Larry Lawson is a Founder and Executive Chairman at Proxima. He has 45+ years of experience in the healthcare industry.
He has been the founder, board member, and executive at several medical device companies: eCardio Diagnostics, Decisio Health, HeartcoR Solutions, and Preventice. He is an Angel Investor with the Goose Society, TMC Venture Fund, and Angel MD.
He is a Distinguished American Award recipient from the Horatio Alger Association.
Kevin Coker is a Co-Founder and the Chief Executive Officer at Proxima. He has 20+ years of experience in the healthcare industry.
He has been the founder, board member, and executive at several life science companies: Worldwide Clinical Trials, McKesson Corporation, and US Oncology.
Kevin is an attorney and is certified in regulatory affairs. He has worked with hundreds of pharmaceutical, biotech, and life science companies.
Matt received his Biomedical Sciences degree from Texas A&M University and has over 15 years of industry experience working across multiple life science businesses in critical areas, including clinical operations, business operations, and business development. He also has experience in the lung, GI, hematology, orthopedic surgery, and radiation oncology research programs.
Isabella Schmitt currently serves as the Regulatory Affairs Consultant at Proxima Clinical Research, Inc. Proxima is a contract research organization focusing on assisting emerging pharmaceutical and medical device companies in clinical product development. Prior to joining the Proxima team, Isabella served as the Senior Regulatory and Quality Manager for a medical device company where she was charged with outlining the regulatory strategy and putting together design controls and design history documentation, and as the Director of CMC and Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.
Isabella has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications. Isabella is a judge and mentor for MedTech Innovator, and in her spare time, she serves as a TMCx advisor and speaker, helping companies with regulatory affairs, quality, and clinical development questions, and as a MassChallenge Houston judge and mentor. She also serves as a pitch coach for SXSW Pitch Competition.
Stephanie received her professional Master's of Science in Clinical Pharmacology with an emphasis in Clinical Trial Design from the Ohio State University. Before joining Proxima, she worked in clinical trial development, trial management, medical writing, and as a consultant to investigator-sponsors. She has extensive oncology experience, including solid tumors and hematological malignancies and dyscrasias.
Jeanelle Lopez currently serves as the Regulatory Project Coordinator at Proxima Clinical Research, Inc. Proxima is a contract research organization focusing on assisting emerging pharmaceutical and medical device companies in clinical product development. Prior to joining the Proxima team, Jeanelle worked in the Oil and Gas Industry as a Project Lead focusing on Quality Control and Compliance and served as a Communications Operations Specialist. Jeanelle dedicated her attention to process analysis for improvements on delivery time. One of the roles Jeanelle held was Document Control Lead, where she was charged with overseeing project progress to ensure division goals were met while governing the preparation, maintenance, and quality control of documents.
Jeanelle Lopez has a Masters in Business Administration, with a focus in Global Management, from the University of Houston – Victoria. Jeanelle also participates as a Houston Chapter Member for Ellevate Network to promote professional development and in her spare time, she volunteers for the American Heart Association helping communities with fundraisers.
Liz is a Clinical Project Manager with over twelve years of experience in diverse roles that center around clinical trials. She has managed and coordinated clinical trials across different research areas, including informatics, cardiology, and medical device implants. She has a B.S in Applied Science and Technology from Thomas Edison State University, an M.A. in Healthcare Administration, and an M.B.A. in Project Management, both from Wayland Baptist University.
Robert received his PA degree from Trevecca University and has over 20 years of clinical research experience working across several perspectives from the Investigator site, Sponsor and CRO. He has a broad experience in clinical operations and many therapeutic areas. He is now located in FL.
Victoria Boss-Oderinde is a Clinical Trial Assistant with over three years of experience in diverse roles that center around clinical trials. She has managed and coordinated clinical trials across different research areas, including hematology oncology, cardiology, and medical devices. She has a B.S in Biology from Brenau University, and an M.P.H. from Mercer University.
Chelsea Isaac is a Business Development Strategist at Proxima Clinical Research, Inc., a contract research organization that serves the emerging medical device and drug industries. At Proxima, Chelsea works to support strategic business initiatives and partnerships with operational team leads and our marketing strategist. She also serves as a client advocate, putting innovators in touch with our industry and subject matter experts. Prior to joining the Proxima team, Chelsea was the SaaS product manager for a continuing medical education software where she led cross-functional teams to define and prioritize product requirements. In that role, she contributed to marketing, product, and operational strategic planning. She also worked many years as an independent consultant in a variety of industries for business, branding, marketing, design, and content creation. Chelsea has over a decade of experience in a variety of operational settings.
With three decades of building and protecting brands, from start-ups to Fortune 500, Jennifer L. Horspool is a business growth strategist employing her skills in PR, marketing, and media to grow companies from vision to multi-million dollars and turn best-kept-secret brands into the Go-To Experts™ for media and target customers. Her vertical deep is healthcare, primarily oncology, with experience in dermatology, anesthesiology, physician MSOs, clinical research, patient care, as well as business and mindset coaching, and a variety of other industries including energy, mortgage, and overall entrepreneurialism.
Chenett has worked in Clinical Research for over 18 years and has 10 years of Project Management experience. She has coordinated phase II-IV trials and managed global and national class II and III medical device trials with indications in Cardiology, Respiratory and Imaging. She holds a master’s degree in Community Health from Cleveland State University.
Deepthi Paknikar currently serves as a Regulatory Affairs Associate at Proxima Clinical Research, Inc. Proxima Clinical Research, Inc. is a contract research organization that assists early-stage pharmaceutical, medical device, and biotechnology startups in all aspects. Upon graduating dental school, Deepthi started working as a general dentist and has experience in the private and public healthcare sector. She also served as adjunct faculty at a Dental Hygiene Program. Deepthi’s previous experience at the University of Michigan included leading research projects and engaging in scientific writing and presentations.
Taylor Lunsford is a Regulatory Affairs Associate at Proxima Clinical Research, a contract research organization specializing in emerging medical device and drug companies. He has contributed to a wide range of regulatory and clinical projects, including regulatory strategies, pre-submission meetings, clinical study synopses, and regulatory agency submissions. Taylor is particularly experienced in working with wearables, machine learning, and innovative cardiovascular devices, but has worked with devices ranging from in vitro diagnostics and implantable devices to robotics and oncological devices. He is also familiar with the regulatory environments for medical devices in Japan, China and the European Union. Taylor is fluent in Mandarin Chinese and has a strong background in medical interpreting and translating medical documents. Before joining Proxima, Taylor served in the Army as an intelligence analyst, instructor, translator and small-unit leader.
Nicole Mathews currently serves as a Regulatory Affairs Associate at Proxima Clinical Research, Inc. Proxima is a contract research organization focusing on assisting emerging pharmaceutical and medical device companies in clinical product development. Prior to joining Proxima, Nicole completed several internships in the fields of pharmaceutical sciences, genetics, and psychology, where she played a critical role in research and development. Nicole has a Master of Professional Science in Biomedical and Health Informatics, with a focus in Public Health, from UNC Chapel Hill and has worked on multiple medical devices from need identification through the FDA submission process. She has also served in additional regulatory affairs roles in which she created regulatory documents for strategizing the development of software medical devices.
Michelle Wawrzyniak is a Clinical Research Associate at Proxima Clinical Research, a partner for the emerging biotech and medical device industry. Over her career, Ms. Wawrzyniak has served in a number of roles that has provided her a well-versed background. Ms. Wawrzyniak started her career in social services working closely with non-profits to provide support to the indigent populations of Detroit, Michigan. After relocating to North Carolina, she worked for several years in real estate, first as a commercial real estate broker and later a property manager. After working several years in the North Carolina community, Ms. Wawrzyniak decided to pursue a career more in line with her previous experience and continue her ongoing goal of finding solutions to humanitarian problems. While pursuing a career in clinical research, Ms. Wawrzyniak has worked in a variety of functions and has a robust perspective on how studies are managed from start to finish. She has experience from managing day to day activities, training staff, database and eTMF management to administering sponsor and FDA audits. Over the past few years, she has focused on clinical monitoring, by gaining first gaining experience as a Clinical Trial Associate. Since joining Proxima Clinical Research, she is now a Clinical Research Associate supporting the clinical monitoring team and supporting several studies. She continues to provide support to the clinical team, new Clinical Trial associates via training, process development and providing metrics to clinical management.
Ms. Wawrzyniak received a B.A. in Psychology, with honors, from Michigan State University. She has been involved in several clinical trials for pharmaceutical and medical device companies pursuing marketing indications and been involved in regulatory submissions for pharmaceutical companies.
Mr. Lewis holds a B.S. in Mathematics and an M.S. in statistics from Stephen F. Austin State University and a Ph.D. candidate in Biostatistics from the University of Texas Health Science Center in Houston. Through his 15 years of experience, he has advised many life science companies on statistical methodologies, regulatory affairs, and clinical product development, and has represented clients at the FDA.
Melissa has over five years of experience in Data Management and has also worked in computer system validation for both EDC systems and electronic signatures. She has also gained experience in SAS programming with both statistical analyses and data manipulation.
Andrew Frink is a Regulatory Affairs Consultant at Proxima Clinical Research, a contract research organization that serves the emerging drug and medical device industries. Andrew works with numerous software, medical device and pharmaceutical companies on regulatory strategy and regulatory body submissions. Prior to working in regulatory affairs, he helped develop quality management systems for a drug distributor. He is certified in Molecular Biology Diagnostic testing and has worked in both clinical and academic settings.
Dr. Kenichiro Fujiwara is a Regulatory Affairs Associate at Proxima Clinical Research, a contract research organization specializing in emerging medical device and drug companies. He has contributed to a wide range of regulatory and clinical projects for clients in both the medical device and pharmaceutical drug fields, including Breakthrough Device Designation applications, Pre-Submission Meeting requests, 510K submissions, CE Mark applications, Clinical Trial protocols and IND submissions. Dr. Fujiwara regularly provides QC and document review for the entire regulatory team and also handles drug and medical device submissions to the FDA.
Joel currently serves as a Regulatory Affairs Associate at Proxima Clinical Research, Inc. Proxima is a contract research organization focusing on assisting emerging pharmaceutical and medical device companies in clinical product development. Prior to joining Proxima, Joel worked as an undergraduate research assistant at the Veterans Administration in Waco and aided in advancing our understanding of neurological deficits seen in the veterans with traumatic brain injuries in the neuroimaging core. Throughout his experience at Proxima, Joel has developed his skills to advise companies in the best path forward in the development of drugs and devices across a range of therapeutic and diagnostic areas.
Ellie Reynolds currently serves a Regulatory and Quality Assurance Manager at Proxima Clinical Research, Inc. Proxima is a contract research organization focusing on assisting emerging pharmaceutical and medical device companies in clinical product development. Prior to joining Proxima, Ellie worked for a small life sciences consulting firm, where she performed market landscape assessments and provided strategic insights to major pharmaceutical companies. Ellie has a Masters in Bioengineering, with a focus in Global Medical Innovation, from Rice University and has worked on multiple medical devices from need identification through the entire development process. She has also served in additional regulatory affairs and quality assurance roles in which she developed regulatory and technical transfer strategies for both medical device and pharmaceutical companies across a range of therapeutic areas.
Alan spent 8 years designing & testing production active sonar systems for the US Navy. He hold a B.S. in electrical engineering from A&M & an M.S. in EE - electromagnetics/acoustics from Uni. of Texas. Since 2015, he has worked for a small medical device design firm implementing design controls, writing specifications & verification procedures, designing & testing circuitry and software algorithms, & managing standards compliance testing.
Jenna has been monitoring clinical trials for over 4 years for both CRO and sponsor companies. She graduated with a B.S. in Biology from North Park University in Chicago, IL and has completed a postgraduate course in Microbiology at James Cook University in Australia.
Syd Wiggins is a Regulatory Affairs Associate at Proxima Clinical Research, a contract research organization that serves the emerging drug and medical device industries. At Proxima, she has worked on various medical device and drug product consulting projects and submissions across all stages of development, including 510(k), BDD, EUA, and IND submissions. Syd has research experience in biomaterials, polymer chemistry, immunology, drug development and delivery, regenerative medicine, and tissue engineering. Prior to joining the Proxima team, Syd received her Masters in Biomedical Engineering from the University of Florida, where her research aimed to develop immunomodulatory biomaterials for allogeneic transplantation. Additionally, Syd has been involved in research evaluating triple-negative breast cancer cell receptor kinetics, biomarkers and in vitro diagnostic devices for traumatic brain injury, optimization of gold nanoparticle synthesis, and transaortic valve replacement design.
Syd is passionate about translating medical research from the benchtop to the bedside. She enjoys engaging with startups and is eager to assist with the advancement of innovative technologies in health care.
Sondra has 12 years of clinical research experience starting with a master's degree in biomedical sciences with a focus in clinical research management. Her experience covers site, sponsor, and CRO support of studies in all phases ranging from small first in human to global phase 3 and post-marketing studies.
Maureen graduated from the University of Texas in San Antonio with a B.S. in Health. Maureen previously worked for a pharmaceutical company where she helped the office manager, regulatory and data management departments accomplish many different tasks on a daily basis.
Aryan Abedi currently serves and Quality Assurance and Regulatory Affairs Associate at Proxima Clinical Research, Inc. Proxima is a contract research organization focusing on assisting emerging pharmaceutical and medical device companies in clinical product development. Prior to joining Proxima, Aryan worked as a Quality Control Intern for Radiomedix where he was responsible for creation and execution of technical and quality procedures, validation of incoming equipment, and execution of quality testing such as Gamma-ray spec and ICMPS to ensure batch integrity and standards. Aryan has a B.S. in Biomedical Engineering with a focus in biomaterials and tissue engineering from Texas A&M University and has worked on development of surgical medical device from need identification through entire development process.