Pharmaceutical and Medical Device Biostatistician Expert

Expertise

• Biotechnology FDA and EMA submission in the pharmaceutical and medical device industries.
• Biostatical litigation specific to pharmaceutical and medical devices.
• Pre- and Nonclinical, Phases I - IV in biostatistics, data management, statistical programming, and etechnology across various therapeutic areas.
• Analysis of over 420 clinical studies, with over 30 in Integrated Summary of Safety and Integrated Summary of Efficacy (ISS/ISE).
• Build effective innovative and dynamic biometrics businesses.
• Data and safety monitoring functions, regulatory for international processes, commercial product development and business development.
• Contributor of 28 NDA/BlA/IDE filing submissions in Europe, U.S.A .and Japan.
• Interactions with FDA and EMA personnel and scientific advisory on behalf of clients.
• Specific statistical methods; Adaptive, recurrent events, experimental design, assays, mathematical modeling and simulation, data-mining and super-computer applications.
• Corrective health: Anti-psychotics, anti-depressives, stroke and Alzheimer's disease - Breast Cancer, Cervical Cancer, Leukemia, Hodgkin's Disease, Prostate, Sarcoma, Non-small Cell Lung Cancer - Infectious Diseases (Anti-Bacterial and HIV/AIDS, CMV, HSV, HCV) - Local Anesthetics and Analgesics - Cardiology - Urology - Rheumatoid Arthritis - Neurology - Psoriasis.

Expert Witness Experience

• Biostatistician Witness in large pharmaceutical litigations, innovative technology, submission strategy and statistical specialty methods, high-intensity modeling and simulation, risk analysis and decision-making strategies.
• Review of medical malpractice documents, patient records with respect medical devices.
• Risks from surgery to be used for the determination of possible malpractice.
• Patent litigation in thermoforming technology.
• Patent infringement.
• Validity of pharmaceutical product label.

Experience

Undisclosed Universities and Professional Growth Centers, 2009 - Present

• Course Director of Biostatistics

Southern U.S. University, 2009 - Present

• Faculty Member and Professor of Biostatistics

INLST., LLC, Founder and Affiliate, 2008 - Present

• Operate an intellectual capital advisory network assists companies shape their business strategy, catalyze the development of innovations, and accelerate commercial success.
• Deliver high quality, comprehensive, and coordinated support for Life Science organizations.
• Focus to advanced technologies for life sciences, biomarkers and diagnostics, pharmaceutical research and development, clinical study design and development, medical devices, Informatics and Information management.
• Executing due diligence, maximizing the value of intellectual property, developing and commercializing technologies, accelerating, research and development, leading and managing innovative teams, projects, and companies.
• Delivering services: Scientific, medical, and strategic insight, market research, product development, Intellectual Property Asset Management, Business Development and Licensing, Strategic Partnerships, Fund Raising.

Stat., Consulting LLC, President, 2006 - Present

• Provide biometrics services to assist the biopharmaceutical and medical device industries in bringing new products to market.
• Full product cycle support, from pre- and non-clinical to first-in-man, dose-response and dose-finding, data and safety monitoring functions, and confirmatory clinical evaluation through submission.
• Provide pharmaceutical litigations services as statistical expert witness.

Vertex Pharmaceuticals Inc., Cambridge, MA, V.P. Medicines Development Group, 1997 - 2006

Positions

Vice President, Biometrics, Medicines Development Group, 2005 - 2006
Senior Director, Biometrics, Drug Evaluation and Approval, 2000 - 2005
Director, Biometrics, Clinical Development, 1997 - 2000

• Built a global strong, efficient and professional team.
• Implemented and validated workflow, database, electronic data capture, CDISC, adaptive designs, SAS, and built a supercomputer simulation system in collaboration with Texas Tech University and SAS Institute.
• Responsibilities include management of Clinical Data Managers, Biostatisticians and Statistical Programmers in pre-clinical, non-clinical, and clinical areas.
• Maintained strong interaction with senior management on program management and improvement initiatives.
• Chaired the Clinical Scientific Committee, "Rational Drug Development", for the enhancement of cross-functional scientific discussions, and for the betterment of study designs and product development.
• Chaired the Knowledge Committee, "Knowledge Management", for the improvement of cross-functional knowledge exchange.
• Project leader for implementation, validation, and training of MedDRA and dsNavigator.
• Chaired and coordinated eight cross- departmental improvement project teams over the entire Development Division.
• Chair of the EDC/CDISC Steering Committee, for the optimization of business processes through EDC and CDISC.
• Drove and lead the initiative of implementing adaptive designs of clinical trials effectivization for clinical drug development. These initiatives have helped Vertex attain its strategic and innovative goals.

Amgen, Thousand Oaks, CA, Department Head, 1995 - 1997

• Oversaw the group for oncology and preclinical biostatistics.
• Built a strong, efficient and professional group (mostly PhD statisticians), and gained valuable experience from the largest biotechnology company in the world.
• Responsibilities included management of biostatisticians in preclinical and non-clinical area as well as in the clinical area of oncology for Neupogen.
• Frequently interacted with the FDA and investigators worldwide regarding two major BLAs.

Parexel International Corporation, Waltham, MA, V.P. Biostatistics-Data Management, 1993 - 1995

• Served on a corporate level to restructure the corporation worldwide, after which the company grew 10-fold.
• Set long-term goals and objectives and developed performance metrics to track the progress of objectives.
• Supervised up to five directors and a staff of 220 people.
• Coordinated statistical, programming, and CDM activities, as well as lead cross-functional activities with other divisions within the company.
• Established and documented department standard operating procedures with continual evaluation of systems improvement.
• Served as a technical advisor to staff, clients, and other divisions in the company worldwide.
• Frequently represented clients at meetings with the FDA. Traveled frequently across the U.S. and Europe to meet with new clients and attract new business.

Director, Biostatistics and Data Management Division, 1993 - 1994

• Coordinated cross-functional activities and improvements within the company.
• Establish and document department standard operating procedures with continual evaluation of systems improvement.
• Prepared proposals, including time estimates and general assumptions, to clients.
• Served as a technical advisor to staff, clients, and other divisions in the company worldwide. Frequently represent the clients at meetings with the FDA.

AstraZeneca, Sdertlje, Sweden, 1982 - 1993

Director, Biostatistics, 1987 - 1993

• Managed and mentored 12 biostatisticians and programmers for consulting on protocol design, data collection and management, statistical analysis and statistical reporting, reviewing reports and contributing overall to the submission of 11 NDAs, in local anesthesia and analgesics, CNS (schizophrenia and depression), antibiotics and antivirals.
• Worked as the Biostatistics liaison, transferring projects to Merck Sharp and Dohme, PA, U.S.A.
• Involved in development and application of standard operating procedures within AstraZeneca worldwide. Frequently met with regulatory bodies and investigators worldwide.

Senior Biostatistician, 1982 - 1987

• Project biostatistician in pre- and non-clinical, toxicology, pharmacokinetics and all phases of clinical drug development; including development of study protocols, analysis plans, CRFs, data review guidelines, programming, statistical analysis and statistical reporting, reviewing reports and contributing overall to the submission of NDAs.
• Therapeutic fields of dentistry, CNS, local anesthetics, anti-biotic and anti-viral. Frequently met with regulatory bodies and investigators worldwide.

University of Stockholm, Sweden, 1974 - 1982

Lecturer and Professor-Department of Statistics

• Lecturing in graduate and post-graduate courses in Probability Theory, Inference Theory, Regression and Analysis of Variance, Time Series Analysis, Sampling Techniques, Dynamic Programming, Epidemiology, and Econometrics.
• Conducted research in the field of survival analysis.

In Silico Biosciences Inc., Woburn, MA, Senior Scientific Advisor, 1999 - 2001

• Served as an advisor on scientific and business issues during the formation of an informatics company.
• Provided technology platform, via computational modeling of physiological systems of CNS Diseases, addressed the urgent needs in information processing of researchers and executives in the pharmaceutical, biotechnology and the healthcare industries.

Nobel Prize Committee-Medicine or Physiology, 1975 - 1982

• Chief Statistical Advisor.

Karolinska Institute, Stockholm, Sweden, 1974 - 1982

• Lecturer-medical statistics.

The Group for Applied Statistics, Stockholm, Sweden, 1975 - 1982

Independent Statistical Consultant and Programmer

• Clients: Roche, Hoechst, Essex, Pharmacia, The Wellcome Foundation Ltd., Karolinska Institute, Karolinska Hospital, Radiumhemmet, Huddinge Hospital, Danderyd Hospital, Sder Hospital, Serafimer Hospital, Sahlgrenska Hospital, Swedish Bacteriological Laboratory, and Swedish Board for Technical Development.

Swedish Academy of Pharmaceutical Sciences, 1982 - 1993

• Lecturer at the in statistical clinical trials methodology.
• Lecturing at various research units and marketing companies worldwide within AstraZeneca.

Educator

• Provide extensive training in leadership, software systems, therapeutic areas, and statistics.
• "Clinical Trials Methodology from a Statistical Point of View" (designed for Clinical Research Scientists).

Honors & Publications

Credentials

• Thesis: Statistical Analysis of Censored Survival Time Data in Clinical Trials (University of Stockholm)
• Business Economics, University of Stockholm, Sweden

Software and IT

• Statistical Packages: SAS, S-PLUS, GLIM, BMDP, MATHEMATICA, RS/1, MINITAB, STATXACT, LOGXACT, EAST, PEST, MAPLE 10, Trial Designer, ACSL, XPRO
• Programming Languages: Fortran, Cobol, Basic, RPL, JCL, SQL
• Word Processing, Spreadsheets and Specialty Packages: Microsoft Word, Microsoft Excel, ClarisDraw, Meeting Maker XP, Adobe Persuasion, Wordmark, WordPerfect, AmiPro, PowerPoint

Languages

• English - Fluent
• Swedish - Fluent
• French - Conversation
• German

Academic and Professional Affiliations

• American Statistical Association - (ASA)
• Chair of the section "Statistical Consulting"
• Reviewer of Statistics in Medicine
• President of the North Carolina Chapter (ASA)
• Member of the International Advisory Committee of the University of North Carolina
• Elected President of the North Carolina Chapter (ASA)
• Chair of Massachusetts Biotechnology Council, Biostatistics and Data Management
• Reviewer to SAS Institute
• Statistical reviewer of Applied Clinical Trials
• President of the Swedish Society for Medical Statistics
• Council member of Swedish Statistical Association
• Council member and co-founder of European Federation of Statisticians in the Pharmaceutical Industry
• Member of ISCB - Working Party on Statistics in European Drug Regulation
• Member of the Adverse Event Management Group in Coordination - AstraZeneca's Clinical Information Systems
• Member of Guideline for the Internal Statistical Report Group
• Member of AstraZeneca Evaluation Planning Team
• Member of World-wide Quality of Life and Health Economics Task Force between AstraZeneca and Merck/U.S.
• Chair of Clinical Trials Methodology from a Statistical Point of View

Awards

• Professional Mentor Recognition Award, School of Public Health and Health Sciences, University of Massachusetts

Publications and Patents

• Over 80 publications and presentations.
• Presenter at various conferences worldwide.

Education

• Ph.D. Statistics University of Stockholm, Stockholm, Sweden,
• B.Sc. Mathematics, Statistics, Computing, University of Stockholm, Sweden
• B.S. Mathematics, (Physics Chemistry Biology) Stockholm's Samgymnasium, Stockholm, Sweden