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.

Indian Council of Medical Research upgrade Clinical Trial Registry of India at par with international standards by WHO http://bit.ly/4fE5Yp

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

Neil de Crescenzo, SVP Oracle Health Sciences http://tinyurl.com/yjklays
Oracle in Health Sciences Industry http://tinyurl.com/yly257v

Oracle Health Sciences On YouTube, and Clinical Research Videos

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

Multi National Pharma sell their Captive Clinical Research Facilities in India

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

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

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

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

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

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

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

3. How can Indian CRO help in personalized medicine initiatives

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

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

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

7. Drug Life cycle management services

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

9. Premarketing Clinical Drug Safety and Risk Assessment

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

twitter.com/clinicalsearch

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

Electronic Data Capture and Integration

In Conversation: Oracle’s Patti Gaves on EDC and Integration

eCliniqua  in Conversation with industry veteran Patti Gaves of Oracle Health Sciences Global Business Unit, eCliniqua was curious about her perspective on the current status of electronic data capture (EDC), the industry’s strong focus on integration of electronic point solutions, and the evolution toward eClinical trials. Gaves, senior director of Life Sciences Product Strategy, has more than 15 years of clinical data management experience and has worked in customer implementation and operations management.

Oracle Announces Oracle® Application Integration Architecture Release 2.5 Announced during the Openworld 2009,

Oracle today announced Oracle® Application Integration Architecture (AIA) Release 2.5, the most extensive Oracle AIA release to date with 10 new cross-industry Process Integration Packs (PIPs) and six new industry-specific PIPs, together with a growing library of more than 1,000 enterprise services and 100 enterprise objects.

Health Sciences: Oracle Remote Data Capture to Oracle’s Siebel Clinical Trial Management System – synchronize study site information; automate patient enrollment tracking and study activity tracking for electronic data capture and clinical trials management systems.

DBMS Consulting Receives Honorable Mention in Life Sciences and Health Care Industry Solution Category at Oracle Open World 2009

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

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New Momentum Teams with Oracle to Help Reduce Counterfeiting in the Life Sciences Industry

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

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

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

challenge 4 Indian Clinical Research outsourcing,CROs and Pharma R&D because Indians are genetically not single large population

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

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

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

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

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

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

The article is available at Nature Magazine

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