Archives: Speakers

Nickie’s experience includes the following: industry experience at contract research organizations (CRO) and biotech. Broad project management across matrix teams encompassing clinical development, alliance management, and business development. Study-level oversight and accountability for multiple functional departments to include project management, clinical operations, data management, pharmacovigilance, quality assurance, start-up and regulatory. Project and line management experience and strong organization skills. CRO business development activities including, client development, alliance relationship management, bid defense meetings, and project costing. Global clinical trial management experience including North America, Europe, Asia Pacific. In depth understanding of the drug development process, clinical trials conduct, GCP, ICH, FDA CFR and international regulations. Experience in Phase I – IV clinical trials, including multi-phase protocol design. Experience evaluating and performing due diligence of potential candidates. Experience in all steps of site start-up.

John McAdory, MHA has a strong background in clinical operations and project management in the healthcare industry. John is currently serving as the Vice President of Clinical Operations at CG Oncology (Cold Genesys).

John has spent the last 20 years global clinical research specializing in the development novel oncolytic therapies. He has lead global clinical operation from clinical study design to submission of final study report including BLA filing. John has expertise in strategy development, risk management, project planning and execution and consistently achieving program goals. With a Six Sigma Green Belt, John specializes in identifying key area to find efficiency in clinical study conduct to save time and reduce cost. John previously held leadership and management positions at SillaJen, Inc, Janssen, Inc, and Amgen. John is a graduate of Hampton University with an BS in biology and has a Masters in Health Administration from the University of North Carolina, Chapel Hill.

Rodney Villanueva, M.D., received his medical degree from the Uniformed Services University of the Health Sciences in Bethesda, Maryland.  He completed a residency in psychiatry at Tripler Army Medical Center in Honolulu, Hawaii and a fellowship in forensic psychiatry at Walter Reed Army Medical Center in Washington, DC. He also holds a certification in LGBTQ Health from Drexel University.  He had an extensive career as a US Army psychiatrist, spending 16 years in the Army, which included a year-long deployment to Iraq.

He is currently a psychiatrist with Atrium Health in Charlotte, NC where, he serves as the Psychiatry Clerkship Director, the Associate Program Director for the Psychiatry Residency Program, and the Co-Medical Director of the Behavioral Health Advanced Practice Provider Fellowship Program.  He is an advocate for diversity and inclusion in healthcare, with particular interest in LGBTQ mental health. He has spearheaded efforts to raise awareness in LGBTQ health such as establishing an annual LGBT healthcare symposium with the Charlotte Area Health Education Center. He has spoken nationally and internationally on LGBTQ mental health as well as on the topic of minorities in clinical trials.

Dr. Villanueva is an Assistant Professor of Psychiatric at Carolinas Medical Center and an Adjunct Associate Professor of Psychiatry at the University of North Carolina School of Medicine.

Kathy Leach is Senior Director, Clinical Study Team Lead at Pfizer. She has been in the pharma industry for 25 years, spanning numerous therapeutic areas, phases and roles supporting clinical trial conduct at several large pharmaceutical companies. Her recent roles have focused on cross functional operational oversight of global programs. Kathy is a certified Project Management Professional, received her bachelor degree from Villanova University and Masters in Organization Leadership from Immaculata.

Tim Koch has spent the last 18 years working in Big Pharma including time at Johnson & Johnson, GlaxoSmithKline, and currently Novartis, along with prior experience in the Financial Services Industry and the Hospital Setting. He is a Lean Six Sigma Black Belt who’s deepest passion is Metrics and Analytics but has a broad range of experience from Finance to IT to Quality Assurance to Resource & Risk Management. He is known as a domain expert in Clinical Trial Optimization via Data and Technology, supporting the operational delivery of thousands of Trials from feasibility/site selection to recruitment planning/tracking to instream monitoring, resource maximization and risk detection to leading health authority inspections. Tim has been an innovative pioneer, infusing an evidence-based analytical culture in countless areas of the business, building multiple Analytics units from the ground up and launching >50 industry-first analytics platforms to >20,000 users in Drug Development. In his current role as  Global Head of Key Account Mgmt, he partners closely with the Trial Mgmt Leadership team providing consultation, solutions and know-how anchored around  the use of data, analytics, processes and technology during Trial Delivery.

Mike Child currently holds the position of Vice President, Clinical Operations at Arbutus Biopharma located In Warminster PA, near Philadelphia. Arbutus Biopharma Corporation (NASDAQ:ABUS) is a publicly traded biopharmaceutical company dedicated to discovering, developing and commercializing a cure for patients suffering from chronic hepatitis B infection, a disease of the liver caused by hepatitis B virus (HBV). Prior to that, Mike spent approximately 31 years at Bristol-Myers Squibb (BMS) near Princeton, NJ where he attained the role of Director, Clinical Operations, Infectious Disease contributing to the global approval of novel therapies designed to treat HIV and Hepatitis C. In addition, while at BMS, Mike spent significant time learning the ways of Drug Development while working in Discovery Labs, in the Data Management Department, and finally in roles of increasing responsibility within Early Development/Clinical Pharmacology. Mike’s additional experience includes that related to due diligence and risk mitigation, outsourcing, model document management, and the maintenance of Standards and Processes. Mike graduated with a BS in Animal Production from The Pennsylvania State University (PSU) and completed graduate coursework in Physiology before leaving PSU for Squibb. Mike was born in Lancaster, PA and currently lives in Newtown, PA where he has raised 2 sons.

Joy Carson is the VP of Clinical Development and Operations at Asklepios Biopharmaceutical (AskBio), where she leads the design and implementation of clinical protocols across indications, and oversees the AskFirst Patient Advocacy program.  With more than 30 years of experience in the design and implementation of clinical trials, she began her career in the Behavioral Neuroscience laboratory at MIT, and has split her experience among academia, sponsors, and CROs.  Currently focused on opportunities using viral vectors in the delivery of gene therapy and vaccines, she also has extensive experience in oncology drug development.  Her experience spans first-in-human through post-registration studies, with study sample sizes from 3 – 500,000.

Ryan Hovda, Senior Director, Strategic Sourcing at Novan, Inc., has ~13 years of Pharmaceutical Industry outsourcing, contracts management, and client/service provider relationship management experience.  Mr. Hovda has represented both service provider and sponsor organization negotiations, beginning his career at Parexel as a pricing analyst and culminating in a contracts departmental leadership position during his tenure there.  Making the switch to sponsor side representation, Mr. Hovda has held leadership roles within the clinical development contracts/vendor management teams at Biogen, Array Biopharma (acquired by Pfizer), and Bioverativ (acquired by Sanofi).  In his current role at Novan, he is responsible for both clinical development outsourcing (encompassing CRO/vendor outsourcing, clinical site contracting, and related financial/relationship management oversight), and also supports pre-clinical, CMC, and other business related contracts and outsourcing activities. Mr. Hovda holds an undergraduate degree in finance, and a MBA from National University.