Michael Hickey is the VP of Clinical Operations at Bio-Path Holdings, LLC, a small biotech focused on developing liposomal antisense oligonucleotides in leukemia, lymphoma and solid tumors. With over 26 years of experience at large and small sponsors including 6 years on the CRO side, Michael brings a truly collaborative approach and broad expertise in oncology and rare disease clinical drug development. His clinical experience has focused on challenging indications such as head-and-neck cancer, colorectal cancer, breast cancer with BRCA mutations as well as chemotherapy induced myelosuppression, hemophilia, and Battens Disease.
Archives: Speakers
Lauren Neighbours
Ravipal Luthra
INGRID OAKLEY-GIRVAN, PHD, MPH
As a scientist, researcher, and educator for more than 25 years, Ingrid looks at healthcare from a holistic perspective — ensuring a patient-driven focus is combined with data-driven science. Using digital data to promote precision medicine, Ingrid focuses on increasing the pace of medical discoveries and ultimately bringing therapies to patients faster, as well as delivering solutions to people when they want them and where they want them. As Senior Vice-President of Research and Strategy for Medable Inc., Ingrid uses strong technical, analytic and genetics background to improve the clinical trial experience for patients. The focus is on modernizing clinical trials, the digital virtual healthcare space, and creating technology and tools to collect precision data so we can get solutions to patients in half the time.
ANDREA PATTON, PHD
Andrea Patton, PhD is a Senior Behavioural Epidemiologist who leads the prevalence research team within the Centre for Substance Use Research Ltd (CSUR), Glasgow, United Kingdom. Andrea has over 15 years of experience working in public health in the United Kingdom for academia, regulatory bodies and industry.
Stephen Khan
John Daly
Dr. William Jackson, PhD
Dr. Tony Jones
NANCY SACCO PHD
Focusing on key role of participants in clinical studies with opportunities for healthcare access and contributions to diversity in clinical trials
Current and former role as VP, Clinical Operations (SiteBridge Research, Takeda, Revance); VP Clinical Development (Meitheal/Xentria, AnaptysBio) and Head of Strategic Operations/Clinical Research Operations (Pfizer, Avexis, Astellas) leveraging early and late stage Drug Development and global clinical trials experience toward creating a high-performance teams and outsourcing plans for clinical trials
Experience in Global Development, Clinical Operations, Scientific Strategy and Clinical Affairs over the last 20+ years from bench to commercial; mergers, licensing and acquisitions and organizational evolution
Global experience including reports both within NA and outside US (including Canada, Eu, Jpn)
Former Astella’s Board member on AVOCA, Operations Committee member with Transcelerate, scientific development liaison for IFPMA/WHO Clinical Fellowship program.
Key driver — business case as part of Takeda strategy for Asia development operations in Singapore
Therapy areas of experience: Women’s Health, Musculo-skeletal Disorders, Oncology, Immunology/Inflammation, InfDiseases, Urology/Nephrology, CKD, Metabolic Diseases, CNS/Pain/Movement Disorders
Notable career achievements:
Contributions to development, regulatory submissions and/or approval of DaxibotulinumtoxinA, ZolgenSMA, Myrbetriq, Xtandi, Rozerem, Cresemba, ACTOS, Lipitor, Lyrica, Actonel; numerous INDs/ODAs including mabs for rare diseases, pivotal trials for dermatologic and respiratory diseases
Developing global strategy for Astellas’ Global Operating Model/Global Project Team, including implementation in US, EU and Jpn ; this model remains in place for some 2000+ colleagues in Astellas Medical/Development.
Globalizing Clinical Operations at Takeda, establishing ‘business units’ with Clinical Program Managers/Study Manager in alignment with key TAs for which Takeda was developing compounds and having high stds/global processes to run projects from Phase I – IV, including internal processes and those for overseeing outsourced study management activities.
Recognized leader and mentor Pfizer, Takeda and Astellas as a leader and mentor.