Gary Barnette
Chief Scientific Officer Veru Inc.
Gary Barnette, Ph.D. is the Chief Scientific Officer of Veru. Prior to joining Veru, Dr. Barnette was Sr. Vice President of Scientific and Regulatory Affairs at Camargo Pharmaceutical Services, LLC, during which he oversaw the development of scientific and regulatory drug development strategies across all therapeutic areas for 6 years. From 2000 to 2012, Dr. Barnette served in various positions at GTx, Inc., including as Vice President, Clinical Development Strategy. Throughout his tenure at GTx, Dr. Barnette managed responsibilities across regulatory, clinical, clinical pharmacology, and medical affairs departments for urology (men?s health) and cancer supportive care. Prior to GTx, Dr. Barnette was a Clinical Pharmacology and Biopharmaceutics Reviewer at the U.S. FDA, where he received numerous awards for reviewing, mentoring, and serving on various FDA guidance development groups and initiative task forces. Dr. Barnette holds a Ph.D. in Basic Pharmaceutical Sciences (Clinical Pharmacology and Pharmacokinetics) from West Virginia University, School of Pharmacy.
Seminars
This intensive workshop will delve into the critical shift from traditional BMI-centric metrics to a more sophisticated regulatory framework that reflects the true biological impact of next-generation obesity therapeutics.
As the FDA moves toward evaluating “quality of weight loss” and metabolic improvement, this session provides a strategic toolkit for biotechs to align their clinical endpoints with modern regulatory expectations. Central to this evolution is the Lancet Commission’s new framework, which offers a structured 18-point system to assess tissue and organ dysfunction. By differentiating between Pre-clinical obesity (excess adiposity without dysfunction) and Clinical obesity (impaired organ function), this framework allows for more precise patient stratification and offers a method to prioritize pharmacological or surgical interventions for those with the highest biological risk.
This session will cover:
- Integrating advanced body composition metrics to move beyond the limitations of the scale, utilizing DEXA and MRI data to quantify changes in visceral adipose tissue and lean muscle mass as primary or key secondary endpoints
- Defining meaningful metabolic endpoints by establishing validated links between drug-induced weight loss and the resolution of comorbidities such as MASH, CKD, and heart failure to support “beyond weight loss” label claims
- Designing trials for functional outcomes that measure improvements in physical mobility, exercise capacity, and respiratory function, providing the FDA with clear evidence of enhanced patient quality of life
- Navigating the regulatory path for maintenance and prevention by developing trial structures that satisfy FDA requirements for long-term safety and weight-regain prevention
- Establishing collaborative regulatory strategies for novel mechanisms (such as gene therapies or non-incretins) where traditional weight-loss benchmarks may not fully capture the drug’s therapeutic value
