Partnerships Asia Pacific Session Spotlight: Identifying the Appropriate Clinical Partners for Your Global Trials

Each week leading up to Partnerships in Clinical Trials Asia Pacific, we'll be highlighting a session from the upcoming conference. It will take place October 5-7, 2010, in Singapore. For more information, visit our webpage to download the brochure.

Featured Session: Identifying the Appropriate Clinical Partners for Your Global Trials
Speakers: Deven Parmar, M.D, Vice President, Clinical Research, WOCKHARDT, India
Christina Bodurow, PhD, Senior Director, External Sourcing, Development Center of
Excellence, ELI LILLY AND COMPANY, USA

About the session:
Strategic partnerships can help reduce costs and increase flexibility in drug development, drive productivity and gain speed to market. Finding a CRO with claims and capabilities matched to sponsors’ needs, can help to mitigate risk, with an understanding of often unclear regulations. In order to minimize surprises and project delays, it is critical to identify and solidify partnerships with service providers in the region who have comprehensive knowledge of regulatory and ethics issues, clinical monitoring staff, quality/compliance, and supply chain management.

• Develop a vendor assessment and selection process
• Know the right questions to ask of potential providers
• Look beyond cost savings to find the best fit for your studies
• Mitigate CRO staff turnover
• Manage sub-contractor risk to ensure that all study components are covered
• Understand and leverage cultural differences – how does this impact relationships when working with local / regional CROs?

Overview of the Indian CRO market

Overview of the Indian CRO market

The Indian CRO’s have been traditionally “branded” or “out looked” upon as companies involved in regular/routine bioequivalence studies of off patent drugs or involved in/ as SMO’s data management activities. The business of the Indian CRO’s has been since many years a “predictable risk free “model. This model inspired a lot of players to move forward and capitalize on a US $20 Billion outsourcing opportunity with a US $ 17 Billion market for the CRO’s in the developed world.



The Indian CRO market was forecasted to grow beyond a US$ 2 billion market size by the end of 2010. However, with onset of a serious market crisis in the global economy in the year 2008, the market growth was restricted.

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Partnerships Poll: The performance of CROs over the past five years

Throughout the month of August, 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.



Stay tuned to Partnerships for the next poll! We'll be launching it this Thursday!

New law ensures patient coverage for clinical trials

The Washington Post sheds light on the new federal law taking effect in 2014 which will mandate that insurance companies cover clinical trials in their insurance plans. Currently, many insurance companies will not cover a patient once they enter the clinical trial, which leaves the patient to pay for medical side effects that may arise during the clinical trial treatment. The law will cover all four phases of clinical trials.

Michelle Andrews, author of the article, believes that this will lead to increased participation in clinical trials. Do you believe that a law like this will increase patient participation and knowledge of the clinical trials that are taking place?

Clinical Partnerships Asia Pacific Video: New Challenges and Opportunities Part 6

As we look forward to the 2nd Annual Partnerships in Clinical Trials Asia Pacific, we're going to look back at one of the presentations from last year. Over the next few weeks, portions from the "New Challenges and Opportunities," will become available on our webpage. In Part 6, Sven Ohiman of AstraZeneca continues to speak about the "Seven Deadly Challenges" of clinical trials in Asia.

Click here to watch the video. The video in the left hand column of the webpage.

Moral of the story for the industry today

Moral of the story for the industry today

1. Will new drugs work?
2. If at all they work, are they safe?
3. If safe drugs are not available any more then where are the ailing patients going to get their suitable cure?
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Need of the hour

1. The need of the hour is to tap emerging markets
2. The most potential market today for outsourcing is India
3. Cost effective generic drugs are going to be in demand in all those countries where healthcare is government funded.
4. Some Asian Countries like Japan are also in need of medicines which are not effective but affordable.
5. Needs to be seen when the affordability criterion will SURPASS the effectiveness criterion

More on Industry Trends at the Veeda CR Corporate blog.

Partnerships August Poll: The performance of CROs over the past five years

Vote in the Partnerships Poll! It closes Friday.

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 August 27 for our results!

Partnerships Asia Pacific Session Spotlight: The Sponsor-CRO Relationship: Obtaining Value From the Partnership in a New Globalized Setting

Each week leading up to Partnerships in Clinical Trials Asia Pacific, we'll be highlighting a session from the upcoming conference. It will take place October 5-7, 2010, in Singapore. For more information, visit our webpage to download the brochure.

Featured Session: The Sponsor-CRO Relationship: Obtaining Value From the Partnership in a New Globalized Setting
Speakers: James Garner, Vice President & General Manager, TAKEDA CLINICAL RESEARCH, Singapore
Larry Fiori, Associate Director, Clinical Trial Outsourcing & Compliance, Compliance and Quality Management, BOEHRINGER INGELHEIM, USA

About the session:
The concept of becoming a “sponsor of choice” has taken on new meaning with the globalization of studies and sites. The necessity of partnering with service providers within different business models introduces yet another level of complexity for pharmaceutical companies. For small to medium-size sponsors, a reliance on the CRO industry to represent them on a global platform will continue to require experimentation to find the optimal models and partners.
• Supplier Relationship Management: How are these relationships best governed?
• Determine the relationship criteria between sponsor and the CRO to enable effective agreements in managing site relationships
• Learn how sponsors can manage attrition due to increasing competition for resources as the CRO market grows in Asia
• Understand the benefits and challenges of working with large and small CROs or multiple CROs

Eli Lilly halts late stage clinical trial

The New York Times looks at the recent drug trial halted by Eli Lilly. The halt of the late stage clinical trial for a potential Alzheimer's treatment because:
The company said patients who had taken the drug, intended to reduce plaque in the brain, actually showed worse cognitive functioning and less ability to perform daily living tasks than patients who had taken a placebo.

This was one of five of Eli Lilly's drugs in late stage clinical trials. To read more about this failed clinical trial, read the article here.

What are the impacts on a company having to pull a high profile drug out of clinical trials?

It is not true all the time

The length and complexity of consent forms for people enrolling in clinical trials don't affect the ability of the participants to understand the key points of the study.






This is true for Bio equivalence studies in USA as well.


In this new study, U.S. researchers had volunteers read either a standard or a concise consent form for a low-risk phase 1 study of a marketed drug. The participants' comprehension levels were similar with both forms, and the shorter form didn't appear to harm the quality of informed consent, the study authors found.






The researchers also noted that paid participants had slightly higher comprehension than unpaid participants. This challenges a common assumption that people who are paid to enroll in research may be "blinded by money" and thus ignore important details about the study when reading the consent form.






Another finding was that overall comprehension was not affected by socioeconomic status. This appears to counter claims that people who are socially or financially disadvantaged require special protections when enrolling in clinical trials.


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Moreon Bio equivalence studies at the Veeda CR Corporate blog -http://blogs.veedacr.com/

LabCorp teams up with Clearstone Central Labs

Announced yesterday, Clearstone Central Laboratories recently formed a partnership with LabCorp. LabCorp will now have access to Clearstone's global network of central labs, which are located in China, France, Singapore, Canada, the US and Belgium.

David P. King, Chairman and Chief Executive Officer of LabCorp, commented, "This collaboration combines the complementary strengths of two leading central laboratories to support drug development. The transaction is an important milestone as it enhances LabCorp's clinical trials central lab offering to customers in key geographies and advances the Company's companion diagnostics and personalized medicine strategy."

Source: MarketWatch

Complimentary registration for Central Labs for clinical research professionals working within biotech and pharmaceutical manufacturers

Partnering with Central Labs is scheduled for September 20-22, 2010 in Boston. The updated program delivers all new topics and speakers who provide the know how to revolutionize outsourcing and data management processes with cutting edge science.

Over the years some people have suggested that IIR make this event FREE for pharmaceutical and biotech executives to ensure the right people are able to access the cutting edge presentations and meet with leading experts in lab operations management.

Well this year IIR recognizes that budgets are tight so for a limited time IIR is inviting clinical lab operations executives from pharmaceutical and biotech manufacturers to attend for free.

Visit the Central Labs webpage and register today to meet the right professionals in your field:
http://bit.ly/crEDBZ

We hope to see you in Boston!

Clinical Partnerships Asia Pacific Video: New Challenges and Opportunities Part 4 & 5

As we look forward to the 2nd Annual Partnerships in Clinical Trials Asia Pacific, we're going to look back at one of the presentations from last year. Over the next few weeks, portions from the "New Challenges and Opportunities," will become available on our webpage. In this portion, in Part 4 Ruiping Dong, Bristol Myers Squibb continues to discusses some of the opportunities to conduct clinical trials in the Asia Pacific region and Sven Ohiman of AstraZeneca speaks about the "Seven Deadly Challenges" of clinical trials in Asia.

Click here to watch the video. The video in the left hand column of the webpage.

Partnerships Asia Pacific Session Spotlight: Understanding the Different Outsourcing Models: Is there Any One Right Model?

Each week leading up to Partnerships in Clinical Trials Asia Pacific, we'll be highlighting a session from the upcoming conference. It will take place October 5-7, 2010, in Singapore. For more information, visit our webpage to download the brochure.

Featured Session: Understanding the Different Outsourcing Models: Is there Any One Right Model?
Speakers: Dr. Rajeev Shrivastava, Senior Manager, Clinical Research, ELI LILLY, India
Albert Liou, Corporate Vice President & General Manager, Asia-Pacific, PAREXEL INTERNATIONAL, Taiwan

About the session:
Under increasing budgetary pressure, sponsors are moving towards more strategic outsourcing where CROs are no longer mere service suppliers, but true collaborators. Many small companies, however, do not have the pipeline to engage in strategic relationships, and must therefore operate on a transactional basis. There is also an evolution to consider outsourcing functions previously considered core competencies (e.g. Drug Safety and Regulatory). With so much to consider, what are the business drivers changing the outlook for model selection and the outsourcing of new areas going forward? Companies considering outsourcing overseas must determine the most advantageous locations and appropriate models. This session delivers a comprehensive overview of the options available and steps needed when seeking an alliance or preferred partner.

• Understand full service and Functional Service Provider (FSP) models
• Review project-specific vs. preferred providers vs. outsourcing full programs
• Incorporate global outsourcing as a component of strategy vs. being the strategy
• Evaluate the global mix and weigh the benefits and cost benefits of outsourcing
• How do you measure the return?

Drug Pricing Policies

Revising Investment options



At first blush, it might seem like the wave of patent expirations could be enough to cut the entire health care sector off at the knees. But while the looming wave of expirations will affect the entire pharmaceutical chain — from drug makers to distributors to wholesalers and even some retail drug stores — the sector as a whole is actually being pulled down by a combination of issues including health care reform in the U.S. and pricing pressures in Europe. As those issues are resolved, the outlook for the sector could improve.


Meanwhile, as big pharmaceutical companies lose their patent protections, many are starting to adjust through consolidation and diversification.


It has been described as both a cliff and a wave, but whatever you call the unprecedented number of pharmaceutical drugs that will lose their patent protection in the next few years, it sets the stage for a host of investment opportunities — and potential pitfalls.

More at the Veeda CR Corporate blog at:

http://blogs.veedacr.com/Lists/Categories/Category.aspx?Name=Drug%20pricing%20policies

Partnerships August Poll: The performance of CROs over the past five years

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 August 27 for our results!

World Courier expanding to meet global need of clinical trial storage

World Courier will open a new distribution center in Singapore early next year. This is in addition to expansion in Tokyo, Buenos Aires, Moscow, an Johannesburg. It is looking to support the infrastructure of the expanding clinical trial market in emerging countries. The company added their clinical trial storage facilities in response to the demand from their customers. According to the article, each facility is staffed by full-time licensed pharmacists, can store materials at temperatures ranging from -70oC to +25oC and uses the proprietary CTM-STAR monitoring system. Outsourcing Pharma has the full story.

Partnerships Asia Pacific Session Spotlight: Overcoming Regulatory Challenges in Clinical Trials

Each week leading up to Partnerships in Clinical Trials Asia Pacific, we'll be highlighting a session from the upcoming conference. It will take place October 5-7, 2010, in Singapore. For more information, visit our webpage to download the brochure.

Featured Session: Overcoming Regulatory Challenges in Clinical Trials - Communicating Effectively with Regulatory Authorities to Enhance Approval Lead Time
Panelists: Wen Chang, PhD, Head of Regulatory Intelligence and Advocacy, Asia and the Pacific, Global Drug Regulatory Affairs, NOVARTIS, China
Geoff Fatzinger, Executive Director, Regulatory Affairs and Strategic Product Development, Europe & Asia Pacific, INC RESEARCH, UK
Dra. Endang Woro, MSc, Director of Directorate of Drug and Biological Product Evaluation, NATIONAL AGENCY FOR DRUG AND FOOD CONTROL, Indonesia
Byungja Marciante, Investigator / Assistant Director, US-FDA SHANGHAI OFFICE, China

About the session:
With the rapid evolution of clinical infrastructures and the patient base, Asia is poised to contribute further to the development of experimental drugs and clinical evaluation of therapy. However, the ethical and regulatory landscape is so diverse. Compared with accepted guidelines and criteria for successful trials in the West, Asia’s regulatory landscape is rapidly evolving. In this session, representatives from the region will share experiences in challenges encountered when conducting clinical trials, providing guidance on how to facilitate this process.

• Navigate the diverse ethical and regulatory landscape
• Adapt to meet local and cultural demands
• Lessons learned from regional experts

The Challenges facing the Global Pharmaceutical Industry

The Challenges facing the Global Pharmaceutical Industry


The global pharmaceutical industry is facing a challenging battle to maintain its productivity in the face of an increasingly difficult research and development landscape.


Companies are starting to commit fewer resources to research activities in recent years, partly due to diminishing returns.


Between 2007 and 2009, the number of treatments whose clinical development was terminated during phase III testing was double the rate seen in 2004-06, while fewer than one in ten drugs reaching first toxicity dose now make it market.

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No of Drugs by Development status


Watch out for some key statistics of the Pharma drug pipeline at-

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