Senior Consultant, Biologics Consulting Group, Inc., Seattle, WA

Principal, Halverson Biopharmaceutical Consulting LLC, Foster City, CA

• Global strategic regulatory affairs, quality assurance, compliance, and management

Vice President – Regulatory Affairs and Quality Assurance
(Oncology, Inflammation, Infectious Disease), SciClone Pharmaceuticals, Inc., Foster City, CA

• Provided strategic guidance and hands-on management of Regulatory Affairs, Quality Assurance, Quality Control, and Medical Writing in support of branded biopharmaceutical approved in Italy, China + 35 other countries;  supported 5 clinical programs with 3 molecules, and in/out licensing diligence in a virtual corporate environment
• Implemented an ICH-compliant quality system
• Filed CTA with SFDA for phase 2 HCV study in China
• Coordinated the development of EU commercial API manufacturing process improvements that increased CMO peptide synthesis yields by 78% and reduced yield variability by 67%
• Developed a commercial manufacturing supply strategy and EMEA and Chinese SFDA regulatory strategies that reduced time to market for emergency commercial product component changes due to vendor financial collapse from over 2 years to 3 months, avoiding catastrophic business interruption
• Developed electronic CTD NDA submission strategies appropriate to the virtual corporate environment
• Managed IT services during year long search for new CFO, improving Sarbanes-Oxley Section 404 compliance

Vice President – Regulatory Affairs (Hemostasis, Oncology, Immunology, Infectious Disease, Medical Devices), ZymoGenetics, Inc., Seattle, WA

• Recruited, trained, and led a world class 15-member regulatory affairs team that submitted ZymoGenetics’ first BLA in fully electronic common technical document format ahead of schedule.
• Implemented policies, procedures and strategies for FDA interactions and submissions that reversed a strained relationship with FDA reviewers.  As a result of improved communication with FDA, several new clinical protocols submitted to existing INDs and a new IND were all accepted by FDA without delays or holds.
• Introduced traditional project management discipline to regulatory submission development resulting in meeting or exceeding all development team submission milestones.
• Provided temporary staffing and quality systems guidance during overhaul and reorganization of Quality Assurance resulting in BLA pre-licensing inspection with no major issues.

Vice President – Regulatory Affairs & Quality Assurance (Oncology:  Gene Therapy), Introgen Therapeutics, Houston, TX.

• Hired to build regulatory affairs and quality assurance organizations to support ADVEXIN® gene therapy BLA and product launch.
• Reorganized QA team and developed comprehensive GXP-compliant quality systems to support licensure and commercialization of gene therapy product, reducing backlog of unresolved change requests and corrective and preventive actions to zero.
• Coordinated team that wrote BLA (CMC, pre-clinical, and Phase 1-2 portions of clinical section) while awaiting completion of Phase 3 study.

Executive Director – Global Regulatory Affairs (Oncology:  Vaccines & Monoclonal Abs), CancerVax Corporation, Carlsbad, CA.

• Hired to build regulatory organization to support completion of Phase 3 studies, BLA submission and launch of live cell therapeutic melanoma vaccine.
• Recruited, trained and led 9-member global regulatory affairs and clinical quality assurance department supporting global clinical trials; converted all regulatory submissions to fully electronic format in preparation for an electronic BLA to facilitate rapid FDA review.
• Developed GXP audit functions and implemented audit and training programs that resulted in a successful California drug manufacturing license for a new 50,000 sq. ft. aseptic oncology product manufacturing facility.
• Conducted / hosted numerous regulatory due diligence investigations of / by potential business partners and investors resulting in acquisition of one company and partnership with global pharmaceutical company.

Director - Regulatory Affairs (In Vitro Diagnostics - Blood Screening), Gen-Probe Inc., San Diego, CA.

• Hired to develop regulatory strategies and bring a biologics regulatory affairs capability to an in vitro diagnostics manufacturing environment.
• Recruited, trained and led biologics regulatory group that wrote and made on-time BLA submission for an HIV-1 / HCV blood screening assay containing clinical data from over 20 million tests and that was approved in a single review cycle.
• Led GXP compliance upgrade program across the company that resulted in a successful pre-approval inspection by FDA of a new 100,000 sq ft classified IVD manufacturing facility (raw materials through fill/finish).

Baxter Healthcare Corporation, Glendale, CA

Director - Global Regulatory Affairs (Therapeutics - Plasma Derivatives), (1997-2008).

• Recruited and directed team of 13 regulatory professionals responsible for domestic and international product and facilities regulatory submissions for $1.2B recombinant protein and plasma derivative manufacturer selling in 110 countries worldwide, improving CMC compliance status and number of global registrations.
• Coordinated regulatory strategy for amplified HIV/HCV plasma screening IND that successfully integrated multiple third party co-sponsors and contract testing facilities.

• Recruited and managed international regulatory affairs group that made over 70 new registrations of existing products worldwide in non-ICH markets.
• Conceived and implemented first U.S. blood product recall notification hotline in response to congressional, FDA, and patient demands while conducting 30 global CJD and compliance-related plasma derivative recalls.

Hybritech Inc., San Diego, CA

Project Manager - Technology Acquisition/Product Development, (1991 to 1994)

• Recruited and managed cross-functional product development team for estimated $1B cardiovascular imaging agent, reducing worldwide break-even time projections by 70% for business unit that was shut down in 1994.
• Managed global technology acquisition program that reviewed over 350 license opportunities, completing 30 license options, and funded research agreements, negotiating highly favorable agreements with universities and companies worldwide, resulting in acquisition of 100% of targeted technologies/products.

Senior Research Scientist - Clinical & Regulatory Affairs (Oncology Products), (1987 to 1991)

• Managed 22 CBER oncology product INDs (melanoma, breast, lung small cell, lung non-small cell, colorectal, ovarian, and prostate carcinomas)
• Wrote oncology product IND for bi-specific antibody imaging agent and obtained Orphan Drug designation for colon cancer imaging agent.  Wrote clinical imaging and dosimetry protocols, CRFs and physician’s brochures for chimeric bi-specific antibody radioimaging and therapy agent trials in colon cancer.

Research Scientist - Cell Biology (Oncology Product Screening), (1985 to 1987)

• Built and staffed 12-technician GLP immunohistochemistry monoclonal antibody screening laboratory.
• Managed preclinical pharmacology and toxicology studies to support oncology product INDs.