Archives: Speakers

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.

Dr. Maida is the Chief Clinical Officer for Oncotelic, Inc. and its joint venture, SapuBioscience, LLC, focused on immunotherapy of cancer and infectious disease. He has over 30 years of experience in clinical research in oncology and has worked with many Center of Excellence and Key Opinion Leaders. He is responsible for overseeing the operations of the company and has experience in finance, operations, research, and commercial clinical and scientific development, regulatory, and manufacturing for various therapeutic modalities. Previously, he served as Vice President of Clinical Research and General Manager, Oncology, World-wide for PharmaNet, Inc., and President and CEO of Replicon NeuroTherapeutics. He raised or assisted in financings in excess of $200 million for start-up and emerging biotechnology companies and negotiated licensing agreements with various centers of excellence and premier pharmaceutical firms. Over the past 18 years, he has served in various executive roles, including Chairman, CEO, COO, CSO, CFO, and business development. He also served as Senior Financial Controller of Lockheed Missiles, a $1.7 billion division.

Amanda Moore became CEO of the the ASF in 2019. Prior to that, she was the Director of Leadership Development, Diversity and Inclusion and Global Strategies at the YMCA of Greater Indianapolis where she worked for over eighteen years. Amanda earned her Masters in Leadership Development as well as a Certificate in Fundraising from the Indiana University School of Philanthropy.

Amanda and her family live in Indianapolis, Indiana. Amanda’s husband, Adam, is a nurse and an amazing artist. In 2015 Amanda and Adam adopted twin boys, Jackson and Baden. Jackson was diagnosed with Angelman syndrome in January of 2017 and since then Amanda has made it her mission to be an advocate for all people with Angelman syndrome.

Mr. Wright serves as VP, Energy, Utilities, & Resources Industry Solutions. In this role he is responsible for global strategy and business development to build and grow revenues across the energy, utilities, and resources (e.g. mining) industries.

Mr. Wright is an accomplished information technology executive with more than 25 years of success in energy-related businesses, across the upstream, midstream, and downstream lifecycle for traditional fossil fuels and renewables industries. He has managed multiple global SAP and Oracle implementations/operations, one of the first production SAP Business Suite on HANA go-lives, and one of the first production S/4HANA go-lives on AWS.

Mr. Wright has been a successful early adopter and developer of several current mainstream cloud technologies including an early online banking system, one of the first Microsoft Office sharing ventures, then as an early adopter of Microsoft’s Business Productivity Online Suite (BPOS), the precursor of Office 365.

Prior to joining Rimini Street, after a short stint in private equity, Mr. Wright was Chief Information Officer and Vice President of IT and Digital for Engie North America, where he was responsible for all IT and Digital for the North American region of the French renewable energy company. His scope included Digital Solutions, Cyber Security, IT Architecture, IT Operations, and business applications for the Renewables, Energy Solutions, Networks, and Thermal/Supply business units.

Previously, Mr. Wright was Chief Information Officer for Pacific Drilling, a startup global deep water drilling contractor with operations in West Africa, Brazil, and the U.S. Gulf of Mexico.

Dave Keating is an American-European journalist based in Brussels who moderates live events. He is ranked as the number one EU social media influencer for 2023, coming second in 2022 and third in 2021 and 2020. He has been covering energy and climate policy for 15 years, most recently as the senior writer for EnergyMonitor.ai. Before arriving in Brussels in 2010, Dave covered the boardrooms of London, the US Congress in Washington, the cafés of Paris, the politics of Prague, the courtrooms of Chicago and the streets of New York City.

Tania Azad is an experienced Global Clinical Project Manager with over 20 years of experience in Oncology, Diabetes and Orthopedics within various organizations, including Clinical Research Organization, Biotech and large pharmaceutical companies. Tania started her career at the Toronto Western Hospital and has since led different phases of clinical research projects including Bioequivalence and Phase I through Phase IV. Tania has been instrumental in leading site feasibility, selection and patient retention and successfully bringing projects to completion and regulatory submission. Currently Tania is the Associate Director, Clinical Project Lead at Alexion – AstraZeneca Rare Disease Unit leading Late Phase Global Registry in Neuromyelitis Optica Spectrum Disorder (NMOSD) and Natural History Study in gene therapy as well as creating an operational framework to optimize ways of working with CRO partners.

Experienced clinical research, project management professional with more than 17years of experience in the industry. In-depth knowledge of drug development process (with immunology, inflammatory & oncology focus) and industry practices.

Leading multiple project teams with broad background in overseeing the conduct of the clinical trial (Phase I-IV) globally following elements of the ICH/GCP or GPP in observational and non-interventional studies. Experienced indication lead overseeing study start up, maintenance and termination activities (database lock, CSR), including but not limited to, site identification, feasibilities, ICF negotiations, IRB/EC and global Regulatory Authority submissions, review and approval of essential documents, remote Site initiation visits (SIV), Monitoring Visit (MV), Source data verification (SDV)/ Source Data Review (SDR), drug accountability, site payments, and close out visits. Extensive study and site management experience. Experienced in RBQM, and systems like cluepoints for data analytics. Experienced in leading cross-sectional study team responsible for clinical study delivery as the primary point for contact for leadership. Experienced with vendor management of multiple complex vendors (EDC build and maintenance, IRT/IWRS, central lab, histopath lab, large global CROs as well as drug packaging and distribution vendors). Knowledge of project management processes and tools with multiple direct reports.

Bruce Lyday is CEO and co-founder of Coronavax, Inc., a Biotechnology Company located in Orange, CA. Coronavax is developing CVAX-001, a new immunotherapeutic for Long COVID. Mr. Lyday has been a researcher in the fields of immunology, virology, oncology, and cell biology. Mr. Lyday has multiple patents and one Investigational New Drug (IND), approval for a novel cancer therapy. Mr. Lyday has successfully negotiated agreements with the U.S. Army at USAMMDA-Ft. Detrick, MD, and the Centers for Disease Control for use of their virus strains to treat cancer.