Biologics Consulting Group, Inc.
is pleased to make the following announcement:

David Pepperl, Ph.D. joined the Biologics Consulting Group, Inc. (BCG) as a Senior Consultant in January 2004.

Prior to joining BCG, David served as toxicologist and Manager of Preclinical Development at TherImmune where he drafted preclincial development strategies, authored nonclinical sections of regulatory submissions and managed preclinical development programs for clients. In this capacity, he designed and managed nonclinical pharmacology and toxicology studies, performed GLP and scientific audits and reviewed study data on behalf of clients. He also served as program manager, working closely with contract research facilities to assure timely completion of nonclinical development programs for small to mid size biopharmaceutical companies. He has authored position papers on comparability and development of biologic products and has participated in the development of pre-IND information packages and the nonclinical sections of INDs.

As a toxicologist and preclinical development manager, David has managed numerous development projects ranging from small peptides, small molecules, monoclonal antibodies, cell and gene therapy products, adenoviral therapies, bacterial based oncology therapies and hormonal therapies. At BCG, David will provide services including development and review of preclinical product development programs, strategic planning of program implementation capabilities, review and preparation of nonclinical study reports and regulatory submissions, and GLP auditing and study monitoring services for both emerging and established biopharmaceutical companies. David's interests and expertise span the following areas:

• Strategic Planning and Evaluations of Nonclinical (pharm/tox) Development Programs
  • Compound selection support and evaluation
    
  • Preclinical study (pharmacology and toxicology) design and sourcing
    
  • Due diligence on therapeutic potential for novel products
    
  • Complete strategic product development plans for overall development of client products, including manufacturing, preclinical, regulatory and clinical development, timelines, budgets and resources
• Program and Project Management Services
  • Client-CRO liaison
    
  • Project timeline and budget management
    
  • Preclinical studies issue resolution
    
  • Management of on-time delivery of Study reports
• Nonclinical Regulatory Support
  • Development of regulatory strategy for preclinical development programs
    
  • Preparation of nonclinical pharmacology reports from available study data
    
  • Preparation/review of Pre-IND packages and other supplemental regulatory submissions
    
  • Preparation/review of pharmacology and toxicology sections of INDs and BLAs
    
  • Assistance in responding to FDA compliance actions or information requests
    
  • Assistance in preparing for FDA meetings
• GLP and Scientific Study Monitoring
  • Sourcing and qualification of Contract Pharmacology and/or Toxicology Service providers (CROs)
  • GLP auditing services including,
    • In-house toxicology monitoring and management of crucial GLP safety studies
      
    • On-site Study monitoring for real-time, objective monitoring of GLP Toxicology studies
      
    • Review of procedures, SOPs, training files, facilities test article storage and preparation facilities, animal facilities and data collection and storage facilities
      
    • Perform mock inspections both for compliance assessment and as an inspection preparation tool

David holds a Bachelors of Science Degree from Michigan State University and Ph.D. in Pharmacology and Toxicology from the University of Arizona. He performed post-doctoral work at Pharmacia & Upjohn and Parke-Davis prior to joining TherImmune in December, 2000.

Dr. Pepperl's experience in pharmacology and toxicology, strategic planning, biotechnology, preclinical development, regulatory affairs and program and project management will provide a valuable resource for clients requiring biologics and drug development support for novel, emerging therapies.

View Dr. Pepperl's Curriculum Vitae...

Page Updated April 13, 2010