Expert Details

Expert in BioStatistics, Pharmaceutical Devices, Biotechnology, and FDA and EMA Submissions

Expert ID: 733544 North Carolina, USA

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Expert holds a Ph.D in Statistics and has 25 years' applicable industry experience. He currently serves as a biostatistical expert witness in high-stakes pharmaceutical and medical device litigations. He has expertise in pre- and non-clinical, Phases I-IV in biostatistics, data management, statistical programming, and eTechnology across various therapeutic areas. He has analyzed over 420 clinical studies, as well as over 30 ISS and ISE.

He has extensive experience successfully building effective, innovative and dynamic biometrics departments. He also has extensive proficiency in data and safety monitoring committee functions.

Expert undertakes project collaborations with biotech, pharmaceutical, medical device companies in the U.S. and Europe. His collaborators have included law firms, Massachusetts Institute of Technology, Georgia Southern University, and the Royal Institute of Technology (Stockholm, Sweden). His expertise is most fully utilized in addressing high-level strategy and problem-solving challenges.

Most of Expert's project collaborations are as an expert witness in large pharmaceutical litigations, on innovative technology, submission strategy and statistical specialty methods, high-intensity modeling and simulation, risk analysis and decision-making strategies. As an independent statistician, he serves on Data and Safety Monitoring Boards. He interacts with FDA and EMA personnel at committee meetings and scientific advisory committee meetings on behalf of his clients.

Expert's experience in therapeutic areas includes 25 years' experience in pre-clinical through Phase IV clinical trials. He has therapeutic specialization in Local Anesthetics and Analgesics, diabetes, Central Nervous System (antipsychotics, anti depressives, stroke and Alzheimer's disease), HIV/AIDS, Oncology (Breast Cancer, Cervical Cancer, Colorectal Cancer, CLL, NHL, Leukemia, Hodgkin's Disease, Pancreatic, Prostate, Sarcoma, SCLC, NSCLC), Infectious Diseases (Anti-Bacterial and CMV, HSV, HCV), Cardiology, Urology, Rheumatoid Arthritis, Neurology, Dentistry, and Psoriasis.

As a consultant and expert witness, Expert's clients have included Novo Nordisk, Ferring Pharmaceuticals, Vertex Pharmaceuticals, Massachusetts Institute of Technology, Royal Institute of Technology, Cephalon, Dechert LLP, Clinton Health Access Initiative, Incyte Corporation, Harvard Apparatus, T2 BioSystems, Stomedix, Pulmetrix, Niconovum, Pharma Group Consulting, Rubin/Anders, The Weinburg Group, Trial Care International, InnaVirVax, Presidio, Pharmalys, Concert Pharmaceuticals, CardioMEMS, Biothera, BioBridges, BioMimetic Therapeutics, Sensible Medical Innovations, Care-Safe, Brooks Rehabilitation, LFB Biotechnologies, CellAct, F Star, Georgia Southern University, and others.

Expert may consult nationally and internationally, and is also local to the following cities: Raleigh, North Carolina - Greensboro, North Carolina - Durham, North Carolina - Winston Salem, North Carolina - Fayetteville, North Carolina - Cary, North Carolina - High Point, North Carolina - Greenville, North Carolina - Rocky Mount, North Carolina - Lynchburg, Virginia

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Education

Year Degree Subject Institution
Year: 1982 Degree: Ph.D Subject: Statistics Institution: University of Stockholm
Year: 1974 Degree: B.Sc Subject: Mathematics, Statistics, and Computing Institution: University of Stockholm

Work History

Years Employer Title Department Responsibilities
Years: 2009 to Present Employer: Undisclosed Title: Course Director Department: Biostatistics Responsibilities: Develop courses and lecturing.
Years: 2009 to Present Employer: Undisclosed Title: Adjunct Faculty Member; Professor Department: Biostatistics Responsibilities: Develop courses and lecturing.
Years: 2008 to Present Employer: Undisclosed Title: Founder and Affiliate Department: Responsibilities: Expert's firm helps companies shape their business strategy, catalyze the development of innovations, and accelerate commercial success. The company catalyzes the delivery of high-quality, comprehensive, and coordinated support for Life Science organizations. The company's focus is on Advanced Technologies for the Life Sciences, Biomarkers and Diagnostics, Pharmaceutical Research and Development, Clinical Study Design and Development, Medical Devices, Informatics and Information Management. The company excels at 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. The company delivers the following services: Scientific, Medical, and Strategic Insight, Market Research, Product Development, Intellectual Property Asset Management, Business Development and Licensing, Strategic Partnerships, and Fund Raising.
Years: 2006 to 2008 Employer: Statogen Consulting LLC Title: President Department: Responsibilities: Expert's firm offers biometrics services to assist the biopharmaceutical and medical device industries in bringing new products to market. They assist throughout the entire product cycle, from pre- and non-clinical to first-in-man, dose-response & dose-finding, data and safety monitoring functions, and confirmatory clinical evaluation through submission. They also assist in pharmaceutical litigations as statistical expert witness.
Years: 1997 to 2006 Employer: Vertex Pharmaceuticals Inc. Title: Director, Biometrics, Clinical Development Department: Responsibilities: Expert served this pharma company as VP of Biometrics -- Medicines Development Group (2005-06); Senior Director of Biometrics -- Drug Evaluation and Approval (2000-05); and Director of Biometrics -- Clinical Development (1997-2000). Among others, his responsibilities included management of Clinical Data Managers, Biostatisticians and Statistical Programmers in the entire pre-clinical, non-clinical, and clinical areas. He also implemented and validated entirely workflow, database, electronic data capture, CDISC, adaptive designs, SAS, and built a supercomputer simulation system in collaboration with Texas Tech University and the SAS Institute.
Years: 1995 to 1997 Employer: Amgen, Thousand Oaks, CA Title: Head of the group for oncology and preclinical biostatistics Department: Oncology and Preclinical Biostatistics Responsibilities: Expert built a strong, efficient and professional group of 16 people (mostly Ph.D statisticians), gaining valuable experience from the largest biotechnology company in the world.
His responsibilities included the management of biostatisticians in the entire preclinical and non-clinical area, as well as in the clinical area of oncology for Neupogen. He frequently interacted with the FDA and investigators worldwide regarding two major BLA's.
Years: 1993 to 1995 Employer: PAREXEL International Corporation Title: Vice President, Biostatistics and Data Management Division Department: Waltham, MA Responsibilities: Expert served the company as VP of Biostatistics and Data Management, where he served on a corporate level to restructure the corporation worldwide, after which the company
grew 10-fold (1994-95). Among other responsibilities, he coordinated statistical, programming, and CDM activities, as well as lead cross-functional activities with other divisions within the company. Previously he was Director of Biostatistics and Data Management (1993-94).
Years: 1982 to 1993 Employer: AstraZeneca Title: Director of Biostatistics Department: Responsibilities: Expert served AstraZeneca as Director of Biostatistics from 1987 to 1993, during which time he managed and mentored 12 biostatisticians and programmers on 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. Previously, as Senior Biostatistician, Expert served as 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 NDA's. Therapeutic fields included dentistry, CNS, local anesthetics, anti-biotic and anti-viral.
Years: 1974 to 1982 Employer: University of Stockholm Title: Lecturer and Professor of Statistics Department: Department of Statistics Responsibilities: Expert lectured 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. He also conducted research in the field of survival analysis.

Career Accomplishments

Associations / Societies
Professional affiliations:
Chair of the section “Statistical Consulting” of ASA
Reviewer of Statistics in Medicine
President of the North Carolina Chapter of the American Statistical Association
Member of the International Advisory Committee of the University of North Carolina at Greensboro
Elected President of the North Carolina Chapter of the American Statistical Association
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 of 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/US
Chair of Clinical Trials Methodology from a Statistical Point of View

Also, Expert maintains active membership in the American Statistical Association.
Professional Appointments
Expert served as Senior Scientific Adviser from 1999 to 2001. Their technology platform employs computational modeling of physiological systems of CNS Diseases in order to address the urgent needs in information processing of researchers and executives in the pharmaceutical, biotechnology and healthcare industries.

Expert was also Chief Statistical Adviser for Medicine or Physiology (1975-82).
He was Lecturer at the Karolinska Institute (Stockholm) in medical statistics
Expert has been Consulting Statistician and Programmer at a variety of groups in Sweden
He was Lecturer at the Swedish Academy of Pharmaceutical Sciences in statistical clinical trials methodology
He also lectured at various research units and marketing companies worldwide within AstraZeneca in "Clinical Trials Methodology from a Statistical Point of View" (a one-week course for Clinical Research Scientists).
Awards / Recognition
Awards: Professional Mentor Recognition Award (won 3 years), School of Public Health and Health Sciences, University of Massachusetts.
Publications and Patents Summary
Expert has presented at a number of conferences worldwide. He has over 80 publications and presentations.

Additional Experience

Expert Witness Experience
• Number of cases: 6
• Experience writing expert witness and rebuttal reports: 19 reports
• Experience testifying at deposition: 4 depositions
• Experience testifying at trial: 2 trial

Review of medical malpractice documents and patient records with respect to hip replacement. Wrote an expert report of expected risks from hip surgery to be used for the determination of possible malpractice. The case did not go to a deposition or trial.
Training / Seminars
Facilitative Leadership Training, Interaction Associates, Cambridge, MA
FDA's New Structured Product Label (SPL) Requirement
From Effectiveness to Greatness, Steven R. Covey seminar
Advancing Preclinical and Clinical Applications of Pain Therapeutics, CBI Research, Inc.
MedDRA Awareness Training, MSSO
Other Relevant Experience
In addition to his extensive experience with standard statistical methods, Expert has special expertise in adaptive methods, recurrent event methods, experimental design, assays, mathematical modeling and simulation, data-mining, and super-computer applications.

Additionally, his computer experience includes the following:
Statistical Packages: SAS, S-PLUS, GLIM, BMDP, MATHEMATICA, RS/1, MINITAB, STATXACT, LOGXACT, EAST, PEST, MAPLE 10, Trial Designer, ACSL, XPRO
Database Experience: Oracle
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, and PowerPoint.

Language Skills

Language Proficiency
English Native or bilingual proficiency
Swedish Native or bilingual proficiency
French Full professional proficiency
German Elementary proficiency

Fields of Expertise

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