The Next Generation of Vaccines

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BlueWillow’s Management Team

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David Peralta

Chief Executive Officer

Dave Peralta has served as the company’s Chief Executive Officer since 2013. He joined BlueWillow (then known as NanoBio Corporation) in 2006 and served as the company’s Chief Operating and Financial Officer through 2012. Dave was promoted to Chief Executive Officer in 2013 and has directed the company’s strategic shift towards use of its nanotechnology platform for the development of intranasal vaccines for respiratory and sexually transmitted diseases.

Prior to joining BlueWillow, Dave served as Chief Financial Officer for Arbortext, Inc., a venture-backed enterprise software company, up through the company’s acquisition in 2005. Before joining Arbortext, Dave served for six years as the Chief Financial Officer of Mechanical Dynamics, a publicly-held software company, where he directed all finance and investor relations activities during the company’s initial public offering and up through the sale of the company in 2002.

Dave earned a BBA, with distinction, from the University of Michigan Ross School of Business.  He currently resides in Northville, MI, with his wife Rose and their four children.

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.

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.

Susan Ciotti, Ph.D.

Director 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 Associate 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.

Douglas M. Smith, Ph.D.

Director of Immunology

Dr. Smith joined BlueWillow Biologics in November 2013 with over 20 years of experience in immunology, including cellular and antibody-based immunotherapies and vaccines against cancer and infectious diseases. He received a B.Sc. degree in microbiology and immunology from McGill University and a Ph.D. in immunology from the University of Chicago. As Principal Scientist and Immunology Program Leader at Aastrom Biosciences, Inc., he established and directed programs for clinical-scale production of dendritic cell vaccines, T-lymphocyte-based adoptive immunotherapies, and immunologic characterization of an adult stem cell product for human tissue repair. Dr. Smith gained extensive experience in the development, characterization, and evaluation of nanoemulsions as novel adjuvants for induction of mucosal and systemic immunity as a faculty member of the Michigan Nanotechnology Institute for Medicine and Biological Sciences (2008–2013) at the University of Michigan. He is currently responsible for development of NanoVax-PanFlu, a nanoemulsion-adjuvanted vaccine against H5N1 pandemic influenza, and other mucosal vaccines to prevent respiratory or sexually-transmitted diseases such as herpes simplex virus and HIV/AIDS.

Frank J. Malinoski, MD, PhD

Clinical Consultant

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.

Regulatory Consultant

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.

Stephen (Steve) Gracon, DVM

Regulatory Consultant

Steve Gracon served as BlueWillow’s Vice President of Regulatory Affairs from 2008 through July 2015, and now serves as a consultant to the company. He has over 30 years of experience in the pharmaceutical industry, including roles at Parke-Davis, Pfizer, Amgen, and Baxter. Steve brings a diversity to BlueWillow, having previously spent eight years in preclinical pathology and experimental toxicology, and more than a decade in clinical research, during which he lead the development of the tacrine (Cognex), the first drug approved for the treatment of Alzheimer’s disease. He then moved to regulatory affairs, gaining both U.S. and international regulatory experience.