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Diabetes Summit

2018-04-192018-02-272018-01-19
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Day 1 - Monday, April 9, 2018
4:00
Registration Opens
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5:00
Opening Remarks by GTCbio
1
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5:10
Program Preview:
Alan Cherrington
Alan Cherrington
Professor of Molecular Physiology and Biophysics
Vanderbilt University
 
Alan Cherrington
Alan Cherrington
Professor of Molecular Physiology and Biophysics
Vanderbilt University
 
About Speaker:

Over the past 44 years Dr. Cherrington has carried out important metabolic research using the conscious dog as a model. During that period he, his colleagues and trainees developed an array of unique surgical approaches (trans-hepatic, renal, gut, head, limb cannulation, 3rd ventricle cannulation, liver and renal denervation, carotid body resection, adrenalectomy, pancreatectomy and duodenal bypass) which when combined with clamping (hormone, metabolite) techniques have allowed the performance of experiments not possible anywhere else in the world. Using the dog, which has high translation value to the human, the Cherrington lab can measure whole body metabolism at the same time as organ balance and molecular signaling (using biopsies). In addition they developed a model of T1DM using alloxan, as well as a model of T2DM using diet manipulation. Using this array of techniques and models the Cherrington lab has assessed the way in which hormones, neural mediators, and metabolites interact to control hepatic glucose production (glycogenolysis/gluconeogenesis) and liver glucose uptake (and storage) in the conscious dog. Their work has resulted in almost 300 peer reviewed papers, as well as 87 review articles. It has been recognized with numerous honors including the Lilly and the Banting Awards for research from the ADA and the Rumbough Award for research from the JDRF.

About twelve years ago Dr. Cherrington decided to devote a significant portion of his research effort to helping expedite drug discovery and device development within the pharmaceutical sector. He set up a structure that provided four opportunities for interaction with pharma and bio-tech partners, 1) consulting, 2) direct help with experiments at a given pharma site, 3) contract research within Vanderbilt and lastly 4) contract research with a 3rd party CRO. This menu of services was based on his many years of experience in the field, as well as the ability to carry out unique proof of concept studies utilizing his conscious dog models. He has now worked with a majority of the major pharmaceutical companies (Merck, Novo Nordisk, Eli Lilly, Sanofi, GlaxoSmithKline, Bristol Myers Squib, Hoffman LaRoche, Biocon, Pfizer, Gilead, Boehringer Ingelheim, Boston Scientific, Abbott, Amylin, Takeda, Tanabe) and many small bio-techs (Abvance, Calibr, Fractyl, Galvani, Metavention, NuSirt, Sensulin, Metabasis, Inhale Therapeutics, Silver Lake, Thermalin, Thetis, VTv Therapeutics, Viacyte, Viking, Zafgen, NGM, OSI). The work performed in Cherrington’s lab was often important in shaping the direction of internal programs and in establishing the credibility of a particular approach both within and without the company. Many of the study outcomes have now been published in peer reviewed journals. Of particular note is the work carried out to investigate novel insulin analogues (Biocon – oral insulin; Novo Nordisk – hepatic-preferential insulin; Eli Lilly – hepatopreferential insulin; Thermalin – ultra rapid insulin; Pfizer – inhaled insulin; Merck – glucose responsive insulin). Likewise, work with GLP-1 (Amylin), incretin mimetics (Amylin) and DPPIV (BMS) inhibitors helped advance that class of compounds. More recently the lab has been working in the electroceutical field (Boston Scientific, Galvani, and Metavention) to establish the feasibility of using nerve stimulation or blockade to alter metabolic regulation in vivo. Finally, it should be noted that Dr. Cherrington’s lab has also carried out studies focused on SGLT-2 inhibitors, 11betaHSD 1 blockers, glucagon receptor antagonists, as well as glucokinase activators. It is worth noting that his collaborations are international, such that he has worked with companies around the world including those based in the USA, Germany, France, Denmark, Japan, Switzerland and India. By offering his expertise and unique models to others he has provided important input into decision making within the pharmaceutical and bio-tech world.

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Focus Group Discussions – Part I (Challenges and Opportunities)

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5:30
Focus Group: Assessing Role of HbA1c in Diabetes Drug Development
Jane  Chiang
Jane Chiang
Chief Medicial Officer
Diasome Pharmaceuticals
 
Jane  Chiang
Jane Chiang
Chief Medicial Officer
Diasome Pharmaceuticals
 
About Speaker:
Focus Group: Manufacturing & Regulatory Landscape for Cell Therapy in Diabetes
Felicia Pagliuca
Felicia Pagliuca
Vice President, Cell Biology R&D
Semma Therapeutics
 
Felicia Pagliuca
Felicia Pagliuca
Vice President, Cell Biology R&D
Semma Therapeutics
 
About Speaker:

Dr. Pagliuca is scientific co-founder of Semma and currently serves as Vice President of Cell Biology R&D. She leads internal R&D efforts focused on Semma's stem cell technologies, including research/discovery, process development, manufacturing, and preclinical testing.  Dr. Pagliuca also works closely with Semma’s CEO on corporate development and overall strategy. Previously, Dr. Pagliuca was a postdoctoral fellow in Professor Doug Melton’s laboratory at the Harvard Stem Cell Institute, where she was part of the team that discovered how to generate stem cell derived beta cells and published a seminal paper in Cell - named a top ten scientific breakthrough in 2014.  She is an expert in stem cell biology and diabetes and one of the inventors of Semma Therapeutics’ key technologies.  Dr. Pagliuca received a B.S. from Duke University and a Ph.D. from Cambridge University where she was a Marshall Scholar. She was previously Director of Technology and Corporate Development at Semma, and is currently on leave from Harvard Business School where she was a Kaplan Fellow.

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6:30
Day 1 Concludes
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Day 2 - Tuesday, April 10, 2018
 
Drug Discovery & Development for Diabetes
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7:30
Hot Breakfast & Registration
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9:50
Morning Networking Break
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Type I Diabetes – Preclinical and Clinical Development
Moderator: Denise Faustman, Harvard Medical School
10:30
JDRF Strategy to Restore Immune Balance in Type 1 Diabetes
 
Julia Greenstein
Julia Greenstein
Vice President, Research Strategy
JDRF
About Speaker: Julia Greenstein is the Vice President of Research Strategy at JDRF. She has been at JDRF for over 10 years beginning in the Beta cell portfolio and serving in a variety of roles in the Cure and Prevention portfolios. Previously she was CEO of Immer... Read Full Bio 
 
 
Julia Greenstein
Julia Greenstein
Vice President, Research Strategy
JDRF
 
About Speaker:

Julia Greenstein is the Vice President of Research Strategy at JDRF. She has been at JDRF for over 10 years beginning in the Beta cell portfolio and serving in a variety of roles in the Cure and Prevention portfolios.

Previously she was CEO of Immerge BioTherapeutics, Inc., a Novartis Pharma/BioTransplant JV and has held the roles CSO at BioTransplant and VP of Discovery Research at ImmuLogic Pharmaceutical Corp.

She received her PhD in Microbiology from University of Rochester Medical School.  She did postdoctoral training at the University of Rochester Medical School and the Dana Farber Cancer Institute of Harvard Medical School and was an Assistant Professor the Dana Farber Cancer Institute. 

In addition, she serves on the Board of Directors of The Sage Colleges and is on the University of Rochester Regional Cabinet.

 
Abstract: JDRF is the largest non-governmental ...Read More 

JDRF is the largest non-governmental funder of research to Cure, Treat and Prevent Type 1 Diabetes (T1D). We work across the pipeline of drug development from discovery research to development and translation of agents that can impact people with diabetes. One area of our focus is resetting, as well as preventing, the autoimmune response to the insulin secreting Beta cell of that pancreas that is involved in the pathophysiology of T1D. We have focused on the potential to use antigen specific immune modifying approaches due to the inherent improved safety of an antigen-specific approach. Our understanding of the different stages of T1D and the immune response that is involved in T1D leads us to support evaluation of combination approaches that have the potential to eliminate effector memory populations, reestablish specific tolerance to the relevant auto-antigens and reset the T regulatory cells in the setting of T1D. Our strategy and highlights of ongoing programs will be presented.

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10:55
Humanized Mouse Models for Type 1 Diabetes Pathogenesis and Therapy
 
Michael  Brehm
Michael Brehm
Associate Professor
University of Massachusetts Medical School
About Speaker: Dr. Brehm has over 16 years experience in biomedical research with an extensive knowledge of immunological responses to infection agents and to transplantation with non-self tissues. He received his Ph.D. in 1999 from the Department of Microbiology a... Read Full Bio 
 
 
Michael  Brehm
Michael Brehm
Associate Professor
University of Massachusetts Medical School
 
About Speaker:

Dr. Brehm has over 16 years experience in biomedical research with an extensive knowledge of immunological responses to infection agents and to transplantation with non-self tissues. He received his Ph.D. in 1999 from the Department of Microbiology and Immunology at the Pennsylvania State University College of Medicine. During Dr. Brehm’s post-doctoral training at the University of Massachusetts Medical School, he investigated how sequential viral infections impact the ability of a host to generated protective immunity and how viral infections influence transplantation tolerance induced by costimulation blockade. In 2008, he joined the Diabetes Division at the University of Massachusetts Medical School to develop cutting edge mouse models that have been implanted with human cells and tissues to study human biology. Dr. Brehm is currently an Assistant Professor in the Program in Molecular Medicine at the University of Massachusetts Medical School and a member of the UMass Diabetes Center of Excellence. Dr. Brehm’s research program is focused on understanding how human effector T cells are regulated in the context of infectious disease, allo-immunity and auto-immunity. His laboratory is developing “humanized” mice to more effectively study human T cell biology. Dr. Brehm has published over 80 manuscripts and reviews and is supported by funding from the JDRF, NIH and the Helmsley Charitable Trust.

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11:20
Updates on Global Trials Using the BCG Vaccine: T1D and Other Autoimmune Diseases
 
Denise Faustman
Denise Faustman
Director of Immunobiology; Associate Professor of Medicine
Massachusetts General Hospital; Harvard Medical School
About Speaker: Denise Faustman, MD, PhD, is Director of the Immunobiology Laboratory at the Massachusetts General Hospital (MGH) and an Associate Professor of Medicine at Harvard Medical School. She currently leadd a clinical trial program investigating the potenti... Read Full Bio 
 
 
Denise Faustman
Denise Faustman
Director of Immunobiology; Associate Professor of Medicine
Massachusetts General Hospital; Harvard Medical School
 
About Speaker:

Denise Faustman, MD, PhD, is Director of the Immunobiology Laboratory at the Massachusetts General Hospital (MGH) and an Associate Professor of Medicine at Harvard Medical School. She currently leadd a clinical trial program investigating the potential of the BCG vaccine as a disease reversal treatment for long-standing type 1 diabetes. Her research accomplishments include the first scientific description of modifying donor tissue antigens to change their foreignness, the identification of interrupted T cell education through MHC class I, and the identification of autoimmune T cell sensitivity to TNF. For autoreactive CD8 T cell death and Treg expansion, she has identified the TNFR2 receptor and downstream signaling pathway as central.   These achievements have earned her awards including the National Institutes of Health and National Library of Medicine “Changing the Face of Medicine” Award as one of 300 American physicians (one of 35 in research) honored for seminal scientific achievements in the United States, the Oprah Achievement Award for “Top Health Breakthrough by a Female Scientist,” , election into the National Academy of Inventors, and the Women in Science Award from the American Medical Women’s Association and Wyeth Pharmaceutical Company.  Dr. Faustman’s research has been highlighted in publications including Science, Nature, The Wall Street Journal, The New York Times, Los Angeles Times, The London Financial Times and Scientific American.

 

 
Abstract: BCG is a 100 year old vaccine origina...Read More 

BCG is a 100 year old vaccine originally developed as a vaccine for tuberculosis and even today represents the most commonly  administered vaccine yearly with over 100,000,000 doses/year. There are now over 10 global clinical trials repurposing the BCG vaccine as a possible therapy for a wide range of autoimmune diseases such as type 1 diabetes and multiple sclerosis, allergic conditions and prevention of diverse infectious diseases.   Our Phase II trials multi-dosing BCG in long term diabetics to lower HbA1c is based on the ability of BCg to rapidly reset of the epigeneitc imprint of the T-regulatory cells (Tregs) towards restored immune balance.

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11:45
Development of a Stem Cell Derived Pancreatic Islet Cell Therapy for Diabetes
 
Felicia Pagliuca
Felicia Pagliuca
Vice President, Cell Biology R&D
Semma Therapeutics
About Speaker: Dr. Pagliuca is scientific co-founder of Semma and currently serves as Vice President of Cell Biology R&D. She leads internal R&D efforts focused on Semma's stem cell technologies, including research/discovery, process development, manufactur... Read Full Bio 
 
 
Felicia Pagliuca
Felicia Pagliuca
Vice President, Cell Biology R&D
Semma Therapeutics
 
About Speaker:

Dr. Pagliuca is scientific co-founder of Semma and currently serves as Vice President of Cell Biology R&D. She leads internal R&D efforts focused on Semma's stem cell technologies, including research/discovery, process development, manufacturing, and preclinical testing.  Dr. Pagliuca also works closely with Semma’s CEO on corporate development and overall strategy. Previously, Dr. Pagliuca was a postdoctoral fellow in Professor Doug Melton’s laboratory at the Harvard Stem Cell Institute, where she was part of the team that discovered how to generate stem cell derived beta cells and published a seminal paper in Cell - named a top ten scientific breakthrough in 2014.  She is an expert in stem cell biology and diabetes and one of the inventors of Semma Therapeutics’ key technologies.  Dr. Pagliuca received a B.S. from Duke University and a Ph.D. from Cambridge University where she was a Marshall Scholar. She was previously Director of Technology and Corporate Development at Semma, and is currently on leave from Harvard Business School where she was a Kaplan Fellow.

 
Abstract: Semma Therapeutics is a preclinical s...Read More 

Semma Therapeutics is a preclinical stage biotechnology company with the mission to transform the treatment of diabetes through development of stem cell derived pancreatic islets, including insulin-producing beta cells, to be used as a cell replacement therapy.   Diabetes results from the dysfunction and/or destruction of the insulin-producing beta cells in the pancreatic islet.  The development of replacement sources of beta cells, combined with effective methods of delivery back into the patient’s body, has the potential to “cure” the disease.  Recent breakthroughs have enabled the virtually unlimited production of replacement beta cells through pluripotent stem cell differentiation.  At Semma, we are focused on further optimization and innovation in differentiation technologies, manufacturing scale-up, and characterization of stem cell derived islets in preclinical studies in order to move into clinical trials.  In parallel, we are engineering innovative encapsulation solutions, using novel materials and device configurations, to solve the challenge of delivering and protecting these therapeutics from immune destruction. 

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12:10
Therapeutic Efficacy of Antidiabetic Drugs in the Diabetic Miniature Swine: A Rationale For Comparative Clinical Trials Modeling in a Translational Animal Model
 
Alain Stricker-Krongrad
Alain Stricker-Krongrad
Chief Scientific Officer
Sinclair Research Center
About Speaker: Alain Stricker-Krongrad is Chief Scientific Officer at Sinclair Research. Alain was previously Chief Scientific Officer and Senior Scientific Adviser at Charles River Laboratories. Alain has managed pharmacokinetics, efficacy and safety departments f... Read Full Bio 
 
 
Alain Stricker-Krongrad
Alain Stricker-Krongrad
Chief Scientific Officer
Sinclair Research Center
 
About Speaker:

Alain Stricker-Krongrad is Chief Scientific Officer at Sinclair Research. Alain was previously Chief Scientific Officer and Senior Scientific Adviser at Charles River Laboratories. Alain has managed pharmacokinetics, efficacy and safety departments for multiple disease indications within Charles River Laboratories, Millennium Pharmaceuticals in the U.S., and Novartis Headquarters and Ciba-Geigy in Switzerland. Alain received his License, Master and Ph.D. degrees from the University of Nancy, France. He conducted his doctoral and post-doctoral research on preclinical and clinical drug evaluation at the National Institute of Scientific and Medical Research (INSERM) for which he has received two international awards for distinguished research. Alain has received accreditations from the National List of Qualifications in both Pharmaceutical Sciences and Pharmacology (France), and is Adjunct Professor of Pharmacology at the Massachusetts College of Pharmacy. He is an elected Member of the American College of Clinical Pharmacology and a member of the American College of Toxicology. Alain has published more than 70 peer-reviewed articles and brings a wealth of expertise in preclinical and early clinical drug efficacy and safety evaluation.

 
Abstract: The major goals of Phase I and Phase ...Read More 

The major goals of Phase I and Phase III human clinical trials for new antidiabetic therapeutic entities (NCEs) are the evaluation of their potency, pharmacokinetic/pharmacodynamic and therapeutic efficacy. In contrast, the major objective of animal models of diabetes is to be able to translate their clinical pharmacology and therapeutic efficacy to human in order to identify clinical trials candidates (drug development selection) or to model clinical trials to improve the prediction of study outcomes (comparative clinical trial modeling).

Therefore the identification and characterization of animal models of diabetes having a high translational value has become more and more important at a time when the severe limitations of the rodent models have been fully recognized[1].

To this extend, we investigated the biopotency, pharmacology and efficacy of different antidiabetic therapeutics in the miniature swine. We evaluated different insulin analogues, insulin secretagogues and glucose homeostasis modifiers in type 1 diabetic miniature swine, in comparison to human clinical trials data generated prior to (retrospective comparative) and after (prospective comparative) the conduct of the animal trials.

Yucatan miniature swine (Sus scrofa) were made diabetic and regulated on insulin. Animals were considered diabetic if they became hyperglycemic (≥150 mg/dL) within 2-5 days following induction. Prototypical and new insulin products were administered at mealtime, then blood glucose profiles recorded using handheld glucometer devices (One Touch Ultra®, Lifescan). The blood glucose kinetic (BGPK) and the blood glucose area under the curve (BGAUC) were used to assess biopotency in the diabetic miniature swine.   

Our data indicate that the biopotency and efficacy of insulin products can be assessed using BGAUC in the miniature swine, and that only the type 1 diabetic miniature swine can discriminate between differences in efficacy for all aspects of the BGPK. In conclusion, our data support the role of the miniature swine to model the human clinical pharmacology and therapeutic efficacy of antidiabetic medications in drug development selection trial and in comparative clinical trial modeling.

[1] Atkinson MA. 2011. Evaluating preclinical efficacy. Sci. Transl. Med. 3:96-22

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12:25
Lunch Workshop
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Lunch Workshop Presentation
Moderator: GTCbio
12:45
Implications of Continuous Glucose Monitoring in Diabetes Research and Patient Management
 
Judith Gorski
Judith Gorski
Senior Director, CVMD and Inflammation Business Unit and Scientific Engagement
Crown Bioscience
About Speaker: Dr. Judith Gorski is Global Director of Scientific Engagement at Crown Bioscience Inc., and is a pharmacologist with over 18 years of experience in drug discovery and development in a large pharmaceutical environment.  She has extensive experience i... Read Full Bio 
 
 
Judith Gorski
Judith Gorski
Senior Director, CVMD and Inflammation Business Unit and Scientific Engagement
Crown Bioscience
 
About Speaker:

Dr. Judith Gorski is Global Director of Scientific Engagement at Crown Bioscience Inc., and is a pharmacologist with over 18 years of experience in drug discovery and development in a large pharmaceutical environment.  She has extensive experience in basic research and targeted drug discovery in the disease areas of type 1 and 2 diabetes, dyslipidemia, atherosclerosis, obesity, and metabolic syndrome.  Dr. Gorski has co-authored publications in Nature, Obesity, Obesity Research, Cell Metabolism, Journal of Lipid Metabolism.

Prior to joining CrownBio, Dr. Gorski’s work at Merck focused on target identification/validation and small molecule and biologics identification/optimization with the aim of recommending lead candidates for clinical development. Her primary responsibilities were to establish and validate appropriate primary, secondary and tertiary in vivo models of dyslipidemia, obesity, metabolic syndrome, and type 1 and 2 diabetes. In addition to preclinical work, Dr. Gorski has been a member of early development teams to move lead candidates into development and has collaborated across an array of disciplines, including drug safety and metabolism, pharmaceutical sciences, early clinical development, medical affairs, regulatory affairs, and commercial development.

Dr. Gorski received her Ph.D. in Neuroscience from University of Medicine and Dentistry, New Jersey.

 
Abstract: Diabetes is a world prevailing threat...Read More 

Diabetes is a world prevailing threat to human health. The paramount goal of diabetic therapy is to maintain normoglycemia. Key to improve glycemic control is the ability to track body glucose level rapidly and accurately. In comparison to classical single glucose measurement, continuous glucose monitoring (CGM) enables frequent sensing of body glucose. Timely knowing glucose level helps patients and clinicians to manage diabetes, including decisions on diet, physical activity, stress management and medication. CGM sensor placed in blood vessel provides very fast (real-time) information about blood glucose level. Indwelling intravascular device is a less acceptable safety profile in humans, but has several advantages in diabetic animal research. On the other hand, noninvasive transcutaneous sensing technologies have been used in many clinical trials and diabetic patients. Overall, subcutaneous glucose sensors have been significantly improved in the precision, accuracy, and usability since 1999 after FDA approval for clinical use. Recently, no user-calibration (factory calibrated) glucose sensors reduce the hassle, painful and cost and are clinically favorable to diabetic care users. CGM transmitter securely sends out vital glucose information for real-time diabetes management without pricking finger, which is making diabetes management more convenient and flexible than ever before. CGM can avoid missing data points due to infrequent glucometer readings or blood samplings. In fact, clinical trials showed CGM resulted in better glycemic control and lower HbA1c compared with conventional glucose tests. CGM is the only technology that can measure hyperglycemic and hypoglycemic exposure in ambulatory care, or provide data for comprehensive assessment of glucose variability. Prevention of hypoglycemia is important not only for diabetic patients but also for other associated disorders that may cause hypoglycemia such as adrenal insufficiency, glycogen storage disorders, and cystic fibrosis. CGM is also a useful tool for clinical evaluation of new glucose-lowering medications and strategies. We therefore summarize the current status and limitations of CGM from the perspective of both clinical use and research. We also present the data collected from the studies using both vascular and subcutaneous glucose sensor technologies in diabetic research. The fast development of new CGM devices will gradually displace single glucose measurements and help to reduce the risk of complications and improve quality of life in patients with diabetes.

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Type II Diabetes – Preclinical and Clinical Development
Moderator: Donald Scott, Icahn School of Medicine
1:50
Untapped Potential of the DASH Family of Post Proline Cleaving Enzymes as Targets for Diabetes
 
William Bachovchin
William Bachovchin
Professor, Department of Biochemistry
Tufts University School of Medicine
About Speaker: Dr Bachovchin received a BS degree in Biology from Wake Forest University a doctoral degree in Chemistry from The California Institute of Technology, and did postdoctoral work at Harvard Medical School before arriving at Tufts.  Dr. Bachovchin is an... Read Full Bio 
 
 
William Bachovchin
William Bachovchin
Professor, Department of Biochemistry
Tufts University School of Medicine
 
About Speaker:

Dr Bachovchin received a BS degree in Biology from Wake Forest University a doctoral degree in Chemistry from The California Institute of Technology, and did postdoctoral work at Harvard Medical School before arriving at Tufts.  Dr. Bachovchin is an author on more than 100 peer reviewed journal articles, and an inventor on more than 40 issued US patents as well as numerous pending applications.  Dr. Bachovchin is a leader in the areas of NMR spectroscopy, enzymes mechanisms and drug design and discovery, especially in areas pertaining to the post proline cleaving family of enzymes.  To date three drugs designed by Dr. Bachovchin have entered human clinical trials and several more are in late stage preclinical testing.  Dr. Bachovchin has founded a several biotechnology companies. These include Point Therapeutic, Arisaph Pharmaceuticals, Bach Biosciences, and IOzyme. He is also Professor of Biochemistry at Tufts University School of Medicine.

 
Abstract: The DASH family of proteases include ...Read More 

The DASH family of proteases include DPP4, FAP, DPP8/9, PREP and DPP2.  DPP4 is now a validated target for the treatment of diabetes owing to its role in degrading GLP-1.  Approved drugs now on the market targeting DPP4 include for example sitagliptin, linagliptin and saxagliptin. FAP is closely related to DPP4 in structure and specificity and even resembles DPP4 in ability to cleave GLP-1, but this activity does not seem to be as biologically significant for FAP as for DPP4, most likely because FAP occurs in much lower amounts and with different expression profile than DPP4.   FAP has nevertheless been implicated as a potential new diabetes target as it has been reported to limit the lifetime of FGF21 and an FAP KO mouse has been reported to have improved glucose tolerance, resistance to diet induced obesity and resistance to dyslipidemia.  Most recently, DPP8/9 have also been implicated as potential targets as inhibiting these enzymes has been demonstrated to activate the NLRP1 inflammasome, and mice with an activating mutation in NLRP1 have been shown to be resistant to obesity and to diet induced metabolic dysfunction via an IL-18 mediated mechanism.   That the DASH family of enzymes may indeed have untapped potential for new anti diabetics is supported by the fact that pan DASH inhibitors appear to significantly outperform DPP4 specific inhibitors with respect to anti diabetic activities in preclinical models. This talk will review and critically evaluate the evidence for FAP and DPP8/9 as targets and the therapeutic potential of pan-Dash inhibitors for the treatment of diabetes.  

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2:15
Clinical Utility of Energy-Sensing Targets for Diabetes & Metabolic Syndrome
 
Michael Zemel
Michael Zemel
Founder and Chief Scientific Officer
Nusirt
About Speaker: Michael Zemel received his PhD in Physiology and Nutrition at the University of Wisconsin-Madison.  He then served on the faculties of Endocrinology and of Nutrition at Wayne State University and as Research Endocrinologist at the VA Medical Center ... Read Full Bio 
 
 
Michael Zemel
Michael Zemel
Founder and Chief Scientific Officer
Nusirt
 
About Speaker:

Michael Zemel received his PhD in Physiology and Nutrition at the University of Wisconsin-Madison.  He then served on the faculties of Endocrinology and of Nutrition at Wayne State University and as Research Endocrinologist at the VA Medical Center associated with Wayne State from 1980 – 1990, where his work focused on endocrine regulation of cell calcium signaling and downstream effects on both blood pressure regulation and insulin sensitivity.  He moved to the University of Tennessee in 1990 where he served as Professor of Nutrition and of Medicine and expanded his work to focus on energy sensing, muscle-fat cross-talk and regulation of adipocyte metabolism.  Michael founded NuSirt in 2007 and left the university in 2012 to devote his full attention to the company, where he leads research programs focused on development of new therapeutics for obesity, diabetes and related co-morbidities.

 
Abstract: Current therapeutic classes for type ...Read More 

Current therapeutic classes for type 2 diabetes focus on improving insulin sensitivity, lowering glucose via renal excretion or suppression of hepatic glucose output, or indirectly or directly increasing insulin. While all provide therapeutic efficacy in lowering HbA1c, meaningful effects on the constellation of associated co-morbidities are rarely achieved. An alternative to modulators of singular endpoints is to instead focus on energy sensing systems controlling multiple endpoints to address not only diabetes, but also its fellow travelers in the metabolic syndrome. This presentation addresses energy-sensing systems, primarily sirtuins, as therapeutic targets with pleiotropic effects impacting multiple metabolic endpoints.

• Sirt1 as a target Experimental data Approaches to target activation Clinical support in diabetes and metabolic endpoints?
• Relationship to other energy-sensors? Other sirtuins AMPK mTOR

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2:40
The Role of Device-based Intervention in Metabolic Disease: The How, What and Why
 
David  Maggs
David Maggs
Chief Medical Officer
Fractyl Laboratories
About Speaker: David is Chief Medical Officer of Fractyl.  David is a board certified endocrinologist and most recently served as Chief Medical Officer of GI Dynamics.  Previously, David spent more than a decade at Amylin Pharmaceuticals where he held positions o... Read Full Bio 
 
 
David  Maggs
David Maggs
Chief Medical Officer
Fractyl Laboratories
 
About Speaker:

David is Chief Medical Officer of Fractyl.  David is a board certified endocrinologist and most recently served as Chief Medical Officer of GI Dynamics.  Previously, David spent more than a decade at Amylin Pharmaceuticals where he held positions of increasing responsibility, led numerous innovative collaborations and was directly engaged with the global diabetes and endocrine community.  David served as Amylin’s vice president, medical research and development, where he was integral to the development and commercialization of all three of the company’s marketed drugs – Symlin(R), Bydureon(R) and Byetta(R), the first amylin and GLP-1 receptor agonists respectively approved by the U.S. Food and Drug Administration for the treatment of diabetes. Prior to his Amylin tenure, David served as director, diabetes and metabolism, for Parke-Davis (now Pfizer). Previously, he held faculty appointments at the Yale School of Medicine. David initially trained at Guy’s Hospital, London, and later completed his medical and endocrine training at the University of Nottingham.

 
Abstract: Diabetes is becoming the major scourg...Read More 

Diabetes is becoming the major scourge of modern society and it has been treated for the last century with an expanding list of pharmacological modalities geared to reduce glycemic burden and/or to leverage endocrine systems and pathways. In recent years, bariatric surgery has illuminated the gastro-intestinal tract as a powerful endocrine organ, and surgical manipulation of the gut results in metabolic and systemic effects that far surpass those exerted by pharmacological treatments. This has raised interest in the gut as an endocrine organ, and whether the gut harbors key molecular signals or targets responsible for its effects, and whether bariatric-like metabolic benefits may be elicited by new pharmacological or device-based treatments. The future treatment of metabolic disease will likely require combinations of pharmacological, surgical and device based approaches, leveraging the enormous potential of the gastro-intestinal tract.

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3:05
Translational PKPD: Empowering Early Drug Development
 
Maria  Trujillo
Maria Trujillo
Principal Scientist, Quantitative Pharmacology and Pharmacometrics
Merck & Co.
About Speaker: Born in New York City. Maria received her PhD from Rutgers University studying human adipose tissue metabolism and endocrine function with Susan Fried followed by a post doc at the Diabetes Research Training Center at Albert Einstein College of Medic... Read Full Bio 
 
 
Maria  Trujillo
Maria Trujillo
Principal Scientist, Quantitative Pharmacology and Pharmacometrics
Merck & Co.
 
About Speaker:

Born in New York City. Maria received her PhD from Rutgers University studying human adipose tissue metabolism and endocrine function with Susan Fried followed by a post doc at the Diabetes Research Training Center at Albert Einstein College of Medicine in Philipp Scherer's lab. In 2006 Maria joined Merck to support projects in the Cardiometabolic Therapeutic Area as an in vivo pharmacologist. Today Maria is a Principal Scientist in the department of Quantitative Pharmacology and Phamacometrics supporting projects from drug discovery through development.

 
Abstract: Predicting accurate therapeutic expos...Read More 

Predicting accurate therapeutic exposures from preclinical data is challenging. To aid clinical development, translational PKPD approaches to advance our understanding of exposure response and translation across species can be employed. This process incorporates preclinical in vitro and in vivo data as well as clinical data to predict clinical outcomes. Preclinical in vivo models supporting this effort must evolve to elaborate on dose response and time course data. In Type 2 diabetes, preclinical models must measure biologically relevant endpoints and facilitate HBA1C predictions to inform dose selection as the program proceeds to Phase 2b. TPKPD efforts of this nature are an innovative approach that improves confidence in the translation of compound properties into the clinic for drug development. Ongoing efforts to expand TPKPD to programs throughout the Merck pipeline aim to improve the success of development teams.

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3:30
Lessons From Studying Glucose-responsive Transcription Factors in Beta Cells
 
Donald Scott
Donald Scott
Professor in the Division of Endocrinology, Diabetes and Bone Disease
Icahn School of Medicine at Mount Sinai
About Speaker: Donald K Scott is a professor of Medicine in the Diabetes Obesity and Metabolism Institute at Icahn School of Medicine at Mount Sinai in New York.  He studies nutrient regulation of gene expression, focusing on mechanisms by which metabolism activat... Read Full Bio 
 
 
Donald Scott
Donald Scott
Professor in the Division of Endocrinology, Diabetes and Bone Disease
Icahn School of Medicine at Mount Sinai
 
About Speaker:

Donald K Scott is a professor of Medicine in the Diabetes Obesity and Metabolism Institute at Icahn School of Medicine at Mount Sinai in New York.  He studies nutrient regulation of gene expression, focusing on mechanisms by which metabolism activates transcriptions factors leading to altered phenotypes that impact glucose homeostasis and diabetes.  Dr. Scott received his PhD from Saint Louis University in 1992.  He trained with Dr. Daryl Granner at Vanderbilt University as a Post-Doc.  He has been a principal investigator at LSU New Orleans, University of Pittsburgh, and most recently moved Mount Sinai in New York in 2012.

 

 
Abstract: Patients with T2D would benefit from ...Read More 

Patients with T2D would benefit from therapies that increase beta cell mass.  Glucose is a natural mitogen that drives adaptive β-cell mass expansion by promoting proliferation. We found that carbohydrate response element binding protein (ChREBP) is necessary for glucose-stimulated beta cell proliferation.  In addition, overexpression of ChREBP leads to an astonishing augmentation of glucose-stimulated beta cell proliferation.  We explored the mechanisms for this effect and found that in addition to strikingly large and active mitochondria, and an augmented anabolic metabolic response; the antioxidant Nrf2 pathway is activated in response to ChREBP overexpression.  Depletion of Nrf2 blocks natural glucose stimulated as well as the ChREBP-augmented beta cell proliferation.  Importantly, we found that adenovirally delivered Nrf2 can drive human beta cell proliferation independent of increased glucose metabolism.  To test if activation of the Nrf2 pathway is necessary for adaptive β-cell expansion in vivo, we used pharmacological inhibitors and activators of Nrf2. Mice were placed on a high fat diet (HFD) or standard chow diet (SD) for 7 days and treated with vehicle or brusatol, which depletes Nrf2 by a post-translational mechanism.  Brusatol treatment ameliorated the increased β-cell proliferation normally seen with a one-week HFD. Brusatol-treated mice also displayed significantly diminished glucose tolerance on a HFD by IPGTT, without altering the food intake or weight of the animals.  Using an activator of Nrf2, bardoxolone methyl (CDDO-Me), for 7 days in the presence of HFD, we found improved glycemic levels and decreased body weight, consistent with previous reports.  Remarkably, CDDO-Me treatment increased β-cell proliferation in mice fed a SD. Crucially, in human β-cells, brusatol inhibited glucose-stimulated proliferation and CDDO-Me increased proliferation in low glucose. Thus, we conclude that the Nrf2 pathway is an exciting novel target for manipulation of β-cell proliferation in vivo.

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3:55
Afternoon Networking Break
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Devices and Digital Aids in Diabetes Management
Moderator: Jane Chiang, Diasome Pharmaceuticals
4:25
mySugr - Stay Smart and Get Out of The Way
 
Scott Johnson
Scott Johnson
Patient Engagement Manager, USA
mySugr GmbH
About Speaker: Scott is an experienced patient advocate. He works with a wide range of stakeholders across the healthcare environment to help them establish effective communication with the patient community. His expertise in the diabetes social media space is reco... Read Full Bio 
 
 
Scott Johnson
Scott Johnson
Patient Engagement Manager, USA
mySugr GmbH
 
About Speaker:

Scott is an experienced patient advocate. He works with a wide range of stakeholders across the healthcare environment to help them establish effective communication with the patient community. His expertise in the diabetes social media space is recognized worldwide and he advises organizations within the healthcare, food, and consumer goods industries.

Today he is Patient Engagment Manager, USA for mySugr and manages a long-standing and award-winning blog “Scott's Diabetes” that reaches hundreds of thousands of people annually.

Scott is also a member of the Children with Diabetes faculty where he develops educational curriculums and content for the Friends for Life annual conference and regional events. He is on the Board of Directors for the Diabetes Community Advocacy Foundation, and is a founding member of Partnering for Diabetes Change, a coalition of people living with diabetes and industry representatives working to support underserved communities. He is interested in how these types of interactions including peer-to-peer support impact patient outcomes and routinely presents his work.

 
Abstract: Learn how mySugr creates smart intera...Read More 

Learn how mySugr creates smart interactions through the user journey by personalizing partnerships and finding ways to reduce engagement while improving outcomes. 

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4:50
Why Digital Behaviour Change is so Powerful When Combined with Real Human Relationships
 
Carl Brandt
Carl J. Brandt
Co-founder & Medical Director
Liva Healthcare
About Speaker: Medical director and co-founder of Liva Healthcare, Dr Carl Brandt is a GP, a research fellow and an entrepreneur. He was one of the co-founders of NetDoctor and has worked on medical solutions to empower patients on the internet for over 15 years. ... Read Full Bio 
 
 
Carl Brandt
Carl J. Brandt
Co-founder & Medical Director
Liva Healthcare
 
About Speaker:

Medical director and co-founder of Liva Healthcare, Dr Carl Brandt is a GP, a research fellow and an entrepreneur. He was one of the co-founders of NetDoctor and has worked on medical solutions to empower patients on the internet for over 15 years. He has founded a number of health services for the internet including NetDoctor, SlankeDoktor.dk, AsktheDoctor24 and most recently Liva Healthcare. He is a research fellow at the University of Southern Denmark and currently works with implementation of online solutions for direct patient communication and lifestyle change. He has undertaken a number of research projects looking at the effectiveness of online digital interventions to help people with their health.

 
Abstract: Innovative Danish-British Liva Health...Read More 

Innovative Danish-British Liva Healthcare was selected by NHS England for the digital stream of its ambitious Healthier You: Diabetes Prevention Programme pilot. The co-founder and medical director of Liva, whose co-founding team also co-founded NetDoctor.co.uk, shares his insights into why 140,000 patients so far have gained great results from their platform interventions driving long term lifestyle changes and disease management.

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5:15
Update on Automated Glucose Control with the Bionic Pancreas
 
Steven Russell
Steven Russell
Associate Professor of Medicine
Harvard Medical School
About Speaker: Dr. Russell is an Associate Professor of Medicine at Harvard Medical School and an Attending Physician at Massachusetts General Hospital Diabetes Research Center. He completed medical and doctoral (MD/PhD) training at University of Texas Southwestern... Read Full Bio 
 
 
Steven Russell
Steven Russell
Associate Professor of Medicine
Harvard Medical School
 
About Speaker:

Dr. Russell is an Associate Professor of Medicine at Harvard Medical School and an Attending Physician at Massachusetts General Hospital Diabetes Research Center. He completed medical and doctoral (MD/PhD) training at University of Texas Southwestern Medical School and a residency in Internal Medicine and fellowship in Endocrinology at the Massachusetts General Hospital. He is board certified in Endocrinology, Diabetes & Metabolism.

Dr. Russell is the principal clinical investigator of a collaboration between Massachusetts General Hospital and Boston University to develop a wearable bionic pancreas systems for automated glycemic management in people with diabetes mellitus. Dr. Russell’s other projects include evaluation of continuous glucose monitoring technology, methods for automated management of glucose in hospitalized patients, investigations of methods to improve insulin pharmacokinetics, investigations of stable formulations of glucagon, and development of a device for minimally invasive continuous insulin monitoring.

Dr. Russell’s research has been supported by the National Institutes of Health (NIH), The Leona M. and Harry B. Helmsley Charitable Trust, the Banting Foundation, the American Diabetes Association, and the Juvenile Diabetes Research Foundation.

 
Abstract: Artificial pancreas systems combine a...Read More 

Artificial pancreas systems combine a continuous glucose monitor, mathematical algorithms, and drug delivery pumps to automatically regulate blood glucose levels for patients with diabetes mellitus. Most artificial pancreas systems partially automate delivery of insulin, and most require the user to count carbohydrates for the determination of meal boluses. The only system cleared for sale, the Medtronic 670G, is a “hybrid” system in that it automatically adjusts basal insulin within limits and suspends insulin delivery when hypoglycemia is predicted, but requires the user to calculate meal boluses and enter plasma glucose values before correction boluses are delivered. A few systems partially or completely automate delivery of both insulin and glucagon. Improvements in the quality of glucose management have been demonstrated with both classes of systems.

Our bionic pancreas system can operate in bihormonal mode, delivering both insulin and glucagon, or in an insulin-only mode, under the control of autonomously adaptive algorithms that require no information about the patient other than body weight to start, and can quickly adapt to changing insulin needs. No carbohydrate counting is required, and qualitative meal announcements are optional. If continuous glucose monitoring is interrupted, intermittent glucose measurements can be substituted until continuous monitoring is reestablished. The bi-hormonal bionic pancreas system has achieved superior blood glucose control vs. usual care with minimal hypoglycemia in volunteers with type 1 diabetes ranging in age from 6 to 76 years in unrestricted outpatient settings for periods of up to 11 days. The bionic pancreas can also operate in the insulin-only mode. The outcomes in the insulin-only mode are markedly superior to those of usual care, but the bihormonal bionic pancreas achieved lower mean glucose values and lower hypoglycemia as compared to an insulin-only version of bionic pancreas and usual care. Study participants expressed greater satisfaction the bihormonal system to the insulin-only version, although they also preferred the insulin-only version to their usual care. Equally important to the glycemic outcomes, the bionic pancreas drastically reduced the burden of diabetes management, and subjects were highly satisfied with the bionic pancreas.

The first studies of the bionic pancreas using the iLet platform, a fully integrated, purpose-built device that incorporates a CGM receiver, a touchscreen user interface, control algorithms, and a dual chamber pump that connects to a dual infusion set, will take place in 2018. A pivotal trial with an insulin-only configuration of the bionic pancreas will begin in early 2019 and a pivotal trial with the bihormonal configuration will begin in middle 2019 when the regulatory requirements for use of a stable glucagon formulation in the pivotal trial will have been met.

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5:40
Networking Reception & Poster Session
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Day 3 - Wednesday, April 11, 2018
 
Funding, Partnering and Commercialization of Diabetes Technologies
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7:00
Hot Breakfast
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Focus Group Discussions – Part II (Solutions & Action Items)

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7:15
Focus Group: Assessing Role of HbA1c in Diabetes Drug Development
Jane  Chiang
Jane Chiang
Chief Medicial Officer
Diasome Pharmaceuticals
 
Jane  Chiang
Jane Chiang
Chief Medicial Officer
Diasome Pharmaceuticals
 
About Speaker:
Focus Group: Manufacturing & Regulatory Landscape for Cell Therapy in Diabetes
Felicia Pagliuca
Felicia Pagliuca
Vice President, Cell Biology R&D
Semma Therapeutics
 
Felicia Pagliuca
Felicia Pagliuca
Vice President, Cell Biology R&D
Semma Therapeutics
 
About Speaker:

Dr. Pagliuca is scientific co-founder of Semma and currently serves as Vice President of Cell Biology R&D. She leads internal R&D efforts focused on Semma's stem cell technologies, including research/discovery, process development, manufacturing, and preclinical testing.  Dr. Pagliuca also works closely with Semma’s CEO on corporate development and overall strategy. Previously, Dr. Pagliuca was a postdoctoral fellow in Professor Doug Melton’s laboratory at the Harvard Stem Cell Institute, where she was part of the team that discovered how to generate stem cell derived beta cells and published a seminal paper in Cell - named a top ten scientific breakthrough in 2014.  She is an expert in stem cell biology and diabetes and one of the inventors of Semma Therapeutics’ key technologies.  Dr. Pagliuca received a B.S. from Duke University and a Ph.D. from Cambridge University where she was a Marshall Scholar. She was previously Director of Technology and Corporate Development at Semma, and is currently on leave from Harvard Business School where she was a Kaplan Fellow.

1
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Industry Partnering with Academia & CROs to Advance Diabetes Research
Moderator: Aaron Schwartz, Novo Nordisk
8:30
The Symbiotic Relationship between Industry, CROs and Academia
 
Alan Cherrington
Alan Cherrington
Professor of Molecular Physiology and Biophysics
Vanderbilt University
About Speaker: Over the past 44 years Dr. Cherrington has carried out important metabolic research using the conscious dog as a model. During that period he, his colleagues and trainees developed an array of unique surgical approaches (trans-hepatic, renal, gut, he... Read Full Bio 
 
 
Alan Cherrington
Alan Cherrington
Professor of Molecular Physiology and Biophysics
Vanderbilt University
 
About Speaker:

Over the past 44 years Dr. Cherrington has carried out important metabolic research using the conscious dog as a model. During that period he, his colleagues and trainees developed an array of unique surgical approaches (trans-hepatic, renal, gut, head, limb cannulation, 3rd ventricle cannulation, liver and renal denervation, carotid body resection, adrenalectomy, pancreatectomy and duodenal bypass) which when combined with clamping (hormone, metabolite) techniques have allowed the performance of experiments not possible anywhere else in the world. Using the dog, which has high translation value to the human, the Cherrington lab can measure whole body metabolism at the same time as organ balance and molecular signaling (using biopsies). In addition they developed a model of T1DM using alloxan, as well as a model of T2DM using diet manipulation. Using this array of techniques and models the Cherrington lab has assessed the way in which hormones, neural mediators, and metabolites interact to control hepatic glucose production (glycogenolysis/gluconeogenesis) and liver glucose uptake (and storage) in the conscious dog. Their work has resulted in almost 300 peer reviewed papers, as well as 87 review articles. It has been recognized with numerous honors including the Lilly and the Banting Awards for research from the ADA and the Rumbough Award for research from the JDRF.

About twelve years ago Dr. Cherrington decided to devote a significant portion of his research effort to helping expedite drug discovery and device development within the pharmaceutical sector. He set up a structure that provided four opportunities for interaction with pharma and bio-tech partners, 1) consulting, 2) direct help with experiments at a given pharma site, 3) contract research within Vanderbilt and lastly 4) contract research with a 3rd party CRO. This menu of services was based on his many years of experience in the field, as well as the ability to carry out unique proof of concept studies utilizing his conscious dog models. He has now worked with a majority of the major pharmaceutical companies (Merck, Novo Nordisk, Eli Lilly, Sanofi, GlaxoSmithKline, Bristol Myers Squib, Hoffman LaRoche, Biocon, Pfizer, Gilead, Boehringer Ingelheim, Boston Scientific, Abbott, Amylin, Takeda, Tanabe) and many small bio-techs (Abvance, Calibr, Fractyl, Galvani, Metavention, NuSirt, Sensulin, Metabasis, Inhale Therapeutics, Silver Lake, Thermalin, Thetis, VTv Therapeutics, Viacyte, Viking, Zafgen, NGM, OSI). The work performed in Cherrington’s lab was often important in shaping the direction of internal programs and in establishing the credibility of a particular approach both within and without the company. Many of the study outcomes have now been published in peer reviewed journals. Of particular note is the work carried out to investigate novel insulin analogues (Biocon – oral insulin; Novo Nordisk – hepatic-preferential insulin; Eli Lilly – hepatopreferential insulin; Thermalin – ultra rapid insulin; Pfizer – inhaled insulin; Merck – glucose responsive insulin). Likewise, work with GLP-1 (Amylin), incretin mimetics (Amylin) and DPPIV (BMS) inhibitors helped advance that class of compounds. More recently the lab has been working in the electroceutical field (Boston Scientific, Galvani, and Metavention) to establish the feasibility of using nerve stimulation or blockade to alter metabolic regulation in vivo. Finally, it should be noted that Dr. Cherrington’s lab has also carried out studies focused on SGLT-2 inhibitors, 11betaHSD 1 blockers, glucagon receptor antagonists, as well as glucokinase activators. It is worth noting that his collaborations are international, such that he has worked with companies around the world including those based in the USA, Germany, France, Denmark, Japan, Switzerland and India. By offering his expertise and unique models to others he has provided important input into decision making within the pharmaceutical and bio-tech world.

 
Abstract: The symbiotic interactions between in...Read More 

The symbiotic interactions between industry, CROs and academia can facilitate discovery research and accelerate the development of new therapies. By working with industry, academic labs can access new technologies and novel compounds, can obtain funding for projects of mutual interest and can increase the visibility of their research. At the same time, industry can access unique animal models and technology and can gain insight into novel targets. By collaborating with CROs in model development, academic labs can facilitate their own research while broadening the impact they have on the discovery process. At the same time, CROs can expand their portfolios to include more sophisticated-proof of concept studies.

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8:55
Partnering with Novo Nordisk
 
Aaron Schwartz
Aaron Schwartz
Director, R&D Innovation Sourcing
Novo Nordisk
About Speaker: Aaron is a Director in Novo Nordisk’s R&D Innovation Sourcing team.  In this capacity, Aaron is responsible for the search an evaluation of new therapeutics and enabling technologies for protein, peptide, and antibody drugs.  Prior to joining... Read Full Bio 
 
 
Aaron Schwartz
Aaron Schwartz
Director, R&D Innovation Sourcing
Novo Nordisk
 
About Speaker:

Aaron is a Director in Novo Nordisk’s R&D Innovation Sourcing team.  In this capacity, Aaron is responsible for the search an evaluation of new therapeutics and enabling technologies for protein, peptide, and antibody drugs.  Prior to joining Novo Nordisk, Aaron worked in the MIT Technology Licensing Office for 13.5 years.  During this time, he worked on license and sponsored research agreements with life sciences companies from startups to big biotech/pharma and everything in between.  He also managed a portfolio of over 650 technologies.  Before Aaron’s time at MIT, he was a management consultant to big pharma and a startup.  Aaron has an undergrad degree in biology from the University of Chicago and a Masters degree in biology from MIT.

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Panel: Industry Partnering with Academia & CROs to Advance Diabetes Research
Moderator: Judith Gorski, Crown Bioscience
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9:20
Moderator:
Judith Gorski
Judith Gorski
Senior Director, CVMD and Inflammation Business Unit and Scientific Engagement
Crown Bioscience
 
Judith Gorski
Judith Gorski
Senior Director, CVMD and Inflammation Business Unit and Scientific Engagement
Crown Bioscience
 
About Speaker:

Dr. Judith Gorski is Global Director of Scientific Engagement at Crown Bioscience Inc., and is a pharmacologist with over 18 years of experience in drug discovery and development in a large pharmaceutical environment.  She has extensive experience in basic research and targeted drug discovery in the disease areas of type 1 and 2 diabetes, dyslipidemia, atherosclerosis, obesity, and metabolic syndrome.  Dr. Gorski has co-authored publications in Nature, Obesity, Obesity Research, Cell Metabolism, Journal of Lipid Metabolism.

Prior to joining CrownBio, Dr. Gorski’s work at Merck focused on target identification/validation and small molecule and biologics identification/optimization with the aim of recommending lead candidates for clinical development. Her primary responsibilities were to establish and validate appropriate primary, secondary and tertiary in vivo models of dyslipidemia, obesity, metabolic syndrome, and type 1 and 2 diabetes. In addition to preclinical work, Dr. Gorski has been a member of early development teams to move lead candidates into development and has collaborated across an array of disciplines, including drug safety and metabolism, pharmaceutical sciences, early clinical development, medical affairs, regulatory affairs, and commercial development.

Dr. Gorski received her Ph.D. in Neuroscience from University of Medicine and Dentistry, New Jersey.

Panelist:
Jane  Chiang
Jane Chiang
Chief Medicial Officer
Diasome Pharmaceuticals
 
Jane  Chiang
Jane Chiang
Chief Medicial Officer
Diasome Pharmaceuticals
 
About Speaker:
Panelist:
Aaron Schwartz
Aaron Schwartz
Director, R&D Innovation Sourcing
Novo Nordisk
 
Aaron Schwartz
Aaron Schwartz
Director, R&D Innovation Sourcing
Novo Nordisk
 
About Speaker:

Aaron is a Director in Novo Nordisk’s R&D Innovation Sourcing team.  In this capacity, Aaron is responsible for the search an evaluation of new therapeutics and enabling technologies for protein, peptide, and antibody drugs.  Prior to joining Novo Nordisk, Aaron worked in the MIT Technology Licensing Office for 13.5 years.  During this time, he worked on license and sponsored research agreements with life sciences companies from startups to big biotech/pharma and everything in between.  He also managed a portfolio of over 650 technologies.  Before Aaron’s time at MIT, he was a management consultant to big pharma and a startup.  Aaron has an undergrad degree in biology from the University of Chicago and a Masters degree in biology from MIT.

Panelist:
Dennis  Guberski,
Dennis Guberski,
President & Chairman
Biomere
 
Dennis  Guberski,
Dennis Guberski,
President & Chairman
Biomere
 
About Speaker:

Dennis Guberski is a recognized expert on the development of rodent models and diabetes.  He founded Biomere as a spin-out of UMass Medical School in 1996.  His experience includes more than 20 years at the University of Massachusetts Medical School, both as a researcher and as Director of the SPF vivarium in the Department of Pathology.

A recognized expert on the development and maintenance of specialized research models including a premier system to study diabetic complications, Dennis has served as the Principal Investigator on the Type 1 Diabetes Rapid Access to Intervention Development (T1D Raid) government contract.  He has previously served as PI on numerous National Institutes of Health (NIH) contracts. Dennis was selected by NIH to participate in a taskforce to develop a National Genetic Resource Repository for laboratory rats and served as a member of the scientific review board for the NIH Autoimmune Rat Repository in Bethesda, Maryland.

Dennis received his MS in Genetics from University of Massachusetts, Amherst, MA.

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10:10
Morning Networking Break
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Funding & Commercialization of Diabetes Technologies
Moderator: Thomas Seoh, Kinexum
10:40
Is it Time For a Patient Centered Approach to Treating Diabetes and Obesity
 
Joseph Cook, Jr.
Joseph Cook, Jr.
President and Executive Chairman of the Board
Nusirt Inc.,
About Speaker: Mr. Cook is a principal and co-founder of Mountain Group Capital, Nashville, TN.  Mr. Cook serves as Executive Chairman of the Board and President of NuSirt Biopharma and a board member of Castle Biosciences, Clinical Products and Corcept Therapeuti... Read Full Bio 
 
 
Joseph Cook, Jr.
Joseph Cook, Jr.
President and Executive Chairman of the Board
Nusirt Inc.,
 
About Speaker:

Mr. Cook is a principal and co-founder of Mountain Group Capital, Nashville, TN.  Mr. Cook serves as Executive Chairman of the Board and President of NuSirt Biopharma and a board member of Castle Biosciences, Clinical Products and Corcept Therapeutics Inc. (NASDAQ: CORT).

He is also a founder and Past-Chairman of the Board of Ironwood Pharmaceuticals Inc. (NASDAQ: IRWD) a biotechnology company in Cambridge, MA where he served as a director from 1998 to 2015.  Mr. Cook served as Chairman of Amylin Pharmaceuticals Inc. (NASDAQ: AMLN) from 1998 to 2009 and was Chief Executive Officer from 1998-2003.  Mr. Cook retired as a Group Vice-President, Global Operations at Eli Lilly and Company in 1993 after more than 28 years of service.

Mr. Cook serves as Chairman of the Board of Mercy Ministries International Inc. with headquarters in Nashville, TN.  He is also a past Chair and current member of the University of Tennessee College of Engineering Advisory Board.  Mr. Cook has served on the national board of the American Diabetes Association, and is past Chairman of the Board of Life Sciences Tennessee.

Mr. Cook graduated from the University of Tennessee in 1965 where he received his BS in Engineering with High Honors and was a UT Torchbearer.

 
Abstract: Current therapies for treating diabet...Read More 

Current therapies for treating diabetes have been developed to a point where some ask: “We have the tools, why are they not producing better results?” Evaluations of drug utilization frequently report patient compliance with prescribed dose and frequency of less than 65%, with some classes exhibiting even greater non-compliance. Obesity is not seen by many as a condition worthy of worry or concern. Without greater attention to the long-term consequences of both diabetes and obesity, these conditions are left untreated until co-morbidities that cannot be ignored are manifested. This approach will result in an ever-increasing percentage of health care expenditures directed at the consequences.  This talk will discuss new approaches to engage patients in ownership of their condition and the outcomes. The passive relationship between patient and physician and or pharmacist may need to be adjusted to transfer some of the duty of performance to the patient rather than solely resting on the shoulders of their health care providers.

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Panel: Funding & Commercialization of Diabetes Technologies
Moderator: Thomas Seoh, Kinexum
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11:05
Moderator:
Thomas Seoh
Thomas Seoh
Chief Executive Officer
Kinexum
 
Thomas Seoh
Thomas Seoh
Chief Executive Officer
Kinexum
 
About Speaker:

Thomas Seoh is an entrepreneur/executive who has held senior leadership positions in public and private, pharmaceutical, biotech and medical device companies for over 25 years. After practicing corporate law in New York and London and serving as General Counsel for several companies, including Viratek in Costa Mesa, which developed the antiviral, VIRAZOLE®, and engaged in antisense oligonucleotide research, he joined Guilford Pharmaceuticals in Baltimore, which commercialized GLIADEL® wafer for glioblastoma multiforme and developed the propofol pro-drug LUSEDRA® and small molecules for Parkinson’s disease. Thomas began as Guilford's VP, General Counsel and Secretary, and later served as SVP Corporate and Commercial Development. He was then CEO of venture-backed Faust Pharmaceuticals in Strasbourg, France, developing a repurposed compound in Phase II for Parkinson’s patients, a re-positioned molecule for Duchenne muscular dystrophy and a GPCR drug discover platform. He also served on the Board of Directors of Arbios Systems, a Cedars Sinai spin-out with an ex vivo liver dialysis device in clinical development. He has additionally served as President of NexGen Medical Systems of Melbourne, Florida, commercializing a novel mechanical thrombectomy device for Deep Vein Thrombosis and stroke and a state-of-the-art neurocatheter, CEO of Eqalix, a regenerative medicine device company in Reston, VA, developing the first plant-based skin substitute wound dressing, and a member of the Hopkins Alliance, an industry-faculty advisory board at Johns Hopkins School of Medicine. Thomas holds an AB in Philosophy and History and a JD from Harvard University.

Panelist:
Jonathan Behr
Jonathan Behr
Managing Director
JDRF
 
Jonathan Behr
Jonathan Behr
Managing Director
JDRF
 
About Speaker:

Jon joined the T1D Fund from Partners Healthcare Innovation, where he was a Market Sector Leader and Executive in Residence, driving technology translation from research hospitals affiliated with Harvard Medical School. He previously held senior venture creation roles including Vice President of New Ventures for Enlight Biosciences and Principal at PureTech Ventures (LON:PRTC). Jon has co-founded and supported seven companies (including holding C-level operating, business development and board director positions) and managed alliances with top pharmaceutical companies. He earned his Ph.D. at Massachusetts Institute of Technology as a Howard Hughes fellow and his B.S. from Rice University.

Panelist:
Joseph Cook, Jr.
Joseph Cook, Jr.
President and Executive Chairman of the Board
Nusirt Inc.,
 
Joseph Cook, Jr.
Joseph Cook, Jr.
President and Executive Chairman of the Board
Nusirt Inc.,
 
About Speaker:

Mr. Cook is a principal and co-founder of Mountain Group Capital, Nashville, TN.  Mr. Cook serves as Executive Chairman of the Board and President of NuSirt Biopharma and a board member of Castle Biosciences, Clinical Products and Corcept Therapeutics Inc. (NASDAQ: CORT).

He is also a founder and Past-Chairman of the Board of Ironwood Pharmaceuticals Inc. (NASDAQ: IRWD) a biotechnology company in Cambridge, MA where he served as a director from 1998 to 2015.  Mr. Cook served as Chairman of Amylin Pharmaceuticals Inc. (NASDAQ: AMLN) from 1998 to 2009 and was Chief Executive Officer from 1998-2003.  Mr. Cook retired as a Group Vice-President, Global Operations at Eli Lilly and Company in 1993 after more than 28 years of service.

Mr. Cook serves as Chairman of the Board of Mercy Ministries International Inc. with headquarters in Nashville, TN.  He is also a past Chair and current member of the University of Tennessee College of Engineering Advisory Board.  Mr. Cook has served on the national board of the American Diabetes Association, and is past Chairman of the Board of Life Sciences Tennessee.

Mr. Cook graduated from the University of Tennessee in 1965 where he received his BS in Engineering with High Honors and was a UT Torchbearer.

Panelist:
Wende  Hutton
Wende Hutton
General Partner
Canaan
 
Wende  Hutton
Wende Hutton
General Partner
Canaan
 
About Speaker:

Wende identifies, builds and invests in companies that can change the practice of medicine by bringing novel drugs, technologies and devices to market. She joined Canaan in 2004 and throughout her career she has partnered with founders to deliver more than a dozen of those innovations to patients. Her track record includes seven IPOs and six acquisitions.

Wende currently sits on the boards of Antiva Biosciences, Chrono Therapeutics, Glooko, Hyalex and OncoResponse . Her prior investments include BiPar Sciences (acquired by Sanofi-Aventis), Chimerix (CMRX), Dermira (DERM), Labrys Biologics (acquired by Teva Pharmaceutical) and Transcend Medical (acquired by Alcon/Novartis). Wende was recognized among Fierce Biotech’s 2014 "Fierce 15" women in biotech.

Wende was previously a General Partner at Mayfield. Earlier in her career, Wende held senior marketing and business development roles at GenPharm International and Nellcor. Wende spends her free time volunteering with global health and conservation organizations. She holds a B.A. in human biology from Stanford University and an M.B.A. from Harvard Business School.

 

Panelist:
Martin Lafontaine
Martin Lafontaine
Commercialization Consultant, Diabetes
Kinexum
 
Martin Lafontaine
Martin Lafontaine
Commercialization Consultant, Diabetes
Kinexum
 
About Speaker:

Martin Lafontaine has over 20 years of experience within the pharmaceutical, medical device and digital health industry, and has been a consultant since 2016. Martin has held various leadership positions in the commercial organization in both multinational (GlaxoSmithKline) and start-up organizations (Locemia Solutions), in North America and Internationally. Most recently, he has been consulting and advising several companies involved in various areas of diabetes care, through his affiliation to Kinexum, a leading regulatory, clinical, commercial and other translational resource consulting firm supporting the strategic, technical, and operational needs of small and large life science companies. Martin possesses strong expertise in commercial go-to-market product launch excellence, marketing, corporate development and business development, solidly anchored in the field of diabetes. Martin is active on the board or serves as an advisor to several diabetes-related organizations in both the for- and not-for-profit sectors, such as AYUDA, The Behavioral Diabetes Institute, and the Team Type One Foundation. Martin’s passion for diabetes has solid roots, beginning at age 13 when he was diagnosed with type 1 diabetes. He authored a chapter in the book, “Successful Men With Diabetes.”

Panelist:
Jason Hafler
Jason Hafler
Senior Director of Investments
Sanofi Ventures
 
Jason Hafler
Jason Hafler
Senior Director of Investments
Sanofi Ventures
 
About Speaker:

Jason joined Sanofi Ventures in 2014 with a background in early stage biotech investing and transactions. Prior to Sanofi, Jason was the Director of Corporate Development at RaNA Therapeutics, LLC a company co-founded by his previous firm Atlas Venture. While at Atlas, Jason was an Associate in the Life Sciences group and a Board Observer for several portfolio companies. Previously, he was a Flagship Ventures Entrepreneurial Fellow, and consulted for the technology transfer company at the University of Cambridge while performing his doctoral research. Before his time at Cambridge, Jason was an analyst at JSB Partners LP, an investment banking firm, focusing on advisory and business development activities in the life sciences space.

Jason currently serves on the Board of Directors for NeuroVia Inc., Expansion Therapeutics and is a board observer for Navitor Pharmaceuticals. In addition, he is on the Board of Directors for one additional Sanofi Ventures-backed seed stage company. In addition, he is on the Board of Trustees at the Buckingham Browne and Nichols school and on the Board of Directors of The Magdalene College Foundation.

Jason graduated with honors from Bowdoin College, and holds a Ph.D. from the University of Cambridge.

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12:00
Lunch Provided by GTCbio
1
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1
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Keynote Panel Discussion
Moderator: Alexander Fleming, Kinexum
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3:00
Summit Concludes