Anthony Atala, MD, is the G. Link Professor and Director of the Wake Forest Institute for Regenerative Medicine. Seventeen of his lab’s technologies have been translated to patients, including the first tissue-engineered organ for permanent implantation in a human. His research led to the discovery of a multipotent source of stem cells from amniotic fluid and placenta, advances in 3D printing of tissues and organs, and body-on-a-chip technologies. His work was twice listed among Time Magazine’s top 10 medical breakthroughs of the year, and he is a recipient of the Smithsonian Ingenuity Award. He has published over 900 journal articles, is the editor of 25 books, and holds over 250 national and international patents. Dr. Atala is a member of the National Academy of Medicine, the National Academy of Inventors, and the American Institute for Medical and Biological Engineering.Ali Arab is an Associate Professor in the Mathematics and Statistics Department of Georgetown University. He received a BS in Applied Mathematics at the Iran University of Science and Technology (1999) and an MS in Applied Mathematics and Statistics at Southern Illinois University Edwardsville (2002) and PhD in Statistics at University of Missouri-Columbia (2007). He joined Georgetown University in 2007. His academic research is mainly focused on statistical modeling, spatio-temporal models, spatial statistics, hierarchical bayesian modeling with focus on environmental and ecological studies. He frequently publishes in peer-reviewed scientific journals and publishes in academic and popular outlets on topics related to human rights. He is actively involved in promoting science and human rights including promoting the role of human rights in science education, and organizing student activities related to science and human rights. He serves as the Outreach and Communication Committee co-Chair for the American Association for the Advancement of Science (AAAS)-Science and Human Rights Coalition. Dr. Mohummad Siddiqui is a fellowship-trained specialist in Urologic Oncology and Robotic Surgery. He joined the faculty at the University of Maryland in 2014 after completing training at MIT, Harvard, and the NIH in the field of Urology and subspecialty of Urologic Oncology. He is the Director of Urologic Oncology and Robotic Surgery at the University of Maryland Medical Center. He specializes in the surgical management of urologic cancers such as prostate, bladder, kidney, and testicular cancer. Dr Adam E. M. Eltorai, MD, PhD completed his graduate studies in Biomedical Engineering and Biotechnology along with his medical degree from Brown University. His work has spanned the translational spectrum with a focus on medical technology innovation and development. Dr. Eltorai has published numerous articles and books.

• INTRODUCTION1. Introduction2. Translational Process3. Scientific Method4. Basic ResearchPRE-CLINCIAL5. Overview of Preclinical Research6. What Problem are you Solving?7. Types of Interventions8. Drug discovery9. Drug Testing10. Device Discovery and Prototyping11. Device testing12. Other product types13. Procedural Technique Development14. Behavioral InterventionCLINICAL: FUNDAMENTALS15. Introduction to clinical research: What is it? Why is it needed?16. Study population: Who and why them?17. Outcome measurements: What data is being collected and why?TATISTICAL PRINCIPLES18. Common issues in analysis19. Basic statistical principles20. Distributions21. Hypotheses and error types22. Power23. Regression24. Continuous Variable Analyses: Student’s t-test, Rank-Sum Test, and Signed-Rank Test25. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel26. Analysis of variance27. Correlation28. Basic science statisticsCLINICAL: STUDY TYPES29. Design principles: Hierarchy of study types30. Case series: Design, measures, classic example31. Case-control study: Design, measures, classic example32. Cohort study: Design, measures, classic example33. Cross-section study: Design, measures, classic example34. Longitudinal Study: Design, measures, classic example35. Clinical trials: Design, measures, classic example36. Meta-analysis: Design, measures, classic example37. Cost-Effectiveness Analysis: Design, Measures, and Classic Example38. Database Research in Urology39. Surveys and questionnaires: Design, measures, classic example40. Qualitative methods and mixed methodsCLINICAL TRIALS41. Randomized Controlled Trials: Design, Measures, and Classic Examples42. Nonrandomized control: Design, measures, classic example43. Historical control: Design, measures, classic example44. Cross-over: Design, measures, classic example45. Withdrawal Studies46. Equivalence and noninferiority: Design, measures, classic example47. Randomization: Fixed or adaptive procedures48. Blinding: Who and how?49. Multicenter considerations50. Phases of Clinical Trials51. Window of Opportunity, Phase 0 Trials52. IDEAL Framework53. Artificial Intelligence54. Patient PerspectivesCLINICAL: PREPARATION55. Sample Size56. Budgeting57. Ethics and review boards58. Regulatory considerations for new drugs and devices59. Funding approaches60. Data management61. Statistical Software62. Subject adherence63. Survival analysis64. Monitoring committee in clinical trialsREGULATORY BASICS65. FDA overview66. IND67. New drug application68. Devices69. Biologics70. Combination Products71. Foods72. CMC and GxP73. Post-Market Drug Safety Monitoring74. Post-Market Device Safety MonitoringCLINICAL IMPLEMENTATION75. Implementation Research76. Design and Analysis77. Population- and Setting-Specific ImplementationPUBLIC HEALTH78. Public Health79. Epidemiology80. Public Health Factors and Social Determinants of Health in Urological Research81. Good Questions82. Population- and Environmental-Specific Considerations83. Healthcare Institutions and Systems84. Public Health Institutions and SystemsPractical Resources85. Presenting Data86. Manuscript Preparation87. Building a Team88. Patent Basics89. Venture Pathways90. SBIR/STTR91. Sample Forms and Templates

Anthony Atala, MD, is the G. Link Professor and Director of the Wake Forest Institute for Regenerative Medicine. Seventeen of his lab’s technologies have been translated to patients, including the first tissue-engineered organ for permanent implantation in a human. His research led to the discovery of a multipotent source of stem cells from amniotic fluid and placenta, advances in 3D printing of tissues and organs, and body-on-a-chip technologies. His work was twice listed among Time Magazine’s top 10 medical breakthroughs of the year, and he is a recipient of the Smithsonian Ingenuity Award. He has published over 900 journal articles, is the editor of 25 books, and holds over 250 national and international patents. Dr. Atala is a member of the National Academy of Medicine, the National Academy of Inventors, and the American Institute for Medical and Biological Engineering.Ali Arab is an Associate Professor in the Mathematics and Statistics Department of Georgetown University. He received a BS in Applied Mathematics at the Iran University of Science and Technology (1999) and an MS in Applied Mathematics and Statistics at Southern Illinois University Edwardsville (2002) and PhD in Statistics at University of Missouri-Columbia (2007). He joined Georgetown University in 2007. His academic research is mainly focused on statistical modeling, spatio-temporal models, spatial statistics, hierarchical bayesian modeling with focus on environmental and ecological studies. He frequently publishes in peer-reviewed scientific journals and publishes in academic and popular outlets on topics related to human rights. He is actively involved in promoting science and human rights including promoting the role of human rights in science education, and organizing student activities related to science and human rights. He serves as the Outreach and Communication Committee co-Chair for the American Association for the Advancement of Science (AAAS)-Science and Human Rights Coalition. Dr. Mohummad Siddiqui is a fellowship-trained specialist in Urologic Oncology and Robotic Surgery. He joined the faculty at the University of Maryland in 2014 after completing training at MIT, Harvard, and the NIH in the field of Urology and subspecialty of Urologic Oncology. He is the Director of Urologic Oncology and Robotic Surgery at the University of Maryland Medical Center. He specializes in the surgical management of urologic cancers such as prostate, bladder, kidney, and testicular cancer. Dr Adam E. M. Eltorai, MD, PhD completed his graduate studies in Biomedical Engineering and Biotechnology along with his medical degree from Brown University. His work has spanned the translational spectrum with a focus on medical technology innovation and development. Dr. Eltorai has published numerous articles and books.

• INTRODUCTION1. Introduction2. Translational Process3. Scientific Method4. Basic ResearchPRE-CLINCIAL5. Overview of Preclinical Research6. What Problem are you Solving?7. Types of Interventions8. Drug discovery9. Drug Testing10. Device Discovery and Prototyping11. Device testing12. Other product types13. Procedural Technique Development14. Behavioral InterventionCLINICAL: FUNDAMENTALS15. Introduction to clinical research: What is it? Why is it needed?16. Study population: Who and why them?17. Outcome measurements: What data is being collected and why?TATISTICAL PRINCIPLES18. Common issues in analysis19. Basic statistical principles20. Distributions21. Hypotheses and error types22. Power23. Regression24. Continuous Variable Analyses: Student’s t-test, Rank-Sum Test, and Signed-Rank Test25. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel26. Analysis of variance27. Correlation28. Basic science statisticsCLINICAL: STUDY TYPES29. Design principles: Hierarchy of study types30. Case series: Design, measures, classic example31. Case-control study: Design, measures, classic example32. Cohort study: Design, measures, classic example33. Cross-section study: Design, measures, classic example34. Longitudinal Study: Design, measures, classic example35. Clinical trials: Design, measures, classic example36. Meta-analysis: Design, measures, classic example37. Cost-Effectiveness Analysis: Design, Measures, and Classic Example38. Database Research in Urology39. Surveys and questionnaires: Design, measures, classic example40. Qualitative methods and mixed methodsCLINICAL TRIALS41. Randomized Controlled Trials: Design, Measures, and Classic Examples42. Nonrandomized control: Design, measures, classic example43. Historical control: Design, measures, classic example44. Cross-over: Design, measures, classic example45. Withdrawal Studies46. Equivalence and noninferiority: Design, measures, classic example47. Randomization: Fixed or adaptive procedures48. Blinding: Who and how?49. Multicenter considerations50. Phases of Clinical Trials51. Window of Opportunity, Phase 0 Trials52. IDEAL Framework53. Artificial Intelligence54. Patient PerspectivesCLINICAL: PREPARATION55. Sample Size56. Budgeting57. Ethics and review boards58. Regulatory considerations for new drugs and devices59. Funding approaches60. Data management61. Statistical Software62. Subject adherence63. Survival analysis64. Monitoring committee in clinical trialsREGULATORY BASICS65. FDA overview66. IND67. New drug application68. Devices69. Biologics70. Combination Products71. Foods72. CMC and GxP73. Post-Market Drug Safety Monitoring74. Post-Market Device Safety MonitoringCLINICAL IMPLEMENTATION75. Implementation Research76. Design and Analysis77. Population- and Setting-Specific ImplementationPUBLIC HEALTH78. Public Health79. Epidemiology80. Public Health Factors and Social Determinants of Health in Urological Research81. Good Questions82. Population- and Environmental-Specific Considerations83. Healthcare Institutions and Systems84. Public Health Institutions and SystemsPractical Resources85. Presenting Data86. Manuscript Preparation87. Building a Team88. Patent Basics89. Venture Pathways90. SBIR/STTR91. Sample Forms and Templates

Anthony Atala, MD, is the G. Link Professor and Director of the Wake Forest Institute for Regenerative Medicine. Seventeen of his lab’s technologies have been translated to patients, including the first tissue-engineered organ for permanent implantation in a human. His research led to the discovery of a multipotent source of stem cells from amniotic fluid and placenta, advances in 3D printing of tissues and organs, and body-on-a-chip technologies. His work was twice listed among Time Magazine’s top 10 medical breakthroughs of the year, and he is a recipient of the Smithsonian Ingenuity Award. He has published over 900 journal articles, is the editor of 25 books, and holds over 250 national and international patents. Dr. Atala is a member of the National Academy of Medicine, the National Academy of Inventors, and the American Institute for Medical and Biological Engineering.Ali Arab is an Associate Professor in the Mathematics and Statistics Department of Georgetown University. He received a BS in Applied Mathematics at the Iran University of Science and Technology (1999) and an MS in Applied Mathematics and Statistics at Southern Illinois University Edwardsville (2002) and PhD in Statistics at University of Missouri-Columbia (2007). He joined Georgetown University in 2007. His academic research is mainly focused on statistical modeling, spatio-temporal models, spatial statistics, hierarchical bayesian modeling with focus on environmental and ecological studies. He frequently publishes in peer-reviewed scientific journals and publishes in academic and popular outlets on topics related to human rights. He is actively involved in promoting science and human rights including promoting the role of human rights in science education, and organizing student activities related to science and human rights. He serves as the Outreach and Communication Committee co-Chair for the American Association for the Advancement of Science (AAAS)-Science and Human Rights Coalition. Dr. Mohummad Siddiqui is a fellowship-trained specialist in Urologic Oncology and Robotic Surgery. He joined the faculty at the University of Maryland in 2014 after completing training at MIT, Harvard, and the NIH in the field of Urology and subspecialty of Urologic Oncology. He is the Director of Urologic Oncology and Robotic Surgery at the University of Maryland Medical Center. He specializes in the surgical management of urologic cancers such as prostate, bladder, kidney, and testicular cancer. Dr Adam E. M. Eltorai, MD, PhD completed his graduate studies in Biomedical Engineering and Biotechnology along with his medical degree from Brown University. His work has spanned the translational spectrum with a focus on medical technology innovation and development. Dr. Eltorai has published numerous articles and books.

• INTRODUCTION1. Introduction2. Translational Process3. Scientific Method4. Basic ResearchPRE-CLINCIAL5. Overview of Preclinical Research6. What Problem are you Solving?7. Types of Interventions8. Drug discovery9. Drug Testing10. Device Discovery and Prototyping11. Device testing12. Other product types13. Procedural Technique Development14. Behavioral InterventionCLINICAL: FUNDAMENTALS15. Introduction to clinical research: What is it? Why is it needed?16. Study population: Who and why them?17. Outcome measurements: What data is being collected and why?TATISTICAL PRINCIPLES18. Common issues in analysis19. Basic statistical principles20. Distributions21. Hypotheses and error types22. Power23. Regression24. Continuous Variable Analyses: Student’s t-test, Rank-Sum Test, and Signed-Rank Test25. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel26. Analysis of variance27. Correlation28. Basic science statisticsCLINICAL: STUDY TYPES29. Design principles: Hierarchy of study types30. Case series: Design, measures, classic example31. Case-control study: Design, measures, classic example32. Cohort study: Design, measures, classic example33. Cross-section study: Design, measures, classic example34. Longitudinal Study: Design, measures, classic example35. Clinical trials: Design, measures, classic example36. Meta-analysis: Design, measures, classic example37. Cost-Effectiveness Analysis: Design, Measures, and Classic Example38. Database Research in Urology39. Surveys and questionnaires: Design, measures, classic example40. Qualitative methods and mixed methodsCLINICAL TRIALS41. Randomized Controlled Trials: Design, Measures, and Classic Examples42. Nonrandomized control: Design, measures, classic example43. Historical control: Design, measures, classic example44. Cross-over: Design, measures, classic example45. Withdrawal Studies46. Equivalence and noninferiority: Design, measures, classic example47. Randomization: Fixed or adaptive procedures48. Blinding: Who and how?49. Multicenter considerations50. Phases of Clinical Trials51. Window of Opportunity, Phase 0 Trials52. IDEAL Framework53. Artificial Intelligence54. Patient PerspectivesCLINICAL: PREPARATION55. Sample Size56. Budgeting57. Ethics and review boards58. Regulatory considerations for new drugs and devices59. Funding approaches60. Data management61. Statistical Software62. Subject adherence63. Survival analysis64. Monitoring committee in clinical trialsREGULATORY BASICS65. FDA overview66. IND67. New drug application68. Devices69. Biologics70. Combination Products71. Foods72. CMC and GxP73. Post-Market Drug Safety Monitoring74. Post-Market Device Safety MonitoringCLINICAL IMPLEMENTATION75. Implementation Research76. Design and Analysis77. Population- and Setting-Specific ImplementationPUBLIC HEALTH78. Public Health79. Epidemiology80. Public Health Factors and Social Determinants of Health in Urological Research81. Good Questions82. Population- and Environmental-Specific Considerations83. Healthcare Institutions and Systems84. Public Health Institutions and SystemsPractical Resources85. Presenting Data86. Manuscript Preparation87. Building a Team88. Patent Basics89. Venture Pathways90. SBIR/STTR91. Sample Forms and Templates