Chad Costley, MD/MBA
President and Chief Operating Officer
Dr. Chad Costley became the President and Chief Operating Officer of BlueWillow Biologics in July 2020 after previously serving as Chief Medical Officer and as a member of the Board of Directors of the company. As the managing director of two investment groups, he’s been involved in the advancement of BlueWillow’s science for over 15 years.
Dr. Costley has 20 years of clinical practice experience as a primary care physician and has advised and served on the Boards of Directors of several technology companies. Dr. Costley is responsible for the overall strategic leadership of both the vaccine and topical antiseptic programs of the company.
Dr. Costley holds MD and BA degrees from the University of Michigan where he also completed medical residency training in family medicine. He also earned a MBA with distinction from Emory University as a Woodruff Scholar.
Ali I. Fattom, Ph.D.
Senior Vice President Vaccine Research and Development
Dr. Fattom joined BlueWillow Biologics in November 2010 with 25 years of experience in vaccine research and development. He initiated his career as a vaccinologist at the National Institutes of Health, where he helped develop several vaccines including Pneumococcus conjugate vaccine, and headed the effort for developing a S. aureus vaccine. He later joined Univax Biologics to pursue the development of conjugate vaccines against bacterial infections including Staphylococci. Following the merger between Univax and North American Biologics to form Nabi Biopharmaceuticals, Dr. Fattom assumed responsibility for other research activities and served as Vice President of Research from 2003 to 2010. He earned a B.S. from The Hebrew University of Jerusalem, a M.S. in microbiology from Tel-Aviv University, and a Ph.D. in Microbial Ecology from the Hebrew University of Jerusalem. From 1983–1986 he held an assistant professorship at Bir-Zeit University, West Bank. Dr. Fattom is author of over 50 peer-reviewed publications, and holds more than 10 patents.
Susan Ciotti, Ph.D.
Vice President & Head of Formulations
Dr. Ciotti directs the development of novel nanoemulsion systems for the treatment of various dermatological conditions and vaccines for intranasal and intramuscular administration. She is also responsible for developing novel formulations to support the nanoemulsion platform, process optimization, and scale-up activities for those formulations. Before joining BlueWillow Biologics, she was an Associate Research Fellow at Pfizer Global R&D in Ann Arbor. She led all the formulation efforts for the Dermatology programs. Prior to joining Pfizer, she was a Principal Scientist in the Topical Formulations & Drug Delivery Technology Resource Center at Johnson & Johnson. Dr. Ciotti is currently an Adjunct Professor of Pharmaceutical Sciences at the University of Michigan, College of Pharmacy in Ann Arbor, Michigan. She lectures on Advanced Drug Delivery Systems and Nanotechnology. She is also a reviewer for several journals, served as an invited speaker at several international conferences, and has been a guest speaker at the FDA in the field of novel drug delivery technologies and nanotechnology.
Tarek Hamouda, MD, Ph.D., MBA
Senior Director of Clinical Research
Dr. Hamouda has over 20 years of experience in vaccine and antimicrobial drug development, including leading pre-clinical research programs and directing Phase 1 through Phase 3 vaccine clinical trials. Prior to joining BlueWillow, he served as the medical director and medical monitor for Pfenex, Inc., a clinical stage vaccine and biosimilar company. Dr. Hamouda has expertise in immunology, microbiology, and molecular biology techniques with experience in GLP labs, GMP manufacturing, and extensive knowledge in pre-clinical research, clinical research and regulatory affairs. He is an inventor on 17 patents and an author of numerous scientific publications covering anti-infective and vaccine research. He received a Ph.D. in microbiology and immunology as well as an MD in medicine and surgery from Cairo University in Egypt, and an MBA from Michigan State University.
Shyamala Ganesan, Ph.D.
Principal Scientist/Program Manager
Dr. Ganesan has over 13 years of combined academic and industrial experience in immunology, microbiology, biochemistry, and cell signaling. She joined BlueWillow Biologics after having served as a Principal Research Scientist at TSRL, Inc., where she worked on the development of antiviral therapeutics. Her technical expertise includes vaccine formulation, assay development, molecular biology/biochemistry techniques, purification and production of viral and cellular proteins under non-GMP conditions, analytical test method development, and validation. At BlueWillow Biologics, Dr. Ganesan is involved in the development of nanoemulsion adjuvanted vaccines against infectious diseases and peanut allergy. She received a B.Sc in Microbiology from University of Madras, and a M.S. and Ph.D. in Microbiology from Birla Institute of Technology and Science, Pilani. She is the author of over 25 peer-reviewed publications.
Frank J. Malinoski, MD, PhD
Frank Malinoski serves as a clinical consultant to BlueWillow. He has over 30 years of experience in the pharmaceutical industry, including roles in the US Military, Lederle-Praxis, Nabi, Wyeth, MedImmune, Liquidia Technologies, EveliQure Biotechnologies, and consultative services to government and NGOs. Frank’s experience spans all phases of clinical development, regulatory consultation, and multiple levels of company management. His product focus has been in anti-infectives, including adult and pediatric vaccines as well as immunotherapy on both a national and international arena. Frank has substantially contributed to the development of vaccines for pneumococcus, influenza, meningococcus, as well as combination pediatric vaccines and RSV immunoprophylaxis.
Frances Kivel, M.S.
Clinical Operations Consultant
Francie Kivel serves as a clinical consultant to BlueWillow, bringing expertise in clinical development, clinical operations, and project management. She has over 30 years of experience across the pharmaceutical, biotechnology and device industries, drawing from her roles at Parke-Davis, Pfizer, Aastrom (now Vericel) and her last 7 years of consulting with small and start-up companies. Francie’s expertise ranges from development of corporate strategy to management of clinical programs to operationalizing clinical trials. She participated in the successful global clinical development of atorvastatin (Lipitor) and pregabalin (Lyrica) and has contributed to several successful INDs as a consultant.
Fiona Cameron, B.Sc.
Fiona Cameron serves as a regulatory affairs consultant to BlueWillow and has over twenty-three years of experience in the regulatory field. Prior to becoming a consultant, she held the positions of Director of Regulatory Affairs at Genentech, Inc., where she played a major role in the approval of Rituxan® for non-Hodgkin’s lymphoma, and Senior Director of Regulatory Affairs at VaxGen, Inc., where she led a collaboration with a Japanese company to evaluate a smallpox vaccine. She works with multiple clients advising on development strategies and writing national and international investigational and marketing applications. She has considerable experience with live viral and bacterial vaccine programs as well as with recombinant protein vaccines.