Leadership

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Corporate Leadership

Mike Nolte joined in 2018 as the Chief Executive Officer. Mike is a seasoned operational leader whose career spans the healthcare, technology and financial services industries. Mike recently serving as Chief Executive Officer at Influence Health. Prior to that position, Mike served as President, Chief Operating Officer and Director of the public company MedAssets (MDAS), prior to which he spent 7 years at General Electric (GE), including roles as Vice President and General Manager of Americas Services for GE’s Healthcare IT business, where he led more than 1,700 teammates focused on GE’s $900 million healthcare software portfolio, VP and GM of GE’s $230 million enterprise revenue cycle software business and VP and GM of marketing and product management for GE Healthcare IT’s ambulatory segment. He also spent five years with McKinsey & Company and started his career as a U.S. Army Officer, finishing up as a Captain and Company Commander for an airborne, rapid deployment, medical supply chain and maintenance organization. Mike holds a Master of Business Administration from The University of Chicago Booth School of Business and a Bachelor’s Degree from the University of Notre Dame.

Mike Nolte

Chief Executive Officer

Mitch Blumenfeld oversees Finance, Quality and all Legal and Regulatory Affairs. He joined from PCI Pharma Services, the world’s largest provider of outsourced pharmaceutical packaging and related services where he was responsible for all financial management for 18 facilities across North America, Europe and Australia. He led PCI’s finance functions during a period of rapid growth, including a ten-fold increase in EBITDA and the successful completion of five acquisitions in the US, UK, Ireland and Australia. Prior to his time with PCI, Mitch worked for AmerisourceBergen as the Senior Vice President and CFO of the Drug Corporation and led the integration and finance functions for World Courier, the world leader in global cold chain and clinical trial logistics with offices in over 140 countries. Mitch started work with GE, having a career spanning 15 years and roles in the US and Europe with the Appliances, Lighting, Information Services and Water Technology businesses as well as five years in the Corporate Audit Staff. He is a graduate of GE’s Edison Engineering Program and Advanced Courses in Engineering. Mitch holds a Bachelor of Science in Computer Science Engineering from Bucknell University and a Master of Science in Computer Science & Applications from Virginia Tech.

Mitch Blumenfeld

Chief Financial Officer

Christopher L. Crucitti, MS, leads the commercial functions of the organization, as well as the go-to-market strategy, to drive the continued growth of our already market-leading clinical technology solutions platform. Chris brings significant experience and expertise in the clinical and R&D domains. He has led organizations to significant revenue and profitability growth, while maintaining a high level of customer service and quality delivery. He joined from Science Exchange, having served as Chief Commercial Officer for the world’s largest enterprise platform to manage outsourced R&D services. Prior to Science Exchange, he held various senior executive-level positions and oversight of commercial functions within the CRO industry (most notably Worldwide Clinical Trials and inVentiv Health Clinical) overseeing solutions spanning technology, consulting, strategic resourcing, clinical development and R&D. Chris holds a Master of Science from American University and a Bachelor of Science from Ithaca College.

Christopher L. Crucitti

Chief Commercial Officer

Mike Nolte joined in 2018 as the Chief Executive Officer. Mike is a seasoned operational leader whose career spans the healthcare, technology and financial services industries. Mike recently serving as Chief Executive Officer at Influence Health. Prior to that position, Mike served as President, Chief Operating Officer and Director of the public company MedAssets (MDAS), prior to which he spent 7 years at General Electric (GE), including roles as Vice President and General Manager of Americas Services for GE’s Healthcare IT business, where he led more than 1,700 teammates focused on GE’s $900 million healthcare software portfolio, VP and GM of GE’s $230 million enterprise revenue cycle software business and VP and GM of marketing and product management for GE Healthcare IT’s ambulatory segment. He also spent five years with McKinsey & Company and started his career as a U.S. Army Officer, finishing up as a Captain and Company Commander for an airborne, rapid deployment, medical supply chain and maintenance organization. Mike holds a Master of Business Administration from The University of Chicago Booth School of Business and a Bachelor’s Degree from the University of Notre Dame.

Mitch Blumenfeld oversees Finance, Quality and all Legal and Regulatory Affairs. He joined from PCI Pharma Services, the world’s largest provider of outsourced pharmaceutical packaging and related services where he was responsible for all financial management for 18 facilities across North America, Europe and Australia. He led PCI’s finance functions during a period of rapid growth, including a ten-fold increase in EBITDA and the successful completion of five acquisitions in the US, UK, Ireland and Australia. Prior to his time with PCI, Mitch worked for AmerisourceBergen as the Senior Vice President and CFO of the Drug Corporation and led the integration and finance functions for World Courier, the world leader in global cold chain and clinical trial logistics with offices in over 140 countries. Mitch started work with GE, having a career spanning 15 years and roles in the US and Europe with the Appliances, Lighting, Information Services and Water Technology businesses as well as five years in the Corporate Audit Staff. He is a graduate of GE’s Edison Engineering Program and Advanced Courses in Engineering. Mitch holds a Bachelor of Science in Computer Science Engineering from Bucknell University and a Master of Science in Computer Science & Applications from Virginia Tech.

Christopher L. Crucitti, MS, leads the commercial functions of the organization, as well as the go-to-market strategy, to drive the continued growth of our already market-leading clinical technology solutions platform. Chris brings significant experience and expertise in the clinical and R&D domains. He has led organizations to significant revenue and profitability growth, while maintaining a high level of customer service and quality delivery. He joined from Science Exchange, having served as Chief Commercial Officer for the world’s largest enterprise platform to manage outsourced R&D services. Prior to Science Exchange, he held various senior executive-level positions and oversight of commercial functions within the CRO industry (most notably Worldwide Clinical Trials and inVentiv Health Clinical) overseeing solutions spanning technology, consulting, strategic resourcing, clinical development and R&D. Chris holds a Master of Science from American University and a Bachelor of Science from Ithaca College.

Susie Robinson oversees human resources for over 1500 employees worldwide where she is focused on executing contemporary people strategies that will accelerate innovation, scale a powerful business and remain focused on expert service for customers. With more than 15 years as a Chief Human Resources Officer and 20+ years as an HR practitioner and advisor, she is a decisive, energetic, results-driven business leader with an eye for talent and a skill for transforming organizations. She has led HR, communications, operational and technical teams of 5 to 120 members in multi-divisional, multi-cultural operations with workforces from 700-6K+ in The Americas, Europe, and Asia. Ms. Robinson holds a Bachelor of Arts in Psychology from the California State University at Fullerton. She serves as an Advisory Board member of the Wharton Center for Human Resources Research Advisory Group of the University of Pennsylvania and as Vice Chairman of the Board of the Women’s Business Development Council.

Susie Robinson

Chief People Officer

Lawrence Miller is the Chief Technology Officer for Signant Health. His career has been focused on leading and scaling commercial, global technology organizations. Lawrence started as a quantitative analytics developer at JP Morgan Chase, eventually leading the development for one of the firm’s electronic trading platforms. In 2004 he joined BlackRock, where he was a Managing Director, overseeing the Development Services team for Aladdin, BlackRock’s asset management platform and the core of its successful SaaS business. While at BlackRock, Lawrence was involved in the formation of Symphony Communication Services and served as a Board Observer prior to joining the startup. At Symphony, Lawrence was Chief Security Officer, overseeing the firm’s security program, managing platform operations, and leading the firm’s regulatory and government affairs. Lawrence also served on the Commodity Futures Trading Commission’s TAC Cybersecurity Subcommittee, the Board of the FINOS FinTech Open Source Foundation, and currently serves on the University of Chicago’s Institute for Molecular Engineering Council. Lawrence holds an MS in Computer Science from The George Washington University, and a BA in Physics from the University of Chicago.

Lawrence Miller

Chief Technology Officer

James Jay

Senior Vice President and General Manager, Endpoint Solutions

James Jay oversees the global service business. He has 18 years of experience building successful software solutions for healthcare and life sciences. For the preceding six years he led the Global Imaging IT business at Agfa HealthCare, where he transformed the business strategy while creating a new market segment and established early market leadership. Prior to Agfa, James spent 13 years at GE, where he led the Global Cardiology IT business and held other roles across R&D and program management. James has an Master of Business Administration in Global Management from American Intercontinental University and a Bachelor of Science in Computer Science from the University of Oregon.

Susie Robinson oversees human resources for over 1500 employees worldwide where she is focused on executing contemporary people strategies that will accelerate innovation, scale a powerful business and remain focused on expert service for customers. With more than 15 years as a Chief Human Resources Officer and 20+ years as an HR practitioner and advisor, she is a decisive, energetic, results-driven business leader with an eye for talent and a skill for transforming organizations. She has led HR, communications, operational and technical teams of 5 to 120 members in multi-divisional, multi-cultural operations with workforces from 700-6K+ in The Americas, Europe, and Asia. Ms. Robinson holds a Bachelor of Arts in Psychology from the California State University at Fullerton. She serves as an Advisory Board member of the Wharton Center for Human Resources Research Advisory Group of the University of Pennsylvania and as Vice Chairman of the Board of the Women’s Business Development Council.

Lawrence Miller is the Chief Technology Officer for Signant Health. His career has been focused on leading and scaling commercial, global technology organizations. Lawrence started as a quantitative analytics developer at JP Morgan Chase, eventually leading the development for one of the firm’s electronic trading platforms. In 2004 he joined BlackRock, where he was a Managing Director, overseeing the Development Services team for Aladdin, BlackRock’s asset management platform and the core of its successful SaaS business. While at BlackRock, Lawrence was involved in the formation of Symphony Communication Services and served as a Board Observer prior to joining the startup. At Symphony, Lawrence was Chief Security Officer, overseeing the firm’s security program, managing platform operations, and leading the firm’s regulatory and government affairs. Lawrence also served on the Commodity Futures Trading Commission’s TAC Cybersecurity Subcommittee, the Board of the FINOS FinTech Open Source Foundation, and currently serves on the University of Chicago’s Institute for Molecular Engineering Council. Lawrence holds an MS in Computer Science from The George Washington University, and a BA in Physics from the University of Chicago.

James Jay oversees the global service business. He has 18 years of experience building successful software solutions for healthcare and life sciences. For the preceding six years he led the Global Imaging IT business at Agfa HealthCare, where he transformed the business strategy while creating a new market segment and established early market leadership. Prior to Agfa, James spent 13 years at GE, where he led the Global Cardiology IT business and held other roles across R&D and program management. James has an Master of Business Administration in Global Management from American Intercontinental University and a Bachelor of Science in Computer Science from the University of Oregon.

Jim Primerano oversees the delivery of the eClinical solutions portfolio. Jim has 20 years of clinical research and technology experience, leading teams to bring innovative solutions to the pharmaceutical industry in support of clinical development. Prior to joining, Jim was Sr. Director of Product Strategy with Medidata Solutions, where he was responsible for driving product portfolio expansion. Jim holds a Bachelor of Arts in Biology from the University of Pennsylvania and a Master of Business Administration in Global Business from Rider University.

Jim Primerano

Senior Vice President and General Manager, eClinical

Rauha Tulkki-Wilke leads cross-functional design and development of eCOA solutions for client and therapeutic area needs, combining science and patient experience with leading technology. Rauha has close to 20 years of experience with all that eCOA encompasses and has a genuine interest in digital health. Prior to moving to the pharmaceutical industry, she developed solutions for anesthesia management and neonatal intensive care. Rauha holds a Master of Science in Biophysics and Biomedical Engineering.

Rauha Tulkki-Wilke

Senior Vice President, Product Management

Clinical Professor of Psychiatry, George Washington University.

Dr. David Daniel provides overall scientific, clinical and strategic direction for our solutions. Dr. Daniel was the founder and President of Global Learning, LLC which was acquired by United BioSource Corporation in July 2006. He formerly served as Medical Director of the NIMH Neuroscience Center at Saint Elizabeth’s, Director of Clinical Trials for the Stanley Foundation and was a founding Principal of Best Practice, LLC. For over 30 years, Dr. Daniel has supervised and trained raters in psychiatric clinical trials globally. He has published numerous scientific articles involving clinical trials and investigations of the psychopathology of mental illness. He has received patent protection for new treatment approaches in epilepsy, anxiety disorders and psychotic disorders. Dr. Daniel graduated Phi Beta Kappa and Magna Cum Laude from Emory University and obtained his medical school and psychiatry post-graduate training at Vanderbilt University, where he served as chief resident. He was a medical staff fellow and senior staff fellow within the intramural program of the National Institute of Mental Health (DIRP, NIMH) for five years.

David Daniel

Senior Vice President, Chief Medical Officer

Jim Primerano oversees the delivery of the eClinical solutions portfolio. Jim has 20 years of clinical research and technology experience, leading teams to bring innovative solutions to the pharmaceutical industry in support of clinical development. Prior to joining, Jim was Sr. Director of Product Strategy with Medidata Solutions, where he was responsible for driving product portfolio expansion. Jim holds a Bachelor of Arts in Biology from the University of Pennsylvania and a Master of Business Administration in Global Business from Rider University.

Rauha Tulkki-Wilke leads cross-functional design and development of eCOA solutions for client and therapeutic area needs, combining science and patient experience with leading technology. Rauha has close to 20 years of experience with all that eCOA encompasses and has a genuine interest in digital health. Prior to moving to the pharmaceutical industry, she developed solutions for anesthesia management and neonatal intensive care. Rauha holds a Master of Science in Biophysics and Biomedical Engineering.

Clinical Professor of Psychiatry, George Washington University.

Dr. David Daniel provides overall scientific, clinical and strategic direction for our solutions. Dr. Daniel was the founder and President of Global Learning, LLC which was acquired by United BioSource Corporation in July 2006. He formerly served as Medical Director of the NIMH Neuroscience Center at Saint Elizabeth’s, Director of Clinical Trials for the Stanley Foundation and was a founding Principal of Best Practice, LLC. For over 30 years, Dr. Daniel has supervised and trained raters in psychiatric clinical trials globally. He has published numerous scientific articles involving clinical trials and investigations of the psychopathology of mental illness. He has received patent protection for new treatment approaches in epilepsy, anxiety disorders and psychotic disorders. Dr. Daniel graduated Phi Beta Kappa and Magna Cum Laude from Emory University and obtained his medical school and psychiatry post-graduate training at Vanderbilt University, where he served as chief resident. He was a medical staff fellow and senior staff fellow within the intramural program of the National Institute of Mental Health (DIRP, NIMH) for five years.

Michelle Ronan

Senior Vice President, Corporate Strategy & Development

Michelle Ronan is responsible for strategic initiatives, including mergers and acquisitions, strategic partnerships, market analysis and pricing strategy. Prior to joining, Michelle was Director of M&A Life Sciences at a large international accountancy firm. She worked across all areas of corporate finance and has significant experience in advising companies across all facets of a transaction, including working with both private equity and trade investors, raising debt finance, deal structuring and business valuations. Michelle is a member of the Institute of Chartered Accountants in England and Wales and holds a Bachelor of Arts (Honors) from University College London.

Thomas Barlow

Vice President, Total Quality Management

Thomas is responsible for all of Signant Health’s Quality Management oversight. Thomas has over 20 years of Quality Management experience. Prior to Signant Health, he was Manager Quality Services for Clarix LLC and Quatern, LLC and the Audit Manager for Almac Clinical Technologies. Thomas holds a BS in Biology from Millersville University and has formalized training in Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), 21 CFR 11, FDA, ICH and IEEE Validation Guidelines, HIPAA, CAPA Management, Deviation / Incident Reporting and Project Management.

Michelle Ronan is responsible for strategic initiatives, including mergers and acquisitions, strategic partnerships, market analysis and pricing strategy. Prior to joining, Michelle was Director of M&A Life Sciences at a large international accountancy firm. She worked across all areas of corporate finance and has significant experience in advising companies across all facets of a transaction, including working with both private equity and trade investors, raising debt finance, deal structuring and business valuations. Michelle is a member of the Institute of Chartered Accountants in England and Wales and holds a Bachelor of Arts (Honors) from University College London.

Thomas is responsible for all of Signant Health’s Quality Management oversight. Thomas has over 20 years of Quality Management experience. Prior to Signant Health, he was Manager Quality Services for Clarix LLC and Quatern, LLC and the Audit Manager for Almac Clinical Technologies. Thomas holds a BS in Biology from Millersville University and has formalized training in Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), 21 CFR 11, FDA, ICH and IEEE Validation Guidelines, HIPAA, CAPA Management, Deviation / Incident Reporting and Project Management.

Scientific Leadership

Clinical Professor of Psychiatry, George Washington University

Dr. Daniel provides overall scientific, clinical and strategic direction for Signant Health’s services. Dr. Daniel was the founder and President of Global Learning, LLC which was acquired by United BioSource Corporation in July 2006. He formerly served as Medical Director of the NIMH Neuroscience Center at Saint Elizabeth’s, Director of Clinical Trials for the Stanley Foundation, and was a founding Principal of Best Practice, LLC. For over 20 years, Dr. Daniel has supervised and trained raters in psychiatric clinical trials in the US and globally. He has published numerous scientific articles involving clinical trials and investigations of the psychopathology of mental illness. He has received patent protection for new treatment approaches in epilepsy, anxiety disorders and psychotic disorders. Dr. Daniel graduated Phi Beta Kappa and Magna Cum Laude from Emory University and obtained his medical school and psychiatry post-graduate training at Vanderbilt University, where he served as chief resident. He was a medical staff fellow and senior staff fellow within the intramural program of the National Institute of Mental Health (DIRP, NIMH) for five years.

David G. Daniel, MD

Sr. Vice President and Chief Medical Officer

Dr. Targum consults widely to the pharmaceutical industry regarding the design and implementation of clinical trials for new psychotropic drugs and the progression of drug development from concept to approval to launch. In addition to his work at Signant, Dr. Targum is a Chief Medical Advisor at Prana Biotechnology Ltd. and has served as Chief Medical Officer at several small biotechnology and pharmaceutical companies. In 1991, Dr. Targum established and operated a multi-site clinical trials program in Philadelphia. As Principal Investigator, he conducted over 200 clinical drug trials in therapeutic areas that included anxiety, depression, mania, schizophrenia, and Alzheimer’s disease. In 2001, Dr. Targum founded PharmaStar, a rater training and medical education company focused on CNS drug development and international clinical trials. The company grew quickly and became the global leader in this niche when it was sold in October 2004 to United BioSource Corporation. Previously, He was Professor of Psychiatry and Vice-Chairman of the Department of Mental Health Sciences at Hahnemann University School of Medicine (Philadelphia) from 1989-1995. He has published over 100 scientific articles in the areas of psychopharmacology, psychobiology, and clinical trials methodology. Dr. Targum has a B.A. in biology from Colgate University and an M.D. from Mount Sinai School of Medicine.

Steve Targum, MD

Scientific Director

Dr. Busner has over 30 years of experience as an academic clinical psychiatric researcher. She has served as the Principal Investigator for 49 industry-sponsored psychiatric clinical trials and Sub-Investigator for 35 additional clinical trials. She has served continuously on University Institutional Review Boards (IRBs) for the 20 years that preceded her move to Bracket. Dr. Busner is an active contributor to the psychopharmacology literature and has authored or coauthored over 100 peer-reviewed articles and national or international scientific presentations. Prior to Bracket, Dr. Busner directed the psychiatric clinical trials units of two major medical schools. She serves as Signant’s Expert Presenter and Scientific Lead for US and multinational studies of depressive disorders, anxiety disorders, attention deficit hyperactivity disorder and all child and adolescent psychiatric indications. She has trained thousands of psychiatric clinical trial investigators across the globe and lectures frequently on the application of objective rating scales in the assessment of diagnosis and efficacy in psychopharmacology, ethics in psychiatric research, the placebo effect in psychiatric research and techniques for its minimization, the role of IRBs and clinical trial methodology. Dr. Busner received her PhD in Experimental Social Psychology and her MA in General Psychology from Adelphi University. She is licensed to practice psychology in Pennsylvania, Missouri and New York.

Joan Busner, Ph.D.

Clinical Vice President

Clinical Professor of Psychiatry, George Washington University

Dr. Daniel provides overall scientific, clinical and strategic direction for Signant Health’s services. Dr. Daniel was the founder and President of Global Learning, LLC which was acquired by United BioSource Corporation in July 2006. He formerly served as Medical Director of the NIMH Neuroscience Center at Saint Elizabeth’s, Director of Clinical Trials for the Stanley Foundation, and was a founding Principal of Best Practice, LLC. For over 20 years, Dr. Daniel has supervised and trained raters in psychiatric clinical trials in the US and globally. He has published numerous scientific articles involving clinical trials and investigations of the psychopathology of mental illness. He has received patent protection for new treatment approaches in epilepsy, anxiety disorders and psychotic disorders. Dr. Daniel graduated Phi Beta Kappa and Magna Cum Laude from Emory University and obtained his medical school and psychiatry post-graduate training at Vanderbilt University, where he served as chief resident. He was a medical staff fellow and senior staff fellow within the intramural program of the National Institute of Mental Health (DIRP, NIMH) for five years.

Dr. Targum consults widely to the pharmaceutical industry regarding the design and implementation of clinical trials for new psychotropic drugs and the progression of drug development from concept to approval to launch. In addition to his work at Signant, Dr. Targum is a Chief Medical Advisor at Prana Biotechnology Ltd. and has served as Chief Medical Officer at several small biotechnology and pharmaceutical companies. In 1991, Dr. Targum established and operated a multi-site clinical trials program in Philadelphia. As Principal Investigator, he conducted over 200 clinical drug trials in therapeutic areas that included anxiety, depression, mania, schizophrenia, and Alzheimer’s disease. In 2001, Dr. Targum founded PharmaStar, a rater training and medical education company focused on CNS drug development and international clinical trials. The company grew quickly and became the global leader in this niche when it was sold in October 2004 to United BioSource Corporation. Previously, He was Professor of Psychiatry and Vice-Chairman of the Department of Mental Health Sciences at Hahnemann University School of Medicine (Philadelphia) from 1989-1995. He has published over 100 scientific articles in the areas of psychopharmacology, psychobiology, and clinical trials methodology. Dr. Targum has a B.A. in biology from Colgate University and an M.D. from Mount Sinai School of Medicine.

Dr. Busner has over 30 years of experience as an academic clinical psychiatric researcher. She has served as the Principal Investigator for 49 industry-sponsored psychiatric clinical trials and Sub-Investigator for 35 additional clinical trials. She has served continuously on University Institutional Review Boards (IRBs) for the 20 years that preceded her move to Bracket. Dr. Busner is an active contributor to the psychopharmacology literature and has authored or coauthored over 100 peer-reviewed articles and national or international scientific presentations. Prior to Bracket, Dr. Busner directed the psychiatric clinical trials units of two major medical schools. She serves as Signant’s Expert Presenter and Scientific Lead for US and multinational studies of depressive disorders, anxiety disorders, attention deficit hyperactivity disorder and all child and adolescent psychiatric indications. She has trained thousands of psychiatric clinical trial investigators across the globe and lectures frequently on the application of objective rating scales in the assessment of diagnosis and efficacy in psychopharmacology, ethics in psychiatric research, the placebo effect in psychiatric research and techniques for its minimization, the role of IRBs and clinical trial methodology. Dr. Busner received her PhD in Experimental Social Psychology and her MA in General Psychology from Adelphi University. She is licensed to practice psychology in Pennsylvania, Missouri and New York.

As Clinical Vice President, Dr. Fredane will serve as the Therapeutic Area Leader for neurology and will oversee Signant’s eCOA, Rater Training, and Quality Assurance work in this important therapeutic area. Prior to joining Bracket, Dr. Fredane served as a practicing neurologist and clinical assistant professor of Neurology at Drexel University College of Medicine in Philadelphia, Pennsylvania. He has worked in pharmaceutical drug development at several companies including at Sanofi/Genzyme Pharmaceuticals, Meda Pharmaceuticals and with CRO Omnicare Clinical Research. He also maintains extensive experience in medical affairs and has published research on multiple sclerosis, pain management and transplantation. Dr. Fredane received his medical degree from Albert Einstein College of Medicine and completed his training with a residency in Neurology at Duke University. He completed fellowships in Clinical Immunology at St. Luke’s-Roosevelt Hospital Center in New York and in Immunology at Yale University School of Medicine in New Haven, Connecticut through a research fellowship with the National MS Society.

Lewis M. Fredane, MD

Clinical Vice President

Adjunct Professor, Stanford University School of Medicine, Dept. of Neurology and Neurological Sciences

Dr. Hamilton was President and Founder of DynaRand, LLC, a software company that pioneered the development of IVRS and IWRS solutions for clinical trials management. DynaRand was acquired by United BioSource Corporation in 2005. Since the inception of DynaRand in 1998, he has pioneered the use of IVRS for automated adaptive studies, especially in the area of dynamic randomization. Dr. Hamilton works closely with pharmaceutical companies regarding the statistical aspects of adaptive trials and randomization algorithms, in addition to monitoring the integrity of Signant’s randomization processes. Previously, Dr. Hamilton held a role of Senior Biostatistician at Genentech, Inc. and is a NI-NINDS Grant Review Committee member. Widely published, he holds memberships in the American Statistical Association and the American Academy of Neurology and Biometrics. Dr. Hamilton received his undergraduate degree from the University of California at Davis in Economics and Rhetoric, his Master of Science from the University of California at Los Angeles in Biostatistics, and his PhD in Biostatistics from the University of North Carolina.

Scott Hamilton, PhD

Principal Biostatistician

Dr. Kalali helps identify innovative technologies to support the evolution of Signant’s growth. In addition, Dr. Kalali will assist in the acceleration of growth in Signant’s CNS product lines in other fields of medicine.  He is Professor of Psychiatry at University of California San Diego, Editor of the journal Innovations in Clinical Neuroscience, and the Lead Editor of the book Essential CNS Drug Development, published by Cambridge University Press. He has authored over 150 peer-reviewed publications. Recognized globally as a leader in drug development and healthcare with an emphasis on  innovation, collaboration, and the intersection with new technology, Dr. Kalali was the Founding Chairman of the Executive Committee of the International Society for CNS Drug Development  (ISCDD), a founding member of the International Society for CNS Clinical Trials and  Methodology (ISCTM), where he serves on Executive Committee, the Scientific Committee, and  previously chaired the Membership and Publication Committees. He is also a founder and Co- Chair of the Scientific Program Committee of the CNS Summit, and serves on the Scientific Program Committee of the American College of Neuropsychopharmacology. Dr. Kalali regularly presents at national and international scientific meetings, and lectures  frequently on drug development, innovation, technology, digital medicine and health.  He is an advisor to the Center for Digital Transformation at the Paul Merage School of Business  at the University of California, Irvine. Dr. Kalali earned his medical degree from the University of London and completed his psychiatry training at University College and Middlesex School of Medicine, University of London.

Amir Kalali, MD

Executive Advisor for Global Strategy

As Clinical Vice President, Dr. Fredane will serve as the Therapeutic Area Leader for neurology and will oversee Signant’s eCOA, Rater Training, and Quality Assurance work in this important therapeutic area. Prior to joining Bracket, Dr. Fredane served as a practicing neurologist and clinical assistant professor of Neurology at Drexel University College of Medicine in Philadelphia, Pennsylvania. He has worked in pharmaceutical drug development at several companies including at Sanofi/Genzyme Pharmaceuticals, Meda Pharmaceuticals and with CRO Omnicare Clinical Research. He also maintains extensive experience in medical affairs and has published research on multiple sclerosis, pain management and transplantation. Dr. Fredane received his medical degree from Albert Einstein College of Medicine and completed his training with a residency in Neurology at Duke University. He completed fellowships in Clinical Immunology at St. Luke’s-Roosevelt Hospital Center in New York and in Immunology at Yale University School of Medicine in New Haven, Connecticut through a research fellowship with the National MS Society.

Adjunct Professor, Stanford University School of Medicine, Dept. of Neurology and Neurological Sciences

Dr. Hamilton was President and Founder of DynaRand, LLC, a software company that pioneered the development of IVRS and IWRS solutions for clinical trials management. DynaRand was acquired by United BioSource Corporation in 2005. Since the inception of DynaRand in 1998, he has pioneered the use of IVRS for automated adaptive studies, especially in the area of dynamic randomization. Dr. Hamilton works closely with pharmaceutical companies regarding the statistical aspects of adaptive trials and randomization algorithms, in addition to monitoring the integrity of Signant’s randomization processes. Previously, Dr. Hamilton held a role of Senior Biostatistician at Genentech, Inc. and is a NI-NINDS Grant Review Committee member. Widely published, he holds memberships in the American Statistical Association and the American Academy of Neurology and Biometrics. Dr. Hamilton received his undergraduate degree from the University of California at Davis in Economics and Rhetoric, his Master of Science from the University of California at Los Angeles in Biostatistics, and his PhD in Biostatistics from the University of North Carolina.

Dr. Kalali helps identify innovative technologies to support the evolution of Signant’s growth. In addition, Dr. Kalali will assist in the acceleration of growth in Signant’s CNS product lines in other fields of medicine.  He is Professor of Psychiatry at University of California San Diego, Editor of the journal Innovations in Clinical Neuroscience, and the Lead Editor of the book Essential CNS Drug Development, published by Cambridge University Press. He has authored over 150 peer-reviewed publications. Recognized globally as a leader in drug development and healthcare with an emphasis on  innovation, collaboration, and the intersection with new technology, Dr. Kalali was the Founding Chairman of the Executive Committee of the International Society for CNS Drug Development  (ISCDD), a founding member of the International Society for CNS Clinical Trials and  Methodology (ISCTM), where he serves on Executive Committee, the Scientific Committee, and  previously chaired the Membership and Publication Committees. He is also a founder and Co- Chair of the Scientific Program Committee of the CNS Summit, and serves on the Scientific Program Committee of the American College of Neuropsychopharmacology. Dr. Kalali regularly presents at national and international scientific meetings, and lectures  frequently on drug development, innovation, technology, digital medicine and health.  He is an advisor to the Center for Digital Transformation at the Paul Merage School of Business  at the University of California, Irvine. Dr. Kalali earned his medical degree from the University of London and completed his psychiatry training at University College and Middlesex School of Medicine, University of London.

Dr. Kott is based in Signant’s Prague office and until recently was Senior Clinical Manager for Europe. Having led the development of the Data Analytics Program for Bracket, he has overseen the design and reporting of data analytics in multiple large schizophrenia studies. For the past seven years, he has also provided training to investigators as an Expert Trainer. Dr. Kott has been responsible for the design and implementation of multiple in-study data quality programs and served as a Product Business Owner for Rater Reliability Statistical Measures Application. Prior to Bracket, Dr. Kott worked as a house officer in Psychiatry at General Teaching Hospital, Department of Psychiatry, and as an Assistant Professor at Charles University, 1st Medical Faculty – Department of Psychiatry, in Prague. Dr. Kott has a Medicinae Universae Doctor (MUDr) from Charles University.

Alan Kott, MUDr

Clinical Vice President and Practice Lead, Data Analytics

Dr. Miller has over 20 years of clinical, clinical research and teaching experience, primarily in the field of geriatric psychiatry. After completing his 2-year fellowship in geriatric psychiatry at the University of Pennsylvania, he joined the faculty and served as an Assistant Professor of Psychiatry. Dr. Miller then went on to the University of Medicine and Dentistry of New Jersey, where he served as an Associate Professor of Psychiatry. Prior to joining Bracket, Dr. Miller served as Chief of Geriatric Psychiatry, Medical Director of ECT, and President of the Medical Staff at Friends Hospital in Philadelphia, PA. At all of these institutions, he oversaw the education and training of medical students, residents and fellows in geriatric psychiatry, and was recognized with a departmental teaching award.  Dr. Miller has served as a Principal Investigator in a number of dementia clinical trials. In addition, he has lectured locally, nationally and internationally on his dementia related research. Dr. Miller serves as the Co-Chair of the ISTAART funded Neuropsychiatric Syndromes in Dementia – Professional Interest Area (NPS-PIA), and as the Co-Chair of the ISCTM Working Group focusing on the same area. Additionally, Dr. Miller is a co-author on the updated ADCS ADAS-Cog administration and scoring manual. Since joining Bracket, Dr. Miller has consulted on multiple dementia protocols and has served as the Expert Presenter at dozens of investigators’ meetings across the globe, including those addressing behavioral abnormalities and agitation in the context of dementia.

David S. Miller, MD, MA

Clinical Vice President

Associate Professor of Psychiatry, Harvard Medical School

Dr. Sachs is the Therapeutic Area Leader in bipolar disease and mood disorders at Signant. He previously co-founded Concordant Rater Systems, a specialty provider of technologies to improve CNS clinical research. Dr. Sachs is a recognized expert clinical trialist with extensive experience in rater training and the methodologies of mood and anxiety disorder research. He has been instrumental in developing technology-based solutions for randomized controlled trials that identify correlates of high placebo response, improve signal detection and reduce the risk of failed trials. Dr. Sachs is the founder and director of the Bipolar Clinic and Research Program at Massachusetts General Hospital (MGH) and is an Associate Professor of Psychiatry at Harvard Medical School. After graduating from the University of Pennsylvania and the University of Maryland Medical School, he completed his residency at MGH. His areas of academic interest include psychopharmacology, chronobiology, bipolar mood disorder and development of pragmatic measure-based practice guidelines. Dr. Sachs is Chair of the National Alliance on Mental Illness Scientific Advisory Board and serves on the Scientific Advisory Board of the Depression and Bipolar Support Alliance. He has authored over 200 articles, abstracts, books and book chapters.

Gary Sachs, MD

Clinical Vice President

Dr. Kott is based in Signant’s Prague office and until recently was Senior Clinical Manager for Europe. Having led the development of the Data Analytics Program for Bracket, he has overseen the design and reporting of data analytics in multiple large schizophrenia studies. For the past seven years, he has also provided training to investigators as an Expert Trainer. Dr. Kott has been responsible for the design and implementation of multiple in-study data quality programs and served as a Product Business Owner for Rater Reliability Statistical Measures Application. Prior to Bracket, Dr. Kott worked as a house officer in Psychiatry at General Teaching Hospital, Department of Psychiatry, and as an Assistant Professor at Charles University, 1st Medical Faculty – Department of Psychiatry, in Prague. Dr. Kott has a Medicinae Universae Doctor (MUDr) from Charles University.

Dr. Miller has over 20 years of clinical, clinical research and teaching experience, primarily in the field of geriatric psychiatry. After completing his 2-year fellowship in geriatric psychiatry at the University of Pennsylvania, he joined the faculty and served as an Assistant Professor of Psychiatry. Dr. Miller then went on to the University of Medicine and Dentistry of New Jersey, where he served as an Associate Professor of Psychiatry. Prior to joining Bracket, Dr. Miller served as Chief of Geriatric Psychiatry, Medical Director of ECT, and President of the Medical Staff at Friends Hospital in Philadelphia, PA. At all of these institutions, he oversaw the education and training of medical students, residents and fellows in geriatric psychiatry, and was recognized with a departmental teaching award.  Dr. Miller has served as a Principal Investigator in a number of dementia clinical trials. In addition, he has lectured locally, nationally and internationally on his dementia related research. Dr. Miller serves as the Co-Chair of the ISTAART funded Neuropsychiatric Syndromes in Dementia – Professional Interest Area (NPS-PIA), and as the Co-Chair of the ISCTM Working Group focusing on the same area. Additionally, Dr. Miller is a co-author on the updated ADCS ADAS-Cog administration and scoring manual. Since joining Bracket, Dr. Miller has consulted on multiple dementia protocols and has served as the Expert Presenter at dozens of investigators’ meetings across the globe, including those addressing behavioral abnormalities and agitation in the context of dementia.

Associate Professor of Psychiatry, Harvard Medical School

Dr. Sachs is the Therapeutic Area Leader in bipolar disease and mood disorders at Signant. He previously co-founded Concordant Rater Systems, a specialty provider of technologies to improve CNS clinical research. Dr. Sachs is a recognized expert clinical trialist with extensive experience in rater training and the methodologies of mood and anxiety disorder research. He has been instrumental in developing technology-based solutions for randomized controlled trials that identify correlates of high placebo response, improve signal detection and reduce the risk of failed trials. Dr. Sachs is the founder and director of the Bipolar Clinic and Research Program at Massachusetts General Hospital (MGH) and is an Associate Professor of Psychiatry at Harvard Medical School. After graduating from the University of Pennsylvania and the University of Maryland Medical School, he completed his residency at MGH. His areas of academic interest include psychopharmacology, chronobiology, bipolar mood disorder and development of pragmatic measure-based practice guidelines. Dr. Sachs is Chair of the National Alliance on Mental Illness Scientific Advisory Board and serves on the Scientific Advisory Board of the Depression and Bipolar Support Alliance. He has authored over 200 articles, abstracts, books and book chapters.