“ unregulated” products “Unapproved”? But what of those not approved but nonetheless in a regulated research environment, such as in trials pursuant to.

Slides:

Advertisements

Similar presentations

Ethics review and oversight for better governance of health research Amar Jesani Indian Journal of Medical Ethics Centre for Studies in Ethics and Rights.

Advertisements

BIOTECHNOLOGY ETHICS Biotechnology II. COMPETENCY: Discuss ethical and practical issues surrounding biotechnology.

Advanced Nursing Practice Regulation A Global Perspective A Global Perspective Fadwa A Affara International Nurse Consultant.

Personalized Medicine in California Kathryn Lowell, Deputy Secretary for Life Sciences and Health Systems February, 2009.

The Radioactive Drug Research Committee Approval Process for Tracer Use Anthony F. Shields, M.D., Ph.D. Karmanos Cancer Institute Wayne State University.

WHAT DO THE NEW LICENSURE REQUIREMENTS MEAN FOR ABA PROVIDERS IN KANSAS? LINDA S. HEITZMAN-POWELL, PH.D. BCBA-D INTEGRATED BEHAVIORAL TECHNOLOGIES, INC.

Adapted from ISEF webpage Society for Science and the Public “Roles and Responsibilities of students and adults” Roles and Responsibilities of students.

Stem Cell Dream: From Reality to Dreams. EuroStemCell is a unique partnership of European scientists, clinicians, ethicists, social scientists and science.

UNITED SPINAL ASSOCIATION AUGUST, 2014 Biologics & Biosimilars: An Overview 1.

Wednesday, December 17, :00pm-4:30pm EST National Coalition for Cancer Survivorship Post-Training Webinar ©2014 National Coalition for Cancer Survivorship.

What’s New in the FDA’s Pharmaceutical Inspectorate and Risk Based Systems Inspection Rick Perlman Chair Food, Drug, and Cosmetic Division ASQ.

REGULATORY ISSUES IN HIV CURE RESEARCH HIV Cure Research Training Curriculum Regulatory Issues Module by: Damon Deming, Ph.D. FDA Division of Antiviral.

Value Based Drug Development April 21 st, 2015 Moderator: Ellen V. Sigal, PhD Chair & Founder, Friends of Cancer Research 1.

Cancer Clinical Trials:

Economic Evaluation of Health Technology: Overview Gerald F. Kominski, Ph.D. Professor, UCLA Department of Health Services.

Professional Guidelines for Stem Cell Translation ISSCR George Q. Daley Director, Stem Cell Transplantation Center Children’s Hospital/ Harvard Medical.

1 THE UNIQUE ROLES OF IRB IN MEDICAL DEVICE CLINICALL TRIAL Chiu Lin, Ph.D. CITI, May, 2009 CITI, May, 2009.

Clinical Research Training

1 Evidence and the next stage of health care reform: Why consumer engagement is so important Steven D. Pearson, MD, MSc President, Institute for Clinical.

Cancer Society of Finland Matti Rautalahti Alternative medicine - sound and safe? Matti Rautalahti Chief Medical Officer Cancer Society of Finland.

Stakeholders In Clinical Research Government and Regulatory Bodies Professor Phil Warner.

Bernard A Fox, PhD Immediate Past President and Chair, Executive Council Society for Immunotherapy of Cancer (SITC) Defining the Critical Hurdles in Cancer.

INTRODUCTION TO RA.

Legal Responses to Scientific & Technological Development.

1 New Program Offerings Dr. Andreea Serban Vice Chancellor Technology and Learning Services, SOCCCD Dr. Rajen Vurdien Vice President Instruction, Saddleback.

Professional recognition and credibility of ERT across Europe. How to leverage? Professor Ruth Roberts, PhD ATS, FBTS, ERT Senior Director Toxicology,

Single Patient Use of Investigational Anticancer Agents: An Industry Perspective Gerard T. Kennealey, MD Vice President, Clinical Research, Oncology AstraZeneca.

1 2-Topic Imaging Workshop: (1)Standards for Imaging Endpoints in Clinical Trials (2) Manufacturing of PET Radiopharmaceutical Products Wendy R. Sanhai,

The Pharmaceutical Industry and International Clinical Research: One Company’s Approach Michael Clayman, M.D. Vice President, Lilly Research Laboratories.

CHAPTER 10 CONSUMER PROTECTION

Letters of Intent (LOIs) Through the NCI’s Cancer Therapy Evaluation Program (CTEP) Dr. Patricia M. LoRusso, D.O. Karmanos Cancer Institute Wayne State.

Industry Certifications CTE Veteran’s Administrator Training February 2012.

FDA Regulation Economically Harmful & Morally Indefensible.

Investigational Devices and Humanitarian Use Devices June 2007.

Standards, Companies, and Senior Executives: What We Discovered Jim Thomas, President ASTM International.

General Regulatory Issues in the Development of Drugs Intended for Treatment of Chronic Illness Sharon Hertz, M.D. Medical Officer Division of Anesthetic,

BDH Discovering Tomorrow’s Healthcare Solutions Today Clinical Research Services, Inc. Basil Halliday, M.Sc. President & CEO BDH Clinical Research Services.

Understanding Clinical Trials – Part 2 Georgianne Arnold, MD Professor of Pediatrics University of Pittsburgh Medical Center Pittsburgh Children’s Hospital.

Wright State University & Premier Health Clinical Trials Research Alliance (CTRA) The CTRA conducts clinical trials throughout the Dayton region in a variety.

Patients access to investigational drugs Steinar Aamdal Dept. of Clinical Cancer Research Oslo University Hospital.

21 CFR Toby A. Silverman, M.D. Branch Chief, Clinical Review Branch Division of Hematology, Office of Blood December 14, 2006.

1 PRIORITY MEDICINES FOR EUROPE AND THE WORLD Barriers to Pharmaceutical Innovation Richard Laing EDM/PAR WHO.

Off Label Use in Managed Care Pharmacy Presentation Developed for the Academy of Managed Care Pharmacy Updated February 2015.

Using Australian Clinical Sites – Challenges for International Sponsors Prof A J (Tony) Webber Clinical Network Services Pty Ltd Brisbane, Australia.

The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress Value-Based Pricing: The Good, The Bad, and The Ugly What Does Value.

EXCEPTION FROM INFORMED CONSENT IN CPR DEVICE TRIALS: PROTECTION OF PATIENTS’ RIGHTS Circulatory System Devices Panel Meeting September 21, 2004 Elisa.

School of something FACULTY OF OTHER Leeds Institute of Medical Education School of Medicine Supporting Medical Educators Skills Day A CPD Event Dr Caitríona.

BA in Applied Research & Data Analytics Dr. Julie Kiotas Professor of Psychology 1.

A capacity building programme for patient representatives

Efficacy and Safety of Medicines

Industry Perspective: Expanded Access Programs

Case Studies in Big Data and Analysis

Clinical Trials — A Closer Look

Expedited Drug Approval Programs

Balancing Regulation and Innovation: An FDA Division of Cardiovascular Devices Perspective Bram Zuckerman, MD, FACC Director, FDA Division of Cardiovascular.

On Human Gene Editing: International Summit Statement

Field Investigation Drug Officer Workshop Goals and Objectives

Introduction of New Technology: An FDA Division of Cardiovascular Devices Perspective Bram Zuckerman, MD, FACC Director, FDA Division of Cardiovascular.

US Early Feasibility Studies (EFS)

Beyond Academia.

Mitch Morris, MD Vice Chairman Deloitte LLP

Urso for PSC - CON Christopher L. Bowlus, MD Professor and Chief

Introduction to TransCelerate

Clinical Research Association TURKEY

Opening an IND: Investigator Perspective

Creating the Next Generation of Clinical Quality Improvement Leaders

This program will include a discussion of off-label treatment and investigational agents not approved by the FDA for use in the US, and data that were.

Clinical Research Services.  It is very important phase in medical science as it determines the safety and effectiveness of medications and treatment.

Stem Cell Research.

W H Y IS M E D I C A L M A R IJU A N A S T I L L N OT L E G A L IN M A N Y STATES?

Presentation transcript:

“ unregulated” products “Unapproved”? But what of those not approved but nonetheless in a regulated research environment, such as in trials pursuant to an IND from FDA in the US? “Unproven”? But what of those, like some off-label uses of drugs, that have been proven to be safe and effective, at least to the satisfaction of the professional community, even if never submitted to a governmental agency? “Pre-Approved”? But what of those that don’t need approval or for which ‘regulation’ might be in the form of professional licensure, professional norms and certifications, medical malpractice threats and professional discipline?

Stem cells hold tremendous potential to advance health and medicine. The evidence to support the medical use of stem cells is still limited, however. Few are proven to be safe and effective. But consumer demand for treatments using stem cells has risen, fueled by direct-to-consumer advertising of stem cell- based treatments. Clinics have been established throughout the world, both in newly industrialized nations such as China, India, and Mexico, as well as developed countries such as the United States and within Europe. Their “treatments” have generally not received stringent regulatory oversight and have not been tested through rigorous trials.

Stem Cell Clinical Trials Map Dr. Paul Knoepfler UC Davis School of Medicine (2013)

Mesenchymal Stem Cell Clinical Trials Map Dr. Paul Knoepfler UC Davis School of Medicine (2013)

Amazon.com

Available at beauty.com

Available at amazon.com

Available at smilox.com

Available at amazon.com

This Workshop Will take a critical look at the current environment Speakers will examine the stem cell treatments that are being offered, the potential benefits and risks to individual health, the evidence base needed to substantiate the clinical application of stem cell technologies, and legal hurdles for establishing standards and criteria to govern stem cell trials and treatments. Potential avenues to enhancing assurances of quality of stem cell therapies will also be examined.

Moderators Ralph J. Cicerone, President, National Academy of Sciences Ellen Feigal, Senior Vice President, Research and Development, California Institute for Regenerative Medicine Irving Weissman, Virginia & D.K. Ludwig Professor for Clinical Investigation in Cancer Research, Stanford University School of Medicine Amy Comstock Rick, Chief Executive Officer, Parkinson’s Action Network Harvey V. Fineberg, President, Institute of Medicine