Dear Colleague,
GTCbio is proud to present the 15th Stem Cell Summit, to be held in Boston, MA. The Stem Cell Summit provides information on cutting-edge developments in all areas of stem cell research from bench to bedside, including the biology, medicine, applications, regulations, product development, and the commercialization of stem cells. This summit comprises of presentations, panels and round-table discussions to highlight pre-clinical and clinical studies in regenerative medicine, immunotherapy, stem cell reprogramming, cell therapy in diabetes, regulatory policies regarding stem cell research, manufacturing and other relevant topics.
| KEYNOTE SPEAKERS | |||
 | Douglas Melton Principal Investigator; HHMI Professor; Harvard University |  | Hans Keirstead Chief Executive Officer AIVITA Biomedical |
 | Evan Snyder Professor and Director, Program in Stem Cell & Regenerative Biology Sanford-Burnham Medical Research Institute |
| Erin Kimbrel Senior Director of Development Astellas Institute for Regenerative Medicine |
The 15th Stem Cell Summit includes two conferences including the joint plenary session:
Joint Sessions:
- Plenary Keynote: Historical Perspective and State of the Industry
- Round Table Sessions
- Lunch Session: Regulatory Challenges in Cell Therapy
- Award Ceremony and Closing Keynote Session – Predictions for the Future
Stem Cell Research & Regenerative Medicine:
- Advances in Adult Stem Cell Research
- Advances in Pluripotent Stem Cell Research
- Translation to the Clinic: What’s in the Pipeline
- Revolution in Immunotherapy
Stem Cell Product Development & Commercialization:
- Stem Cells for Drug Discovery and Disease Modeling
- Partnering between Industry, Academia and CROs to Advance Research
- Manufacturing and Scalable Processes for Cell Therapy
- Funding & Commercialization of Cell Therapy
We hope to see you in Boston!
Best regards,
The 2018 Advisory Committee
| 2018 Advisory Board Members |
| Anthony Ting, Athersys |
| Robert Deans, BlueRock Therapeutics |
| Douglas Losordo, Caladrius Biosciences |
| Evan Y. Snyder, Sanford-Burnham Medical Research Institute |
| Mark Zimmerman, Viacyte |
| Matthew Durdy, Cell Therapy Catapult |
| Gil Sambrano, California Institute for Regenerative Medicine |
| Alain Vertès, NxR Biotechnologies GmbH |
| Khalid Shah, Harvard Medical School |
| Satish Medicetty, GTCbio |
Schedule for Sessions
Continental Breakfast & Registration
Opening Remarks by GTCbio
Opening Keynote Session – Historical Perspective and State of the Science & Industry
8:30-Douglas Melton - Stem Cells for Diabetics
9:15-Hans Keirstead - Clinical and Commercial Application of Scaled Human Stem Cell Derivates
Morning Networking Break
Partnering between Industry, Academia, and CROs to Advance Research
10:30-Brock Reeve - Cross-institutional Collaboration in Academia and Industry
10:55-Anthony Ting - Advancing MultiStem for ARDS with Academia and a CRO
Advances in Adult Stem Cell Research
10:30-Sally Temple - Addressing Age-related Macular Degeneration with Adult Retinal Pigment Epithelial Stem Cells
10:55-Douglas Losordo - Recent Breakthroughs with CD34+ Cell Therapy in Cardiovascular Disease: Insights from Clinical Trials in >700 Patients
11:20-Buddhadeb Dawn - Bone Marrow Cells for Heart Repair: Cumulative Clinical Evidence and Insights
11:45-Alain Vertès - Cellular Medicines for Intractable Serious and Life-Threatening Diseases
Panel Discussion: Partnering between Industry, Academia, and CROs to Advance Research
11:20-Anthony Ting - Panelist:
11:20-Yang (Ted) D Teng - Panelist:
11:20-Brock Reeve - Moderator:
11:20-Evan Snyder - Panelist:
Lunch on Provided by GTCbio
Stem Cells for Drug Discovery & Disease Modeling
1:45-James Hickman - Stem Cell Derived Human-on-a-chip Systems for Use in Efficacy and Toxicological Investigations in Pre-clinical Drug Discovery
2:10-Yang (Ted) D Teng - Devising A MedicalGas Therapy for SCI: Roles of Adult Neurogenesis
2:35-Devyn Smith - A Next Generation Modality for Cell and Gene Therapies
Advances in Pluripotent Stem Cell Research
1:45-Kristin Baldwin - Precision Engineering and Genome Editing of Human Disease-relevant Cell Types
2:10-Kevin Eggan
2:35-Hardy T S Kagimoto - Update: Healios’s Business Strategy, Management, Finance and Advancement of Pipelines
3:00-Mahendra Rao
Afternoon Networking Break
Regulatory Challenges in Cell Therapy
4:10-Toshio Miyata - Japanese Policy for Regulatory Science of Stem Cell Therapies
4:35-Melody Eble - Global Regulatory Policy and Project Update
Networking Reception & Poster Session
Continental Breakfast
Manufacturing and Scalable Processes for Cell Therapy
8:30-Katy Spink - Controlling Cost of Goods for your Autologous Process: Key Considerations and Levers
8:55-Emily Titus - Progress Towards Large Scale Manufacturing of Stem Cells for Cell Therapy
9:20-Kevin Murray - Efficient Scale Up/Scale Out of Cell Therapies
9:45-Wilfried Dalemans - Cell Therapy Manufacturing, a Continuous Development
Translation to the Clinic: What’s in the Pipeline
8:30-Jacques Galipeau - Mesenchymal Stromal Cells – Pre-clinical Science, Clinical Development and Pathway to Marketing Approval
8:55-Luis Rodriguez-Borlado Martinez - Clinical Development of CAP-1002 for Duchenne Muscular Dystrophy: Opportunities & Challenges
9:20-Bob Valamehr - Clinical Translation of Pluripotent Cell-Derived Off-the-Shelf Natural Killer Cell Cancer Immunotherapy
9:45-Scott Olson - Clinical Trials in TBI: Preventing the Next Failure
Morning Networking Break
Funding & Commercialization of Cell Therapy
10:40-Gil Sambrano - Accelerating Stem Cell Therapy Development
11:05-Patrick Keenan - Innovative Funding to Achieve Data-Driven Value Inflections
Revolution in Immunotherapy
10:40-Khalid Shah - Next Generation of Immunomodulatory Stem Cells for Cancer
11:05-Richard Morgan - Next Generation of CAR T Cells
11:30-Paul Rennert - IMPACT: Re-engineered CAR19 T cells have Potent Activity Against Hematologic and Solid Tumors
11:55-MyLinh Duong - Controlling Adoptive T Cell Therapy with Molecular ON and OFF Switches
Panel: Funding & Commercialization of Cell Therapy
11:30-Gail Naughton - Panelist:
11:30-Michael May - Panelist:
11:30-Gregory Bonfiglio - Panelist:
11:30-Matthew Durdy - Moderator:
Lunch & Round Table Session Sponsored by Biological Industries USA
Round Table Session
12:40-Anthony Ting - Round Table 1: Barriers to Cellular Therapy Implementation
12:40-Alain Vertès - Round Table 2: Combination Therapies in Oncology: Small Molecules, Biologics, and Cell-based Therapies
12:40-Gail Naughton - Round Table 3: Developing Potency Assays to Predict Outcomes of Stem Cells After Infusion
12:40-Gregory Bonfiglio - Round Table 4: Financing Environment for Regenerative Medicine Technologies
Award Ceremony & Closing Keynote Session: Predictions for the Future
1:25-Evan Snyder - Using Stem Cells to Model Neurological Disease & Advance Personalized Medicine
2:10-Erin Kimbrel - A Glimpse of the Next 10 Years for Pluripotent Stem Cell-based Therapies
Keynote Panel Discussion
2:25-Erin Kimbrel - Moderator:
2:25-Evan Snyder - Panelist:
2:25-Sally Temple - Panelist:
Summit Concludes
Amber Kempf at 626-256-6405 or amber.kempf [at] gtcbio.com
Corporate Partner
http://www.nordmark-pharma.de/en/biochemicals/
Nordmark Biochemicals provides collagenases and other proteases used for tissue dissociation and cell isolation. The Collagenase NB products manufactured by Nordmark were previously marketed and distributed worldwide exclusively by SERVA. In 2018, Nordmark took over distribution in order to offer production, sales, marketing and support from one source. Pharmaceutical manufacturing standards result in high lot-to-lot consistency, safety and superior quality to guarantee cell viability and high yields. Supporting documentation and access to drug master files registered with the FDA are available for GMP grade users. The portfolio includes animal-free Collagenase AF-1 GMP Grade and Neutral Protease AF GMP Grade.
Premium Sponsors
http://www.biospherixmedical.com/
BioSpherix will be exhibiting the Xvivo System, world’s first and only cytocentric barrier isolator optimized for cells. Economical and practical alternative to cleanrooms for cGMP compliant production of cells for clinical use. Get better contamination, process and quality control. Stop by BioSpherix booth to learn more about the only total quality platform for cells!
http://www.bioind.com/
Biological Industries USA (BI-USA) offers a comprehensive portfolio of optimized, innovative solutions for general cell culture, stem cell research, and cell therapy applications. With our state-of-the-art serum-free, xeno-free stem cell media produced under cGMP and ISO-certified regulations, we strive to offer an unmatched commitment to quality, defining BI-USA’s culture of excellence.
Program Partners
http://www.viracor-eurofins.com/
Viracor Eurofins provides clinical trial biomarker testing services with expertise in custom assay transfer, design and validation for phase I-IV trials. Our CAP/CLIA and NY state accredited laboratory has over 30 years of experience in molecular testing, immune response monitoring, vaccine safety/efficacy assessment, allergy and hypersensitivity testing.
Exhibitor
http://cbset.org/
CBSET is a not-for-profit translational research institute specializing in the evaluation of drugs, biotherapeutics, combination products, and medical devices. We provide preclinical services including in-life testing, histopathology and regulatory consulting. Our GLP-compliant facilities host a multidisciplinary team of medical, scientific and regulatory experts who actively collaborate in getting novel technologies to market.
https://fmcna.com/apheresis-services/
Fresenius Medical Care is the largest mobile Therapeutic Apheresis provider supported by a quarter century of industry leading expertise. Providing customers with a fully equipped apheresis program. Quality centered organization supporting successful FACT accreditation for cell collections. Providing adult and pediatric apheresis services in inpatient and outpatient setting.
Media Partners
