Novartis, Pfizer, and Eli Lilly partner for new clinical trial software platform

57% Americans would be interested in participating in a clinical trial. However, most clinical studies struggles to recruit sufficient patients. The issue has attracted a number or software as well contract service firms that specialize in clinical trial recruitment, even using social medial tools. Then there is long going debate and efforts for integrating EHR data into clinical trial and identifying potential suitable target population of patients directly from de-identified EHR data

In order to connect patients and researchers, Novartis, Pfizer and Eli Lilly and Company, are partnering in the U.S. to provide a new platform to improve access to information about clinical trials. The platform will enhance clinicaltrials.gov and is expected to be launched by early 2014 with a database of about 50 clinical research studies from the participating companies.

The new platform will provide more detailed and patient-friendly information about the trials, including a machine readable “target health profile” to improve the ability of healthcare software to match individual health profiles to applicable clinical trials.

As part of the project, patients can search for trials using their own Blue Button data. To preserve data privacy de-identified Blue Button data, used only as an “index to search,” will not be stored anywhere outside of the patient’s application.

Other sponsors of clinical research studies may upload information about their trials, while software companies develop tools to deliver this information to interested patients.

India announce new formula for compensating death during clinical trials

 India has released formula to determine quantum of compensation in cases of SAEs of deaths occurring during clinical trials

The formula is available at (http://www.cdsco.nic.in/formula2013SAE.pdf)

The Guideline is available at (http://www.cdsco.nic.in/compention.pdf)

As per the new rule the compensation is calculated as

Compensation = B * F * R/99.37

Here, B = Base amount (Rounded) which is fixed as INR 800000. This base amount has been fixed with consideration of minimum wages act.

F = Factor depending on the age of the subject as per the Annexure given, which is based on Workmen Compensation Act.

R = Risk factor depending on the seriousness and severity of the disease, presence of co – morbidity and duration of disease of the subject at the time of enrolment in the clinical trial between a scale of 0.5 to 4.0 as under:
0.50 – Terminally ill patient (Expected survival not more than 6 months)
1.0 – Patient with high risk (Expected survival between 6 to 24 months)
2.0 – Patient with moderate risk (Moderate risk if not defined)
3.0 – Patient with mild risk (Mild risk is not defined)
4.0 – Healthy volunteers or subject of no risk

Here, 99.37 is the factor for age 65 in the table of worksmen compensation act. The concept used is that the base amount INR 8,00,000 should refer to the age of 65 years which corresponds to factor 99.37.

Thus, considering an example:
If the age of the subject is 30 years, the factor F as per the factor given in the table comes to 207.98
If the subject is Healthy, R = 4.0
Thus,
Compensation = 8,00,000 * 207.98 * 4.0 / 99.37 = 6,697,554/-

However, in case of patients whose expected mortality is 90% or more within 30 days, a fixed amount of INR. 200000 should be given.

If calculations are done, the compensation amounts range from Rs. 400,000 to a maximum of Rs. 7,360,000 depending on the following factors:
a) Age
b) Risk factor

The CDSCO has still not released any clarity on the calculation of compensation amount in case of clinical trial related injury (Which does not progress to death)

Content from email by: SenseCR

Clinical Research Sites Struggle With Increasing Trial Complexity yet most depend on, Google (or other search sites) as the primary information tool

A new survey of 500+ clinical research site professionals outlines the  impact of complex, clinical trials in clinical trial sites. The survey focused on 3-year trial trends and found key challenges in subject recruitment/retention and tracking and reporting data. Increased complexity also impacted trial financials– especially negotiating contracts and managing profitability.

The December, 2010 survey was conducted among investigators, study coordinators and other clinical site professionals from large organizations, such as Mayo Clinic and Johns Hopkins, hospitals like Rush Presbyterian and the Hospital for Sick Children, as well as multi-specialty and private practices. Clinical Research Site Training (CRST), conducted the survey.

Analysis of the survey findings shows that

  • 66% of large organizations report an increase in trials conducted
  • 60% of trial sites report increasing difficulty in managing trial profitability
  • 40% report increasing difficulty in recruiting and retaining subjects
  • Training remains a major issue, even though over 50% report an increase in training
  • 80%+ of nurses want more QA training
  • 60%+ of all respondents want more FDA Audits training

The survey also explored sites’ Web use for work information. In spite of increased specialized Web content about the clinical research site “world”, awareness and usage were both relatively low.

  • Google (or other search sites) was the primary information tool
  • Only the NIH and Clinical Trial Network sites have over 50% awareness among all site professionals
  • Usage of major specialized sites averaged less than 40% for nurses and less than 20% for doctors

CRST suggest that clinical research sites should:

  • Increase training on financial management, site QA, subject recruitment/retention and FDA inspections;
  • Manage the convergence of increased and more complex trials by improving both new staff recruitment and experienced staff retention;
  • Reach out on the Web for new/improved ways of working from both formal information sites and clinical research site communities.”

Full results of the survey are available on the CRST website www.crstnet.com

Contacts

CRST
Lester Levine, 484-798-7503
President
Fax: 215-477-2522
lester.levine@crstnet.com

 

 

PharmaNet unveils touch screen capable data capture platform for Phase I Clinical Trials

The implementation of this platform enables rapid study set-up, automated CRF generation and better study recruitment and communication tools for general and special populations. Mobile workstations allow for rapid data entry and data is captured directly using bar codes and interfaces to medical equipment, such as blood pressure monitors. The Initiator platform also interfaces with the Company’s LIMS, as well as its diagnostic laboratory software and investigational drug management system.

Detailed PR available at PharmNet website

http://phx.corporate-ir.net/phoenix.zhtml?c=234619&p=irol-newsArticle&ID=1506686&highlight=

 

Sanofi-Aventis ties up with Oxford Univ for oncology research in India

Sanofi-Aventis and Oxford University have entered into an agreement with INDOX, an academic oncology network to conduct oncology clinical and translation research in India.

The company said that through this partnership, Sanofi-Aventis will have access to experience and expertise of India’s top oncologists which will help the company in conducting clinical research. “The collaboration between sanofi-aventis, Oxford University and the Indian Cancer Centers fosters a model for academic researchers and industry to work together for the benefit of patients,” said Debasish Roychowdhury, MD, Senior Vice President, Head of Oncology, sanofi-aventis.

Sanofi-Aventis said that the company will provide financial assistance to Oxford University to manage INDOX’s eigh cancer reseach centres in India. The university, on its part, will provide training and support to investigators and reseach coordinators to help in carrying out the research.

INDOX is a partnership between Oxford University and India’s top eight cancer research centres in India.

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

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

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

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.”


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.

 

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/

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

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

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

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

exerpts from the article

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

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

First Chinese Clinical Research Outsourcing Industry Standard Under Development

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.

Translational Research: From Bench to Bedside

‘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: http://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- India

O_Healthsciences_clr1

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

India to implement E-Governance for Clinical Trials

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.

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