Key Staff...

Scott began his career at PPD’s Phase 1 clinic in Austin as a Study Coordinator. From there he went on to become a CRA for Clinicor, a small CRO in Austin specializing in Ophthalmology and Dermatology. After several years at Clinicor, Scott accepted a CRA position at ILEX Oncology and was one of their first employees in the Products Division as they attempted to refocus on their pipeline. While at ILEX Scott monitored and managed numerous Phase 1 and 2 studies for multiple “new” agents in ILEX’s pipeline. Eventually Scott was assigned to the phase 3 post-approval study for Campath. He managed this trial for over two years and well through the final enrolled patient. This trial led to the front-line approval of Campath in CLL.

Scott’s tenure at ILEX Oncology provided a tremendous amount of experience. He gained experience in many different oncology indications, working directly with numerous Key Opinion Leaders as well. Scott worked on a countless number of Phase 1 studies and also gained global Phase 3 experience. Finally, Scott was able to manage numerous projects from start-up to database lock and final study report which seems, unfortunately, to be a rare occurrence.

Scott eventually moved to Houston to be closer to family and took a job with Encysive Pharmaceuticals. Scott worked extremely hard and quickly obtained promotions to Sr. PM, Director of Project Management, and Director of Clinical Operations. In this final role, Scott was responsible for the Data Management, Biostatisitics, and Clinical Operations departments. Scott had approximately 30 employees, 10 clinical trials with over 1,500 patients enrolled, and 6 other studies in planning stages.

Encysive Pharmaceuticals went on to merge with one of the leading pharmaceutical companies in the world. The acquiring company approached Scott and asked him to start a CRO in order to provide continued services for their PAH pipeline. Scott accepted the opportunity and founded TRIBE Clinical Development Inc.

Scott’s research experience is primarily in oncology (solid tumor and hematologic) with additional significant experience in cardiology, cardio-pulmonology, ophthalmology, and dermatology.

Scott earned both Bachelor and Master of Science degrees from Texas State University and was certified as a Clinical Research Associate by ACRP.

Lynette came out of nursing roughly ten years ago and got her start as a Clinical Research Assistant for Quintiles CVA, Inc. Following her time at Quintiles she worked for ILEX Oncology, a biotech company strictly focused in Oncology. At ILEX she quickly established one of the top reputations in the company because of her drive, initiative, and reliability. She played an integral role in the approval of clofarabine (Clolar) in pediatric ALL, having Project Management and Monitoring responsibilities on its pivotal trials. Her responsibilities also included working directly with members of the Independent Response Review Panel for the product and assembling reports and independently leading the review meetings. Eventually Lynette was recruited to Encysive Pharmaceuticals where she again, quickly established herself as one of the key PMs in the company. Most of Lynette’s research experience has been in oncology indications including solid tumor and hematologic diseases - both adult and pediatric. She has also successfully managed PAH, Diastolic Heart Failure, and cardiac bypass studies most recently.

Lynette earned her Bachelor of Science in Nursing from the University of Texas Health Science Center San Antonio, is a Registered Nurse in the State of Texas and was certified as a Clinical Research Associate by ACRP.

Michelle spent several years at the start of her career as a Study Coordinator. She worked for local investigational sites and in addition spent time as a coordinator for a SMO. This experience eventually led to Clinical Research Associate positions with MDS pharmaservices and sanofi-aventis. Michelle came to Encysive as a Project Manager and successfully completed a Phase 2, 150 patient study of sitaxsentan in diastolic heart failure. This was a high-profile trial at Encysive and she had leadership responsibilities from start to finish. Michelle has very strong interpersonal skills which in part, gained her the role of Associate Director at Encysive managing both the Data Management team as well as the CRAs. Michelle has maintained her role as CRA manager with TRIBE in addition to her PM responsibilities.

Michelle’s research and development experience has crossed a multitude of indications including infectious disease, CNS, cardio-pulmonary, dermatological, and cardiovascular among others, but her passion lies in the endocrine/metabolic area having been diagnosed with Type 1 diabetes in 1982. She has been on the other side of the table as a volunteer in clinical research studies, currently controls her disease with an insulin pump and believes that without this industry, she would not be alive today.

Michelle has a Bachelor of Science degree from Arizona State and was certified as both a Clinical Research Coordinator and a Clinical Research Associate by ACRP.

Jessica began her career as a Chemist for Quintiles and later transitioned within her company to a CRA position. Jessica stayed in the CRA role with Quintiles obtaining Lead and Senior level promotions and after several years, gained experience in multiple therapeutic areas and all phases of study conduction. Jessica came to Encysive as a Project Manager and as a go-getter, became involved in the majority of studies they were sponsoring. Jessica’s experience at Encysive included single center Phase I studies, proof-of-concept Phase 2 studies, as well as global Phase 3 trials. Jessica has relentless drive and frequently beat the estimated time for start-up on her assigned studies. She also has excellent computer skills and became the go-to person for creative study tracking tools.

Jessica’s research experience includes oncology, cardiology, cardio-pulmonary, endocrinology, and gastro-intestinal indications.

Jessica holds BS and MS degrees from the University of Missouri-Rolla and South East Missouri State University respectively.

Renee began her career as a Research Assistant at Texas A&M University Research Center more than eleven years ago. She went on to become a Lead Clinical Research Associate for ILEX Oncology before moving into the role of Project Manager at INC Research, an oncology focused CRO. It wasn’t easy for Renee to resign from her position at ILEX however. As a valued employee, she was told by Sr. Management that her resignation was not accepted. Renee did leave ILEX however and gained significant project management experience in oncology while at INC Research. She eventually was recruited to Encysive where she established a strong reputation for delivering projects at the highest level of quality.

Renee spent the majority of her career in oncology (mainly solid-tumor indications) but while at Encysive, gained significant experience in cardio-pulmonary and renal disease.

Renee has a Bachelor of Science degree from Angelo State University and was certified as a Clinical Research Associate by ACRP.

Neda got her start in the industry as a Study Coordinator at Massachusetts General Hospital followed by a CRA position at the biopharmaceutical company Repligen Inc. She then took a Sr. CRA position at a CRO before moving on to Encysive as a Project Manager. While at Encysive, Neda was the lead Project Manager for the entire PAH program having over 1,200 patients on the study she was responsible for. She gained an invaluable amount of experience and in particular, had significant involvement in the regulatory approval of THELIN (sitaxsentan) in Europe, Australia, and Canada. This led to Neda having a key role in the commercial transition of study patients and market launch of the product.

Neda has successfully monitored and managed studies across all clinical phases and in a wide range of therapeutic areas including oncology, gastroenterology, neuropsychiatry, immunology, rheumatology and most recently, cardio-pulmonary.

Neda holds a Master of Public Heath degree in Epidemiology and Biostatistics from Boston University and a Bachelor of Science degree in Health Promotion/ Disease Prevention from the University of Houston.

Teresa spent 9 years at Johns Hopkins Hospital, 6 of which were spent as a Critical Care Registered Nurse at the start of her career. Teresa then went on to become a Study Coordinator and was responsible for establishing a new Cardiac Surgical Research Program at her center, gaining 10 years of Cardiovascular Catheterization Lab experience. From there, Teresa accepted Lead Regulatory Specialist and Lead CRA positions for PRA International. Teresa quickly became one of the top Sr. CRAs after eventually moving on to Encysive Pharmaceuticals. Teresa’s nursing background and knowledge base earned her respect with her sites and she consistently provided clean, monitored data.

Teresa’s therapeutic experience includes cardiology, oncology, pulmonology, renal, and infectious diseases.

Teresa has a Bachelor of Science degree in Nursing from Seton Hall University, is a Registered Nurse in the State of Maryland, and is certified by the American Registry of Radiological Technology.

Monica began her career as a Clinical Associate at LSU Health Science Center. From there she went on to be a CRA for St. Jude Children’s Research Hospital and roughly 4 years later, began her tenure at Encysive Pharmaceuticals, also as a CRA. Monica’s career path has allowed her to teach and train others, develop a variety of tools and manuals, track progress and deliverables, and speak publicly. She most recently was invited to present at the Society of Clinical Research Associates 2010 conference.

Monica’s therapeutic experience mainly includes cardiology, pulmonolgy, and hematology oncology.

Monica has a Master of Science degree from the University of Houston and a Bachelor of Science degree from Louisiana Tech University. She is also a Certified Clinical Research Professional through the Society of Clinical Research Associates.

Craig recently completed his 10th year of monitoring and has held CRA positions with Covance, PPD, and Encysive Pharmaceuticals before coming to TRIBE. Craig has very strong interpersonal skills which have made him effective in dealing with Study Coordinators and PIs at his assigned sites. So effective that while recently employed at Encysive, one of his sites emailed Sr. Management to state that it had been a pleasure to have worked with Craig and they hoped that he would be their monitor on future trials. As CRAs are considered the face of the sponsor, CRO, and the clinical trial, you can trust that Craig will represent well.

Craig has worked on a variety of study indications including cardiology, pulmonology, dermatological, genitor-urinary, rheumatologic, and gastro-intestinal disorders.

Craig earned his Bachelor of Science degree in Microbiology from Middle Tennessee State University.