Louise C. Johnson, MS, will join Biologics Consulting Group, Inc., as a Senior Consultant on
March 1, 2007.

Louise has over 28 years experience in the biotechnology and pharmaceutical industry. Prior to joining Biologics Consulting Group, Louise spent the past 17 years in regulatory leadership roles at Renovis, Elan Pharmaceuticals, Athena Neurosciences, and DuPont Pharmaceuticals. Since 2004, Louise has served as the Senior Director of Regulatory Affairs at Renovis where her responsibilities included management of and strategic planning for regulatory affairs and quality assurance functions. This role also included participation in in-licensing and M&A activities, where she provided regulatory and developmental assessments and participated in due diligence. Louise has substantial experience working with project teams to support 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.

Louise has a track record of success in product development and gaining product approval. Her previous work includes the initial IND filing for Tysabri for Athena Neurosciences, approval of 2 anticonvulsants in the US and Canada for Elan Pharmaceuticals, and the initial IND filing a therapeutic vaccine for Alzheimer's disease for Elan Pharmaceuticals.

In her early career, Louise supervised a pharmacology discovery lab at E.I. du Pont de Nemours & Co. (subsequently DuPont Pharmaceuticals). During her 11 years in this position, she conducted in vivo research specializing in CNS diseases such as epilepsy, schizophrenia, depression, and Alzheimer's disease.

As a Senior Consultant with Biologics Consulting Group, Ms. Johnson will use her regulatory, R&D, and marketed product expertise to assist clients in:

• Creation, implementation, and review of regulatory strategies
  
• Planning, creation, and review of regulatory filings
  
• Orphan product applications and maintenance
  
• Regulatory agency meetings (FDA, HPFB, and MHRA)
  
• Regulatory review of adverse experience reports and procedures
  
• Planning, writing, review of responses to agency questions
  
• Assistance with the planning and conduct of clinical trials, including GCP requirements, review of protocols, consent forms, Investigator's Brochures, and clinical study reports
  
• Planning, preparing for and presenting at FDA Advisory Committee Meetings
  
• Negotiation of regulatory approvals and interpretation of regulatory agency requests
  
• Package insert writing, review, negotiation with FDA
  
• Review of advertising and promotional materials
  
• Establishment of procedures and policies for Regulatory Affairs and Quality Assurance functions
  
• Advice on current regulatory landscape
  
• Due diligence related to in-licensing or mergers/acquisitions
  
• FDA and DEA requirements for Schedule II through Schedule IV controlled substances
  

View Ms. Johnson's Curriculum Vitae...

Page Updated June 12, 2007