Exclusive Offer to DIA Members: Register for Two Webinars and Save $250.

Exclusive Offer to DIA Members: Register for Two Webinars and Save $250. Busy life sciences professionals need affordable, convenient, and immediate access on the latest developments in the ever-changing health care industry. DIA webinars offer just that - access to timely and authoritative information. Take advantage of this special offer. Offer ends October 18. Check Out These Hot Topics: The Current State of Quality Oversight in the Pharmaceutical Industry October 9 | 11:00AM-12:30PM ET With definitions remaining unclear as to what, exactly, quality oversight (QO) should entail and how optimal quality oversight programs can be effected. This webinar will provide a definition of QO and delve deeper into the state of QO today. Connecting the Right Sites to Promising Trials: The Role of Web-based Feasibility Assessment October 23 | 11:00AM-12:30PM ET This webinar will address common weaknesses in the established process of feasibility assessments and site selection, from the point of view of both trial planners and research centers. The speakers will review relevant key performance indicators (KPIs) and how to address them, global country selection strategies, and better management of site feasibility assessment. FDASIA Year in Review October 24 | 11:00AM-12:30PM ET Hear what FDASIA has given us this past year – and what we might expect in the coming year. This webinar will focus on the progress of the PDUFA V and initiatives to promote innovation and speed to patient access covering: user fee levels, perspective on the new molecular entity review process, status update on Benefit-risk assessment activities, and FDA’s interpretation of the fast track, breakthrough therapy, accelerated approval, and priority review programs. CDER Town Meeting: Safety Hot Topics October 30 | 2:30-4:00PM ET In this interactive webinar, participants will submit questions regarding safety to senior leadership from the US FDA Center for Drug Evaluation and Research through an anonymous, computerized Q&A function. CardioVascular Safety: The New Paradigm - Proarrhythmic Assessment of New Drugs Without the Thorough QT Study October 31 | 11:00AM-12:30PM ET Explore the current approach to assessing the possible proarrhyrhmic potential of drugs and its strengths and weaknesses, a new paradigm that relies more fully on preclinical testing and its advantages and challenges, and key regulatory issues surrounding implementing a new paradigm. CardioVascular Safety – What are the Key Issues Regarding Blood Pressure Assessment During Clinical Development November 7 | 11:00AM-12:30PM ET Explore the current approach to assessing the possible proarrhyrhmic potential of drugs and its strengths and weaknesses, a new paradigm that relies more fully on preclinical testing and its advantages and challenges, and key regulatory issues surrounding implementing a new paradigm. Aligning the Voices of Change in the Health Care System November 12 | 11:00AM-12:30PM ET Several legislations have been introduced calling for regulatory reform in the health care process. FDA is under pressure from industry to enable a regulatory framework for translational medicine but at the same time preserve the public health. This 90-minute webinar will show how important it is for the patient voice to be included when these legislations are drafted. More Upcoming Webinars: Practical Aspects and Examples of Using Large Datasets for Identifying and Investigating Product Safety and Effectiveness in the US and EU November 18 | 11:00AM-12:30PM ET The Case of the New England Compounding Center: Learning from the Tragedy November 19 | 11:00AM-12:30PM ET Social and Collaborative Tools in Regulatory Intelligence November 21 | 11:00AM-12:30PM ET Electronic Submissions 101 – Essential MS Word and Adobe Acrobat Tools/Skills and Current IT Options December 4 | 11:00AM-12:30PM ET Combination Products and Convergence: An Overview of Clinical Benefits, Regulatory Issues & Manufacturing Challenges December 5 | 11:00AM-12:30PM ET Global Overview - Economic Power in Asian Countries December 11 | 11:00AM-12:30PM ET View the Full List of Webinars for Complete Details *Offer only valid for webinars included in this email and cannot be combined with any existing promotions.

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What current regulatory, global, and public opinion trends have the potential to impact biologics?

Regulatory Affairs for Biologics
June 23 from 9:00AM – 5:00PM in Boston

Participants in this tutorial will learn the differences between traditional biologics and biotechnology products, the regulatory needs and requirements for biologics, the unique aspects in the development of specific biologics such as vaccines and gene therapy, and the different ways that CBER and CDER view product development.

Instructor:
Carol H. Danielson, DrPH,MS
President
Regulatory Advantage, United States

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.

Global Regulatory Track at DIA's 49th Annual Meeting

CBER Town Hall: Ongoing initiatives, guidances, and regulations

CDER Town Hall: Hot topics in drug development and regulation (part 1)/(part 2)

PMDA Town Hall: Japanese regulation activities and initiatives

What are areas of convergence in regulatory science between CDE-China and CDE-Taiwan?

What is the current regulatory system and government R&D program?

European Town Hall: Implementation of New Safety Legislation

What do stakeholders need to know about the Canada-US #RCC?

What is the current drug supply situation in US, EU and Japan?

What are Canadian approaches to Regulatory Modernization and Int'l Engagement?

Latin America Town Hall: How are LA regulations modeled after and differ from EMA and FDA regulations?

Discuss PDUFA V Statistical Topics and Emerging New Issues - Apr 28 - May 1

Discuss PDUFA V Statistical Topics and Emerging New Issues Now in its seventh year, this unique forum continues the dialogue on issues including FDA guidance development and regulatory science initiatives including PDUFA V initiatives, as well as statistical opportunities and challenges associated with data standards and innovative approaches to the design, monitoring, analysis, and reporting of clinical trials and assessments of safety and effectiveness in the pre- and postmarket settings. Over the three days, in-depth discussions on key topics relevant to the evaluation of therapeutic products will take place, and include input from key thought leaders from regulatory agencies, industry, and academia. With the success of last year’s forum we will continue to offer additional avenues for interaction and scientific discourse via a scientific poster session during the networking reception and an interactive round-table luncheon event. Keynote Speakers: International Year of Statistics April 29 | 9:00-10:30AM ET Janet Woodcock, MD Director Left for Drug Evalulation and Research FDA Robert N. Rodriguez, PhD Senior Director Statistical Research and Development SAS Institute, Inc. PDUFA V Overview April 29 | 11:00AM-12:00PM This session will discuss the key PDUFA V commitments, current plans for their implementation, areas of interest for statisticians in particular, and perspectives on the potential impact on stakeholders. Speakers:      • Stephen J. Ruberg, PhD, Distinguished Research Fellow, Eli Lilly and Company      • Theresa M. Mullin, PhD, Associate Director, Office of Planning and Informatics, CDER, FDA      • Jay P. Siegel, MD, Chief Biotechnology Officer, Head Global Regulatory Affairs         Janssen Research & Development, LLC      • Stephen E. Wilson, DrPH, Director, Division of Biometrics III, CDER, FDA      • Robert T. O'Neill, PhD, Senior Statistical Advisor, Office of Translational Sciences, CDER, FDA (Premarketing) Benefit-Risk Assessment in Clinical Development and Regulatory Review April 30 | 1:30-3:00PM In this session, speakers will discuss various Benefit-risk assessment approaches that can be potentially used to meet the needs of global regulatory agencies and prescribers, as well as challenges that may arise in implementing them. Speakers:      • Qi Jiang, PhD, Executive Director, Amgen Inc.      • Jonathan D. Norton, PhD, Mathematical Statistician, Division of Biometrics V, OB, CDER, FDA      • Scott Evans, PhD, Senior Research Scientist, Harvard University School of Public Health      • Steven M. Snapinn, PhD, Vice President, Global Biostatistical Science, Amgen Inc.      • Frank W. Rockhold, PhD, Senior Vice President, Global Clinical Safety and Pharmacovigilance        GlaxoSmithKline      • Patrick Frey, Director, Office of Planning and Analysis, CDER, FDA Overview and Commentary of FDA Guidances: Multiplicity and/or Enriched Populations May 1 | 3:00-4:30PM Key contributors from FDA will present highlights of the FDA guidances, and speakers from industry and academia will provide key suggestions and comments on the draft guidances. Speakers:      • Walter Offen, PhD, Global Head of Statistical Innovation & Safety Statistics, Abbvie      • Mohamed A. Alosh, PhD, Team Leader, FDA      • Frank Bretz, PhD, Global Head of Statistical Methodology, Novartis Pharma AG, Switzerland      • Gary G. Koch, PhD, MS, Director, University of North Carolina at Chapel Hill      • Lisa M. LaVange, PhD, Director, Office of Biostatistics, Office of Translational Science        CDER, FDA      • Stephen J. Ruberg, PhD, Distinguished Research Fellow, Eli Lilly and Company      • Robert J. Temple, MD, Deputy Left Director for Clinical Science, CDER, FDA      • Kathleen S. Fritsch, PhD, Mathematical Statistician, OTS, CDER, FDA      • Sue-Jane Wang, PhD, MA, MS, Associate Director, Adaptive Design & Pharmacogenomics        Office of Biostatistics, OTS, FDA      Jumpstart Your Education at this Annual Forum by Adding a Tutorial:      • Statistical Methods for Safety Surveillance      • Missing Data in Clinical Trials          • Benefit-Risk Evaluation   Overview | Agenda | Register Online          Upcoming Webinars: March 27 | 10:00-11:30AM ET April 24 | 11:00AM-12:30PM ET April 25-26 | 10:00-11:30AM ET

Fake Internet-Sold Medicine Becoming Public Health Threat.

The Chicago Tribune (10/16) reports that the FDA in "recent years has confiscated millions of dollars worth of counterfeit and other illegal medicine" sold online. The agency, in "partnership with international regulatory, customs and law enforcement agencies from 100 countries, shut down thousands of Internet pharmacies selling illegal drugs and seized about $10.5 million worth of pharmaceuticals during a weeklong crackdown on counterfeit and unapproved medications that began in late September. But such enforcement action isn't nearly enough to stop the proliferation of phony medicine." The FDA's Center for Drug Evaluation and Research Office of Compliance Director Ilisa Bernstein said, "This is a drop in the bucket. ... We may have some impact on these 4,100 websites, but they can pop up days or weeks later using another URL and another way to deceive consumers."

 

DIA Daily is a digest of the most important news selected from thousands of sources by the editors of BulletinHealthcare. The presence of content or advertising does not endorse, nor imply endorsement of, any products or services by the Drug Information Association. Neither BulletinHealthcare nor the Drug Information Association is liable for the use of or reliance on any information contained in this briefing.

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Global Regulatory Track at DIA2012

Global Regulatory Track

Interact with global regulators to create a new, more efficient collaborative paradigm to share information, experiences, and develop strategies to improve medical product development. This track seeks to establish mechanisms to facilitate the exchange of information, share best practices, identify commonalities, and develop approaches to overcome regulatory barriers.

• CDER Town Hall: Parts 1 and 2
• CBER Town Hall
• European Town Hall: Parts 1 and 2
• Indian Town Hall
• International Regulatory Cooperation: A Canadian Perspective
• Latin American Town Hall
• Pediatric Drug Development Progress: 15 Years Later and Across the Globe
• Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall
• SFDA Town Hall
• State of Electronic Submissions at CDER, CBER, and CDRH
• Update from the EMA-FDA Parallel Assessment Pilot
• Update on EMA, FDA, and PMDA International Activities

For more details, please visit Global Regulatory offerings at DIA 2012.

Collaborate to Innovate

The Challenges to Implementing Innovation in Drug Development – What can be Done?

Last month, DIA teamed up with the FDA and Hearth Rhythm Society to present a meeting on Cardiovascular Safety and State-of-the-Art Development Issues: Type 2 Diabetes Mellitus Medications, QT, Benefit/Risk Assessment, Arrhythmias, Thrombosis, and Cardiotoxicity (Apr 17 2012 8:00AM - Apr 18 2012 5:00PM at the Washington Marriott Hotel)  
Designed to improve pharmaceutical and medical product development by analyzing and mitigating potential risks, participants had the opportunity to:

• Learn how to optimize cardiovascular (CV) safety assessments in the hopes of developing more effective medications to treat type 2 diabetes mellitus and other diseases
• Attend plenary sessions and select from two tracks on diabetes and CV safety
• Participate in debate-style presentations
• Interact with FDA and other regulatory officials
• Attend scientific abstract presentations
• Engage in robust networking opportunities

Several of the presentations are available on the FDA website.  

CDER professionals participate in several meetings, conferences and workshops throughout the year. Appealing primarily to the pharmaceutical industry and health care professionals, topics can range from users fees, to drug advertising and marketing, to genomics, to over-the-counter products. Materials and overviews from some of those meetings are listed in the presentations library.

The Challenges to Implementing Innovation in Drug Development – What can be Done? Douglas C. Throckmorton, MD
Deputy Director, Regulatory Programs, Office of the Center Director, CDER
FDA, United States 

Integrating Patient Preferences into Benefit-Risk Analysis
Robert J. Temple, MD
Deputy Center Director for Clinical Science, CDER
FDA, United States



Balance on CV SafetyDo We Have It Right?
Robert J. Temple, MD
Deputy Center Director for Clinical Science, CDER
FDA, United States


For the full listing of CDER FDA presentations, please visit this link
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm074833.htm

FDA NEWS RELEASE - Report: FDA strengthens monitoring of post-approval drug safety

FDA NEWS RELEASE

For Immediate Release: April 21, 2012
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov; or Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov;
 
Consumer Inquiries: 888-INFO-FDA
Report: FDA strengthens monitoring of post-approval drug safety Safety of approved drugs given same priority as premarket drug review
A strengthened and modernized postmarket drug safety program has resulted in a substantial improvement in the U.S. Food and Drug Administration’s oversight of drugs once they reach the American public, according to a new report released today by the agency’s Center for Drug Evaluation and Research (CDER). The report, “Advances in FDA’s Safety Program for Marketed Drugs¹,” describes new scientific tools and enhanced capabilities that give the same priority to postmarket drug safety monitoring as to premarket drug review.

The report says CDER is also delivering earlier, more effective drug safety information to the public to protect patients from harm. In 2011, CDER issued 68 drug safety communications – up from 39 in 2010. The communications provide early information to patients and health care professionals about drug safety issues as they emerge.

“Our oversight of the safety of marketed drugs has changed significantly over the past few years,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This report shows that the quality, accountability, and timeliness of postmarket drug safety decisions have been enhanced, and our public communication of this information is more effective.”

CDER introduced a comprehensive plan to strengthen drug safety in 2004 that was further enhanced with the passage of the Food and Drug Administration Amendments Act (FDAAA) of 2007. FDAAA authorized major changes to how the safety of drugs would be monitored once on the market, giving FDA the authority to require postmarket studies of drug safety concerns and drug labeling changes when new drug safety information is identified.

Since 2008, the FDA has:
• required 65 safety-related labeling changes, in addition to the safety labeling changes done voluntarily by drug manufacturers
• required manufacturers to implement a variety of Risk Evaluation and Mitigation Strategies (REMS) to ensure that the benefits of a drug or biological product outweigh its risks. FDA has required 64 complex REMS, in addition to a number of less complex REMS. Some of these REMS include plans for restricted access to certain high-risk products
• doubled staff in CDER’s Office of Surveillance and Epidemiology from 123 in 2007, to 245 in 2012. This group of drug safety specialists includes physicians, pharmacists, epidemiologists, and other professionals
• established specific safety positions within each of the Office of New Drugs’ 18 divisions that review applications for new drugs. Each division’s deputy director for safety and safety regulatory project manager helps ensure the appropriate handling of postmarket safety issues related to the drugs approved within their division.
New programs such as Safety First, Sentinel², and Safe Use³ all demonstrate CDER’s work to strengthen the critical sciences that underpin drug safety monitoring. These new capabilities advance the FDA’s ability to track drug safety concerns, identify potential safety signals early, analyze data for its clinical significance, and determine whether a regulatory change or other solution is needed to further protect patients from drug risks.

Specific examples of the FDA’s use of new drug safety tools include:
• the Mini-Sentinel pilot project that enables FDA to assess medical product safety issues by utilizing secure access to the electronic health care information of more than 125 million patients, provided by 17 data partners nationwide

• a new division in CDER’s Office of Biostatistics that focuses exclusively on postmarket drug safety
• an expanded program that enables FDA epidemiologists and statisticians to work with outside collaborators who have access to both large population-based health care data and the expertise to use those data for drug safety studies
• advances in pharmacogenomics, or  personalized medicine, to help doctors use genetic testing to anticipate the safety and effectiveness of a given drug for a given patient.
For information visit:
Report: Advances in FDA’s Safety Program for Marketed Drugs⁴
Drug Safety Communications⁵
Safe Use⁶
Sentinel⁷

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Links on this page:

1. /Drugs/DrugSafety/ucm297389.htm
2. /downloads/Safety/FDAsSentinelInitiative/UCM233360.pdf
3. /Drugs/DrugSafety/SafeUseInitiative/default.htm
4. /Drugs/DrugSafety/ucm297389.htm
5. /Drugs/DrugSafety/ucm199082.htm
6. /Drugs/DrugSafety/SafeUseInitiative/default.htm
7. /downloads/Safety/FDAsSentinelInitiative/UCM233360.pdf

Page Last Updated: 04/21/2012

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm301165.htm

FDA Calls For Text-Mining Software.

Modern Healthcare (4/6, McKinney, Subscription Publication) reports, "The Food and Drug Administration has put out a call to vendors for text-mining software that relies on natural language processing. The software will be used by the agency's Center for Drug Evaluation and Research 'to rapidly analyze documents to find therapeutically useful and possibly unknown associations between drugs, disease processes, adverse events and therapeutic agents,' the FDA said in a request for proposals published on the Federal Business Opportunities website." The FDA expects "to choose a vendor based on overall value" and to announce the award in May.

Connecting The FDA And Pharma / Biotech Industry

http://www.lifescienceleader.com/magazine/current-issue-3/item/4077-fda-connects-with-pharmaceutical-biotechnology-industries

Even with more than 8,800 employees and an annual budget of around $3.2 billion, the FDA’s task of protecting the public health seems daunting, considering the complexity of products being developed by industry. Factor in other issues such as counterfeiting, terrorism, drug reimportation, and the globalization of drug discovery, development, and manufacturing, and you soon realize that working at the FDA is indeed quite a challenge.

Jeffrey Baker, Ph.D., is learning how true that statement is. Baker, who was hired in 2011, is the deputy director, office of biotechnology products at the FDA’s Center for Drug Evaluation and Research (CDER). His hiring is an example of how the FDA, in an effort to learn more about the industry it governs, brought in someone with extensive industry experience.

Having spent 20 years working for the likes of Eli Lilly and MedImmune, Baker arrived at the FDA with what he describes as his “industry toolbox,” which includes a Lean Six Sigma Black Belt — indicating significant competency with a variety of tools and techniques that represent the best practices for quality in process improvement. Perhaps more importantly, he brought a willingness to learn.  “I am trying to share my relevant experiences and be an active listener, a student of folks who have been doing this for years.” With that mindset, Baker’s goal is to help develop a shared vocabulary and shared expectations between the FDA and industry, thereby making it not just a governing body, but an enabling body.

Developing A Shared Vocabulary
When Baker first joined FDA, one of the first things he wanted to do was to meet as many people as he could to gain a greater understanding of the organization...