Richard J. Fitzpatrick, PhD, MBA, Chief Executive Officer
Richard Fitzpatrick, PhD, MBA is a co-founder of Flatley Discovery Lab and serves as its CEO and CSO. Richard received his PhD in Chemistry from the Pennsylvania State University and his MBA from Babson College. He has spent more than 20 years in biotechnology working on a wide variety of projects, including DNA and peptide synthesis, protein separation and purification, and drug discovery and development. Prior to FDL, Richard spent ten years at Genzyme Corporation as a Principal Scientist working in drug discovery for infectious disease, oncology, and metabolic indications.
Claudia Ordonez, MD, Chief Medical Officer
Claudia Ordoñez, MD is our Chief Medical Officer. Claudia joined FDL on October 2015 with 10 years of industry experience in early and late stage programs. Prior to joining FDL, Claudia served as Senior Medical Director at Biogen, where she led the clinical development program for Tecfidera. Before that, she served as Senior Medical Director at Vertex Pharmaceuticals where she led the development and registration of Kalydeco. Claudia served as an Instructor in Pulmonary Medicine at Boston Children’s Hospital from 1998 to 2014. She earned a MD from the University of California San Francisco, and a BA from the University of Maryland.
John Wm. Ferkany, PhD, MAS, Senior Vice President, Development
John Ferkany, PhD, MAS serves as Flatley Discovery Lab’s Senior Vice President for Development and is responsible for all non clinical safety and manufacturing efforts. John joined FDL in early 2013 and brings over 30 years of industry experience in to the organization. He has managed research and discovery teams, and has extensive experience in progressing drug candidates from the laboratory through the development process. His background in discovery science as well as understanding of the regulatory process has contributed to FDL’s advancement of multiple candidates from the laboratory to clinical trials. John’s knowledge of the mid stage biopharmaceutical process makes him an ideal fit to the FDL environment. John has a BS in Zoology from the University of Michigan where he graduated with honors, a PhD in Biomedical Sciences (Pharmacology) from the University of Texas Medical Center at Houston as well as a Masters Degree in Administrative Science awarded from the Johns Hopkins University in Baltimore.
Andrew Kolodziej, PhD, DABT, Vice President for Preclinical Safety
Andrew Kolodziej, PhD, DABT joined Flatley Discovery Lab in 2011 with more than 20 years experience in drug discovery, and has served as Vice President, Nonclinical Safety since 2014. Prior to his role in toxicology, he was Vice President of Research where he was responsible for leading the CFTR modulator discovery programs. Andrew worked at EPIX Pharmaceuticals where he was Product Leader for the company’s cystic fibrosis drug discovery programs. His early career at EPIX focused on developing targeted molecular imaging contrast agents for MRI diagnosis of thrombosis and fibrosis. He received a B.S. with Honors from the University of Chicago, and a PhD in chemistry from MIT, and is a co-author on dozens of peer reviewed publications and co-inventor on several US patents.
Jianmin Mao, PhD, Senior Director, CMC
Jianmin Mao, PhD, joined FDL in 2015. Jianmin brings more than 17 years of experience in small molecule drug discovery and development, having held positions at both biotechnology and pharmaceutical companies across a broad range of therapeutic areas. Most recently, Jianmin served as a principal scientist at Melinta Therapeutics, where he contributed to the success of Baxdela (Delafloxacin). Prior to that, Jianmin devoted his effort in oncology drug development with ArQule, where he contributed to the development of numerous anti-cancer agents, most notably Tivantinib. He is an author of more than 30 peer-reviewed publications and is an inventor on 12 patents. Jianmin received his BS in chemistry from Lanzhou University, China and his PhD in organic chemistry from the same University.
Jenna Tagliaferri, Senior Director of QA
Jenna is the Senior Director of Quality Assurance. Jenna joined FDL in March of 2018 and has over 30 years of experience in quality systems, drug development, formulations, and program management. Prior to joining FDL Jenna has held senior positions in QA and Program Management for a number of pharmaceutical, biotechnology, and device companies including Altea Therapeutics, CibaVision-Alcon, Advisys, and Kimberly-Clark. Jenna is well-versed in quality management and GMP practices and has managed the overall quality for startups as well as for fully integrated organizations carrying out research, development, testing, manufacturing and clinical trials. She is particularly adept in the development of Quality Systems for newer or emerging organizations. Jenna received her BS in Biology from North Carolina State University.
Mayur S. Dudhedia, Director CMC
Mayur S. Dudhedia joined Flatley Discovery Lab (FDL) in 2018 as the Director of CMC. Over the past 20 years, he worked at Boehringer Ingelheim Pharmaceuticals with roles of increasing responsibilities and most recently as an independent pharmaceutical consultant. He brings extensive and diverse CMC experiences to FDL with expertise in inhalation product development (drug-device combo/metered dose inhalers), solid oral dosage form development, technology assessments and their applications in drug product development to enable formulations and progressing them through various stages of development and global regulatory approval.
Also, he was a lead (US team) member of international Task force for DP Differentiation to minimize medication error. He has embraced the core values of “Lead and Learn” principles and was a recipient of numerous Boehringer Ingelheim Development awards.
He has over 27 presentations at national meetings and publications in peer-reviewed scientific journals including patents. Mayur has a Masters in Pharmaceutical Sciences, a degree in pharmacy and wide-ranging pharmaceutical development experience, and is currently focused on leading development of FDL’s cystic fibrosis portfolio.
Timothy O’Toole, Director of Clinical Operations
Timothy O’Toole, MS, CPH Director, Clinical Operations: Pharmaceutical professional with over 30 years of Biotechnology/Pharmaceutical experience. Prior to joining Flatley Discovery Laboratory, LLC in 2017, he served in clinical operations leadership roles at Alkermes, Wyeth, EMD Serono, and Sotio. Timothy received his MS in Pharmacology from Northeastern University, CPH from Harvard Extension, and BA from Boston College.
Mauri Krouse, PhD, Director of Biology
Mauri E Krouse joined Flatley Discovery Lab in 2012 as Principal Scientist. Prior to FDL, Dr. Krouse worked on cystic fibrosis and CFTR function at Stanford University for 25 years. At FDL he was promoted to Head of Electrophysiology, then Director of Electrophysiology, and has been Director of Biology for the last 2 years. He developed the first potentiator assay at FDL and was pivotal in progressing both correctors and potentiators through pre-clinical testing and onto clinical trials. He received his PhD in Biology from Caltech, and is a co-author on many peer reviewed publications and is highly regarded in the CF community.
Mary Hoffee, MS, MBA, Director of Program and Portfolio Management
Mary Hoffee is the Director of Program and Portfolio Management. Mary Joined FDL in April of 2017. Mary has over 20 years of experience in drug development, program, portfolio and CMC management of early and late stage programs. Prior to joining FDL, Mary was the program director for vaccine programs and co-development programs involving checkpoint modulators at Agenus. She has managed early stage programs (research to Phase I) for biologicals at ImmunoGen Inc as well as Phase I and II CMC programs at Biogen. Mary was program executive for multi-phase biosimilar programs at Epirus. Mary has a MS in biology from Northeastern University and a M.B.A from the Olin School of Business at Babson College.