Life Sciences at Oracle Open World 2010

Learn more about the strategic dynamics of Life Sciences at Oracle Open World 2010, from September 19-23. Attend the Life Sciences track to learn how Oracle’s powerful combination of technology and comprehensive business applications can help you address key challenges such as costly, high-risk discovery periods and shrinking patent expiration limits.
Leading life sciences organizations will discuss how they are moving toward modernizing their
business process, architecture, and technology infrastructure in an attempt to address the challenges faced by the industry today. Find out more and register here: http://bit.ly/a1thgy

How useful would be the Single-patient clinical trials for improving the hopes of Personalized medicine

Single patient Clinical Trial are not new idea, FDA did not focus since such trial canot prove the efficacy and safety of medicine over a large pool of patient with sufficient data. But I was forced to re-think after reading the article http://www.technologyreview.in/biomedicine/12537/ why cant we use the the concept mentioned in to overcome the ethical and other challenges in current mode of trials.

So I decided to ask the question to the linkedin audience http://www.linkedin.com/answers/technology/biotech/TCH_BIO/667022-9262868?browseIdx=0&sik=1272969161323&goback=.amq

GE Healthcare announces SaaS Electronic Medical Records Management

http://newsroom.gehealthcare.com/

GE Health Care is rolling out a new, cloud-based platform that makes it easier for physicians with small practices to maintain and keep track of the electronic medical records of their patients. The new SAAS offering is part of GE’s Centricity offering.

Introducing Centricity Advance
Colonnades Family Medicine is running on Centricity Advance, a web-based EMR solution launched today by GE Healthcare and specifically designed for the smaller physician practice.

Unlike most clinical and financial management solutions, Centricity Advance is a web-based service that costs less than a standard client-server software deployment and is maintained and supported with little or no strain on the healthcare provider’s resources, freeing up more time for patient care.

Ideal as a Web-Based Service
The fact that Centricity Advance was designed from the ground up as a web service is significant. Instead of simply providing web-based gateway into a standard EMR application, the Centricity Advance is created with anywhere/anytime access in mind, resulting in an intuitive and efficient interface without sacrificing functionality. Since system management is centralized as part of the Centricity Advance service, small practices don’t have to worry about data protection, updates, equipment failures and other typically stressful responsibilities of user-driven IT management.

Another key feature of Centricity Advance is the Patient Self-Service Portal, which connects patients to their care. By using their own secure password to log in, patients can communicate privately with their doctor and view their own information such as statements, prescriptions and lab results. Patients can also request and confirm appointments, request prescription refills and get automatic reminders for immunizations and lab tests.

Grid computing projects supported by Big Blue announced significant progress in looking for new potential drugs in cancer treatment

http://www.cioupdate.com/features/article.php/3888281/IBM-Volunteers-Help-Locate-Anti-Cancer-Drugs.htm

22 Million Australian Cloud computing initiative to benefit life science researchers

The Australian Research Collaboration Service (ARCS) www.arcs.org.au has launched its Computer Cloud scheme, a $22 million project funded by the government’s National Collaborative Research Infrastructure Strategy.

More details check http://www.arcs.org.au/index.php/services/cloud-computing

Bob Correll, the chief information officer for the Department of Immigration and Citizenship, said his agency is also looking into using cloud computing for its electronic visa system

GSK, MedTrust launch iPhone/iPad app for cancer trials

GlaxoSmithKline has teamed up with MedTrust Online,  provider of specialist data and technology to oncologists, to launch CancerTrialsApp, described as “the first free geo locating cancer clinical trials application” for the Apple iPhone and iPad.

The application enables cancer doctors to find and share with their patients information about experimental therapies in clinical trials

F.D.A. Says Millions Got Unapproved Drugs, Should the new bioequivalence and bioanalytical guidelines for 2010, be made more stringent

Plans by  FDA to Adopt stricter standards for Bioequivalence, Bioavailability for generic drugs could sound trouble for Indian Generic Manufactures. Already most of the smaller companies are finding it difficult to get FDA approval letters. QSR Draft Guidance An industry working group has urged the FDA to consider adopting its guidance to outline quality system requirements (QSR) for bioequivalence and bioavailability testing during drug clinical trials.

There was a recent report in NY times that mentioned about several thousand patients receiving nitroglycerin tablets that were not approved by FDA http://www.nytimes.com/2010/03/27/business/27nitro.html

FDA recently evaluated 2070 human studies conducted between 1996 and 2007. These studies compared the absorption of brand name and generic drugs into a person’s body. These studies were submitted to FDA to support approval of generics. The average difference in absorption into the body between the generic and the brand name was only 2.3%. Some generics were absorbed slightly more, some slightly less. This amount of difference would be expected and acceptable, whether for one batch of brand name drug tested against another batch of the same brand, or for a generic tested against a brand name. In fact, there have been studies in which branded drugs were compared with themselves, as well as with a generic. As a rule, the difference for the generic-to-brand comparison was about the same as the brandto- brand comparison” (www.fda.gov/ Drugs/ResourcesForYou/Consumers/ BuyingUsingMedicineSafely/Under standingGenericDrugs/ucm167991. htm)

Fore more updates attend the event below

Attend the http://www.informaglobalevents.com/event/beba

New microarray chip improves drug safety, helps stop animal testing

Jonathan West a micro-engineer and his colleagues at the University of Dortmund in Germany, has  developed the new microarray chip which can test an estimated 30,000 chemicals  their toxicological risk.

Called a Network Formation Assay (NFA), the chip lets researchers test compounds faster and more reliably. A normal drug test takes up to 10 hours because each compound is tested 30 times at 10 different doses. With this new chip, it will take just a few hours at most.

This approach involves patterning neuronal cells within a hexagonal array to standardize the distance between neighbouring cellular nodes, and thereby standardize the length of the neurite interconnections. This feature coupled with defined assay coordinates provides a streamlined display for rapid and sensitive analysis

The invention includes a new protocol for the detection of the neurite outgrowth, which requires neither fixation nor staining of cells.

For details contact

http://www.provendis.info/?id=496&L=3

http://www.rsc.org/publishing/journals/LC/article.asp?Type=AdvArticle&Page=0&GA=on

FDA launches “Basics” transparency microsite

The FDA unveiled phase 1  of its transparency initiative with the launch of FDA Basics, a microsite aimed at demystifying the agency’s workings for the public.

It’s the first of a 3 phase transparency initiative launched FDA as part of the Obama Administration’s broader commitment to openness.

Phase 2, will deal with disclosure of sensitive information like clinical trials and postmarket surveillance data,

Phase 3, dealing with the agency’s transparency to regulated industries, will be completed by 2010 mid

NVidia to launch a touch screen Android OS PC powered by 8 core chip that runs for 25 days

NVIDIA and Notion Ink, launches ‘Adam’, a touch screen tablet at the Las Vegas Consumer Electronics Show in January 2010, a high-tech IT product that was completely developed in India, marking the country’s big entry into product development.

With NVIDIA’s Tegra system-on-chip at its heart, Adam is a device the new generation technology user dreams of. Its battery can work for 25 days. It will have only a screen and no physical key board. One can manoeuvre the cursor using the finger commands from the front or at the back. It will have a camera that can rotate to take pictures and videos, or for video chat. It can talk to other smart devices, including phones.

Tech Spec

OS                            Google Android
General                 2G , 3G Network Triband UMTS/HSDPA GSM 850/900/1800/1900
3G Network          HSDPA 1700 / 2100 / 900
Status                    Available. January 2010
Size                        Dimensions     6.3 x 9.8 x 0.6 inches , 1.7 pounds
Display                 10.1 inch display capable of displaying 1024 x 600 pixels, Full HD capability Digital Compass, Accelerometer, Proximity,     Ambient light, Water sensors
Memory
Internal                Solid State 16/32 GB storage, can be increased further with SD card
Card slot               microSD,
Data                     GPRS     Class 32
3G                         HSDPA, 10Mbps; HSUPA, 2Mbps
WLAN                   Wi-Fi 802.11 b/g, DLNA
Bluetooth              Yes, v2.1 with A2DP
Connectivity           USB, HDMI,
Sound                   a 3.5mm headphone jack and a microphone input
USB                     Yes, v2.0 microUSB
Camera                  Primary     3MP, 2576×1936 pixels,
CPU                     eight-core NVIDIA’s Tegra T20 system-on-chip
GPS                     Yes, with A-GPS support;
Battery                Standard battery, Li-Ion 1320 mAh (BL-5J)
48hrs standby on its integrated rechargeable Li-Ion battery,
8hrs of HD video playback and 16hrs of internet surfing over WiFi
25 Days on Music play

6.3 by 9.8-inch device works on Google’s Android and Mary Lou’s Pixel Qi that offers a paper display, putting no pressure on the eyes. With 1024X600 wide SVGA colour resolution, the screen contains finger-print-resistant oleophobic coating. With a capacity of up to 32 GB flash drive, it would have SD card support, a digital compass, GPS and Wi-Fi.

It can run for 25 days if one wants to listen to just music. It can run eight hours of high-definition video or 16 hours of Wi-Fi Web use, Rohan Shravan, founder and Director, Creatives, of Notion Ink, claims.

The half-inch thick device is likely to be priced at USD$ 300. The device would be connected to specially-devised servers called Genesis.

How they managed to tackle these challenges one by one could be a good case study for wannabe entrepreneurs.

With angel funding from an IT consultant, the team started looking for people to work on the project. They needed about 50 engineers, both hardware and software.

After discussions with several colleges, they tied up with BVRIT, a technology institute not very far from the Hi-Tec City, the hub of all the IT activity in Andhra Pradesh.

The arrangement was simple. Notion Ink would utilise the lab as its development centre and the students as its workforce, while the students get training in the industry-ready technologies such as Android and cloud.

“We then roped in the National Institute of Design (at the Bangalore Research and Development campus) to discuss the user interface that should go into the next generation tablet,” Shravan explains.

As some of them got down to the task of planning the design, internal architecture of the product, HR aspects and infrastructure, the remaining members of the team went to the US and Taiwan to address the hardware and manufacturing needs. While they joined hands with NVIDIA for Tegra, they teamed up with TPK for touch screens and another Original Device Manufacturer for manufacturing the complete product.

Seeing a good idea, NVIDIA offered to handhold the team. “Theirs is a brilliant idea and we have seen the burning desire in them to create an innovative product. It has got good potential in India in the fields of education, entertainment and telemedicine,” J.A. Chowdhary, Managing Director of NVIDIA India, points out.

After nearly a year’s hard work and consuming all the monies they earned for a year or two before Notion Ink, the team has not run out of steam as yet.

They are now busy testing the device with some telecom companies for cross-check connectivity issues.

“We are going to get the first batch of 60 Adams. We are in talks with content providers and have signed pacts in some segments. These tie-ups will be for content delivery and content aggregation,” Shravan says.

Looks like Notion Ink will be competing with a similar system laucnhed by Converged Devices

Android 2.0 Eclair
186mm x 158mm x 18mm
7″ Touchscreen
NVIDIA Tegra
512 DDR / 512 NAND
1.3 MP Web Cam
4GB Internal SD (non removable)
Micro SD
Bluetooth 2.1
Wireless 802.11 b/g
USB 2.0
2g/3g Data
Cellular
3.5mm Audio Jack
Accelerometer
Ambient light sensor
Dual digital microphones
FM Radio

More news

http://notionink.wordpress.com/

Research on plants to produce pharmaceutical drugs

I have got too lazy after I started using twitter. So instead of posting  news story in my blog I just updated my twitter @clinicalsearch about  Dr Josh Mylne from the Institute for Molecular Bioscience (IMB) at University of Queensland receiving research fund to support research on plants to produce pharmaceutical drugs http://digs.by/10R9

My first thoughts about the news was,  there is already a science called Ayurveda that uses the plants themselves. But of course that’s ancient science and does not offer huge commerical potential and yes, where is the green cover to create enough medicinal plants.

Surprisingly FDA and USDA has an ongoing work to produce draft guidance for industry in the production and use of pharmaceutical producing plants.

Not Surprisingly there is an article that dates back to 2004, requesting for a ban on Plant-based Transgenic Pharmaceuticals refered at the time as pharm crops.

But today the idea is gaining momentum again, in Feb 2009 SmartCell, an EU-funded project, has been awarded EUR 6 million to develop tools to synthesise valuable pharmaceutical products using plant cells.

One in 10 hospital prescriptions in UK ‘is wrong

I am not concerned about the number of mistakes made in UK hospitals. As a pharmacist I am concerned, if UK has such a high rate of medication errors, then what would be the rates in countries like India, where Pharmacists almost never over ride the prescriptions and physicians treat more than 100 patients every day.

Read about the study published in Gurdian which states that   Doctors in UK make mistakes in about 8% of the prescriptions they write for hospital patients, and depends on pharmacist and nurses to correct them- the study was commissioned by the General Medical Council (GMC).

http://www.guardian.co.uk/commentisfree/2009/dec/03/prescription-errors-junior-doctors

http://www.timesonline.co.uk/tol/life_and_style/health/article6942289.ece

http://www.guardian.co.uk/society/2009/dec/03/junior-doctor-prescription-mistakes-study

Indian Government to make biometric ID mandatory for clinical trials

Hit with allegations in the western media about unethical practices in conducting clinical trials, The Indian government and regulatory authorities are making a bolder move planning mandatory biometric identification for clinical trial volunteers in India.

The Ministry of Health and Family Welfare plans to ask all clinical research organisations to enforce biometric identification for the volunteers they recruit for their clinical trials, according to officials at the ministry. Data from the trials will then have to be made available for scrutiny by regulators, civil society groups and the clinical trial industry.

Incidently the government is already started working on a The national Unique Identity Card project (popularly called UID project), mooted on the lines of Social Security Numbers in US.  Heades now by former Infosys CEO Nandan Nilekani who said to have influeced the Book the World is Flat by Friedman. The Indian UID project is project is expected to cost $ 30 Billion USD.

According to the plan, govt proposes to issue a unique identification number to all citizens by 2011. The Unique Identification Authority of India shall own and operate the unique identification number database and also look after its updation and maintenance on an ongoing basis. In the beginning, the UID number will be assigned based on the National Population Register or electoral rolls. Photographs and biometric data will be added to make the identification foolproof

read on the details at http://www.business-standard.com/india/news/govt-may-make-biometric-id-mandatory-for-clinical-trials/378554/

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

———————————–

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.

———————————–

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

————————————

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

————————————

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

————————————

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.

————————————

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 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

%d bloggers like this: