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
• Understand how time savings were achieved in the provision of data to monitoring committees
• Realize the benefits of working together where activities are outsourced and how the latest technologies can derive benefit

Register today for this thought-leading event!

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
  
• How current regulations and guidance apply to your particular situation
  
• 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
  
• The 6 types of adult online consumers
  
• Social media advertising trends
  
• How brand reputation is affected by growing product awareness, patient interaction and portability
  
• Social media tools — which are high risk, which are low risk
  
• Developing an innovative social media monitoring program
  
• Using social media monitoring and text mining to create models and identify consumer trends
  
• And plenty more!

Because this seminar is web-based and totally interactive, you’ll have plenty of opportunity to email all your questions and receive answers before the session ends.

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
  
• Sales and marketing professionals
  
• Medical affairs personnel
  
• General/corporate counsel
  
• Regulatory/legislative affairs professionals
  
• Communications/public relations professionals
  

Register now!

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.

Webinar Details
Date:	Thursday, Nov. 19, 2009
Location:	Your office or conference room (no need to travel!)
Time:	11:00 a.m. – 12:30 p.m. EST 10:00 a.m. – 11:30 a.m. CST 9:00 a.m. – 10:30 a.m. MST 8:00 a.m. – 9:30 a.m. PST 4:00 p.m. – 5:30 p.m. GMT
Price:	Webinar PLUS Audio CD and Transcript: $527 — Best Value! You’ll have access to one log–in and dial–in for the live 90–minute webinar for unlimited participants! You’ll also receive all presentation materials and the opportunity to ask questions by phone and email, PLUS an audio CD and written transcript of the entire session. Webinar Only: $327 You’ll have access to one log–in and dial–in for the live 90–minute webinar for unlimited participants! You’ll also receive all presentation materials and the opportunity to ask questions by phone and email.

Register Today!
Please mention priority code 09N06 when registering.

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Can’t Attend?
Choose between the Audio CD and transcript or listening in on the Encore presentation:

• Audio CD and Transcript Only: $327 (plus shipping and handling)
  You’ll receive an audio CD, written transcript of the entire 90-minute audioconference, including the Q&A period, and all presentation materials four weeks after the session.

• 24/7 ENCORE™ Audio Presentation: $327
  You’ll have access to one dial-in for an archived recording of the entire 90-minute audioconference, including the Q&A period, for unlimited participants. You can dial in any time of day or night for three weeks, from Nov. 23 – Dec. 11, 2009. You’ll also receive all presentation materials.

FDAnews offers a variety of webinars and audioconferences to keep you and your staff current on today’s most important regulatory, legislative and business issues. Click here to view a complete list of the topics available and register today.

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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.

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.

According to information from the The Contract Research Organization Union China (CROU) under the China National Pharmaceutical Technology Market Association, it is developing the first industry standard for the Chinese CRO sector, Guidelines for Clinical Trial Services of Contract Research Organizations. Currently drafting of the document is already completed and it is likely to be introduced before the end of this year.

The Guideline was formulated with references to relevant WHO documents, ICH-GCP, the Drug Administration Law of China, Provisions for Approval of Drugs, and Guidelines for Quality Control of Clinical Trials (Chinese GCP), according to Gong Yanhua, Secretary General of CROU.

Members of the technical work group are mostly experts from leading clinical CRO such as Quintiles and Pharmanet, while those of the academic advisory group are mostly representatives of MNC and leading local pharma companies. As its next step, CROU hopes to establish a technical committee for standardization of clinical trial services of Chinese CROs soon

in preclinical research service, Chinese CROs possess better service capabilities than Indian CROs; whereas in clinical research service, it is just opposite. In process R&D and scale-up synthesis, both countries possess similar capabilities. However, Indian companies possess better skills and capabilities than Chinese companies in formulation, manufacturing and marketing of generic drugs

The pharma outsourcing industries in both countries have grown rapidly in the recent few years. They are currently valued at about $1.42 B in China and $1.77 B in India, respectively; each occupying only about 2% share in the global pharma outsourcing market. On the other hand, both markets are posed to still grow rapidly in the future as they are driven by a number of positive factors. However, China appears to have higher future growth potential than India as it has fewer growth resistors. It will very likely catch and even surpass India after 2010.

At present, India is better than China in small molecule drug R&D and manufacturing. But China is superior over India in biotechnologies including the R&D and manufacturing of macro compounds. India offers better product quality but China has more cost reduction advantage. In terms of investment opportunities, China seems to present more attractions than India as its industry infrastructure and biotechnologies are more advanced.

Indian Council of Medical Research (ICMR) has decided to upgrade the  Clinical Trial Registry of India (CTRI) on par with international standards as per the norms set by the WHO.

Oracle Health Sciences Global Business Videos
1. Neil de Crescenzo, SVP and General Manager, Oracle Health Sciences http://tinyurl.com/yjklays
2. Oracle in Health Sciences Industry http://tinyurl.com/yly257v

MNC pharma companies to control 8% of $20bn worth Indian medicines market by 2015. According to a FICCI study more than 60% of trials in India is conducted by Global Big Pharma companies.  Indian Clinical Research arena is often compared to the Indian outsourcing success and hte wave of BPO industry success in India.

Multi national companies that launched their own captive BPO centres India have now sold them to Indian vendors,  that trend has grown, the likes of , GE, Citi Bank, all have sold their captive centres to Indian vendors

In curent wave or Indian CRO success in clinical research is compared to such trends. There may be a possiblity that the likes of Novartis, Pfizer, Lilly, Sanofi, GSK can sell their captive centres that focus on clinical research to Indian CRO’s.

But for the time being such ambitions by Indian CRO will remain as pipe dream untill they will move  away from “I can do it cheaper and faster than in west”- sales pitch. And gains credibility and resources to offer value added service to Global Pharma

For example Indian CRO can offer backend integration with Indian Medicinal chemistry experts and companies to provide drug re-licencing /re-positioning services. They need to think about offering these value add services. Following are some of the areas Indian CRO’s can look

1. what happens to failed Clinical Trial and how can Indian CRO help Global Pharma to Drug repositioning/Re-profiling of drugs

2. How can Indian CRO provide Pharmacogenomics  services with clinical trial

3. How can Indian CRO help in personalized medicine initiatives

4. Even though it serves the vested interests of Global Pharma how can Indian CRO help in Extending patents of existing drugs with ANDA and NDDS

5. Pharmacovigilance and Post -Market Surveillance for Risk Assesement and Risk Mitigation

6. Data Warehousing and Data Mining by integrating clinical and non clinical data from multiple studies

7. Drug Life cycle management services

8. Generating Key opinion leaders and KOL platform by using data from multiple trials and resources

9. Premarketing Clinical Drug Safety and Risk Assessment

10. Designing Pharmacoepidemiology and Pharmacoecconomics stratgey and Aiding Evidence based pharmacotherapy

Sinnce I am out of the pitch due to fever , I am going to be on my twitter for a while. May be head gone crazy or its the fever, But I was thinking why cant we use the tinyurl.com in Adverse event reporting, i mean the concept . I mean if I dont have to fill every column and row in a ADR report every time and instead just click on one single button which would fill out all entries from a previous matching database and I just have to add what is anything has changed from that.

DBMS Consulting has received an Honorable Mention in the Life Sciences & Health Care Industry Solution category at the Oracle Open World 2009 Partner North America Alliances and Channels Titan Award Ceremony. DBMS Consulting was chosen from among several candidate

details

New Momentum, a leading provider of SaaS‐based anti‐counterfeiting and channel integrity solutions, is working with Oracle to help pharmaceutical companies combat the escalating problem of counterfeit drugs and meet new regulatory compliance requirements.

According to the Center for Medicine in the Public Interest, worldwide pharmaceutical counterfeits are expected to increase by 13% annually nearly twice the pace of legitimate drugs. This means that counterfeit drugs could become a $75B industry by 2010. As these bad drugs flood the market, patient wellness is at risk and so are manufacturers’ revenues and brand reputation. This growing counterfeit problem, combined with the expected federal regulations for serialized drug products and electronic pedigrees, creates significant challenges for pharmaceutical companies.

New Momentum’s CEO, Stuart Clifton, commented, “The best way to meet these challenges is to incorporate internal enterprise and supply chain data with external data on counterfeit suspects and activity. That’s why we’re working closely with Oracle’s Life Sciences team to provide the first solution to offer pharmaceutical companies the ability to track units through the supply chain as well as quickly identify and find counterfeits.”
Oracle is focusing on helping manufacturers with a total solution that includes the ability to serialize each sellable unit and then track that unit through the supply chain via electronic pedigree. By integrating its 24/7 real‐time view of counterfeit suspects, New Momentum expects to help pharmaceutical customers be proactive in their anti‐counterfeiting efforts and comply with serialization and pedigree mandates. Prototypes of this solution will be demonstrated at Oracle OpenWorld, New Momentum Booth #2619A and Oracle Booth #S‐082 from October 11‐15 in San Francisco.

challenge 4 Indian Clinical Research outsourcing, R&D plans because of a new discovery that Indians are genetically not single large population

“Drug companies engaged in clinical trails could be worried as our research shows that many groups in modern India descend from a small number of founding individuals. A common drug may not be the answer, considering the genetic variation in the Indian population. For instance, medicines tested on the Western population may not be effective on the Indian population,” said Lalji Singh, former director of the Centre for Cellular and Molecular and Biology (CCMB) who has co-authored the research findings on Reconstructing the Indian Population History, said on Thursday.

The work, published in the latest issue of Nature, has medical implications for people of Indian descent. More than three-fourths of India’s over one billion people are burdened with genetic disorders. The study shows that Indians have been genetically different from other groups and this could be a major cause of recessive diseases. The incidence of genetic diseases among Indians is, therefore, different from the rest of the world.

That could spell bad news for Clinical Research Outsorucing to India and Indian CRO companies, FDA can request for Pharmacogenomics supplementary data to prove that, Results of clinical trial are applicable to American populations.

“Drug trials should take into account diseases that are specific to the population,” said Lalji. A senior official of a top Indian drug-maker who did not wish to be identified said that pharma companies, the world over, are alive to the issue as the success of clinical trails and the efficacy of a drug hinges on the gene pool.

Ofcourse they knew about it all the time, Indian Ayruvedic medicine was aware that all humans canot be treated for the sames diseases with same treatment, more than 1000 years ago.

The article is available at Nature Magazine

http://www.nature.com/news/2009/090923/full/news.2009.935.html

To gain an understanding of the current state of pharmacovigilance in the industry, Life Science Leader spoke with Sujith Eramangalath, the senior analyst in medical imaging, healthcare IT, and life sciences IT at Frost & Sullivan; Drew Kilpatrick, Ph.D., director of global safety and pharmacovigilance at Kendle; John Loucks, VP of Oracle Health Sciences; Nayan Nanavati, M.S., M.T., VP and general manager, peri- and post-approval research and worldwide head of pharmacovigilance at PAREXEL; and Charles Saldarini, CEO of Sentrx.

The Original Article published at Life Science Leader http://tinyurl.com/yzbqubv

unSAP the Lifescience Industry with Oracle’s Healthy Lead in Lifescience Vericals. According to the latest IDC Insight Report
In the Oracle vs. SAP life sciences battle, Oracle gains a healthy lead. read the full report at

http://searchoracle.techtarget.com/news/article/0,289142,sid41_gci1368762,00.html

‘Translational Research: From Bench to Bedside’ Capitol Hill Breakfast Briefing Hosted by the Council for American Medical Innovation

The Briefing is the second in a three-part series on “Achieving Recovery Through Discovery”

This is the second in a three-part briefing series examining the role of public policy in promoting medical innovation to help our nation recover from health and economic crises.

For details on other briefings, visit: www.americanmedicalinnovation.org. WHO:

Remarks by:

Amy Comstock Rick, CEO of the Parkinson’s Action Network –The Honorable Patrick Kennedy, U.S. Representative (D-RI) (invited) — Debra Lappin, President of the Council for American Medical Innovation — Alan Leshner, Ph.D., President of the American Association for the Advancement of Science (AAAS) — Lesa Mitchell, Vice President of the Ewing Marion Kauffman Foundation

For Regiserting for the next event on October chek the site

http://www.regonline.com/builder/site/Default.aspx?eventid=767604

Oracle’s 3rd Annual Drug Development and Safety Forum 2009

October 21 – 22, 2009

Oracle invites you to the 2009 Drug Development and Safety Forum

At this forum we will be discussing important topics and issues facing the Indian Pharmaceutical Biotechnology, and CRO industry. This event will be highlighted by presentations from key industry thought leaders who will share their perspective on industry best practices as well as their unique experiences.

The content will cover important topics in clinical development, and safety. You will hear how Oracle solutions have enabled organizations in the industry shorten their time to market, gain operational efficiencies, reduce clinical study costs and accelerate insight into action

As a follow up to the success of last two year’s Clinical Development and Safety Forum this year’s event will prove to be a must attend event.

October 21 – 22, 2009

The Leela Kempinski
Sahar, Mumbai, India

To Register Now , contact Sushma at sushma.bs@oracle.com +91 80 4029 1295 (include your name, company, e-mail address, contact mobile number, arrival/departure – dates/time).

Highlights:
•    Keynote Presentations
•    Networking lunch
•    Networking Dinner on the first day
•    Perspectives from industry strategists and thought leaders
•    Hear about business best practices and lessons learned from leading companies
•    A unique networking opportunity with colleagues, industry and Oracle experts

The health ministry of India  is planning to introduce e-governance for clinical trials in four years. The move will enable drug companies that

want to carry out clinical trials in India to register online from any part of the world. Once the required approval for conducting trials is obtained, the companies can also submit research data online to the country’s drug regulator Drug Controller General of India (DCGI), seeking marketing approval for their drug.

To maintain confidentiality, once the data is fed into the Software the software will split the information into components and no one individual would have an access to the complete information provided by a company.

“Confidentiality of the data submitted by companies would be taken care of,” the official added. The software will automatically send relevant data to various departments for clearances.

The drug regulator would deliver online approvals to companies after validating all the information submitted by companies. According to the official, it would take about four years to put the system in place and e-governance is expected to be implemented in the country by 2013.

The government also intends to make use of IT to discourage volunteers to enroll into more than one clinical trial resulting in adverse drug reactions. The government is using a finger printing software available through which clinical trial centres can be interlinked.

The drug regulator has also asked companies to install the software so that they can enroll first time volunteers and avoid drug reactions during trials.

Whats the relationship among hollywood and clinical trial, only thinng I could think of is controversy, money and perhaps the uncertainity of success or failure. I am not aware of any celebrity ever being part of a clinical trial project , till this date. In emrging market (read the BRIC countires) human watch groups accuse Sponosre of trials of targeting the underprivileged for conducting clinical trials and companies violating ethical practices while executing clinical trial project.

Hollywood, Health & Society ¹ is a project at the University of Southern California Annenberg School of Communications, that in association with NCI, provides entertainment industry professionals with accurate and timely information for health storylines.

But that apart a google search did not return any good results. Despite  the fact that many celebritites endorse HIV eradication/ Cancer Research and many other disease eradication and cure research programmes.

Few comments that I heard in the past was Media should be deemed as a tool for education and not for publicity. But what if celebrities like Bollwood Super star Sharukh Khan, who confessed to have an addiction to smoking and Several other Hollwood well knowns who made a de-addiction centre their second home , to become part of a clinical research. Will it not help to allay the fears and educate the public about Clinical Research, yes obviously only if  the sponsor does not use the opportunity to promote other products.

in 2006 the BUPA Foundation UK has awarded the BUPA Foundation Communication Award  to the producer of an all-singing, all-dancing Bollywood-style comedy film that is successfully educatingcommunity about the dangers of heart disease. The award was presented to Dr Rumeena Gujral, a trustee of the South Asian Health Foundation.