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Home About us Management

Management

Mario Guralnik, PhD

Mario Guralnik 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.  Dr. Guralnik 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 - eryhtropoietin.  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.

 

Dr. Mario Guralnik has held over 20 positions on 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.

 

 

Alfred McIntosh, MD

Dr. Alfred McIntosh has over 25 years of industry experience.  Alfred has been a key player in R&D efforts for 6 major NDAs.  He brings with him extensive experience in infectious disease drug development programs, as well as years of R&D work on cardiology device work.

 

Alfred participates at multiple levels, and overseas medical affairs of all projects at Synergy Research.  Supervising and actively involved in our pharmacovigilance efforts as well.

 

 

Yvette Yamanouchi, PhD, MD

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 pharmacoeconomic program development.

 

 

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