Michael Spector – President and Chief Executive Officer
Mr. Spector was named President and Chief Executive Officer of Caelum and a member of the board of directors in January 2017. He joins Caelum from Fortress Biotech, where he leveraged more than 25 years of biotechnology experience to identify emerging and innovative technologies to launch as new biotech and specialty pharmaceutical companies. Prior to Fortress, Mr. Spector served as Senior Vice President, Global Commercial Operations at Iroko Pharmaceuticals. Earlier in his career, he spent 15 years at GlaxoSmithKline in multiple senior management positions, including Vice President and General Manager of GlaxoSmithKline South Africa, where he led the overall business strategy and was elected to run the South African Pharmaceutical Manufacturers Association. Mr. Spector is also a founding member of Windhoek Healthcare, where he launched two specialty pharmaceutical companies: Laurel Pharmaceuticals and North Creek Pharmaceuticals. Mr. Spector holds an M.B.A. from Rider University in Lawrenceville, N.J., where he serves on the Business and Scientific Advisory Boards, and a B.S. in biology from the University of Pittsburgh. He also serves on the Board of Directors of Jacaranda Health, a nonprofit organization that seeks to transform maternal and neonatal healthcare in East Africa.
Susan Sobolov, Ph.D. – Chief Operating Officer
Dr. Sobolov joined Caelum as Chief Operating Officer in March 2019. Prior to Caelum, Dr. Sobolov was Vice President of Program Management at Mustang Bio from August 2018 until March 2019. Dr. Sobolov began working with Caelum and Mustang in November of 2017 when she joined Fortress Biotech as Vice President of Program Management. Prior to Fortress, Dr. Sobolov was a Research and Development Team Leader at Alexion where she led the late stage development of Strensiq™, an enzyme replacement therapy for hypophosphatasia, and led Alexion’s collaborations with Blueprint and Moderna. Before joining Alexion, Dr. Sobolov was Global Head of the PMO at Novartis Institute of Biomedical Research. Earlier in her career she was Vice President and Program Executive for Incivek™ in late stage development at Vertex. Dr. Sobolov began her industry career at Pfizer as a medicinal chemist in oncology providing development support for Tarceva™ and rose through positions of increasing responsibility to Senior Director and Global Development Team Leader in Neuroscience. She holds a PhD., MS, and M.Phil degree in organic chemistry from Yale University. Dr. Sobolov completed an American Cancer Society post-doctoral fellowship at Harvard Medical School in enzymology and molecular biology.
Michael Imperiale, M.D. – Chief Medical Officer
Dr. Imperiale joined Caelum as Chief Medical Officer in June 2019. He joins Caelum from Nektar Therapeutics, where he led the development of their immuno-oncology program. Prior to Nektar, Dr. Imperiale was Global Medical lead for Medical Affairs at BioMarin where he led the Lysosomal Storage disease and PKU franchises. Dr. Imperiale was Director, Clinical Trial Development at Exelixis, Inc. where he was responsible for U.S. Food and Drug Administration clinical filings, building external investigator relationships, and overseeing oncology and nephrology clinical trial programs. Dr. Imperiale began his career in drug development at Boehringer-Ingelheim Pharmaceutical Corporation, where he initiated the International Medical Affairs division for Virology; in recognition for his achievements, he received the prestigious Medical Marketing Award. He received a Doctor of Medicine with an Academic Distinction in Medicine from Hahnemann University School of Medicine and a Bachelor of Arts degree from Villanova University.
Eileen Daniel – Senior Vice President, Development Operations
Ms. Daniel joined Caelum in March 2019 with three decades of clinical operations leadership as sponsor, CRO and entrepreneur. Her experience spans all phases of clinical development across a diversity of therapeutic areas and functional domains for multi-national programs. At Nektar Therapeutics, Ms. Daniel led the clinical operations teams responsible for trials in oncology, immunology and pain. At Endo Pharmaceuticals, her clinical operations and data management teams were accountable for delivery of programs in pain, oncology, and endocrinology. At Reliance Life Sciences in India, she developed infrastructure and capabilities to transform BA/BE clinics for conduct of first in human studies. Prior to her biopharmaceutical roles, Ms. Daniel spent over 15 years at Covance where she held multiple management positions, including VP and General Manager of the cardiac safety business unit. She is co-founder of myClin, a clinical study collaboration platform used by sponsor companies to connect clinical trial stakeholders and document evidence of oversight. Ms. Daniel is a graduate of the University of Nevada and the Templeton Advanced Management Programme at the University of Oxford.
Daniel R. Brady, Ph.D. – Head of Regulatory Affairs
Dr. Brady has been leading Regulatory Affairs at Caelum since January 2017. Dr. Brady received his Bachelor of Science degree in Biology from Creighton University, his Master of Arts in Biology from the University of Nebraska at Omaha, and his PhD (Anatomy) at the University of Iowa. After his post-doctoral training at the City of Hope he began his career of over 30 years in clinically based research. He initially focused on human neurodegenerative disorders while at the National Institutes of Health (National Institute on Aging), where he also served as a Special Government Employee for the FDA. He subsequently joined the Global Regulatory Affairs Department at Eli Lilly and Company, from which he retired after 17 years. His scientific acumen, pharmaceutical development knowledge and regulatory expertise allow him to successfully drive drug development and commercialization opportunities employing creative strategies and meticulous implementation. Dr. Brady attributes his success in regulatory affairs to his emphasis on patients, science and regulations, in that order.
Anthony S. Lubiniecki, Sc.D. – Head of CMC
Dr. Lubiniecki has been leading CMC at Caelum since March 2019. Dr. Lubiniecki is a member of AL Associates LLC, a consulting firm for biopharmaceutical development and CMC issues of biotechnology products. He retired from Janssen R&D, LLC in 2017 as Senior Scientific Director & Fellow, CMC Strategy, Pharmaceutical Development & Manufacturing Sciences. During his 43 years in industry, he worked on development of over 50 recombinant derived investigational products using both microbial and eukaryotic expression systems, of which thirteen have become marketed products, including Simponi, Stelara, Sylvant, Darzalez, and Tremfya during his 13 years at Janssen R&D LLC. At Janssen, he served as CMC Strategist on a number of large molecule projects including daratumumab and several cell therapy projects, and as Vice President of Cell Culture and Tech Transfer. At GlaxoSmithKline and predecessor firms, he was Vice President of biopharmaceutical development for 16 years. At Genentech, he was Director, Cell Culture Process Development for 6 years. Dr. Lubiniecki also has been active in shaping regulatory policy by serving as a Pharmaceutical Research & Manufacturers of America representative to the International Conferences on Harmonization (ICH) Expert Working Groups for 6 Q5-Q7 guidance documents, and served as Rapporteur for two of them (ICH Q5D & Q5E). He was a member of the HHS Secretary’s Advisory Committee on Xenotransplantation, a member of the Department of Commerce Material Technical Advisory Committee, and advisor to the Department of Defense biodefense measures program through the National Research Council/National Academy of Sciences. He earned his Doctor of Science degree in Public Health Microbiology from the University of Pittsburgh in 1972, and his Bachelor of Science degree in Biological Sciences from Carnegie Mellon University in 1968. He is also Adjunct Professor of Chemical & Biochemical Engineering at University of Maryland Baltimore County since 1991.