The Role of Medical Affairs in Shaping Brand Development PRINCETON PHARMA COMPLIANCE CONFERENCE June 7, 2004 Michael Edwin Kafrissen, MD, MSPH.

Slides:

Advertisements

Similar presentations

Mary Ellen Turner MD, MPH Vice-President

Advertisements

FIT FOR PURPOSE An employers perspective from Rolls-Royce Richard Hill Hanoi, 6 February 2007 CD07105/FEB01.

EP Roles and Responsibilities for non legal advisers leading teams including lawyers. Michael Perkins TEP – Special Counsel.

Personalisation Implications for the workforce. On the internal workforce –What does the new agenda mean for social care staff? –What changes will we.

The Context Clare Culpin Director of Nursing and Quality

Pharmaceutical Compliance Current Trends: Hot Button Issues to Look at this Year in Sales, Marketing, Clinical, Medical Affairs and Government Pricing.

Relating Professionalism in CanMEDS Linda Snell MD, MHPE, FRCPC, FACP How to reference this document: Snell. L., Relating Professionalism in CanMEDS. Train-the-Trainer.

December 14, FDA Advisory Committee for Pharmaceutical Science Nonclinical Studies Subcommittee Efficient advancement to clinical trials Jack A.

Matthew & Brita Willis URBAN PIONEERS Urban Pioneers - Exploring the Frontier of Sustainable Design Presented by Brita & Matthew Willis.

Joan E. St. Onge, M.D. UMMSM At Holy Cross Hospital Internal Medicine Residency Faculty Development January 23, 2013 The Evaluation Toolkit.

1 Creating an Entrepreneurial Marketing Environment February 2010.

Dr. Dalal AL-Matrouk KBA Farwaniya Hospital

Innovation and Efficiency in clinical research solutions Clinical Trial solutions Luca Emili – CEO

Healthy North Carolina 2020 and EBS/EBI 101 Joanne Rinker MS, RD, CDE, LDN Center for Healthy North Carolina Director of Training and Technical Assistance.

The Entrepreneurial start-up process

GLOBAL REGULATORY STRATEGY CONSIDERATIONS SCIENTIFIC SARAH POWELL EXECUTIVE DIRECTOR, REGULATORY STRATEGIES SEPTEMBER 14-17, 2008 BOSTON, MA.

Identity & Purpose Desired State Vision 2012 Target Achievements Projection into the external environment Key Successful factors / Value Drivers / Internal.

Contract Management ACC Europe Annual Conference June 1st, 2015.

Family Medicine Program By the end of this session, faculty will 1.Understand what is meant by competence and the competence trajectory expected during.

Growth and Success through Partnering & Outsourcing.

Making medicine information work: a new approach to improving adherence to therapy Jerome Reinstein PhD, Co-facilitator.

Kim D.G. Alexander-Cook Clare G. Smith Partner General Counsel N N OVATION LLP Labatt Breweries of Canada T HE P OSSIBLE M EETS THE P ERMISSIBLE M EETS.

Responsible CarE® Product Stewardship – Building Your Team David Sandidge Director, Responsible Care American Chemistry Council June 2010.

P ROFESSIONAL ORGANIZATIONS : WHY YOU SHOULD JOIN Presenter 1 Presenter 2 or position/site information.

1 Value Assessment of Development-Stage Assets Pharmaceutical Products, Medical Devices, and Related Intellectual Property Frank S. Castellana, M.D., Eng.Sc.D.

Zia Qureshi, Chief Executive Business Catalyst

Communicating your business plan to investors James Hoggan & Associates June 25, 2002.

The New ACGME Competencies for Internal Medicine.

Company LOGO Importance of Trained Manpower in Industry In view of Growing Market Demand By, Mahesh Silveri Head Operations, CLINI INDIA Contact no. +91-

International Business: Actions Entry mode (I)

Stakeholders In Clinical Research The Pharma Company Professor Phil Warner.

Commissioning Self Analysis and Planning Exercise activity sheets.

Advancing Cooperative Conservation. 4C’s Team An interagency effort established in early 2003 by Department of the Interior Secretary Gale Norton Advance.

Seal of Approval Breakthrough Group Patty Mabry, Ph.D. Office of Behavioral and Social Science Reasearch NIH.

Mary Manning, Executive Director. Getting started The Academy of Medical Sciences: who we are Getting started on policy work Governance Selecting topics.

Case Study SummaryChallenges Boston Scientific needed medical translation in different areas in the medical field, including technical, legal and corporate.

A Third-Party Model for Expanded Access Programs 1. We can deliver large EAPs, far in advance of FDA approval. 2. We can do it in today’s regulatory environment.

NHS engagement with the EU NHS Confederation Conference 23 June 2010.

Copyright © 2012 by The McGraw-Hill Companies, Inc. All rights reserved. McGraw-Hill/Irwin CHAPTER NINE SYSTEMS DEVELOPMENT AND PROJECT MANAGEMENT CHAPTER.

Science of Nurture 2H Session Two: Identifying Objectives and Target Audiences. Using Buyer Journeys and Personas.

Setting the Scene: The Role of Ethics and Compliance in the Biopharmaceutical Market.

1 Platform for Privacy Preferences and RBC Financial Group Della Shea Manager Enterprise Web Compliance RBC Financial Group P3P Implementation Workshop.

Francois Nader, MD, MBA Aventis June 6-9, 2004 Princeton, NJ The Pharma, Biotech and Device Colloquium Medical Affairs Organization Of The Future.

Agenda for Session Compliance in Clinical Research

To find out more or to apply, please visit our career portal and post your CV to the attention of: Awa BERNARD Human Resources  –

SSCs in Dundee Dr Michael Murphy SSC Convenor Clinical Senior Lecturer in Biochemical Medicine

CURRENT DEMANDS AND CHALLENGES OF THE INSURANCE SECTOR Recruitment Specialists Niched within the insurance industry.

What happened in Space Life Sciences and how did we respond to it?

NJE sugnHR1 Michael Conway ) David Quigley 2004 Pharma, Biotech and Device.

FOUR DOMAINS Domain 4: Domain 1: Professional Planning & Responsibilities Preparation Domain 3: Domain 2: Instruction Classroom Environment.

Trends Trends 2005 Good Practices in Corporate Reporting 6 th annual publication 

BEST PRACTICES, ® LLC Pharmaceutical New Product Planning Role and Activities for Medical Affairs Report Summary Best Practices, LLC.

Objectives To review the key components of the Nursing Program. To understand the roles and responsibilities of the student, preceptor and faculty liaison.

Primary Care Improvement Infrastructure: The Role of Practice Facilitation Michael L. Parchman, MD MPH MacColl Center for Health Care Innovation AHRQ Annual.

Prepared by Collaborative Economics. EXECUTIVE SUMMARY  San Diego is participating in a new global innovation economy  San Diego’s global reach has.

Educational Solutions for Workforce Development EDUCATION & DEVELOPMENT FRAMEWORK FOR SENIOR AHPs SUSAN SHANDLEY EDUCATIONAL PROJECTS MANAGER, AHP CAREERS.

ACGME SIX CORE COMPETENCIES Minimum Program Requirements Language Approved by the ACGME, September 28, 1999 “The residency program must require its residents.

Pharmaceutical Society of Ireland – The Pharmacy Regulator The Role of the Pharmacist in Self Care Telephone: Shrewsbury Rd Fax:

SUCCESSFUL BUSINESS PLANNING AND WHERE LEGAL PLANNING FITS Jon E Worren Sr. Director & Entrepreneur in Residence MaRS Discovery District.

Creating a New California Department of Public Health: Organizational and Leadership Challenges and Opportunities Mark B Horton, MD, MSPH Director and.

©2009 HP Confidential1 1 Teresa Schlegelmann CMS World Cup 2010 AMS - Houston Solution Consulting Services.

Organization Theory and Design

How Innovating for Health Could Benefit Patients and our Trusts’ Wealth What Could We Do Differently? Suzanne Goodband

© 2016, 2017 Change Healthcare Solutions, LLC. All Rights Reserved.

Building the future Workshop 3 24 November 2017

CanMEDS Roles Covered Medical Expert (as Medical Experts, physicians integrate all of the CanMEDS Roles, applying medical knowledge, clinical skills, and.

CanMEDS Roles Covered Medical Expert (as Medical Experts, physicians integrate all of the CanMEDS Roles, applying medical knowledge, clinical skills, and.

The Evolving Role Of Medical Affairs (MA)

Introductions Michael M. Breggar, Global Director, Life Sciences Deloitte & Touche LLP Leonard Jokubaitis, MD, Vice President, Data Generation, Janssen.

Presentation transcript:

The Role of Medical Affairs in Shaping Brand Development PRINCETON PHARMA COMPLIANCE CONFERENCE June 7, 2004 Michael Edwin Kafrissen, MD, MSPH

Key Themes Changing Environment – Changing Roles for Medical Affairs Medical Affairs and Its Partners – How the Elements of the Company Differ Clinical Commercial Optimization – Planning vs. Reaction Enablers and Obstacles

Medical Affairs and HCC Clinical commercial optimization requires specialized skills, involvement beginning in development and extending through life cycle. A mastery of HCC facilitates not only legal and ethical behavior but also commercial success.

Changing Environment – Changing Roles 1.What we demonstrate is what we can say – label, publication, evidence-base. 2.HCC codifies business ethics and good science – neither meets universal agreement. 3.Pipeline, development costs, margins – the product/molecule life cycle value. 4.Customer types, customer expectations.

Medical Affairs and Partners – Time & Space* DivisionTimeFocus Research Development 3-10 Years +Drug to Development Approval Medical AffairsCrisis-7 YearsLife Cycle New Product2-3 YearsLaunch Brand¼ - 1 YearMarket & Share SalesWeek – 1 YearComp. Plan * Rough examples for discussion.

Clinical Commercial Optimization Planning Steps Understand molecule, clinical issues, customer drivers. Early advice from experts, KOL’s, promotional partners. Develop clinical, epidemiologic, outcomes, and publication plan. Influence requires expertise – team may evolve. Execution requires expertise – team may evolve. Information must be in place to permit appropriate adoption, including CME. Flexibility – new data, new technology, competitive activity.

As customers consolidate, evidence is demanded, and regulation clarifies, Medical Affairs role will grow in life cycle planning, execution, communication, and episodic issue management. Each product/molecule must be characterized appropriately and developed to its optimal extent. A skilled and enabled Medical Affairs function is the best investment for the foreseeable future.