Archives: Speakers

Michelle Carpenter, J.D., RAC has extensive work experience in regulatory affairs and project management. Michelle is currently serving as the EVP of Regulatory Affairs and Project Management at Star Therapeutics since January 2020. Prior to this, they worked at RPSpharma as the President since September 2013. Michelle has also worked as an instructor at UCSC Extension Silicon Valley from January 2014 to August 2023. Michelle has held leadership positions at True North, Afferent Pharmaceuticals, Acucela Inc., Dow Pharmaceuticals, Oculus Innovative Sciences, Dey Labs, and Santen, Inc. Michelle has successfully led various regulatory and clinical strategies, obtained regulatory approvals, and negotiated development programs and clinical studies throughout their career.

Michelle Carpenter, J.D., RAC has a comprehensive education history. Michelle earned their J.D. degree in health law from Golden Gate University, School of Law, attending from 1987 to 1991. Prior to that, they attended UC Santa Barbara, where they pursued a B.A. degree in sociology with a focus on biology, chemistry, and sociology. However, specific start and end years for their undergraduate studies are unavailable at this time.

Ms. Lane has over 25 years of experience in the Pharma/Biotech industry in clinical operations and project management. She is currently the VP of Clinical Operations at Star Therapeutics and has held leadership positions at Genentech, Avalanche, Geron, Pfizer and Sanofi. Her extensive experience in Clinical Operations includes operational execution of phase II-IV trials across multiple therapeutic areas, as well as IND,BLA, CTA filings. She has vast experience in CRO/vendor management, program and clinical site management and monitoring as well as patient recruitment.

Hayley Mason MPA, is a dedicated professional with a fervent commitment to promoting effective governance and public policy. Holding a Master of Public Administration (MPA) degree from American University in Washington, DC, and a Bachelor’s degree in Global Affairs from George Mason University, Hayley brings a comprehensive understanding of governmental structures, policy analysis, and program evaluation to her advocacy work for individuals with rare diseases. Throughout her career, Hayley has focused on enhancing public service delivery and driving positive societal change.

Hayley’s journey began as an intern for the United States Senate and then at the Ability Center of Virginia, a nonprofit organization dedicated to supporting children and adults with disabilities lead productive lives in Virginia Beach, Virginia.

Drawing from these diverse experiences, Hayley currently serves as a Policy Analyst with the National Organization for Rare Disorders. In this role, she collaborates with advocates, Congress, and government officials to champion increased treatments, access, and inclusion for individuals living with rare diseases. Driven by a profound desire to effect meaningful societal change, Hayley is committed to inspiring others to pursue excellence in public service and harnessing the power of effective governance for the betterment of all

Head of Clinical Operations for Epic Bio, where he oversees all Clinical Operations activities in support of Epic’s clinical trials. He has a background in patient care setting, as well as research-focused clinics on the ground level of clinical trials before moving into research management. For the last 20+ years he has led cross-functional teams carrying out global multicenter trials – in all phases of drug development – and multiple therapeutics areas including Neuro, Oncology and Immunology. He has experience with both large and small molecules therapeutics as well as gene therapies and now epigenetic therapies with Epic Bio.

For the last decade his focus has been on building capabilities for startup Biotechs to tackle rare and ultra-rare diseases and has launched first-in-human therapeutics for companies like Genentech, Audentes, Cytokinetics, Jasper Therapeutics and Kezar Life Sciences.

Ken has an International Executive MBA in Business and Finance from the International School of Management (ISM) in Paris, France.

Nasser Al-Ali is currently a senior Clinical Programmer at Denali Therapeutics and a PhD student in Statistics and Data Science at the University of Nevada, Reno. He is deeply interested in programming, particularly in automating processes to enhance efficiency and effectiveness. His focus extends to the utilization of machine learning in data cleaning, aiming to elevate data quality through innovative, real-time cleaning strategies.

Katrina “Kat” Paz is a Director of Clinical Programming from Denali Therapeutics.  Serving as a programmer for over two decades, Katrina has worked at Genentech, Gilead Sciences and Nektar Therapeutics.  She has worked as a Data Manager and Statistical Programmer but found her niche in Clinical Programming, creating outputs for data cleaning and monitoring.  Kat’s joys are leading technical teams with a focus in mentoring and finding efficiencies via tools and processes.

Stephen has been in biopharma for over 25 years and has worked in neurology with Elan Pharmaceuticals, gene therapy for rare diseases with Audentes Therapeutics and Encoded Therapeutics, virology with Gilead Sciences, and oncology with Genentech, Medivation, Clovis Oncology, and 23andme, and, currently, Corcept Therapeutics.  I started my career in clinical operations where I led company-sponsored studies and oversaw investigator-initiated studies.  I made the move to project/program management in 2014 to work on all phases of drug development from discovery through post-marketing activities and have assumed business development and alliance management responsibilities as needed for my programs.  I earned an MBA through the Gilead Sciences MBA cohort program, an MA in East Asian Art from the Sotheby’s Institute of Art in London, and an MS in Project Management.  I am a team leader dedicated to bringing new drugs to patients. I believe in life long learning, appreciate the here and now, strive to treat everyone with compassion and dignity, and lead with integrity and drive to meet corporate goals.

Nicole Miller, PhD is the Vice President of Molecular Diagnostics at Ultragenyx, a patient-focused biotech company led by Emil Kakkis that develops therapies for rare genetic disease. She focuses on advancing biochemical and genetic testing in support of reducing the diagnostic odyssey for rare disease patients. She has partnered to develop and launch ten gene locus specific databases and published several variant reviews for rare genetic disorders.  Prior to Ultragenyx, Nicole developed and led a similar function at BioMarin for about 9 years, focusing on rare disease patient diagnosis. Since 2010, Nicole has worked closely with the newborn screening and sequencing community in support of improving newborn screening for rare disease.  Prior to working in the rare disease field, she led a molecular pharmacology research team at Exelixis and led a biomarker program there for about a decade supporting research through clinical development. Nicole has a bachelor’s degree in genetics from U.C. Davis, a PhD in oncology from U.W. Madison and her postdoc was at UCSF. She sits on the board of the Professional Science Master’s program at the University of San Francisco since the program’s inception.