Conducting Successful Oncology Clinical Trials in Asia Pacific: PharmaNet experience using Case Studies

Size: px
Start display at page:

Download "Conducting Successful Oncology Clinical Trials in Asia Pacific: PharmaNet experience using Case Studies"

Transcription

1 Conducting Successful Oncology Clinical Trials in Asia Pacific: PharmaNet experience using Case Studies Emily Tan Executive Director Asia Pacific PharmaNet

2 Conducting Successful Oncology Clinical Trials in Asia using Case Studies 1. Areas that impact quality of oncology study data in Asia Pacific 2. Phase III Sarcoma study in China 3. Phase III Hepatocellular carcinoma study in Korea, Taiwan, Hong Kong 4. Phase III Prostate cancer study in Singapore, Australia, Hong Kong 5. Phase III Breast cancer study in India 6. Expanded access program in Breast cancer in China, Korea, Taiwan, Australia, Singapore, Hong Kong, Malaysia, Indonesia 7. Phase III Multiple Myeloma study in Australia

3 Areas that Impact quality of oncology study data Efficacy CT scan scheduling RECIST Safety NCI CTC criteria for AE reporting Survival endpoints (PFS, DFS, OS) Informed consent process Investigator and patient motivation

4 Common Observations in Oncology studies in Asia Pacific NCI CTC criteria Inadequate source documentation of adverse event grading Study coordinators are sometimes inappropriately delegated responsibilities such as assessment and recording of CTC AE grade In some studies, CTC AE grades dictate dose adjustment schedules When improperly handled, will jeopardize patient safety

5 Common Observations in Oncology studies in Asia Pacific Informed consent issues Patients not aware of cancer diagnosis Patients unable to accept randomisation into standard of care or placebo arm Illiterate patients

6 Common hot topics for debate Compensation for SAEs Standard of care

7 Case Study 1: Phase III Sarcoma Study in China Global randomised phase III IND study In Metastatic Soft Tissue and Bone Sarcoma Pharmacologic class: mtor inhibitor Key Study Parameters: IND study involving 23 countries 165 sites in Americas, EU and Asia Pacific PharmaNet is responsible for China, which started later as back up country Start-up of the program required complexities of a phase III study EDC study Central Imaging Radiology vendor Centralized independent pathology review Study drug is distributed and stored in controlled temperature conditions (2~8 deg C) 8 sites in China enrolled target number of patients in one-third the planned recruitment period (25 patients in 2 months)

8 Case Study 1 Sarcoma: Timelines Global enrolment duration was 2 years China reached enrolment target in only 2 months. China enrolment started 1.5 years later than other countries, but was 5 th highest enrolling among 23 countries

9 Case Study 1 Sarcoma: Timelines SFDA approval: 23 Sep 09 1 st EC approval: 28 Sep 09 Last EC approval: 3 Nov 09 FPI: LPI: 25-Nov Jan-10 Page 9

10 Case study 1 Sarcoma: Success factors Good coordination and close follow up with GCP office and investigators to expedite EC submission and approval Site training prior to study start is critical to ensure rapid study start EDC training to obtain user account Training of all levels of site staff on protocol requirements at least twice Site staff screened patients in database to pre-identify suitable patients Coordinate logistics Procuring lab kits and setting up process for sending tissue samples to central pathology lab Ensuring that local central depot is properly set up and interfaces well with the randomization system Securing freezers for sites well before study start An experienced monitoring and project team is critical to support sites and trouble shoot

11 Case Study 2: Phase III Hepatocellular Carcinoma study Global Randomized, Double-blind, controlled Phase III study Pharmacologic class: Cytotoxic + Device Key Study Parameters: Enrolled over 120 patients across sites in Americas, Europe and Asia Start-up of the program required complexities of a phase III study Central Imaging Radiology vendor Study drug is distributed and stored in frozen condition (-20 deg C) Challenging patient enrolment Fairly rare patient population and high level of competition due to several recent drug approvals currently in the market Active area of clinical research with numerous ongoing research studies competing for available patients High screen failure rate due to strict inclusion criteria

12 Case study 2 HCC: Timelines AVERAGE APPROVALS / FPI TIMES Weeks Target EC submission date met for 83% of sites CA approval received within timelines of 4 to 8 weeks in 3 out of 4 countries (75%) EC approval received within 4 weeks in 50% of sites 0 Hong Kong Korea Taiwan Average EC review time Countries Average RA review time Average total review time Page 12

13 Case Study 2 HCC: Success Factors Anticipation of potential queries from EC and CA Project team and regulatory worked together to draft proposed responses to IRB and agency queries. This facilitates sponsor review and approval Support sites in patient recruitment activities Prepare physician referral and patient education materials Increasing awareness of study through organizing dinner meetings with targeted physician groups High level of effort for maintenance of investigator interest in continued participation Proactively planning for study set up Availability of protocol-required supportive care, comparators, and premedications Procure freezers in place prior to study start 13

14 Case Study 3: Global Prostate Cancer Study Global Multi-Center, Double-Blind, Randomized Phase III Study in Patients with Hormone Refractory Prostate Cancer with Bone Metastases Pharmacologic class: Targeted Radiopharmaceutical Key Study Parameters: 750 patients enrolled across 165 sites in 19 countries (Norway, Sweden, Australia, United States, Canada, Brazil, Germany, France, Netherlands, Poland, Spain, United Kingdom, Italy, Russia, Israel, Czech Republic, India, Hong Kong, Singapore) Medical challenges of study differences in pattern of chemotherapy administration based on region Reduced access to bisphosphonates in select countries Change in definitions of HRPC/CRPC Multiple and different logistical requirements in countries for the use of investigational product (ex: customs, licenses, transportation to sites)

15 Case study 3 Prostate cancer: Medical Considerations Medical monitors work closely with site to explain and communicate precise definition of patient population: HRPC, CRPC, PSA progression Access and reimbursement of specific medications especially if newer targeted treatments are prerequisite Rationale of difference in frequency of CT scans (standard of care vs. investigational requirements) should be carefully explained to ethics committees and regulatory agency Planning for differences in local standard of care for patients in each country bisphosphonate use pain management guidelines Limited access to bone scans in select countries

16 Case study 3 Prostate cancer: Operational Considerations Histology or cytology reports must be available Good communication at site among different departments (eg Oncology, Urology, Nuclear units) is essential for success of the study (start up and recruitment of patients) Local practice patterns and stage impacts whether patients are treated by urologists and/or oncologists Proactive management of and acceptance from complex intra-site logistics involving several departments and vendors: urology clinics, oncology department, radiology department, pathology department, biochemistry lab, and pharmacy Nominate a key point of contact on site, usually the study coordinator, to take the administrative lead pre and post surgery

17 Case Study 4: Global Study in Metastatic Breast cancer in India A Phase III Randomized, Controlled Trial of XXX, Trastuzumab and Paclitaxel versus Trastuzumab and Paclitaxel for First Line Therapy of Metastatic Breast Cancer Pharmacologic class: Cytotoxic Key Study Parameters: 364 patients enrolled across 81 sites in 11 countries (US, Latin America, Europe, Asia Pacific) Study challenges include Central Pathology lab for HER-2+ confirmation Central Imaging Laboratory used for primary efficacy analysis Local drug depots in selected countries managed by PharmaNet Trastuzumab administration schedule amended during course of study

18 Case study 4 Breast cancer: Medical Considerations Precise definition of patient population/ specific tumour characteristics is key to ensuring enrolment success Real time assessment of biomarkers/ Local molecular profiling eg FISH for HER2+ status may not be available in some sites and countries May require central reassessment of tumor receptor status Evolving standard of care and response criteria in long duration oncology trials Standard of care can change during a lengthy study, impacting trial enrollment, protocol compliance and possible need for protocol amendment One of the tumor types with the highest level of competition: Multiple clinical trials with different compounds and mechanisms of action Approval of new drug could compete with enrollment For previously treated patients, eligibility is often limited by availability of standard of care options.

19 Case study 4 Breast cancer: Operational Considerations In some countries, the sponsor is required to pay for comparator or co-administered drugs, significantly increasing the cost of development Complexity increases if sponsor has to procure and supply such drugs eg labelling and import permit requirements Local practice pattern of GCSF impacted site reimbursement requests Awareness of regional practices Eg febrile neutropenia requires hospitalization in India - potential impact on global evaluation of SAEs Long follow-up period Loss to follow-up in some regions due to referrals returning to their initial physicians Difficulty in obtaining survival data when enrollment is confined to tertiary care facilities Investigators lose motivation to cooperate actively

20 Case Study 5: Expanded access program in Metastatic Breast Cancer Global Program In Locally Advanced or Metastatic Breast Cancer in up To 50 Countries with a Kinase Inhibitor Pharmacologic class: Dual kinase inhibitor Key Study Parameters: More than 4,600 subjects enrolled globally at more than 450 sites in 50 countries (Americas, EU and Asia Pacific) Targeted investigators were those with major access to breast cancer patients To provide open label access to drug until local marketing approval was granted on a country by country basis. Protocol had complex and strict eligibility criteria and underwent 7 protocol amendments Full service outsourcing including management of vendors PharmaNet responsible for GMP oversight of drug vendor and global drug distribution with 12 drug depots Interaction with sponsor affiliates in most participating countries allows for flexibility while maintaining study integrity

21 Case study 5 EAP: Recruitment in Asia Pacific Page 21

22 Case study 5 EAP: Success Factors Nature of such studies require close planning between sponsor and CRO Managing increased drug supply needs, due to much greater enrolment. Carefully match clinical trial activity with regulatory and commercial plans eg marketing approval in some countries took longer than anticipated Good engagement with local sponsor affiliates in every country Site management Motivating sites when investigator fees are minimal. Ensuring protocol compliance with remote monitoring and biweekly phone contacts only Many sites in Asia Pacific are still very dependent on CRAs to perform many tasks that are site responsibilities Patients experienced increased survival due to early availability of drug Page 22

23 Case Study 6: Global study in Multiple Myeloma in Australia A Multicenter, Randomized, Parallel-group, Double-blind, Placebo-Controlled Study of XXXX in Previously Treated Subjects with Multiple Myeloma Pharmacologic class: immunomodulating agent Key Study Parameters: 1,100 patients enrolled across 200 sites (6 sites & 57 patients in Australia with one site the top recruiter ROW) Sites located in United States, Canada, United Kingdom, France, Germany, Switzerland, Sweden, Spain, Italy, Poland, Hungary, Belgium, Bulgaria, Ukraine, Russia, Greece, Australia, Enrollment period of 18 months Patient treatment period of 12 months Program consisted of 4 protocols PharmaNet provided full service outsourcing function

24 Case study 6 Multiple Myeloma: Lessons learned Challenges Logistics related to a program that was conducted in many countries across 4 protocols Lack of drug availability Keeping sites motivated throughout the study Slow initial enrollment Key Results and Lessons Learned Enrollment completed ahead of schedule Site by site drug distribution plan implemented due to lack of availability Geographical redistribution of sites resulted in increased enrollment Studies led to a change in the standard of care in Multiple Myeloma Page 24

25 How can we do better in Asia Pacific Training of site study team is key Understanding RECIST criteria, NCI CTC AE grading criteria, staging, and molecular footprint of the tumors Handling of safety data and concomitant medications Understanding constant flow of central reading for echocardiograms, CT scans, and other imaging modalities Creating a dialog with the investigator for opinions of the compound that could help sponsor to anticipate issues or questions from the site Training investigators on the Informed consent process

26 Thank you Acknowledgements Robin Hu, Associate Director, Clinical Research China Robyn Carrington, Manager Clinical Research Australia

Summary of Results for Laypersons

Summary of Results for Laypersons What was the Study Called? Summary of Results for Laypersons A Randomized, Double-blind, Parallel-group, Placebo- and Active-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability

More information

Sirtex Medical Limited (ASX:SRX)

Sirtex Medical Limited (ASX:SRX) Sirtex Medical Limited (ASX:SRX) Macquarie Australia Conference Mr Gilman Wong, CEO Dr David Cade, CMO Sydney, 8 th May 2014 SIR-Spheres is a registered trademark of Sirtex SIR-Spheres Pty Ltd 1 Understanding

More information

For personal use only

For personal use only Sirtex Medical Limited (ASX:SRX) Macquarie Inaugural Annual Emerging Healthcare Conference Mr Gilman Wong, CEO Mr Darren Smith, CFO Dr David Cade, CMO Wednesday, 10 October 2012 Macquarie Securities Group

More information

Design and Analysis of a Cancer Prevention Trial: Plans and Results. Matthew Somerville 09 November 2009

Design and Analysis of a Cancer Prevention Trial: Plans and Results. Matthew Somerville 09 November 2009 Design and Analysis of a Cancer Prevention Trial: Plans and Results Matthew Somerville 09 November 2009 Overview Objective: Review the planned analyses for a large prostate cancer prevention study and

More information

Ready for a CRO That Values Performance Over Promises? CHALLENGE. At Clinipace, it s personal.

Ready for a CRO That Values Performance Over Promises? CHALLENGE. At Clinipace, it s personal. Ready for a CRO That Values Performance Over Promises? CHALLENGE At Clinipace, it s personal. Who We Are At Clinipace, It s Personal. We Will PROVE IT. With us, you get the A team. We deliver a level of

More information

Primary Endpoint The primary endpoint is overall survival, measured as the time in weeks from randomization to date of death due to any cause.

Primary Endpoint The primary endpoint is overall survival, measured as the time in weeks from randomization to date of death due to any cause. CASE STUDY Randomized, Double-Blind, Phase III Trial of NES-822 plus AMO-1002 vs. AMO-1002 alone as first-line therapy in patients with advanced pancreatic cancer This is a multicenter, randomized Phase

More information

JOSEFIEN VENDRIK, QUALITY MANAGER IRENE JONGENELEN, COÖRDINATOR CLINICAL SUPPLIES MANAGEMENT/ SENIOR CLINICAL STUDY MANAGER

JOSEFIEN VENDRIK, QUALITY MANAGER IRENE JONGENELEN, COÖRDINATOR CLINICAL SUPPLIES MANAGEMENT/ SENIOR CLINICAL STUDY MANAGER Food for Thought JOSEFIEN VENDRIK, QUALITY MANAGER IRENE JONGENELEN, COÖRDINATOR CLINICAL SUPPLIES MANAGEMENT/ SENIOR CLINICAL STUDY MANAGER CLINOPS DAG, 12 APRIL 2018 HISTORY OF RESEARCH AND DEVELOPMENT

More information

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives:

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Bio-Rad Laboratories. Hemoglobin Testing. VARIANT II Hemoglobin Testing System For HbA 1c

Bio-Rad Laboratories. Hemoglobin Testing. VARIANT II Hemoglobin Testing System For HbA 1c Bio-Rad Laboratories Hemoglobin Testing VARIANT II Hemoglobin Testing System For HbA 1c Bio-Rad CDM System CDM 5.1 VII Instrument Patient Report V2_A1c_NU Patient Data Sample ID: AD Patient ID: Name: Physician:

More information

Global EHS Resource Center

Global EHS Resource Center Global EHS Resource Center Understand environmental and workplace safety requirements that affect your global operations. 800.372.1033 bna.com/gelw Global EHS Resource Center This comprehensive research

More information

Kenneth W. Mahaffey, MD and Keith AA Fox, MB ChB

Kenneth W. Mahaffey, MD and Keith AA Fox, MB ChB Once-daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation Kenneth W. Mahaffey, MD and Keith AA Fox, MB ChB on behalf

More information

Trial record 1 of 1 for: Previous Study Return to List Next Study

Trial record 1 of 1 for: Previous Study Return to List Next Study 1 von 6 14.01.2014 09:11 A service of the U.S. National Institutes of Health Trial record 1 of 1 for: 2012-001834-33 Previous Study Return to List Next Study Study of Cabozantinib (XL184) Versus Prednisone

More information

The first and only fully-automated, multiplexed solution for Measles, Mumps, Rubella and Varicella-zoster virus antibody testing

The first and only fully-automated, multiplexed solution for Measles, Mumps, Rubella and Varicella-zoster virus antibody testing Bio-Rad Laboratories BioPlex 2200 System BioPlex 2200 MMRV IgG Kit The first and only fully-automated, multiplexed solution for Measles, Mumps, Rubella and Varicella-zoster virus antibody testing Bio-Rad

More information

B I ABOUT BI DISEASE AREA & MECHANISM OF ACTION. For journalists outside UK/US/Canada only B A C K G R O U N D E R

B I ABOUT BI DISEASE AREA & MECHANISM OF ACTION. For journalists outside UK/US/Canada only B A C K G R O U N D E R For journalists outside UK/US/Canada only B I 1 4 8 2 6 9 4 1. About BI 1482694 2. Disease area & mechanism of action 3. Development status 4. Data overview 1. ABOUT BI 1482694 BI 1482694* (HM61713**)

More information

D7.1 Report summarising results of survey of EU countries to identify volumes and trends in relation to the import and export of stem cells

D7.1 Report summarising results of survey of EU countries to identify volumes and trends in relation to the import and export of stem cells Disclaimer: The content of this Deliverable represents the views of the author only and is his/her sole responsibility; it cannot be considered to reflect the views of the European Commission and/or the

More information

D7.1 Report summarising results of survey of EU countries to identify volumes and trends in relation to the import and export of stem cells

D7.1 Report summarising results of survey of EU countries to identify volumes and trends in relation to the import and export of stem cells Disclaimer: The content of this Deliverable represents the views of the author only and is his/her sole responsibility; it cannot be considered to reflect the views of the European Commission and/or the

More information

Terms and Conditions. VISA Global Customer Assistance Services

Terms and Conditions. VISA Global Customer Assistance Services Terms and Conditions VISA Global Customer Assistance Services Visa Global Customer Assistance Services (VGCAS) 1 The Visa Global Customer Assistance Services are co-ordinated by the Global Assistance Centre

More information

FEASIBILITY ASSESSMENT: CORNERSTONE OF SUCCESSFUL CLINICAL TRIAL PLANNING

FEASIBILITY ASSESSMENT: CORNERSTONE OF SUCCESSFUL CLINICAL TRIAL PLANNING FEASIBILITY ASSESSMENT: CORNERSTONE OF SUCCESSFUL CLINICAL TRIAL PLANNING VERONIKA FEKETE, MD MANAGER FEASIBILITY RESEARCH AND PATIENT RECRUITMENT SERVICES, PSI CRO 1 WHAT CAN GO WRONG WITH A CLINICAL

More information

Oncology Treatment Network Structure in Russia and its Impact on the Success of Oncology Clinical Studies

Oncology Treatment Network Structure in Russia and its Impact on the Success of Oncology Clinical Studies Oncology Treatment Network Structure in Russia and its Impact on the Success of Oncology Clinical Studies Julia Kondakov Director Business Development, Accell Clinical Research 2016 Case Study: Setting

More information

FOURIER STUDY GREYLOCK PRESS: CTS PRODUCT SAMPLE - FOURIER YES. Did the study achieve its main objective?

FOURIER STUDY GREYLOCK PRESS: CTS PRODUCT SAMPLE - FOURIER YES. Did the study achieve its main objective? FOURIER STUDY Did the study achieve its main objective? 2 15% 1 5% 9.8% YES FOURIER compared Repatha with placebo in patients who were taking a statin and had hardening or narrowing of the arteries and

More information

Bio-Rad Laboratories HEMOGLOBIN Testing Bio-Rad A1c. VARIANT II TURBO Link System. Fully-Automated HbA 1c Testing

Bio-Rad Laboratories HEMOGLOBIN Testing Bio-Rad A1c. VARIANT II TURBO Link System. Fully-Automated HbA 1c Testing Bio-Rad Laboratories HEMOGLOBIN Testing Bio-Rad A1c VARIANT II TURBO Link System Fully-Automated HbA 1c Testing Bio-Rad Laboratories HEMOGLOBIN Testing VARIANT II TURBO Link System Efficient streamlined

More information

PPD S EXPERT HEMATOLOGY AND ONCOLOGY TEAM

PPD S EXPERT HEMATOLOGY AND ONCOLOGY TEAM HEMATOLOGY ONCOLOGY PPD S EXPERT HEMATOLOGY AND ONCOLOGY TEAM COMMITTED TO ADVANCING DRUG DEVELOPMENT IN ONCOLOGY $ MARKETPLACE COMPLEXITIES increasingly competitive marketplace and rising cost pressures

More information

Bio-Rad Laboratories HEMOGLOBIN Testing Bio-Rad A1c. VARIANT II TURBO Link. Fully-Automated HbA 1c Testing

Bio-Rad Laboratories HEMOGLOBIN Testing Bio-Rad A1c. VARIANT II TURBO Link. Fully-Automated HbA 1c Testing Bio-Rad Laboratories HEMOGLOBIN Testing Bio-Rad A1c VARIANT II TURBO Link Fully-Automated HbA 1c Testing Bio-Rad Laboratories HEMOGLOBIN Testing VARIANT II TURBO Link Efficient streamlined process Powerful

More information

NobelProcera Implant Bar Overdenture complete range of fixed and removable solutions.

NobelProcera Implant Bar Overdenture complete range of fixed and removable solutions. NobelProcera Implant Bar Overdenture EXPERIENCE THE NEW WORLD OF CAD/CAM DENTISTRY 2 NobelProcera Implant Bar Overdenture NobelProcera Implant Bar Overdenture complete range of fixed and removable solutions.

More information

Pharmaceutical, Medical and Health-related Government and Regulatory bodies around the world.

Pharmaceutical, Medical and Health-related Government and Regulatory bodies around the world. 1 International International Conference on Harmonization (ICH) World Health Organization (WHO) 2 Argentina National Administration of Drugs, Food and medical Technology. Australia s Department of health

More information

NobelDesign 1.3 Installation guide

NobelDesign 1.3 Installation guide NobelDesign 1.3 Installation guide 2 NobelDesign 1.3 Installation guide // English Disclaimer of liability: This product is part of an overall concept and may only be used in conjunction with the associated

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 14 Dec 2018 00:34:23 GMT) CTRI Number Last Modified On 07/02/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

Men & Health Work. Difference can make a difference Steve Boorman & Ian Banks RSPH Academy 2013

Men & Health Work. Difference can make a difference Steve Boorman & Ian Banks RSPH Academy 2013 Men & Health Promotion @ Work Difference can make a difference Steve Boorman & Ian Banks RSPH Academy 2013 Difference can make a Difference Mens health: State of mens health Use of services Role of the

More information

Professional International Study Management

Professional International Study Management Professional International Study Management Services Phase I Study Consulting Phase II-IV IV Study Conduct for Drugs and Devices Protocol Design and Development Study Feasibilities Site Identification,

More information

EU Market Situation for Poultry. Committee for the Common Organisation of the Agricultural Markets 20 April 2017

EU Market Situation for Poultry. Committee for the Common Organisation of the Agricultural Markets 20 April 2017 EU Market Situation for Poultry Committee for the Common Organisation of the Agricultural Markets 2 April 217 -9.% -11.% -5.% -.1% -.7% -2.2% 3.% 1.7% 1.2%.8%.6%.%.%.% 7.9% 7.% 6.4% 6.2% 6.% 5.5% 5.3%

More information

BioPlex 2200 Infectious Disease Panels

BioPlex 2200 Infectious Disease Panels BioPlex 2200 System BioPlex 2200 Infectious Disease Panels An Expanding Multiplexed Assay Menu Lyme HIV Ag-Ab MMV IgM Syphilis Total & RPR MMRV EBV HSV-1 & HSV-2 EBV IgM ToRC IgM ToRC Leading the way with

More information

CYCLOTRONS WORLD MARKET REPORT & DIRECTORY EDITION TOC and Summary USED IN NUCLEAR MEDICINE MARKET DATA, COMPANIES PROFILES.

CYCLOTRONS WORLD MARKET REPORT & DIRECTORY EDITION TOC and Summary USED IN NUCLEAR MEDICINE MARKET DATA, COMPANIES PROFILES. CYCLOTRONS USED IN NUCLEAR MEDICINE WORLD MARKET REPORT & DIRECTORY MARKET DATA, COMPANIES PROFILES TOC and Summary EDITION 2015 A report written by Paul-Emmanuel Goethals & Richard Zimmermann Page 1/5

More information

EPIDEMIOLOGY. Accurate, in-depth information for understanding and assessing targeted markets

EPIDEMIOLOGY. Accurate, in-depth information for understanding and assessing targeted markets EPIDEMIOLOGY Accurate, in-depth information for understanding and assessing targeted markets WHY ACCURATE MARKET FORECASTS Start with accurate understanding Epidemiology is the study of disease patterns

More information

NobelProcera Implant Bar Overdenture EXPERIENCE THE NEW WORLD OF CAD/CAM DENTISTRY

NobelProcera Implant Bar Overdenture EXPERIENCE THE NEW WORLD OF CAD/CAM DENTISTRY NobelProcera Implant Bar Overdenture EXPERIENCE THE NEW WORLD OF CAD/CAM DENTISTRY 2 NobelProcera Implant Bar Overdenture NobelProcera Implant Bar Overdenture complete range of fixed and removable solutions.

More information

Regulatory Considerations in Oncology Trials in China. Jiang, Frank, MD, PhD VP, Asia Pacific R&D, Sanofi

Regulatory Considerations in Oncology Trials in China. Jiang, Frank, MD, PhD VP, Asia Pacific R&D, Sanofi Regulatory Considerations in Oncology Trials in China Jiang, Frank, MD, PhD VP, Asia Pacific R&D, Sanofi 1 Disclaimer The views and opinions provided are those of the speaker and do not reflect those of

More information

Proton Therapy Market Outlook - Global Analysis

Proton Therapy Market Outlook - Global Analysis Proton Therapy Market Outlook - Global Analysis Proton Therapy Market Outlook - Global Analysis BioPortfolio has been marketing business and market research reports from selected publishers for over fifteen

More information

Cardiac Assessment Controls A critical element of reliable cardiac testing

Cardiac Assessment Controls A critical element of reliable cardiac testing Cardiac Assessment Controls Cardiac Assessment Controls A critical element of reliable cardiac testing Choose the products best suited for your cardiac assessment needs Each year, 17.7 million people on

More information

Experience from an SME in initiating clinical trials

Experience from an SME in initiating clinical trials Experience from an SME in initiating clinical trials Tom Vanthienen Senior Director RA & QA May 28, 2010 AGENDA Introduction PregLem Clinical trials at PregLem Experience with Phase III trials Lessons

More information

Global review of the challenges in use of traditional medicine and WHO perspective

Global review of the challenges in use of traditional medicine and WHO perspective Global review of the challenges in use of traditional medicine and WHO perspective Dr Xiaorui Zhang Coordinator Traditional Medicine Department of Technical Cooperation for Essential Drugs and Traditional

More information

Cardiac Assessment Controls

Cardiac Assessment Controls Bio-Rad Laboratories CARDIAC ASSESSMENT CONTROLS Cardiac Assessment Controls Value Assigned for Clinical Laboratory and Point of Care Test Systems Solving the Challenges of Troponin I Testing for the Central

More information

Corporate Overview. May 2017 NASDAQ: CYTR

Corporate Overview. May 2017 NASDAQ: CYTR Corporate Overview May 2017 NASDAQ: CYTR CytRx Safe Harbor Statement THIS PRESENTATION CONTAINS FORWARD-LOOKING STATEMENTS THAT INVOLVE CERTAIN RISKS AND UNCERTAINTIES. ACTUAL RESULTS COULD DIFFER MATERIALLY

More information

LONDON CANCER NEW DRUGS GROUP RAPID REVIEW

LONDON CANCER NEW DRUGS GROUP RAPID REVIEW LONDON CANCER NEW DRUGS GROUP RAPID REVIEW Abiraterone for the treatment of metastatic castration-resistant prostate cancer that has progressed on or after a docetaxel-based chemotherapy regimen Disease

More information

Overall survival: 1 st line therapy

Overall survival: 1 st line therapy 1 3 Overall survival: 1 st line therapy 2-year OS phase III studies mm Prices per month of oncology medicin Bloomberg Business weekly 26 Feb 2015 Presented By Veena Shankaran at 2016 ASCO Annual Meeting

More information

European Experience and Perspective on Assessing Value for Oncology Products. Michael Drummond Centre for Health Economics, University of York

European Experience and Perspective on Assessing Value for Oncology Products. Michael Drummond Centre for Health Economics, University of York European Experience and Perspective on Assessing Value for Oncology Products Michael Drummond Centre for Health Economics, University of York Outline of Presentation The European landscape on access to

More information

Type 1 Diabetes Australian Research Impact Analysis

Type 1 Diabetes Australian Research Impact Analysis Type 1 Diabetes Australian Research Impact Analysis Executive Overview Summary Type 1 diabetes research in Australia Australia is making a significant contribution to the quantity and quality of the global

More information

Rare Cancers: The added value of closer cooperation

Rare Cancers: The added value of closer cooperation Rare Cancers: The added value of closer cooperation Denis Lacombe Director EORTC Headquarters Brussels, Belgium Plan About EORTC Some specifics to be highlighted Examples of different models Global European

More information

The health economic landscape of cancer in Europe

The health economic landscape of cancer in Europe 1 Approval number The health economic landscape of cancer in Europe Bengt Jönsson, Professor Emeritus of Health Economics Stockholm School of Economics 2 Disclaimer This presentation was developed by Professor

More information

AstraZeneca Hepatocellular Cancer Feasibility - Market Company Input

AstraZeneca Hepatocellular Cancer Feasibility - Market Company Input AstraZeneca Hepatocellular Cancer Feasibility - Market Company Input DrugDev is working with AstraZeneca to gather your feedback for allocation consideration for the upcoming A Phase III Randomized, Open-label,

More information

IMPLANTABLE MAGNETIC TRANSCUTANEOUS BONE CONDUCTION HEARING SYSTEM REIMBURSEMENT CODING GUIDE

IMPLANTABLE MAGNETIC TRANSCUTANEOUS BONE CONDUCTION HEARING SYSTEM REIMBURSEMENT CODING GUIDE IMPLANTABLE MAGNETIC TRANSCUTANEOUS BONE CONDUCTION HEARING SYSTEM REIMBURSEMENT CODING GUIDE This document provides general reimbursement information to assist in obtaining coverage and reimbursement

More information

TGX and TGX Stain-Free FastCast Acrylamide Kits

TGX and TGX Stain-Free FastCast Acrylamide Kits Electrophoresis TGX and TGX Stain-Free FastCast Acrylamide Kits The newest frontier for handcast gels It s Time to Expect More from Handcast Gels! FastCast kits provide unparalleled convenience and performance.

More information

Louisville '19 Attachment #69

Louisville '19 Attachment #69 Telephone Meeting Approved and why I propose Using zoom to fulfill both Phone and Virtual video meeting Formats. The first established phone meeting Sanctioned by Gamblers Anonymous (listed on Trustee

More information

Infectious Disease Testing. ULTRA Product Line. Safety is not a Matter of Chance

Infectious Disease Testing. ULTRA Product Line. Safety is not a Matter of Chance Infectious Disease Testing ULTRA Product Line Safety is not a Matter of Chance ULTRA Product Line The best answer for HBV, HCV and HIV screening: a global automated solution for safe results. Monolisa

More information

ESMO 2017, Madrid, Spain Dr. Loredana Vecchione Charite Comprehensive Cancer Center, Berlin HIGHLIGHTS ON CANCERS OF THE UPPER GI TRACT

ESMO 2017, Madrid, Spain Dr. Loredana Vecchione Charite Comprehensive Cancer Center, Berlin HIGHLIGHTS ON CANCERS OF THE UPPER GI TRACT ESMO 2017, Madrid, Spain Dr. Loredana Vecchione Charite Comprehensive Cancer Center, Berlin HIGHLIGHTS ON CANCERS OF THE UPPER GI TRACT DOCETAXEL, OXALIPLATIN AND FLUOROURACIL/LEUCOVORIN (FLOT) FOR RESECTABLE

More information

Edith A. Perez, Ahmad Awada, Joyce O Shaughnessy, Hope Rugo, Chris Twelves, Seock-Ah Im, Carol Zhao, Ute Hoch, Alison L. Hannah, Javier Cortes

Edith A. Perez, Ahmad Awada, Joyce O Shaughnessy, Hope Rugo, Chris Twelves, Seock-Ah Im, Carol Zhao, Ute Hoch, Alison L. Hannah, Javier Cortes BEACON: A Phase 3 Open-label, Randomized, Multicenter Study of Etirinotecan Pegol (EP) versus Treatment of Physician s Choice (TPC) in Patients With Locally Recurrent or Metastatic Breast Cancer Previously

More information

A Summary of Childhood Cancer Statistics in Australia,

A Summary of Childhood Cancer Statistics in Australia, What is the Australian Paediatric Cancer Registry (APCR)? The APCR is one of only a few national registries of childhood cancer in the world. It covers all Australian children aged 0-14 years old at diagnosis.

More information

GBG 93 - PADMA. EudraCT no.: Priv. Doz. Dr. Marc Thill, AGAPLESION MARKUS KRANKENHAUS, Frankfurt / Main

GBG 93 - PADMA. EudraCT no.: Priv. Doz. Dr. Marc Thill, AGAPLESION MARKUS KRANKENHAUS, Frankfurt / Main GBG 93 - PADMA A randomized, open-label, multi-center phase IV study evaluating palbociclib plus endocrine treatment versus a chemotherapy-based treatment strategy in patients with hormone receptor positive

More information

Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine [ID1059]

Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine [ID1059] Contains AIC Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine [ID1059] Multiple Technology Appraisal Background and Clinical Effectiveness Lead team: Femi Oyebode

More information

o Dental Implants Market By Material, Type, Structure Global Forecast To 2022 Report ID: MRDH Publishing Date: July, 2017

o Dental Implants Market By Material, Type, Structure Global Forecast To 2022 Report ID: MRDH Publishing Date: July, 2017 o Dental Implants Market By Material, Type, Structure Global Forecast To 2022 Report ID: MRDH-10401 Publishing Date: July, 2017 Sr. No. License Type Price 1 Single User License $4,175.00 2 Multiple User

More information

PhotoCure ASA. Presentation. Results 1 Quarter 2004

PhotoCure ASA. Presentation. Results 1 Quarter 2004 PhotoCure ASA Presentation Results 1 Quarter 2004 7 th of May 2004 Progress towards sustained profitability Continued product roll out Metvix European sales continue to grow Final US approval for Actinic

More information

Spectrum Pharmaceuticals

Spectrum Pharmaceuticals Spectrum Pharmaceuticals Joe Turgeon President and CEO June 2018 Investor Presentation 1 Safe Harbor Statement This presentation contains forward looking statements regarding future events and the future

More information

Immunohematology. IH-QC Modular System. Select. Combine. Control.

Immunohematology. IH-QC Modular System. Select. Combine. Control. Immunohematology IH-QC Modular System Select. Combine. Control. IH-QC Modular System Select. Combine. Control. Transfusion guidelines recommend regular checking of test materials, test methods, local working

More information

GLP in the European Union Ecolabel detergents, GLP and accreditation

GLP in the European Union Ecolabel detergents, GLP and accreditation GLP in the European Union Ecolabel detergents, GLP and accreditation Maik Schmahl Brussels, 25/03/2010 Chemicals Unit Outline What is GLP? How has it developed? The role of the Member States, the European

More information

What was the study about?

What was the study about? Dear Reader, Pharmaceutical companies (sponsors) plan and conduct clinical studies to test medicines. Afterwards, they write study reports. A study report describes how a study was done and what the results

More information

Enriched RWE study in the Nordics a case study

Enriched RWE study in the Nordics a case study Enriched RWE study in the Nordics a case study RWD conf. Helsinki, November 28, 2018 Susanne Kihlblom, MSc Pharm., Diplom.Clin.Trials Copyright 2017 IQVIA. All rights reserved. IQVIA 2017. All rights reserved.

More information

Main developments in past 24 hours

Main developments in past 24 hours ECDC DAILY UPDATE Pandemic (H1N1) 2009 Update 02 October 2009, 09:00 hours CEST Main developments in past 24 hours Weekly Influenza Surveillance Overview to be published today; Media highlights and Eurosurveillance

More information

BACKGROUND AND RATIONALE

BACKGROUND AND RATIONALE ULTRA RARE DISEASE EXAMPLE: SURVIVAL IN PATIENTS WITH NIEMANN PICK-C DISEASE Daniel Rosenberg, PhD Head of Epidemiology BACKGROUND AND RATIONALE Niemann Pick Type-C (NP-C) disease is an ultra rare condition

More information

World Connections Committee (WCC) Report

World Connections Committee (WCC) Report World Connections Committee (WCC) Report 06 Co-Dependents Anonymous Service Conference Countries Where CoDA Exists This report reflects the World Connections Committee (WCC) support of the growth and development

More information

Access to treatment and disease burden

Access to treatment and disease burden Access to treatment and disease burden Robert Flisiak Department of Infectious Diseases and Hepatology Medical University in Białystok, Poland Moulin de Vernègues, 27-29 August 2015 Disclosures Advisor

More information

Sperm donation Oocyte donation. Hong Kong þ Guideline þ þ Hungary þ þ þ þ Israel þ þ þ þ Italy þ þ þ. Germany þ þ þ þ Greece þ þ þ þ

Sperm donation Oocyte donation. Hong Kong þ Guideline þ þ Hungary þ þ þ þ Israel þ þ þ þ Italy þ þ þ. Germany þ þ þ þ Greece þ þ þ þ CHAPTER 8: Donation Although there has been a reduction in the use of donor sperm because of ICSI and the impact of the removal of anonymity in some countries (1), sperm donation is still used and has

More information

National Cancer Institute Clinical Trial Cooperative Groups

National Cancer Institute Clinical Trial Cooperative Groups National Cancer Institute Clinical Trial Cooperative Groups Perspectives from the National Surgical Adjuvant Breast and Bowel Project Joyce Mull, MPM Director, Regulatory Affairs NSABP Foundation, Inc.

More information

National Cancer Policy Forum Workshop on Multi-Center Phase 3 Clinical Trials and NCI Cooperative Groups

National Cancer Policy Forum Workshop on Multi-Center Phase 3 Clinical Trials and NCI Cooperative Groups National Cancer Policy Forum Workshop on Multi-Center Phase 3 Clinical Trials and NCI Cooperative Groups Session 3: Data Collection Standards to Establish Safety and Efficacy: How Much Data Is Enough?

More information

Global Trade in Lightweight Coated Writing Paper TradeData International Pty Ltd (www.tradedata.net) Page 1 5/18/2015

Global Trade in Lightweight Coated Writing Paper TradeData International Pty Ltd (www.tradedata.net) Page 1 5/18/2015 Page 1 5/18/2015 An Analysis of Global Trade in Lightweight paper, coated with inorganic substances, used for writing etc., of which more than 10% by weight of total fibre content consists of fibres obtained

More information

ORBE Summary of Benefits

ORBE Summary of Benefits www.wellaway.com ORBE Summary of Benefits www.wellaway.com Summary of Benefits Annual Limit 5,000,000 Coinsurance ORBE 90 ORBE 100 WellAway s share of costs on a covered service Your share of costs on

More information

ALIENOR GINECO-OV222/ENGOT-OV7

ALIENOR GINECO-OV222/ENGOT-OV7 GCIG RARE TUMOUR COMMITTEE Closed Trial status update ISABELLE RAY-COQUARD ALIENOR GINECO-OV222/ENGOT-OV7 Trial setting: Sex chord-stromal ovarian tumors Study Design: Randomized, open label, phase II

More information

Evolving Challenges in the Evaluation and Treatment of Lower Extremity PAD -- The Peripheral Academic Research Consortium (PARC)

Evolving Challenges in the Evaluation and Treatment of Lower Extremity PAD -- The Peripheral Academic Research Consortium (PARC) Evolving Challenges in the Evaluation and Treatment of Lower Extremity PAD -- The Peripheral Academic Research Consortium (PARC) W. Schuyler Jones, MD FACC Director, Adult Cardiac Catheterization Laboratory

More information

Procedure for Expedited Review of imported pre-qualified vaccines for use in national immunization programmes

Procedure for Expedited Review of imported pre-qualified vaccines for use in national immunization programmes Procedure for Expedited Review of imported pre-qualified vaccines for use in national immunization programmes Dr Nora Dellepiane/Dr Anil Kumar Chawla WHO/HQ-Geneva, Switzerland 1 Expedited review procedure

More information

Building Shareholder Value

Building Shareholder Value Building Shareholder Value June 4, 2014 Jefferies Healthcare Conference Tim Clackson, Ph.D. Hans Loland P r e s i d e n t o f R & D, C h i e f S c i e n t i f i c O f f i c e r with wife Cynthia A R I

More information

- Network for Excellence in Health Innovation

- Network for Excellence in Health Innovation Real-world evidence is evidence from any and all sources of data that may contribute to more effective health care, including health care best tailored to the needs of individual patients. - Network for

More information

PROTON THERAPY. Proton Therapy Edition 2016 WORLD MARKET REPORT & DIRECTORY EDITION

PROTON THERAPY. Proton Therapy Edition 2016 WORLD MARKET REPORT & DIRECTORY EDITION Proton Therapy Edition 2016 PROTON THERAPY WORLD MARKET REPORT & DIRECTORY EDITION 2016 A report written by Paul-Emmanuel Goethals & Richard Zimmermann Page 1/7 www.medraysintell.com Proton Therapy Edition

More information

Cell Therapy. Cytori Corporate Presentation January 2012

Cell Therapy. Cytori Corporate Presentation January 2012 Cytori Corporate Presentation January 2012 Safe Harbor This presentation may contain certain forward-looking statements. All statements, other than statements of historical fact, that address activities,

More information

The MOVE Trial Summary. Palovarotene FAQs. 1. What is the MOVE Trial?

The MOVE Trial Summary. Palovarotene FAQs. 1. What is the MOVE Trial? MOVE TRIAL FAQS Contents The MOVE Trial Summary... 1 1. What is the MOVE Trial?... 1 Palovarotene FAQs... 1 2. What is palovarotene?... 1 3. What is an Orphan designation?... 2 4. What is a Fast Track

More information

Health Care Providers:

Health Care Providers: Health Care Providers: 1. What is SERVE-HF? SERVE-HF is a multinational, multi-center, randomized controlled trial designed to assess whether treatment of predominantly Central Sleep Apnea with Adaptive

More information

THE FUTURE OF VACCINES ASCO ANNUAL MEETING JUNE 4, 2016

THE FUTURE OF VACCINES ASCO ANNUAL MEETING JUNE 4, 2016 THE FUTURE OF VACCINES ASCO ANNUAL MEETING JUNE 4, 2016 1 BAVARIAN NORDIC INVESTOR & ANALYST UPDATE & RECEPTION Welcome and Introduction to Bavarian Nordic s Cancer immunotherapy Programs Paul Chaplin,

More information

Meeting report, September 2005

Meeting report, September 2005 European Medicines Agency Post-authorisation Evaluation of Medicines for Human Use London, 24 October 2005 Doc. Ref. EMEA//322553/2005 COMMITTEE ON HERBAL MEDICINAL PRODUCTS () Meeting report, 19-20 September

More information

A GLOBAL LEADER IN PERSONALIZED NUTRITION

A GLOBAL LEADER IN PERSONALIZED NUTRITION A GLOBAL LEADER IN PERSONALIZED NUTRITION Forward Looking Statements Management will make forward-looking statements during this presentation. Actual results could differ from those projected in such forward-looking

More information

MARKET NEWS for pig meat

MARKET NEWS for pig meat MARKET NEWS for pig meat Market analysis 17 December 2018 Week 51 MARKET SITUATION Europe: Trading in legs and other cuts is at unchanged or slightly falling prices. UK: Prices are reported as stable.

More information

3.1 PHASE 2 OF THE GLOBAL PROJECT

3.1 PHASE 2 OF THE GLOBAL PROJECT RESULTS CHAPTER 3 3.1 PHASE 2 OF THE GLOBAL PROJECT (1996 1999) This new report of the Global Project provides data on anti-tuberculosis drug resistance from 58 geographical settings. Of these, 28 provided

More information

Summary of Results for Laypersons

Summary of Results for Laypersons What was the Study Called? Summary of Results for Laypersons A Multicenter, Four Arm, Randomized, Open Label Clinical Study Investigating Optimized Dosing in a Prograf -/Advagraf -Based Immunosuppressive

More information

More information at

More information at Report Information More information at https://www.htfmarketreport.com/reports/1288313 Global Homeopathic Products Market Professional Survey Report 2018 Report Code: HTF1288313 Pages: 111 Price: 1-User

More information

MARKET NEWS for pigmeat

MARKET NEWS for pigmeat MARKET NEWS for pigmeat Market analysis 12 February 2018 Week 7 MARKET SITUATION Europe: Trading in fresh legs is at increasing prices. With regard to other cuts, trading is at slightly increasing prices.

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. 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

Tobacco: World Markets and Trade

Tobacco: World Markets and Trade United States Department of Agriculture Foreign Agricultural Service Circular Series FT -09-05 Sep. 2005 List of Tables Tobacco: World Markets and Trade Table 2 U.S. Tobacco Trade: 2004-2005 Table 3 Unmanufactured

More information

Injection Techniques Questionnaire (ITQ) WorldWide Results Insulin Usage

Injection Techniques Questionnaire (ITQ) WorldWide Results Insulin Usage Injection Techniques Questionnaire (ITQ) WorldWide Results 2014-2015 Insulin Usage BACKGROUND Lipohypertrophy in Diabetes or How much does a lipo cost? Dr. Treichel, Magdeburg Studies * have shown that

More information

508 the number of suicide deaths in deaths per 100,000 people was the suicide rate in Suicide deaths in 2013 by gender

508 the number of suicide deaths in deaths per 100,000 people was the suicide rate in Suicide deaths in 2013 by gender An overview of suicide statistics This document summarises information about suicide deaths in New Zealand covering up to 13. It does not attempt to explain causes of suicidal behaviour or causes of changes

More information

Prostate Cancer Panel. June 2018

Prostate Cancer Panel. June 2018 Prostate Cancer Panel June 2018 Forward Looking Statements Certain of the statements made in this presentation are forward looking, such as those, among others, relating to future spending, future cash

More information

Genta Incorporated. A Multiproduct Late-Stage Oncology Company

Genta Incorporated. A Multiproduct Late-Stage Oncology Company Genta Incorporated A Multiproduct Late-Stage Oncology Company This presentation may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking

More information

WELLNESS COACHING. Wellness & Personal Fitness Solution Providers

WELLNESS COACHING. Wellness & Personal Fitness Solution Providers WELLNESS COACHING Wellness & Personal Fitness Solution Providers Introducing Ourselves... We are Personal Wellness Coaches 2 We help people look and feel better by: - Educating on proper nutrition (80%)

More information

Oncology Therapeutics without Compromise APRIL 2011

Oncology Therapeutics without Compromise APRIL 2011 Oncology Therapeutics without Compromise APRIL 2011 Forward Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties, including among other

More information

Promotion of Regulatory Cooperation Perspectives from the International Regulatory Cooperation for Herbal Medicines (IRCH)

Promotion of Regulatory Cooperation Perspectives from the International Regulatory Cooperation for Herbal Medicines (IRCH) Promotion of Regulatory Cooperation Perspectives from the International Regulatory Cooperation for Herbal Medicines (IRCH) Presentation to ICDRA Members 16 September 2008 YEE Shen Kuan Division Director

More information

Trial record 1 of 1 for: GO28341 Previous Study Return to List Next Study

Trial record 1 of 1 for: GO28341 Previous Study Return to List Next Study 1 von 5 11.12.2013 09:04 A service of the U.S. National Institutes of Health Trial record 1 of 1 for: GO28341 Previous Study Return to List Next Study A Study of GDC-0068 in Combination With Fluoropyrimidine

More information