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Dr. Allen Fleishman

President
Allen Fleishman Biostatistics, Inc
141 Roundtop Road/Marlborough MA
 

Brief Biography:


ALLEN I. FLEISHMAN, Ph. D., PStat®
141 Roundtop Road, Marlborough, Massachusetts 01752-2774
(508) 485-9652
allen-fleishman@comcast.net

SUMMARY
Thirty years of experience in the pharmaceutical/medical device/CRO industry, designing, planning and analyzing phase I-IV clinical trials.  Emphasize development of FDA clinical trial reports with quick turn-around time. Highly accomplished independent performer who works well with others in a team setting.

PROFESSIONAL EXPERIENCE
ALLEN FLEISHMAN BIOSTATISTICS INC., Marlborough, Massachusetts 2000-Present Private Consultant
Designing trials and assisting with FDA preparations and presentations for multiple clients.  Therapeutic areas include: Blood substitute (adaptive design), xeroderma pigmentosum, hip, knee, ankle, spine devices, analgesic pump, diagnostic devices (sensitivity and specificity trials), orphan drugs for rare genetic disorders, oncology safety and PK.  Tasks include writing SOPs for SAP, ISS and ISE development, and preparations for FDA submissions.

EDUCATION
UNIVERSITY OF ILLINOIS
Ph.D. in Quantitative Psychology, 1978

Minor in Mathematical Statistics
MS in Quantitative Psychology, 1976
CITY COLLEGE OF NEW YORK  

BS in Psychology, 1970
Minor in Pre-Med

 

Academic positions:


PROFESSIONAL EXPERIENCE
ALLEN FLEISHMAN BIOSTATISTICS INC., Marlborough, Massachusetts 2000-Present
Private Consultant
Designing trials and assisting with FDA preparations and presentations for multiple clients.  Therapeutic areas include: Blood substitute (adaptive design), xeroderma pigmentosum, hip, knee, ankle, spine devices, analgesic pump, diagnostic devices (sensitivity and specificity trials), orphan drugs for rare genetic disorders, oncology safety and PK.  Tasks include writing SOPs for SAP, ISS and ISE development, and preparations for FDA submissions.

BOSTON BIOSTATISTICS (Averion), Framingham, Massachusetts[AIF1] 1998-2000[AIF2]
Biostatistician
Responsible for analyzing data from clinical trials and leading statistical teams.  Therapeutic areas include: Acute Respiratory Distress Syndrome, tinea versicolor, xeroderma pigmentosum, quality of life, breast cancer regimen, lipid lowering, device for osteoporosis, and blood substitute.
• Set up and designed IVRS system for randomization balancing stratification and site.
• Designed trials and lead team to do analyses including ISS and ISE for NDA submission; consulted with FDA.
PAREXEL, Waltham, Massachusetts[AIF3] 1996-1998[AIF4]

Principal Statistician
Responsible for analyzing data from clinical trials and leading statistical teams.  Therapeutic areas include: vaccine trials; bacterial vaginosis; anti-platelet compound PK, HIV (protease inhibitor), local block anesthesia/analgesia, insulin replacement therapy, renal insufficiency, and blood substitute.
• Assisted in pivotal clinical trial leading to FDA approval of HIV protease inhibitor, Viracept.
• Designed and analyzed 6 pivotal US trials for anesthesia/analgesia.  Designed and analyzed NDA ISS summarizing 25 worldwide trials leading to FDA approval of Levobupivacaine.
• Lead Waltham team on pivotal trials for insulin reduction therapy leading to FDA approval, Avandia
• Evaluated and clarified problems in adaptive IVRS
• FDA representative for blood substitute and cancer diagnostic device.
• Created randomization program to handle most clinical designs for multiple clients.
CIBA OPTHALMICS and QLT PHOTO-THERAPEUTICS, Duluth, Georgia[AIF5]               1996[AIF6]

Statistical Consultant
Assisted in development of “wet” macular degeneration protocol leading to eventual FDA approval.
CIBA VISION CORPORATION, Duluth, Georgia[AIF7] 1995-1996[AIF8]

Manager Biostatistics and Data Entry
Responsible for setting up a Biostatistics unit.  The first in-house statistician for this contact lens device and solution company.  Implemented double-data entry and enhanced data validation.
• Designed, planned and analyzed ophthalmic lens and solution trials for early human trials, marketing trials, and assisted in designing pivotal FDA clinical trials.
• Consulted or assisted in the analyses for bench scientists and planned studies.
• Designed generic SAS program to analyze many parameters in a turn-key approach, which resulted in data being verified, analyzed and presented in short time frame (e.g., one day).
• Taught classes on experimental design and analysis to company scientists and clinicians.

J&J PHARMACEUTICAL RESEARCH INSTITUTE, Raritan, New Jersey[AIF9] 1993-1995[AIF10]
Principal Statistician
Number two priority project at J&J, a wound healing biologic.  (Project moved from Ethicon.)
• Designed, planned, and analyzed trials for diabetic ulcer and pressure ulcer studies leading to FDA approval of rhPDGF-BB.
• Validated laboratory-imaging measurements.
• Critically analyzed disease process, including ‘growth’ modeling.
• Implemented responses to FDA recommendations with clinical team.
 
J&J ETHICON, Somerville, New Jersey[AIF11] 1992-1993[AIF12] 
Section Manager
Responsible for planning, designing, and analyzing their number one project, a wound healing biologic.
• Sole company statistical representative with FDA.
• Analyzed wound adhesions and surgical devices.
• Analyzed stability studies.
• Assisted scientists in analyzing data.

SANDOZ RESEARCH INSTITUTE, East Hanover, New Jersey[AIF13] 1989-1992[AIF14] 
Statistician IV
As highest non-management rank statistician responsible for spear heading special projects.
• Designed, implemented trials, and guiding their analysis by a team of statisticians for an OTC switch NDA application of a novel anti-heartburn medication, reporting directly to Vice Pres.
• Sole company statistical representative with FDA.
• Analyzed bioavailability and bio-equivalence.
• Assisted in NDA for a dermatological agent, Integrated Summary of Safety.

LEDERLE LABORATORY, Pearl River, New York[AIF15] 1980-1989
Senior Statistician
Responsible for entire vaccine division and psychotropic therapeutic area and other drug programs.
• Sole responsibility for successful H-flu submission and key participant in two other NDA applications presented at the FDA.  Analysis and reporting of key results was often available within a very short time frame (e.g. 2 workdays).
• Consulted with physicians, designed, planned, and analyzed trials for: devices (bowel anastomosis and respiratory devices); 2 anti-cancer compounds; systemic and topical NSAID; anti-emetic; vaccines (H-flu, Polio, Pertussis, polyvalent pneumococcal antibiotic); vitamin availability; immunomodulator (AIDS compound); psychotropics (2 anti-anxiety, anti-depressant, anti-psychotic, and nootropic compound).
• Wrote generic program to analyze all parameters for many clinical trials in NDA.
• Analyzed bioavailability.

 

Research interests:


Clinical Research, methodology, biostatistics

 

Any other information:


PROFESSIONAL AFFILIATIONS
American Statistical Association
Accredited Professional Statistician™ 2011[AIF16]
PUBLICATIONS
Nine papers in major refereed journals.  Research included: Monte Carlo study discovering method with 35 times less mean squared error than multiple linear regression; interim analysis; ability to prove the null hypothesis; confidence intervals for correlation ratios; Box Jenkins approach to time series; robustness and new approaches for estimation of means and correlations after censoring; a program for an nxm Fisher Exact Test; and greater efficiency in computer simulations.  Presented to DIA on adaptive designs.

 

What I think of the idea behind WebmedCentral:


No clear idea as of yet

 

Home Page:


allenfleishmanbiostatistics.com