Chief Executive Officer
Previously, Randy Milby was Chief Executive Officer of CorMedix, Inc. (NYSE American:CRMD). Prior to CorMedix, Mr. Milby was co-founder and a managing director of WaterStone Bridge, LLC, a healthcare consulting services firm. In his 11-year tenure at DuPont Company, he held several management positions, most recently Global Business Director, Applied Biosciences. From 1998 through 1999, Mr. Milby was a Healthcare Analyst at Goldman Sachs & Company. Mr. Milby received his Pharmacy degree at the University of Kansas and his MBA from Washington University, St. Louis.
J. Michael Ramstack, Ph.D.
Head of Clinical Manufacturing
Dr. Ramstack has played a significant impact on moving complex therapeutic formulations from the research bench to clinical trials to approved products including RISPERDAL CONSTA®, VIVITROL® and BYDUREON® extended release microspheres. Previously Dr. Ramstack worked with Tarveda (formerly Blend) Therapeutics, Cerulean Pharma, Alkermes, DuPont and Johnson & Johnson, where he had positions of increasing responsibilities in the areas of medical device design, drug product development, process development and manufacturing scale-up. He is an author on several peer-reviewed publications and holds numerous patents. He received his Ph.D. in Chemical Engineering and M.S. in Biomedical Engineering from Northwestern University and a B.S. in Mechanical Engineering from the University of Notre Dame.
Trinh T. Le, M.B.A.
Head of Clinical Operations
Ms. Le is a clinical professional with over 25 years of broad operational and industry experience across the biotechnology, pharmaceuticals and contract research organization industries. She currently serves as a Principal at Collaborative Clinical Research Consulting, Inc. She has held senior level positions at Intellikine (acquired by Takeda), SGX Pharmaceuticals (acquired by Eli Lilly), Metabasis Therapeutics (acquired by Ligand) and Chiltern International. She earned an MBA from University of Redlands and a B.A. with a focus in biology and chemistry from University of California, San Diego.
Richard Lowenthal, M.Sc. M.B.A.
Head of Regulatory
Mr. Richard Lowenthal is an executive with over 28 years of Medicinal Product Development, Project Management, Regulatory Affairs and Quality Assurance experience in various roles at both small and large biotechnology or pharmaceutical companies. Mr. Lowenthal has extensive experience with strategic global development as well as product registration of biologics, new drugs and drug or biologic and device combinations in the United States, Europe and Japan. He also has extensive experience with global business collaborations and evaluation of product licensing or investment opportunities. Mr. Lowenthal, as a past FDA review in both the Division of Neuropharmacology Drug Products and Division of Oncology at the US FDA, has direct experience working within the Agency that facilitates interactions and an understanding of the FDA perspective.
Taunia Markvicka, Pharm.D., M.B.A.
Taunia has more than 25 years of pharmaceutical experience from regulatory/clinical to new product planning and commercialization. She served previously as Chief Commercial Officer (CCO) of Symbiomix Therapeutics, which was sold to Lupin Pharmaceuticals. She was also CCO at Pacira Pharmaceuticals, where she took the company public and successfully launched EXPAREL®. Prior to Pacira, Taunia held commercial leadership positions with Advantage Healthcare serving roles with Biovail and Reliant, The Medicines Company, and Allergan (formerly Watson Pharmaceuticals). She entered the pharmaceutical industry after completing a post-doctorate fellowship with Novartis. Taunia began her career as a hospital pharmacist.
Taunia earned her doctorate in pharmacy from the University of Nebraska Medical Center and post-doctoral fellowship with Rutgers University/Sandoz Pharmaceuticals. She went on to complete her MBA at St. Joseph’s University. She completed her Bachelors in Pharmacy at Creighton and practiced as a registered pharmacist prior to her pharmaceutical industry career.
Lynne A. Bui, M.D.
Lynne A. Bui, MD is the Co-Founder, President and CEO of Khloris Biosciences, Inc. She is a board-certiﬁed hematologist oncologist, seasoned entrepreneur, angel investor and drug developer, having unparalleled experience in basic, translational and clinical research spanning over 15 years with direct patient care and leading clinical development programs from preclinical IND enabling studies to Phase 1 to 3 registration studies for multiple approved drugs. She has held senior level positions at Exelixis, Onyx, and Intellikine, and has experience with small molecules, antibodies, dendritic cell vaccines, gene therapies, embryonic stem cells, and cell therapies. She is also the Founder and Chairman of Global Cancer Research Institute (GCRI) and GCRI Foundation. She received her M.D., internal medicine residency and hematology/oncology fellowship from UCLA School of Medicine, and her B.A. in molecular and cellular biology with an emphasis in neurobiology from UC Berkeley.
Grace M. Furman, Ph.D. D.A.B.T.
Head of Toxicology
Grace received her Ph.D. in Biomedical Sciences with a specialization in toxicology from Northeastern University in Boston, MA (1992). She also holds a B.S. in toxicology (1986) and has been a Diplomate of the American Board of Toxicology since 2000. Grace is an active member of the American College of Toxicology (ACT) and has served ACT as a 2-term Council member (2009-2011 and 2017-2019), a member of the Nominating Committee (2008), as Secretary (2013-2014), and as co-chair (2017/2018) and chair (2018/2019) of the Education Committee. Grace is also an active member of the Society of Toxicology and the Southern California Chapter of the Society of Toxicology and has held several Executive Council positions, including President, within the Regional Chapter. Grace is chair emeritus of the San Diego Biotechnology Discussion Group and a founding member of San Diego's Women in Biosciences. Additionally, Grace designed and instructed the "Toxicology" classroom and distance-learning courses offered through University of California/San Diego Extension's Drug Discovery and Development and AMDET Process Certificate Programs (2005-2014).