Archives: Speakers

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.

A biomedical product development professional experienced with GMP, GLP, and GCP requirements for products seeking U.S. regulatory approval. My primary experience encompasses the design and execution of clinical trials with oversight of clinical data input through the phases of Endovascular products development life cycle. I transitioned to the clinical research industry after being a Pharmaceutical Chemist for several years.

Thirty-five years experience in clinical research and development (oncology, cardiovascular, dermatology, immunology, antiinfective/antiviral, central nervous system, inflammatory diseases). Ability to build and manage highly-functioning clinical operations teams.

Experienced project management professional with a strong background in medical device clinical trials. Elizabeth is currently a Sr. Clinical Project Manager at Recor Medical, a medical device company located in Palo Alto, California. Previous work experience includes knowledge manager at a big three strategy consulting firm, and archivist at UCLA organizing, preserving, and providing access to collection materials.

As CEO & Founder of BioSapien, Khatija Ali MD is dedicated to transforming patient care with the MediChip, focusing on local cancer treatment. With over 4 years of experience in venture capital and private equity, Khatija specializes in diligence, capital raising, and portfolio management across biotech. She is recognized for her networking skills and philanthropic efforts. Recognitions include Meet The Drapers competition, the Startup Prize and Top 25 CEOs in Biotech. Outside of work, Khatija enjoys outdoor activities and racing cars.

Eric Pittman currently serves as the Program Division Director (PDD) for the Bioresearch Monitoring Division II (BIMO-W) staff.  As the PDD, he provides leadership in directing and managing programs and a professional staff in locations from Detroit, MI to Hawaii covering all clinical and non-clinical facilities.  In addition to being the PDD for BIMO-W, Eric is one of the U.S. Representatives to the Organization for Economic Co-Operation and Development (OECD).

Supplement to his work experience with the FDA, Eric has worked in the Medical Device, Food and Drug Industries serving in various capacities such as a Regulatory Affairs Associate and Director of Quality.

Eric attended Purdue University School of Pharmacy and while there also earned a degree in radiation physics. He has an MBA from Youngstown State University along with several certifications for various quality and regulatory activities.