John is a senior executive with over 25 years’ experience at transforming technology-based companies into product-based organizations. He combines a unique set of strategic, financial, talent management, and operating skills to identify unmet medical needs optimizing an organization to translate cutting–edge technology into products that address our most pressing hard to treat diseases to enhance people’s lives.
Prior to co-founding and joining Cour, John was Co-Founder and CEO of Tolera Therapeutics. He led the company from initial startup through manufacturing optimization, pre-clinical, completion of a Phase 2 clinical trial, and filing of a Phase 3 Special Protocol Assessment (SPA) with the FDA. The company built significant barriers to entry by achieving several orphan drug designations and issuance of composition of matter patents utilizing a unique patent strategy.
John was also instrumental to the startup of Cleveland Heart Labs (sold to LabCorp). He has served on the boards of Third Wave Technologies (NASDQ:TWTI) and ProNAi Therapeutics (NASDQ:DNAI), Tolera Therapeutics. John is a current board member at Cour Pharmaceuticals and advisory board member of NewCures of Northwestern University. He is also a member of the Economic Club of Chicago.
Prior to Tolera, he was President and CEO of Third Wave Technologies (NASDAQ: TWTI), a biotechnology company, where he led the transformation of a non-sustainable genomics tools business into a robust growth-driven molecular diagnostics company primarily by leading the development of hard to detect infections and cancers. Third Wave was eventually sold for $600 million. John also served as a strategic consultant to DEKALB Genetics Corporation (NYSE) that was ultimately sold for $3.2 billion. Earlier in his career, John was with Spencer Stuart and Egon Zehnder International, in their life sciences practice groups where he consulted with biotech and pharmaceutical firms. After receiving his BS in Accounting from Northern Illinois University, John started his career at Arthur Andersen and also worked for Price Waterhouse. He received his MBA from the Kellogg School of Management at Northwestern University.
John is a senior executive with over 25 years’ experience at transforming technology-based companies into product-based organizations. He combines a unique set of strategic, financial, talent management, and operating skills to identify unmet medical needs optimizing an organization to translate cutting–edge technology into products that address our most pressing hard to treat diseases to enhance people’s lives.
Prior to co-founding and joining Cour, John was Co-Founder and CEO of Tolera Therapeutics. He led the company from initial startup through manufacturing optimization, pre-clinical, completion of a Phase 2 clinical trial, and filing of a Phase 3 Special Protocol Assessment (SPA) with the FDA. The company built significant barriers to entry by achieving several orphan drug designations and issuance of composition of matter patents utilizing a unique patent strategy.
John was also instrumental to the startup of Cleveland Heart Labs (sold to LabCorp). He has served on the boards of Third Wave Technologies (NASDQ:TWTI) and ProNAi Therapeutics (NASDQ:DNAI), Tolera Therapeutics. John is a current board member at Cour Pharmaceuticals and advisory board member of NewCures of Northwestern University. He is also a member of the Economic Club of Chicago.
Prior to Tolera, he was President and CEO of Third Wave Technologies (NASDAQ: TWTI), a biotechnology company, where he led the transformation of a non-sustainable genomics tools business into a robust growth-driven molecular diagnostics company primarily by leading the development of hard to detect infections and cancers. Third Wave was eventually sold for $600 million. John also served as a strategic consultant to DEKALB Genetics Corporation (NYSE) that was ultimately sold for $3.2 billion. Earlier in his career, John was with Spencer Stuart and Egon Zehnder International, in their life sciences practice groups where he consulted with biotech and pharmaceutical firms. After receiving his BS in Accounting from Northern Illinois University, John started his career at Arthur Andersen and also worked for Price Waterhouse. He received his MBA from the Kellogg School of Management at Northwestern University.
Catherine J. Mackey, Ph.D. brings over thirty years of accomplishment in the biotechnology, pharmaceutical, and agricultural industries to her role as Chairman of the Board. She is an experienced corporate director and currently serves on the Boards of Directors of Avid Bioservices (CDMO), and Trillium Therapeutics (TRIL). In addition she is a member of the Board of Directors of Rady Children’s Hospital and Rady Children’s Institute of Genomic Medicine. Dr. Mackey received her B.S. and Ph.D. degrees in microbiology from Cornell University. She is the former Vice President of DEKALB Genetics, Inc, and Sr. Vice President of Pfizer Global Research and Development.
Catherine J. Mackey, Ph.D. brings over thirty years of accomplishment in the biotechnology, pharmaceutical, and agricultural industries to her role as Chairman of the Board. She is an experienced corporate director and currently serves on the Boards of Directors of Avid Bioservices (CDMO), and Trillium Therapeutics (TRIL). In addition she is a member of the Board of Directors of Rady Children’s Hospital and Rady Children’s Institute of Genomic Medicine. Dr. Mackey received her B.S. and Ph.D. degrees in microbiology from Cornell University. She is the former Vice President of DEKALB Genetics, Inc, and Sr. Vice President of Pfizer Global Research and Development.
Jim is a financial and operations executive with over 25 years experience spanning finance, product development, manufacturing and regulatory, in both diagnostics and therapeutics. Jim co-founded Tolera Therapeutics, where he worked with CEO John Puisis to raise $20 million and bring its MAb therapy from pre-clinical to a Phase 3 Special Protocol Assessment. Prior to this, Jim served as CFO for Third Wave Technologies (NASDAQ: TWTI), where he oversaw long-range and annual planning, company-wide systems and infrastructure development, operational management as well as quality system oversight. Jim oversaw the company’s first FDA 510k filing for a molecular diagnostic and the launch of its multiplexing diagnostic platform. Jim is a graduate of the University of Notre Dame and the University of Chicago (MBA).
Jim is a financial and operations executive with over 25 years experience spanning finance, product development, manufacturing and regulatory, in both diagnostics and therapeutics. Jim co-founded Tolera Therapeutics, where he worked with CEO John Puisis to raise $20 million and bring its MAb therapy from pre-clinical to a Phase 3 Special Protocol Assessment. Prior to this, Jim served as CFO for Third Wave Technologies (NASDAQ: TWTI), where he oversaw long-range and annual planning, company-wide systems and infrastructure development, operational management as well as quality system oversight. Jim oversaw the company’s first FDA 510k filing for a molecular diagnostic and the launch of its multiplexing diagnostic platform. Jim is a graduate of the University of Notre Dame and the University of Chicago (MBA).
M. Roy First, M.D. was Vice President and Global Therapeutic Area Leader, Transplantation at Astellas Pharma Global Development, Inc. After graduating from medical school at the University of Witwatersrand in Johannesburg, South Africa, he moved to Chicago in 1972 to take the position of Renal Research Fellow at the Michael Reese Hospital.
In 1974, he was appointed Assistant Professor of Medicine in the Division of Nephrology at the University of Cincinnati, later becoming full Professor and Director of the Section of Transplantation, a position that he held until 2002, when he moved to Fujisawa (later Astellas). During his distinguished academic career, Dr. First has published more than 390 articles on transplantation, as well as 39 book chapters and two books. He is a past President of the American Society of Transplant Physicians (ASTP, subsequently AST) and has served on many United Network for Organ Sharing (UNOS) committees, including chairing the Organ Donation Committee, on the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA), as a reviewer for the National Institutes of Health (NIH), on the NIH Data Safety and Monitoring Board for Clinical Trials in Transplantation, and as a Councilor of the Transplantation Society. Dr. First has been on the editorial board of a number of journals including Transplantation, Transplantation Proceedings, Clinical Transplantation, the American Journal of Transplantation, and the Journal of the American Society of Nephrology. In 2013 he received the AST Lifetime Achievement Award.
M. Roy First, M.D. was Vice President and Global Therapeutic Area Leader, Transplantation at Astellas Pharma Global Development, Inc. After graduating from medical school at the University of Witwatersrand in Johannesburg, South Africa, he moved to Chicago in 1972 to take the position of Renal Research Fellow at the Michael Reese Hospital.
In 1974, he was appointed Assistant Professor of Medicine in the Division of Nephrology at the University of Cincinnati, later becoming full Professor and Director of the Section of Transplantation, a position that he held until 2002, when he moved to Fujisawa (later Astellas). During his distinguished academic career, Dr. First has published more than 390 articles on transplantation, as well as 39 book chapters and two books. He is a past President of the American Society of Transplant Physicians (ASTP, subsequently AST) and has served on many United Network for Organ Sharing (UNOS) committees, including chairing the Organ Donation Committee, on the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA), as a reviewer for the National Institutes of Health (NIH), on the NIH Data Safety and Monitoring Board for Clinical Trials in Transplantation, and as a Councilor of the Transplantation Society. Dr. First has been on the editorial board of a number of journals including Transplantation, Transplantation Proceedings, Clinical Transplantation, the American Journal of Transplantation, and the Journal of the American Society of Nephrology. In 2013 he received the AST Lifetime Achievement Award.
Michael Boyne, PhD. is an accomplished scientific professional. Before joining Cour, he was a Senior Consultant at BiotechLogic where he advised pharmaceutical manufacturers on drug development and CMC strategy, including drafting, reviewing, and authoring Pharmaceutical Quality/CMC sections (Module 3) of the CTD for regulatory submissions. Prior to consulting, he was a Research Chemist in the Division of Pharmaceutical Analysis at the US Food and Drug Administration where he established a laboratory developing and applying modern analytical technologies for the evaluation and regulation of complex drug products.
Michael has authored over 30 peer-reviewed publications and is an internationally recognized speaker on the application of modern analytical technologies. He is currently the chair of the 15th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry and sits on the organizing committee for the inaugural CASSS meeting on Cell and Gene Therapies.
Michael Boyne, PhD. is an accomplished scientific professional. Before joining Cour, he was a Senior Consultant at BiotechLogic where he advised pharmaceutical manufacturers on drug development and CMC strategy, including drafting, reviewing, and authoring Pharmaceutical Quality/CMC sections (Module 3) of the CTD for regulatory submissions. Prior to consulting, he was a Research Chemist in the Division of Pharmaceutical Analysis at the US Food and Drug Administration where he established a laboratory developing and applying modern analytical technologies for the evaluation and regulation of complex drug products.
Michael has authored over 30 peer-reviewed publications and is an internationally recognized speaker on the application of modern analytical technologies. He is currently the chair of the 15th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry and sits on the organizing committee for the inaugural CASSS meeting on Cell and Gene Therapies.
Greta Wodarcyk, PhD. is an experienced molecular biologist, having spent her career to date working in novel chemoprevention drug development, where she has led several multi-disciplinary, translational research projects.
Greta obtained her doctorate in biological sciences at Northwestern University. Her doctoral research focused on the nanoscale epigenetic structure-function relationship of chromatin in cancer cell chemo-evasion and the development of strategies to physiochemically target chromatin structure as a means of increasing chemotherapeutic efficacy. Previously, Greta worked as a research fellow at Mayo College of Medicine in Rochester, MN, where she developed clinical assays to quantify low levels of Metformin in patient blood plasma and customize dosage based on patient-specific metabolism. While at Northwestern University, Greta received a year-long fellowship from the NIH-funded Biotechnology Training Program as well as a two-year fellowship with the Robert H. Lurie Comprehensive Cancer Center Translational Bridge Program. Greta has authored several peer-reviewed publications that appear in top tier scientific journals such as Nature Biomedical Engineering and Proceedings of the National Academy of Sciences and has presented her work at several national research conferences.
Greta Wodarcyk, PhD. is an experienced molecular biologist, having spent her career to date working in novel chemoprevention drug development, where she has led several multi-disciplinary, translational research projects.
Greta obtained her doctorate in biological sciences at Northwestern University. Her doctoral research focused on the nanoscale epigenetic structure-function relationship of chromatin in cancer cell chemo-evasion and the development of strategies to physiochemically target chromatin structure as a means of increasing chemotherapeutic efficacy. Previously, Greta worked as a research fellow at Mayo College of Medicine in Rochester, MN, where she developed clinical assays to quantify low levels of Metformin in patient blood plasma and customize dosage based on patient-specific metabolism. While at Northwestern University, Greta received a year-long fellowship from the NIH-funded Biotechnology Training Program as well as a two-year fellowship with the Robert H. Lurie Comprehensive Cancer Center Translational Bridge Program. Greta has authored several peer-reviewed publications that appear in top tier scientific journals such as Nature Biomedical Engineering and Proceedings of the National Academy of Sciences and has presented her work at several national research conferences.
Robbin is a clinical operations executive with more than 22 years of experience building successful research programs in large academic and community cancer centers.
She recently came to COUR from a large global CRO where she led several patient and site centric operational programs. She is experienced in all areas of trial operations with a passion for streamlining operational efficiencies to ensure the safe delivery of investigational drugs into the outpatient setting. She has extensive experience in industry, cooperative group and investigator initiated clinical trials in all phases of the drug development process. She is a graduate of Oklahoma State University where she received her BSc in Zoological sciences and focused her graduate work in genetics and toxicology.
Robbin is a clinical operations executive with more than 22 years of experience building successful research programs in large academic and community cancer centers.
She recently came to COUR from a large global CRO where she led several patient and site centric operational programs. She is experienced in all areas of trial operations with a passion for streamlining operational efficiencies to ensure the safe delivery of investigational drugs into the outpatient setting. She has extensive experience in industry, cooperative group and investigator initiated clinical trials in all phases of the drug development process. She is a graduate of Oklahoma State University where she received her BSc in Zoological sciences and focused her graduate work in genetics and toxicology.
Dr. Joseph Podojil is an experienced investigator with a keen interest in the expression and function of the novel immune modulatory proteins and mechanisms. Dr. Podojil has extensive experience with the analysis of T cell and B cell responses both in vivo and in in vitro. During his graduate school training, Dr. Podojil’s work focused on the ability of neurotransmitters released from the sympathetic nervous system to modulate B cell function/antibody production during an immune response. During Dr. Podojil’s postdoctoral training, his primary research focus was to determine the cellular and molecular mechanisms underlying the differential effect of costimulatory and co-inhibitory molecules expressed by T cells to modulate immune cell function in disease models of multiple sclerosis, type-1 diabetes, and cancer.
Dr. Podojil has published manuscripts in top tier scientific journals including Nature, Nature Neuroscience, Nature Communications, Nature Reviews Immunology, the Journal of Biological Chemistry, and the Journal of Immunology. Dr. Podojil holds a B.S. in Molecular Biology from Benedictine University, and Ph.D. in Cell Biology, Neurobiology, and Anatomy from Loyola University Chicago Medical School. He has also trained at the Ohio State University and Northwestern University. Dr. Podojil has ten years of experience consulting with a number of biotechnology and pharmaceutical companies, having assisted in the development of new therapeutics from proof of concept through to Phase 1 clinical testing.
Dr. Joseph Podojil is an experienced investigator with a keen interest in the expression and function of the novel immune modulatory proteins and mechanisms. Dr. Podojil has extensive experience with the analysis of T cell and B cell responses both in vivo and in in vitro. During his graduate school training, Dr. Podojil’s work focused on the ability of neurotransmitters released from the sympathetic nervous system to modulate B cell function/antibody production during an immune response. During Dr. Podojil’s postdoctoral training, his primary research focus was to determine the cellular and molecular mechanisms underlying the differential effect of costimulatory and co-inhibitory molecules expressed by T cells to modulate immune cell function in disease models of multiple sclerosis, type-1 diabetes, and cancer.
Dr. Podojil has published manuscripts in top tier scientific journals including Nature, Nature Neuroscience, Nature Communications, Nature Reviews Immunology, the Journal of Biological Chemistry, and the Journal of Immunology. Dr. Podojil holds a B.S. in Molecular Biology from Benedictine University, and Ph.D. in Cell Biology, Neurobiology, and Anatomy from Loyola University Chicago Medical School. He has also trained at the Ohio State University and Northwestern University. Dr. Podojil has ten years of experience consulting with a number of biotechnology and pharmaceutical companies, having assisted in the development of new therapeutics from proof of concept through to Phase 1 clinical testing.
Dr. Adam Elhofy has over 14 years of scientific research experience in the areas of immunology, neuroscience, and oncology, with multiple publications and grants. He was funded by both the National Institutes of Health and the Multiple Sclerosis society as an investigator at Northwestern University Medical School. He has served in various roles from Principal Investigator of a Nanotech start-up to Chief Science officer. He developed the core technology for the Cell-Ess® line of products and aided in creating patents around novel uses of materials.
His doctoral research won him the award of the Top 5 trainee scientists by the American Association of Immunologists. Dr. Elhofy has 15 scientific publications in peer reviewed journals. He has played a variety of roles with start-up biotech companies ranging from Principal Investigator to Director of Corporate Development.
Dr. Adam Elhofy has over 14 years of scientific research experience in the areas of immunology, neuroscience, and oncology, with multiple publications and grants. He was funded by both the National Institutes of Health and the Multiple Sclerosis society as an investigator at Northwestern University Medical School. He has served in various roles from Principal Investigator of a Nanotech start-up to Chief Science officer. He developed the core technology for the Cell-Ess® line of products and aided in creating patents around novel uses of materials.
His doctoral research won him the award of the Top 5 trainee scientists by the American Association of Immunologists. Dr. Elhofy has 15 scientific publications in peer reviewed journals. He has played a variety of roles with start-up biotech companies ranging from Principal Investigator to Director of Corporate Development.
Nick is a proven manager and operator with a strong analytical background and strategic mindset. At COUR, he oversees long-term forecasting, program budgets, and key processes across finance, accounting, and operations. Previously, Nick worked at several high-growth companies in the online retail and fintechindustries. He has broad experience in functional areas such as strategy & analytics, sales operations, technology program management, and corporate finance. Nick has a BBA in Finance from the University of Notre Dame, and is currently pursuing an MBA through the Kellogg School of Management at Northwestern University.
Nick is a proven manager and operator with a strong analytical background and strategic mindset. At COUR, he oversees long-term forecasting, program budgets, and key processes across finance, accounting, and operations. Previously, Nick worked at several high-growth companies in the online retail and fintechindustries. He has broad experience in functional areas such as strategy & analytics, sales operations, technology program management, and corporate finance. Nick has a BBA in Finance from the University of Notre Dame, and is currently pursuing an MBA through the Kellogg School of Management at Northwestern University.
Jill is a financial executive with significant experience in financial and operational management. She initially joined Cour as Controller. Prior to joining Cour, Jill worked in financial management at two major media companies with an emphasis on earnings and process improvement. She started her career in banking and later joined the FDIC. Jill is a licensed CPA and she is a graduate of the University of Illinois (BS, Accountancy) and DePaul University (MBA).
Jill is a financial executive with significant experience in financial and operational management. She initially joined Cour as Controller. Prior to joining Cour, Jill worked in financial management at two major media companies with an emphasis on earnings and process improvement. She started her career in banking and later joined the FDIC. Jill is a licensed CPA and she is a graduate of the University of Illinois (BS, Accountancy) and DePaul University (MBA).
Tushar Murthy, Ph.D. is a Biotechnology Analyst at Cour where he currently helps manage and build the company’s intellectual property portfolio, develop business plans, monitor market developments and provide competitive intelligence to the R&D and management teams.
Tushar obtained a Ph.D. in Molecular Biology from Northwestern University where his doctoral thesis focused on the mechanism by which disease-associated mutations in splicing factor proteins contribute to the pathogenesis of hematologic disorders. His doctoral research has been published in major peer-reviewed journals.
While at Northwestern, Tushar earned a Certificate in Management from Northwestern University’s Kellogg School of Business and also gained experience in business and entrepreneurship via internships at the University’s Innovation and New Ventures Office and the N.XT Venture fund where he leveraged his technical expertise in conducting due diligence on technologies emerging from the University’s research labs.
Prior to graduate school at Northwestern University, Tushar worked in drug development at Walter Reed Army Institute of Research in Silver Spring, MD. Tushar also holds a Master’s degree in Biotechnology from Pennsylvania State University, University Park.
Tushar Murthy, Ph.D. is a Biotechnology Analyst at Cour where he currently helps manage and build the company’s intellectual property portfolio, develop business plans, monitor market developments and provide competitive intelligence to the R&D and management teams.
Tushar obtained a Ph.D. in Molecular Biology from Northwestern University where his doctoral thesis focused on the mechanism by which disease-associated mutations in splicing factor proteins contribute to the pathogenesis of hematologic disorders. His doctoral research has been published in major peer-reviewed journals.
While at Northwestern, Tushar earned a Certificate in Management from Northwestern University’s Kellogg School of Business and also gained experience in business and entrepreneurship via internships at the University’s Innovation and New Ventures Office and the N.XT Venture fund where he leveraged his technical expertise in conducting due diligence on technologies emerging from the University’s research labs.
Prior to graduate school at Northwestern University, Tushar worked in drug development at Walter Reed Army Institute of Research in Silver Spring, MD. Tushar also holds a Master’s degree in Biotechnology from Pennsylvania State University, University Park.
Samantha Genardi, PhD. is an experienced immunologist. In her current role at COUR Pharmaceuticals she designs pre-clinical and clinical assays, manages several COUR CNP Platform Products in pipeline development, and drafts regulatory documents for IND submissions. Samantha has been involved in the management of COUR’s pipeline product CNP-104 for the treatment of primary biliary cholangitis from the early concept stage up through IND submission.
Dr. Genardi obtained her doctorate in immunology at Northwestern University. Her doctoral research focused on the role of unconventional T cells (Natural Killer T cells, Mucosal Associated Invariant T cells) in methicillin-resistant Staphylococcus aureus infection. In addition to her immunology training in the lab, she was selected for a clinical collaboration between Northwestern University and the Infectious Disease (ID) department at Lurie Children’s Hospital to immerse Ph.D. candidates in the clinic.
Prior to graduate school, Dr. Genardi worked as a co-op student at Dana Farber Cancer Institute where she characterized knockdown of target genes using shRNA and CRISPR in cancer cell lines. Dr. Genardi also worked as a co-op student at GlaxoSmithKline where she generated and validated DNA oligo libraries to screen drug candidates.
Dr. Genardi has authored manuscripts in several peer-reviewed publications including Frontiers in Immunology, JEM, and PLOS Pathogens and has presented her work at several national research conferences.
Samantha Genardi, PhD. is an experienced immunologist. In her current role at COUR Pharmaceuticals she designs pre-clinical and clinical assays, manages several COUR CNP Platform Products in pipeline development, and drafts regulatory documents for IND submissions. Samantha has been involved in the management of COUR’s pipeline product CNP-104 for the treatment of primary biliary cholangitis from the early concept stage up through IND submission.
Dr. Genardi obtained her doctorate in immunology at Northwestern University. Her doctoral research focused on the role of unconventional T cells (Natural Killer T cells, Mucosal Associated Invariant T cells) in methicillin-resistant Staphylococcus aureus infection. In addition to her immunology training in the lab, she was selected for a clinical collaboration between Northwestern University and the Infectious Disease (ID) department at Lurie Children’s Hospital to immerse Ph.D. candidates in the clinic.
Prior to graduate school, Dr. Genardi worked as a co-op student at Dana Farber Cancer Institute where she characterized knockdown of target genes using shRNA and CRISPR in cancer cell lines. Dr. Genardi also worked as a co-op student at GlaxoSmithKline where she generated and validated DNA oligo libraries to screen drug candidates.
Dr. Genardi has authored manuscripts in several peer-reviewed publications including Frontiers in Immunology, JEM, and PLOS Pathogens and has presented her work at several national research conferences.
Dr. Kandela has spent more than fifteen years working on drug development at the interface of academia and industries. Her experience includes preclinical testing of small compounds, biologics, and devices, study protocol designs, animal model selections, creation of IACUC protocol and compliance, and project management. She worked at a Radiopharmaceutical company as Manager of the Biology Department in Madison, Wisconsin. She and her team filed seven patent applications and several INDs applications to FDA. During her tenure at Northwestern University as the Assistant Director of Developmental Therapeutics Core, she collaborated with more than 150 clients, including Academic and Company’s Principal Investigators, Professors, Post-docs, and graduate students.
Before joining Cour Pharmaceutical in July 2021, she joined a device manufacturing company, NeuroLux, as the Director of Operations. She is responsible for writing and submitting SBIR/STTR grant applications, organizing IACUC protocol, surgery suite for neuroscience-based laboratory, completing system and device manufacturing, managing collaboration with several academic collaboration and human resources aspects of the company.
Dr. Kandela received her Ph. D from the School of Pharmacy, University of Wisconsin-Madison, United States, and Bachelor of Science and Doctor of Pharmacy (Pharmacist) from Bandung Institute of Technology, Indonesia.
Dr. Kandela has spent more than fifteen years working on drug development at the interface of academia and industries. Her experience includes preclinical testing of small compounds, biologics, and devices, study protocol designs, animal model selections, creation of IACUC protocol and compliance, and project management. She worked at a Radiopharmaceutical company as Manager of the Biology Department in Madison, Wisconsin. She and her team filed seven patent applications and several INDs applications to FDA. During her tenure at Northwestern University as the Assistant Director of Developmental Therapeutics Core, she collaborated with more than 150 clients, including Academic and Company’s Principal Investigators, Professors, Post-docs, and graduate students.
Before joining Cour Pharmaceutical in July 2021, she joined a device manufacturing company, NeuroLux, as the Director of Operations. She is responsible for writing and submitting SBIR/STTR grant applications, organizing IACUC protocol, surgery suite for neuroscience-based laboratory, completing system and device manufacturing, managing collaboration with several academic collaboration and human resources aspects of the company.
Dr. Kandela received her Ph. D from the School of Pharmacy, University of Wisconsin-Madison, United States, and Bachelor of Science and Doctor of Pharmacy (Pharmacist) from Bandung Institute of Technology, Indonesia.
Sam is responsible for process design and management of new and existing manufacturing efforts. She is also involved in the translation of COUR therapies from R&D to production, building experimental plans targeting manufacturing considerations for products under development and scale-up. Samantha has over seven years of intensive hands-on experience in the startup biotechnology product development space. Most recently, she was a Project Manager and Product Development Engineer at a biotechnology company in Massachusetts developing innovative solutions for cell culture and tissue repair technologies. Samantha led all cleanroom operations and process development efforts for new and commercial products. Her background includes: cleanroom design (ISO 14644), design control, process validation, and Good Manufacturing Practices, (ISO 9001, 21 CFR Part 211), and lyophilization. Samantha received her Bachelor of Science degree in Chemical Engineering with a Biomolecular Concentration from the University of Notre Dame.
Sam is responsible for process design and management of new and existing manufacturing efforts. She is also involved in the translation of COUR therapies from R&D to production, building experimental plans targeting manufacturing considerations for products under development and scale-up. Samantha has over seven years of intensive hands-on experience in the startup biotechnology product development space. Most recently, she was a Project Manager and Product Development Engineer at a biotechnology company in Massachusetts developing innovative solutions for cell culture and tissue repair technologies. Samantha led all cleanroom operations and process development efforts for new and commercial products. Her background includes: cleanroom design (ISO 14644), design control, process validation, and Good Manufacturing Practices, (ISO 9001, 21 CFR Part 211), and lyophilization. Samantha received her Bachelor of Science degree in Chemical Engineering with a Biomolecular Concentration from the University of Notre Dame.
Deven is a solutions-oriented process engineer with a wide breadth of experience across the lifecycle of biologic processes from development through commercial support. At COUR, she will be responsible for process scale-up and tech transfer of advancing therapies as well as supporting manufacturing optimization efforts with an eye towards commercialization. Prior to joining COUR, Deven was a proven leader within MS&T at a fully integrated gene therapy company where she was responsible for all data management & process monitoring activities for Luxturna™, the first gene therapy product licensed for a genetic disease in the U.S.
Deven received her Bachelor of Science degree in Chemical Engineering from the University of South Carolina. She has a strong background in data analysis and has extensive experience leading cross-functional projects including process characterization, process validation, continued process verification / statistical monitoring, and technology transfer.
Deven is a solutions-oriented process engineer with a wide breadth of experience across the lifecycle of biologic processes from development through commercial support. At COUR, she will be responsible for process scale-up and tech transfer of advancing therapies as well as supporting manufacturing optimization efforts with an eye towards commercialization. Prior to joining COUR, Deven was a proven leader within MS&T at a fully integrated gene therapy company where she was responsible for all data management & process monitoring activities for Luxturna™, the first gene therapy product licensed for a genetic disease in the U.S.
Deven received her Bachelor of Science degree in Chemical Engineering from the University of South Carolina. She has a strong background in data analysis and has extensive experience leading cross-functional projects including process characterization, process validation, continued process verification / statistical monitoring, and technology transfer.
Abby S. Gelb, PhD. is an experienced bioanalytical mass spectrometrist with expertise in proteomics and glycoproteomics. At COUR, she is involved in the development of analytical analyses from R&D to QC.
Abby obtained her bachelor’s degree in chemistry from the University of Arizona in 2012 with 3 years of research experience. Her doctorate was completed at the University of Nebraska-Lincoln in 2018 with her doctoral research focused on ion mobility spectrometry coupled to mass spectrometry for the analysis and characterization of glycopeptides. In 2015, she was awarded an NIH T32 predoctoral training grant to extend her research towards clinical analysis of prostate cancer-related enzymes. Abby obtained a postdoctoral fellowship at the Edith Nourse Rogers Memorial Veteran’s Affairs Hospital (Bedford, Massachusetts) in collaboration with the Center for Biomedical Mass Spectrometry, Boston University School of Medicine in 2018 to analyze post-mortem brain tissue samples from Alzheimer’s patients for analysis by imaging mass spectrometry. In 2019, Abby moved full time to the Boston University to analyze glycoconjugates, specifically glycolipids, sourced from human and animal milks. Abby has authored several peer-reviewed publications appearing in Analytical Chemistry and The Analyst and has presented her work at several national and international research conferences.
Abby S. Gelb, PhD. is an experienced bioanalytical mass spectrometrist with expertise in proteomics and glycoproteomics. At COUR, she is involved in the development of analytical analyses from R&D to QC.
Abby obtained her bachelor’s degree in chemistry from the University of Arizona in 2012 with 3 years of research experience. Her doctorate was completed at the University of Nebraska-Lincoln in 2018 with her doctoral research focused on ion mobility spectrometry coupled to mass spectrometry for the analysis and characterization of glycopeptides. In 2015, she was awarded an NIH T32 predoctoral training grant to extend her research towards clinical analysis of prostate cancer-related enzymes. Abby obtained a postdoctoral fellowship at the Edith Nourse Rogers Memorial Veteran’s Affairs Hospital (Bedford, Massachusetts) in collaboration with the Center for Biomedical Mass Spectrometry, Boston University School of Medicine in 2018 to analyze post-mortem brain tissue samples from Alzheimer’s patients for analysis by imaging mass spectrometry. In 2019, Abby moved full time to the Boston University to analyze glycoconjugates, specifically glycolipids, sourced from human and animal milks. Abby has authored several peer-reviewed publications appearing in Analytical Chemistry and The Analyst and has presented her work at several national and international research conferences.
James M. Sulzberger is an industry vetted biopharmaceutical scientist with over a decade of industry experience. Jim has substantial experience designing and developing GMP-ready manufacturing processes and corresponding analytical methods for gene therapy vectors, VLPs, recombinant proteins, peptides, amino acids, and other therapeutic and diagnostic biological molecules expressed from bacterial, mammalian, plasma, plant, and other transgenic animal and plant sources.
Before joining COUR, Jim was a Technical Director at Aldevron LLC, where he was responsible for conceiving, designing, and guiding manufacturing processes and analytical methods for bacterially expressed proteins. Prior to this, Jim held consultant positions at Bio-Rad Laboratories and Pall Corporation (Danaher), where he was responsible consulting on developing, scaling, and validating downstream manufacturing processes for many different therapeutic modalities and expression systems.
As an industry key opinion leader for modern purification methods such as mixed-mode chromatography and continuous bioprocessing, Jim has presented purification theories and new methodologies at many global conferences annually (ACS Biot, PREP, Recovery, Pittconn). Jim is a graduate of Northeastern Illinois University (MS, Chemistry – Emphasis: Separation Sciences) and the University of Illinois at Chicago (BS, Biology).
James M. Sulzberger is an industry vetted biopharmaceutical scientist with over a decade of industry experience. Jim has substantial experience designing and developing GMP-ready manufacturing processes and corresponding analytical methods for gene therapy vectors, VLPs, recombinant proteins, peptides, amino acids, and other therapeutic and diagnostic biological molecules expressed from bacterial, mammalian, plasma, plant, and other transgenic animal and plant sources.
Before joining COUR, Jim was a Technical Director at Aldevron LLC, where he was responsible for conceiving, designing, and guiding manufacturing processes and analytical methods for bacterially expressed proteins. Prior to this, Jim held consultant positions at Bio-Rad Laboratories and Pall Corporation (Danaher), where he was responsible consulting on developing, scaling, and validating downstream manufacturing processes for many different therapeutic modalities and expression systems.
As an industry key opinion leader for modern purification methods such as mixed-mode chromatography and continuous bioprocessing, Jim has presented purification theories and new methodologies at many global conferences annually (ACS Biot, PREP, Recovery, Pittconn). Jim is a graduate of Northeastern Illinois University (MS, Chemistry – Emphasis: Separation Sciences) and the University of Illinois at Chicago (BS, Biology).
Sara Rupich, PhD, is an experienced nanoparticle chemist, who studied the synthesis and characterization of colloidal nanoparticles. Before joining Cour, she was the Scientific Officer of the International Institute of Nanotechnology at Northwestern University where she provided scientific oversight and assisted in the development of nanotechnology research, education, and mentoring programs. She oversaw the study design development and implementation of multi-disciplinary research projects in diverse areas including nanoparticle synthesis and assembly, materials synthesis and discovery, nanolithography, and nanoparticle-based immunology.
Sara has authored over 20 peer-reviewed publications that appear in top tier scientific journals including the Journal of the American Chemical Society, Nature Materials, and Nature Communications and has presented her work at several national research conferences. She earned her PhD from the University of Chicago and her B.S. in chemistry from the University of Rochester.
Sara Rupich, PhD, is an experienced nanoparticle chemist, who studied the synthesis and characterization of colloidal nanoparticles. Before joining Cour, she was the Scientific Officer of the International Institute of Nanotechnology at Northwestern University where she provided scientific oversight and assisted in the development of nanotechnology research, education, and mentoring programs. She oversaw the study design development and implementation of multi-disciplinary research projects in diverse areas including nanoparticle synthesis and assembly, materials synthesis and discovery, nanolithography, and nanoparticle-based immunology.
Sara has authored over 20 peer-reviewed publications that appear in top tier scientific journals including the Journal of the American Chemical Society, Nature Materials, and Nature Communications and has presented her work at several national research conferences. She earned her PhD from the University of Chicago and her B.S. in chemistry from the University of Rochester.
Qichen Xu, MS is a recent Biomedical Engineering graduate from Northwestern University where she worked on nanoparticle vaccine development. She has previous industrial experience with Genentech and Seattle Genetics where she worked on protein purification and analysis strategies.
Qichen holds a BS in Bioengineering from the University of Washington and an MS in Biomedical Engineering from Northwestern University.
Qichen Xu, MS is a recent Biomedical Engineering graduate from Northwestern University where she worked on nanoparticle vaccine development. She has previous industrial experience with Genentech and Seattle Genetics where she worked on protein purification and analysis strategies.
Qichen holds a BS in Bioengineering from the University of Washington and an MS in Biomedical Engineering from Northwestern University.
Dr. Lin graduated from University of Nebraska Medical Center where her doctoral research focused on the development of long-acting nanoformulations for the treatment and prevention of HIV/AIDS. At COUR Zhiyi oversees numerous research and product development activities including polymer development and new product designs and formulations. Zhiyi holds a BS in Tradition Chinese Medicine Development and an MS in Pharmaceutical Science from China Pharmaceutical University. She also had one-year internship in Chinese National Institute for Food and Drug Control. Zhiyi has published several peer-reviewed papers in top tier scientific journals such as Nature, Biomaterials, and Chemical Communications.
Dr. Lin graduated from University of Nebraska Medical Center where her doctoral research focused on the development of long-acting nanoformulations for the treatment and prevention of HIV/AIDS. At COUR Zhiyi oversees numerous research and product development activities including polymer development and new product designs and formulations. Zhiyi holds a BS in Tradition Chinese Medicine Development and an MS in Pharmaceutical Science from China Pharmaceutical University. She also had one-year internship in Chinese National Institute for Food and Drug Control. Zhiyi has published several peer-reviewed papers in top tier scientific journals such as Nature, Biomaterials, and Chemical Communications.
Sandeep Kakade, MS is a seasoned scientist and biomedical engineering expert in the field of drug/gene/vaccine delivery systems. He has studied and worked in nanomedicine for the past 11 years with more than 8 years of experience carrying out research in nanotechnology-based drug delivery systems for atherosclerosis, cancer and inflammatory diseases.
Prior to joining Cour, he worked as a Nanoparticle Scientist in Lonnie Shea’s lab at The University of Michigan. He has published in major peer-reviewed journals such as Langmuir and International Journal of Pharmaceutics. He has also presented his research findings at multiple research symposiums such as American Institute of Chemical Engineers annual meeting, Society of Biological Engineering’s Bioengineering and Translational Medicine Conference, The Society for Biomaterials Annual Meeting and Controlled Release Society Annual Symposium and Meeting.
Sandeep has a two Master’s degrees; one in Chemical Engineering from Iowa State University and another in Materials Science and Engineering from Wayne State University, Detroit, MI. He obtained his Bachelor’s degree in Chemical Engineering from B.M.S. College of Engineering, Bangalore, India.
Sandeep Kakade, MS is a seasoned scientist and biomedical engineering expert in the field of drug/gene/vaccine delivery systems. He has studied and worked in nanomedicine for the past 11 years with more than 8 years of experience carrying out research in nanotechnology-based drug delivery systems for atherosclerosis, cancer and inflammatory diseases.
Prior to joining Cour, he worked as a Nanoparticle Scientist in Lonnie Shea’s lab at The University of Michigan. He has published in major peer-reviewed journals such as Langmuir and International Journal of Pharmaceutics. He has also presented his research findings at multiple research symposiums such as American Institute of Chemical Engineers annual meeting, Society of Biological Engineering’s Bioengineering and Translational Medicine Conference, The Society for Biomaterials Annual Meeting and Controlled Release Society Annual Symposium and Meeting.
Sandeep has a two Master’s degrees; one in Chemical Engineering from Iowa State University and another in Materials Science and Engineering from Wayne State University, Detroit, MI. He obtained his Bachelor’s degree in Chemical Engineering from B.M.S. College of Engineering, Bangalore, India.
Carlos Montoya joined the COUR in 2018. As the Operations Supervisor, Carlos is responsible for overseeing the readiness of the COUR facilities and participating in the manufacture of pre-clinical and clinical materials in the GLP and GMP facilities. He has participated in several training programs since joining COUR, including the Comprehensive Pharmaceutical Aseptic course sponsored by the UT Health Science Center, Project Management Academy Training Course, and Certified Quality Improvement Associate from ASQ.
Carlos received his B.S. from the University of Illinois Urbana-Champaign in 2008 with a double major in Economics and Spanish. Carlos is also a certified fitness and training coach and an owner and operator of his own training center in Glenview, Illinois.
Carlos Montoya joined the COUR in 2018. As the Operations Supervisor, Carlos is responsible for overseeing the readiness of the COUR facilities and participating in the manufacture of pre-clinical and clinical materials in the GLP and GMP facilities. He has participated in several training programs since joining COUR, including the Comprehensive Pharmaceutical Aseptic course sponsored by the UT Health Science Center, Project Management Academy Training Course, and Certified Quality Improvement Associate from ASQ.
Carlos received his B.S. from the University of Illinois Urbana-Champaign in 2008 with a double major in Economics and Spanish. Carlos is also a certified fitness and training coach and an owner and operator of his own training center in Glenview, Illinois.
Janice is an experienced Project/Program Manager with years of working in academic research labs and biotech companies. Her research experiences in academic labs involve in the study of reactivation of latent virus in immunocompromised individuals and the mechanism of glioma stem cells and how it promotes chemoresistance in glioblastoma multiforme. She has participated and authored in academic journals during those years and continues to grow her interest in science. She also has experience working as a Clinical Data Analyst and a Variant Scientist at a cancer biotech company where she facilitated clinical data curation process and analyzed gene variant sequences in cancer patients. She then transitioned to work as a Project/Program Manager at an ECG Core lab company and managed various projects in clinical trials to completion. Janice holds a Bachelor of Science degree in Molecular Cellular Biology from the University of Illinois Urbana- Champaign and has studied at Northwestern University to further her science education.
Janice is an experienced Project/Program Manager with years of working in academic research labs and biotech companies. Her research experiences in academic labs involve in the study of reactivation of latent virus in immunocompromised individuals and the mechanism of glioma stem cells and how it promotes chemoresistance in glioblastoma multiforme. She has participated and authored in academic journals during those years and continues to grow her interest in science. She also has experience working as a Clinical Data Analyst and a Variant Scientist at a cancer biotech company where she facilitated clinical data curation process and analyzed gene variant sequences in cancer patients. She then transitioned to work as a Project/Program Manager at an ECG Core lab company and managed various projects in clinical trials to completion. Janice holds a Bachelor of Science degree in Molecular Cellular Biology from the University of Illinois Urbana- Champaign and has studied at Northwestern University to further her science education.
At COUR, Amanda is responsible to perform Quality Control testing to support clinical phase lot release and stability as well as research, preclinical and GLP products. She has 5 years quality experience having worked in quality assurance and quality control. Her experience includes working as a QC analyst at a fully integrated gene therapy company where she was involved in testing and releasing the first gene therapy drug to market. Amanda graduated from University of the Sciences in Philadelphia with a BS in Pharmaceutical Sciences.
At COUR, Amanda is responsible to perform Quality Control testing to support clinical phase lot release and stability as well as research, preclinical and GLP products. She has 5 years quality experience having worked in quality assurance and quality control. Her experience includes working as a QC analyst at a fully integrated gene therapy company where she was involved in testing and releasing the first gene therapy drug to market. Amanda graduated from University of the Sciences in Philadelphia with a BS in Pharmaceutical Sciences.
Kevin joined COUR in 2020 as an Inventory and Vendor Specialist. He brings with him over 20 years of retail operations experience and 12 years of accounting experience in the hotel industry. At COUR he assists with readiness of the COUR facilities and participates in the manufacture of pre-clinical and clinical materials in the GLP and GMP facilities. On the accounting side he assists on purchase order creation and accounts payable. Kevin attended Harper College where he majored in Accounting.
Kevin joined COUR in 2020 as an Inventory and Vendor Specialist. He brings with him over 20 years of retail operations experience and 12 years of accounting experience in the hotel industry. At COUR he assists with readiness of the COUR facilities and participates in the manufacture of pre-clinical and clinical materials in the GLP and GMP facilities. On the accounting side he assists on purchase order creation and accounts payable. Kevin attended Harper College where he majored in Accounting.
Abby Moynihan joined COUR in July 2020. Abby is an experienced auditor professional, previously working at top public accounting firms, KPMG and EY, as a CPA prior to COUR. Her background in auditing includes significant experience in inventory and financial audits. As the Operations Audit and Quality System Manager, Abby is responsible for regular audits of key components of the quality management system, specifically document control management and supplier- product quality management. Abby is a licensed CPA and holds a BS in Accounting from Truman State University and a MAcc from the University of Michigan.
Abby Moynihan joined COUR in July 2020. Abby is an experienced auditor professional, previously working at top public accounting firms, KPMG and EY, as a CPA prior to COUR. Her background in auditing includes significant experience in inventory and financial audits. As the Operations Audit and Quality System Manager, Abby is responsible for regular audits of key components of the quality management system, specifically document control management and supplier- product quality management. Abby is a licensed CPA and holds a BS in Accounting from Truman State University and a MAcc from the University of Michigan.
Madeline Gorczak joined COUR in April 2021. Madeline is an experienced auditor professional, previously working at a top public accounting firm, EY, as a CPA prior to COUR. Her background in auditing includes significant experience in financial and inventory audits. As the Operations Audit and Quality System Manager, Madeline is responsible for regular audits of key components of the quality management system, specifically document control management and supplier- product quality management. Madeline is a licensed CPA and holds a BS in Accountancy from The University of Illinois at Urbana Champaign.
Madeline Gorczak joined COUR in April 2021. Madeline is an experienced auditor professional, previously working at a top public accounting firm, EY, as a CPA prior to COUR. Her background in auditing includes significant experience in financial and inventory audits. As the Operations Audit and Quality System Manager, Madeline is responsible for regular audits of key components of the quality management system, specifically document control management and supplier- product quality management. Madeline is a licensed CPA and holds a BS in Accountancy from The University of Illinois at Urbana Champaign.
Emily graduated with her Bachelors in Psychology from Marquette University where she worked as a lab assistant and data manager collecting, analyzing, and entering lab data to further research in the field of Affective Neuroscience and emotional regulation. She went on to teach ABA therapy to children with autism followed by teaching preschool. At Cour, Emily is the Site Coordinator assisting in roles for Quality Document Control and organizational and management tasks.
Emily graduated with her Bachelors in Psychology from Marquette University where she worked as a lab assistant and data manager collecting, analyzing, and entering lab data to further research in the field of Affective Neuroscience and emotional regulation. She went on to teach ABA therapy to children with autism followed by teaching preschool. At Cour, Emily is the Site Coordinator assisting in roles for Quality Document Control and organizational and management tasks.
Ben Hoekstra joined the COUR Manufacturing Operations team in June 2021. As an Operations Technician, Ben helps maintain the COUR GMP and GLP manufacturing and laboratory facilities and assists in the manufacture of pre-clinical and clinical products. He also manages the maintenance and qualification activities for the analytical instruments in all COUR facilities.
Prior to joining COUR, Ben was involved in the regulated environmental industry. He worked on coastal water quality in Massachusetts with the USDA and on hazardous waste management at Northwestern University. Ben received a Bachelor of Arts in Chemistry from Grinnell College.
Ben Hoekstra joined the COUR Manufacturing Operations team in June 2021. As an Operations Technician, Ben helps maintain the COUR GMP and GLP manufacturing and laboratory facilities and assists in the manufacture of pre-clinical and clinical products. He also manages the maintenance and qualification activities for the analytical instruments in all COUR facilities.
Prior to joining COUR, Ben was involved in the regulated environmental industry. He worked on coastal water quality in Massachusetts with the USDA and on hazardous waste management at Northwestern University. Ben received a Bachelor of Arts in Chemistry from Grinnell College.