The past six months have highlighted both existing and unexpected enrollment challenges, as sponsors, CROs, and sites have been pressed to evolve their recruitment strategies.  Join us as Rho experts discuss their approach to adapting CNS trial enrollment to a rapidly changing clinical landscape. This webinar will address:

  • Optimizing site feasibility, recruitment, and selection
  • Embracing decentralized models and technologies with regard to patient enrollment, retention, and visit compliance
  • The role of patient and caregiver centricity in protocol design, implementation, and data collection


Featured Speakers

Brett Gordon

Senior Director Operations
Rho

With more than 20 years of clinical development experience at both CROs and sponsor companies, Brett Gordon brings the individual focus a project requires while also providing a wider perspective of the clinical development landscape as a whole.  Working on both domestic and international trials of varying sizes and complexity, Mr. Gordon provides extensive knowledge of clinical operations, including initial development plan formulation, protocol writing, trial implementation, monitoring and delivery, clinical study report writing, and marketing applications.  While he has worked across numerous therapeutic areas over his career, Mr. Gordon possesses in-depth CNS and pain expertise having managed or monitored trials in acute pain, chronic pain (neuropathic and musculoskeletal), epilepsy, bipolar disorder, major depressive disorder, generalized anxiety disorder, alcohol dependence, and ADHD.  Mr. Gordon graduated from Duke University where he obtained a BS in biology with a concentration in neuroscience.

Natalia Marder

Project Director, Clinical Trial Operations
Rho

Dr. Natalia Marder has more than 14 years of clinical development experience in the CRO environment, including managing multiple global studies, as well as both mega-trials and small trials with niche biopharma companies. For 10 years, she has been focused on the operational management and clinical development of compounds for the treatment of numerous neurodegenerative disorders, including psychiatric diseases, neuropathies, pain, neurogenic bladder, and Parkinson’s Disease (motor and non-motor symptoms). Her areas of expertise also include collaboration with the spina bifida associations and networks, controlled substance supply management, and medical review of the data collected in the clinical trials. As a Project Director, Dr. Marder plays a leading role in the oversight and management of both programs and individual clinical trials, Phases 1 – 4. Her therapeutic expertise also includes various general medicine indications – vaccines, types of pneumonia and other infections, urology, endocrinology and cardiovascular diseases, as well as pediatric and ICU trials.

Amy Goodykoontz

Senior Project Manager, Clinical Trial Operations
Rho

A creative, purpose-driven project manager with over 12 years of global clinical trial experience, Amy Goodykoontz started her career in a Phase 1 clinical unit as a study manager, shifting to study participant recruitment manager, landing on her passion in 2012 as a project manager. Over the span of her career, Ms. Goodykoontz has supported multiple Phase 1 – Phase 3 study protocols emphasizing complex study designs in a range of therapeutic areas with an emphasis in CNS trials. Ms. Goodykoontz excels in the management of specialized vendors critical to CNS trials, such as laboratories, central imaging, patient travel and rater services for the assessment of cognition and motor function.

Alexa Bawden

Clinical Team Lead, Clinical Trial Operations
Rho

Alexa earned her BS in Clinical Research from the University of North Carolina at Wilmington. She has over eight years of industry experience across Phase 1 through 3 studies in a variety of indications that include attention deficit hyperactivity disorder (ADHD), multiple sclerosis (MS), post-operative pain, and osteoarthritis. She has a strong understanding of clinical trial management and operations, and is experienced in all aspects of ICH/GCPs, regulatory requirements, and site management.

Date:  Wednesday, November 18, 2020
Time:  1pm ET / 10am PT
Duration:  1 Hour

Register now for this webinar