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Directory of Consultants
Bay Area Biomedical Consultants Network (BABCN)
Name and Educational Degree(s) Bukar, Julie, BS, MBA
Business Name JGB BioPharma Consulting Inc.
Certifications
Education

BS  -- Biochemical Nutrition --  Cornell University

MBA -- San Francisco State Unversity (SFSU)

Dietetian Internship (For Registered Dietitians) - Hines VA Hospital

Business Address 2621 Sequioa Way
Belmont, CA 94002
USA
Contact information
Telephone:
Fax:
Email address:
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Specialties

JGB BioPharma Consulting Inc. provides consulting services in the biopharmaceutical, medical device, and diagnostics industries. Our clients include start-up biotech companies, established pharmaceutical companies, venture capital firms, diagnostics and device companies.  At any given time, we have approximately 30 consultants working at our Client companies.  We offer very competitive prices, have robust general liability insurance, and also cover Workmen's Compensation insurance.

The areas we focus on include:

  • Project Management
  • Clinical Operations
  • Clinical Research (e.g. MDs)
  • Quality
  • Formulations, CMC
  • Process Development
  • Medical Writing
  • Regulatory
  • Safety/Pharmacovigilence
  • Biostatistics, SAS Programming, and Data Management
  • Auditing (GMP, GLP, GCP)
  • Device Hardware, Software, and Electrical Engineering
  • We also have regionally located
    clinical monitors
Experience

Experience Summary:

Julie Bukar is the Managing Director  of JGB BioPharma Consulting Inc which provides consulting and recruiting services to the biopharma, medical device, and diagnostics industries.   Before founding JGB BioPharma Consulting, Julie worked as Senior Director Product Development at Rinat Neurosciences (now Pfizer); Director Program Management at Nektar, Director Corporate Development at Affymax, and Group Leader Clinical Research at Genentech.  At Rinat and Nektar she established the team structure and led the company’s 1st large programs (anti-NGF AB and inhaled insulin), filed the 1st INDs, started the Technical Writing department, and was the alliance manager for collaborations with Pfizer and Genentech.  She played a critical role in the product development of Exubera (inhaled insulin) from Phase I through NDA.  She has >20 years experience in the pharmaceutical industry which includes 8 years in Clinical Research (Ph I, II, III) from Genentech and Amgen, where she was hired as the first CRA.  Her educational background is a MBA from SFSU and a BS from Cornell University.  In addition, she was trained as a Registered Dietitian (RD).  Ms. Bukar has >20 published papers and abstracts and has spoken at a variety of business and technical meetings.   She currently consults in the areas of project / product management and clinical.   

Experience Details:

CEO and Founder      JGB BioPharma Consulting Inc.Belmont, CA                        2005 - Present

JGB BioPharma provides R&D consulting services to the biopharma, medical device, and diagnostics industries. Our clients include start-up biotech companies, established pharmaceutical companies, venture capital firms, diagnostics and device companies.  

Skills include: Business acumen, Budget scenario planning, Strategic development, overall or department specific operations/ project management, contract negotiation, clinical operations,  medical writing, technical editing.

 Sample of consulting positions include:

  • Acting Vice President Project Management at a start up (Kalobios Pharmaceuticals)      Member of senior executive team.  Established project management systems (team structures, management committees, Go/No Go decision criteria for molecule selection, electronic team rooms, budgets, system for resource allocation); Managed 2 Director level project managers.  Project leader/ manager for one program.
  • Clinical Project Manager for a 40 country Phase III international program (Theravance).       Established a system to track enrollment at the site level due to poor performance of the CRO.  Established metrics and prepared powerpoint updates for senior management.  Site enrollment dramatically increased after the implementation of this program.
  • Project Manager / Leader of the CMC area for 2 Pre-IND start-ups (Proteolix and AcelRx)
  • Worked with Diagnostics start-up (Entelos) to establish requirements for their first clinical study. Budget scenario planning in order to ensure final protocol fit into the company budget; Wrote protocol, selected CRO, Reviewed CRFs, Hired monitors, assessment of competitive landscape. 

Senior Director Product Development   Rinat Neurosciences Inc. (now part of Pfizer); S San Francisco, CA; 2003 – 2005 

Director, Corporate Development  Affymax; Palo Alto, CA; 2002 –  2003

Director, Program Management  Nektar (formally known as Inhale Therapeutic Systems); San Carlos, CA;  1995 -  2002 

Genentech 1988 - 1995: South San Francisco, CA See Details Below

  • Project Manager, Product Development    1994 - 1995
  • Group Leader, Clinical Research                  1992 - 1994
  • Senior Clinical Research Associate            1990 -  1992 
  • Clinical Research Associate                          1988 -  1990

Clinical Research Monitor Amgen, Inc.; Thousand Oaks, CA; 1986 - 1988

Chief Research Dietitian St. Lukes/Roosevelt Hospital, N.Y.C., New York; 1984 - 1986

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