Professionals medische sector bekijken toekomst biosimilars in VS

DIA kondigt samen met FDLI (The Food and Drug Law Institute) de bijzonderheden aan van de conferentie over de toekomst van biosimilars in de VS, die op 4 en 5 mei in Bethesda, Maryland gehouden wordt. Deze conferentie belicht de perspectieven van de US Food and Drug Administration (FDA), alsmede van de medische sector, juristen, academici, artsen, investeerders en patienten met betrekking tot de introductie van biosimilars in de VS.

Deze eerste echte alomvattende conferentie over biosimilars sinds de introductie van de Biologics Price Competition and Innovation Act (BPCIA) in 2010 is gericht op de belangrijkste uitdagingen en huidige ideeen van belanghebbenden bij de ontwikkeling en beschikbaarheid van biologische medicijnen in de VS.
Engelstalig bericht:

DIA today announced with FDLI (The Food and Drug Law Institute), distinguishing features of The Future of Biosimilars in the US Conference to be held May 4 – 5, 2011 in Bethesda, Maryland.

This first-of-its-kind conference will feature perspectives from the US Food and Drug Administration (FDA), as well as industry, lawyers, academics, clinicians, payers and patients on the introduction of biosimilars to the US.

This first truly comprehensive conference on biosimilars since the enactment of the Biologics Price Competition and Innovation Act (BPCIA) in 2010 will focus on the critical challenges and current ideas of stakeholders impacted by the development and availability of biological medicines in the US. Featured topics will include industry challenges in developing biosimilars and the need for biosimilars, as well as associated economic and legal considerations. The conference program will feature the following key presentations representing patient, regulatory, and industry viewpoints:

• Patience Haydock White, MD, MA, Chief Public Health Officer of the Arthritis Foundation, the nation’s largest national, nonprofit health agency working on behalf of 43 million Americans with doctor diagnosed arthritis and related diseases, will present “Patient Access to High Quality, Safe and Effective Biological Medicines.”
• Steven Kozlowski, MD, Director, Office of Biotechnology Products, CDER, FDA, will present “FDA: The Agency’s Approach to Biosimilars.”
• Sandra Dennis, JD, Deputy General Counsel of the Biotechnology Industry Organization (BIO), and John Coster, PhD, RPh, Senior Vice President for Government Affairs, Generic Pharmaceutical Association, will present “Industry Challenges in Developing Biosimilar Medicinal Products.”

Susan C. Winckler, President and CEO of FDLI and Paul Pomerantz, Worldwide Executive Director of DIA, will provide the welcome and opening remarks for the event. Program Chairperson Philip L. Huang, MBA, MD, Vice President, Vaccine Strategy & Innovation, Merck & Co, Inc., will present the first session of the conference entitled “Overview of Biosimilars: Patient Access, Challenges, Statutory Framework Enacted as Part of Affordable Care Act.”

“Participants will be exposed to all the significant issues, opportunities, and challenges associated with biosimilars development and commercialization in the US, including the perspective of the FDA,” says Alberto Grignolo, PhD, Corporate Vice President, Global Strategy and Services, PAREXEL Consulting, and a member of the Program Committee. “These learnings will provide the foundation for strategic decisions that companies will need to make, and will no doubt lead to further debates, initiatives, and events, as this field continues to evolve.”

Register for The Future of Biosimilars in the US: Legal, Regulatory, Scientific, Clinical and Payer Issues Conference.

About DIA

DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related health care products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China. For more information visit: www.diahome.org.

About FDLI

The Food and Drug Law Institute, founded in 1949, is a non-profit organization that provides a marketplace for discussing food and drug law issues through conferences, publications and member interaction. The scope of FDLI includes food, drugs, animal drugs, biologics, cosmetics, diagnostics, dietary supplements, medical devices and tobacco. As a not-for-profit 501(c)(3) organization, FDLI does not engage in advocacy activities. For more information visit: www.fdli.org.

Redactie Medicalfacts / Alida Budding - Hennink

https://www.medicalfacts.nl

Samen met mijn dochter Janine Budding verzorg ik dagelijks het online medisch nieuws voor zorgverleners, zodat zorgverleners elke dag weer op de hoogte zijn van het nieuws wat voor hen relevant is. De rol en beleving van patiënt & Healthy Ageing, zijn voor mij speerpunten om extra aandacht aan te besteden.

Ik heb jarenlang ervaring in diverse functies in thuiszorg.