Brian has over 25 years of experience founding and building successful technology companies. He was chairman and CEO of Sterilmed, a medical device company, from 2003 until its sale to Johnson & Johnson for $330 million in 2011. Previously he was co-founder and CEO of Recovery Engineering, a filtration company that he took public and subsequently sold to Proctor and Gamble for $265 million in 1999. He has received nine U.S. patents. He graduated magna cum laude with distinction from Harvard College with an A.B. degree in economics.
Lance’s career spans more than 20 years in drug discovery research and technology development. He received his doctorate in biophysics and biochemistry from Johns Hopkins University and completed a National Institutes of Health postdoctoral fellowship at Washington University Medical School. He has received 22 U.S. patents. His drug discovery research career began at Scriptgen/Anadys Pharmaceuticals (purchased by Novartis), where he worked under Professor Peter Kim, the recently retired president of Merck Research Laboratories. Most recently, Lance served as an executive director for an international drug discovery and development company.
Lance has built a world-class science team that includes drug discovery, cell signaling, high-throughput drug screening, molecular oncology and human primary cell culture scientists.
Vicky has more than 20 years of financial leadership experience, including the past 10 years in the healthcare industry. Prior to joining Celcuity, Vicky served as Controller of Respiratory Technologies Inc., a medical device manufacturer. While at Respiratory Technologies, she played a key role in the due diligence process to sell the company to Koninklijke Philips. Prior to Respiratory Technologies, she served as Controller for Ability Network Inc., a healthcare information technology company. From September 2007 through June 2012, Vicky served as Controller of Sterilmed Inc., a medical device reprocessing company, where she played a key role in the sale of the company to Johnson & Johnson. Prior to these roles, Vicky held several senior financial positions at SimonDelivers Inc., including Chief Financial Officer. Vicky has extensive experience in early stage, high growth companies with responsibilities including financial controls and stewardship, financial analysis, mergers and acquisitions, building infrastructure, and systems. She received a Bachelor of Science degree in Finance and Accounting from Northern State University and received her CPA certificate in 1990.
Igor has over two decades of hands-on oncology drug development experience, including successful regulatory IND and NDA/BLA filings across several drug classes. Prior to joining Celcuity, Igor worked for MEI Pharma (MEI), an oncology focused biopharmaceutical company, where he was the VP of Clinical Development. MEI’s pipeline included zandelisib, an oral PI3K-delta inhibitor. He had previously served as the VP of Clinical Science at Iovance Biotherapeutics, as a Global Clinical Leader at Bayer Pharmaceuticals, and as a Senior Medical Director at Daiichi-Sankyo a global pharmaceutical company. At Bayer, his responsibilities included leadership of the Global Clinical Development Team for ALIQOPA (copanlisib), a pan-PI3K inhibitor approved by the FDA for treatment of patients with follicular lymphoma. Prior to joining industry, he was a practicing clinician treating a broad range of tumor types in adults and children. Igor received his medical training at Omsk State Medical Academy with specialty training in clinical immunology at Chelyabinsk State Medical Academy.
Nadene has over 20 years of experience working in clinical operations for clinical-stage pharmaceutical and biotechnology companies. She has broad experience in therapeutic areas (oncology, psychiatry, rheumatology & pain, pulmonology, infectious disease, and women’s health). Before joining Celcuity, Nadene held positions of increasing responsibility at Pfizer, Cypress Bioscience, Aragon Pharmaceuticals, and Daré Bioscience, leading to NDA submissions and approvals for milnacipran (Savella®) and apalutimide (ERLEADA®), and XACIATO™, respectively.
Nadene holds a Bachelor of Science Degree in Health Science from San Diego State University and a Master of Science in Clinical Research Administration from George Washington University.
Bernhard has over 30 years of drug development experience in the pharmaceutical and biotech industries, including 10 years in large, fully integrated pharmaceutical companies, including Gilead and GSK. He received his PhD in Medicinal Chemistry from the University of Georgia in 1989. Bernhard has authored/co-authored publications in peer-reviewed journals and is the co-inventor on patents on the manufacture of antiviral drugs.
Mark Mannebach, Ph.D., R.Ph., has over thirty years of experience in the Pharmaceutical Industry, with the majority of these years in Regulatory Affairs, with additional expertise in Quality Assurance, Program Management, and Pharmaceutical Sciences. Mark has been a regulatory consultant for the last five years for several start-up biotech companies. Before being a regulatory consultant, he was the VP of Global Regulatory Affairs at Mallinckrodt Pharmaceuticals and Santen Pharmaceutical. Earlier in his career, Mark held roles of increasing responsibility at Sanofi, Pharmacia, Baxter, and Pfizer.
Mark has broad experience in developing branded & specialty pharmaceuticals and biologics in many therapeutic areas, including oncology, ophthalmology, pain management, CNS, metabolic disorders, cardiovascular diseases, and rare diseases. Mark has experience interacting and meeting with many health authorities, including FDA & Health Canada in North America, EMA, AEMPS, BfArM, MHRA, MPA & ANSM in the EU, PMDA & CFDA (NMPA) in Asia, and ENVISA (Brazil) and TGA (Australia).
David has over 30 years of experience as a quality assurance leader, including quality oversight responsibilities for laboratory, manufacturing, and clinical functions. Prior to joining Celcuity, David was Director of Quality Assurance at the Duke University Clinical Research Institute, one of world’s largest academic clinical research organizations. He had previously served as Senior Director, Quality Assurance for Chimerix, a biopharmaceutical company developing antiviral therapies, and Clinical Quality Assurance Leader at EMD Pharmaceuticals, the US affiliate for Merck KGaA.
Pratima has over 20 years of expertise in the field of hematology-oncology. She has broad experience launching products for acute and chronic leukemias, solid tumors, transplant, benign hematology, and immunology. Before joining Celcuity, Pratima was the Senior Medical Director at Atara Biotherapeutics. She led the medical affairs activities to develop a leading allogeneic T-cell therapy in the US and Europe. Prior to that, she held leadership roles of increasing responsibility at Agios, Rigel, Ariad/Takeda, Jazz Pharmaceuticals, and Becton Dickinson. Before transitioning to industry, Pratima worked at Stanford University in the Department of Medicine.
Pratima received her medical training at The Vijaynagar Institute of Medical Sciences in India and The University of California San Francisco with a specialty in Infectious Diseases.
Fred has over 30 years of program management and clinical operations experience in the pharmaceutical industry. Before joining Celcuity, Fred was VP of Clinical Operations at CytomX Therapeutics where he oversaw the execution of their oncology programs, including a Phase 2 program in breast cancer. Prior to CytomX, Fred was with the immuno-oncology company Immune Design, a subsidiary of Merck, where he was the VP of Project Management and Clinical Operations. Fred also spent 10 years at Johnson & Johnson, where he served in various program management, new product development and strategic marketing roles. He has an MBA in science and technology from LaSalle University and a BS degree in psychology / biochemistry from Texas A&M University.
John has over 30 years of experience in all aspects of pharmaceutical drug development and licensing. He led the preclinical and clinical R&D efforts at MGI Pharma, an oncology-focused company, from 1996 through 2005, and served as a consultant through MGI’s acquisition by Eisai in 2008. Prior to MGI he worked in large pharma at Warner-Lambert (now Pfizer) and in academia as an NIH funded researcher at UC San Francisco. Since 2006 he has remained active in drug development as a consultant advising academic institutions, startup and small pharma companies as the founder of Ridge Road Consulting and as the acting CEO of PepTx, Inc., a University of Minnesota startup. Dr. MacDonald earned a PhD in Pharmacology and Toxicology from the University of Arizona.