ª Analytical, energetic and innovative pharmaceutical industry professional with over
20 years operational and compliance experience.
ª Highly successful corporate team player. ª Process-oriented leader with exceptional logical, problem-solving and organizational
ª Direct, clear communicator with ability to communicate at all levels of an organization.
ª Instituting compliance programs that meet regulatory and legal requirements, including
procedural frameworks, risk-based auditing and employee training programs.
ª Leading cross-functional groups to establish efficient, high-quality and compliant
International Pharmaceutical Development Experience
RCG Consulting, Inc.
Established a consulting business offering compliance and operational expertise to biopharmaceutical companies.
ª GCP-QA advice to large Pharma company and inspection-readiness in advance of
ª FCPA audit strategy for global diagnostics business. ª Procedural framework for one of the top 6 global Pharma companies. ª Process mapping of Development operations for $250M oncology company. ª Pre-approval inspection readiness for hospital-focused biopharmaceutical company. ª Advice on management of late-phase clinical studies and role of MSLs for a leading
ª GXP-QA advice to mid-sized company, including inspection-readiness for potential
ª Reengineered QA function for an 80% down-sized biopharmaceutical company. ª Clinical operations and strategic sourcing support to a VC-backed biopharmaceutical
company entering later Phase development.
ª In-licensed a $150M Phase 3 product and established development operations for a
company that subsequently secured $32M Series B finance.
Elan Pharmaceuticals, South San Francisco, CA
Vice President, Global Quality Assurance & Process Improvement
Reporting to the EVP, Global Development. Responsible for ensuring all operational processes
ª Reorganized global quality function to provide QA operation, auditing and validation
ª Within the corporate risk-management plan, established and led Development Business
Continuity Team, adopting a value-based approach for business continuity of key Development programs.
Chiron Corporation, Emeryville, CA
Vice President, Compliance and Process Improvement
2005 - 2006
Reporting to the SVP, Global Regulatory Affairs, Pharmacovigilance & Compliance with dotted line report to President, BioPharmaceuticals.
ª Established commercial compliance function meeting PhRMA and OIG Guideline
ª As Corporate Compliance Officer for BioPharmaceuticals, developed key corporate
ª Led cross-functional team to develop and implement global Development work practices. ª Implemented business continuity plans for Development organization.
Elan Pharmaceuticals, San Diego, CA
Vice President & Global Head, Quality & Process
Reported to the EVP, Antegren Business as a member of the Tysabri® launch team. Involved in
key strategic decisions regarding sales, marketing, medical support, distribution and pricing of
this potential blockbuster. Ensured key processes would support commercialization of Tysabri®
in two indications:
ª Designed and built-out customer support services, including product website.
ª Established data feeds to provide management reporting metrics.
ª Implemented global pharmacovigilance process.
Vice President, Global Regulatory Compliance
Reported to the President, Research & Development and responsible for driving initiatives to
optimize the output of Elan’s Global Development function.
ª Implemented a global GCP-QA Group with audit, SOP and document management,
training and IT validation functions to support clinical studies of development (Antegren, Prialt, Alzheimer’s program) and marketed (Zonegran, Myobloc) products.
ª Led cross-functional teams to develop global clinical operational structure. ª Created and led Strategic Outsourcing function and, through new preferred-provider
relationships, reduced outsourcing spend >$7M during the period 2003-5.
Quintiles Transnational Corp., Durham, NC
Head, Global Quality Management Group
Reported to the CEO, Clinical Development Services with dotted line report to SVP, Corporate Compliance. Established and led this group, focusing on initiatives that reduced corporate risk.
ª Analyzed competitive intelligence and customer feedback to identify and remediate areas
ª Managed and re-engineered centralized subject enrollment, randomization and drug
ª Led global Part 11 compliance program.
Acting General Manager, Quintiles Laboratories
Reported to the Global COO of this $100M global analytical laboratory headquartered in
Atlanta. Working with Outside Counsel, led and managed six functional areas (350 people) and
re-engineered business process to optimize operational efficiency, ensure data integrity and meet
regulatory and contractual obligations.
Campbell Charles Associates Limited, East Horsley, Surrey, UK
Campbell Charles Associates was a boutique provider of pharmaceutical development resource
to international drug companies. Responsible for founding this company and management of
clinical research, business development and medical advisory personnel.
ª Provided clinical trial services to clients including: Bayer (metrifonate,
oxymoxyfloxaccin), Glaxo (ondansetron), Kabi Pharmacia (terodiline), Medeva (tetanus/diphtheria and flu vaccines), Rhone Poulenc (zimovane, perchlorperazine), Sanofi Winthrop (ciprofibrate, verapamil), Solvay-Duphar (fluvoxamine) and Zyma (OTC cold medications).
ª Expanded corporate experience to encompass 18 therapeutic areas, including
cardiovascular, CNS, endocrinology, neurology, urology and virology/immunology.
May & Baker Pharmaceuticals Limited, Dagenham, Essex, UK
Reported to the UK Medical Director. Jointly responsible for the planning, initiation, monitoring
and reporting of Phase 1-3 studies within the CNS Area. Products included chlorpromazine
(Largactil), perchlorperazine (Stemetil and Stemetil Eff), pipothiazine (Piportil), suriclone and
zopiclone (launched as Zimovane). Summary of Education, Qualifications and Interests
Six Sigma Black Belt
PhD in Experimental Surgery (University of London)
BSc (First Class Honours) in Biochemistry/Physiology (University of London)
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B A B E T T E K ü S T E R Muster und Moden Der auf dem Vorblatt reproduzierte Bericht von der Leipziger Frühjahrs-messe 1811 vermittelt den Eindruck, daß damals, ebenso wie heute auf den großen Schauen in Paris, Mailand, New York und London, im Früh-jahr und Herbst die jeweils neuesten Modetrends vorgestellt wurden und für ein halbes Jahr Gültigkeit behielten. Die Mode- und Handelsjournale