IS BIOSIMILARS COMPETITIVE INTELLIGENCE DIFFERENT?
|
|
- Berenice Malone
- 6 years ago
- Views:
Transcription
1 IS BIOSIMILARS COMPETITIVE INTELLIGENCE DIFFERENT? Duncan Emerton Senior Director, Syndicated Insights & Analysis FirstView (a division of FirstWord Pharma) T: E: Pharma CI USA September 9-10, 2014 Hilton Parsippany Hotel, NJ
2 AGENDA INTRODUCTIONS KEY DYNAMICS AND MARKET SNAPSHOT... KEY CHALLENGES IN BIOSIMILARS CI CRITICAL SUCCESS FACTORS IN BIOSIMILARS CI... IS BIOSIMILARS CI DIFFERENT...? THANK YOUS AND Q&A... 2
3 AGENDA INTRODUCTIONS KEY DYNAMICS AND MARKET SNAPSHOT... KEY CHALLENGES IN BIOSIMILARS CI CRITICAL SUCCESS FACTORS IN BIOSIMILARS CI... IS BIOSIMILARS CI DIFFERENT...? THANK YOUS AND Q&A... 3
4 INTRODUCTIONS Copyright and Disclaimer Copyright 2014 Doctor s Guide Publishing Limited. All rights reserved. No part of this publication may be reproduced or used in any form or by any means graphic, electronic or mechanical, including photocopying, recording, taping or storage in information retrieval systems without the express permission of the publisher The content and views in this presentation are the views of the author and do not reflect the views of P/S/L Group s.a.r.l, FirstWord Pharma or FirstView. P/S/L Group s.a.r.l, First Word Pharma, FirstView and the author make no representations regarding the accuracy or completeness of the data presented or data used from referenced sources While the facts in this slide pack are believed to be correct at the time of publication, they cannot guaranteed. The facts in this slide pack are also a summary of key events, and must not be considered an exhaustive analysis of the biosimilars market The author, P/S/L Group s.a.r.l, FirstWord Pharma and FirstView can accept no liability whatsoever for actions taken based on any information that may subsequently prove to be incorrect Sources: FirstView 4
5 INTRODUCTIONS What qualifies me to talk about CI in the biosimilars market? Extensive industry experience, focused on biosimilars since 2006 (the year the first biosimilar was approved) Previous roles include R&D, sales, marketing, medical affairs, business analysis and strategic consulting Spent 9 years at Datamonitor, final role was Director and Biosimilars Practice Lead within the healthcare consulting team Primarily focused on supporting CI, BD&L and brand strategy functions; have worked with originators and biosimilar developers (but never at the same time) Published/quoted on the subject of biosimilars, regular presenter and Chair at biosimilar conferences Editor-in-Chief, The Biosimilarz Blog! ( Sources: FirstView 5
6 INTRODUCTIONS Sources of data and insight (1) Semi-structured interviews (approximately 30 mins) with three (3) competitive intelligence professionals focused purely on biosimilars Combined CI experience of over 30 years, currently working for an originator (n=1; EU based, global role) and biosimilar developer (n=2; both EU based, primarily focused on Europe and emerging markets) Key areas of focus during discussions included perceived differences between biosimilars CI and other forms of CI (e.g. branded, novel product, generics), key challenges and critical success factors Sources: FirstView 6
7 INTRODUCTIONS Sources of data and insight (2) Biosimilar Index: Tracking the Biosimilar Development Landscape The Future of Biosimilars: Mapping Critical Uncertainties and the Impact of Future Events Biosimilars in Emerging Markets: Expert Insights and Critical Success Factors for Future Success Sources: FirstView 7
8 AGENDA INTRODUCTIONS KEY DYNAMICS AND MARKET SNAPSHOT... KEY CHALLENGES IN BIOSIMILARS CI CRITICAL SUCCESS FACTORS IN BIOSIMILARS CI... IS BIOSIMILARS CI DIFFERENT...? THANK YOUS AND Q&A... 8
9 A (VERY) QUICK REVIEW OF WHAT S BEEN HAPPENING Key events, key questions Clinical Regulatory Commercial Legal Other ~40 key biosimilar clinical trials initiated since the beginning of 2013 (e.g. mabs, insulin, fusion proteins) in multiple indications and multiple countries How and where are we/they sourcing the reference product? What study design are we/they using; endpoints, patients, dosing, indications? What regulatory guidelines are being used? Local requirements? Which products should we be following? (Direct and Indirect competition) Data presentations at key therapy area conferences (e.g. ASCO, ACR, EULAR, ASD) How biosimilar are these products compared to our brand and/or biosimilar? What impact could this data have on our clinical and regulatory strategy? How likely is extrapolation to other indications based on this data? Too early? Sources: FirstView s Biosimilar Index (September 2014) 9
10 A (VERY) QUICK REVIEW OF WHAT S BEEN HAPPENING Key events, key questions Clinical Regulatory Commercial Legal Other New guidelines are emerging, old guidelines and being updated and controversies continue to appear How will new guidelines impact my current and future development strategy? (FDA) What regulatory changes can we expect in emerging markets? (BRICMAT) Which guidelines with EMA update next, and will this affect me? When can we expect interchangeability guidance, what will it include? (FDA) Submissions and approvals; multiple countries, multiple products, multiple indications maybe? What analogues can I use for submission/review timelines? (US vs. EU vs. JP vs. RoW) Which biosimilar programmes against my company s product will submit next? What s the expected impact of national position statements on biosimilar use? (Italy/UK) How will differing approaches to extrapolation influence other agencies? (Canada) Sources: FirstView s Biosimilar Index (September 2014) 10
11 A (VERY) QUICK REVIEW OF WHAT S BEEN HAPPENING Key events, key questions Clinical Regulatory Commercial Legal Other Over 60 new biosimilar focused deals and alliances have been forged since the start of What do these deals and alliances mean? How much of an impact will deals in emerging markets affect global strategy? Do I only need to focus on the ones involving Big Biopharma, or everything? What do the affiliates think? Market value remains a hotly debated topic, with the value of the market forecast to reach between $4-$200 billion by 2020! What analogues and proxies can we use to assess up take and impact? Does the evolution of the generics market provide any meaningful guidance? What advice can I provide my PR&MA colleagues? What can they tell me? Which market scenario should we adopt as a our base case? Sources: FirstView s Biosimilar Index (September 2014); (1) The Biosimilarz Blog (here) 11
12 A (VERY) QUICK REVIEW OF WHAT S BEEN HAPPENING Key events, key questions Clinical Regulatory Commercial Legal Other Challenges to IP begin to gain importance How robust is our IP strategy for our branded biologic? Is there any way that we can extend our IP position? Do we need to? What tactics can we use to challenge the IP of the product we are targeting? What about device patents? How do we defend/attack these? Do we need to focus on IP when it comes to brand defense? How can we use regulations and claims of biosimilarity in each of the markets to defend our market share? (Roche) Sources: FirstView s Biosimilar Index (September 2014) 12
13 A (VERY) QUICK REVIEW OF WHAT S BEEN HAPPENING Key events, key questions Clinical Regulatory Commercial Legal Other Policy changes at the national and state level What could be the impact of France s stance on automatic substitution? How will each state handle substitution laws in the US? (Lobbying) Will different INNs make any difference to the market s evolution? (US, WHO) Stakeholder awareness and understanding of biosimilars back in the spotlight Do key stakeholders know enough about biosimilars? What efforts must we exert to improve knowledge and understanding? What does our educational strategy need to include? Sources: FirstView s Biosimilar Index (September 2014) 13
14 THE CURRENT STATUS OF THE MARKET Which molecules, companies, markets and diseases? Class Molecule Indications Companies Countries mabs the dominant class (excludes fusion proteins) due to the perceived commercial opportunities Filgrastim and EPO-alfa the most common target, with rituximab the most popular mab target for biosimilar developers Cancer, rheumatology and diabetes are the dominant therapy areas for biosimilar developers Mix of companies is diverse, including many big players! Sources: FirstView s Biosimilar Index (September 2014) 14
15 THE CURRENT STATUS OF THE MARKET Which molecules, companies, markets and diseases? Class Molecule Indications Companies Countries mabs the dominant class (excludes fusion proteins) due to the perceived commercial opportunities Filgrastim and EPO-alfa the most common target, with rituximab the most popular mab target for biosimilar developers Cancer, rheumatology and diabetes are the dominant therapy areas for biosimilar developers Mix of companies is diverse, including many big players! Sources: FirstView s Biosimilar Index (September 2014) 15
16 THE CURRENT STATUS OF THE MARKET Which molecules, companies, markets and diseases? Class Molecule Indications Companies Countries mabs the dominant class (excludes fusion proteins) due to the perceived commercial opportunities Filgrastim and EPO-alfa the most common target, with rituximab the most popular mab target for biosimilar developers Cancer, rheumatology and diabetes are the dominant therapy areas for biosimilar developers Mix of companies is diverse, including many big players! Sources: FirstView s Biosimilar Index (September 2014) 16
17 THE CURRENT STATUS OF THE MARKET Which molecules, companies, markets and diseases? Class Molecule Indications Companies Countries mabs the dominant class (excludes fusion proteins) due to the perceived commercial opportunities Filgrastim and EPO-alfa the most common target, with rituximab the most popular mab target for biosimilar developers Cancer, rheumatology and diabetes are the dominant therapy areas for biosimilar developers Mix of companies is diverse, including many big players! Sources: FirstView s Biosimilar Index (September 2014) 17
18 THE CURRENT STATUS OF THE MARKET Which molecules, companies, markets and diseases? Class Molecule Indications Companies Countries Sources: FirstView s Biosimilar Index (September 2014) 18
19 KEY TAKEAWAY Diversity, complexity, uncertainty Sources: FirstView s Future of Biosimilars (May 2014) 19
20 AGENDA INTRODUCTIONS KEY DYNAMICS AND MARKET SNAPSHOT... KEY CHALLENGES IN BIOSIMILARS CI CRITICAL SUCCESS FACTORS IN BIOSIMILARS CI... IS BIOSIMILARS CI DIFFERENT...? THANK YOUS AND Q&A... 20
21 CHALLENGES IN BIOSIMILARS CI Or how to keep multiple plates spinning at the same time Sources: FirstView 21
22 CHALLENGES IN BIOSIMILARS CI Key productivity pirates Information Forecasting Speed Markets Agony Aunt Uncertainty Sources: FirstView 22
23 AGENDA INTRODUCTIONS KEY DYNAMICS AND MARKET SNAPSHOT... KEY CHALLENGES IN BIOSIMILARS CI CRITICAL SUCCESS FACTORS IN BIOSIMILARS CI... IS BIOSIMILARS CI DIFFERENT...? THANK YOUS AND Q&A... 23
24 CRITICAL SUCCESS FACTORS What do the CI professionals think? INFORMATION & INSIGHT Work hard for your information; if you don t know, find out Focus on data and insight quality, especially in emerging markets Balance global vs. local insight it s not just about the 7MM PROCESSESS Make sure your reporting processes are robust and engaging, and seek feedback Do as much as you can to automate what you do, so you can focus on interpreting the meaning and implications Critical Success Factors RELATIONSHIPS Build an experienced support team, including internal and external people Strive for strong internal support and understanding of biosimilars CI Get to know your brand teams and your affiliates! PERSONAL Be able to say no when you don t have time, and give good reasons Be comfortable with uncertainty, and be able to instil this comfort others Sources: FirstView 24
25 AGENDA INTRODUCTIONS KEY DYNAMICS AND MARKET SNAPSHOT... KEY CHALLENGES IN BIOSIMILARS CI CRITICAL SUCCESS FACTORS IN BIOSIMILARS CI... IS BIOSIMILARS CI DIFFERENT...? THANK YOUS AND Q&A... 25
26 IS BIOSIMILARS CI DIFFERENT? In my opinion, biosimilars competitive intelligence is unique. There is a need to understand multiple issues, from manufacturing, clinical trials, IP, regulatory issues, device technology, to name a few. You also need to be knowledgeable on several therapy areas. Compared to innovative product CI, the competitive landscape is deeper, wider and broader YES 26
27 AGENDA INTRODUCTIONS KEY DYNAMICS AND MARKET SNAPSHOT... KEY CHALLENGES IN BIOSIMILARS CI CRITICAL SUCCESS FACTORS IN BIOSIMILARS CI... IS BIOSIMILARS CI DIFFERENT...? THANK YOUS AND Q&A... 27
28 QUESTIONS, COMMENTS,
The Advent of Subsequent Entry Biologics: Biosimilars Canada. The Advent of Subsequent Entry Biologics. Biosimilars in Canada
The Advent of Subsequent Entry Biologics: Biosimilars Canada The Advent of Subsequent Entry Biologics Biosimilars in Canada Spring 2014 Author: Patrick J. Mott, MSc. Editors Allison Hillier BA, MA Heather
More informationFebruary Effective Pharma KAM Teams: Challenges and solutions from the front line (2016) A FirstWord ExpertViews Dossier Report
AM PL E PA G ES S A G ES S the front line (2016) A FirstWord ExpertViews Dossier Report the front line (2016) Published Copyright 2016 Doctor s Guide Publishing Limited All rights reserved. No part of
More informationApril New KOL Engagement: Building Relationships with the Digital KOL Generation ES SAMPLE PAGES SA. A FirstWord ExpertViews Dossier Report
A FirstWord ExpertViews Dossier Report Published Copyright 2016 Doctor s Guide Publishing Limited All rights reserved. No part of this publication may be reproduced or used in any form or by any means
More informationMay Patient Reported Outcomes: Strategies for gaining or expanding market access ES SAMPLE PAGES SA. A FirstWord ExpertViews Dossier Report
A FirstWord ExpertViews Dossier Report Published Copyright 2016 Doctor s Guide Publishing Limited All rights reserved. No part of this publication may be reproduced or used in any form or by any means
More informationBuild a deeper appreciation and understanding of HTA needs into your wider organization. Stefan Holmstrom
Build a deeper appreciation and understanding of HTA needs into your wider organization Stefan Holmstrom Executive Director HEOR Medical Affairs, Global Astellas Pharma 1 Outline of presentation 1. Changing
More informationBIOSIMILARS OF PROTEIN BASED DRUGS: CURRENT STATUS AND FUTURE DIRECTIONS
BIOSIMILARS OF PROTEIN BASED DRUGS: CURRENT STATUS AND FUTURE DIRECTIONS George Dranitsaris B.Pharm. PhD Consultant in Health Economics and Biostatistics What is a Biosimilar? Protein based drugs are made
More informationBiosimilar medicines rising to the cost challenge
Chapter 3 Biosimilar medicines rising to the cost challenge Addressing the rising cost of biological medicines has become a priority for governments and healthcare systems around the globe. Biosimilar
More informationLabelling & Naming. European Biosimilars Group (EBG) perspective. >400 Million patient days worldwide clinical experience with EU biosimilar medicines
Labelling & Naming European Biosimilars Group (EBG) perspective >400 Million patient days worldwide clinical experience with EU biosimilar medicines Elke Grooten, Director Public Affairs Sandoz Europe
More informationBiosimilar medicines rising to the cost challenge
Chapter 3 Biosimilar medicines rising to the cost challenge Addressing the rising cost of biological medicines has become a priority for governments and healthcare systems around the globe. Biosimilar
More informationInnovations in Drug Pricing and Reimbursement:
ADVISORY REPORT AM PL E PA G ES S A S G ES A FirstWord Dossier Advisory report and Reimbursement Published Copyright 2016 Doctor s Guide Publishing Limited Part of the FirstWord Dossier family of reports
More informationThe Potential For Litigation In New Era Of Biosimilars
The Potential For Litigation In New Era Of Biosimilars By Christian Frois, Richard Mortimer and Alan White; Analysis Group, Inc. Law360, New York (September 20, 2016, 4:06 PM EDT) Christian Frois Richard
More informationHospira at a 5/20/2015. The World s Leading Provider of Injectable Drugs and Infusion Technologies
Sumant Ramachandra, MD, PhD SVP and Chief Scientific Officer Alliance for Health Reform May 20 th, 2015 Hospira at a glance The World s Leading Provider of Injectable Drugs and Infusion Technologies Market
More informationProfessor Andrea Laslop, MD, Austria
GaBI Scientific Meetings ROUNDTABLE ON BIOSIMILARS with participation by European Regulators and Medical Societies 12 January 2016, Sheraton Brussels Airport Hotel, Belgium Professor Andrea Laslop, MD,
More informationBuilding a Career in the Pharmaceutical Industry: Personal Reflections. Carlo Nalin, PhD Executive Director Novartis Oncology
Building a Career in the Pharmaceutical Industry: Personal Reflections Carlo Nalin, PhD Executive Director Novartis Oncology 2 Career Development: Personal Reflections C Nalin 5 April 2016 Cornell BEST
More informationThe EU Market Environment for Biosimilar Medicines
1 The EU Market Environment for Biosimilar Medicines 12 th Annual IGPA Conference Sep 30-Oct 2, 2009 Montreal Suzette Kox Senior Director Scientific Affairs European Generic medicines Association 2 Outlines
More informationInterchangeability: What is Next? Analysis of the concept & of the FDA Draft Guidance
Interchangeability: What is Next? Analysis of the concept & of the FDA Draft Guidance Hillel Cohen, Executive Director of Scientific Affairs Leading on Biosimilars: The 2017 AAM Biosimilars Council Conference
More informationThe Future of Market Access A FirstWord ExpertViews Dossier Report
AM PL E PA G ES S A G ES S A FirstWord ExpertViews Dossier Report Published Copyright 2016 Doctor s Guide Publishing Limited All rights reserved. No part of this publication may be reproduced or used in
More informationBiosimilars contracting in the NHS. Maggie Dolan Regional Pharmacy Procurement Specialist South East Coast
Biosimilars contracting in the NHS Maggie Dolan Regional Pharmacy Procurement Specialist South East Coast Aim Introduction Managing the Medicine Budget in the NHS The Biosimilar Medicine Challenges Questions
More informationMapping the Patient Journey: Harnessing the power of big data and analytics A FirstWord ExpertViews Dossier Report
AM PL E PA G ES S A S G ES data and analytics A FirstWord ExpertViews Dossier Report Published Copyright 2016 Doctor s Guide Publishing Limited All rights reserved. No part of this publication may be reproduced
More informationApril Customer Experience (CX) in Physician and HCP Engagement: Meeting Expectations at Every Level. A FirstWord ExpertViews Report
AM PL E PA G ES S A S G ES A FirstWord ExpertViews Report Published Copyright 2016 Doctor s Guide Publishing Limited All rights reserved. No part of this publication may be reproduced or used in any form
More informationTHE BIOSIMILARS LANDSCAPE: STRATEGIES FOR CLINICAL AND COMMERCIAL SUCCESS
THE BIOSIMILARS LANDSCAPE: STRATEGIES FOR CLINICAL AND COMMERCIAL SUCCESS What all developers need to know Alicia Baker Director, Global Regulatory Affairs Strategy, Covance John Carlsen, MHA Vice President,
More informationASBM Biosimilars. Canada Prescribers and Biosimilars October, Kevin Olson, CEO Industry Standard Research
ASBM Biosimilars Canada Prescribers and Biosimilars October, 2017 Kevin Olson, CEO Industry Standard Research KevinO@ISRreports.com Table of contents Page 3 Methodology 5 Sample Characteristics 6 Executive
More informationAre Biosimilars the Panacea for High Cost Specialty Drugs?
Are Biosimilars the Panacea for High Cost Specialty Drugs? Mid-sized Retirement and Healthcare Plan Management San Francisco, CA March 27, 2018 2018. Innovative Rx Strategies, LLC. All rights reserved.
More informationHTAs and EMA working together: 23 parallel scientific advice procedures later - what have we learned?
HTAs and EMA working together: 23 parallel scientific advice procedures later - what have we learned? DIA 26th Annual EuroMeeting, Vienna 2014 Jan Regnstrom, MD, PhD Senior Scientific Officer An agency
More informationCORPORATE PRESENTATION January 2019
CORPORATE PRESENTATION January 2019 1 DISCLAIMER This presentation contains forward-looking statements about Outlook Therapeutics, Inc. ( Outlook Therapeutics or the Company ) based on management s current
More informationACG Public Forum. Join ACG, the FDA, and EMA for a discussion on biosimilars and IBD. Monday, 12:45 pm 2:15 pm
ACG Public Forum Join ACG, the FDA, and EMA for a discussion on biosimilars and IBD Monday, 12:45 pm 2:15 pm ACG 2017: FDA-EMA workshop on biosimilars Joachim Musaus EMA Product Lead Gastroenterology Human
More informationInterdisciplinary Perspectives on Development of Naming Standards for Biosimilar Medicines
Interdisciplinary Perspectives on Development of Naming Standards for Biosimilar Medicines Richard Dolinar, MD Chairman, Alliance for Safe Biologic Medicines Disclaimer The views and opinions expressed
More informationWebinar Series Physician Relations. Referral Development. Advancing the Physician Relations Program Structure
Webinar Series 2017 Physician Relations Referral Development Advancing the Physician Relations Program Structure Webinar Series 2017 Physician Relations Today s Agenda You will Learn: What are the right
More informationBiosimilar Medicines: Opportunities for Sustainable Healthcare. Opening Address Greg Perry Director General EGA London 3-4 May 2007
Biosimilar Medicines: Opportunities for Sustainable Healthcare Opening Address Greg Perry Director General EGA London 3-4 May 2007 Building on The Generic Medicines Legacy 1. Generic medicines account
More informationMedicines Agency EMA & Biosimilar update: Trends from marketing authorisation applications, scientific advice procedures and policies
EMA & Biosimilar update: Trends from marketing authorisation applications, scientific advice procedures and policies Presented by: Peter Richardson Head of Quality Office Specialised Scientific Disciplines
More informationThe Future has Arrived: Biosimilars
The Future has Arrived: Biosimilars Overview of the Regulatory Framework and FDA s Guidance for the Development and Approval of Biosimilar and Interchangeable Products in the US Sue Lim, M.D., Director
More informationLEVERAGING OUR BIOLOGICS EXPERTISE IN BIOSIMILARS SCOTT FORAKER VICE PRESIDENT AND GENERAL MANAGER, BIOSIMILARS
LEVERAGING OUR BIOLOGICS EXPERTISE IN BIOSIMILARS SCOTT FORAKER VICE PRESIDENT AND GENERAL MANAGER, BIOSIMILARS SAFE HARBOR STATEMENT This presentation contains forward-looking statements that are based
More informationThe Future has Arrived: Biosimilars
The Future has Arrived: Biosimilars Overview of the Regulatory Framework and FDA s Guidance for the Development and Approval of Biosimilar and Interchangeable Products in the US Sue Lim, M.D., Director
More informationRoche Position 1 on Similar Biotherapeutic Products Biosimilars
Roche Position 1 on Similar Biotherapeutic Products Biosimilars Similar Biotherapeutic Products Biosimilars Innovative biotherapeutic products (e.g.monoclonal antibodies) are losing market exclusivity,
More informationBiosimilars 2016 Balancing Fast Uptake with Industry Sustainability. Dan Ionescu Head of Pricing and Market Access Sandoz Biopharmaceuticals
Biosimilars 2016 Balancing Fast Uptake with Industry Sustainability Dan Ionescu Head of Pricing and Market Access Sandoz Biopharmaceuticals 10 years on, biosimilars have had a strong impact on global healthcare
More informationType of Activity. Universal Activity Number L04-P
Below are the pharmacy designated Universal Activity Numbers (UANs) and type of activity that is applicable for each of the following program offerings Session # Title 104 Impact of Biologics, Vaccines,
More informationBiosimilar regulation in Republic of Korea and Asia-Pacific Economic Cooperation (APEC) developments
Biosimilar regulation in Republic of Korea and Asia-Pacific Economic Cooperation (APEC) developments Ministry of Food and Drug Safety Jeewon Joung Outline I. Korean Regulatory Framework for Biosimilar
More informationPharmamarketing - strategic challenges
Pharmamarketing - strategic challenges Biomedicine Master Program Lund University Course: Biomedicine the Profession Anna Chérouvrier Hansson, MSc. December 16th, 2014 1. Pharmamarketing - definitions
More informationWorkshop on Access to and Uptake of Biosimilar Medicinal Products
EUROPEAN COMMISSION Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs Consumer, Environmental and Health Technologies Biotechnology and Food Supply Chain Workshop on Access to
More informationGlobal Biosimilar Development
Transforming Clinical Trials Global Biosimilar Development The PharmaVoice podcast that accompanies this whitepaper can be found at: pharmavoice.com/podcasts TERMINOLOGY Many terms have been used to describe
More informationNATIONAL SURVEY A Survey of Likely Voters October 2, 2014
NATIONAL SURVEY A Survey of Likely Voters October 2, 2014 Sample Size : 1,000 Gender Men 48% Women 52% 1. Starting out, are you registered to vote at your current address? Yes 100% 2. I know it s still
More informationREFERENCE CODE GDHC347DFR PUBLICAT ION DATE FEBRUARY 2014 SIMPONI (ULCERATIVE COLITIS) - FORECAST AND MARKET ANALYSIS TO 2022
REFERENCE CODE GDHC347DFR PUBLICAT ION DATE FEBRUARY 2014 SIMPONI (ULCERATIVE COLITIS) - Executive Summary Table below provides a summary of the key metrics for Simponi in the 10MM Ulcerative Colitis (UC)
More informationImportant Facts. Health Care Professionals Should Know About Biosimilars
Important Facts Health Care Professionals Should Know About Biosimilars Biosimilars: Defining Characteristics Biosimilars are highly similar versions of reference biologics, with no clinically meaningful
More informationLicense Agreement of Tildrakizumab for Psoriasis in Europe
License Agreement of Tildrakizumab for Psoriasis in Europe July 28 th 2016 Disclaimer This document has been prepared by Almirall, S.A. (the Company ) exclusively for use during the presentation. This
More informationFMCG Business Confidence Report H Reference code: CS4625PR Published: July 2015 Single user price: US$1950
FMCG Business Confidence Report H2 2015 Reference code: CS4625PR Published: July 2015 Single user price: US$1950 Summary FMCG Business Confidence Report H2 2015 is a new report by Canadean that globally
More informationBiosimilars Update 4/23/2015. The Biosimilar Roadmap From concept to delivery. Conflict of Interest Disclosure. Collaborate Cultivate Educate
Collaborate Cultivate Educate Biosimilars Update Conflict of Interest Disclosure We have no actual or potential conflict of interest in relation to this program and presentation. Brad Patten Patrick Leary
More informationImplications of the FDA Draft Guidance on Biosimilars for Clinicians: What We Know and Don t Know
368 Journal of the National Comprehensive Cancer Network Implications of the FDA Draft Guidance on Biosimilars for Clinicians: What We Know and Don t Know Edward Li, PharmD, BCOP, and James M. Hoffman,
More informationAn interview with. Bernard Vrijens. Chief Science Officer, MWV Healthcare. Transform to the power of digital
An interview with Bernard Vrijens Chief Science Officer, MWV Healthcare Transform to the power of digital Bernard Vrijens, PhD Chief Science Officer MWV Healthcare Introduction MeadWestvaco (MWV) is a
More informationMultiregional Regulatory Considerations in Pediatric Drug Development
Multiregional Regulatory Considerations in Pediatric Drug Development Lynne Yao, M.D. Director Division of Pediatric and Maternal Health Office of New Drugs Center for Drug Evaluation and Research U.S.
More informationDigital Pathology World Market Report 2017
Research Proposal Publishing October 2018 Market Reports Digital Pathology World Market Report 2017 2017 Edition This is a research proposal for a new Market Report on Digital Pathology, to be published
More informationREFERENCE CODE GDHC348DFR PUBLICAT ION DATE FEBRUARY 2014 APRISO (ULCERATIVE COLITIS) - FORECAST AND MARKET ANALYSIS TO 2022
REFERENCE CODE GDHC348DFR PUBLICAT ION DATE FEBRUARY 2014 APRISO (ULCERATIVE COLITIS) - Executive Summary Table below provides a summary of the key metrics for Apriso in the 10MM Ulcerative Colitis (UC)
More informationBEST PRACTICES IN BEST PRACTICES IN STUDY FEASIBILITY
BEST PRACTICES IN P R E V I E W O F BEST PRACTICES IN STUDY FEASIBILITY A U G U S T, 2 0 1 6 REPORT OVERVIEW One of the primary challenges to successfully completing a clinical study is estimating the
More informationJP Morgan Healthcare Conference January 9, 2012
JP Morgan Healthcare Conference January 9, 2012 SAFE HARBOR Certain statements in this presentation concerning our future growth prospects are forward-looking statements, which are subject to a number
More informationA Physician s consideration towards Biosimilars. João Eurico Fonseca
A Physician s consideration towards Biosimilars João Eurico Fonseca Disclosure I received unrestricted research grants or acted as a speaker for Abbvie, Amgen, BMS, Celtrion, Celgene, Janssen, MSD, Novartis,
More informationREFERENCE CODE GDHC354DFR PUBLICAT ION DATE FEBRUARY 2014 UCERIS (ULCERATIVE COLITIS) - FORECAST AND MARKET ANALYSIS TO 2022
REFERENCE CODE GDHC354DFR PUBLICAT ION DATE FEBRUARY 2014 UCERIS (ULCERATIVE COLITIS) - Executive Summary Table below provides a summary of the key metrics for Uceris in the 10MM Ulcerative Colitis (UC)
More informationGLOBAL DISPOSABLE MEDICAL DEVICES SENSORS MARKET
GLOBAL DISPOSABLE MEDICAL DEVICES SENSORS MARKET By Type [Biosensor, Image Sensor, Accelerometer] Monitoring [Smart Pill, Pulse Oximeter] Diagnostic [Capsule Endoscope, Blood Glucose Strip] Therapeutic
More informationPatent Analytics Research Report
SANGAMO THERAPEUTICS Patent Analytics Research Report May 2018 CRISPR IP assets Copy for IPStudies Corporate access Executive summary This research report specifically reviews the IP strategy and positioning
More informationThe importance of interchangeability in the procurement of medications: Biosimilar case
The importance of interchangeability in the procurement of medications: Biosimilar case ALIMS Congres, Kragujevac, November 6, 2015 Prof. Borut Štrukelj, PhD Brief CV Current position: professor, Pharmaceutical
More informationEvolving Trends in Biopharmaceutical Licensing Deal assessments, drivers and resistors
HEALTHCARE Evolving Trends in Biopharmaceutical Licensing Deal assessments, drivers and resistors By Melissa Zebrowski Table of Contents Melissa Zebrowski Melissa Zebrowski has seven years of experience
More informationMargins of pharmaceutical companies are continuing to decline the future lies in new ecosystems
Karin Mateu Media Relations Tel.: +41 (0) 58 286 44 09 karin.mateu@ch.ey.com Margins of pharmaceutical companies are continuing to decline the future lies in new ecosystems Glaxo is leading the way in
More informationFDA s Implementation of the Legal and Regulatory Framework for Biosimilars
FDA s Implementation of the Legal and Regulatory Framework for Biosimilars Sally Howard Deputy Commissioner for Policy, Planning, and Legislation 1 What are therapeutic biologics? Many biologics treat
More informationElective Course BTC 1860H. GAMBiT GENERATIONS OF ADVANCED MEDICINE: BIOLOGICS IN THERAPY. Leigh Revers. Winter/Spring Term 2016
MASTER OF BIOTECHNOLOGY PROGRAM Elective Course BTC 1860H GAMBiT GENERATIONS OF ADVANCED MEDICINE: BIOLOGICS IN THERAPY Leigh Revers Winter/Spring Term 2016 BTC 1860H: GAMBiT BTC 2010H Course Outline Prof.
More informationAndrew Schorr: Is there anything you ve been discussing that you d like to update people about now?
News from ASH: Advances in Bleeding Disorders ASH Conference Coverage December 8, 2008 Craig Kessler, M.D. Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors,
More informationBiosimilars Market Update
Biosimilars Market Update Panel: Matthew Brougham Consultant Economist, Brougham Consulting Inc Mark Jackson Consultant Pharmacist, TELUS Health Dr. Ed Keystone Professor of Medicine, University of Toronto
More informationFrom discussion to implementation: How to negotiate and implement a risk-sharing agreement
July 2017 From discussion to implementation: How to negotiate and implement a risk-sharing agreement At the table with payers and manufacturers Background The groundswell of interest in value-based drug
More informationBiosimilar Development Clinical Investigator Considerations
Biosimilar Development Clinical Investigator Considerations June 2011 www.ppdi.com Biosimilar products are not new in the pharmaceutical industry. However, the pending expiration of numerous therapeutic
More informationWhat next? Manufacture the biosimilar product
What next? Manufacture the biosimilar product Design manufacturing process to match QTPP Full quality dossier required. Use state of the art technologies In accordance with relevant ICH and CHMP guidelines
More informationWhite paper The Polish pharmaceutical market has undergone many changes as a result of the new Reimbursement Act
White paper The Polish pharmaceutical market has undergone many changes as a result of the new Reimbursement Act Published: July 2014 Author: Anantharaman Kavassery Viswanthan Anantharaman Kavassery Viswanathan
More informationFacebook Business Page Set Up Guide For Real Estate Agents
Facebook Business Page Set Up Guide For Real Estate Agents k n o w l e d g e a b l e a n d c r e A U T H O R : T O N I L A R S E N Legal / Disclaimer The Publisher has strived to be as accurate and complete
More informationBusiness plan
Business plan 2017-20 The text of this document (but not the logo and branding) may be reproduced free of charge in any format or medium, as long as it is reproduced accurately and not in a misleading
More informationThree steps to drive integrated care, faster. Start your transformation journey with the end in mind
Three steps to drive integrated care, faster Start your transformation journey with the end in mind Start your transformation journey with the end in mind The future of the NHS is always hotly debated,
More informationFREQUENTLY ASKED QUESTIONS
CLINICAL TRIALS FREQUENTLY ASKED QUESTIONS PARTICIPATING IN A CLINICAL TRIAL What is a clinical trial? Clinical trials are research studies that involve people. Through clinical trials, researchers find
More informationBuilding Strong Cross functional Medical Affairs Teams A FirstWord Dossier ExpertViews Report
Building Strong Cross functional A FirstWord Dossier ExpertViews Report Published Copyright 2015 Doctor s Guide Publishing Limited All rights reserved. No part of this publication may be reproduced or
More informationPrecision Medicine & Health Insurance Business Model Disruption? A Data& Evidence perspective
Precision Medicine & Health Insurance Business Model Disruption? A Data& Evidence perspective December 12 th, 2017 Dr. Tim Wintermantel Real World Insights Lead, Switzerland Copyright 2017 IQVIA. All rights
More informationEffective application of Risk Management techniques to Drug Safety: a pragmatic approach
Effective application of Risk Management techniques to Drug Safety: a pragmatic approach Dr Mark Perrott WCI Consulting ltd 19th October 2009 1 Disclaimer The views and opinions expressed in the following
More informationREFERENCE CODE GDME1082CFR PUBLICAT ION DATE JANUARY 2014 DIAGNOSTIC ULTRASOUND IMAGING - APAC ANALYSIS AND MARKET FORECASTS
REFERENCE CODE GDME1082CFR PUBLICAT ION DATE JANUARY 2014 DIAGNOSTIC ULTRASOUND IMAGING - Executive Summary Diagnostic Ultrasound Imaging Key Metrics: Key Events and Pipeline Assessment 2012 Market Sales
More informationForeign Affairs, Defence and Trade Select Committee Parliament Wellington. 24 March 2016
Foreign Affairs, Defence and Trade Select Committee Parliament Wellington 24 March 2016 Dear Committee Members, Our apologies for a delayed written submission (attached) on the International treaty examination
More informationHarmonizing clinical trials for Biogenerics. Dr. Akhilesh Sharma M.D.;C Clin. Research & P.V. (UCBC - USA & Luton - UK)
Harmonizing clinical trials for Biogenerics Dr. Akhilesh Sharma M.D.;C Clin. Research & P.V. (UCBC - USA & Luton - UK) Senior Vice President & Global Head Global Medical Affairs (C.M.O) Dr. Reddy's Laboratories
More informationOverview of Biologics (Including Biosimilars)
Overview of Biologics (Including Biosimilars) 2015 Sandoz Inc. All Rights Reserved. The material contained in this slide deck may not be altered or reproduced without express written consent from Sandoz
More informationDigging Deeper: Focus on Best Practices Medical Affairs Compliance
Digging Deeper: Focus on Best Practices Medical Affairs Compliance Dr Kelvin Tan MRCP (UK) Vice President Medical Affairs AP Erinn Hutchinson Partner, PricewaterhouseCoopers 1 Digging Deeper: Focus on
More informationCompetition in the off-patent biological market:
November 14th, 2018 ISPOR Europe, Barcelona Competition in the off-patent biological market: Policies for biosimilars in Europe Evelien Moorkens PhD researcher Market access biosimilars Promotors: prof.
More information33rd SQA Annual Meeting, National Harbor, MA, USA Session C // Presentation C 2 28 March 2017 // 1:30 3:00 PM // V1.0
Computerized Systems Using Artificial Intelligence (AI) Components in a Regulated Environment: Implications on and Challenges of Establishing a Validated State René Kasan NNIT Switzerland AG Zürich, Switzerland
More informationClinical Supply Packaging for Biological Products
Clinical Supply Packaging for Biological Products Part 2 of the Clinical Supply Knowledge Share Series: Understanding and Delivering your Global Clinical Supply Chain Almac Clinical Services Clinical Supply
More informationBenchmarking the Pharma Industry s HEOR Functions
EW PR EV I Benchmarking the Pharma Industry s HEOR Functions Info@ISRreports.com 2013 Industry Standard Research www.isrreports.com Report Overview This report provides pharmaceutical and biotech organizations
More informationSupporting Innovation through Scientific Advice
Supporting Innovation through Scientific Advice PEARRL Regulatory Science Symposium, 21 st June 2017, University College Cork HPRA Dr Peter Kiely Disclaimer All views expressed in this presentation are
More informationREFERENCE CODE GDHC342DFR PUBLICAT ION DATE FEBRUARY 2014 ENTYVIO (ULCERATIVE COLITIS) - FORECAST AND MARKET ANALYSIS TO 2022
REFERENCE CODE GDHC342DFR PUBLICAT ION DATE FEBRUARY 2014 ENTYVIO (ULCERATIVE COLITIS) - Executive Summary Table below provides a summary of the key metrics for Entyvio in the 8MM Ulcerative Colitis (UC)
More informationEU health policy. Strategy for the pharmaceutical industry and biosimilars. Salvatore D'Acunto. DG Research. DG Internal Market. DG Health & Consumers
Strategy for the pharmaceutical industry and biosimilars Salvatore D'Acunto European Commission Enterprise and Industry Directorate-General London, 3 April 2014 EU health policy DG Research R&D, innovation
More informationMedical Affairs for Modern Pharma New Challenges & Competencies
2-Day Course Medical Affairs for Modern Pharma New Challenges & Competencies Learn how medical affairs can enhance the commercial success of pharma brands with market insight generation, brand value definition,
More informationYour partner for successful biopharmaceutical development and approval
Your partner for successful biopharmaceutical development and approval About the Founders Experienced experts with unique agency and industry backgrounds Dr. Gabriele Dallmann + 25 years of experience
More informationBusiness Spotlight. Your monthly hotline to 500 UK decision makers.
Brochure Business Spotlight Welcome to Business Spotlight, the monthly telephone omnibus survey from IFF Research. Every month, we conduct 500 telephone interviews with a representative sample of senior
More informationMARKET ACCESS & PUBLIC AFFAIRS MANAGER BELUX
MARKET ACCESS & PUBLIC AFFAIRS MANAGER BELUX Sofie Paeps Valerie Van Sannen Senior Executive Search Consultant Executive Search Consultant 0032.478.93.15.11 0032.485.97.52.32 sofie.paeps@hronegroup.com
More informationRe: Therapeutic Goods Administration, Consultation: Nomenclature of Biological Medicines
September 7, 2017 Biological Science Section Therapeutic Goods Administration (TGA) PO Box 100 Woden ACT 2606 Re: Therapeutic Goods Administration, Consultation: Nomenclature of Biological Medicines Dear
More informationDoctor/pharma relationships: the latest research
Creating connections, improving healthcare Doctor/pharma relationships: the latest research medicine media metamorphosis The huge shift in knowledge sharing has affected how doctors interact with the healthcare
More informationform of testing is used and is
Universal Biosensors, Inc. ABN 51 121 559 993 1 Corporate Avenue Rowville Victoria 3178 Australia Telephone: +61 3 9213 9000 Facsimile: +61 3 9213 9099 Email: info@universalbiosensors.com www.universalbiosensors.com
More informationBiosimilar regulation from a clinical point of view
Biosimilar regulation from a clinical point of view an update on immunogenicity and interchangeability LIS-TNFBio seminar 2018 Scandic Nidelven Hotel Trondheim 20.-21. mars Senior Advisor Project leader
More informationDefining Strategic Metrics to Demonstrate Impact
The Value of Medical Affairs: Defining Strategic Metrics to Demonstrate Impact www.envisionpharmagroup.com The Value of Medical Affairs: Defining Strategic Metrics to Demonstrate Impact Objectives Establish
More informationGLOBAL DIAGNOSTIC ECG MARKET
GLOBAL DIAGNOSTIC ECG MARKET R e p o r t D e s c r i p t i o n T a b l e o f C o n t e n t s L i s t o f T a b l e s S a m p l e T a b l e s R e l a t e d R e p o r t s A b o u t M a r k e t s a n d M
More informationCancer Vanguard. Biosimilars Trust Policy Template
Cancer Vanguard Biosimilars Trust Policy Template Aim of this document: The document provides generic guidance and outline for the development of local trust policies in relation to the adoption of biosimilars
More informationBiosimilars 101: How similar are they?
Biosimilars 101: How similar are they? Matthew Marston, Pharm.D., BCPS, BCOP Senior Manager of Clinical Pharmacy Services Miller Drug, LLC Outline Describe the approval and manufacturing process of biologics
More informationFive years as EMA Liaison at US FDA
Five years as EMA Liaison at US FDA TOPRA Annual Human Medicines Symposium 2 4 October 2017 - Victoria Park Plaza Hotel, London Presented by Dr Sabine Haubenreisser on 2 October 2017 European Medicines
More information