This guideline contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics and genomic data and sample coding categories.

Pharmacogenomics is defined as the investigation of variations of DNA or RNA characteristics (see guideline for examples) as related to drug response.

Pharmacogenetics is a subset of Pharmacogenomics and is defied as the influence of variations in DNA sequence on drug response.

For an excellent discussion of the possible future of Pharmacogenomics see the Price Waterhouse Coopers report "Personalized Medicine - The Emerging Pharmacogenomics Revolution."

See also the FDA Guidance document "Guidance for Industry - Pharmacogenomic Data Submissions" - March, 2005.

Contact Dr. James Kenimer...

ANDREW ZELAR, PH.D.

Dr. Andrew Zelar has joined BCG as a Senior Consultant. He is located in San Diego and will work through BCG's CA Office. He has over seventeen years of industry experience in the drug discovery, technical, and regulatory requirements of biopharmaceutical product development and commercialization. He is a protein biochemist with expertise in R&D, GLP and cGMP activities from startup organizations to large multinational pharmaceutical corporations. His specialties include biotechnology product characterization, product and process development, analytical test method development, product and process comparability studies, biotechnology transfer projects, laboratory quality, and the effective management of outsourced biopharmaceutical testing and manufacturing.

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STUART PORTNOY, MD

Dr. Stuart Portnoy has joined BCG's VA Office as a Senior Consultant. He has expertise in regulatory strategy for medical technologies, product development for drug/device and biologic/device combination products, assisting clients with strategy and development of preclinical testing, and designing clinical protocols and drafting other documents that comply with FDA regulations and expectations. He has served as a Medical Officer and Clinical Reviewer at Center for Device Evaluation and Radiological Health and was most recently a medical device consultant for PharmaNet.

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Biotech companies face multiple challenges, not least of which, is the investment of time and money associated with product development. In FDA's March 2004 report entitled "Challenge and Opportunity on the Critical Path to New Medical Products," it is estimated that the cost of developing a new medicine is as high as $ 800 million to $1.7 billion, with a significant amount of the cost related to clinical trials. Much of these clinical trial costs are associated with activities related to protecting the safety of human subjects and trying to ensure the quality and integrity of clinical research data. With the cost of development so high, biotech companies are not in the position to waste time or limited financial resources by failing to address issues related to poor data quality or incomplete safety information.

As part of FDA's commitment to modernize the regulation of clinical trials and update its approach to bioresearch monitoring, it recently issued three guidances to assist Sponsors, Clinical Investigators and IRBs in conducting clinical studies. The guidances were issued during April-May 2007 and cover the following three areas:

• Protecting the Rights, Safety and Welfare of Study Subjects (Draft, May 2007)
  
• Adverse Event Reporting-Improving Human Subject Protection (April 2007)
  
• Computerized Systems Used in Clinical Investigations (May 2007)
  

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Contact Michael Trapani...

We are seeking a Senior Regulatory Affairs Consultant with experience in biologics drug development. The successful candidate will play an important role in assisting clients create development plans based on your input into the regulatory strategy. He/she will oversee the preparation, organization and submission of IND's, BLA's, annual reports and license maintenance documents based on a clear understanding of FDA regulations, policies and guidelines. The successful candidate will be expected to have an extensive network of industry contacts. Working with the regional Office Head, these contacts will be developed into generating new consulting opportunities in Regulatory Affairs and other areas in Biologics drug development.

Responsibilities

Assist clients with:

• Understanding the current FDA regulations, policies and guidelines.
  
• Developing regulatory strategy for current development stage and for entire Product Development Plan.
  
• Managing the preparation, organization and submission of IND's, BLA's, annual reports and other documents critical in a product's life cycle
  
• Working with project teams to insure thorough understanding of FDA requirements and risks associated with development alternatives
  
• Requesting, planning and managing FDA meetings to include preparation of briefing documents
  

Assist North Carolina Office Head with:

• Identifying and contacting new client leads
  
• Working with companies to identify needs and creating client Proposals
  Requirements
  
• Ph.D. in scientific discipline or equivalent related experience
  
• 10+ years with increasing Regulatory Affairs responsibility in biopharmaceutical development. FDA work experience is a bonus
  
• Comprehensive knowledge of current FDA regulations and guidelines to include GMP, GLP and GCP regulations
  
• Excellent verbal and written communication skills
  
• Able to work independently and in a team environment
  
• Experience in the following areas is also helpful:
  
  • Proven history of IND and BLA submissions
    
  • Experience communicating, planning and managing FDA meetings
    
  • Biopharmaceutical process development
    
  • Analytical method validation and development

Email Curriculum vitae to Gene Johnston, Head of our North Carolina Office:

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.

Target Immunotherapeutics and Vaccine Summit

"Selecting a Study Population"

AAPS Workshop on Stability: Developing a Stability Program for the Global Market

Stability Challenges of OTCs, Nutraceuticals and Combination Products

Annual Conference & Exhibition

"Regulatory Considerations for Starting a Gene Therapy Trial in the US" (Miller)

"Facility Design Considerations for Biologics" (Godshalk)

Somatic Cell Therapy Symposium

“Use of Devices in Cell Therapy Manufacturing”

Capturing the Science of Stability Testing

"Out-of -Specification Investigations for Stability Samples"

Annual Meeting & TXPO 2007

“New Technologies in Cellular Product Testing”

Getting it Right the First Time, Every Time

"Combination and Device Inspections"