Larry Z. Shen
Vice President, Clinical Informatics
Troy G. Fohrman
Senior Director, Business Development
Jenny C. Han
Executive Director, Statistics
Jay Zhou
Executive Director, Programming Operations
Orville Kolterman
Senior Medical Director
Nuwan Nanayakkara
Senior Director, Statistics, Modeling & Simulation
Terri Blythe
Senior Director, Data Management
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
Vice President, Clinical Informatics
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
Executive Director, Statistics
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.
Jay Zhou
Executive Director, Programming Operations
Jay has more than 20 years of clinical development experience. He is a SAS expert and has developed numerous systems and tools to facilitate the programming processes for clinical data compliance with CDISC data standards (SEND, SDTM, and ADaM), data quality control, data analysis, clinical study reports, and regulatory submissions.
Jay has led and contributed to more than 14 successful NDA submissions in therapeutic areas including metabolic disorders, neurological disorders, oncology, cardiovascular disease, insomnia disorder, allergy/immunology, and more.
Prior to co-founding Pharmapace, Inc., Jay was a director at MAP Pharmaceuticals, Inc. (acquired by Allergan in 2013), responsible for clinical data management and statistical programming from 2011 to 2013. He served as Vice President of Operations at Q2BI from 2010 to 2011. Jay was a senior director and head of statistical programming at Amylin Pharmaceuticals, Inc. from 2002 to 2010.
Prior to joining Amylin, Jay held multiple positions at Quintiles, Hoechst Marion Roussel, Inc., and Pharmaceutical Research Associates, Inc. Jay received his Master of Science degree from Louisiana State University and Master of Business Administration degree from Rady School of Management, University of California at San Diego.
Orville Kolterman
Senior Medical Director
Dr. Kolterman’s professional career has been dedicated to the field of diabetes treatment and related clinical research.
He began as a full-time academic investigator and in 1992 embarked upon a parallel career in drug development at Amylin Pharmaceuticals where he held multiple positions as a member of the senior management team.
During his blended career, Dr. Kolterman gained experience in the design, conduct and analysis of clinical studies related to diabetes.
He has served as a Principal Investigator of the Diabetes Control and Complications Trial (DCCT) and continues to serve as the Principal Investigator for the UC San Diego participating center in the Epidemiology of Diabetes in Control (EDIC).
Nuwan Nanayakkara
Senior Director, Statistics, Modeling & Simulation
Dr. Nuwan Nanayakkara joined Pharmapace as Vice President of Statistics, Modelling, and Simulation in 2017 with over 20 years of experience in the design and analysis of clinical trials. He brings to the company a wealth of knowledge in clinical trials ranging over a wide variety of therapeutic areas: dermatology, neurodegenerative disorders, immunology, endocrine and metabolic disorders, and oncology.
He played the lead or support statistician roles in Phase 1-Phase IV studies conducted by pharmaceutical/biotech companies such as Eli Lilly, Sandoz, Searle, Parke Davis, Pfizer, Alexion, Novartis, and Amgen. He is an expert in statistical design including sample size calculations, choosing endpoints and writing statistical sections of protocols, designing eCRFs and databases, conducting UATs, and guiding statistical programmers. Additionally, he has actively participated in meetings with the FDA clarifying statistical design and resolving methodological issues.
Dr. Nanayakkara holds a PhD in Statistics from Iowa State University of Science and Technology. He started his career as an academician, teaching undergraduate and graduate courses at Iowa State University, North Dakota State University, and the University of Kentucky. His exceptional ability to explain complex statistical concepts to non-statistical audiences stems from his passion for teaching. Prior to joining Pharmapace, he was the Director of Biostatistics at Halozyme Therapeutics, Inc. Prior to Halozyme, he held similar positions at Favrille, Amylin Pharmaceuticals and Kendle International.
Terri Blythe
Senior Director, Data Management
Terri has over 30 years of clinical development experience. She brings the company a wealth of knowledge in the development of eCRFs, database design, tools for cleaning the data and working with our customers. She has developed and facilitated the development of databases in a number of EDC systems using CDASH and CDISC standards in a number of therapeutic areas successfully for Pharmaceutical, Biopharmaceutical, and device companies.
She has developed a data management department from the ground up and researched/proposed and implemented a new Data Management System into the company, facilitated the change process, training and mentoring teams on the new system.
She has played a leading role in the data management department in the Phase I area of Hoechst Marion Roussel and Quintiles working with global teams. She has lead teams while at PRA, Regulatory/Clinical Consultants and Clinipace. She has experience building strong data management teams that support each other and their project teams along with ensuring the integrity of the data. Her teams have developed global libraries using CDISC standards to shorten development time and make set up process more efficient with less duplicate work. She has led cross-functional teams on clinical projects to ensure project expectations and budgets were met. She is also good at working with clients to assess their needs when starting projects and also to determine if expectations are being met on ongoing projects.
Troy G. Fohrman
Senior Director, Business Development
Troy Fohrman is a 25-year veteran in the healthcare industry. Mr. Fohrman held executive, management, sales and sales training roles, for which he received a significant number of awards for individual achievements as well as his team(s)’ results during his career. Most recently, Mr. Fohrman developed Real World Evidence business-lines for new data service products with a major Electronic Medical Records company. Prior to entering into business development and sales management, Mr. Fohrman held key leadership roles for the technical development for two blockbuster Enzyme ImmunoAssays as well as oversight of final quality-control teams for market release of products from these platforms.
Mr. Fohrman has experience in developing and executing KPI-driven LRPs & strategies for company start-ups and capital procurement, as well as operational budget management, sales forecasting, and proven expertise in building field-sales teams. Learning from his years of experience in cGMP/ISO code/lot/date manufacturing, development and implementation of both quality assurance and manufacturing documentation, including electronic regulatory system, as well as advanced technical product development, field-based sales, sales training and operations management, Mr. Fohrman has the unique ability to convey complex selling messages in the simplest of terms. Mr. Fohrman graduated with degrees in biology and chemistry from Northern Illinois University, DeKalb, IL.
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