDs, IDEs, and 510(k)s, as well as numerous MBRs, SOPs, and analytical validation protocols and reports. He has also prepared clients for, or facilitated, numerous meetings with regulatory agencies, including European Scientific Advice, Pre-IND/BIA, INTERACT, Pre-submission and Type B/C/2/4 FDA meetings, Advisory Committee meetings, and Pre-Licensure Inspections. Dr. Strauss has served as regulatory representative to FDA for numerous client products.
Dr. Strauss’s dissertation research was on the characterization of inherent filament assembly elements within the Myosin Heavy Chain tail. Following his Ph.D., Dr. Strauss joined Eppendorf 5 Prime, the reagent arm of Eppendorf AG. Dr. Strauss helped develop Eppendorf’s first proteomics product, the PerfectPure C18 Desalting Tip, and led groups that cloned, expressed and characterized numerous novel PCR enzyme systems, and developed novel nucleic acid purification products. His achievements as manager included finalizing the release of the Orimaster product, that allows users to quickly produce sequencing-grade DNA without a liquid culture step. Dr. Strauss joined CBR International in 2006, following the sale of Eppendorf 5 Prime to Qiagen GmbH.
Dr. Strauss received his B.A. from Oberlin College. Although much of his Ph.D. dissertation research was carried out at the University of Colorado Boulder campus, he received his M.S. and Ph.D. from Albert Einstein College of Medicine in New York.