Leadership

  • Management
  • Board of Directors
  • Scientific Advisory Board
James Mackay President & CEO
Nihar Bhakta, M.D. Chief Medical Officer
John Montana Chief Operating Officer
Sara McCutchan Senior Regulatory Affairs Manager
Deanne Reid Director, Operations
James Mackay President & CEO
Kenneth Harrison Principal, Novo Ventures
Tiba Aynechi Partner, Novo Ventures
Ciara Kennedy President & CEO, Amplyx Pharmaceuticals, Inc
Brian Kotzin, M.D. (Chair) SVP, Clinical Development at Nektar Therapeutics, Inc.
Jay Birnbaum, Ph.D Clinical and Regulatory Consultant
Co-Founder of Hallux, Inc.
Michael Howell, Ph.D SR Director of Translational Research at Incyte Corporation
Camilla Simpson, MSc Managing Member and President of Rare Strategic, LLC
James Mackay President & CEO

James Mackay, PhD, Founder, President and Chief Executive Officer, has over 25 years of development and commercialization expertise in the pharmaceutical industry, including 6 drug product approvals across multiple therapeutic areas. Prior to founding Aristea, he was President and Chief Executive Officer of Ardea Biosciences, Inc., following the company’s acquisition by AstraZeneca in 2012. James was instrumental to setting up an innovative model for Ardea Biosciences that retained the biotech’s independence and accountability for the development of the gout franchise while also developing a synergistic and collaborative relationship with the parent company, AstraZeneca. Prior to Ardea, James held senior executive positions at AstraZeneca where he led the development and commercialization of drugs across a range of therapy areas. and managed significant global functional departments.

James plays a pivotal role in the San Diego Ecosystem and currently sits on the Board and Executive Committee of CONNECT and sits on the Board of BIOCOM. He is a former Board member of the San Diego Economic Development Corporation (EDC). James holds a BS in Genetics and PhD in Medical Genetics from Aberdeen University, Scotland.

Nihar Bhakta, M.D. Chief Medical Officer

Dr. Bhakta brings extensive experience in strategic clinical development, medical affairs, market evaluation, patient advocacy and regulatory oversight to Aristea. This experience includes multiple successful IND and NDA submissions to the U.S. FDA and MAA filings to the EMA. Most recently, Dr. Bhakta was Project Team Leader at Gossamer Bio (Gossamer). Prior to Gossamer, Dr. Bhakta served in several key positions at Ardea Biosciences (acquired by AstraZeneca in 2012) including Global Clinical Lead of the Gout Franchise. Dr. Bhakta has previously served in medical positions of increasing responsibility at Bristol Myers Squibb and Roche. Dr. Bhakta completed his training at the Cleveland Clinic Foundation for his residency and at UCLA Medical Center for his subspecialty training.

Dr. Bhakta received an A.B. in Biology from Brown University, M.D. from Penn State College of Medicine, and Board Certification in Pediatrics and Pediatric Nephrology. Dr. Bhakta is an author or co-author on numerous scientific publications and is a licensed physician in the state of California.

John Montana Chief Operating Officer

John Montana, Chief Operating Officer, has a proven track record in advancing discovery and development stage assets in pharmaceutical companies over the last thirty years, including 4 drug product approvals in multiple therapeutic areas. Prior to joining Aristea, he was Vice President, Project Management and Finance for Ardea Biosciences. Following the company’s acquisition by AstraZeneca in 2012, John was a strategic leader and member of the site Executive Team, responsible for leadership and management of portfolio governance and execution level teams, and maintained key interactions with the wider AstraZeneca organization. Prior to Ardea, he was Vice President, Portfolio Management for Anadys Pharmaceuticals (acquired by Roche) and Executive Director and Site Leader, Development Operations for Pfizer, La Jolla. Prior to that, John was Project Leader, Research and Development at Genetic Systems Corporation.

John is currently an Advisory Board Member for BioPharmaPM. He received his Bachelor of Science degree in Microbiology/Immunology from the University of Washington and a Project Management Professional (PMP) Certification from the Project Management Institute.

Sara McCutchan Senior Regulatory Affairs Manager

Sara McCutchan, Senior Regulatory Affairs Manager, has significant regulatory and quality assurance expertise in global marketing authorizations in diverse markets. Prior to joining Aristea, she played an integral role in the Regulatory Affairs function at Ardea Biosciences where she obtained and managed marketing authorizations in the US, EU, Latin America, Australia, and New Zealand. Sara has proven experience in managing projects and people across a range of providers and licensing partners. In addition to her Regulatory Affairs role at Ardea, Sara spent several years in Quality Assurance where she supported three successful FDA inspections, managed internal quality systems, and employee training.

Sara holds a BS in Cognitive Science from the University of California, San Diego and has a Regulatory Affairs Certification (RAC).

Deanne Reid Director, Operations

DeAnne Reid, Director of Operations, has deep experience in successfully leading Operations across a range of industries. At Aristea, she is accountable for Finance, HR, IT and Administration. Prior to joining Aristea, she led administrative planning for all functional areas at Ardea Biosciences and managed specific projects including FDA Advisory Committee preparation and two successful Business Development deals. Prior to joining Ardea, she held administrative and operations roles at Genentech, The Advantage Network and Tang Capital Management.

James Mackay President & CEO

James Mackay, PhD, Founder, President and Chief Executive Officer, has over 25 years of development and commercialization expertise in the pharmaceutical industry, including 6 drug product approvals across multiple therapeutic areas. Prior to founding Aristea, he was President and Chief Executive Officer of Ardea Biosciences, Inc., following the company’s acquisition by AstraZeneca in 2012. James was instrumental to setting up an innovative model for Ardea Biosciences that retained the biotech’s independence and accountability for the development of the gout franchise while also developing a synergistic and collaborative relationship with the parent company, AstraZeneca. Prior to Ardea, James held senior executive positions at AstraZeneca where he led the development and commercialization of drugs across a range of therapy areas. and managed significant global functional departments.

James plays a pivotal role in the San Diego Ecosystem and currently sits on the Board and Executive Committee of CONNECT and sits on the Board of BIOCOM. He is a former Board member of the San Diego Economic Development Corporation (EDC). James holds a BS in Genetics and PhD in Medical Genetics from Aberdeen University, Scotland.

Kenneth Harrison Principal, Novo Ventures

Ken joined Novo Ventures (US) Inc. in San Francisco, California in 2015.

Ken brings experience as a Senior Market Planning Manager at Genentech, where he helped guide strategic decision making for the Ophthalmology and HER2 franchises. Prior to Genentech, Ken worked as a management consultant at L.E.K. Consulting and as the Entrepreneurship Program Manager at QB3/Mission Bay Capital, where he helped create new programs to launch and support life sciences companies in the Bay Area.

Ken studied cellular lipid storage and metabolism as an A.P. Giannini Foundation Fellow at the J. David Gladstone Institutes, earned a PhD in Pharmacology from Yale University, and has a BS in Molecular Biology from Texas Tech University, where he was a Howard Hughes Medical Institute undergraduate research fellow.

Tiba Aynechi Partner, Novo Ventures

Tiba joined Novo Ventures (US) Inc. in San Francisco, California in 2010. She is a member of the Board of Directors of AnaptysBio Inc., Arcellx Inc., Nkarta, Inc., Cianna Medical Inc., iRhythm Technologies Inc., Battersea, and Spruce Biosciences. Previously, she was a board member of Thesan Pharmaceuticals Inc. Tiba has more than 10 years of combined research and banking experience in life sciences that spans various therapeutic areas and technology platforms. Prior to joining Novo Ventures (US) Inc., Tiba was a Director with Burrill & Company where she has completed regional and cross-border M&A, licensing, and financing transactions for biotech and large pharmaceutical companies.

Tiba received her PhD from the Graduate Group in Biophysics at the University of California, San Francisco where her research involved developing computational methods for drug discovery. She has an undergraduate degree in physics from the University of California, Irvine. Tiba is also a published author of scientific articles and book chapters in the area of rational drug design.

Ciara Kennedy President & CEO, Amplyx Pharmaceuticals, Inc

Dr. Kennedy joined the Aristea Board of Directors in May 2019. Currently, Dr. Kennedy serves as President and CEO of Amplyx Pharmaceuticals, Inc. Prior to Amplyx, Dr. Kennedy was COO of Lumena Pharmaceuticals, driving the development of assets licensed from Pfizer and Sanofi and securing venture capital financing. Lumena was acquired by Shire Pharmaceuticals in June 2014. Prior to Lumena, she was a senior strategist and VP of operations at Cypress Bioscience, where she played a key role in obtaining FDA approval for Savella®, a therapy for fibromyalgia. Additionally, Dr. Kennedy held several positions in the program and alliance department of Biogen Idec, managing projects spanning the drug discovery and development continuum.

Dr. Kennedy received her doctorate at the Queen’s University of Belfast, Northern Ireland, and continued her research in the field of apoptotic proteases at the Sanford Burnham Prebys Medical Discovery Institute in La Jolla, California. In 2004, she became a member of the inaugural class of the Rady School of Management at University of California, San Diego, where she earned her MBA.

Brian Kotzin, M.D. (Chair) SVP, Clinical Development at Nektar Therapeutics, Inc.

Brian Kotzin, M.D., Chair of Aristea’s SAB, is a board-certified rheumatologist and internist with more than three decades of experience in the fields of inflammation and immunology in academia and industry. Currently, Dr. Kotzin is Senior Vice President, Clinical Development at Nektar Therapeutics, Inc. Before Nektar, Dr. Kotzin served as Vice President of Global Clinical Development and Head of the Inflammation Therapeutic Area at Amgen, directing the global development efforts for Amgen’s inflammation product candidates. During his 11 years at Amgen, he also served as Vice President of Medical Sciences, which encompassed early development, biomarker development, and clinical immunology. Prior to his industry career, Dr. Kotzin served as Head of Clinical Immunology in the Department of Medicine and Director of the Autoimmunity Center of Excellence at the University of Colorado Health Sciences Center in Denver. Dr. Kotzin has authored more than 200 publications in medical journals, books and book chapters, and has served on the editorial boards of Arthritis and Rheumatism, The Journal of Immunology and the Journal of Clinical Investigation. Dr. Kotzin received a B.S. in mathematics from the University of Southern California and an M.D. from Stanford University School of Medicine. He completed a residency in internal medicine and a fellowship in rheumatology and medicine at Beth Israel Hospital in Boston. He was a postdoctoral fellow in the Division of Immunology and Rheumatology at Stanford University School of Medicine. He is board certified in rheumatology and internal medicine.

Jay Birnbaum, Ph.D Clinical and Regulatory Consultant
Co-Founder of Hallux, Inc.

Jay Birnbaum, Ph.D. is a recognized drug development consultant with more than 30 years of experience spanning discovery research, formulation, clinical R&D, regulatory, and marketing. He has been instrumental in the development of numerous dermatology drugs, devices and consumer product brands including Lamisil® antifungal products, Cyclosporine Neoral® and Elidel®, Kybella®, Apligraf®, and Skin Caviar®. Dr. Birnbaum is the co-founder of Hallux, Inc. and was a co-founder and Chief Medical Officer of Kythera Biopharmaceuticals (acquired by Allergan). Previously, he was Executive Vice President of Global Product Development at Thesan Pharmaceuticals, Vice President, Global Project Management at Novartis/Sandoz and he held several key positions at the Medical and Consumer Products Divisions of American Cyanamid Corporation (Wyeth). He has served as a member of the board of directors of Sonoma Pharmaceuticals, Excaliard Pharmaceuticals (acquired by Pfizer), and Hallux, Inc. and the scientific advisory boards of many companies. Dr. Birnbaum received a B.S. degree from Trinity College and a Ph.D. in Pharmacology from the University of Wisconsin.

Michael Howell, Ph.D SR Director of Translational Research at Incyte Corporation

Michael Howell, Ph.D., is an experienced immunologist with more than 15 years of experience in the development of immunological, autoimmune and inflammatory disease drugs. He is the designer of translational medicine approaches supporting clinical development, patient stratification, and personal health care strategies for all clinical phases and has been actively involved in numerous regulatory filings including IND, CTA, PMDA, and NDA applications.

Currently, Dr. Howell serves as the Senior Director of Translational Research at Incyte Corporation. Prior to joining Incyte Corporation, Dr. Howell was an assistant professor in the Division of Pediatric Allergy and Clinical Immunology at National Jewish Health before transitioning to industry where he has held positions of increasing responsibility at Boehringer Ingelheim, Immune Tolerance Network and MedImmune/AstraZeneca. Throughout his career, Dr. Howell’s research has been highlighted in national and international meetings, publications, and patents for therapeutic interventions and biomarker strategies. Dr. Howell received a B.S. in Biology from Messiah College and a Doctor of Philosophy (Ph.D.) in Microbiology and Immunology from the West Virginia University School of Medicine.

Camilla Simpson, MSc Managing Member and President of Rare Strategic, LLC

Camilla Simpson, MSc, has over two decades of business and strategy experience across a diverse group of organizations in biotech, large pharma and rare disease advocacy. Throughout her career, Ms. Simpson has demonstrated a proven track record in delivering novel products for many rare disease indications to global markets in areas of high unmet medical need. Currently, Ms. Simpson is the Managing Member and President of Rare Strategic, LLC, where she provides global regulatory and product development guidance to rare disease and gene therapy companies. Prior to this, Ms. Simpson held numerous executive leadership positions including SVP, Head of Product Portfolio Development at BioMarin Pharmaceutical Inc. and VP Global Regulatory Strategy Early Development and Business Development at Shire Pharmaceuticals in the United Kingdom. Ms. Simpson serves as an independent member of the board of directors of Spruce Biosciences, Inc. Ms. Simpson received a BSc, Science from National University of Ireland, Galway, a BSc Hons, Chemistry from Kingston University and a MSc with distinction, Analytical Chemistry from Birkbeck College, University of London.