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

Craig A. Halverson joined the Biologics Consulting Group, Inc. as a Senior Consultant in May, 2010.

Craig has over 25 years of scientific, regulatory and quality experience in the biopharmaceutical and in vitro diagnostics industries. This experience was gained at six biotechnology companies, a clinical reference laboratory, and an in vitro diagnostics company. He is an experimental pathologist with product development experience that spans pre-clinical characterization, manufacturing process and analytical method development through IND and BLA/NDA acceptance.
Craig has interacted with regulatory agencies, biotechnology companies, and the preclinical, clinical, manufacturing and diagnostics industries on the development of diagnostic and therapeutic monoclonal antibodies, plasma derivatives and their recombinant counterparts, synthetic peptides, a nucleoside analogs, an adenovirus-delivered gene therapies, therapeutic tumor vaccines, and a commercial blood screening assay for HIV-1 and HCV employing a viral nucleic acid amplification technology.  His specialties include the development and successful implementation of regulatory product development and registration strategies and quality systems, recruiting and managing RA and QA groups, crisis management and solving complex compliance problems.  He communicates effectively at the senior management level as well as with manufacturing, engineering, process development, quality control, clinical and pre-clinical technical personnel.

As Vice President of Regulatory Affairs and Quality Assurance at SciClone Pharmaceuticals, Inc, Craig installed an ICH compliant quality system, developed a Quality and Regulatory document management system, recruited and built the infrastructure to support electronic regulatory submissions, filed an IND for a dipeptide with an inflammation indication in oncology, filed a CTA in China for an HCV indication, developed quality and regulatory strategies for a marketed product that prevented supply interruptions during a major manufacturing supplier crisis, and coordinated the development of API manufacturing process improvements that dramatically increased yields while reducing yield variability.  In addition, he developed regulatory due diligence strategies for both in- and out-licensing projects.
As Vice President of Regulatory Affairs at Zymogenetics, Inc, Craig recruited and managed a 15 member regulatory affairs group that supported multiple development projects in hemostasis, oncology, immunology, infectious disease, with successful electronic submissions for a cytokine IND and a BLA for recombinant human thrombin that was subsequently approved. 

As Vice President of Regulatory Affairs and Quality Assurance at Introgen Therapeutics, Craig reorganized the Quality Assurance group, introduced an ICH compliant quality system, and brought together a team of outside consultants and led the BLA writing effort for an adenovirus-delivered gene therapeutic.

As Executive Director of Global Regulatory Affairs at CancerVax Corporation, Craig recruited and managed the Regulatory Affairs department with electronic publishing, CMC, pre-clinical, clinical and clinical quality assurance capabilities in support of a therapeutic tumor vaccine.  He advised on manufacturing process and facility, utility, and equipment validation and met with US, Canadian and Australian regulatory authorities to develop registration strategies in each of those countries.

As Director of Regulatory Affairs at Gen-Probe Incorporated, Craig built a biologics regulatory capability, developed the registration strategy for a complex amplified nucleic acid blood screening test and managed development of the IND and BLA for that test, which was subsequently approved by FDA.  Craig advised Manufacturing, Quality Control, Quality Assurance, Facilities, and Engineering on matters of regulatory compliance in support of the commissioning of a 100,000 sq ft classified manufacturing facility in preparation for a successful pre-approval inspection for that product.
As Director of Global Regulatory Affairs at Baxter Healthcare Corporation, Hyland Division (now Baxter BioScience), Craig recruited and managed an international regulatory affairs group that completed over 70 new registrations for plasma derived Factor VIII, supported the registration of recombinant FVIII, managed the Hyland manufacturing establishment license and conducted over 30 class I recalls of plasma derivatives affected by blood donors who died of Creutzfeldt-Jacob disease.

As Senior Research Scientist in Clinical and Regulatory Affairs at Hybritech Incorporated, Craig managed 22 oncology INDs for monoclonal antibodies to various tumor associated antigens and wrote the IND for a bi-specific therapeutic antibody in oncology.  He also built, recruited and managed an immunohistochemistry screening laboratory and coordinated pre-clinical primate toxicology studies in support of INDs for these antibodies.
At the University of Southern California Clinical Laboratories Craig developed a reference assay for terminal transferase, and introduced flow cytometry equipment and methods for the determination of T4/T8 ratios. 

View Mr. Halverson's Curriculum Vitae...

Page Updated June 29, 2010