Biologics Consulting Group, Inc (BCG) is initiating a search for the position of Head of our North Carolina Office. The office currently has a staff of four located at 5001 Weston Parkway, Suite 200A, Cary, NC. BCG plans, over the next several years, to increase the staff at this office to at least ten consultants, and is searching for a person with extensive first-hand biologic product regulatory experience to lead this expansion.

The position requires both management and business development skills as well as excellent consulting skills as related to a specific area of biologic product development. Compensation will be based on billable time plus the ability to successfully grow the NC office and meet agreed revenue goals. BCG offers a comprehensive benefits package including an Employee Stock Ownership Plan (ESOP).

Interested persons should send their CV to the attention of Jim Kenimer, Ph.D., President & CEO of BCG.

MELANIE HARTSOUGH, PH.D.

Dr. Hartsough is joining the BCG team on February 20th. She has experience as both a CMC reviewer at CBER and a pharm/tox reviewer at CDER. She has reviewed cytokines, growth factors, enzymes, toxins, thrombolytics and monoclonal antibody products. Her experience includes IND and BLA submissions, design and interpretation of toxicology studies, including relevant species and immunogenicity issues and appropriate PK/TK studies, product review for biotechnology-derived products, planning and participating in FDA meetings, insights into the changes occurring with the review of nonclinical studies for biotechnology-derived products in CDER. Read Announcement

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RONALD MARCHESANI

Mr. Marchesani is joining the BCG team February 28th. Ron is a respected opinion leader in the field of Quality Systems. He has been invited as a speaker or facilitator at professional meeting and enjoys dealing with the different Regulatory GMP expectations during product development, vaccine and GMP compliance audits. Ronald's areas of expertise include: quality system assessment/development, GMP oversight of contract services (manufacturing and testing), GMP training, SOP development, inspection readiness (Routine/PAI), document system development/review. Read Announcement

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LOUISE JOHNSON, M.S.

Ms. Johnson is joining the BCG team March 1st. Her experience includes management of and strategic planning for regulatory affairs and quality assurance functions, participation in in-licensing and M&A activities, where she provided regulatory and developmental assessments and participated in due diligence, supported regulatory filings and negotiations from pre-IND meetings through development, NDA filing and approval, and post-marketing support. She has worked with small molecule, monoclonal antibody, and vaccine submissions and has experience with FDA, Health Canada's HPFB, and the UK's MHRA. Read Announcement

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LIANA HARVATH, PH.D.

Dr. Harvath is joining the BCG team March 5th. She has 33 years of U.S. government scientific experience and has published more than 60 articles in immunology and cell biology. Her experience includes assistance in writing various sections of pre-IND, IND, IDE, BLA/NDA and 510k submissions, comprehensive "FDA style" reviews of IND, IDE, BLA and NDA draft submissions, development of risk management strategies to more effectively assess and monitor product profiles, preparation for FDA and Advisory Committee meetings, assistance with strategic and operational initiatives involving governmental or other agencies and/or advisory groups, advertising and promotional labeling. Read Announcement

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The demand for biologics including therapeutic proteins, monoclonal antibodies, vaccines and cell-based therapies is on the increase worldwide and the US remains the largest and one of the most lucrative markets for these therapeutic products.

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BCG has supplemented its advisory committee preparation services by teaming with the regulatory communication group Pharmapprove to assist companies in the preparation of high impact FDA advisory committee presentations. If you have an advisory committee appearance in your future, and would like to maximize the impact of your presentation, please contact Jim Kenimer.

BCG consultants attend numerous conferences every year during which they are available to provide company information or consulting expertise. Below are some conferences that BCG consultants will be attending in the near future. Please feel free to contact the attending consultant either before, or during the conference for company information or to discuss a business opportunity.

2nd Annual Commercial Implications of Stem Cell Research

Track 6 at Molecular Medicine Tri-Conference; Panel Expert on Regulatory Issues for Neural Regeneration

EU CMC Strategy Forum

“Life Cycle Approach to Establishing Biotechnology Product Specifications”

“Regulatory Requirements for Successful Product Development”

World Vaccine Congress 2007

Agenda

Spring Cell Therapy Conference

Moderating session on Novel Cell Therapies