Holly McNair Scott, a former FDA Field Investigator, will be joining Biologics Consulting Group, Inc., as a Senior Consultant for Biologics and Dietary Supplement inspections, investigations, and audits, on September 1, 2009.

Holly comes to BCG with over 18 years of multi-office experience with the Food and Drug Administration, including 4 years as a Consumer Safety Officer with the Center for Biologics Evaluation and Research, and 14 years as a Field Investigator with the Office of Regulatory Affairs Florida District Office (Miami and Orlando), specializing in the inspections of Blood, Plasma, and Human Tissue establishments, and Dietary Supplement Manufacturers.  In addition, Holly brings many years of experience as a Clinical Investigator, IRB, Sponsor/Investigator, and Drug GMP Inspector.  In 2002, Holly was awarded her FDA Level II Certification in Blood Banks and Plasma Centers, recognizing her expertise in the area of Biologics Inspections.

Read Announcement

See Curriculum Vitae

Project Manager - Associate Level (click for full job ad)

Position available: Project Manager – Associate level

Biologics Consulting Group, Inc. (BCG) seeks to hire a full-time Project Manager with practical experience with INDs and/or BLAs, and related regulatory maintenance activities.   The successful candidate will assist clients with producing quality regulatory documents for submission to the FDA within projected timelines.
Candidate may work predominantly from home; however, must be located in sufficient proximity to work in BCG’s Virginia office, as necessary.

Qualified candidates should email Curriculum Vitae to:

RAPS Annual Conference
September 13-16
Philadelphia, PA

BCG representatives at the meeting will include:

Dr. John Jessop, Director of Pharmacology-Toxicology at BCG who has expertise in pharmacology-toxicology, regulatory affairs and product development for biologics and drugs and served as an FDA reviewer at CDER for nine years.

Contact Dr. Jessop

Dr. Melanie Hartsough, Senior Consultant (Pharmacology-Toxicology) at BCG who has expertise in pharmacology and toxicology, nonclinical development of biologic products and nonclinical and clinical immunogenicity issues served as an FDA reviewer at CBER for five years. Dr. Hartsough is speaking on "Implementation of the Case-by-Case Approach: Practical Applications" during the conference.

Contact Dr. Hartsough

Ms. Calley Herzog, Consultant (Medical Devices) at BCG who has expertise in regulatory project management for all types of premarket submissions and served as an FDA biomedical reviewer at CDRH for three years.

Contact Ms. Herzog

Dr. Ian Millett, Senior Consultant (Medical Devices) at BCG who has expertise in driving successful regulatory strategies for medical devices and combination products in the EU, Canada, and U.S. and served as an FDA IVD reviewer at CDRH for three years.

Contact Dr. Millett

Dr. Miriam Provost, Senior Consultant (Medical Devices) at BCG who has expertise in developing successful regulatory strategies for medical devices and combination products and served as an FDA reviewer at CDRH for thirteen years. Dr. Provost is speaking on "Navigating the Scientific and Regulatory Dividing Line Between Drugs and Devices"and chairing a session titled "Tissue Engineered Combination Products— Coordination Is Key."

Contact Dr. Provost

Ms. Kelly Reich, Associate at BCG with eight years of expertise in project management and regulatory submissions including INDs and BLAs.

Contact Ms. Reich

Ms. Holli Vaughan, Associate at BCG with twelve years of regulatory affairs expertise in product development strategies, planning and management as well as being responsible for all regulatory activities, including the preparation of regulatory submissions, the drafting of protocols and reports, the establishment of SOPs and the assurance of data quality and integrity.

Contact Ms. Vaughan

Please visit us at booth #520!

International Society for the Biological Therapy of Cancer
October 28-31
Washington, DC

2009 BioWest Conference
November 10
Denver, CO

2009 Mid-Atlantic Bio Conference
November 4-6, 2009
Washington, DC

BioFlorida 12th Annual Conference
November 4-6, 2009
Orlando, FL

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.

National Non-Clinical Careers For Physicians

"Networking Your Way Into a Non-Clinical Career: Industry, Government & Consulting"

Annual Conference - Booth #520

"Implementation of the Case-by-Case Approach: Practical Applications" (Hartsough)

"Combination Products & Cross Labeling -- Fact or Fiction?" (Portnoy)

"Navigating the Scientific and Regulatory Dividing Line Between Drugs and Devices" (Provost)

"Tissue Engineered Combination Products— Coordination Is Key" (Provost)

Melanie Hartsough, PhD (speaker)

Calley Herzog

Ian Millett, PhD

Stuart Portnoy, MD (speaker)

Miriam Provost, PhD
(speaker/chairperson)

Michael Trapani, MS, MBA

Kelly Reich, MS

Holli Vaughan, MS, RAC

PDA Combination Products Workshop

"Status of Current Regulatory Frameworks and Perceived Problems" (Gross)

"Plenary Session 6 - Safety Reporting" (Portnoy)

Michael Gross, Ph.D. (speaker)

Stuart Portnoy, MD (speaker)

Current Trends in Stability

"Stability requirements for Biologics"

Nanda Subbarao, Ph.D.
(speaker/moderator)

BMES 2009 Annual Fall Scientific Meeting

"Translational Bioengineering: Overcoming the Ultimate Barrier to Entry: Commercialization, Regulation, and the FDA"

Annual Meeting & TXPO

Validation Rules & Regs:  How do they apply to me?

Joseph Fratantoni, MD

Ellen M. Areman, MS, SBB
(moderator)

Melanie Hartsough, PhD

John Jessop, Ph.D., MPH

Health Care Compliance Certification Program

"Advertising & Promotion of Medical Devices"

Melanie Hartsough, PhD

John Jessop, Ph.D., MPH