+50% Market share for biosimilar G-CSF 2
|
|
- Brenda Tate
- 6 years ago
- Views:
Transcription
1 The Biosimilar Market Leader s Perspective Carol Lynch, Global Head of Sandoz Biopharmaceuticals April 28, years on, biosimilars have had a strong impact on global healthcare Product Approvals 20+ Products approved by the European Medicines Agency over 10 years 1 Market Acceptance +50% Market share for biosimilar G-CSF 2 Patient Experience +250m Patient days of safe clinical experience with Sandoz biosimilars alone 3 Healthcare system savings 551M Estimated cumulative savings from biosimilars epoetins in Germany Increased patient access 10 Increase in standard units of filgrastim in the UK from (post biosimilar launch) 5 1. European Medicines Agency Website 2. IMS MIDAS 3. Sandoz Product Safety Update Report (accessed October 2015) 4. IMS Institute for Healthcare Informatics: Assessing biosimilar uptake and competition in European markets. Date of Report: Oct IMS Institute for Healthcare Informatics: Delivering on the Potential of Biosimilar Medicines. Date of Report: Mar Medicines for Europe Biosimilars Conference April 2016
2 However, the status quo must change for biosimilars to deliver on its promise Critical Challenges Strategic Imperatives 1. Stakeholder understanding and acceptance Build Trust & Confidence 2. Disproportionate focus on acquisition costs Ensure Sustainable Market Policies 3. Continued legal and regulatory uncertainties (mainly in US) Clarify Legal and Regulatory Uncertainties 3 Medicines for Europe Biosimilars Conference April 2016 Recent US and EU biosimilar launches indicate progress in building stakeholder acceptance... Filgrastim US 25 Infliximab EU5 Pre-launch educational efforts across stakeholders helped address key concerns 20 17% 17% 2 Physicians accept biosimilar concept in acute care settings Economic value recognized by payors & healthcare providers Prescriptions (in %) % 0 Jan-15 Feb-15 MAR/15 1 9% 3% Apr-15 MAY/15 15% 5% 2% Jun-15 Source: IMS Pharmascope 1 Community medical center: MVZ in Germany, therefore, possible multiple specialties are included 4 Medicines for Europe Biosimilars Conference April 2016 Gastro Rheuma Derma GPs/community medical centers Others Total Biosimilar penetration
3 ...However, all stakeholders must contribute to improving trust and confidence in biosimilars Regulators: Engage with HCPs on robustness of regulations/extrapolation Payors: Support biosimilar education amongst HCPs HCPs: Deepen understanding of biosimilars and help reassure patients Increasing adoption of biosimilars Patient Groups: Develop and share educational content for patients Govt: Continue to highlight societal value of biosimilars across stakeholders Manufacturers: Ensure availability of science-based information on biosimilars Collectively address the scourge of misinformation 5 Medicines for Europe Biosimilars Conference April 2016 Considerable variation across the EU exists in terms of payer policy approaches to biosimilars Most patients out of reach for manufacturers Competition averse Foster competition Many patients available for manufacturers to compete for National management passive (i.e. fixed biosimilar price reduction) No prescribing incentives No prescription quota Increased active management nationally Education of physicians by payers Biosimilar prescribing stimulated (quotas) Source: Adapted from IMS Health, IMS Consulting Group, March Medicines for Europe Biosimilars Conference April 2016
4 Healthcare systems must advance policies that ensure sustainability Sustainable Procurement No winner takes all tenders Acknowledge that biosimilars are not generics: no mandatory price cuts Promote fair competition and levelplaying field Prescribing Incentives Gain-sharing that helps hospitals to benefit from savings Quotas to create competition while retaining prescriber choice Support acquisition of most cost-effective medication by hospitals 7 Medicines for Europe Biosimilars Conference April 2016 Legal and regulatory clarity essential for further development of the biosimilars industry BPCIA Ambiguities INN & Labeling Interchangeability Maintain established regulatory framework 8 Medicines for Europe Biosimilars Conference April 2016
5 Collectively, we can ensure biosimilars play an even more transformational role in global healthcare Generate savings for healthcare systems Improve patient access 49-98B Expected cumulative savings from biosimilars in US+EU5 1 ~5% Patients with moderate-to-severe psoriasis receiving biologic medicines 2 1. IMS Institute for Healthcare Informatics: Delivering on the Potential of Biosimilar Medicines. Date of Report: Mar Ref: Nast A, et al. Arch Dermatol Res 2013;305(10): Medicines for Europe Biosimilars Conference April 2016
Biosimilars are interchangeable with their reference products under the supervision of a health care person.
EXTENDING THE USE OF BIOSIMILAR DRUGS: ARE WE WILLING TO ACCEPT THE UNCERTAINTY RELATED TO SWITCHING IN ORDER TO IMPROVE PATIENT ACCESS TO MODERN MEDICINES? Tomas Tesar, PharmD, PhD, MBA, MSc Member of
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 informationSandoz Biopharmaceuticals. Sandoz Biosimilars. From concept to reality
Sandoz Biopharmaceuticals Sandoz Biosimilars From concept to reality 2 SANDOZ BIOPHARMACEUTICALS The basics of biosimilars Biosimilars explained Biologic medicines are produced by a complex process involving
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 informationGoldman Sachs Key Debates In Biosimilars Conference
Goldman Sachs Key Debates In Biosimilars Conference Diem Nguyen Regional President North America, Global Established Pharmaceuticals April 2, 2015 1 2 Forward Looking Statements Our discussions during
More informationFactors Supporting a Sustainable European Biosimilar Medicines Market PROJECT SUMMARY FOR EXTERNAL COMMUNICATION
Market Access Factors Supporting a Sustainable European Biosimilar Medicines Market PROJECT SUMMARY FOR EXTERNAL COMMUNICATION A study undertaken by GfK Market Access on behalf of the European Biosimilars
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 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 informationWHITE PAPER ON. Public Procurement of Biological Medicines
WHITE PAPER ON Public Procurement of Biological Medicines JUNE 2015 Table of contents 1. 2. 3. 4. 4.1. 4.2. 4.3. 4.3.1 4.3.2 Executive summary Introduction EU policy framework Procurement of biological
More informationNaming, tracing, switching and other safety issues after 10 years learning
Naming, tracing, switching and other safety issues after 10 years learning Prof. Dr. Irene Krämer, Department of Pharmacy Johannes Gutenberg-University Medical Center, Mainz (Germany) Disclosures Speaker
More informationDelivering on the Potential of Biosimilar Medicines
March 2016 Delivering on the Potential of Biosimilar Medicines The Role of Functioning Competitive Markets Introduction As biologic medicines play a more significant role in patient care across a growing
More informationProfessor Ahmed H Al-jedai, PharmD, MBA, BCPS, FCCP, FAST, Saudi Arabia
GaBI Scientific Meetings First GCC Stakeholder Meeting on Approval Process, Interchangeability/Substitution and Safety of Biosimilars 20 November 2017, Holiday Inn Izdihar Riyadh, Saudi Arabia Professor
More informationNew Cardinal Health (Post-Spin)
New Cardinal Health (Post-Spin) George Barrett Vice Chairman and Chief Executive Officer Healthcare Supply Chain Services and Chief Executive Officer Cardinal Health, Inc. (post-spin) January 14, 2009
More informationThe Future of Generic Pharmaceuticals
The Future of Generic Pharmaceuticals David R. Gaugh, R.Ph. Senior Vice President, Sciences and Regulatory Affairs Generic Pharmaceutical Association A Look Ahead Aging Demographics 1 YEARS OF AGE A Look
More informationFIFARMA Position: Transparency in regulatory decision making on the approval for biosimilar products
FIFARMA Position: Transparency in regulatory decision making on the approval for biosimilar products CASSS LATAM Forum, Sep 5-6, Mexico City Thomas Schreitmueller, Co-chair FIFARMA Regulatory and Biologics
More informationSurvey 1 - Rheumatoid Arthritis (RA) Patients perception on originator biologics and biosimilars
SUPPLEMENTAL MATERIAL - Perception of originator biologics and biosimilars: a survey amongst Belgian rheumatoid arthritis patients and rheumatologists BioDrugs Eline van Overbeeke 1, Birgit De Beleyr,
More informationReport on the Expert Consultation on Improving Access to and Use of Similar Biotherapeutic Products
Report on the Expert Consultation on Improving Access to and Use of Similar Biotherapeutic Products Salle IV, International Labour Organization, Geneva, Switzerland 2-3 May 2017 1 WHO/EMP/RHT/TSN/2017.01
More informationThe Competition Council launched for public consultation the report on sector inquiry on pharma market
The Competition Council launched for public consultation the report on sector inquiry on pharma market One of the conclusions of the sector inquiry on pharma sector carried out by the Competition Council
More informationSummary of Medicines Plan
Summary of Medicines Plan Ministry of Public Health, Welfare and Sport Summary of Medicines Plan 1 Content Introduction 4 1 Accessibility of innovative medicines 5 Go to action 2 Tackle the high price
More informationThe State of Sustainable Agriculture in the EU
The State of Sustainable Agriculture in the EU ISO SEMINAR 29 November 2017 DG Agriculture and Rural Development European Commission Jens SCHAPS Director Markets and Observatories 2 2 Public consultation:
More informationPrescription Medicines: Costs in Context
Prescription Medicines: Costs in Context 2017 We are in a new era of medicine where breakthrough science is transforming care with innovative treatment approaches... Then Now Medicines made of chemical
More informationBrand Plan Sample Template. Akademia Marketingu Farmaceutycznego
Brand Plan Sample Template Akademia Marketingu Farmaceutycznego Key Marketing Questions 1. 1 What is the basic definition of your market? 2. 2 Who are your target audiences in the marketplace? 3. 3 What
More informationInsights into the Evolving Pricing & Market Access Environment
Insights into the Evolving Pricing & Market Access Environment UBC Global Market Access Survey July 2012 JULY 2012 GLOBAL MARKET ACCESS SURVEY UBC s Global Market Access Survey: Setting the Stage For those
More informationHatch-Waxman: Driving Access, Savings & Innovation
Hatch-Waxman: Driving Access, Savings & Innovation Introduction Thirty years ago, Congress sought to create a balance between access to lower cost generic medicines and incentives to innovate new and better
More informationPolicy Position. Pharmacy-mediated interchangeability for Similar Biotherapeutic Products (SBPs)
Pharmacy-mediated interchangeability for Similar Biotherapeutic Products (SBPs) Geneva, April 2016 Appropriate use of biotherapeutics including SBPs - SBPs, also known as biosimilars, are developed to
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 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 informationMEDICINES FOR EUROPE COUNTRY SPECIFIC MARKET ACCESS POLICIES
MEDICINES FOR EUROPE COUNTRY SPECIFIC MARKET ACCESS POLICIES 2017 Follow us on Rue d Arlon 50-1000 Brussels Belgium T: +32 (0)2 736 84 11- F: +32 (0)2 736 74 38 www.medicinesforeurope.com Executive Summary
More informationUptake of innovative products across EU countries: How to address existing discrepancies?
Fourth European Healthcare Policy Deciders Forum Encouraging and Rewarding Innovation Medicines Policy Effectiveness and efficiency in resource allocation February 17 th 18 th, London Francis Arickx National
More informationJim Boswell, CEO Baptist Medical Group Robert Vest, COO Baptist Medical Group Anne Sullivan, MD, Medical Director of Quality Programs
Jim Boswell, CEO Baptist Medical Group Robert Vest, COO Baptist Medical Group Anne Sullivan, MD, Medical Director of Quality Programs Understand the historical context of isolated silos of medical practices
More informationBiosimilars: business opportunities beyond the EU and the US
Biosimilars: business opportunities beyond the EU and the US Fernando de Mora, PhD, MBA Professor Department of Pharmacology, Therapeutics and Toxicology Universidad Autónoma de Barcelona SPAIN Universidad
More informationBiosimilars: Theory, Empirics, and Policy Implications
Biosimilars: Theory, Empirics, and Policy Implications Fiona M. Scott Morton, Ariel Dora Stern, and Scott Stern May 15, 2014 We are grateful to seminar participants at Boston University and UCLA for helpful
More informationMaximizing Market Access: THE 5 MOST CRITICAL QUESTIONS TO ASK WHEN LAUNCHING A SPECIALTY DRUGS
Maximizing Market Access: THE 5 MOST CRITICAL QUESTIONS TO ASK WHEN LAUNCHING A SPECIALTY DRUGS by Jan Nielsen, division president, Access & Patient Support Are You Asking the Right Questions? We ve all
More informationHow to Make IT the Underpinning of the Enterprise Strategy
How to Make IT the Underpinning of the Enterprise Strategy Session #146 February 22, 2017 1 John Ward, CIO TriHealth Bob Schwyn, Director The Chartis Group Speaker Introductions John Ward, CIO Chief Information
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 informationAn Economic Analysis of Generic Drug Usage in the U.S.
September 2011 $931 Billion SAVINGS An Economic Analysis of Generic Drug Usage in the U.S. EXECUTIVE SUMMARY As government leaders in Washington and across the country look for ways to cut health care
More informationINFORMATION GOVERNANCE STRATEGY. Documentation control
INFORMATION GOVERNANCE STRATEGY Documentation control Reference Date Approved Approving Body Version Supersedes Consultation Undertaken Target Audience Supporting procedures GG/INF/01 TRUST BOARD Information
More informationReinforce, expand, refocus Ashfield s syndicated services
Reinforce, expand, refocus Ashfield s syndicated services A syndicated detail slot offers a compelling way to conduct detailed promotional sales calls for newly launched products, campaign realignment
More informationCommercial Pricing and Contracting 101
Commercial Pricing and Contracting 101 Reimbursement and Contracting CBI Conference Philadelphia, PA February 4, 2016 Althea Danzey, Director of Contracting Tina Still, Senior Manager of Contracting Eisai
More informationCDASH Clinical Data Acquisition Standards Harmonization
CDISC Italian User Group Meeting 16 November 2007 CDASH Clinical Data Acquisition Standards Harmonization 1 Outline Background Organization Goals Timelinesand Process Review of progress Results Future
More informationNew WHO Report: Access to new medicines in Europe: Technical review of policy initiatives and opportunities for collaboration and research
New WHO Report: Access to new medicines in Europe: Technical review of policy initiatives and opportunities for collaboration and research Hanne Bak Pedersen Programme Manager Health Technologies and Pharmaceuticals
More informationPresenter. Guy Clark. Searle Pharmaceuticals Sales, Marketing, BD. Business Development Director, IVAX Europe. President, Glenmark Europe
Presenter Guy Clark Searle Pharmaceuticals Sales, Marketing, BD 1992-2001 Business Development Director, IVAX Europe 2001-2005 President, Glenmark Europe 2005-2008 Business Development Consultant 2009-2010
More informationPolicy considerations for originator and similar biotherapeutic products
Pharmaceuticals Policy and Law 18 (2016) 121 139 121 DOI 10.3233/PPL-160438 IOS Press Policy considerations for originator and similar biotherapeutic products Gustavo Grampp a,, Robert W. Kozak b and Thomas
More informationMARKET REVIEW BIOSIMILAR MEDICINES MARKETS POLICY OVERVIEW
MARKET REVIEW BIOSIMILAR MEDICINES MARKETS POLICY OVERVIEW 2017 Acknowledgements National Association / Association/ Company Contact Person Member Company National Association / Association/ Company Member
More informationFDA Experience with the Sentinel Common Data Model: Addressing Data Sufficiency
FDA Experience with the Sentinel Common Data Model: Addressing Data Sufficiency Michael D. Nguyen, MD Office of Surveillance and Epidemiology Center for Drug Evaluation and Research US Food and Drug Administration
More informationMDIC. Change Adoption Plan
MDIC Change Adoption Plan 1 Agenda What is the Change Adoption Plan? Desired Outcomes of CfQ Adoption Desired Future State Benefits of CfQ Adoption Culture of Quality Quality System Model Benefits Challenges
More informationStatement. For. United States Senate Committee on Finance. June 8, :45 a.m.
Statement of The National Association of Chain Drug Stores For United States Senate Committee on Finance On The President s Fiscal Year 2018 Budget 9:45 a.m. 215 Dirksen Senate Office Building National
More informationInfectious Disease. Results 18:1. Campaign Objective. Media Plan. Measuring ROI
At BulletinHealthcare, we provide physicians with the highest quality content every day. These physicians are the members of 29 leading medical associations. GENERATING ROI Because our readers rely on
More informationECU PHYSICIANS NEW PROGRAM REQUEST FORM
Date Submitted: ECU PHYSICIANS NEW PROGRAM REQUEST FORM Department: ECU Physicians Section: Administrator/Contact Person: Brian Jowers, Executive Director Program Name: Banner Fund/Org: Expected Start
More informationSanten Acquisition of InnFocus, Developer of MicroShunt Glaucoma Implant Device
Santen Acquisition of InnFocus, Developer of MicroShunt Glaucoma Implant Device Akira Kurokawa President & CEO August 2, 2016 Copyright 2016 Santen Pharmaceutical Co., Ltd. All rights reserved. 1 External
More informationDr Paul Cornes Disclosures August 2017
Dr Paul Cornes Disclosures August 2017 Salary received: United Kingdom National Health Service Honoraria received: Accord Healthcare Amgen Bernstein British Medical Journal European Generics Association
More informationDeveloping a Policy & Governance Framework for an Operational Learning Health System Discussion with the NCHICA Informatics & Analytics Roundtable
Developing a Policy & Governance Framework for an Operational Learning Health System Discussion with the NCHICA Informatics & Analytics Roundtable April 7, 2015 What is a Learning Health System? IOM Report
More informationJOB DESCRIPTION. The appointment is full time and will be for an initial 2 year period which could be extended.
JOB DESCRIPTION POST TITLE: REPORTING TO: GRADE: LOCATION: HOURS: Programme Lead Patient Safety Director of Programmes, Change & Performance Management tbc 10 Greycoat Place, London SW1 1SB 37.5 hours
More informationCommunicating Emerging Drug Therapies Prior to FDA Approval. May 4, 2017
Communicating Emerging Drug Therapies Prior to FDA Approval May 4, 2017 Michelle Drozd Deputy Vice President, Policy and Research Pharmaceutical Research Manufacturers Association (PhRMA) Michael Labson
More informationOverview and Life Cycle Planning for Biosimilars
September 23, 2011 The Biosimilars i il Competition and Innovation Act: Overview and Life Cycle Planning for Biosimilars Stephen Paul Mahinka Chair, Life Sciences & Healthcare Interdisciplinary Group smahinka@morganlewis.com
More informationABPI response to European Commission consultation on advanced therapy medicinal products
ABPI response to European Commission consultation on advanced therapy medicinal products 28 March 2013 ABPI response to European Commission consultation on the regulation of advanced therapy medicinal
More informationTrust Board Meeting: Tuesday, 12 February 2013 TB Quarterly HR and Workforce Report. A paper for information and discussion
Trust Board Meeting: Tuesday, 12 February 2013 Title Quarterly HR and Workforce Report Status A paper for information and discussion History Previous quarterly reports Board Lead Director of Workforce
More informationThe U.S. Food and Drug Administration (FDA) is expected
Perspective C O R P O R A T I O N Expert insights on a timely policy issue The Cost Savings Potential of Biosimilar Drugs in the United States Andrew W. Mulcahy, Zachary Predmore, and Soeren Mattke The
More informationEUROPEAN GENERIC MEDICINES ASSOCIATION
biosimilars biosimilars contents Introduction... 6 What this Handbook Covers Whom this Handbook is for Executive Summary... 8 The Importance of Biosimilar Medicines... 11 For Patients For Clinicians For
More informationUsing Big Data to Improve Clinical Quality at Kaiser Permanente, Southern California
Using Big Data to Improve Clinical Quality at Kaiser Permanente, Southern California Presentation to the Canadian Medical Protective Association at the Information Session of the Annual Meeting August
More informationCore Values and Concepts
Core Values and Concepts These beliefs and behaviors are embedded in highperforming organizations. They are the foundation for integrating key performance and operational requirements within a results-oriented
More informationPharmacovigilance: Vigilantia initiative
Pharmaceuticals Policy and Law 18 (2016) 157 162 157 DOI 10.3233/PPL-160440 IOS Press Pharmacovigilance: Vigilantia initiative Juan Carlos Trujillo and Ma. Alejandra De Guzman Bogota, Colombia Every day
More informationCreating Pre-Patient Relationships through Employer Outreach
Employer Engagement as a Consumer Acquisition Strategy: Creating Pre-Patient Relationships through Employer Outreach Jan Hess Vice President Professional and Administrative Services, St. Luke s Hospital
More informationYASHAJIT SAHA & ABHISHEK SHARMA, SUBJECT MATTER EXPERTS, RESEARCH & ANALYTICS ADVANCED ANALYTICS: A REMEDY FOR COMMERCIAL SUCCESS IN PHARMA.
YASHAJIT SAHA & ABHISHEK SHARMA, SUBJECT MATTER EXPERTS, RESEARCH & ANALYTICS ADVANCED ANALYTICS: A REMEDY FOR COMMERCIAL SUCCESS IN PHARMA wns wns ADVANCED ANALYTICS: A REMEDY FOR COMMERCIAL SUCCESS IN
More informationAMERICAN COLLEGE OF RHEUMATOLOGY POSITION STATEMENT
AMERICAN COLLEGE OF RHEUMATOLOGY POSITION STATEMENT SUBJECT: PRESENTED BY: FOR DISTRIBUTION TO: Biosimilars Committee on Rheumatologic Care Members of the American College of Rheumatology Medical Societies
More informationThe Future Role of Biosimilars: An Unknown Frontier in IBD Treatment
The Future Role of Biosimilars: An Unknown Frontier in IBD Treatment Miguel Regueiro, MD, FACG Professor of Medicine Medical Director, IBD Center Senior Medical Lead, Specialty Homes University of Pittsburgh
More informationPricing of RES in the EU
Pricing of RES in the EU Introduction to remuneration of RES Mara Marthe Kleiner Mario Ragwitz Andreas Jahn BEIJING, 12 DECEMBER 2017 Set-up of European energy markets Europe introduced competitive energy
More informationecqm Implementation and Submission Insights Cerner Corporation Nebraska Methodist Health System
ecqm Implementation and Submission Insights Cerner Corporation Nebraska Methodist Health System Agenda: 2015 Pilot Program Overview Client Perspective Questions 1 2015 ecqm Pilot Program Overview of 2015
More informationBiosimilars. Their regulatory status and their use
Biosimilars Their regulatory status and their use Bruno Flamion, MD, PhD Professor of Physiology & Pharmacology, University of Namur, Belgium Past Chair of the European Medicines Agency (EMA) Scientific
More informationWhy even have this talk? Disclosures. What will biosimilars mean for us? Annual Revenue Due to Adalimumab. Biosimilars 2017: What We Need to Know
Biosimilars 2017: What We Need to Know Why even have this talk? Miguel Regueiro, M.D. Professor of Medicine IBD Clinical Medical Director Senior Medical Lead, Specialty Medical Homes University of Pittsburgh
More informationShifting Pharma Sales Models. Text for a pull out can go heretext for a pull out can go heretext for a pull out can go
Text for a pull out can go heretext for a pull out can go heretext for a pull out can go Text for a pull out can go here Text for a pull out can go here Shifting Pharma Sales Models to Focus on Providing
More informationPh. Eur. monographs and biosimilars
Ph. Eur. monographs and biosimilars Emmanuelle Charton, Ph. D. European Pharmacopoeia Department European Directorate for the Quality of Medicines & HealthCare 1 Place of the Ph. Eur. within the EU regulatory
More informationKey Regulatory Issues in Biosimilars
Key Regulatory Issues in Biosimilars May 4, 2017 John Manthei, Esq. Moderator Latham & Watkins LLP Latham & Watkins operates worldwide as a limited liability partnership organized under the laws of the
More informationRules of Engagement for MSLs - Appropriate Interactions with Internal and External Stakeholders
Rules of Engagement for MSLs - Appropriate Interactions with Internal and External Stakeholders Daniel Snyder, PhD Medical Director, Neurology North America Medical Affairs Ipsen Biopharmaceuticals, Inc.
More informationehealth-strategien im Wettbewerb: Erfolgsfaktor oder schmückendes Beiwerk? ehealth Kongress Darmstadt, 17 Oktober 2014
ehealth-strategien im Wettbewerb: Erfolgsfaktor oder schmückendes Beiwerk? ehealth Kongress Darmstadt, 17 Oktober 2014 Health care is in the middle of a perfect storm Changing demographics Unmet needs
More informationNEW YORK STATE BAR ASSOCIATION FOOD, DRUG AND COSMETIC LAW SECTION AND HEALTH LAW SECTION COMMITTEE ON MEDICAL RESEARCH AND BIOTECHNOLOGY
NEW YORK STATE BAR ASSOCIATION FOOD, DRUG AND COSMETIC LAW SECTION AND HEALTH LAW SECTION COMMITTEE ON MEDICAL RESEARCH AND BIOTECHNOLOGY MEMORANDUM IN SUPPORT OF AN AMENDMENT TO NEW YORK S PHARMACY LAW
More informationdavidbaileyfcca finance development consultancy Winning NHS Tenders What Is A Tender? Winning NHS Tenders
Objectives At the end of the workshop, participants will be able to: Identify tenders they should submit Identify potential conflicts of interest Complete Selection Questionnaire (SQ) documentation Complete
More informationThe MSO (Management Services Organization) Concept
The MSO (Management Services Organization) Concept August 2010 Presented By: Ken Welch, Hawaiian HealthCare Consultant MSO, A Definition A Management Services Organization is an organization that can provide
More informationA GUIDE TO THIS REFLECTIONS B RESEARCH STUDY IF YOU RE FIGHTING BREAST CANCER, YOU RE NOT ALONE
A GUIDE TO THIS REFLECTIONS B327-02 RESEARCH STUDY IF YOU RE FIGHTING BREAST CANCER, YOU RE NOT ALONE Do you have breast cancer that has spread to outside the breast? Has your tumor tested positive for
More informationAbout DRG Consulting 1
About DRG Consulting 1 DRGC Capabilities Overview Decision Resources Group (DRG) is a global information and technology services company that provides proprietary data and solutions to the healthcare industry
More informationMEANINGFUL USE CRITERIA PHYSICIANS
MEANINGFUL USE CRITERIA PHYSICIANS The first list is of the 25 Stage 1 Meaningful Use criteria for eligible providers (EP) and comes from the proposed rule: "Medicare and Medicaid Programs; Electronic
More informationInternational Evolution
EMA Biosimilar update: International Regulatory Convergence Presented by: Peter Richardson, 29 April 2016 Head of Quality Office Specialised Scientific Disciplines Department, EMA An agency of the European
More informationDEMONSTRATING YOUR MEDICINE S VALUE TO ALL STAKEHOLDERS TRUSTED COMMERCIALIZATION AND MARKET ACCESS EXPERTISE
CATALYSTS DRIVING SUCCESSFUL DECISIONS IN LIFE SCIENCES DEMONSTRATING YOUR MEDICINE S VALUE TO ALL STAKEHOLDERS TRUSTED COMMERCIALIZATION AND MARKET ACCESS EXPERTISE WHEN COMMERCIALIZING A MEDICINE, IT
More informationCrisis, Opportunity or the New Normal?
Crisis, Opportunity or the New Normal? Dave Emery VP/General Manager, Healthcare Research Kantar Media dave.emery@kantarmedia.com 847-375-5071 1 Topics Media consumption of healthcare professionals The
More informationSpecialty Drug Spending
Specialty Drug Spending The IMS Institute for Healthcare Informatics reported that spending on specialty pharmaceuticals almost doubled from 2010 to 2015, and spending on this subset of drugs was responsible
More informationBuilding a Strategic Vision for Your Employed Physician Network
Building a Strategic Vision for Your Employed Physician Network June 22, 2017 1 Dr. McWilliams - BIO Terrence R. McWilliams, MD, MSJ, FAAFP Chief Clinical Consultant tmcwilliams@hsgadvisors.com (502) 614-4292
More informationKeywords: Biological medicines, biosimilars, off-patent market, pricing and reimbursement policy
Generics and Biosimilars Initiative Journal ORIGINAL RESEARCH For personal use only. Not to be reproduced without permission of the publisher (editorial@gabi-journal.net). What pricing and reimbursement
More informationImportance of Pharmacovigilance for Pharmaceutical Industry
Importance of Pharmacovigilance for Pharmaceutical Industry JARIR AT THOBARI, MD, DPHARM, PHD FACULTY OF MEDICINE GADJAH MADA UNIVERSITY YOGYAKARTA, INDONESIA Role of Pharma Company Globally Investment
More informationDIGITAL EDITION BONUS CONTENT
DIGITAL EDITION BONUS CONTENT Denise Myshko Forecasting Pharma s Future Given the volatility of today s financial landscape, c ompanies, more than ever, need a robust forecasting strategy that is clear,
More informationWHAT S IN A NAME? The Importance of Biosimilar Nonproprietary Names for Healthcare Innovation
POLICY PAPER WHAT S IN A NAME? The Importance of Biosimilar Nonproprietary Names for Healthcare Innovation Sumant Ramachandra, M.D., Ph.D. Senior Vice President and Chief Scientific Officer EXECUTIVE SUMMARY
More informationOverview of Vizient and Our Capabilities
Overview of Vizient and Our Capabilities 29 July 2016 Robert Alford VP, Product Management Agenda About Vizient Benefits of a Vizient Contract Open Discussion 2 Vizient Presentation May 2016 Confidential
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 informationOpen Networks Project
Open Networks Project Consultation on Phase 2 Work Programme 30 January 2018 Document Ref: ON-Phase 2 Programme T +44 (0) 20 7706 5100 W www.energynetworks.org.uk E info@energynetworks.org 1 Introduction
More informationNOTABLE INDUSTRY TRENDS TO WATCH
IDN SUMMIT NOTABLE INDUSTRY TRENDS TO WATCH Avalere published their 2016 trends we look GREAT! Political focus on the cost of and access to specialty drugs and biologics will continue Patient engagement
More informationBiopharmaceuticals Investor & Analyst Day
Adequate picture Biopharmaceuticals Investor & Analyst Day Strategic perspective on Merck KGaA, Darmstadt, Germany Karl-Ludwig Kley CEO Darmstadt, Germany September 18, 2014 Disclaimer Remarks All comparative
More informationPosition Paper c o n n e c t t o t h e w o r l d o f d a i r y
2017 A p r i l Position Paper Simplifying and Modernising the CAP: Competitivity in Agricultural Production CONTEXT In developing CAP for 2020 policymakers need to be mindful of a number of key factors
More information