Chief Executive Officer
Senior Statistical Advisor
Fellow, American Statistical Association
Our management team has more than 20 years of experience in the drug development industry. The four co-founders have worked together to successfully conduct multiple regulatory submissions that have led to product approvals.
Our experience spans across all phases of drug development as well as post-marketing product support. We have successful product submissions in the therapeutic areas of:
- Metabolic Disease
- Oncology
- Central Nervous System
- Cardiovascular Disease
- Ophthalmology
Our Values
- Scientific Quality – We are passionate about maintaining the scientific integrity of our client’s data. More than half of our staff have advanced degrees in a life sciences field.
- Operational Quality – We are passionate about delivering quality products to our customers. Each team member is extensively trained on our robust quality process to ensure consistently high quality results.
- Customer Focus – We work from project beginning to end to establish a professional connection that will continue to grow after our goals have been met.
- Regulatory Compliance – Our highly qualified medical writers, statisticians, programmers, and data managers work together to ensure a fully compliant regulatory submission package.
- Cost-Effectiveness – We work with you to ensure all costs are competitive and transparent. Our turn-around time is fast, generating lower overall costs for your projects.
- Efficiency – Your studies’ success depends on an efficient team of highly qualified statisticians and programmers to meet project goals. Our team works meticulously and effectively to ensure deliverables are met in a timely manner.
Larry Z. Shen
Chief Executive Officer
Senior Statistical Advisor
Fellow, American Statistical Association
Dr. Shen is a fellow of the American Statistical Association (A.S.A.) and is past President of the San Diego Chapter of the A.S.A.
Prior to co-founding Pharmapace, Dr. Shen was Vice President of Quantitative Sciences and Medical Disclosures at Amylin Pharmaceuticals, Inc., which was acquired by Bristol-Myers Squibb and AstraZeneca. Beginning in 1997, Dr. Shen built the Biometrics department from the ground up into a department with multiple functions including Statistics, Statistical Programming, and Data Management.
Dr. Shen has implemented rigorous procedures for data processing, analyses, and reporting to ensure data integrity and statistical excellence. Under his leadership, the department has played a critical role in the development and approval of four innovative medicines.
Dr. Shen obtained his Ph.D. in Statistics from the University of California at Berkeley, as well as both his BS and MS degrees from Beijing University in China.
Jenny C. Han
Chief Financial Officer
Head of Statistics & Operation
Ms. Han brings over 20 years of experience in biostatistics and drug development in the pharmaceutical industry. Prior to co-founding Pharmapace, she was Associate Director and Head of the Statistics Department at Amylin Pharmaceuticals, which was acquired by Bristol-Myers Squibb and AstraZeneca.
During her professional career, Ms. Han has contributed to nine investigational new drug development programs, four new drug approvals, and various successful interactions and meetings with regulatory agencies. In addition to her passion in statistics, Ms. Han is also a trained medical researcher.
Ms. Han received her MS degree in Biostatistics from University of Michigan at Ann Arbor, and her MS degree in Nutrition/Biochemistry from the Ohio State University at Columbus. Ms. Han is Past Secretary of the American Statistical Association, San Diego Chapter.
Adrian Hsing
Chief Development Officer
Head of Data Strategy and Innovation
Publications
On Chiang’s explicit solutions for the Kolmogorov differential equations
LZ Shen – Statistics & probability letters, 1993 – Elsevier
On optimal B-robust influence functions in multidimensional parametric models
L Zaiqian Shen – Communications in statistics-theory and methods, 1994 – Taylor & Francis
On optimal B-robust influence functions in semiparametric models
LZ Shen – The Annals of Statistics, 1995 – JSTOR
Robust Estimation for Semiparametric Exponential Mixture Models
LZ Shen – Statistica Sinica, 1995 – JSTOR
Optimal robust estimates for semiparametric symmetric location models
LZ Shen – Statistics & Risk Modeling, 1994 – degruyter.com
Consistency of continual reassessment method under model misspecification
LZ Shen, J O’QUIGLEY – Biometrika, 1996 – academic.oup.com
Continual reassessment method: a likelihood approach
J O’Quigley, LZ Shen – Biometrics, 1996 – JSTOR
Application of boundary calculation methodologies to group sequential testing in general parametric models
LZ Shen, HR Al-Khalidi – Communications in statistics-theory and …, 1997 – Taylor & Francis
Estimation of mean quality adjusted survival time
LZ Shen, E Pulkstenis, M Hoseyni – Statistics in medicine, 1999 – Wiley Online Library
Two-sample continual reassessment method
J O’Quigley, LZ Shen, A Gamst – … of Biopharmaceutical Statistics, 1999 – Taylor & Francis
Using a one-parameter model to sequentially estimate the root of a regression function
LZ Shen, J O’Quigley – Computational statistics & data analysis, 2000 – Elsevier
Design and analysis of dose escalation studies to mitigate dose-limiting adverse effects
LZ Shen, MS Fineman, A Baron – Drug information journal, 2006 – journals.sagepub.com
A practical and efficient approach to database quality audit in clinical trials
LZ Shen, J Zhou – Therapeutic Innovation & Regulatory …, 2006 – search.proquest.com
A Bayesian approach to utilizing prior data in new drug development
LZ Shen, T Coffey, W Deng – Journal of biopharmaceutical …, 2008 – Taylor & Francis
A Novel Design for Decision Rules Based on Statistical Testing Strategies of Binary Endpoints in a Definitive Go/No-Go Single-Treatment Clinical Study
M Zhou, LZ Shen – Therapeutic Innovation & Regulatory …, 2014 – journals.sagepub.com
Statistical review
LZ Shen – Journal of Emergency Medicine, 1993 – jem-journal.com
Cigarette Smoking Behavior in the United States (PDF)
DM Burns, L Lee, LZ Shen, E Gilpin, HD Tolley… – pdfs.semanticscholar.org
Steady-state bioavailability of estradiol from two matrix transdermal delivery systems, Alora and Climara.
A Buch, L Shen, S Kelly, R Sahota, C Brezovic, C Bixler… – 1998 – journals.lww.com
Significant differences in estradiol bioavailability from two similarly labelled estradiol matrix transdermal systems
AB Buch, LZ Shen, SC Kelly, DA Russell, RS Sahota… – …, 1999 – Taylor & Francis
A randomized study and open-label extension evaluating the long-term efficacy of pramlintide as an adjunct to insulin therapy in type 1 diabetes
F Whitehouse, DF Kruger, M Fineman, L Shen… – Diabetes …, 2002 – Am Diabetes Assoc
AC2993 (synthetic exendin-4) added to existing metformin (Met) and/or sulfonylurea (SFU) treatment improved glycemic control in patients with type 2 …
MS Fineman, T Bicsak, L Shen, K Taylor, E Gaines… – Diabetes, 2002 – insights.ovid.com
Pramlintide as an adjunct to insulin therapy improves long-term glycemic and weight control in patients with type 2 diabetes
PA Hollander, P Levy, MS Fineman, DG Maggs… – Diabetes …, 2003 – Am Diabetes Assoc
Addition of pramlintide to insulin therapy lowers HbA1c in conjunction with weight loss in patients with type 2 diabetes approaching glycaemic targets
P Hollander, R Ratner, M Fineman… – Diabetes, Obesity …, 2003 – Wiley Online Library
Effect of pramlintide on A1C and body weight in insulin-treated African Americans and Hispanics with type 2 diabetes: a pooled post hoc analysis
D Maggs, L Shen, S Strobel, D Brown, O Kolterman… – Metabolism, 2003 – Elsevier
Adjunctive therapy with pramlintide lowers A1c without concomitant weight gain in patients with type 2 diabetes approaching ADA glycemic targets
C Weyer, M Fineman, T Burrell, S Strobel, L Shen… – Diabetes, 2003 – insights.ovid.com
Effect of pramlintide on weight in overweight and obese insulin‐treated type 2 diabetes patients
P Hollander, DG Maggs, JA Ruggles, M Fineman… – …, 2004 – Wiley Online Library
Amylin replacement with pramlintide as an adjunct to insulin therapy improves long‐term glycaemic and weight control in Type 1 diabetes mellitus: a 1‐year …
RE Ratner, R Dickey, M Fineman, DG Maggs… – Diabetic …, 2004 – Wiley Online Library
Effectiveness of progressive dose‐escalation of exenatide (exendin‐4) in reducing dose‐limiting side effects in subjects with type 2 diabetes
MS Fineman, LZ Shen, K Taylor… – Diabetes/metabolism …, 2004 – Wiley Online Library
Exenatide improves glycemic control and reduces body weight in subjects with type 2 diabetes: a dose-ranging study
T Poon, P Nelson, L Shen, M Mihm… – Diabetes …, 2005 – online.liebertpub.com
Pharmacokinetics, pharmacodynamics, and safety of exenatide in patients with type 2 diabetes mellitus.
OG Kolterman, DD Kim, L Shen… – American Journal of …, 2005 – search.ebscohost.com
Exenatide improves glycemic control and reduces body weight in subjects with type 2 diabetes: a dose-ranging study
T Poon, P Nelson, L Shen, M Mihm… – Diabetes …, 2005 – online.liebertpub.com
Adjunctive therapy with pramlintide lowers HbA1c without concomitant weight gain and increased risk of severe hypoglycemia in patients with type 1 diabetes …
R Ratner, F Whitehouse, MS Fineman… – Experimental and …, 2005 – thieme-connect.com
Properties of pramlintide and insulin upon mixing.
C Weyer, MS Fineman, S Strobel… – American journal of …, 2005 – search.ebscohost.com