Central Labs Podcast: Guy Mascaro & Linda Sullivan

With Central Labs East taking place this September, we are going to look back at the interview series from Central Labs West.

Today, we feature the podcast with Central Labs East speaker Guy Mascaro, President of the Metrics Champion Consortium (MCC) and Linda Sullivan, Vice President of Operations, Metrics Champion Consortium (MCC). During this podcast, he answer the following questions:

• A look at the history of the MCC and current initiatives at the Metric Champion Consortium
• Where they think companies go wrong in trying to measure vendors
• They look at the speed of growth at MCC and how it's become a pivotal player in the industry.
• A look at the panel discussion on MCC Metrics adoption implementation and updates at the Labs West program, tell us how you get companies to change their processes and adopt a new way of doing things.
• How can quantifying Labs deliverables make companies more profitable?
• Other thoughts.

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Download Guy Mascaro's podcast here.

Central Labs East will be taking place September 20-22, 2010, and before then, we're going to highlight some of the hot topics we'll be hearing about. We invite you to join our Central Labs LinkedIn group to network and communicate with others before and during the event!

Partnerships Poll: June results

Throughout the month of June, we asked members of the Partnerships online network including Partnerships in Clinical Trials blog, @PartnershipCROs Twitter, and our Partnerships with CROs LinkedIn group, and the Partnerships in Clinical Trials webpage to weigh in on the poll question below. Do the results surprise you?

Stay tuned to this blog! On July 9, we will be launching another poll!

FDA Looking to link healthcare data and product safety

According to Medical News Today, the FDA is looking for a way to better connect medical product safety with healthcare data. Harvard Pilgrim Health Care Inc. has been chosen to create a program to collect all data from electronic health record systems, administrative and insurance claims databases and medical registries to create a full picture of the true safety of medical products.

Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, commented,
"The FDA has been doing the groundwork for a nationwide Sentinel System. Once operational, the Sentinel System will help us find answers to important drug safety questions, leading to stronger safeguards for public health, while still protecting the privacy and security of individual health information."

Click here to read the full article.

Veeda in the News

Veeda to conduct bulk of $8.4 mn clinical research projects in India.

Nearly 60% of its global TO comes from India.http://blogs.veedacr.com/Lists/Categories/Category.aspx?Name=Veeda%20in%20the%20News


Columbus headquartered Veeda Oncology, a full service Oncology clinical research organisation (CRO) with facilities in North America, Europe and India, plans to conduct the bulk of the recent $8.4 million of new clinical research programs it has been awarded in the last one month in India itself. The awarded work will be conducted in India, Europe and the US. A large part of the clinical trials and data management and biostatistics work would be conducted in India. Matt Bowman, president and CEO of Veeda Oncology, said "We are enjoying our continued repeat business from our existing clients as well as these five new clients".


The CRO has invested around Rs75 crore in its Indian operations so far, and employs around 400 people. "We plan to recruit more people in India,US and Europe", the company said in an e-mailed response. Veeda Oncology is part of Veeda Group, the largest Phase I CRO in India also engaged in early clinical development and Phase II clinical research since 2005 having 6 offices across India, UK, USA & Europe.

Research versus intuition

The Regenexx blog recently looked at the differences between medical innovation and classified them into two categories: pragmatic and research based. Pragmatic innovation mainly affects one individual and one doctor, as it is a very singular based trail. However, with research based innovation in the clinical field, clinical trials are often tested on large groups of people.

The article states:
One pathway can lead to the other, as it’s common for doctors who discover new techniques to test these via controlled trials. The opposite is also true, as research findings that seem to hold great promise in controlled trials fail to work as well in real world medical practice. This last problem is very common, as physicians in the field often find that the single variable study design doesn’t apply to their multivariate patient populations. There is societal benefit to make sure that both of these discovery pathways thrive, as both benefit medical innovation.

What do you think of the authors beliefs? Do you agree or disagree?

Read the full article here.

Leukemia drug taken off market

In a recent report at the New York Times, they report on Mylotarg, a drug recently taken off the market, which was proven unsafe in clinical trials. The drug, developed to treat acute myeloid leukemia, saw safety concerns arise after a fatal liver condition developed in patients, while showing no benefit to the patients disease. Read the full article here.

Partnerships Latin America Session Spotlight: Drug Depots: Overcome the Challenges of Getting Investigational Drug into Latin American Countries

Each week leading up to Partnerships in Clinical Trials Latin America, we'll be highlighting a session from the upcoming conference. It will take place August 2-4, 2010, in Buenos Aires, Argentina. For more information, visit our webpage to download the brochure.

Featured Session: Drug Depots: Overcome the Challenges of Getting Investigational Drug into Latin American Countries
Presented by: Cecilia D'Antuono, PhD, Manager, Site Management, Regional Clinical Operations, BRISTOL-MYERS SQUIBB-LATIN AMERICA – ARGENTINA

About the session:
• Get what you need into the region from the study drug to the lab kits to the computers.
• Get patient samples out of the region for testing, and storage.
• What are the hurdles surrounding customs turnaround?

Quintiles Central Lab adequately prepped for cancer analysis

At Center Watch, they look at the new addition to Quintiles suite of offerings biomarker assays to help biopharmaceutical companies investigate the phosphoinositide 3-kinases (PI3K) cancer survival pathway. The Quintiles Central Laboratory claims it is the only central lab with enough tissue analysis tools to, and can properly assess the PI3K pathway. Read the full article here.

Industry Trends in India

The Indian Economy is growing…

The Indian Banking sectors are the volume drivers for the economy. The insurance sector is expected to achieve a fivefold increase in its size by the end of the fiscal year 2019-2020. It is presumed that the insurance sector will be the growth driver for the economy. The increasing health consciousness and the rising need for improving quality of life among the urban educated masses has led to increasing their insurance coverage via the private companies which in turn are expected to provide a "reasonable" coverage. Needless to say the health insurance policies would be accounting for some part of the reimbursement of drugs being used by the patient/consumer for their ailments. The consumer /patient in order to derive maximum benefit of the insurance coverage would definitely prefer the usage of cost effective medicines for his /her ailments.

Web link

More on Industry Trends at the Veeda CR Corporate Blog

Clearstone Central Laboratories looks to focus more on laboratories

According to Center Watch, Clearstone Central Laboratories is looking to downsize their services that work with cardiac services. This is in addition to re-structuring for strategic repositioning.

Clearstone CEO Lewis Cameron stated,“Clearstone has set out to be a market leader, and in doing so we have had to make some strategic decisions to position the business for service excellence and growth. This action allows us to focus all of our efforts on further developing our core laboratory business. We will continue to make significant investments in our facilities, people, technology and processes.”

Read the full article here.

Partnerships Latin America Session Spotlight: Competing Globally: Clinical Trials in Emerging Markets

Each week leading up to Partnerships in Clinical Trials Latin America, we'll be highlighting a session from the upcoming conference. It will take place August 2-4, 2010, in Buenos Aires, Argentina. For more information, visit our webpage to download the brochure.

Featured Session: Competing Globally: Clinical Trials in Emerging Markets

Presented by: DiegoMartin Glancszpigel, Corporate Vice President, PAREXEL INTERNATIONAL

About the session:
Although Latin America offers access to wide patient populations, regulatory timelines are still an obstacle for many sponsors. As emerging regions such as China and India are on the rise, Latin America faces great competition for clinical research.
• How can Latin America sites and CROs overcome competition from other emerging regions?
• What should Latin American countries focus on to remain competitive in emerging markets?
• How can companies compete with lower priced countries for raw materials from countries such as India and China
• How the industry can address concerns around counterfeits and product quality

Central Labs Podcast: Craig Lipset , Pfizer

With Central Labs East taking place this September, we are going to look back at the interview series from Central Labs West.

Today, we feature the podcast is with Craig Lipset, a member of the Central Labs East advisory board. During this podcast, he answer the following questions:

-What are Craig's passion points?
-Why does the Central Labs West conference resonate with him?
-He discusses how industry continues to explore novel imaging techniques in the context of their early phase development programs.
-He discusses some of the standardization taking place in the industry.
-Lipset looks at what he sees coming in the future for this industry.

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Download Craig Lipset's podcast here.
Download a transcript of Craig Lipset's podcast here.

Central Labs East will be taking place September 20-22, 2010, and before then, we're going to highlight some of the hot topics we'll be hearing about. We invite you to join our Central Labs LinkedIn group to network and communicate with others before and during the event!

Indian Pharmaceutical Industry

The “changed” landscape of the Indian Pharma Industry


Background-


Indian pharma market & industry has been more of a provider of service to markets & consumers. But in recent time of pricing pressures in the Western world, increased Generic competition & regulatory hurdles pharma companies now look at India as a favorable market. The growth potential in India is tremendous as we witness development of Healthcare sector from unorganized to organized sector.


Analysis -

Indian pharma market & industry has been more of a provider of service to markets & consumers. But in recent time of pricing pressures in the Western world, increased Generic competition & regulatory hurdles pharma companies now look at India as a favorable market.


More at the Veeda CR Corporate Blog-
http://blogs.veedacr.com/Lists/Categories/Category.aspx?Name=Indian%20Pharma

Partnerships Poll: We want to hear from you!

We want to make the Partnerships in Clinical Trials an interactive, online network for you! This summer through our online Partnerships network, we have monthly polls for you to participate in. You can vote by visiting any of these sites in the Partnerships network: Partnerships in Clinical Trials blog, @PartnershipCROs Twitter, and our Partnerships with CROs LinkedIn group, and the Partnerships in Clinical Trials webpage. Vote and check on June 30 for our results!

Central Labs East Agenda Now Available!

The 8th Annual Central Labs East program is now available for download! Partnering with Central Labs is coming back to the northeast! Much has changed in the industry since the Central Labs conference began in 2002 in Princeton. Central Labs East will be taking place September 21-22, 2010 in Boston, MA.

Two things remain constant about your Central Labs Event:
- Building strong core lab partnerships is essential to improving outsourcing efficiencies.
- This highly specialized meeting is still the only place for central lab outsourcing and data management professionals to improve their relationships with central, ECG and imaging labs partners.

Download the brochure now!

Indian CRO

Forecast -



By 2012, analysts project that more than 65 percent of all FDA-regulated trials will take place outside the United States. This is reflected in the Indian biotechnology market, which is expected to grow at a compounded annual growth rate of 30 percent, and the Indian CRO market, which is expected to see growth of 49 percent annually.


Basis-

According to Clinical trials Gov, Currently greater than 50, 000 clinical trials have been registered in North America where the US accounts for around 46,000 of the same. If the above forecast holds true then presuming that all trials are FDA regulated and industry sponsored and outsourced to India, then the market for clinical trials in India would take a market look as follows:

More at-

http://blogs.veedacr.com/Lists/Categories/Category.aspx?Name=Indian%20CRO

Partnerships Latin America Session Spotlight: Master Site Selection Processes and Monitoring Efficiencies

Each week leading up to Partnerships in Clinical Trials Latin America, we'll be highlighting a session from the upcoming conference. It will take place August 2-4, 2010, in Buenos Aires, Argentina. For more information, visit our webpage to download the brochure.

Featured Session: Master Site Selection Processes and Monitoring Efficiencies

Presented by: Marcelo Belgrano, Clinical Lead, Novartis – Argentina S.A

About the session:
This session emphasizes the importance of an adequate site selection and explains the selection process. Our speaker shares common issues and ways to improve the process and describes the required sites characteristics, as well as reinforce the value of monitoring activities.

Key issues discussed include:
· The landscape of Latin American sites
· The utilization of Megasites
· How to identify adequate sites
· How to ensure sites are in compliance with GCP requirements

Social Media Marketing and Pharma

Business Practices on the web

Pharmaceutical industry has now taken social media as one the major areas for its product promotion. Veeda CR occupies a niche position as it one of the one Indian CRO companies promoting its services on the Social media via business blogging.

A few inferences on the above facts:
* Majority of the Big Pharma companies already have more mature Social Media strategies. Overall Social Media will play a bigger role in companies' marketing strategies during the coming years.
* Twitter is more important for proactive Social Media companies. Google is equally used at profiled companies.
* Twitter, LinkedIn and Face book mean the greatest benefit for corporations actively engaged in Social Media efforts.
* A few Companies report Social Media has the greatest impact on product branding and building the corporate image, followed by customer communication and education.

This blog is co-posted with the Veeda Clinical Research Blog.