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Together we Drive the Future

Stem Cell Research & Regenerative Medicine

2017-02-222017-03-092017-02-13
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2017 Agenda
Day 1
 
Day 1 - Wednesday, April 5th, 2017
7:30
Continental Breakfast & Registration
9:05
Opening Remarks
10:00
Morning Networking Break
Advances in Adult & Pluripotent Stem Cell Research

10:30
Healios' Pipelines and Strategy toward Commercializations of iPS Cell
 
Hardy T S Kagimoto
President and Chief Executive Officer
Healios K.K (RIKEN Venture)
About Speaker: ... Read Full Bio 
 
 
Hardy T S Kagimoto
President and Chief Executive Officer
Healios K.K (RIKEN Venture)
 
About Speaker:
 
Abstract: Healios would introduce its corporate strategy and pipelines to enable cell therapy in the light of Japanese accelerated approval system. 1...Read More 

Healios would introduce its corporate strategy and pipelines to enable cell therapy in the light of Japanese accelerated approval system.

1st pipeline: Bone marrow derived Somatic stem cell pipeline, which Healios is conducting randomized, double blinded 110 vs 110, P2/3 study for acute brain stroke.

2nd pipeline: iPS based RPE cell, which Riken started world first clinical research using autologous iPS.  It’s been 2 years and 6 months and the patient is free from any anti-VEGF injections for the eye she had implantation but the fellow eye still requires constant injections.  Recently, Riken has gained approval from ministry of health in Japan to start world first clinical research using allogeneic haplo bank iPS cell lines for those who are suffering from wet Age-related Macular degeneration.  Healios will be presenting the consistent flow from clinical research to clinical trials to gain approval for iPS cell based therapy.

3rd pipeline: Healios’s another focus is organ bud technology which is proprietary technology which enables to generate various type of organs.  With Yokohama City University, Healios is planning to start world first clinical research in 2019 for patients suffering from congenital lever enzyme deficiency.

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10:55
Erin Kimbrel
Senior Director of Development
Astellas Institute for Regenerative Medicine
About Speaker: ... Read Full Bio 
 
 
Erin Kimbrel
Senior Director of Development
Astellas Institute for Regenerative Medicine
 
About Speaker:
11:20
Regenerative Therapies for Cardiovascular and CNS Degenerative Disease
 
Robert Deans
Cheif Technology Officer
BlueRock Therapeutics
About Speaker: ... Read Full Bio 
 
 
Robert Deans
Cheif Technology Officer
BlueRock Therapeutics
 
About Speaker:
11:45
Anthony Ting
Vice President
Athersys
About Speaker: Dr. Ting is the Vice President of Regenerative Medicine and Head of Cardiopulmonary Programs. With more than thirty years of experience in cell and stem cell biology, Dr. Ting has developed expertise in translational clinical studies with adult stem ... Read Full Bio 
 
 
Anthony Ting
Vice President
Athersys
 
About Speaker:

Dr. Ting is the Vice President of Regenerative Medicine and Head of Cardiopulmonary Programs. With more than thirty years of experience in cell and stem cell biology, Dr. Ting has developed expertise in translational clinical studies with adult stem cell therapies and has been responsible for all stages of the development of MultiStem® from the bench to the bedside. Dr. Ting manages all programs in the cardiovascular and pulmonary areas at the Company, as well as the evaluation of potential new uses for the cell therapy product. Dr. Ting serves on several regenerative medicine society committees including the International Society for Cell Therapy, the Alliance for Regenerative Medicine and the American Society for Gene and Cell Therapy. From 1995 to 2001, Dr. Ting was a Principal Investigator and Head of the Screening for Novel Inhibitors group at the Institute of Molecular and Cell Biology (IMCB) at the National University of Singapore. Prior to joining IMCB, he was a post-doctoral fellow in the department of Molecular and Cellular Physiology at Stanford University. Dr. Ting received his Ph.D. in Cell Biology from Johns Hopkins University and his B.A. in Biology from Amherst College.

12:10
Lunch Provided by GTCbio
Revolution in Immunotherapy

1:25
Placental Natural Killer Cells (PNK-007) for the Treatment Of Hematologic Malignancies
 
Wolfgang Hofgartner
Vice President, Research
Celgene Cellular Therapeutics
About Speaker: Dr. Hofgartner is Vice President of Research & Development at Celgene Cellular Therapeutics, which is a clinical stage company with multiple phase 1/2 programs. The company is focused on developing and advancing a number of distinct cellular immu... Read Full Bio 
 
 
Wolfgang Hofgartner
Vice President, Research
Celgene Cellular Therapeutics
 
About Speaker:

Dr. Hofgartner is Vice President of Research & Development at Celgene Cellular Therapeutics, which is a clinical stage company with multiple phase 1/2 programs. The company is focused on developing and advancing a number of distinct cellular immuno-oncology programs for therapeutic areas with high unmet medical need. Prior to joining Celgene Cellular Therapeutics in 2004, Dr. Hofgartner was Medical Director at Becton Dickinson, a global medical technology company. By background he is a board certified Clinical Pathologist, trained at the University of Washington in Seattle, with subsequent fellowship training in Molecular Pathology at the University of Pittsburgh.

 

 
Abstract: Clinical studies suggest that adoptive transfer of allogeneic natural killer (NK) cells represent a promising treatment for patients with hematolog...Read More 

Clinical studies suggest that adoptive transfer of allogeneic natural killer (NK) cells represent a promising treatment for patients with hematological malignancies and solid tumors. Celgene Cellular Therapeutics has established a cultivation process to generate human NK cells (PNK-007) from umbilical cord blood CD34+ cells with substantial cytolytic activity against several human tumor cell lines, primary AML and primary multiple myeloma cells. Two Phase 1 clinical studies of PNK-007 infusion, one in AML and the other in multiple myeloma, will be discussed.

Bullet Points:

  • Placental Natural Killer Cells (PNK-007) are expanded and differentiated from cord blood CD34 cells
  • PNK-007 constitutes an allogeneic, off-the-shelf product for systemic application
  • PNK-007 is currently in Phase 1 studies in AML and multiple myeloma
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1:50
Margo Roberts
Sr VP, Discovery Research
Kite Pharma
About Speaker: Dr. Roberts has more than two decades of biomedical research, drug discovery and development experience. From 1999 to 2013, Dr. Roberts held an Associate Professor position at the University of Virginia where she pursued interdisciplinary research in... Read Full Bio 
 
 
Margo Roberts
Sr VP, Discovery Research
Kite Pharma
 
About Speaker:

Dr. Roberts has more than two decades of biomedical research, drug discovery and development experience. From 1999 to 2013, Dr. Roberts held an Associate Professor position at the University of Virginia where she pursued interdisciplinary research in the area of immunity and inflammation. From 1990 to 1998, she served as Principal Scientist and Director of Immune and Cell Therapy at Cell Genesys, Inc. Dr. Roberts is the inventor on the first set of CAR patents, including second-generation CAR constructs that incorporate the domains of costimulatory receptors, such as CD28, aimed at improving CAR T cell survival and function. She is the author of more than 25 scientific publications and inventor on 13 issued US patents and three published US patent applications related to CAR technology and tumor vaccine therapies. Dr. Roberts was a postdoctoral fellow at Yale and at the LGME of the CNRS in France. She received her BSc with honors and her PhD from the University of Leeds in England.

2:15
Jane Lebkowski
President, Research & Development
Asterias Biotherapeutics
About Speaker: Jane Lebkowski has been actively involved in the development of cell and gene therapies since 1986 and is currently President of R&D and Chief Scientific Officer at Asterias Biotherapeutics Inc, where she is responsible for all R&D of Asteria... Read Full Bio 
 
 
Jane Lebkowski
President, Research & Development
Asterias Biotherapeutics
 
About Speaker:

Jane Lebkowski has been actively involved in the development of cell and gene therapies since 1986 and is currently President of R&D and Chief Scientific Officer at Asterias Biotherapeutics Inc, where she is responsible for all R&D of Asterias’ products.  From 1998 to 2012, Dr. Lebkowski was Senior Vice President of Regenerative Medicine and Chief Scientific Officer at Geron Corporation.  Dr. Lebkowski led Geron’s human embryonic stem cell program, being responsible for all research, preclinical development, product development, manufacturing, and clinical development activities.  Prior to Geron, Dr. Lebkowski was Vice President of Research and Development at Applied Immune Sciences.  Following the acquisition of Applied Immune Sciences by Rhone Poulenc Rorer (RPR, currently Sanofi), Dr. Lebkowski remained at RPR as Vice President of Discovery Research.  During Dr. Lebkowski’s tenure at RPR, she coordinated preclinical investigations of gene therapy approaches for treatment of cancer, cardiovascular disease and nervous system disorders, and directed vector formulations and delivery development.  Dr. Lebkowski received her Ph.D. in Biochemistry from Princeton University in 1982, and completed a postdoctoral fellowship at the Department of Genetics, Stanford University in 1986.

Dr. Lebkowski has published over 70 peer reviewed papers and has 13 issued U.S. patents.  Dr. Lebkowski has served on the board of Directors of the American Society for Gene and Cell Therapy and as the co-chair of the Industrial Committee of the International Society for Stem Cell Research. Dr Lebkowski serves on several scientific advisory boards and other professional committees.

2:40
Monoclonal Antibody Delivery with MSCs
 
John E Davies
Professor, Institute of Biomaterials and Biomedical Engineering (IBBME); President & Cheif Executive Officer
University of Toronoto; Tissue Regeneration Therapeutics Inc.
About Speaker: ... Read Full Bio 
 
 
John E Davies
Professor, Institute of Biomaterials and Biomedical Engineering (IBBME); President & Cheif Executive Officer
University of Toronoto; Tissue Regeneration Therapeutics Inc.
 
About Speaker:
3:05
Afternoon Networking Break
Translation to The Clinic: What’s in the Pipeline

3:35
Encapsulated Stem Cells Targeting Apoptotic and Immune Modalities for Cancer
 
Khalid Shah
Director Center for Stem Cell Therapeutics and Imaging
Harvard Medical School
About Speaker: Dr. Shah is an Associate Professor at Harvard Medical School. He is also the Director of Center for Stem Cell Therapeutics and Imaging and Vice Chair of Research at Brigham and Women’s Hospital and a Principal Faculty at Harvard Stem Cell Institute... Read Full Bio 
 
 
Khalid Shah
Director Center for Stem Cell Therapeutics and Imaging
Harvard Medical School
 
About Speaker:

Dr. Shah is an Associate Professor at Harvard Medical School. He is also the Director of Center for Stem Cell Therapeutics and Imaging and Vice Chair of Research at Brigham and Women’s Hospital and a Principal Faculty at Harvard Stem Cell Institute in Boston. His laboratory focuses on developing therapeutic stem cells for receptor targeted therapies for cancer and testing their efficacy in clinically relevant mouse tumor models. In recent years, Dr. Shah and his team have pioneered major developments in the stem cell therapy field, successfully developing experimental models to understand basic cancer biology and therapeutic stem cells for cancer, particularly brain tumors. These studies have been published in a number of very high impact journals like Nature Neuroscience, PNAS, Nature Reviews Cancer, JNCI, Stem Cells and Lancet Oncology, validating the use of therapeutic stem cells alone and in combination with clinically approved drugs for cancer therapy.

Recently, Dr. Shah's work has caught the attention in the public domain and as such it has been highlighted in the media world-wide including features on BBC and CNN. Dr. Shah holds current positions on numerous councils, advisory and editorial boards in the fields of stem cell therapy and oncology. The technologies from Dr. Shah’s laboratory have led to the foundation of a biotech company, AMASA Technologies Inc. whose main objective is the clinical translation of therapeutic stem cells in cancer patients.

 
Abstract: Stem cell-based therapies are emerging as a promising strategy to tackle cancer. Using our recently established invasive, recurrent and resection m...Read More 

Stem cell-based therapies are emerging as a promising strategy to tackle cancer. Using our recently established invasive, recurrent and resection models of primary brain tumors and metastatic tumors in the brain that mimic clinical settings, we have shown that receptor targeted encapsulated adult stem cells expressing novel bi-functional proteins or loaded with oncolytic viruses target both the primary and the invasive tumor deposits and have profound anti-tumor effects. Recently we have shown the efficacy of encapsulated stem cell released immunomodulatory agents in syngeneic mouse tumor models that mimic the clinical scenario of tumor resection and growth. These studies demonstrate the strength of employing engineered stem cells in preclinical-therapeutic tumor models and form the basis for their clinical translation. This presentation considers the current status of stem cell-based treatments for cancer and provides a rationale for translating the most promising preclinical studies into the clinic.

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4:00
Progenitor Cell Activation - an Enabling Technology for In-Situ Tissue Regeneration
 
Chris Loose
Co-founder & Chief Scientific Officer
Frequency Therapeutics
About Speaker: ... Read Full Bio 
 
 
Chris Loose
Co-founder & Chief Scientific Officer
Frequency Therapeutics
 
About Speaker:
4:25
Bringing CRISPR Therapeutics into the Clinic
 
Bill Lundberg
Chief Scientific Officer
CRISPR Therapeutics
About Speaker: Dr Bill Lundberg has extensive experience across all aspects and phases of drug development in both academic and industry settings. He was previously vice president and head of translational medicine at Alexion Pharmaceuticals, where he oversaw the p... Read Full Bio 
 
 
Bill Lundberg
Chief Scientific Officer
CRISPR Therapeutics
 
About Speaker:

Dr Bill Lundberg has extensive experience across all aspects and phases of drug development in both academic and industry settings. He was previously vice president and head of translational medicine at Alexion Pharmaceuticals, where he oversaw the progression of numerous compounds from early research to clinical proof-of-concept. Before that, Bill held senior positions at Taligen Therapeutics, Antisoma, Xanthus (acquired by Antisoma), Wyeth (now Pfizer) and Genzyme, overseeing the development of diverse portfolios.

Bill received his BS in biology from the Massachusetts Institute of Technology, MD from Stanford Medical School and MBA from the University of Massachusetts Amherst. As a post-doctoral fellow, he studied at the Whitehead Institute at MIT and trained in internal medicine and oncology at Brigham and Women’s Hospital and Dana-Farber Cancer Institute.

 
Abstract: Only five short years after Emmanuelle Charpentier, Jennifer Doudna and colleagues demonstrated how to use the CRISPR ...Read More 

Only five short years after Emmanuelle Charpentier, Jennifer Doudna and colleagues demonstrated how to use the CRISPR system with a programmable RNA to precisely cleave specific DNA sequences, applications using the technology in stem cells and other cell types are already in development. The adoption of CRISPR-Cas9 gene editing for use in research, and for developing novel medicines, has been remarkably rapid, in part because it is so easy to apply these fundamental discoveries to higher organisms including humans. CRISPR/Cas9 edited T-cells are currently being tested in patients, and numerous other applications of both ex vivo in vivo applications are in late preclinical testing. This talk will review programs in development with a particular focus on an application in hematopoietic stem cells, and provide a discussion of remaining considerations and technical hurdles that still need to be addressed as we bring CRISPR therapeutics into clinical stage testing in patients.

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4:50
Chronic Disability after Stroke: Can Neural Stem Cells Provide a Cure?
 
John Sinden
Chief Scientific Officer
ReNeuron
About Speaker: John Sinden is Chief Scientific Officer of ReNeuron. From 1998 to 2015 he was a director of the ReNeuron companies. Prior to founding ReNeuron and becoming its first employee, he was Reader in Neurobiology of Behaviour at the Institute of Psychiatry ... Read Full Bio 
 
 
John Sinden
Chief Scientific Officer
ReNeuron
 
About Speaker:

John Sinden is Chief Scientific Officer of ReNeuron. From 1998 to 2015 he was a director of the ReNeuron companies. Prior to founding ReNeuron and becoming its first employee, he was Reader in Neurobiology of Behaviour at the Institute of Psychiatry at Kings College London. He graduated in Psychology from the University of Sydney and completed a Ph.D. in Neuroscience from the University of Paris at the College de France. He subsequently held post-doctoral appointments at Oxford University and the Institute of Psychiatry prior to joining the tenured staff of the Institute in 1987. Dr. Sinden is an Honorary Professor in the Faculty of Medical Sciences at University College London and has over 140 scientific publications and book chapters. He holds Fellowships of the Royal Society of Medicine and the Royal Society of Biology and is a member of the International Society for Stem Cell Research and the Expert Working Group on Cell and Gene Therapies for the Bioindustry Organization BioSafe Committee.

 
Abstract: CTX is a conditionally immortalised clonal neural stem cell line generating a stable frozen cell therapy product able to be manufactured to GMP at ...Read More 

CTX is a conditionally immortalised clonal neural stem cell line generating a stable frozen cell therapy product able to be manufactured to GMP at large scale and with long shelf life for clinical and commercial use.

Several published preclinical studies have shown recovery of motor function in rodents with stable disability post middle cerebral artery occlusion. Survival and neural differentiation of grafted cells at the implant sites are seen, along with a range of host regenerative mechanisms, including vascular genesis, enhanced post-stroke neurogenesis and reparative modulation of the damaging immune response to the occlusion.

Recently, we have published excellent long-term safety across a range of cell doses in a Phase I trial of intracerebrally delivered CTX in 11 chronic stroke patients with significant and stable motor disability. Improvements in motor function compared to pretreatment baseline were seen in the majority of patients. More recently, a Phase II single arm study looking at a range of outcome efficacy measures in hemiparetic stroke patients has recently reported interim data which are promising across a range of motor, disability and activities of daily life measures.

Future placebo controlled pivotal studies are under discussion with FDA and EMA, including the use of placebo surgery as a control.

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5:20
Networking Reception & Poster Session
Day - 2 Thursday, April 6th, 2017
7:30
Continental Breakfast & Registration
Joint Plenary Session: Where do We Stand with Cell Therapy in Diabetes?

9:15
Douglas Losordo
Chief Medical Officer, Senior Vice President of Clinical, Medical & Regulatory Affairs
Caladrius Biosciences
About Speaker: ... Read Full Bio 
 
 
Douglas Losordo
Chief Medical Officer, Senior Vice President of Clinical, Medical & Regulatory Affairs
Caladrius Biosciences
 
About Speaker:
9:40
Mesenchymal Stromal Cells as Cellular Therapeutics to Enhance Human Pancreatic Islet Transplantation in Type-1 Diabetes
 
John Campbell
Associate Director, Research, Development & Innovation
SNBTS, National Science Laboratory
About Speaker: Professor John Campbell is Associate Director of Research and Development at the Scottish National Blood Transfusion Service (SNBTS) in Edinburgh. He completed his PhD in Pathology at Edinburgh in 1995 on the immunopathogenesis of lymproliferative di... Read Full Bio 
 
 
John Campbell
Associate Director, Research, Development & Innovation
SNBTS, National Science Laboratory
 
About Speaker:

Professor John Campbell is Associate Director of Research and Development at the Scottish National Blood Transfusion Service (SNBTS) in Edinburgh. He completed his PhD in Pathology at Edinburgh in 1995 on the immunopathogenesis of lymproliferative disease, and has worked in the cellular therapy field for over 20 years in academic and industry positions. He is currently the national head of research for SNBTS and holds academic appointments at the Universities of Glasgow and Edinburgh. SNBTS has a substantial cellular therapy research programme, with over 40 full time scientists working on basic cellular function; translation of laboratory protocols to full GMP processes; and production of cellular therapeutics for treatment of patients. SNBTS has a dedicated, fully MHRA licensed, GMP cellular therapy production centre at the Scottish Centre for Regenerative Medicine. This GMP manufacturing and development capacity will be substantially increased when SNBTS moves to the Jack Copland Centre, Edinburgh, in early 2017. Cellular therapeutics in development and early phase clinical trials include, mesenchymal stromal cells, corneal limbal stem cells, macrophages for tissue repair and virus -specific T Lymphocytes.

 
Abstract: Islet transplantation is of proven efficacy in subjects with Type 1 diabetes where glycaemic control is problematic, stabilizing glycaemic control ...Read More 

Islet transplantation is of proven efficacy in subjects with Type 1 diabetes where glycaemic control is problematic, stabilizing glycaemic control and restoring awareness of hypoglycaemia where this has been compromised. However, long term graft survival remains poor and patients typically require two to three islet transplants.  Innate and adaptive immune responses contribute to early and ongoing graft attrition. Therapeutic strategies to improve graft function are urgently needed. Ideally, a therapeutic strategy would modulate the inflammatory and immune response and enhance engraftment of islets. Mesenchymal stromal cells (MSCs) are multipotent cells found in the majority of tissues and have been shown to support regeneration of tissues by supporting blood vessel formation through a broad spectrum of growth factors and extracellular matrix secreted. This tissue building function is accompanied by the ability to suppress T cell responses and modulate inflammatory infiltration. We have investigated the ability of GMP-grade human MSC to support human Islet engraftment and function in vivo pre-clinical models. In this presentation we will discuss the properties of MSC from different source tissues and how they can be used to support and improve islet graft function.

Learning outcomes:

Understanding the impact of islet transplantation on the health of patients with severe Type-1 Diabetes

Understanding the function of Mesenchymal Stromal Cells as cellular therapeutics, including the challenges of GMP manufacturing

In vivo models of human islet transplantation – what can be learned and what are the limitations

Measuring the improvement in transplant function when co-transplanted with cellular therapeutics

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10:05
Developing Cell Therapies for Diabetes
 
Mark Zimmerman
Vice President, Strategy and Business Development
ViaCyte
About Speaker: Mark Zimmerman received his bachelors in Biology from Syracuse University and his masters and doctorate in Biomedical Engineering from Rutgers University. Mark joined UMD-New Jersey Medical School as an Assistant Professor in 1986 and left in 1996 as... Read Full Bio 
 
 
Mark Zimmerman
Vice President, Strategy and Business Development
ViaCyte
 
About Speaker:

Mark Zimmerman received his bachelors in Biology from Syracuse University and his masters and doctorate in Biomedical Engineering from Rutgers University. Mark joined UMD-New Jersey Medical School as an Assistant Professor in 1986 and left in 1996 as an Associate Professor of Surgery with tenure. His research interests spanned musculoskeletal tissue engineering, sports medicine, trauma, and spine biomechanics and biomaterials.

Mark joined Johnson and Johnson in 1997 as a principal scientist/group leader and transitioned into regenerative medicine projects related to orthopaedic surgery, wound healing, vascular biology, and diabetes. Mark was appointed executive director of a Lifescan incubator, BetaLogics, in July 2002. BetaLogics transitioned to a Johnson and Johnson Internal Venture in 2004. The mission of BetaLogics was to discover and develop a cellular product to treat diabetes. Mark was appointed Venture Leader/Vice President of BetaLogics, a business unit of Janssen R&D LLC in 2009. Janssen completed a business transaction with ViaCyte in 2015 and merged the assets of BetaLogics into ViaCyte. Mark is currently seconded to ViaCyte and serves as the Vice President of Strategy and Business Development.

 
Abstract: ViaCyte’s product candidates are based on the directed differentiation of pancreatic progenitor cells from human pluripotent stem cells. These pa...Read More 

ViaCyte’s product candidates are based on the directed differentiation of pancreatic progenitor cells from human pluripotent stem cells. These pancreatic progenitor cells are implanted in a durable and retrievable encapsulation device. Once implanted, these cells are designed to further mature to the pancreatic endocrine cells, including beta cells, which secrete insulin and other regulatory factors in response to blood glucose levels. ViaCyte has two products in development. The PEC-Direct™ product candidate delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients that have severe hypoglycemic episodes, extreme glycemic lability, and/or impaired hypoglycemia awareness. The PEC-Encap™ (also known as VC-01) product candidate delivers pancreatic progenitor cells in an immunoprotective device and is currently being evaluated in a Phase 1/2 trial in patients with type 1 diabetes who have minimal to no insulin-producing beta cell function. This presentation will describe first-hand experience with the challenges and progress in developing pluripotent stem cell-derived products, including manufacturing and quality control, methods of delivery, clinical trials, and market opportunities.

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10:30
Morning Networking Break
12:30
Lunch Provided by GTCbio