Drug companies conducting their own clinical trials leads to Conflict of Interest a Debate

Ben Goldacre @bengoldacre argues that the financial interests of drug companies lead to distorted evidence, but Vincent Lawton believes that adequate safeguards exist to keep bias in check. Full text of the article is published on BMJ

Dr Goldacre and Prof Lawton faced each other on the same issue recently as opposing speakers at PharmaTimes’s Great Oxford Debate in September, when Dr Goldacre told drugmakers that, by withholding or distorting data, “you shoot yourself in the foot, you undermine your own credibility and mine as a doctor.”

The Pharmatimes review is available at their website http://www.pharmatimes.com/clinicalnews/article.aspx?id=16978&src=EWorldNews

This is interesting , I had written about an actual initiative taken by The Massachusetts Institute of Technology  and 12 Major drug makers to share clinical trial data called NEW Drug Development ParadIGmS or NEWD. details on my earliar post – collaborative clinical trials

World Ecconomic Forum India Economic Summit | Collaborative strategy for drug discovery

The Coverage of the World Ecconomic Forum India Economic Summit is available at  http://blog.livemint.com/wefindia/

I was more interested in the Collaborative Strategy for Drug Development read the interview with Suven Lifesciences a prefered partner to Eli Lilly and Co in Drug Discoverya dn Development in India. http://www.livemint.com/2009/11/10204140/India-Economic-Summit–Collab.html

 

National Library of Medicine wants health care organizations to test drive Medical mapping tool

The National Library of Medicine wants health care organizations and vendors to test drive its new mapping tool that covers 5,000 standardized clinical terms , to create a standard medical vocabulary to support applications for electronic health records

The Obama administration is distributing more than $19 billion in payments to doctors and hospitals that buy and use digital record systems for patients.

The library released a draft mapping tool that links terms from the Systematized Nomenclature of Medicine-Clinical Terms (SNOMED-CT) to the International Classification of Diseases, Ninth Revision (ICD-9). The SNOMED-CT is the terminology used for clinical purposes, while the ICD-9 has terms used for billing and administrative support.

The map was designed with help from SNOMED-CT terms most often used by Kaiser Permanente and the University of Nebraska, to support semi-automated administrative reporting and reimbursement for health care services.

The library wants users to “test drive”’ the map from Dec. 1 through Feb. 1, 2010, and to provide feedback to guide developing related maps. The related maps include mapping of SNOMED-CT to the ICD-Tenth revision, Clinical Modification and Procedure Coding System.

Linkedin and Social Media is ruining my people- feeble attempts to fight of Social Media and the Compliance nightmare

There has been a flurry of discussion around social media and its implication in the last few  months , So I thought it would be good to have some of these arguments laid out in one single post. Social Media has entered every business and industry even, inside the US Intelligence Community, who sorted out their knowledge-sharing problem and a problem with locating expertise—throughout the  bureaucracy of 16 federal agencies—using  simple tools like an intelligence community–wide Wiki and blogging environments among other things

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Social Media and Sales

“My sales people are wasting valuable time on Facebook and Linkedin when they should be selling”: that usual rhetoric many sales managers would say now a days.   Does Social Networking help sales people sell I liked that statement especially since it came from Microsoft executive.  As I have also faced the ire of top management for using social media in my career, . So this report is an eye opener for opponents of social media for sales. Read the Full Article.

LinkedIn insiders know that you can use the site’s information for more than job, sales, and partnering leads – you can find out what others are up to as well. There are downside to using Linkedin last fall an Apple employee revealed that he was managing a team developing a new chip for the iPhone while the information was still secret. . So be careful LinkedIn or any other social tools can bite you back if not used properly.

I would partly agree to the argument that social media and internet created a lot of distractions, but I dont think this is something new, we had distractions in our daily life and in office environments even before theadvent of internet. the only difference now it is easier not to do your job and indulge in something else while you are supposed to be at work when in office.

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Social Media and Influence on Decision Making

Second on my reading list was the study conducted by Don Bulmer (Vice President Global Communications- SAP ) with Society for New Communications Research. Take a look at this in his blogpost  at Social Media’s Impact on Business and Decision Making Everyday Influence blog .  Result of the study concludes that Top execs  are influenced by social networks . The copy of the report is on SNRC website

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Social Media Investments

Third on the reading list was a New Study from Deloitte, Beeline Labs and the Society for New Communications Research Indicates Despite the Recession, 94 Percent of Enterprises Continue to Invest in Online Communities & Social Media  Full Article

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Then there was  presentation by Steven Tylock, on Social networking meets sales , the presentation is on  Microsoft website

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Compliance and Social Media

The Society of Corporate Compliance and Ethics and the Health Care Compliance Association conducted a survey among compliance and ethics professionals in late August 2009 to see what employers are doing about the use of these sites by their employees.

They got back almost 800 responses from their members using an online survey tool.

• 50% of respondents reported that their company does not have a policy for employee online activity outside of the workplace
• Of those companies that do have a policy, 34% include it in a general policy on online usage
• Of those companies that do have a policy, just 10% specifically address the use of social network sites

It would be interesting to see How companies are going to include a clause on their information protection and compliance rules to define what information an employee can add to his linkedin profile during or after his tenure with the organization, especially information related to projects.

For example When an IA rep uses Twitter to send a link to an article from an online magazine, newspaper, or other site to clients and prospects “following” him, that communication is subject to SEC advertising rules. However, Bernstein says that merely sending a link is not advertising—as long as you don’t give your opinion.

A “recommendation” on your Linkedin profile by a client does indeed constitute a testimonial and, thus, violates SEC rules prohibiting RIAs from using client testimonials in advertising.

The SEC will be busy in coming months addressing the many issues posed by advisor use of social media. FDA has already release its framework on use of social media in Drug Marketing.

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Drugs, Heallthcare, FDA and Social Media

The FDA is currently considering how to handle social media, such as SideWiki, Facebook, etc. Companies such as Google, Sermo, and Twitter are playing an increasing role in marketing products to consumers and healthcare professionals, whether our customers like it or not. Technology and Life Sciences companies are pushing the FDA to come up with standards and templates. The following article has some great links to presentations from PhRMA, Google, and even from Pfizer’s Chief Medical Officer.  

Read about Googles pitch to FDA for online Drug Advertisements from the wall street journal

An archived webcast and other details of the FDA  Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools is available at the FDA website

Here what emerged from this hearing

FDA explained in the Federal Register notice that “entities should review any Internet sites sponsored by them for Drug Adverse Event Information, but are not responsible for reviewing any Internet sites that they do not sponsor; however, if they become aware of an Adverse Drug Event on an Internet site that they do not sponsor, they should review the adverse experience and determine if it should be reported to FDA.”

Numerous speakers stated that drug manufacturers are hesitant to fully engage in online social media specifically because they want to avoid learning about potential AEs and the resulting reporting obligations, particularly because the guidance in this area is unclear

Pending further guidance, companies should prepare for further FDA scrutiny of this area by developing compliance
policies to address the challenges of involvement in Internet and social media tools, including but not limited to:
„„policies relating to employee involvement in social media, and in particular statements regarding company products;

„„company involvement in physician and patient-focused social media, including both company-sponsored sites and third-party sites run by third-party organizations (and particularly those receiving manufacturer support through grants or other funding);

„„addressing the challenge of Sidewiki and similar functions that make third-party generated information directly available in conjunction with company websites;

„„updating promotional review policies to ensure consistency with developing FDA approaches to risk communication on the Internet, including sponsored links;

„„policies regarding statements that company-affiliated parties (e.g., investigators, patients) may make on the Internet, which may constitute endorsements or testimonials requiring both review and specific disclosures; and

„„ensuring a consistent and compliant approach to pharmacovigilance with respect to Internet-reported adverse events of Drugs.

 

I know one company that provides  Content Monitoring, Control & Recording across Web 2.0; User Behavior Reporting over Multiple Modalities, Regulatory Compliance for management and security of Web 2.0 applications such as social networking, blogs, wikis, webmail and social networking sites such as Twitter, Facebook and YouTube instant messaging, and Unified Communications. But at a cost of $9,200, it would be out of reach for individual and SMEs.  Still have a look at the recent press release by factime on its FaceTime’s Unified Security Gateway

Myth=My sales people are wasting valuable time on Linkedin when they should be selling, Reality= Social Networking helps in Sales -Top execs say they are influenced by social networks

“My sales people are wasting valuable time on Facebook and Linkedin when they should be selling”: Now thats what most sales managers would say. I know thats true , I have irritated fare share of my managers by using social media to create and close sales and in lead generation. And I continue to do it today, thanks to my current orgnaizations forward looking ways , this time around I have the support of my management to these activities.

Society for New Communications Research (SNCR) has oublished a research that shows that company executives are influenced by their online networks.

Here are some key findings from this survey 365 business professionals:

– Professional decision-making is becoming more social – enter the era of Social Media Peer Groups (SMPG)

• Traditional influence cycles are being disrupted by Social Media as decision makers utilize social networks to inform and validate decisions
• Professionals want to be collaborative in the decision-cycle but not be marketed or sold to online; however online marketing is a preferred activity by companies.

– Professional networks are emerging as decision-support tools

• Decision-makers are broadening reach to gather information especially among active users

– Professionals trust online information almost as much as information gotten from in-person

• Information obtained from offline networks still have highest levels of trust with slight advantage over online (offline: 92% – combined strongly/somewhat trust; online: 83% combined strongly/somewhat trust)

– Reliance on web-based professional networks and online communities has increased significantly over the past 3 years

• Three quarters of respondents rely on professional networks to support business decisions
• Reliance has increased for essentially all respondents over the past three years

– Social Media use patterns are not pre-determined by age or organizational affiliation

• Younger (20-35) and older professionals (55+) are more active users of social tools than middle aged professionals.
• There are more people collaborating outside their company wall than within their organizational intranet

I have also found a similarlt interesting  blog . Hosted at Sales20Book.com

“My sales people are wasting valuable time on Facebook and Linkedin when they should be selling”: Now thats what most sales managers would say. But does Social Networking help sales people sell Full Article . I liked that statement especially since it came from Microsoft executive. . As I have also faced the ire of top management for using social media in my career, some time even in Oracle. So this report is an eye opener for opponents of social media for sales.

The complete presentation and arguments are available on http://www.sales20book.com/wp/2009/05/social-networking-in-sales-show-me-the-money/

India looses USD 1 Billion Investment in Drug R&D to China due to lax Indian patent laws-

Did I really read the news correct or was I just plain drunk on a weekend while reading it. Turns out it is true. Just a week after the Novartis CEO has blasted the Indian IP laws, Novartis has announced plans to invest 1 Billion US Dollar in China for Drug Discovery and Developement. The plan calls for hundreds of new hires and new research facilities in Changshu.

Novartis is  waging a high-stakes court fight over patent protection for the cancer blockbuster Gleevec, No wonder the Novartis CEO Daniel Vasella had enough and announced that the subcontinent’s reputation as a low-cost R&D center is losing its luster.

In his interview he has quoted “There is a significant difference between India and China–in the political system, in the decision making processes, in the complexities of the processes and in the continuity,” Vasella tells the Economic Times. “I think India has potential but things take longer to get done. It may come as a surprise but China has made tremendous progress in IP and is enforcing IP in pharmaceuticals.” And the CEO made it clear that a high court ruling on Gleevec could prove a decisive turning point for India’s R&D industry.

In 2006, Novartis made a commitment to build a $125 million R&D facility in Hyderabad. The next year, after the company lost a patent battle over its blockbuster cancer drug, Gleevec (

I thought China also didnt had a great IP law to speak of. How many times we saw news stories about fake chinesse counterbrands.

But here is the upside , the chineese dont challenge the patents in Courts. China is behind India in pharmaceutical chemistry, so they are not so keen in spending time to another way to manfacture the drug. But China is way ahead of India in Medicinal Chemistry,  pre-clinical and toxicological study infrstructre. SFDA the Chineese equivalent of FDA, is taking a lot bold steps and investment to ensure fast trial registration, proper Pharmacovigilance reporting etc. net net it is faster to run R&D in China

India is yet to have solid infrastructre or plans for clinical trial monitoring or pharmacovigialance . The WHO fund for a national pharmacovigilance monitoring policy and infrastructre has already elasped in 2008. And we are yet to see any increase in number of adverse events reported in India .

India will make similar progress, he opined, when Indian pharmaceutical companies have more IP they want to protect. Then, the companies will force the government to act and increase IP protection.

Pfizer announced it would close six out of its 20 R&D facilities around the globe as part of its post-Wyeth-acquisition consolidation but the company’s Shanghai R&D operation is not affected – an implicit endorsement of China’s R&D.

Ok we Indians will wait till then , and just pray that the Red Dragon is not going to burn the Indian the pharma industry till that time

Shorter Path to drug Discovery share research on failed compounds between companies the new MIT lead approach-

The moment I learned about this new project started by MIT, I could think of only one thing, I want to be part of it.  The Massachusetts Institute of Technology, have, started a pharmaceutical innovation program  to help drug companies adapt some successful approaches now used in aeronautics, like lean management and information-sharing among rivals.

The M.I.T. initiative, called NEW Drug Development ParadIGmS or NEWDIGs has garnered the support of

• Aetna
• Bayer Healthcare
• Brookings Institution
• Centers for Disease Control and Prevention (CDC)
• Eli Lilly and Company
• U.S. Food and Drug Administration (FDA)
• Johnson & Johnson
• Medco Health Solutions Inc.
• Pfizer Inc.
• Quintiles Transnational Corp.
• Vertex Pharmaceuticals Inc.
• WellPoint Inc.

One short-term goal is to identify, and rectify, the root causes of bottlenecks in the existing system. Longer term, the ambition is to create new prediction models, new ways to share information about the biology of diseases, and a new inclusiveness involving earlier participation of regulators, health insurers, health care providers and patients.

So How do they plan to change the way we conduct drug discovery and developement?

1.  share information about compounds they have tried and shelved, for reasons like toxicity or inefficacy.

Results of clinical trials are availale online for free, whether or not they succeed. But no pharma company talks about projects that fail at an earlier stage. A result is that companiesother  waste many millions going down experimental paths that their competitors have already tried and failed.

A visual Path of the changes suggested in the Enterprise Transformation is shows here , the document can be downloaded from the MIT website

Can we use the new Intel Product that Captures, Printed Text to Digital Text and then Reads Text- in clinical trials

Intel Corp.’s Digital Health Group has introduced a handheld product to convert printed text to digital text, then read it aloud to the user.

The Intel Reader is designed for persons with dyslexia, other learning disabilities or impaired vision, according to the Santa Clara, Calif.-based vendor. The reader includes a high-resolution camera to point and shoot text, and a processor to convert and read the text.

The reader can be used with a Portable Capture Station that eases capturing large amounts of data from a chapter or entire book. More information is available at intel.com/healthcare/reader/index.htm.

Boy this is much better than Kindle or Google Reader.  I had a completely different thought while reading about the product. If it was cheaper Clinical Research companies in Developing countries can use it in paper trials.

Ofcourse it is not designed with that purpose. The idea started with Ben Foss, director of access technology for Intel, who was identified with dyslexia in elementary school.

The Intel Reader is easy to use. Just point, shoot, and listen to quickly access printed text such as schoolwork, work material, or menus on the spot. The Intel Reader does not require sight to operate. Easy-to-locate buttons, audio and visual navigation, and straightforward menus make it easy to locate the functions you need. For people with low vision, the large screen display can zoom in and out and text size can easily be adjusted.

India begins serious efforts to ensure patient safety- Rejoice if you are in US Obama is going to penalize hospitals with high one-month readmission rates for transitioned patients

MUMBAI: A mop left inside a patient’s stomach after a surgery, an expired drug administered to an ailing person or a hospital-acquired

infection-medical errors are a nightmare for both doctors and patients. Such incidents, which are usually swept under the carpet, will now be recorded and reported to an independent body in India. This will be done in an attempt to streamline and improve the Indian healthcare system.

Indian Confederation for Healthcare Accreditation (ICHA), a non-profit organisation consisting of various associations, would spell out clear-cut healthcare standards, train employees of hospitals, nursing homes and clinics in spotting medical errors and adverse reactions as well as encourage them to report the same in order to create a database

ICHA is organizing the first Patient Safety Conference in India on November 27-29 at Delhi. India is still trying to increase the number  Adverse Event Reporting related to cliical trials and post makret surveillance. Indian community doctors and helath expert swamped with treating more ethan  hundered patients every day ( yes I mean more than Hundered, average Indian physician attemps to more than 100 patients in Indian community hospital and governments run medical colleges), has no time to report Adverse Event and Drug Safety concerns on time and effectively. This is despite the formation of a National Drug Safety and Pharmacovigilance Programe supported by severl regional centres.

In United States one in five patients discharged from the hospital experiences an adverse event within three weeks. Two-thirds of those outcomes are drug-related, with many of them potentially avoidable, according to a recent report issued by an expert panel of internists, hospitalists and emergency physicians.

The Transitions of Care Consensus Policy Statement published jointly in August in the Journal of Hospital Medicine and the Journal of General Internal Medicine by the American College of Physicians, the Society of Hospital Medicine, the Society of General Internal Medicine, the American Geriatrics Society, the American College of Emergency Physicians and the Society for Academic Emergency Medicine.

The panel said hospitals and outpatient physicians should be held accountable for properly transitioning patients, coordinating care, involving family in decision-making and communicating key information in a timely fashion. The group also called for national standards and performance metrics.

It proposed that the following elements about patients should always be communicated as quickly as possible:

• Principal diagnosis and problem list.
• Medication list, including over-the-counter items.
• Medical home or transferring physician or institution and contact information.
• Patient’s cognitive status.
• Test results and pending test results.

The recommendations come on the heels of increased scrutiny of how well doctors and hospitals prevent readmissions. President Obama has proposed bundling payments for hospitalization and care delivered within 30 days after discharge, penalizing hospitals with high one-month readmission rates. The administration says the move would save $8.4 billion and give hospitals more financial incentive to reduce the 20% 30-day readmission rate among Medicare patients.

Data Management and Integration for the Future of Clinical Trials webcast

Upcoming Webcast: Data Management and Integration for the Future of Clinical Trials

Attend this interactive webcast presented by Applied Clinical Trials and Oracle Health Sciences featuring speaker Tom O’Leary, Senior Vice President, Data Management, ICON Clinical Research and Claire Castaings, Vice President Worldwide Director, Clinical Data Management Sanofi-Aventis. This session examines the use of the latest electronic data capture technology to efficiently integrate critical data sources.

Webcast Details

Speakers:
Tom O’Leary, Senior Vice President, Data Management, ICON Clinical Research
Claire Castaings, Vice President Worldwide Director, Clinical Data Management, Sanofi-Aventis

Live webcast date and time: November 10, 2009 at 8:00 AM PT/11:00 AM EST

To register for this event, click here.

The integration of data from the various technologies employed in clinical trials continues to increase in complexity. The typical clinical trial today integrates data from IVR, EDC, ePRO & Laboratories, to name but a few. Achieving a seamless integration of data greatly improves the speed at which data is available, enhances the quality and consistency of that data, and reduces costs. The pharmaceutical industry continues to strive for this efficiency while reducing the cost of getting drugs to market. Outsourcing drug development to CRO’s using the latest technology platforms is a key strategy in this quest. This webcast will explore how a leading pharmaceutical company and ICON used the latest electronic data capture technology to efficiently integrate all critical data sources, ultimately enabling the continuous assessment of patient data.

In this webcast you will learn how to:

• Have a deeper understanding of ways in which technologies can interface to integrate data
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• Realize the benefits of working together where activities are outsourced and how the latest technologies can derive benefit

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FDA Webinar Drug Marketing and Advertising Are You Prepared for the Challenges of Social Media?

Since the FDA cracked down on social media marketing and online advertising, drugmakers have been walking on eggshells. A key FDA meeting is scheduled for Nov. 12-13. Read on …

Drug Marketing and Advertising
Are You Prepared for the Challenges of Social Media?
An FDAnews Webinar
Thursday, Nov. 19, 2009 • 11:00 a.m. — 12:30 p.m. EST

Register Today!

Internet marketing and social media offer powerful new tools to communicate the benefits of your drugs and biologics. But with the FDA a threatening question mark, it’s hard to know how to move forward.

What are the best practices firms can employ while the FDA determines its approach to regulating social media and internet advertising?

Consult the experts.

Dr. Mark DeWyngaert is a leading consultant in drug sales and marketing; he helps drug and biologic makers thread through the FDA maze. Alan Bennett is managing partner in the Washington, D.C. office of Ropes & Gray and has represented clients at the FDA and in Congress on many of the critical issues that affect the pharmaceutical industry. We’ve invited them to spend 90 minutes with you, explaining what the FDA is doing, where it’s heading, and how you can meet your marketing goals — without crossing regulatory boundaries.

In 90 fast-paced minutes, without ever leaving the convenience of your office, you’ll have the opportunity to pick our experts brains — at a cost that’s a fraction of what you’d pay for an on-site consulting visit. They’ll fill you in on key points from the November public meeting and help you prepare for whatever new FDA strategies emerge. Here’s just a taste of this webinar’s agenda:

• The 5 issues DDMAC is citing in enforcement letters
  
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• The 3 main types of social media: user-generated content, bookmarking and sharing, and social networking
  
• What YouTube, Wikipedia, Facebook, Linked-in and Twitter have in common, and how consumers are using them
  
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Advertising and marketing cut across many company departments and functions. Dozens in your company may wish to attend. That’s no problem. As many personnel may log on as you like — for one low registration fee. There are no restrictions except that all registrants must be at the same company location.

The FDA has made no bones about plans to step up enforcement, and DDMAC is at the forefront of agency plans. Now is the time to prepare. Make plans now to log on for this one-time-only session.

Who Will Benefit

• Compliance officers
  
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Meet Your Instructor
Dr. Mark DeWyngaert is a managing director in the Life Sciences Advisory Practice at Huron Consulting. Trained as a molecular biologist, he specializes in assisting pharmaceutical manufacturers, biotechnology and medical device companies with identifying and mitigating regulatory risks and valuing intellectual property. As a consultant, he leads teams in the assessment of sales and marketing, medical affairs and clinical development activities, and he assists companies in the redesign of business practices to comply with regulations and standards.

Alan Bennett is managing partner in the Washington, D.C. office of Ropes & Gray and formerly served as co-chair of the firm’s Life Sciences Group. He focuses on legal issues surrounding the development and marketing of medical products and has served as outside counsel to many pharmaceutical and medical device firms. Alan’s practice at Ropes & Gray has involved counseling clients, and representing them at the FDA and in Congress, on many of the critical issues that affect the pharmaceutical industry. He is a recognized expert on issues that arise under the Hatch-Waxman Act, as well as on issues involving pharmaceutical marketing, promotion and education.

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Connect the physical world with digital information- Indian scientist work in MIT Media Lab

A PhD student at the Massachusetts Institute of Technology’s famed Media Lab, Mr Pranav Mistry, 28, has come a long way from being the president of the Young Scientists Club at hometown, Palanpur, in northern Gujarat, India

‘SixthSense’ is a wearable gestural interface that augments the physical world around us with digital information and lets us use natural hand gestures to interact with that information.

Called SixthSense, the prototype is made of a pocket projector, a mirror and a camera. The hardware components are coupled in a pendant-like mobile wearable device, while the projector and the camera are connected to the mobile computing device in the user’s pocket via bluetooth.

SixthSense promises to combine the physical world with digital information, without compromising on the ease of doing an ‘offline’ transaction. Its easy-to-grab applications: walk into a random book store, and see the price, ISBN, and a short review displayed on the cover. Or, draw a circle on your wrist, and check the time.

“When you’re cooking, you are also smelling the preparation and your mind starts working accordingly. What we need is a similar seamless communication with the physical world using this solution,” Mr Mistry says.
Press Coverage and several videos available at the website http://www.pranavmistry.com/projects/sixthsense/#VIDEOS

According to Mr Mistry, the real power of SixthSense will be to empower people who lack fourth or fifth sense. “There are some organisations talking with me about how to empower the visually-challenged and hearing-impaired using this technology,” he says.
Meanwhile, consumer electronic companies, including Samsung and LG apart from Microsoft and many others, have expressed interest in making SixthSense a commercial reality.

“Most of these companies already sponsor projects at the Media Lab, and they have been working with me,” said Mr Mistry. Some of the potential applications could include real-time surgery using SixthSense, besides, bundling mobile phones with software, which will empower users to try different applications.

How should you safely outsource pharmacovigilance to an Indian contract research organization?

Published in hte Indian Journal of Pharmacology. Edwards B. How should you safely outsource pharmacovigilance to an Indian contract research organization?. Indian J Pharmacol 2008;40:24-7

The articles focus on different types of CRO that operate in India and the concerns western companies should address before deciding to oursource the trial to Indian companies.

exerpts from the article

The heterogeneous concept of a Contract Research Organization (CRO) in India is that, a CRO might refer to independent locally owned CROs, an affiliate of a multinational CRO, one owned by a larger non-healthcare companies (such as an IT company wanting to move into pharmaceuticals), one owned by a healthcare or pharmaceutical company or a hybrid of a CRO and a site management organization. In addition, there are significant differences in costs and capabilities. Only a small number have experience in multinational Phase II and III studies sponsored by US or EU companies. Costs for CRO services can vary by as much as fivefold. For instance, the cost per monitoring visit can vary between $400 and $2500 per visit. Employee turnover can be as high as 60% (a healthy number in a Western CRO might be approximately 10-20%); 95% or more of investigators meet recruitment goals. However, although for US studies query rate are typically 10-20%, the rate rarely exceeds 5%. Thus, there is no cohesive business strategy to develop the Indian pharmaceutical sector with enormous amount of variations in existing CROs.

Sponsors should be aware that high rates of staff attrition and turnover study monitors may well impact a CROs’ safety capability. Previously training in pharmacovigilance and GCP is a major issue with very few training courses in India, resulting in not enough GCP and pharmacovigilance trained personnel. The consequence of these factors may lead to the more experienced sites becoming overloaded with projects and the better investigators conducting proportionately more trials. In addition, the more attractive sites for recruitment may indicate that medical investigators already have a high patient load for their normal clinical practice, squeezing time for research subjects. This point is critical because of the challenge of informed consent from illiterate patients as described in a BBC documentary. Thus, it is critical the CRO industry rises to the Quality challenge by building quality as an integral part of all processes. This indicates that recognizing the costs of quality control and quality assurance checks are essential, not just an overhead.