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J O S E P H   K I M ' S   O F F I C I A L   W E B S I T E

Biography
I am not only a Bible teacher but also a scientist.

I was born in Korea in a Christian family and I have become a Christian when I was in college.

Since then I have studied the Bible and have taught the Bible for more than 30 years. I am frequently invited speaker and Bible teacher.

Currently I am atteding Colonial Baptist Church in Cary, North Carolina with my wife and children.

Below is my CV as a clinical pharmacologist. Recently, I have moved my job from GSK to PAREXEL as a director of Medical Affairs in Quantitative Clinical Development Business Unit.

Full CV (as of April 2017)
NAME:  Joseph Yong Ho Kim

JOB TITLE:  Senior Director, Quantitative Clinical Development

SUMMARY OF EXPERIENCE:

More than 12 years industry experience at GSK Clinical Pharmacology Modeling & Simulation group
Two years experience as a consultant in a consulting company at Pharsight, Cary, NC
More than 10 years pharmacist experience in US and Korea
Extensive Asia Pacific regional experience, including 15 months secondment in Shanghai, China
Frequently invited speakers and consultant for Korean pharmaceutical companies as well as KoreaFDA
PK and PK/PD support for numerous clinical studies including FTIH, POC, DDI, POP PK, BA/BE studies


Current Position:
Director, Medical Affairs, Quantitative Clinical Development, PAREXEL, RTP, NC (Starting March 2015)
Director,  Clinical Pharmacology Modeling & Simulations Group, Quantitative Sciences, Research & Development, GlaxoSmithKline, Research Triangle Park, NC
 

Skills Description:

Clinincal pharmacology studies (including Bioequivalence/Bioavailability study, Relative Bioavailability study, First time in Man study, Drug Interaction study, Drug Probe cocktail study, Special Population study, Proof of Concept study, Phase II and Phase III studies, Population PK study): study design, protocol writing, data analysis, result interpretation and report writing for regulatory submission

Population PK/PD modeling with NONMEM and Phoenix NLME(Non Linear Mixed Effect)

Modeling & Simulation with WinNonLin, NONMEM and Trial Simulator

WinNonlin Script writing for Noncompartmental Analysis Report for BA/BE/DDI/Food study,

Crystal Ball-Risk Analysis Tool for Risk Analysis, Sigma Plot, Wings for NONMEM, Perl Speaks NONMEM, MATLAB

Instructor for Crystal Ball, WinNonlin, NONMEM and PK/PD modeling workshop

SAS, S-Plus, R-language, ANOVA, LinMix, and bootstrapping

Programming with Pascal, Visual Basics applications, and DOS

MS Office programs (Word, Excel, Access, Power Point)

 

 

Education:

 
University of the Pacific, Graduate School, Stockton, CA

Ph.D. in Pharmaceutical Sciences

Dissertation Title: Population PK and PD of ZDV, ddI and Nevirapine in children and adolescents with advanced HIV disease

 

Kyung Hee University, School of Pharmacy, South Korea

M.S. in Clinical Pharmacy

Thesis Title: The effect of cadmium on copper transport across rat jejunum.

 

Kyung Hee University, School of Pharmacy, South Korea

B.S. in Pharmacy

 

 

Work History :

 

2011 to present

Director,  Clinical Pharmacology Modeling & Simulations Group, Quantitative Sciences, Research & Development, GlaxoSmithKline, Research Triangle Park, NC

In addition to the work of Principal Clinical Pharmacokineticist below, more managerial and training role were added.  Interviewing potential candidates (phone interview, face to face interview, background check, reference contacts) and hired new employee (scientists). Involved in HIV and HCV drug development for Phase I and Phase II study- planning, study design, protocol writing, data analysis, report writing, regulatory submission of the results and publications of the results to peer reviewed journals. Train director level colleague regarding how to do PK analysis, write report and do QC and all the steps related to drug development processes. Helped a director level colleague on how to prepare POP PK dataset, how to write a RAP and how to do the POP PK analysis.  In addition to the work of Director, I have assigned as a global assignee to GSK R&D Shanghai to hire/establish CPMS group in the newly opened R&D center and do more strategic and external collaboration work.  Actively participated the Clinical Pharmacology Working group in Shanghai with other global companies such as Pfizer, J&J, Roche, Norvatis, BMS, Sanofi-Aventis and helped the working group regarding what  to learn from Korean drug industry and  regulatory agency.  Trained many scientists on clinical pharmacology, pharmacokinetics and drug development.

 

Principal Clinical Pharmacokineticist.  Clinical Pharmacology & Modeling Simulations Group, Research & Development, GlaxoSmithKline, Research Triangle Park, NC

               2006 to 2011

Involved in various stages of clinical trials from first time in human studies (FTIH) to Phase IV studies. Designed and executed multiple clinical studies including preparation of study protocols and analyzing the PK data and writing clinical study report for regulatory submission (FDA and EMEA).  Supported diverse therapeutic area: HIV/AIDS (NNRTI, PI, Integrase inhibitor, CCR5 antagonist), Hepatitis C treament compound, Diabetes compound, Hepatic Fibrosis treament compound, Oncology compounds, Diabetes compounds, Biologicals, Supportive care compounds (anemia). Provide PK/TK input to the pre-clinical, DMPK and toxicological study team.  Support Project Team and Clinical Matrix Team regarding clinical studies and clinical development (study design, dose selection, dose escalation,  PK/PD modeling and simulation, Regulatory response writing etc.).  Writing various clinical pharmacokinetic and pharmacodynamic study design and study reports (first dose in human study, bioavailabilitiy/bioequivalence(BA/BE), food effect study, dose proportionality, mass balance, proof-of-concept, drug interactions(DDI), regional absorption study, human radio label study, etc), including IND PK/PD related sections. Present clinical study results at Project Team, Clinical Matrix Team, Global Safety Board, Regulatory Agents and International scientific meetings. Attended  meeting with the US FDA as clinical pharmacokinetics representative.  Design, analyze and report pharmacokinetic and pharmacodynamic studies with a special focus on "population" studies.  Develop novel modeling and simulation approaches, including clinical trial simulations that helps the efficient development of new compounds. Support Pre-clinical scientists in the application of novel modeling and simulation methods. Interpreting results of PK/PD analysis with respect to their impact on development and clinical use of drugs applying novel pharmacokinetic and pharmacodynamic approaches that supports dose selection leading to more efficient clinical drug development. Experienced in outsourcing and managing externally-placed clinical PK, POP PK studies.

Developed and taught training material with Crystal Ball for global CPK R&D organization. Modeling and Simulation using WinNonlin, NONMEM, Trial Simulator, Crystal Ball for Phase III dose selection and presentation preparation for senior management.  Teaching/supporting/giving consultation to many GSK collegues in doing modeling and simulation using softwares such as WinNonilin, NONMEM, Trial Simulator, S-Plus, R, and Crystal Ball. Established strong relationship with Korean FDA (KFDA) and provided numerous presentations and consultations for diverse KFDA departments.  Currenlty supervise a KFDA BE department reviewer’s training at GSK who has come to GSK for training for 2 years. 

 

 

Senior Clinical Pharmacokineticist.  Clinical Pharmacokinetics Modeling & Simulations Group, Research & Development, GlaxoSmithKline, Research Triangle Park, NC

               2002 to 2006

Involved in various stages of clinical trials from first time in human studies (FTIH) to Phase IV studies.  Provide PK/TK input to the pre-clinical, DMPK and toxicological study team.  Support Project Team and Clinical Matrix Team regarding clinical studies and clinical development (study design, dose selection, dose escalation,  PK/PD modeling and simulation, Regulatory reponse writing etc.).  Writing various clinical pharmacokinetic and pharmacodynamic study design and study reports (first dose in human study, bioavailabilitiy/bioequivalence, food effect study, dose proportionality, mass balance, proof-of-concept, drug interactions, regional absorption study, human radio label study, etc), including IND PK/PD related sections. Present clinical study results at Project Team, Clinical Matrix Team, Global Safety Board, Regulatory Agents and International scientific meetings. Design, analyze and report pharmacokinetic and pharmacodynamic studies with a special focus on "population" studies.  Develop novel modeling and simulation approaches, including clinical trial simulations that helps the efficient development of new compounds. Support Pre-clinical scientists in the application of novel modeling and simulation methods. Interpreting results of PK/PD analysis with respect to their impact on development and clinical use of drugs applying novel pharmacokinetic and pharmacodynamic approaches that supports dose selection leading to more efficient clinical drug development. Experienced in outsourcing and managing externally-placed clinical PK, POP PK studies.

 

 

Adjunct Professor, School of Pharmacy Graduate School, University of North Carolina at Chapel Hill, NC

January 2006 to present

Teach Advanced Pharmacokinetics class for Graduate School Students. Overview of Population Pharmacokinetics, FDA Guidance (POP PK goal, methods, applications etc.), Mixed effect modeling and NONMEM.  Teaching/guiding UNC/GSK pharmacokinetics fellows in their training at GSK.  Advising a PhD student for pharmacometrics major.

 

 

Founder and the 2nd President of Research Triangle Park Bioscience and Biotechnology Meeting, Durham, NC

2009 to present

Organized Korean American biopharmaceutical scientists in the Research Triangle Park area and is serving as the 2nd president of the meeting. The meetings are consists of members from research universities (Duke, UNC Chapel Hill, NC state university), government research centers (NIEHS-NIH) and private companies (GSK, Monsanto, Syngenta etc).

 

 

Consulting Scientist, Product trainer, Scientific Support Specialist.  Pharsight Corporation, Cary, NC

               November 2000 to September 2002

               Head of Support Team in US-Provide technical and scientific assistance to users of Pharsight’s software products (WinNonlin, WinNonMix and Trial Simulator) and supervise and guide other support members

               Teach courses in the use and application of Pharsight software at the customer’s site as well as in-house

               Technical lead on Script Development-Developing WinNonlin scripts for customers and assist computer engineer for PK/PD related issues

               Present software demonstrations for marketing and business development at scientific meetings and on-site

               Involving development of product features and enhancements

              

Partner, senior researcher for PK/PD data analysis, Trials by Design, LLC, Stockton, CA

November 1997 to 2000

Traditional and population pharmacokinetic/pharmacodynamic project planning

Model development, evaluation, validation, and application

Develop Scripts for bootstrap sampling and multiple NONMEM runs.

Reviewing reports for regulatory submission

 

Staff Clinical Pharmacist, PharMerica Pharmacy, Stockton, CA

December 1997 to October 2000

Evaluate prescription and patients medical history and recommend therapeutic regimen to medical doctor if needed. Prepares and/or oversees the preparation and dispensing of prescription medications to patients or medical practitioners; makes decisions regarding generic substitution of prescribed pharmaceuticals. Counsels patients and/or medical practitioners on drug indications/contraindications, dosage, drug interactions, and side effectss; provides other drug and pharmaceutical information as appropriate. Oversees the acquisition and disbursement of drugs and medications to various offices, clinics, and other sites.

Establishes and maintains methods and manner of storage and recordkeeping systems to provide for safekeeping of pharmaceuticals.

 

Staff Pharmacist, CPS Pharmacy, Sacramento, CA

May 1995 to November 1997

Prepares and/or oversees the preparation and dispensing of prescription medications to patients or medical practitioners; makes decisions regarding generic substitution of prescribed pharmaceuticals. Counsels patients and/or medical practitioners on drug indications/contraindications, dosage, drug interactions, and side effectss; provides other drug and pharmaceutical information as appropriate. Evaluate prescription and patients medical history and recommend therapeutic regimen to medical doctor/nurses if needed. Oversees the acquisition and disbursement of drugs and medications to various offices, clinics, and other sites.

Establishes and maintains methods and manner of storage and recordkeeping systems to provide for safekeeping of pharmaceuticals.

 

Visiting Researcher, The Pediatric Pharmacology Research Unit, University of California, San Diego, La Jolla, CA

April 1997 to May 1997, May 1999

Design data retrieval from ACTG 245 study for population PK/PD analysis using NONMEM

NONMEM analysis for ACTG 245 trial.

 

Clinical Rotations and research, Veterans Administrations Medical Center, Palo Alto, CA

April 1992 to August 1992 ; January 1994 to August 1994

Pharmacokinetics services for inpatient’s digoxin, phenytoin, and theophyllin therapy.

Research for population pharmacokinetics of digoxin therapy.

 

Intern and staff pharmacist, MAI Pharmacy, Sacramento, CA

November 1994 to May 1995

 

Intern pharmacist, Mowry Medical Pharmacy, Fremont, CA

August 1993 to January 1994

 

 

Teaching Assistant, University of the Pacific, School of Pharmacy, Stockton, CA

January 1990 to July 1994

Teaching 2nd year PharmD students at Clinical Pharmacokinetics, Clinical Laboratory and Physical Assessment Technique course

 

Pharmacist (Owner), BUBU (means husband and wife) Drug Store, Korea

October 1988 to December 1989

 

Staff Pharmacist (Night Shift), Inha University Hospital, Korea

February 1987 to September 1988

 

Teaching Assistant, School of Pharmacy, Kyung Hee University, Korea

March 1985 to February 1987

Teaching 2nd, 3rd, and 4th year Pharmacy B.S. students at Analytical Chemistry and Pharmacology Labs.

 

 

Training:

 

GlaxoSmithKline, Research Triangle Park, NC

NONMEM 7 with Predictive Modeling Environment 2.4,  Oct 2010

Phoenix WinNonlin 6.1 training, Oct 2010

Monoclonal antibody PK/PD by Joseph Balthasar. Mar 2009

MATLAB fundamentals and programming technique.  Sep 2008

Competitive Intelligence Tools Training. Sep 2008

HIV Care 2008:Antiretroviral Therapy,Hepatitis B/C, Addiction,And Adherence.  May 2008

Advanced R for Pharmacometrics, GSK/Mango Solutions   April 2008

NONMEM VI Intermediate Workshop, CDDS-UCSF/Uppsala University  Mar 2008

Pharsight Pheonix alpha/beta tester training, Pharsight, Cary, NC    June 2007

CPDM study management induction course  Mar 2007

Biorelevant dissolution tests: state of the art by Professor Jennifer Dressman Sept 2006

PK/PD Modeling course by William Jusko at SUNY Buffalo, NY June 2006

Health Outcomes in Drug Development June 2006

CPDM-MET meeting on drug drug interactions, May 2006

Conducting drug trials in asia pacific by Covance, May 4, 2006 

HIV Care 2006:Antiretroviral Therapy,Hepatitis B/C, Addiction,And Adherence.  May 2006

Data Analysis using Monte Carlo Methods and Bayesian Stochastic Simulation by Dr. George Casella  April 2006

"Conducting Drug Trials in Central & Eastern Europe" presented by Covance Mar 2006

Phase II Metabolism of Drugs:  Biology and Clinical Relevance, February 22, 2006

CPDM Liver Safety Update by Chris Hunt, Julie Borland, & Jenny Leong November 15

Liver Safety, Liver Chemistry Stopping Criteria for Subjects in Clinical Studies, Nov 2005

Introductory and Advanced Crystal Ball, Oct 2005

Kingstree Presentation, May 2005

HIV Care, May 2005

CDER Live - CDER's Drug Safety Initiative, May 2005

DRUG-INDUCED LIVER INJURY Symposium, Mar 2005

Structural and functional aspects of cytochrome P450 2B dependent drug metabolism, Feb 2005

Drug combination symposium, Feb 2005

Modeling Viral Infections, Jan 2005

The use of meta-analysis in candidate selection and PoC Jan 2005

Drug Discovery & Development Simulation Part II:

from candidate selection to lifecycle management. Sept 2004

HIV Care, May 2004        

Issues and Challenges in Drug Discovery and Development, 2003

Running Studies under an IND, 2003

               HIV Care, 2003

               Modelling In-Vitro/In-Vivo data, 2003

               Reducing Attrition in Drug Discovery, 2003

Introduction to Enzyme Kinetics for Drug Metabolism, 2002

Immunology Short Course, 2002

               Simulations workshop-using NONMEM and Trial Simulator, 2002

 
Pharsight Corporation, Mountain View, CA

               Advanced PK/PD modeling methodology course, 2002

               Intermediate PK/PD modeling methodology course, 2001

               Trial Simulator Hands-on course, 2001

               WinNonMix Hands-on course, 2001

               GxP for industry course, 2001

Introduction to CATD methodology course, 2000

Population PK/PD modeling methodology course, 2000

 

 

 

 

Computer programs developed by Yong Ho Kim :

 

Expiration Date Wizard – A computer program for generation of ‘Expiration Date Chart’ according to United States Pharmacopoeia and National formulary (USP/NF) when medications are repackaged in blister pack. 1998

 

Manna – A computer program for Bootstrapping in NONMEM.  Manna is a program that generates Bootstrap Samples using S-Plus Script, runs Multiple NONMEMs, and calculates Optimism. 1997

 

Licenses :

 

Registered Pharmacist, California, 1995

Registered Pharmacist, South Korea, 1985

 

 

Honors :

Received a GSK R&D Recognition Award-Bronze, July, 2014

 

Received a GSK R&D Recognition Award-Gold, Jan, 2013

 

Received a GSK R&D Recognition Award-Silver, Sept, 2012

 

Received a scientific community service recognition award from Consulate General of the Republic of Korea in Atlanta, USA, Feb 2011

 

Received a GSK R&D Recognition Award-Gold, Nov, 2010

 

Received a GSK R&D Recognition Award-Silver, Sept, 2010

 

Received a GSK R&D Recognition Award-Silver, March, 2010

 

Received a GSK R&D Recognition Award-Silver, July, 2008

 

Received a GSK R&D Recognition Award-Silver, June, 2008

 

Received a GSK R&D Recognition Award-Silver, Dec, 2007

 

Received a GSK R&D Recognition Award-Silver, June, 2007

 

Received a GSK R&D Recognition Award-Silver, February, 2007

 

Received a GSK R&D Recognition Award-Silver, September, 2006

 

Received a GSK R&D Recognition Award-Silver, November, 2005

 

Received a GSK R&D Recognition Award-Bronze, September, 2003

 

Rho Chi Pharmacy Honor Society

 

Served as the President of the Rho Chi Society 1991

 

Six years full scholarship for undergraduate and graduate school, Kyung Hee University, Seoul, Korea.  1981-1987

 

 

Selected Invited Speeches, Lectures and Oral Presentations:

10/31/2014, Use of Clinical Pharmacology Modeling Simulation in the Drug Development, Graduate Seminar Program, NC State University, Biomanufacturing Training and Education Center, NC, USA

 

10/11/2014, How to prepare your career, Korean American Scientist and Engineers-Young Generation Career Workshop, UNC-CH, USA

 

9/27/2014, Career development in industry, Career Development Workshop, RTP Bioscience and Biotechnology Meeting, Syngenta, NC

 

7/15/2014, Application of PK, PK/PD modeling in clinical studies:impact on study design, protocol and study procedures, webinar at WIRB Corpernicus group, USA

 

4/18/2014, Things to Consider in New Drug Development – Application of  FDA Guidance and PK/PD Modeling and Simulation, Korean Pharmaceutical Society Annual Convention 2014, Seoul, Korea

 

4/12/2014, Clinical Studies: From First Time in Human study to Pivotal Study – Importance of PK, PK/PD and Regulatory Guidance, RTP Bioscience and Biotechnology 2014 Spring Symposium, Durham, North Caroina

 

8/9/2013, Use of Pharmacokinetics Modeling & Simulation in the Drug Development: From Discovery to Development, The Ultimate Linkage for Top Research Advisor Meeting Biotechnology Session, New York, USA

 

4/15/2013, Experience Sharing of Global Assignment to China R&D, Scientific Licensing Partnering Forum, RTP, North Caroina, GSK

 

1/13/2013 Choosing The Right Dose: The Role Of PK/PD Modeling & Simulation From Discovery Performance to Medicine, 3D seminar, GSK, Shanghai

 

12/6/2012, Working as a Pharmacometrician in US/UK/EU – what are they looking for? Hiring manager’s perspective, Population Approach Group in Korea 1st Annual Meeting, Seoul, Korea

 

11/8/2012 Overview of PK in drug development and the importance of pre-clinical studies in relation to clinical drug development,Korea Society of Non-Clinical Study-  Korea Society of Toxicologic Pathology Joint Symposium , Oak Valley, Wonju, Korea

 

8/17/2012 Selecting a starting dose for a FtiH clinical Trial, Science Salon, RDC, Shanghai, China, GSK

 

8/17/2012 Defining appropriate dose-level increments: Dose Escalation, RDC, Shanghai, China, GSK

 

6/12/2012, Overview of PK Use in Drug Development, CR Forum, RDC, CMD, Shanghai, China, GSK

 

1/26/2012 Clin Pharm study strategy, Regulatory Affairs, GSK, Korea

 

12/26/2011 Drug development and PK/PD workshop, Daeduck Innovatation Center, Daejeon, Korea

 

6/17/2011  Intermediate Clinical Pharmacology Training-Phoenix WNL, GSK China, Shanghai

 

6/9/2011 Choosing the Right Dose in Clinical Studies: Small Molecule and Biological, 2011 Bio and Medical Forum, COEX, Seoul, Korea

 

6/7/2011 Choosing the Right Dose in Clinical Studies: Small Molecule and Biological, GSK Korea, Seoul, Korea

 

6/7/2011 The role of pharmacist in USA and the education system of US PharmD course, School of Pharmacy, Kyung Hee University, Seoul, Korea

 

 

1/21/2011 History, Opportunities and Future of Quantitative Pharmacology and Pharmacometrics in USFDA and Pharma Industry, Korea FDA (KFDA), Osong, Korea

 

1/17/2011 Drug development and PK/PD workshop, Daeduck Innovatation Center, Daejeon, Korea

 

8/2/2010 Key In vitro In vivo DMPK Aspects to consider - clinical studies in mind, Korea Research Institute of Bioscience & Biotechnology (KRIBB), Daejeon, Korea

 

7/29/2010 Choosing the right dose-The Role Of  PKPD Model In Every Phases of  Clinical Drug Development, Jeonbook National University Clinical Research Center, Jeonju, Korea

 

 

7/28/2010 2010 Choosing the right dose-The Role Of PKPD Model In Every Phases of  Clinical Drug Development, Korea Institute of Science and Technology(KIST), Seoul, Korea

 

7/28/2010 Key In vitro In vivo DMPK Aspects to consider - clinical studies in mind, Korea FDA, Seoul, Korea

 

7/23/2010 Phoenix WinNonlin, IVIVC, NLME Symposium. Inje University, Busan, Korea

 

6/15/2010 Decision making in the face of uncertainty and variability: Is there a better way? Using a Risk Analysis Tool for Dose Selection of a Phase 2b HIV Treatment Study, Workshop session speaker/demo, Clinical Pharmacology Symposium 2010, GSK, Philadelphia

 

3/19/2010 Using a Risk Analysis Tool for Dose Selection of a Phase 2b HIV Treatment Study, Special session speaker/demo, American Society for Clinical Pharmacology and Therapeutics Annual Meeting 2010, Atlanta, GA

 

11/5/2009 Application of PK/PD Modeling and Simulation In Drug Development: Focus on Clinical Study Dose Selection, Ewha Women’s University, Seoul, Korea

 

11/4/2009 Current Trend in Clinical Research, Aju University, Suwon, Korea

 

11/4/2009 Clinical studies  in drug development- What do we need why,When, Green Cross, Seoul, Korea

 

11/3/2009 The Application Of PK/PD Modeling and Simulation In Drug Development- Focus on Clinical Study, GSK Korea, Seoul

 

10/14/2009  Two-Day Basic Clinical Pharmacology Training, GSK China, Shanghai

 

7/17/2009--How to Approach your Professional Career in US Industry, Young Generation & Professionals Forum, Korean American Sceintists and Engineer Convention, Raleigh, NC

 

7/8/09-- The Role Of Clinical Pharmacology In Drug Development, GSK Pharm Dev, Early Development Group - Biopharmaceutics, RTP, NC

 

3/28/2009-Career in US Industries for Korean-American Scientists and Engineers, Korean-American Scientists and Engineers NC Chapter, NIEHS, RTP, NC

 

1/23/2009- Choosing the right dose-The Role Of PKPD Model In Every Phases of  Clinical Studies, Biotechnology & Biopharmaceutical Meeting in RTP, Duke University, Durham, NC

 

1/5/2009-How to Decide First Time in Human Study Dose in New Drug Development and Important Things to Consider, Yuhan Pharmaceutical R&D, Seoul, Korea

 

12/29/08 US Pharmacy Education and Korea’s New 6-Year Pharmacy Program: ACCP Report and Personal View, Kyung Hee University, School of Pharmacy, Seoul, Korea

 

12/16/08 Choosing The Right Dose-The Role Of PK/PD Model In Every Phases of  Clinical Studies, GSK China, Shanghai, China

 

12/3/07 R&D - Challenges and Opportunities of New Drug Development. Sung Kyun Kwan  University, School of Engineering, SuWon, Korea

 

11/28/07 R&D - Challenges and Opportunitites of New Drug Development. Sook Myung Women’s  University, School of Pharmacy, Seoul, Korea

 

11/27/07 Current Trend in Clinical Research: Model-based Drug Development. The 13th Symposium on the Development of New Drugs and Health Functional Foods from Natural Products, Kyung Hee University, Seoul, Korea

 

11/13/07 Current Trend in Clinical Research. Korean American Pharmaceutical Scientist Association meeting, San Diego, CA

 

07/27/07 FTIH study in US Europe and Korea—Stories and Challenges, GSK Korea, Seoul Korea

 

07/26/07 FTIH study in US Europe and Korea—Things to consider, KFDA, Seoul Korea

 

12/22/06 Animal to Human- How to select the first time in human study first dose-- Stories and challenges. GSK Korea, Seoul, Korea

 

12/18/06 First Time in Human Study in  New Drug Development.  Inje University, Busan, Korea

 

12/4/06 Stories and challenges of New Drug Development. Korean Research Institute of Chemical Technology, Daejeon, Korea

 

11/02/06 Northwick Park Incident and First Time in Human (FTIH) Study. Korean American Pharmaceutical Scientist Association meeting, San Antonio, TX

 

01/27/06 Impact of PK Variability on Toxicologic Stopping Criteria. Clinical Pharmacology and Discovery Medicine Antivirals Family Encounter meeting, GSK, NC

 

12/21/05 FDA Guidance, Allometric scaling and Simulations in Estimating Safe Starting Dose in Initial Clinical Trials.  Seoul National University Hospital, Seoul, Korea

 

12/06/05 Impact of alcohol on Modified Release Formulations - Focus on the PK and recent US FDA actions.  Kyung Hee University, Seoul, Korea

 

12/05/05 FDA Guidance, Allometric scaling and Simulations in Estimating Safe Starting Dose in Initial Clinical Trials. KFDA, Seoul, Korea

 

12/02/05 Impact of alcohol on Modified Release Formulations - Focus on the PK and recent US FDA actions. Korean Society of Pharmaceutics, Seoul, Korea

 

11/29/05 Application of Crystal Ball® in CPK M&S - Case studies. Clinical Pharmacokinetics Modeling & Simulation US Department Meeting, GSK, Philadelphia

 

11/02/05 Impact of PK Variability (CV%) on Stopping Criteria. CPK/DMPK/SA Forum, GSK, Research Triangle Park, NC

 

12/02/04 Drug Research and Development: Challenges and Opportunities, Health Industry Technology Exposition Korea  2004, Seoul Kyoyuk Munhwa Hoekwan, Seoul, Korea KHIDI (Korea Health  Industry Development Institute), Ministry of Health and Welfare, Korea

 

12/01/04 Drug R&D: Challenges and Opportunities, Dae Woong Pharmaceutical, Seoul, Korea

 

11/30/04 The importance of PK/TK in drug development, School of Pharmacy, Kyung Hee University, Seoul, Korea

 

11/25/04 Interpretation of PK Parameters and Related Calculations in BE studies: A Close Look of an Example, Korean Society of Pharmaceutics 34th Annual Meeting, Seoul Kyoyuk Munhwa Hoekwan, Seoul, Korea

 

11/23/04 The importance of PK/TK modeling and simulation in drug development, Green Cross Research Institute, Seoul, Korea

 

11/20/04 Population PK analysis with NONMEM and WinNonMix:Input, Output files and Important Terminology, KFDA, Seoul, Korea

 

11/10/04 Simulation of GW695634G, a Next Generation NNRTI, with Regional Absorption Study Results, GSK – Clinical Pharmacology and Discovery Medicine US Department Meeting- Loews Hotel – Philadelphia, PA

 

12/02/03 WinNonlin and NONMEM workshop, Korea Food and Drug Administrations, KFDA Training Center, Seoul, Korea

 

11/27/03 Use of FDA Guidance and Computer Simulation to optimize BA/BE study outcomes. --Focusing on Sample size, Sampling time and Food effect. Korean Society of Pharmaceutics 33rd Annual Meeting, Seoul National University, Seoul, Korea

 

11/26/03 Pharmacy in America-Pharmacy school, practice and industries. School of Pharamcy, Kyung Hee University, Seoul, Korea

 

1/04/03 The application of population PK in drug dose regimen evaluation- Focus on the FDA POP PK Guidance and more. KFDA, Seoul, Korea

 

12/27/02 The Bootstrap Approach: Application to Population Pharmacokinetics. School of Pharmacy, Kyung Hee University, Seoul, Korea

 

 

Publications/Abstracts/Poster Presentations:

David A. Wilfret, Jill Walker, Christian Voitenleitner, Sharon Baptiste‐Brown, Mark Lovern, Joseph Kim, Kimberly Adkison, Brad Shotwell, Amanda Mathis, Lee Moss, Daniel Lee, Lou Yu, Jianjun Gan, and Andrew Spaltenstein. A Randomized, Double Blind, Dose Escalation, First Time in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Single Doses of GSK2485852 in Chronically Infected Hepatitis C Subjects. 

Clinical Pharmacology in Drug Development 3(6) 439–448, 2014

 

S.D. Gardner, J. Kim, V. Lopez, R. Hamatake, K. Gan, Z. Zhu, M. Leivers, M.T. Paff, Z. Hong. First Time in Human (FTIH) and Proof of Concept (POC) Studies of GSK2878175 (GSK175), a Potent Pan-Genotypic Non-Nucleoside NS5B Polymerase Inhibitor of HCV Replication, AASLD, Boston, November, 2014

 

S. L. Ford, J. Chiu, M. Lovern, W. Spreen, J. Kim. Population PK Approach to Predict Cabotegravir (CAB, GSK1265744) Long-Acting Injectable Doses for Phase 2b, ICCAC, Washington DC, September, 2014

 

Stephen Piscitelli, Joseph Kim, Elizabeth Gould, Yu Lou, Scott White, Mark de Serres, Mark Johnson, Xiao-Jian Zhou, Keith Pietropaolo, Douglas Mayers, Drug interaction profile for GSK2248761, a next-generation non-nucleoside reverse transcriptase inhibitor. British Journal of Clinical Pharmacology, 74(2) 336–345 Feb 2012

 

Carlos Zala, Marty St. Clair, Kathleen Dudas, Joseph Kim, Yu Lou, Scott White, Stephen Piscitelli, Etienne Dumont, Keith Pietropaolo, Xiao-Jian Zhou, and Douglas Mayers  Safety and Efficacy of GSK2248761, a Next-Generation Non-nucleoside Reverse Transcriptase Inhibitor, in Treatment-Naive HIV-1-Infected Subjects, Antimicrobial Agents and Chemotherapy, 56(5):2570-5 2012 May.

 

Paul J. Williams, Yong Ho Kim, Ene I. Ette. The Epistemology of Pharmacometrics. In: Pharmacometrics Ene I. Ette, Paul J. Williams, editors: John Wiley & Sons, Inc, 2006: 223-244

 

Paul J. Williams, Yong Ho Kim Resampling Techniques and Their Application to Pharmacometrics. In: Pharmacometrics Ene I. Ette, Paul J. Williams, editors: John Wiley & Sons, Inc, 2006: 401-419

 

Chuanpu Hu, Katy H. P. Moore, Yong Ho Kim and Mark E. Sale. Statisical issues in a modeling approach to assessing bioequivalence or pk similarity with presence of sparsely sampled subjects, Journal of Pharmacokinetics and Pharmacodynamics,Vol. 31, NO.4, August 2004 321-339

 

 

Ette EI, Williams PJ, Kim YH, Lane JR, Liu M, Capparelli EV. Model Appropriateness and Population Pharmacokinetic Modeling. J Clinical Pharmacology 2003:43(6);610-624.



 

Paul J. Williams, James R. Lane, Edmund V. Capparelli, Yong Ho Kim, and Robert Coleman.  Direct comparison of three methods for predicting digoxin concentrations.  Pharmacotherapy 1996; 16(6): 1085-1092

 

 

10/27/2011 Tae Eun Kim1, Joseph Y. Kim and Peter Bonate Use of population pharmacokinetic-pharmacodynamic/ HCV viral dynamic model to examine the impact of drug exposure –effectiveness curve slope on HCV treatment outcomes, Poster Presentation  #R6184, 2011 AAPS Annual Meeting, Washington DC,

 

9/15/2010 S. M. WHITE, Y. LOU, E. DUMONT, C. ZALA, X. J. ZHOU, J. Y. KIM

Safety, Efficacy, Pharmacokinetic (PK), and PK/Pharmacodynamics (PK/PD) of GSK2248761 , a Next Generation NNRTI, Administered as Short-term Monotherapy in Therapy-Naïve HIV-1 Infected (NV) Subjects, Poster Presentation, Boston, MA

 

9/15/2010 J. KIM, E. GOULD, Y. LOU, E. DUMONT, M.B. WIRE, S. PISCITELLI. Effect of GSK2248761 on CYP450 probe compounds and interactions with RTV-Boosted Protease Inhibitors. , Poster Presentation, Boston, MA

 

4/7/2010 J. Zhang, T.E. Kim, J. Kim, I. Song. Population PK and Viral Dynamic Modeling of S/GSK1349572 in Patients with HIV Infection. 11th International workshop on clinical pharmacology of HIV therapy, Oral Presentation, Sorrento, Italy

 

 

10/20/09 Meg Ehm, Louise Hosking, Astrid Yeo, Lon Cardon, Frank Hoke, Joseph Kim, Joseph Polli, Virginia Schmith, Zhengyu Xue, Colin Spraggs,  Nine Years of Genetic Experimentation in Phase I Clinical Trials- What Have We Learned? American Society of Human Genetics a platform presentation in the American Society of Human Genetics 59th Annual Meeting, Abstract 310, Platform presentation, Honolulu, Hawaii

 

10/4/09 Tae Eun Kim, Gary Pollack and Joseph Y. Kim, The evaluation of the impact of in vitro dose-response curve slope on the clinical antiviral activity prediction of an HIV drug using PK-PD-Disease model-based simulation, American Conference on Pharmacometrics (ACoP), Mashantucket, CT

 

6/18/09 Tae E Kim, Joseph Y Kim. A Pharmacokinetic-Pharmacodynamic-Disease Model to Evaluate the Effect of Dose-Response Curve Slope on Prediction of Clinical Activity of an HIV Drug. University of North Carolina Graduate Program Retreat, Poster,

 

 

11/29/05 Joseph Kim, William Symonds, Judith Ng-Cashin, Janna Scott, Marty St. Clair, Katy Moore. Probability of achieving various efficacy responses using pharmacokinetic/ pharmacodynamic (PK/PD) modeling and simulation of GW695634 following repeat oral dose administration to HIV-1 infected subjects. CPDM Global Science Forum, GSK, Philadelphia, PA

 

11/29/05 Ivy Song, Joseph Kim, and Steve Weller. Pediatric Dose Recommendation for Valtrex Oral Suspension. CPDM Global Science Forum, GSK, Philadelphia, PA

 

 

07/24/05 S Becker, J Lalezarri, C Walworth, P Kumar, J cade, J Ng-cashin, Y Kim, J scott, M St. clair, L jones, W symonds on behalf of the NN210005 study team. Antiviral activity and Safety of GW695634, a novel next generation NNRTI, in NNRTI-resistant HIV-1 Infected Patients. The 3rd IAS Conference on HIV Pathogenesis and Treatment. Rio de Janeiro, Brazil.

 

 

03/15/05 Joseph Kim, Anh Nguyen and GW695634G Project Team. Simulation of GW695634G, a Next Generation Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), with Regional Absorption Study Results, The second annual GSK Mathematical Modeling Symposium, Ware, United Kingdom.

 

 

10/30/04 Kim YH, Symonds W, Steel H, Ng-Cashin J, Moore KHP, Denning J, Sanderson B .  Safety and pharmacokinetics (PK) of 695634 following repeat dose administration to healthy subjects. 44rd Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, DC, [Abstract No. 2028, A-23].

 

10/30/04 Persky AM, Moore KHP, Kim YH, Symonds W, Denning J, Frye RF. Effect of 695634, a new NNRTI, on cytochrome P450 (CYP) probe substrates. 44rd Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, DC, [Abstract No. 2792].

 

07/11/04 Symonds W, Denning J, Kim J, Moore K, Edwards L, Steel H, Sanderson B.  A double-blind, parallel, randomized, placebo-controlled, single ascending dose study to investigate 695634X and 678248X safety, tolerability and pharmacokinetics following oral administration of 695634G to healthy male subjects.  15th International AIDS Conference, Bangkok, [Abstract No. 4480].

 

 

04/01/04 Yongho Kim, Chuanpu Hu, Mary Wire, Katy Moore, Mark Sale, and GW433908 Study Group. Steady-State Amprenavir Pharmacokinetics are Similar between Healthy and HIV-Infected Subjects Following GW433908 ± Ritonavir Using Population Pharmacokinetic  Analysis -- 5th International Workshop on Clinical Pharmacology of HIV Therapy, Poster #7.5, Rome, Italy

 

01/12/04 Joseph Kim, Katy Moore, William Symonds, Mark Deserres, Jackie Greene, Jeff Wald, Mark Sale, David Alpers, Colin Dollery. Estimating Relative Human Intestinal Mucosal GW678248X Concentrations From Rat Data. -- Poster#31, Upper Marion, PA GSK Mathematical modeling symposium

 

 

06/12/03 A Modeling Approach to Assessing Bioequivalence (BE) with Presence of Sparsely Sampled Subjects, C. Hu, J.Y. Kim, K.H.P. Moore, M.E. Sale, Verona, Italy Population Application Group in Europe(PAGE) meeting

 

05/06/2003 ‘NN210001 A Double-Blind, Parallel, Randomized, Placebo-Controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of GW695634G  Administered to Healthy Volunteers (Preliminary Data)’ Poster #4, at GSK Pipeline Day, RTP Joseph Kim, Jill Denning, Daniel Stein, Gautam Aggarwal, Vince Barnett, Katy Moore, Bill Symonds

 

01/04/03 ‘The application of Population Pharmacokinetics in drug dose regimen evaluation--Focus on the FDA POP PK Guidance and more’  National Institute of Toxicological Research, Korea Food and Drug Administration, Seoul, Korea

 

 

12/27/02 ‘The Bootstrap Approach: Application to Population Pharmacokinetics’ East-West Pharmaceutical Research Institute, College of Pharmacy, Kyung Hee University, Seoul, Korea

 

 

11/16/99 ‘5-Fluorocytosine: Population pharmacokinetics model development, nonparametric bootstrap validation, and dosing strategy evaluation’  American Association of Pharmaceutical Scientists, Annual Meeting, New Orleans, LA

 

12/10/96 ‘Direct Comparison .of Three Methods for Predicting 5-fluorcytosine Concentrations’, IBC conference, Washing D.C.

 

5/94  ‘Using Weighted Residuals to Access the Predictability of Digoxin Serum Concentrations’, NONMEM Conference, San Francisco, CA.

 

2/9/93  ‘Direct comparison of three population pharmacokinetic methods for digoxin prediction error analysis’, Winter Practice and Research Forum, American College of Clinical Pharmacy, Fort Lauderdale, FL.