We make it happen!
Mario Guralnik, PhD brings 31 years of drug-device-biological development experience to our client's projects. His expertise is in Regulatory Affairs and designing Strategic Development Plans for life science products. A very common area over the past 12 years has been in focusing and defining these activities specifically for startup companies. Whether a virtual company, a company outside the US wishing to pursue an FDA-regulated pathway, or a project being contracted out, these all require a special set of development rules to make them successful. He has packaged this capability and we are applying it towards our client's product approvals.
Mario started in this industry out of UCLA, straight into the biotech world at Amgen. As an early employee of Amgen, he participated in many aspects of their development efforts, especially, and focusing on, the blockbuster biological drug, EPO - erythropoietin. His work on clinical and regulatory affairs while at Amgen allowed for an extensive and broad career in drug development. While at UCLA, Mario also participated in several federally funded programs in drug-device development. Spending several years in transdermal drug delivery systems.
Mario has held over 20 positions on the board of directors and scientific advisory boards in life science-related companies and projects; past and current; foreign and domestic. Mario has repeatedly been a key player on several high-profile and successful launch programs for our client's products.
For over 25 years, Stacey Lense has provided quality clinical research to the pharmaceutical and biotech industries and acquired a positive reputation for the quality of her work and the professionalism of her client-focused clinical research. She is experienced in all aspects of Phase I through Phase IV studies covering many therapeutic areas. Her extensive knowledge of CRO operations and Sponsor culture gives her an edge in contributing to a progressive and innovative research community.
For much of her career, she has worked with innovative companies that haven’t fully developed their internal departments. She understands the unique tension that a young developing company has and can work to help implement a methodology that reduces some of the obstacles it faces, all while creating a culture that will be able to expand with its ever-changing growing needs. She has lent her expertise to support companies by providing hands-on project management or regulatory affairs services for an interim period, or for the span of the project and successfully started and developed departments in emerging companies that grew strong and became self-sufficient. Additionally, she understands how to work with upper management to cultivate goal-oriented clinical programs designed for the life cycle of their proprietary entities and help Sponsors strategically plan their clinical development programs, create protocols and supporting documents, and assist them during the regulatory process.
As Vice President of Clinical Affairs, Stacey is responsible for the development and management of clinical programs from pre-IND to NDA. We like to work with unique companies developing novel drugs and devices that are being designed to improve patient care and quality-of-life.
Dr. Yvette Yamanouchi has over 18 years of experience in drug and device development. Past activities have placed her in charge of clinical development teams, regulatory affairs deparments, data management and statistical services, pharmacovigilance / R&D safety boards, IND through NDA teams, pre-launch activities, and extensive work in pharmacoeconomics program development.