Pre-clinical DMPK and relevance to the clinic

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Pre-clinical DMPK and relevance to the clinic"

Transcription

1 Pre-clinical DMPK and relevance to the clinic Richard Weaver Ph.D Managing Director and Founder of XenoGesis limited BioCity Nottingham Pennyfoot Street Nottingham, UK NG1 1GF 1

2 Drug Discovery & Drug Development Drug Discovery multiple compounds profiled Target Selection Hit Identification (HI) Lead Identification (LI) Lead Optimisation Candidate Drug Nomination Drug Development single compound profiled Pre-Clinical Development Phase 1 Phase 2a Phase 2b Phase 3 & Launch 2

3 Design Synthesise Test Hit Identification (HI) Lead Identification (LI) Lead Optimisation (LO) Candidate Drug Nomination (CD) Primarily in vitro DMPK and physicochemical evaluation Enable hit selection In vitro and In vivo DMPK and physicochemical evaluation Enable lead series selection In vitro and In vivo DMPK and physicochemical evaluation Further detailed profiling Dose to Man estimation Candidate drug identified with minimal DMPK risk, to progress into development CD Single compound and series rejection Compound rejection 3

4 Numbers of compounds per LO campaign Design Test Synthesise In vitro DMPK, pharmacology and safety testing In vivo DMPK testing In vivo Pharmacology testing In vivo disease hypothesis testing In vivo safety testing XenoGesis impacts through whole process. Removing poor compounds from further expensive progression & recommending good compounds, thus saving significant time and money 1 CD 4

5 DMPK / ADME(T) Drug Metabolism and Pharmacokinetics What the body does to the drug (xenobiotic) ADME(T) Absorption Distribution Metabolism Excretion Toxicity 5

6 What are we trying to achieve during drug discovery? In vitro (animal) In vitro (human) In vivo PK (animal) Predict to man In vivo PK/PD (animal) 6

7 PK / PD Pharmacokinetics What the body does to the drug Relationship between drug concentration and time Pharmacodynamics What the drug does to the body Relationship between drug concentration and effect 7

8 Plasma conc (nm) % inhibition PK / PD PK Time (hrs) concentration C t = C 0 * e -kt E = E max * C C + C 50 8

9 What dose? All things are poison and nothing is without poison, only the dose makes a thing be poison Paracelsus ( ) Over 500 years later and it s very valid 9

10 What dose? What dose should we give, whether in vitro or in vivo, to cause the desired effect without inducing a negative (toxic) response? Desired Effect Toxic Effect Effect Dose 10

11 PK/PD the correct exposure A) Dose to low: Animals die from uncontrolled tumour growth despite dosing a potent drug B) Dose too high: Animals suffer/die from administered drug, despite reduction in tumour growth C) Correct dose: Only when potency and exposure are within the right range tumour growth can be inhibited without serious side effects 11

12 Prediction of Hepatic Metabolic Clearance in Man Observed unbound intrinsic clearance Includes range of acid, neutral and basic compounds Predicted unbound intrinsic clearance Clearance of a range of marketed drugs is well predicted and thus validates this approach in discovery 12

13 Predicting Oral Dose from Simple PK concepts Target concentration (C min ) C min, ss F. Dose k V e 1 = t doses t = dosing interval Where k = = CL T 1/2 V 13

14 Influence of DMPK & Physicochemical Science on all key Discovery Disciplines Absorption Metabolism Predicted pre-clinical and human half-life DDIs (CYPs and Transporters) Potency anomalies Medicinal Chemistry Reactive metabolite mitigation Dosing regime design of safety studies Metabolite testing Predicted whole blood potencies DMPK & Phys. Chem. Reactive metabolite mitigation MIST guidelines 3Rs appropriate molecules for in vivo testing Designing appropriate dosing regimes for PD studies PK/PD relationships Biological Sciences Safety Assessment TK support Safety Margin calculations Cmax:Cmin, total / free AUC etc. Dose to Man prediction 14

15 Truly Integrated Drug Discovery Medicinal Chemistry DMPK & Physicochemical Science Biological Sciences Safety Assessment Candidate Drug Nomination Key to success core project team multi-lingual in the four key pillars of drug discovery All disciplines equally involved in integrated drug design and delivery, from HI to CD nomination 15

16 March PK / 2010 PD AstraZeneca R&D Charnwood closure announced 16

17 Now PK / what? PD Go to work for AZ at another site or other Pharma Set up my own company Luckily had 12 months to decide 17

18 Why was I thinking about setting up my own company? Disillusioned with the state of the Pharma industry Had passion for the science and a drive to do my best (and to make some money) In my latter years at AZ saw a huge shift in outsourcing Was in charge of evaluating CROs in the far east Worked with a far east company on a project Knew what they did well Knew what they didn t do well 18

19 The Landscape The traditional Large Pharma model is not working anymore Looming patent cliff $78 billion erosion of sales Spiralling R&D costs From $65 billion in 2002 to estimated $140 billion in 2014 The cost of bringing a drug to market is, on average, $1.3 billion (The Pharmaceutical Research and Manufacturers of America PhRMA) Superimposed on a near flat-level level number of FDA approvals for the last 18 years Attrition remains very high 90% from Phase 1 to launch 19

20 Site closures 18 R&D sites closed in the US ( ) 54% of the total 14 R&D sites closed in the EU ( ) UK 6 R&D site closures ( ) 19% of the total 20

21 The Landscape GC Green, The CRO Market Outlook to 2014 emerging markets, leading players and future trends, Business Insights, copyright, 2009, Datamonitor Limited reproduced with permission of Datamonitor Limited How to reduce costs and maintain (or increase) success? Outsourcing is the current trend 21

22 XenoGesis Company History XenoGesis Limited, pre-clinical DMPK/ADME CRO, launched June 2011 with Dr. Richard Weaver as the founding Director Secured private investment to kick-start the business Board of Directors Richard Weaver Ph.D (ex AstraZeneca DMPK Group Leader) Glenn Crocker Ph.D (CEO of BioCity) John Dixon Ph.D (JD International Consulting, Former VP of AstraZeneca) Number of strategic alliances completed and actively pursued e.g. Strategic alliance with XenoTech in the US Ambitious but realistic growth planned Client base: UK, Europe and US 29 companies to February 2013: Virtual companies, SMEs, mid-sized Pharma 3 academic institutions 22

23 What materials do we need to deliver? Our business model of service provision heavily focussed on in vitro data Why? 3R s initiative human tissue and extracts accessible (in theory) We can scale in vitro to in vivo What do we need to enable better delivery Access to human fresh blood, plasma, tissue Access to fresh rat and human hepatocytes Access to diseased tissue Access to animal tissue Access to specialist equipment LC/MS/MS, accurate mass MS, ultracentrifuge Can you help? 23

24 Summary The landscape of delivering new and needed drugs is changing at a pace never seen before Innovation and integrated solutions are essential for success The XenoGesis business USP relies on innovation and great science Actively looking for opportunities to work with other groups to be more successful in delivery 24

25 Acknowledgements AstraZeneca R&D staff Our team and board BioCity Nottingham 25

DMPK: Experimentation & Data

DMPK: Experimentation & Data DMPK: Experimentation & Data Interpretation Mingshe Zhu, Mike S. Lee, Naidong Weng, and Mark Hayward Prerequisite: Entry-level scientists with hands on experience in LC/MS as well as advanced students

More information

What ADME tests should be conducted for preclinical studies? Hong Wan

What ADME tests should be conducted for preclinical studies? Hong Wan ADMET & DMPK 1(3) (2013) 19 28; doi: 10.5599/admet.1.3.9 Open Access : ISSN : 1848 7718 Perspective What ADME tests should be conducted for preclinical studies? Hong Wan Shanghai Hengrui Pharmaceutical

More information

Pharmacology skills for drug discovery. Why is pharmacology important?

Pharmacology skills for drug discovery. Why is pharmacology important? skills for drug discovery Why is pharmacology important?, the science underlying the interaction between chemicals and living systems, emerged as a distinct discipline allied to medicine in the mid-19th

More information

Biological importance of metabolites. Safety and efficacy aspects

Biological importance of metabolites. Safety and efficacy aspects Biological importance of metabolites Safety and efficacy aspects Bernard Walther Technologie Servier Biological importance of metabolites Safety testing of drug metabolites Bioanalytical strategy Structural

More information

Lead optimization services

Lead optimization services Lead optimization services The WIL Research Company (WRC) has extensive experience in fast track tailor-made screening strategies to help you with the challenging task of selecting your best candidate

More information

A Peak at PK An Introduction to Pharmacokinetics

A Peak at PK An Introduction to Pharmacokinetics Paper IS05 A Peak at PK An Introduction to Pharmacokinetics Hannah Twitchett, Roche Products Ltd, Welwyn Garden City, UK Paul Grimsey, Roche Products Ltd, Welwyn Garden City, UK ABSTRACT The aim of this

More information

Clinical trials preclinical requirements. Clinical trials - legislation

Clinical trials preclinical requirements. Clinical trials - legislation Clinical trials preclinical requirements Mikael Andersson, PhD Senior Expert Medical Products Agency, Sweden Tallinn 9/10 2009 Clinical trials - legislation Directive 2001/20/EC Clinical trial directive

More information

FACT SHEET TESTETROL, A NOVEL ORALLY BIOACTIVE ANDROGEN

FACT SHEET TESTETROL, A NOVEL ORALLY BIOACTIVE ANDROGEN FACT SHEET TESTETROL, A NOVEL ORALLY BIOACTIVE ANDROGEN General Pantarhei Bioscience B.V. is an emerging specialty pharmaceutical company with a creative approach towards drug development. The Company

More information

Teriflunomide is the active metabolite of Leflunomide, a drug employed since 1994 for the treatment of rheumatoid arthritis (Baselt, 2011).

Teriflunomide is the active metabolite of Leflunomide, a drug employed since 1994 for the treatment of rheumatoid arthritis (Baselt, 2011). Page 1 of 10 ANALYTE NAME AND STRUCTURE TERIFLUNOMIDE Teriflunomide TRADE NAME Aubagio CATEGORY Antimetabolite TEST CODE PURPOSE Therapeutic Drug Monitoring GENERAL RELEVANCY BACKGROUND sclerosis. The

More information

Alterações empresariais sustentadas pelo conceito de engenharia do Produto Patrício Soares da Silva, MD, PhD

Alterações empresariais sustentadas pelo conceito de engenharia do Produto Patrício Soares da Silva, MD, PhD Alterações empresariais sustentadas pelo conceito de engenharia do Produto Patrício Soares da Silva, MD, PhD 1 Summary Hypothesis Generation Candidate Development Commercialization Target Identification

More information

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE S1A. Current Step 4 version

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE S1A. Current Step 4 version INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE GUIDELINE ON THE NEED FOR CARCINOGENICITY STUDIES

More information

Plasma Drug Concentration Time Profile Plotting Data

Plasma Drug Concentration Time Profile Plotting Data UNIT 2 PHARMACOKINETICS-BASIC CONSIDERATIONS Plasma Drug Concentration Time Profile Plotting Data S. SANGEETHA., M.PHARM., (Ph.d) Department of Pharmaceutics SRM College of Pharmacy SRM University INTRODUCTION

More information

Statistics and Pharmacokinetics in Clinical Pharmacology Studies

Statistics and Pharmacokinetics in Clinical Pharmacology Studies Paper ST03 Statistics and Pharmacokinetics in Clinical Pharmacology Studies ABSTRACT Amy Newlands, GlaxoSmithKline, Greenford UK The aim of this presentation is to show how we use statistics and pharmacokinetics

More information

BIOAVAILABILITY & BIOEQUIVALENCE TRIALS

BIOAVAILABILITY & BIOEQUIVALENCE TRIALS BIOAVAILABILITY & BIOEQUIVALENCE TRIALS Shubha Rani,, Ph.D. Technical Director & Head-Biometrics and Data Management Synchron Research Services Pvt. Ltd. Ahmedabad 380 054 drshubha@synchronresearch.com

More information

Eudendron: an Innovative Biotech Start-up

Eudendron: an Innovative Biotech Start-up Eudendron: an Innovative Biotech Start-up Mauro Angiolini & Fabio Zuccotto I Venti dell Innovazione, Ville Ponti - Varese, 20 Marzo 2013 Bioindustry Park S. Fumero (Ivrea) - Italy Eudendron: a Quick Description

More information

UK- India Science Bridge: BioPharm 2020

UK- India Science Bridge: BioPharm 2020 DST INDIA - RESEARCH COUNCILS UK UK- India Science Bridge: BioPharm 2020 Entrepreneurial Opportunities for Indian and UK Scientists in the Pharmaceutical and Biotechnology Industries UK-India Impact Symposium

More information

The Clinical Trials Process an educated patient s guide

The Clinical Trials Process an educated patient s guide The Clinical Trials Process an educated patient s guide Gwen L. Nichols, MD Site Head, Oncology Roche TCRC, Translational and Clinical Research Center New York DISCLAIMER I am an employee of Hoffmann-

More information

How to develop Antibody Drug Conjugates: Bioanalysis Contribution

How to develop Antibody Drug Conjugates: Bioanalysis Contribution How to develop Antibody Drug Conjugates: Bioanalysis Contribution Recommendations and survey results Presenter: Matt Barfield on behalf of the EBF TT43 7th Open Symposium 19 th November 2014 Barcelona

More information

Interface of Different Modules Within Simcyp

Interface of Different Modules Within Simcyp Data Entry & Input Interface of Different Modules Within Simcyp Flexibility for Variable Input & Added Complexity Compound Parameters Library Parameters LIVER GI TRACT KIDNEY 1. Whole Organ Clearance MPPGL

More information

From The Lab To Your Medicine Cabinet:

From The Lab To Your Medicine Cabinet: From The Lab To Your Medicine Cabinet: A Pharmaceutical Drug s Journey Presented by: Dr. Steven Hansel Sr. Director; Pfizer Moderated by: Sam Gilchrist Ph.D. Candidate; UBC The Drug Development Process

More information

Effective Outsourcing of Clinical Pharmacology Studies in Europe. John Horkulak Executive Director, Eurasian External Clinical Study Operations

Effective Outsourcing of Clinical Pharmacology Studies in Europe. John Horkulak Executive Director, Eurasian External Clinical Study Operations Effective Outsourcing of Clinical Pharmacology Studies in Europe John Horkulak Executive Director, Eurasian External Clinical Study Operations Key Questions Do clinical pharmacology studies require a different

More information

Outsourcing in Drug Development From the Bench to the Market. Steven A. Kates, PhD Ischemix LLC

Outsourcing in Drug Development From the Bench to the Market. Steven A. Kates, PhD Ischemix LLC Outsourcing in Drug Development From the Bench to the Market Steven A. Kates, PhD Ischemix LLC Ischemix LLC 2012 Introduction Drug Development Process Ischemix LLC 2012 2 Introduction Drug Development

More information

Achieving Regulatory Success: Areas of focus for biotechnology companies. Michael J. Schlosser, PhD, DABT April 21, 2013

Achieving Regulatory Success: Areas of focus for biotechnology companies. Michael J. Schlosser, PhD, DABT April 21, 2013 Achieving Regulatory Success: Areas of focus for biotechnology companies Michael J. Schlosser, PhD, DABT April 21, 2013 Regulatory Success Outline Regulatory Initiatives Regulatory Science Pre-Regulatory

More information

ICH Topic S 1 A The Need for Carcinogenicity Studies of Pharmaceuticals. Step 5

ICH Topic S 1 A The Need for Carcinogenicity Studies of Pharmaceuticals. Step 5 European Medicines Agency July 1996 CPMP/ICH/140/95 ICH Topic S 1 A The Need for Carcinogenicity Studies of Pharmaceuticals Step 5 NOTE FOR GUIDANCE ON THE NEED FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS

More information

Data Visualization in Cheminformatics. Simon Xi Computational Sciences CoE Pfizer Cambridge

Data Visualization in Cheminformatics. Simon Xi Computational Sciences CoE Pfizer Cambridge Data Visualization in Cheminformatics Simon Xi Computational Sciences CoE Pfizer Cambridge My Background Professional Experience Senior Principal Scientist, Computational Sciences CoE, Pfizer Cambridge

More information

Guideline on the investigation of drug interactions

Guideline on the investigation of drug interactions 21 June 2012 CPMP/EWP/560/95/Rev. 1 Corr. 2** Committee for Human Medicinal Products (CHMP) Discussion in the Efficacy Working Party (EWP) June/October 1996 February 1997 Transmission to the CPMP March

More information

Guidance for Industry Safety Testing of Drug Metabolites

Guidance for Industry Safety Testing of Drug Metabolites Guidance for Industry Safety Testing of Drug Metabolites U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) February 2008 Pharmacology

More information

Pharmaceutical Sciences

Pharmaceutical Sciences Is a Career in the Pharmaceutical Sciences Right for Me? Check out our online Student Center to find out more: www.aapspharmaceutica.com/students How do I know if a career in the pharmaceutical sciences

More information

The Future of R&D Outsourcing

The Future of R&D Outsourcing OUTSOURCING The Future of R&D Outsourcing Investigating development hurdles, key challenges & strategies to optimize CRO relationships By Alison Sahoo Alison Sahoo Alison Sahoo is a pharmaceutical industry

More information

Session 6 Clinical Trial Assessment Phase I Clinical Trial

Session 6 Clinical Trial Assessment Phase I Clinical Trial L1 Session 6 Clinical Trial Assessment Phase I Clinical Trial Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager, Clinical Group I Office

More information

1/17/2013. Dose Response and Concentration Response Analysis of Drug Effects

1/17/2013. Dose Response and Concentration Response Analysis of Drug Effects Dose Response and Concentration Response Analysis of Drug Effects Juan J. L. Lertora. M.D., Ph.D. IH Clinical Center January 17, 213 1 DOSE-EFFECT RELATIOSHIP The intensity and duration of a drug s effect(s)

More information

CTC Technology Readiness Levels

CTC Technology Readiness Levels CTC Technology Readiness Levels Readiness: Software Development (Adapted from CECOM s Software Technology Readiness Levels) Level 1: Basic principles observed and reported. Lowest level of software readiness.

More information

Goals & Objectives. Drug Development & the FDA Pharmacy 309. Outline. An History of Disasters. Be able to describe

Goals & Objectives. Drug Development & the FDA Pharmacy 309. Outline. An History of Disasters. Be able to describe Drug Development & the FDA Pharmacy 309 Tom Hazlet, Pharm.D., Dr.P.H. 616-2732 thazlet@u... Goals & Objectives Be able to describe the major regulatory events in the drug development process the concepts

More information

PharmaPendium. The definitive source of best-in-class drug information

PharmaPendium. The definitive source of best-in-class drug information Please contact us for more information Americas E-Customer Service 360 Park Avenue South New York, NY 10010-1710 USA Tel: +1 888 615 4500 (+1 212 462 1978, if calling from outside the USA and Canada) Fax:

More information

Rochester BioVenture Center November 14th

Rochester BioVenture Center November 14th Rochester BioVenture Center November 14th Calvert Holdings, Inc. Established in 1996 Parent company for several subsidiaries Focus: health care services and investments Corporate HQ located in Cary, NC

More information

THE BIOTECH & PHARMACEUTICAL INDUSTRY

THE BIOTECH & PHARMACEUTICAL INDUSTRY THE BIOTECH & PHARMACEUTICAL INDUSTRY ESSENTIAL CAREERS INFORMATION CALUM LECKIE KATIE BISARO CAREERS CONSULTANTS What we will cover Sector overview Types of role Graduate recruitment trends and issues

More information

Accelerating Lead Generation: Emerging Technologies and Strategies

Accelerating Lead Generation: Emerging Technologies and Strategies Brochure More information from http://www.researchandmarkets.com/reports/1057249/ Accelerating Lead Generation: Emerging Technologies and Strategies Description: The number of approvals for new drugs and

More information

De novo design in the cloud from mining big data to clinical candidate

De novo design in the cloud from mining big data to clinical candidate De novo design in the cloud from mining big data to clinical candidate Jérémy Besnard Data Science For Pharma Summit 28 th January 2016 Overview the 3 bullet points Cloud based data platform that can efficiently

More information

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE ON THE PRE-CLINICAL EVALUATION OF ANTICANCER MEDICINAL PRODUCTS

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE ON THE PRE-CLINICAL EVALUATION OF ANTICANCER MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit London, 23 July 1998 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE ON THE PRE-CLINICAL

More information

Careers in Biostatistics and Clinical SAS Programming An Overview for the Uninitiated Justina M. Flavin, Independent Consultant, San Diego, CA

Careers in Biostatistics and Clinical SAS Programming An Overview for the Uninitiated Justina M. Flavin, Independent Consultant, San Diego, CA PharmaSUG 2014 Paper CP07 Careers in Biostatistics and Clinical SAS Programming An Overview for the Uninitiated Justina M. Flavin, Independent Consultant, San Diego, CA ABSTRACT In the biopharmaceutical

More information

Drug Prescribing in Kidney Disease: Initiative for Improved Dosing

Drug Prescribing in Kidney Disease: Initiative for Improved Dosing Drug Prescribing in Kidney Disease: Initiative for Improved Dosing Effects of impaired kidney function on drug pharmacokinetics and pharmacodynamics Section Leaders: William Bennett and Domenic Sica Passage

More information

EXIGENCIA DE ESTUDIOS DE BIOEQUIVALENCIA A TRAVÉS DE METODOS IN VITRO

EXIGENCIA DE ESTUDIOS DE BIOEQUIVALENCIA A TRAVÉS DE METODOS IN VITRO EXIGENCIA DE ESTUDIOS DE BIOEQUIVALENCIA A TRAVÉS DE METODOS IN VITRO Q.F. ALEXIS ACEITUNO, PhD Jefe Subdepto. Biofarmacia & Bioequivalencia Agencia Nacional de Medicamentos Instituto de Salud Pública

More information

Exploiting the Pathogen box

Exploiting the Pathogen box Exploiting the Pathogen box Dr Richard Gordon Director Strategic Health Innovation Partnerships 9 May 2014 www.ship.mrc.ac.za Background Worked with MMV in many areas Servicing Partner Consultant Collaborator

More information

Public Assessment Report Scientific discussion. Tenofovir disoproxil Teva (tenofovir disoproxil) SE/H/1432/01/DC

Public Assessment Report Scientific discussion. Tenofovir disoproxil Teva (tenofovir disoproxil) SE/H/1432/01/DC Public Assessment Report Scientific discussion Tenofovir disoproxil Teva (tenofovir disoproxil) SE/H/1432/01/DC This module reflects the scientific discussion for the approval of Tenofovir disoproxil Teva.

More information

Day 3 Exercise 2 Parameter Optimization and Sensitivity Analysis: An Example Using a PBPK Model for Warfarin. April 19-23, 2010.

Day 3 Exercise 2 Parameter Optimization and Sensitivity Analysis: An Example Using a PBPK Model for Warfarin. April 19-23, 2010. Day 3 Exercise 2 Parameter Optimization and Sensitivity Analysis: An Example Using a PBPK Model for Warfarin A Course on Physiologically Based Pharmacokinetic (PBPK) Modeling and In Vitro to In Vivo Extrapolation

More information

GLP vs. non-glp: A Practical Applicaton. Comparing required elements in a GLP-compliant and non-glp study TECHNICAL PAPER. contract research expertise

GLP vs. non-glp: A Practical Applicaton. Comparing required elements in a GLP-compliant and non-glp study TECHNICAL PAPER. contract research expertise contract research expertise TECHNICAL PAPER GLP vs. non-glp: A Practical Applicaton Comparing required elements in a GLP-compliant and non-glp study 2 GLP vs. non-glp: A Practical Application Abstract...

More information

Metabolic Studies of Drug Candidates for Neurological Disorders and Asthma Based on GABA A Receptor Subtype Selective Ligands using Mass Spectrometry

Metabolic Studies of Drug Candidates for Neurological Disorders and Asthma Based on GABA A Receptor Subtype Selective Ligands using Mass Spectrometry Metabolic Studies of Drug Candidates for eurological Disorders and Asthma Based on GABA A Receptor Subtype Selective Ligands using Mass Spectrometry Revathi Kodali 1, Margaret L. Guthrie 1, Michael M.

More information

TGN 1412 Welche Änderungen haben sich für die Erstanwendung am Menschen aus Sicht des BfArM ergeben?

TGN 1412 Welche Änderungen haben sich für die Erstanwendung am Menschen aus Sicht des BfArM ergeben? TGN 1412 Welche Änderungen haben sich für die Erstanwendung am Menschen aus Sicht des BfArM ergeben? PD Dr. med. Thomas Sudhop Bundesinstitut für Arzneimittel, Bonn Bundesinstitut für Arzneimittel IMP

More information

NCT Preliminary Report: Phase I Dose Escalating Study to Evaluate the Safety,

NCT Preliminary Report: Phase I Dose Escalating Study to Evaluate the Safety, NCT02020291 Preliminary Report: Phase I Dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles of Foxy-5 in Patients with Metastatic Breast, Colon or Prostate

More information

RapidFire High-throughput MS technology. Enhancing Drug Discovery Turning Mass Specs into Plate Readers

RapidFire High-throughput MS technology. Enhancing Drug Discovery Turning Mass Specs into Plate Readers RapidFire High-throughput MS technology Enhancing Drug Discovery Turning Mass Specs into Plate Readers 1 Drug Discovery with RapidFire Target Selection High-throughput Target Screening (HTS) Lead Optimization

More information

Preclinical Support Services

Preclinical Support Services Preclinical Support Services Expert toxicology solutions providing consultation, study design testing and site monitoring to ensure a seamless transition of projects through IND-enabling studies and into

More information

Fexinidazole a new oral treatment for sleeping sickness update of development

Fexinidazole a new oral treatment for sleeping sickness update of development Fexinidazole a new oral treatment for sleeping sickness update of development SMe O 2 Me CH 2 O Antoine TARRAL Olaf Valverde Séverine Blesson Clélia Bardonneau Wilfried Mutumbo September 2011 Fexinidazole

More information

EVT Execute & EVT Innovate World-class drug discovery

EVT Execute & EVT Innovate World-class drug discovery EVT Execute & EVT Innovate World-class drug discovery Evotec AG, First Quarter Report 2015, 12 May 2015 Forward-looking statements Information set forth in this presentation contains forward-looking statements,

More information

QSAR. The following lecture has drawn many examples from the online lectures by H. Kubinyi

QSAR. The following lecture has drawn many examples from the online lectures by H. Kubinyi QSAR The following lecture has drawn many examples from the online lectures by H. Kubinyi LMU Institut für Informatik, LFE Bioinformatik, Cheminformatics, Structure independent methods J. Apostolakis 1

More information

Proof-of-Concept Studies and the End of Phase IIa Meeting with the FDA

Proof-of-Concept Studies and the End of Phase IIa Meeting with the FDA Medpace Discovery Series presents Proof-of-Concept Studies and the End of Phase IIa Meeting with the FDA DR. JIM WEI: Today my topic is going to be Proof-of-Concept Studies and FDA End of Phase 2a Meetings

More information

Nursing 113. Pharmacology Principles

Nursing 113. Pharmacology Principles Nursing 113 Pharmacology Principles 1. The study of how drugs enter the body, reach the site of action, and are removed from the body is called a. pharmacotherapeutics b. pharmacology c. pharmacodynamics

More information

Quality by Design Concept

Quality by Design Concept 3rd Jerusalem Conference on Quality and Pharma Sciences 6-7 June, 2012 QbD in Clinical Research - Where Can QbD Impact Clinical Research Practices? Dr. Yafit Stark Vice President, TEVA Pharmaceutical Industries,

More information

Introduction to pharmaceutical technology

Introduction to pharmaceutical technology Introduction to pharmaceutical technology Marie Wahlgren Chapter 1 What is the topics of today Introduction to the course Introduction to the project assignment How to choose a new drug formulation 1 Contacts

More information

Can India be the Leader in Global Generics. Rtn. J. Jayaseelan.,B.Pharm., M.B.A., Managing Director

Can India be the Leader in Global Generics. Rtn. J. Jayaseelan.,B.Pharm., M.B.A., Managing Director Can India be the Leader in Global Generics Rtn. J. Jayaseelan.,B.Pharm., M.B.A., Managing Director Indian Pharma Industry Before 1970 Depending on MNC from USA and Europe for supply of Medicines Hardly

More information

Diabetes and Drug Development

Diabetes and Drug Development Diabetes and Drug Development Metabolic Disfunction Leads to Multiple Diseases Hypertension ( blood pressure) Metabolic Syndrome (Syndrome X) LDL HDL Lipoproteins Triglycerides FFA Hyperinsulinemia Insulin

More information

PHARMACOKINETICS (PK) AND PHARMACODYNAMICS (PD) STUDY IN THE ESTABLISHED STATUS EPILEPTICUS TREATMENT TRIAL. Lisa Coles, MS, PhD

PHARMACOKINETICS (PK) AND PHARMACODYNAMICS (PD) STUDY IN THE ESTABLISHED STATUS EPILEPTICUS TREATMENT TRIAL. Lisa Coles, MS, PhD PHARMACOKINETICS (PK) AND PHARMACODYNAMICS (PD) STUDY IN THE ESTABLISHED STATUS EPILEPTICUS TREATMENT TRIAL Lisa Coles, MS, PhD Key Personnel Personnel Institution Role James Cloyd, PharmD UMN Pharmacology

More information

Importing pharmaceutical products to China

Importing pharmaceutical products to China Importing pharmaceutical products to China Imported pharmaceutical products need pre-market approval before entering the Chinese market Imported drugs for human use are required to obtain pre-market approval

More information

Clinical Research Workshop

Clinical Research Workshop Clinical Research Workshop Introduction In these activities, pupils learn about how new medicines are developed from the initial idea, through the science that turns them into treatments, to the clinical

More information

Drug Development Process

Drug Development Process Drug Development Process Original Arthur: Addie D. Anderson CRB Consulting Engineers, Inc. Overview Important milestones establishing our current system of regulations Step-by-step overview of the drug

More information

Is a Career in the. Pharmaceutical. Check out our online Student Center to find out more: www.aaps.org/forstudents

Is a Career in the. Pharmaceutical. Check out our online Student Center to find out more: www.aaps.org/forstudents Is a Career in the Pharmaceutical Sciences Right for Me? Check out our online Student Center to find out more: www.aaps.org/forstudents How Do I Know If a Career in the Pharmaceutical Sciences is Right

More information

Dr Alexander Henzing

Dr Alexander Henzing Horizon 2020 Health, Demographic Change & Wellbeing EU funding, research and collaboration opportunities for 2016/17 Innovate UK funding opportunities in omics, bridging health and life sciences Dr Alexander

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of the clinical

More information

OCT Practical Aspects of Conducting Clinical Trials for Russian Innovative Companies

OCT Practical Aspects of Conducting Clinical Trials for Russian Innovative Companies OCT Practical Aspects of Conducting Clinical Trials for Russian Innovative Companies Innovative Drug Research and Development in Russia 2012 OCT: CRO in Russia, Central and Eastern Europe Russian Innovative

More information

Building innovative drug discovery alliances. Profitable. Growth Go

Building innovative drug discovery alliances. Profitable. Growth Go Building innovative drug discovery alliances Innovation n & Profitable Growth Go Evotec AG, H1 Presentation, 8 th August 2012 Forward-looking statements Information set forth in this presentation contains

More information

PIRAMAL DISCOVERY SOLUTIONS

PIRAMAL DISCOVERY SOLUTIONS PIRAMAL DISCOVERY SOLUTIONS Pharma Solutions products and services Delivering Globally Integrated Solutions across the drug lifecycle We are the Contract Development & Manufacturing arm of Piramal Healthcare,

More information

MATHEMATICAL MODELS OF TUMOR GROWTH INHIBITION IN XENOGRAFT MICE AFTER ADMINISTRATION OF ANTICANCER AGENTS GIVEN IN COMBINATION

MATHEMATICAL MODELS OF TUMOR GROWTH INHIBITION IN XENOGRAFT MICE AFTER ADMINISTRATION OF ANTICANCER AGENTS GIVEN IN COMBINATION MATHEMATICAL MODELS OF TUMOR GROWTH INHIBITION IN XENOGRAFT MICE AFTER ADMINISTRATION OF ANTICANCER AGENTS GIVEN IN COMBINATION Nadia Terranova UNIVERSITÀ DI PAVIA New model development: course of action

More information

ICH M3 (R2) Guideline on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

ICH M3 (R2) Guideline on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals ICH M3 (R2) Guideline on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals International Conference on Harmonisation of Technical Requirements

More information

Exploring Metabolic Outcomes and Toxic Effects. DiscoveryGate SM Version 1.4 SP2 Workshop Guide

Exploring Metabolic Outcomes and Toxic Effects. DiscoveryGate SM Version 1.4 SP2 Workshop Guide Exploring Metabolic Outcomes and Toxic Effects DiscoveryGate SM Version 1.4 SP2 Workshop Guide Exploring Metabolic Outcomes and Toxic Effects DiscoveryGate Version 1.4 SP2 Workshop Guide Elsevier MDL

More information

Lead generation and lead optimisation:

Lead generation and lead optimisation: Lead generation and lead optimisation: the value of linking HT co-structure analysis and HT chemistry The coupling of High Throughput co-structure analysis with focused library generation is not only proving

More information

Creative Utilization of Existing Knowledge to Harness Innovation for the Neglected

Creative Utilization of Existing Knowledge to Harness Innovation for the Neglected Creative Utilization of Existing Knowledge to Harness Innovation for the Neglected Els Torreele, PhD Senior Project Manager Drugs for Neglected Diseases initiative Best Science for the Most Neglected Stakeholders

More information

Not All Clinical Trials Are Created Equal Understanding the Different Phases

Not All Clinical Trials Are Created Equal Understanding the Different Phases Not All Clinical Trials Are Created Equal Understanding the Different Phases This chapter will help you understand the differences between the various clinical trial phases and how these differences impact

More information

Gene Silencing Oligos (GSOs) Third Generation Antisense

Gene Silencing Oligos (GSOs) Third Generation Antisense Gene Silencing Oligos (GSOs) Third Generation Antisense Walter R. Strapps, Ph.D. Executive Director, RNA Therapeutics Idera Pharmaceuticals Cambridge, MA NASDAQ: IDRA www.iderapharma.com Idera is a leader

More information

Design and Synthesis of N-heterocyclic Building Blocks for Pharmaceutical R&D. Feb 2016

Design and Synthesis of N-heterocyclic Building Blocks for Pharmaceutical R&D. Feb 2016 Design and Synthesis of N-heterocyclic Building Blocks for Pharmaceutical R&D Feb 2016 Who we are Liverpool ChiroChem (LCC) supplies chiral building blocks for pharmaceutical R&D. LCC also develop synthetic

More information

EVT Execute & EVT Innovate Leading drug discovery

EVT Execute & EVT Innovate Leading drug discovery EVT Execute & EVT Innovate Leading drug discovery Evotec AG, Nine-month 2015 Interim Report, 10 November 2015 Forward-looking statements Information set forth in this presentation contains forward-looking

More information

Longitudinal Modeling of Lung Function in Respiratory Drug Development

Longitudinal Modeling of Lung Function in Respiratory Drug Development Longitudinal Modeling of Lung Function in Respiratory Drug Development Fredrik Öhrn, PhD Senior Clinical Pharmacometrician Quantitative Clinical Pharmacology AstraZeneca R&D Mölndal, Sweden Outline A brief

More information

Drug Excretion. Renal Drug Clearance. Drug Clearance and Half-Life. Glomerular Filtration II. Glomerular Filtration I. Drug Excretion and Clearance

Drug Excretion. Renal Drug Clearance. Drug Clearance and Half-Life. Glomerular Filtration II. Glomerular Filtration I. Drug Excretion and Clearance t/.drugexcretion AINTRAVENOUSDOSE 36848765430TIME(hours) t/ Drug Excretion Dr. Robert G. Lamb Professor Pharmacology & Toxicology Drug Excretion and Clearance Drug Excretion: is the movement of drug from

More information

New Advances in Cancer Treatments. March 2015

New Advances in Cancer Treatments. March 2015 New Advances in Cancer Treatments March 2015 Safe Harbour Statement This presentation document contains certain forward-looking statements and information (collectively, forward-looking statements ) within

More information

The Aptuit Center for Drug Discovery & Development Verona, Italy. Uncommon Expertise. Exceptional Results.

The Aptuit Center for Drug Discovery & Development Verona, Italy. Uncommon Expertise. Exceptional Results. The Aptuit Center for Drug Discovery & Development Verona, Italy Uncommon Expertise. Exceptional Results. 2 The Aptuit Center for Drug Discovery & Development Verona, Italy Aptuit in Verona: uncommon expertise,

More information

INVESTMENT IN DISRUPTIVE EXPONENTIAL TECHNOLOGIES

INVESTMENT IN DISRUPTIVE EXPONENTIAL TECHNOLOGIES INVESTMENT IN DISRUPTIVE EXPONENTIAL TECHNOLOGIES Deep Knowledge Ventures Deep Knowledge Ventures is a Hong Kong investment fund focusing on biotechnology, regenerative medicine, drug discovery, Artificial

More information

New Drug Application (NDA) Checklist

New Drug Application (NDA) Checklist New Drug Application (NDA) Checklist New Drug Applications (NDA) are very complex and detailed. It is difficult to know whether a company has included all of the information that is required by the applicable

More information

Quality and Safety Evaluation of Gene Therapy Products in Japan

Quality and Safety Evaluation of Gene Therapy Products in Japan Quality and Safety Evaluation of Gene Therapy Products in Japan Review Mechanism for Gene Therapy in Japan The review mechanism for gene therapy in Japan was partially amended to simplify the necessary

More information

Lead Optimization Latin America (LOLA)

Lead Optimization Latin America (LOLA) The Lead ptimization Latin America (LLA) consortium: collaborative drug discovery for eglected Tropical Diseases (TDs) Luiz Carlos Dias 1 ; Marco A. Dessoy 1, Brian lafer 1, Adriano Andricopulo 2, Dale

More information

Guidance on dose level selection for regulatory general toxicology studies for pharmaceuticals

Guidance on dose level selection for regulatory general toxicology studies for pharmaceuticals Guidance on dose level selection for regulatory general toxicology studies for pharmaceuticals The 3Rs: Replacement refers to methods that replace or avoid the use of animals in areas where animals would

More information

Current version dated 5 March 2012

Current version dated 5 March 2012 M3(R2) Implementation Working Group M3(R2) Guideline: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals Questions & Answers

More information

The Commercialization of Technology Concepts into Medical Products

The Commercialization of Technology Concepts into Medical Products The Commercialization of Technology Concepts into Medical Products Kevin J. Scanlon, Ph.D. New Zealand 2006 International BioScience Overview Pharmaceutical Industry Biotechnology Startups Investment Community

More information

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION

More information

CTD Dossier Preparation. Sr.Manager-Regulatory Affairs

CTD Dossier Preparation. Sr.Manager-Regulatory Affairs CTD Dossier Preparation K. Srikantha Reddy Sr.Manager-Regulatory Affairs Medreich Limited Srikanth.k@medreich.com CTD Dossier Preparation CTD (Common Technical Document) contains 5 modules Module 1 Module

More information

MSc program Pharmaceutical Design and Engineering. Peter Heegaard, Head of Studies DTU Veterinary

MSc program Pharmaceutical Design and Engineering. Peter Heegaard, Head of Studies DTU Veterinary MSc program Peter Heegaard, Head of Studies DTU Veterinary There is a need for Pharma graduates Pharma industry in its widest sense (see next slide) Research institutions (public and private) Consultants

More information

NONCLINICAL EVALUATION FOR ANTICANCER PHARMACEUTICALS

NONCLINICAL EVALUATION FOR ANTICANCER PHARMACEUTICALS INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE NONCLINICAL EVALUATION FOR ANTICANCER PHARMACEUTICALS

More information

Study (s) Degree Center Acad. Period. 1201 - Grado de Farmacia FACULTY OF PHARMACY 3 Annual 1211 - PDG Farmacia-Nutrición Humana y Dietética

Study (s) Degree Center Acad. Period. 1201 - Grado de Farmacia FACULTY OF PHARMACY 3 Annual 1211 - PDG Farmacia-Nutrición Humana y Dietética COURSE DATA Data Subject Código 34081 Name Biopharmacy and Pharmacokinetics Cycle Grade ECTS Credits 10.5 Curso académico 2014-2015 Study (s) Degree Center Acad. Period year 1201 - Grado de Farmacia FACULTY

More information

Guidance for Industry

Guidance for Industry Guidance for Industry S9 Nonclinical Evaluation for Anticancer Pharmaceuticals U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs General Considerations DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments

More information

Lessons for the United States: Biosimilar Market Development Worldwide

Lessons for the United States: Biosimilar Market Development Worldwide Lessons for the United States: Biosimilar Market Development Worldwide Sumant Ramachandra, MD, PhD, MBA Senior Vice President, Chief Scientific Officer Hospira $67B+ of 2012 LMV is expected to face biosimilar

More information

STRUCTURE-GUIDED, FRAGMENT-BASED LEAD GENERATION FOR ONCOLOGY TARGETS

STRUCTURE-GUIDED, FRAGMENT-BASED LEAD GENERATION FOR ONCOLOGY TARGETS STRUCTURE-GUIDED, FRAGMENT-BASED LEAD GENERATION FOR ONCOLOGY TARGETS Stephen K. Burley Structural GenomiX, Inc. 10505 Roselle Street, San Diego, CA 92121 sburley@stromix.com www.stromix.com Summary Structural

More information