trends in the life sciences and pharma research and development outsourcing (RDO)

Vicki Phelan, Managing Director, Pharmaceutical and Life Sciences Practice
with Stan Lepeak, Managing Director, Global Research

Trends in the life sciences and pharma research and development  outsourcing (RDO)

The complete report is available at http://goo.gl/MgVBu

Oracle Business Intelligence Enteprise Edition (OBIEE) for Clinical Trial Management System (CTMS)

Oracle Siebel CRM is the base application behind Oracle’s Siebel CTMS.

Prepackaged OBIEE Applications does not have a module for Clinical Analytics and so there is a need to develop a complete custom OBI application in order to accomplish the requirements. This was untill Oracle has introduced Oracle Clinical Development Analytics (CDA) which is based on OBIEE+

Oracle CDA includes prebuilt data models, prebuilt Extract-Transform-Load programs sourcing from Oracle Clinical / Remote Data Capture and Oracle’s Siebel Clinical Trial Management System

Business Intelligence can be deployed in several Core functions

  • Protocol Design and Study Start-Up
  • Patient and Investigator Recruitment
  • Clinical Trial Management
  • Clinical Data Management
  • Data Analysis
  • Clinical Supplies
  • Regulatory and Safety

Nonclinical Use of  Business Intelligence in Clinical Trial
There are a number of ways in which business intelligence as a technology platform can be used to support the pharmaceutical value chain. There is ample evidence to show how business intelligence has been used successfully in a number of areas including:

  • Sales and Marketing
  • Manufacturing
  • Finance
  • Human Resources
  • Information Services
  • Executive and Portfolio Management

Clinical Use  of  Business Intelligence in Clinical Trial
Within clinical research, the strongest use of technology is in pre-clinical research, clinical, statistical programming and supporting other groups such as:

  • Data management (patient profiles)
  • Medical writing
  • Finance
  • Project management
  • Patient registries and post-marketing surveillance

 

Without CDA an OBIEE architect needs to understand CRM data model and also the actual business process flow of a CTMS application.It is observed that usually there is a customization to an extent of 25% on the CRM application.

Original Old Article on OBIEE for CTMS which was the only Business Intelligence solutions for Clinical trial management before Oracle announced CDA is Available at http://www.obieetalk.com

Requirements gathering sessions must be interactive with group of SME’s, Team of members from business, project sponsors to mitigate any risk of
slipping the time lines. It is recommended to plan for regular client reviews and approvals of every build to avoid any gaps in the expectations by the client .

At a high level the reporting requirements may include tracking budget and finance, clinical trials, activities, investigators,Initiations, enrollments, expiration’s, terminations. Cross dimensional hierarchies from Program to Protocol to Site to Subject is commonly desired.

Major dimension tables specific to CTMS includes Program, Protocol,Site,Subject, application, Investigator. Other common dimensions include Accounts, Contacts, Activities, Time, Geography,product, etc.

Here is a screen shot of a sample rpd for CTMS

Microsoft in Clinical Trials Management System (CTMS) and Electronic Data Capture (EDC)

one of the very few interesting article by Microsoft Engineers on Clinical Research Industry. Certainly interesting as it is written by none other than      Les Jordan-CTO, Life Sciences Industry Unit at Microsoft . Microsoft and IBM had much longer and deepr association with Lifescience/Healthcare/Bioinformatics industry than Oracle.

But I love to see microsoft grow beyond Sharepoint for Clinical Research and the BioIT alliance. Also love to ask microsoft what is the current status of some of those applications mentioned in the blog by Les, Especially the Microsoft Clinical Trial Initiation solution

Original article from microsoft website

Interesting how weeks become months when you’re writing and updating blogs.  This CTMS project certainly hasn’t gone away, but it did go on a bit of a hiatus while my “day job” intervened.  Enough excuses.  Mea Culpa.  On to the fun!

As we discussed in the previous post, the key to a clinical trials management system is thinking of it in terms of a project – after all, the people who run the clinical trial think of it in terms of a project, and it is measured in project management terms, so why not treat it that way from an architectural point of view?

A second and equally important “requirement” is one that we are increasingly seeing as an industry trend: having EDC (Electronic Data Capture) functionality and CTMS (Clinical Trials Management System) functionality in the same system, or at the very least having EDC and CTMS closely integrate and interoperate.

The clinical trials world of today is fairly fractured.  Think of all the different systems – often standalone systems – that are used by Life Science organizations:

  • EDC – Electronic Data Capture
  • CTMS – Clinical Trials Management Systems
  • CLIP – Clinical Investigator Portals
  • Project – Clinical Trials Project Management
  • Analysis – OK, it’s SAS, but how do you get the data there?  What about real-time analytics?
  • IRB & DSMB – Outside organizations with their own management systems, like a Click Commerce Research Compliance Automation solution?

What if you could have a system that gets close to doing all of that – or at least being able to manage all of it – through one interface?  How much would that save in training costs, integration costs, and implementation costs?

Well – that’s the vision.  Here’s how we pull it off:

  1. Start with Microsoft Office SharePoint Server 2007 and SQL Server 2008 as the foundation to build upon.
  2. As discussed in the last post, we’ll use Microsoft Office Project Server as a way to organize the information and provide us with a trial specific taxonomy, along with roll-up of reporting metrics.
  3. To cover the EDC aspects, we’ll utilize Microsoft Office Forms Server 2007 – which is a web facing InfoPath solution – to handle data entry and front-ending the workflow for data checks, etc.

EDC forms in Forms Server can even handle digital signatures (with compliance and security being the subject of a future post) inside the InfoPath forms.  This has implications for those organizations that are involved with SAFE BioPharma (worth checking out).

The beauty of all of this is that it is all Web Service enabled, which means that you have easier integration mechanisms with existing analysis and EDC systems:

  • SAS – With integration with .NET, SOAP, and Web Services.
  • Medidata – We’ve demonstrated use of their Web Services API module that utilizes CDISC.
  • Perceptive Informatics – At the DIA annual meeting a couple years ago, we did a demonstration using DataLabs (now Perceptive) and InfoPath integration, using Web Services and about 5 lines of code!
  • EHR/EMR Integration – While it is still on the horizon, I think it is getting closer.  Check it out.

Resources to get you started:

Finally – there are other organizations and software vendors that are thinking along these lines.  Check out the following solutions:

Next up in this series:

  • Using MOSS templates for maintaining Part 11 compliance
  • Extranets & Identity Management
  • Architecture Diagrams & Screen shots
  • Validation and compliance

Clinical Trial and Pharmacovigilance process automation

I had posted last month about the Pegasystem pharmacovigilance solution.

Pega Systems the industry leader in Business Process Management (BPM) software solutions, released a Pharmacovigilance case processing software.

Pega has experience in clinical trial space, specifically in Clinical Trial Management. The solution is designed for rapid deployment to quickly leverage existing adverse event processing rules and requirements and can produce specialized documentation to help ensure compliance in a validated environment.

pega.JPG

 

 

 

 

 

 

 

 

I have not come across any new updates after that. But apparently Accenture  has acquired Knowledge Rules, Inc., a Philadelphia-based consulting company that focuses exclusively on implementing and integrating business solutions using Pegasystems’ Business Process Management (BPM) software.

Accenture has a very large Pharmacovigilance division serving several large pharmaceutical companies. It would not be very suprising if Accenture roles out the BPM software for their pharmacovigilance services.

I think that is a possibility because Accenture  has announced plans to use the applications for all its Fortune 500 customers.

I would predict that United Health Group could be one of those customers as they are an existing customer of Pega.

Speaking of which Pega sounds like an attractive target Oracle can acquire

collaborative clinical trials management software for Central Laboratories

Laboratory Corporation of America Holdings…announced…a collaboration between Esoterix Clinical Trials Services, a division of LabCorp, and Clearstone Central Laboratories, a global central laboratory specializing in drug development and pharmaceutical services.…The collaboration provides LabCorp with access to Clearstone’s global network of labs, including China, France, Singapore and Canada, in addition to LabCorp’s existing labs in the United States and Belgium. The companies will collaborate on providing standardized central laboratory testing for clinical trials to their respective clients. The transaction also provides LabCorp access to Clearstone’s clinical trials management system APOLLO CLPM clinical trials management software, enhancing the ability of clients to conveniently send, receive and manage data.

APOLLO CLPM is a secured globally accessible web based, 21 CFR part 11 validated clinical trials management software. Designed and developed by subject matter experts of every applied discipline integral to the system. Built on an Oracle database, the APOLLO CLPM system is a truly singular database that replaces multiple legacy systems and sub-systems, helping to drive improvements in efficiency and quality across the central laboratory business Apollo provides for global standardization of requisitions, reports, kits, barcode labels, as well as scientific information, and improves the accuracy and speed of sample reception and processing

MNC Pharma tries to capture the $1.9 billion Indian OTC market by selling Drugs through India’s 170000 post offices

The multinational pharma companies are planning to approach the health ministry with a proposal calling for the utilisation of the 1.7 lakh post offices across the country to distribute over the counter drugs.

The move if implemented would increase the reach of OTC drugs by 20%.

The plan initially submiited 2 years ago requires  the approval of and coordination between department of pharma under the ministry of chemicals and fertiliser, department of post under ministry of communications and the health ministry.

The Organization of Pharmaceutical Producers of India (OPPI), an association of multinational pharma companies, is in the process of reviving the proposal as top officials at the health ministry have shown interest in discussing it and considering its implementation

The Indian over-the-counter (OTC) medicines market, the 11th largest globally, is pegged at $1.9 billion. It is the second fastest growing market globally with a growth rate of around 9% per annum.

Ranjit Shahani, country president, Novartis gives the analogy of the how petrol pumps have metamorphosed into multi-utility centres in last two decades. “One simple legislation can change that for over the counter medicines,”

Would you support this, even in US where people are more educated and FD keeps a watch on drug advertisement , people are often misguided.

India is yet to come up with a strong and comprehensive adverse drug event reporting infrastructre.

Scott Stern Kellogg School of Management speaks about “New Drug Development: From Laboratory to Blockbuster to Generic,”

Scott Stern, Associate Professor, Kellogg School of Management, speaks on the topic of, “New Drug Development: From Laboratory to Blockbuster to Generic,” at the Judicial Symposium on The Pharmaceutical Industry: Economics, Regulation, and Legal Issues, hosted by the Northwestern Law Judicial Education Program

Widespread fraud in the Clinical Trial of Drugs is pervasive event in United States

There have been several cases where Fraud in clinical trial has questioned the  Integrity of Data and ethics , when conducting clinical trial in India, which have been used by crusaders against outsourcing. But the new evidence suggest that the clinical trial fraud is more prevalent even in US. The most recent being MannKind Corporation Accused of Covering Up Adverse Clinical Trial Results

India’s poor history on adhering to patents, strong legal system, and the image of corruption means, any fraud in conducting clinical trial in India will invite serious punishment from FDA and western world. Yes we can cry that we will be singled out , or we can take necessary steps to avoid incidents such as above

MNC pharma MannKind is accused of Data Fraud Coverup  in securing FDA approval for Afrezza the inhaled insulin drug. A senior manager uncovered unlawful clinical trial conduct pertaining to the company’s Afrezza inhalant insulin device.  John Arditi, who was MannKind’s senior director of worldwide regulatory affairs, filed a wrongful termination lawsuit against his former employer, in New Jersey Superior Court, claiming he was unfairly fired by MannKind after internal audits he conducted in November 2009 uncovered “potential fraud and scientific misconduct” involving Afrezza clinical trial data

Arditi discovered discrepancies in data at both a Russian and Bulgarian trial site, according to his lawsuit.  For several months, Adverse event results were either not being recorded properly, or were fabricated to favor the approval of Afrezza.  Arditi’s lawsuit asserts that he informed superiors at MannKind, on November 9, 2009, of his adverse findings and encouraged the company to approach the U.S. Food and Drug Administration (FDA) but MannKind did not contact the agency because negative information would delay approval of the New Drug Application (NDA) for Afrezza.

The new revelation on MannKind Afrezza Clinical Trial that emerged last week , comes just days after the report published by The Council for Clinical Research Subject Safety & Data Integrity (CCRSSDI)  on widespread fraud in the Clinical Trial drugs by pharma and CROs in Unites States.

Two time Emmy winning reporter Kathy McDevitt led an investigative team from The Council for Clinical Research Subject Safety & Data Integrity (CCRSSDI), to record Subjects committing fraud. Her investigation led to on-air confessions by two such subjects on the nature and the extent of the fraud in the industry

Ms. McDevitt and CCRSSDI have jointly released a documentary tilted “Pervasive Fraud in the Clinical Trial World” . It is available on the CCRSSDI website. Copies of the DVD may also be requested by the video.

Among the findings in the documentary:

  • Multiple simultaneous trial enrollments by Subjects
  • Inability of research sites to check for dual clinical trial enrollments
  • No single record of all the studies a subject has taken
  • Inability to verify amount of actual drug usage by a Subject in a Study
  • Potential for flawed results in Studies

Watch the Documentary on YouTube

“I was shocked by how lax the identification process is for potential Study Subjects”, said Kathy McDevitt. “I always had assumed that a thorough identification and verification was required to enroll qualified patients in studies for drugs that you and I take”

Kerri Weingard, the Director of CCRSSDI, further adds “We here at the Council have consistently raised this issue. Many members of this Council run their own Study Sites and we have seen the level of fraud increase year after year. Unfortunately, no steps are being taken by the industry as a whole to combat this problem. If this problem is left unchecked, the whole industry will suffer and public confidence in our Drug Testing process will be fundamentally undermined”

CCRSSDI has led the charge on this issue. Its charter clearly defines that the primary goal of CCRSSDI is to ensure that every study by every site and every sponsor utilizes and identification and verification process to ensure that there is no fraud occurring and that subjects are not dual-enrolled or have been expelled from previous studies.

Download the explosive documentary “Pervasive Fraud in the Clinical Trial World”, at www.CouncilForClinicalResearch.com

For further information please contact Kerri Weingard, Director, Council for Clinical Research Subject Safety & Data Integrity at KWeingard(at)CouncilForClinicalResearch(dot)com or 646-225-6624

Council for Clinical Research Subject Safety & Data Integrity is composed of established members of the medical profession. Its goal is to ensure that our testing process for Clinical Research Trials remains error free and that Subject Safety is always assured. meetings are open to all. For further information please email  at info@CouncilForClinicalResearch.com.
ONE of Australia’s most senior cancer specialists has accused pharmaceutical companies of manipulating some clinical trials of medicines for commercial reasons, including deliberately delaying the release of negative findings and being reluctant to fund research into the toxicity of their drugs.  More details

Professor Stephen Clarke, who has conducted clinical trials involving humans for 15 years, agreed to speak publicly for the first time because he said it was essential for governments to fund trials of great public importance rather than leaving critical research solely to drug companies.

A number of researchers who spoke to The Age agreed, saying commercial decisions meant the public did not always get the full picture about a drug’s usefulness and safety.

Other more high profile clinical trial related issues in recent past are PPD Inc responsibility in Ketek Trial for Aventis

The FDA found the fraud 2002 in a trial supervised by PPD, the doctor was indicted 2003, convicted 2004 and Ketek was approved 2004 by the FDA using the faulty data. It wasn’t until early 2006 that liver problems in patients using Ketek came to light and subsequently, the continued reliance on the fraudulent data. Congressional hearings were called for in 2006 which were held 2007 and again 2008 when Fred Eshelman, founder of PPD testified

The FDA and drug maker Aventis were directly faulted. Eshelman washed his hands. . This clip is one of three showing Fred Eshelman’s verbal responses to questions.

Some of the other high profile cases are

News that Schering-Plough, one of the largest drug companies in the world, has been outright bribing physicians to prescribe drugs and operate sham clinical trials http://www.naturalnews.com/001298.html

University of California findings in the October issue of the Annals of Internal Medicine, that 167 placebo-controlled trials published in peer-reviewed medical journals in 2008 and 2009 and found that 92 percent of those trials never even described the ingredients of their placebo pills.

The Utah Attorney General has filed a lawsuit charging GlaxoSmithKline illegally marketed its controversial Avandia diabetes pill as a new “wonder drug” that would reduce cardiovascular risks for diabetes, but instead increased the possibility of heart attacks. Consequently, the AG alleges Glaxo hoodwinked the state Medicaid program out of $7.8 million, which is the amount Utah spent to purchase Avandia between Jan. 1, 2001 and June 30, 2010

The more recent events in India were

Glenmark Pharmaceuticals and Omnicare have closed a clinical trial site in India operated by the contract research organisation (CRO) amid accusations that an investigator acted fraudulently.

Clinical Trial Fraud – How to Identify and Steps to Handle If Found, events like these makes adherence to GCP and training of CRA, and all stake holders in clinical trial more and more important

SalesForce.com partner introduces CRM for clinical trial management on Force Platform

Had an interesting chat with the CEO of the US based IT service provider for clinical research industry in June. Apparently the company a SalesForce.com partner introduces new CTMS application in India. Just came to know that they are going commercial this month. The applications is aimed at clinical trial management, Study site management and Patient Recruitment in the clinical research industry . Aimed at CROs, Hospitals, University Research centers and clinical trial Study Sites.

The application is based on Force platform by SalesForce and already have few Indian Organization using it for several months. The product will be offered in SaaS/Hosted/Cloud versions, which will render affordable TCO and higher ROI with less or no Capital investmental.

Harvard Medical Schools new automated safety surveillance system provides faster early warnings in the postmarket evaluation of medical device safety

Implementation of a computer-automated safety surveillance system of clinical outcomes registries for cardiovascular devices resulted in the identification of a drug-releasing stent that had significantly higher rates of major adverse cardiac events than similar stents

“Monitoring the safety of approved medical products is of vital public health importance, given that in clinical practice such medical products are often used in numbers far greater and in patient populations more diverse than when studied in premarket evaluations and clinical trials,” the authors write. “Ensuring the safety of medical devices challenges current surveillance approaches, which rely heavily on voluntary reporting of adverse events. Automated surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety.”

“In conclusion, automated safety surveillance of medical devices is feasible using automated monitoring tools applied to detailed clinical registries and can efficiently help identify emerging potential postmarket safety risks. Automated medical product surveillance can complement existing public health strategies, providing an additional mechanism to assess the comparative safety of approved medical products and improve the quality of health care delivered,” the authors write.

 

Original article on

http://www.scientificcomputing.com/news-DA-Computer-automated-System-for-Identifying-Medical-Devices-with-Safety-Risks-111110.aspx

FDA has poor oversight in medical device monitoring and post market surveillance

According to a British Medical Journal, article on the effectiveness of post-market surveillance, medical device manufacturers “often fail to properly conduct safety studies” and the Food and Drug Administration (FDA) “provides scant oversight” in post-approval monitoring of these devices.

The article is published by Jeanne Lenzer and Shannon Brownlee, called  “Why the FDA can’t protect the public,” on British Medical Journal, November 6, 2010.

Lenzer is a medical investigative journalist, and Brownlee is an instructor at the Dartmouth Institute for Health Policy and Clinical Practice.

“Most devices and drugs on the market are supported by studies that are underpowered to detect rare but potentially life threatening events that can kill tens of thousands of people if the drug or device is widely used,” the authors write. “The impracticality of conducting large scale clinical trials before approval for every drug and device places a burden on post-approval surveillance.”

The authors also note that “FDA’s ability to detect potentially unsafe devices is further hampered by the fact that many post-approval studies required as a condition of the device’s approval are not conducted or conducted so poorly as to be meaningless.”

FDA’s Manufacturer and User Facility Device Experience (MAUDE) database is its most “comprehensive source of information about the safety and effectiveness” of medical devices, the authors claim. But they cite several problems associated with this “imperfect tool,” especially “the fact that manufacturers—not the FDA or any other independent body—can decide whether the device is connected with a negative outcome.” Other alleged problems with MAUDE include (i) “the voluntary nature of the reports,” (ii) “fear of litigation by surgeons and others in a position to report the event,” and (iii) “failure by patients and healthcare providers to connect new medical problems with a device.”

In response to the report, an FDA spokesperson reportedly said that the agency considers “very seriously” post-approval device monitoring, that FDA has “a variety of initiatives underway to bolster postmarket surveillance” and that the agency is reworking its 510(k) premarket approval process for lower-risk medical devices.

That FDA response comes  little more than two weeks after the FDA rescinded approval of the Menaflex Collagen Scaffold knee replacement device. The agency admitted that the medical device was approved without being properly researched due to political pressure and the overly flexible requirements of a program designed to fast-track certain devices through the approval process.

It also comes just three months after DePuy Orthopaedics issued a recall for 93,000 artificial hips, which had failure rates of 12% and 13%. Many individuals who received one of the defective hips are pursuing a DePuy hip lawsuit, alleging that doctors were expressing concerns to DePuy about a higher-than-expected failure rate for the metal hip system before the recall. The implants have been found to shed metal particles into the bloodstream, which could lead to cobalt toxicity.

A study by the Government Accountability Office (GAO) released in June 2009 found significant shortcomings in FDA medical device approval procedures, and a heavy reliance on the 510(k) process. The GAO report identified gaps in the FDA reviewing process, deficiencies in the agency’s postmarket surveillance, and also found that FDA has not kept up with regular inspections of medical device manufacturing facilities. Many devices which should be put through the more stringent premarket approval process are put through the premarket notification process instead, the GAO found.

Health Council of Canada says some prescription drugs approved for use in Canada may be less safe than consumers think, due to poor Pharmacovigilance/Post Market Surveillance rules

Canada’s Food and Drugs Act relies on drug companies to submit adverse reaction reports, which drug users submit if they suspect they are experiencing negative side effects. Drug users also can submit the reports directly to Health Canada, but it still leaves the government to rely on outside parties to report problems.

In 2009, Health Canada received 27,496 adverse reaction reports — a number that has increased steadily over time. Health Canada needs the power to require pharmaceutical companies to conduct more post-market monitoring and to share the results, Abbott said. The council also would like to see the federal government hold the power to impose penalties for companies that do not comply.

Health Canada is already modernizing its regulations to allow for stronger monitoring after the drug goes to market. The government also has established a Drug Safety and Effectiveness Network to study the safety of drugs in the market.

The Canadian pharmaceutical industry welcomes modernized regulation, said Mark Ferdinand, vice-president of police research and analysis for RX&D, the pharmaceutical industry association in Canada.

However, Ferdinand said consumers should recognize that there is already a formal, rigorous post-market reporting system in place.

“No one has any interest in seeing a drug used inappropriately in the real world. A lot of people have invested a lot of time, effort, certainly money … to ensure what they are producing and what they are providing to patients is safe and effective,” he said.

Ferdinand said drug safety often depends on the way medicine is prescribed. He said it has to be “the right medication, for the right person, at the right time.”


Site Coordinator’s Role in Clinical Trials Success

Industry Standard Research (ISR) today announced the launch of a new and substantial research report titled “The Voice of the Site Coordinator.” This report presents data and analysis from 124 interviews with Study / Site Coordinators from the US, Europe, Latin America, and Asia.

Kevin Olson, CEO, Industry Standard Research. Olson says “Our data suggest that directly engaging a site’s coordinator is likely to yield both faster recruitment and higher quality data.”

The report provides a detailed analysis of coordinators’ responsibilities; coordinators’ critical perspectives on improving the accuracy of feasibility estimates; and their insights into current patient recruitment practices and how to meaningfully improve them. The report even profiles sites’ uses of – and preferences for – different eDC and ePRO technologies.

“Drug development professionals are forever looking for ways to strengthen their partnerships with sites, and for good reason.

 

Indian Goverment’s Department of Science and Technology launches enhanced clinical research units in colleges

The Department of Science and Technology (DST) will set up enhanced clinical research units in select colleges across India ,

Delivering the valedictory address at the International Conference on Radiation Biology hosted by Sri Ramachandra University, DST Secretary  T. Ramasami said the idea behind the joint inter-agency initiative that also involved the Indian Council of Medical Research and the Department of Biotechnology would upgrade facilities at about a dozen colleges in which medical research is already being pursued.

The DST Secretary  T. Ramasami pointed out that there were only 1.40 lakh scientists engaged in full-time research in a country that had a legacy of Ayurveda, yoga, astronomy and astrophysics.

S. P. Thyagarajan, Pro-Chancellor, SRU, said the Memorandum of Understanding between SRU and the Sylvester Cancer Center, Miami, U.S., that was one of the outcomes of the conference, envisaged collaboration in education, training, research and exchange of faculty and students.

 

Chinese drug discovery market predicted to grow 23% per annum

China’s health and medical industry is advancing rapdily within genomics, combinatorial chemistry and high-throughput screening, China has been recognised as an important location to which drug discovery is being outsourced.

The Chinese drug discovery market reached US$315.0 million in 2009 and is predicted to expand at a compound annual growth rate of 23% from 2009 to 2016.

China has opportunities for scientific expertise and complete infrastructure, which are important for drug discovery activities. Separate from India, China is also viewed as a profitable market, this will assist pharmaceutical companies improve drug finding at a reasonable cost.

 

Eli Lilly CIO Michael Heim says Lilly will increase use of cloud computing in clinical data management

Eli Lilly’s CIO Michael Heim says that the drug giant’s right to know where in the cloud its data resides, and to know the provider’s disaster recovery plans are chief issues that will drive the use of cloud computing in clinical data within drug discovery and development projects.

An interview with Michael Heim is available at InformationWeek

Clinical approval success highest for smallest firms among the top 50 Pharmaceutial companies

The top 10 pharmaceutical companies out of the world’s top 50 have lower estimated overall clinical approval success rates than do smaller firms in that group, but nonetheless appeared to have some R&D productivity advantages, according to a new study completed by the Tufts Center for the Study of Drug Development.

Despite experiencing lower overall clinical success rates, the top 10 firms terminated a greater proportion of their failures in early stage clinical testing, compared to the other 40 companies in the group, the study found. Failing early lets developers redirect resources into other projects and avoid more costly later stage failures.

While the very largest firms had lower approval success rates, they did make the decision to terminate earlier in the development process, which can help improve productivity of their new product pipelines.

The study was based on 1,734 compounds that entered clinical testing between 1993 and 2004, for the top 50 companies, which had 2006 revenues of more than $1 billion. The timeframe allowed for analysis of the full development cycle. Clinical approval success rate is the share of investigational new compounds entering clinical testing that eventually obtain FDA marketing approval.
The study, reported in the September/October Tufts CSDD Impact Report, released today, also found that:
1.  Small molecules accounted for 85% of the drugs that entered the clinical pipelines of top 50 pharmaceutical firms in the 1993-04 period.
2. Large molecule clinical approval success rates outpaced small molecules by nearly 2:1 for each top-50 pharma size group examined.
3. Across all top company size groups, transitioning compounds from Phase II to Phase III was a substantial hurdle.

the study is available at http://csdd.tufts.edu/

personalized medicine might be making drug development more complicated

According to a new report from the Tufts Center for the Study of Drug Development at Tufts University 12 to 50 percent of the drugs companies are developing, depending on the company, involved a personalized medicine approach.

The Tufts report is based on a survey of 25 companies, large and small, to which 16 companies responded, as well as interviews with representatives of 13 companies.

Relatively few drugs are now accompanied by such so-called companion diagnostic tests. They are most common in oncology. The breast cancer drug Herceptin, for instance, is given only to women whose tumors have an abundance of a protein called Her2.

According to the report Other key therapeutic areas in which personalized medicine is making headway include cardiovascular, central nervous system, and immunologic therapies, whereas personalized medicine development is just getting started for metabolic and respiratory therapies, as well as virology.

 

Paper instead ‘chips’ may be used as medical testing devices to fight disease

George Whitesides, a Harvard chemistry professor has designed technology in which patients’ blood is dropped on a piece of paper, and water-repellent ink resembling that of a comic book creates diagnostic colors on the other side, CNN reports. The technology may be incorporated into mobile phones, according to CNN.

Whitesides’ prototype allows for testing of STDs and non-sexually transmitted diseases, including HIV, malaria, tuberculosis, hepatitis and gastroenteritis.

 

UK’s Medical Research Council grants Clinical Research consortium $6.4 million to develop chips & software to use mobile phones/PCs as testing devices for sexually transmitted disease (STD)

UK’s Medical Research Council grants a Clinical Research consortium $6.4 million to develop chips & software to use mobile phones/PCs as testing devices for sexually transmitted disease (STD)

If successful individuals will drop their blood, urine or saliva on a mobile chip, which they then insert into a mobile phone or PC. Software on the phone or PC then delivers a diagnosis, schedules a clinic appointment or sends an electronic prescription to a pharmacy. Consumers will be able to purchase the chips in vending machines or at a local pharmacy

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