Mary Mills, R.N., C.C.R.A., is a distinguished clinical research professional with over 30 years of experience in the pharmaceutical, biotech, and medical device industries. She began her career as a registered nurse in the intensive care units at The Regional Medical Center in Memphis, a premier teaching hospital where she gained extensive exposure to clinical research. Since transitioning into clinical trials in 1987, Mary has been a driving force in clinical development, serving as a consultant, educator, and project leader.

Her expertise spans a wide range of therapeutic areas, including neurology, cardiology, and oncology, with a strong focus on both pharmaceutical and medical device clinical trials. Mary has held leadership roles as a Clinical Project Manager, Clinical Research Coordinator, and Study Coordinator, managing global, multi-center trials with a strategic focus on risk-based approaches. She has successfully led one of the largest international risk-based clinical trials in the industry and has played a key role in federally funded studies where risk-based monitoring (RBM) methodologies are applied to enhance trial efficiency and data integrity.

Mary is widely recognized as an industry thought leader in risk-based approaches to clinical trials. She actively participates in an international RBM workgroup and is a sought-after speaker at industry conferences. She has presented at FDA-CTTI Quality by Design (QbD) meetings, representing Boehringer Ingelheim’s groundbreaking risk-based strategies in clinical research.

Committed to advancing clinical research methodologies, Mary maintains her nursing licensure and dedicates significant time to mentoring, training, and consulting across multiple clinical specialties. She is an active member of the Drug Information Association (DIA) and the Association of Clinical Research Professionals (ACRP), continuously contributing to the evolution of best practices in pharmaceutical, biotech, and medical device research.

Mary’s extensive experience, strategic leadership, and dedication to innovation make her an invaluable asset to the clinical research community.

Atul is a seasoned clinical research professional with 28 years of experience spanning all phases of clinical trials, from study start-up and interim monitoring to close-out and FDA submission. He has held key roles, including In-House Clinical Research Associate, QA Auditor, Field Clinical Research Associate, and Lead Clinical Research Associate, demonstrating expertise in study management, monitoring, regulatory compliance, and quality assurance.

His extensive therapeutic expertise covers a diverse range of indications, including Parkinson’s, Alzheimer’s, Oncology (Solid and Liquid Tumors), CNS, Cardiovascular, Neurology, Pediatrics, Orthopedics, Hepatology, Nephrology, Infectious Disease, Allergy, Women’s Health, Pain Management, Dermatology, Blood Products, Gastrointestinal, Rare Diseases, and Respiratory conditions. Atul’s comprehensive experience and leadership make him a valuable asset in clinical research, driving studies from initiation to regulatory approval with precision and efficiency.

Amber is a highly skilled and adaptable clinical research professional with extensive experience managing multisite, multi-phase clinical trials across pharmaceuticals, biologics, and medical devices. With a strong foundation in Good Clinical Practice (GCP) regulations, essential document management, and compliance, she brings seamless integration and immediate value to any clinical research team.

Over her career, Amber has contributed to Phase I-IV clinical trials, post-market registries, and investigator-initiated studies, working with leading pharmaceutical and biotech companies. Her expertise spans vaccine development, infectious diseases, maternal-fetal health, central nervous system disorders, and women’s health, among other therapeutic areas. She has coordinated studies across diverse indications, including:

• Vaccine Trials – RSV, SARS-CoV-2, meningococcal, Group B streptococcus

• Pharmaceutical & Biologic Trials – obsessive-compulsive disorder, endometriosis, and vasomotor symptoms

• Medical Device & Neurological Studies – neurovascular research, intracranial brain aneurysm treatment, infant formula interventions and early childhood nutrition research

• Complex Multicenter Studies – pediatric and adult populations

Amber’s strategic oversight of clinical trial execution, combined with her meticulous attention to detail and ability to navigate complex regulatory landscapes, ensures studies are conducted efficiently and in full compliance with industry standards. Her collaborative approach, critical thinking, and strong organizational skills make her a trusted resource for clinical research teams looking for experienced, high-performing professionals.

Amber is passionate about advancing clinical research and committed to supporting clients in executing high-quality, compliant, and impactful studies.

Kurt has dedicated his career to being a successful business advisor to executives, working directly with entrepreneurs and economic development specialists to develop key strategic relationships in an effort to uncover commercial opportunities across the globe for his clients. He has worked with a diverse range of clientele, including industry leaders such as Bioventus, Depuy Synthes, Dfine (acquired by Merit Medical for $97.5 MM), JNJ, Medacta, Moximed, OrthoPediatrics, Salient Surgical (acquired by Medtronic for $525 MM), Smith & Nephew, United Orthopedic Corp, Vertiflex (acquired by Boston Scientific for over $450 MM), and Zimmer Biomet. Kurt’s career includes key senior management and founder positions at companies such as BD Catalysts, LLC; Clinical Alliance Group (merger); Burgess Ventures, LLC; Telos Partners, LLC (acquired); CAS Systems (acquired); Rainmaker Systems; and Hilton Hotels.

Yvonne has held a number of industry executive positions, most recently as Chief Executive Officer of Alyve Medical, a start-up in the musculoskeletal space. Prior to that she spent more than a decade with Zimmer Biomet in a variety of leadership positions, including President and GM.  Yvonne spent 6k years at Medtronic Spine & Biologics focusing on health economics and outcomes.  Early in her career, she worked in hospital administration and spent several years as Executive Vice President at QuadraMed, a healthcare IT company.

Yvonne is a highly accomplished business operations executive and market access expert with a proven track record of leading transformational initiatives in the healthcare and life sciences industries. With extensive experience driving commercialization of groundbreaking devices and therapies, she has played a pivotal role in the successful launch of numerous products, guiding them from early-stage development through to market adoption.

As a strategic leader, Yvonne excels in navigating complex business landscapes and building high-performing teams that deliver results.  Her deep expertise in market access and business operations enables her to identify innovative solutions, optimize processes, and ensure sustainable growth.  Passionate about driving change and creating lasting impact, she is known for her ability to think strategically while executing with precision.  With a strong focus on delivering value and enhancing patient outcomes, Yvonne is dedicated to advancing the intersection of healthcare innovation and market success.

A board-certified orthopedic surgeon at Austin Orthopedic Institute, Tyler’s specialty lies in adult joint reconstruction as well as primary and revision joint surgery. His clinical interests include computer-assisted orthopedic surgery and robotics. Tyler is recognized as an innovator, designer, and educator, in addition to being the fourth surgeon in America to introduce passive robotic technology for total knee replacement and the first surgeon in Texas to perform AMIS in early 2008. Tyler is involved in multiple professional organizations for the advancement of technology intended to benefit patient care with numerous articles in the medical literature and a regular speaker at national and international meetings regarding orthopedic surgery.