FDA meets to hear from the REMS Community

The InVivo blog covered the recent meetings the FDA held with Risk Evaluation & Mitigation Strategy authorities. Stakeholders presented over 70 different presentations to discuss how to safely and effectively market drugs. For all the coverage, InVivo mentions coverage of the proceedings are available at The Pink Sheet, The Pink Sheet DAILY, and The RPM Report. The two days spent with the FDA show the importance that they will be placing on REMS in the future.


This September, drug safety professionals will also be convening in Baltimore for the The Safety Continuum in the Medical Product Life Cycle event. During this three-day conference, experts offer strategies to overcome critical drug safety challenges faced through-out a product’s life cycle from premarketing clinical trials all the way to postmarketing safety surveillance/vigilance, and risk management. Participants learn about current regulatory national and international standards, state-of-the art methods and techniques in premarketing testing and evaluation, quality safety-related compliance and procedures, effective signal detection and assessment, adverse event reporting, and the latest risk management approaches in the US and abroad.

Partnerships Poll: Promoting the societal benefit of new drugs

Throughout the month of July, 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 on August 4.

Partnerships Latin America Speaker Spotlight: Dr. Eduardo Motti

Dr. Eduardo Motti, Regional Head Clinical Operations
PFIZER – BRAZIL

Panel Presentation: Get Your Study Approved: Current Regulatory Requirements and Timelines for Conducting Clinical Trials in the Latin America Region

Dr. Motti developed his career first in academia, as an infectious disease specialist, working at University of Sao Paulo, Brazil. In 1984, he joined the pharmaceutical industry, as a clinical research manager and later director for Merck & Co. in Brazil; he also worked at Eurotrials Brazil (a CRO), Schering AG, and Pfizer. Dr. Motti is currently Regional Head, Clinical Operations for Latin America for Pfizer Global Research & Development. He also authored a patient-oriented book on clinical research.

Central Labs Podcast: Solomon Babani, Celtic Pharma Development Services

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

In this podcast, Solomon Babani, Celtic Pharma Development Services. During this podcast, he answers the following questions:

-Advice for smaller pharmaceutical companies to streamline their operational processes?
-The differences between Partnerships in Clinical Trials and Central Labs West
-How the economic downturn is affecting outsourcing
-Some advice for smaller pharmaceutical companies to streamline their operational processes

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Download Solomon Babani's podcast here.
Download a transcript of Solomon Babani'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!

Clinical Partnerships Asia Pacific Video: New Challenges and Opportunities Part 3

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, Ruiping Dong, Bristol Myers Squibb continues to discusses some of the opportunities to conduct clinical trials in the Asia Pacific region.

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

Partnerships Asia Pacific Session Spotlight: FDA Updates: Ensuring Quality & Compliance in Your Study to Streamline Clinical Development in Asia

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: FDA Updates: Ensuring Quality & Compliance in Your Study to Streamline Clinical Development in Asia
Presenter: Byungja Marciante, Investigator / Assistant Director, US-FDA SHANGHAI OFFICE, China

Currently, almost every major US pharmas are running clinical trials in Asia. This presents many new challenges and growing international work for the agency regarding safety and quality management. To address this, FDA launched the “Beyond Our Borders” initiative. This session will provide details and open the discussion on how to work with FDA to ensure GCP compliance while conducting studies in Asia.

• Understand FDA foreign country inspection procedures
• Gain insights into the GCP auditing process and learn how to prepare for FDA inspections
• Site selection criteria – avoid pitfalls in choosing qualified trial conducting sites
• Fulfill US FDA requirements on data quality and compliance to expedite the approvals process

Clinical Partnerships Asia Pacific Video: New Challenges and Opportunities Part 2

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, Larry Fiori continues to discusses some of the challenges of conducting clinical trials in the Asia Pacific region.

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

Moving to Cost effective locations- A unique shift

Moving to Cost effective locations- A unique shift

Moving to cost effective locations is an effort by almost all major pharma companies in the last 6-8 months particularly in the areas of drug manufacturing . One of the key locations today in manufacturing is the Asia Pacific region particularly the Indian geography. Companies like GSK and Pfizer have already moved their manufacturing capacities to India. One of the recent examples is Eisai, a leading Japanese pharma drug maker which has taken the bold step to manufacture Aricept Alzheimer's drug in India for exports to Japan, the United States and Europe as early as 2011. Eisai will start producing the drug at a newly constructed plant in the Indian state of Andhra Pradesh. Aricept accounts for about 40 percent of Eisai's total sales. Eisai is also expected to begin Indian production of the ulcer treatment Pariet, which will go off-patent in the United States in 2013.


Source:
http://blogs.veedacr.com/Lists/Categories/Category.aspx?Name=Industry%20Trends%20

Vote in the Partnerships Poll: Social benefits of new drugs

Don't forget to vote in this month's Partnerships in Clinical Trials poll! 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. Voting ends this Thursday, and results will be revealed Friday!

Louisana University possibly dropping clinical lab program

Louisiana State University at Alexandria's Clinical Lab program is facing funding issues and may be dropped from the program. According to The Town Talk, it is in trouble due to the budget troubles facing the university. Should this program be cut, the area surrounding the university will be affected. There will be a shortage of medical professionals in the local area reaching as far as the local hospitals, there will not be staff to replace the Boomers who are currently retiring with no professionals to replace them. Although small enrollment is common for clinical labs programs throughout the country, there are currently six students enrolled in the program, which makes it a reason for the potential cut.

Partnerships Latin America Speaker Spotlight: Jeffrey S. Kasher, Ph.D.

Jeffrey S. Kasher, Ph.D., was named vice president and chief operating officer, global clinical development for Eli Lilly and Company in February 2007.

He received a Bachelor of Science degree in chemistry from Franklin & Marshall College (Lancaster, Pa), a doctorate in pharmacology from the State University of New York (Syracuse) and a postdoctoral fellowship in physiology at Yale University School of Medicine.

Kasher joined Lilly in 1986 as a senior pharmacologist in the department of drug metabolism and disposition where he made numerous contributions to the discovery and development of projects in the infectious disease therapeutic area. In 1992, he was named manager of pharmaceutical project management. Kasher had operational responsibility for the Zyprexa (olanzapine) heavyweight team from 1995 to 1998, successfully leading the late phase development, global submissions, and launches of the product. In 1998, he was named director of pharmaceutical products, where he helped establish Lilly’s product team organization.

Kasher moved to Belgium in 2000 as the managing director for the research and development site in Mont Saint-Guibert. Upon his return to Indianapolis in 2003, he served as operations director and then executive director for discovery biology in Lilly Research Labs, leading the transformation of the division into therapeutically-focused drug hunting teams.

Most recently, Kasher served as the executive director of the osteoarthritis/rheumatoid arthritis platform team, leading the development of an integrated strategy for a portfolio of novel drug candidates.

Jeffrey Kasher, PhD, Vice President and COO, Global Clinical Development, Eli Lilly and Company, is the 2010 Partnerships in Clinical Trials Latin America Conference Chair. He will also be presenting, "Understand the Different Outsourcing Models."

Clinical trials for the safety of drugs on the market

GlaxoSmithKline Plc's diabetes drug Avandia is at the center of controversy. During recent clinical trials of the drug, safety issues have arisen. This brought up the issue looking at whether or not it was ethical to look at the risks of a drug already in use.

The Institute of Medicine concluded:
Clinical trials aimed at pinpointing emerging safety problems with drugs already on the market should only be conducted when other, less invasive research is not possible.

Read the full article here. What do you think of this statement?

Partnerships Asia Pacific Session Spotlight: Clinical Outsourcing in Asia - Practical Insights and Recent Industry Survey Data Revealed

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: Clinical Outsourcing in Asia - Practical Insights and Recent Industry Survey Data Revealed
Presenter: Christopher R. Albani, Managing Director, PRTM, Japan

About the session:
Today, pharmaceutical companies are contending with a series of new challenges. With blockbuster drugs representing more than $50B in annual revenue coming off patent in the next few years, the industry faces steep declines in revenue. On the hunt for new opportunities, pharmaceutical companies are turning their attention to Asia. The region is attractive not only because of its oft-touted opportunities for revenue growth, but also because of its attraction as a center for new drug development. Major multinational pharmas are incorporating the Asian region as a significant part of their global development strategies. An industry-wide survey
of clinical research outsourcing practices in Asia conducted between late 2009 through early 2010 provides insights into the most pressing challenges facing pharma companies in the APAC region. With data from more than 75 respondents, this session will reveal various perspectives collected from your industry peers along with practical insights offered from one of the world’s largest pharma companies.

Industry Trends and Generic Drugs

Emerging-market and established-product growth strategies

Abbott gains the rights to at least 24 Zydus products and will have an option for an additional 40 products. Abbott anticipates that the agreement will produce the first product launches in 2012.



In March 2010, AstraZeneca (London) signed a license and supply agreement with the Indian Drug Company and manufacturer Torrent Pharmaceuticals, under which Torrent will supply to AstraZeneca a portfolio of generic medicines for emerging markets.


In 2009, GlaxoSmithline (GSK, London) partnered with India's Dr. Reddy Laboratories (Hyderabad, Andhra Pradesh, India) under which Dr. Reddy will manufacture and supply drugs to GSK, which will license and comarket the drugs in various countries in Africa, the Middle East, Asia-Pacific, and Latin America.
Source: http://blogs.veedacr.com/Lists/Posts/Post.aspx?ID=278
 
__________________________________________________________________________________________

Risks of the past are benefits in the present

Five years ago, Novartis was viewed as a lumbering giant in the pharmaceutical world--a behemoth that was running out of products and bereft of a bulging pipeline. The Swiss drug maker, which was known for its branded pharmaceutical products, made a fateful decision in February 2005: In a bid to create the world's largest generic drug-maker, it bought Germany's Hexal and Eon Labs, its U.S. division, for about $8.3 billion at the time.



Today, Novartis's bet appears to have paid off. The giant drug maker said second-quarter net profit jumped 19% to $2.46 billion (1.92 billion euros) compared with $2.04 billion in the same period a year ago. The company said sales in its pharmaceuticals business offset healthcare cost-cutting efforts by some European governments.


Contributing to the stronger profits was Novartis's generics business where sales grew 11% to $1.97 billion, outpacing the 8% sales rise in the company's core pharmaceuticals business. Though Sandoz's second-quarter sales beat consensus estimates by 1.4%, its core earnings before interest and taxes missed consensus forecasts by 3.3%, UBS said in a research note.


The Swiss drug maker's earnings helped lift pharmaceuticals stocks within Bloomberg's European 500 index, pharmaceuticals notched a 0.81% gain, making them the second-best performer in early trading. Among the biggest gainers in the drug sector were Elan and Novartis.
Source: http://blogs.veedacr.com/Lists/Posts/Post.aspx?ID=319


____________________________________________________________________________________________
 
Is there enough left in the Indian market?



MNC pharmaceuticals firms that left India in the 1970's and 1980's when the Drug Price Control Order (DPCO) began to squeeze margins, are now coming back even as a host of Indian firms are exiting, to a great extent, because they find the price controls onerous. The latest to join this group — Mylan bought Matrix Laboratories in 2006, Daiichi Sankyo bought Ranbaxy in 2008, Frensenius Kabi bought Dabur Pharma in 2008, Sanofi Aventis bought Shantha Biotech in 2009 and Hospira bought Orchid Chemicals' injectables business in 2009 — is Piramal Healthcare which has sold off 350 branded drugs along with one manufacturing unit to Abbott Laboratories for $3.72 billion (Rs 17,000 crore).

Source:http://blogs.veedacr.com/Lists/Posts/Post.aspx?ID=284

Play a role at the 20th Anniversary Partnerships in Clinical Trials Celebration

WHO: Sponsor Executives from Pharma, Biotech, Medical Device
WHAT: 20th Anniversary Partnerships in Clinical Trials
WHERE: Phoenix Convention Center - Phoenix, AZ
WHEN: March 30- April 1, 2011
WHY: Become part of the largest, most diverse and comprehensive collection of speakers found at a clinical development event worldwide

Partnerships approaches a huge milestone in 2011 — 20 years as your trusted partner in examining critical issues and decisions around different sourcing models, who to outsource clinical research to and best practices in successfully managing the many facets of clinical trials. We are proud to be your partner in delivering timely information, connections and resources to help you and your team stays ahead of the curve.

PLAY A ROLE AT THE 20TH ANNIVERSARY PARTNERSHIPS CELEBRATION

We are now recruiting professionals in Strategic Sourcing and Procurement, Clinical Development Operations, Project Management, Quality, Drug Safety and Regulatory roles from large, mid-size and small/virtual pharmaceutical, biotech and medical device companies who can share first-hand perspectives, insights, and real-world case studies.

Visit the Partnerships in Clinical Trials Webpage here:
http://bit.ly/9vU7QA

Submission Guidelines & Details

To submit a session proposal or to express interest in joining the 2010 speaking faculty, email Lesly Atlas at latlas@iirusa.com. The deadline to submit is Friday, August 6, 2010.

Partnerships in Clinical Trials is now accepting proposals for case studies and thought-provoking panel discussions in areas including:
• Strategic Sourcing
• Budget and Contract Management
• Innovative Drug Development Partnerships
• Wall Street, Investment, VC Outlook
• Process Efficiencies & Cost Containment
• Quality Vendor Oversight
• Site Monitoring/Investigator Site Relationships
• Globalization and Patient Access
• Alliance Management and Co-Development Deals
• Medical Device Clinical Trials
• Biosimilars
• And much more

For consideration, please e-mail Lesly Atlas with the following information no later than Friday, August 6, 2010. Be sure to include:

• Proposed speaker name(s), job title(s), and company name(s)
• Contact information including address, telephone, fax number and e-mail
• Benefit-driven session title that illustrates objective of presentation
• Summary of the talk (4-6 sentences)
• What the audience will gain from your presentation (3-5 key “takeaways”)

NOTE: Due to the high volume of submissions, we are unable to respond to each submission. Those individuals selected to participate will be notified by August 27, 2010.

Do you want to reach this audience?

Partnerships in Clinical Trials is the ultimate venue to:
• Foster new client relationships
• Generate sales leads
• Position yourself as a thought leader
• Strengthen contacts with existing clients
• Build brand awareness
• Gain market share within the clinical space

Partnerships in Clinical Trials offers you a unique opportunity to showcase your products and services in front of key decision-makers. Maximize your 2011 marketing dollars by exhibiting at this event or increase your exposure even further by sponsoring a breakfast, luncheon or cocktail reception. To learn more about these marketing opportunities, please contact: Andrew Sinetar, Sales Manager at 646-895-7484 or asinetar@iirusa.com.

Clinical Partnerships Asia Pacific Video: New Challenges and Opportunities

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, Larry Fiori discusses some of the challenges of conducting clinical trials in the Asia Pacific region.


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

What can you learn at Partnerships in Clinical Trials Latin America?

Partnerships in Clinical Trials: Latin America
August 2-4, 2010 – Buenos Aires, Argentina

Over the past few months, we've highlighted the sessions that will be taking place at Partnerships in Clinical Trials Latin America. To find out more about the Partnerships In Clinical Trials Latin America Event, visit the webpage here.

Review them here:
*Training Experienced AND Naive Site Investigators: Moving from a One Country Pilot Plan

*Master Site Selection Processes and Monitoring Efficiencies

*Drug Depots: Overcome the Challenges of Getting Investigational Drug into Latin American Countries

*Competing Globally: Clinical Trials in Emerging Markets

*Master Site Selection Processes and Monitoring Efficiencies

*Meet the Demands and Expectations for Patients in Latin American Trials: Ethical Challenges to Consider

*Get Your Study Approved: Current Regulatory Requirements and Timelines for Conducting Clinical Trials

*Uncover the Advantages, Risks and Key Factors in Conducting Successful Clinical Trials in Latin America

*Industry Update: Impact of the Economic Crisis and Industry Consolidation on the Global Development

Central Labs Podcast: Peter Colbourne, ConcentRx Consulting

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

Our next podcast is with Central Labs speaker Peter Colbourne. During this podcast, he answers the following questions:
-A look at Logistics standardization
-A preview of the Logistics Taskforce
-Some Logistics advice

Discover Simple, Private Sharing at Drop.io

Download Peter Colbourne's podcast here.
Download a transcript of Peter Colbourne'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 Asia Pacific Session Spotlight: Mapping the Clinical Trial Landscape in Asia: Advantages, Disadvantages and Realities of Conducting Trial

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: Mapping the Clinical Trial Landscape in Asia: Advantages, Disadvantages and Realities of Conducting Trials in the Region
Panelists:
Darshan Bhatt, MD, MPhil, Director, Clinical Safety, VANTHYS PHARMACEUTICAL DEVELOPMENT PVT LTD, India
Mark Bach, PhD, Vice President, Head of R&D, Regulatory Affairs and Safety, JANSSEN PHARMACEUTICALS KK, Japan
SungIn Hong, Director, Clinical Operations, Asia Pacific Operations, RPS, INC, Korea
Balaji Iyengar, Country Manager & CEO, ECRON ACUNOVA, India

About the session:
The regulatory approval process relative to recruitment time frames is key. While some countries have access to patients, many have sequential processes leading to country start up time frames greater than six months when sites must be up and running from that point. Panelists discuss the demographics, challenges, opportunities and expertise of selected individual countries as well as deliver a high-level overview of regulations with global implications:

• Understand the trends for trial placement and insights on evolving cost per subject
• Discover which countries are delivering true return on investment
• Understand the regulatory and operating environment of selected markets
• Grasp the realities of available subject populations and GCP trained investigators
• Navigate the cultural intricacies and ethical considerations in deciding on trial placement

Veeda Oncology in the News

Veeda Oncology gains $8.4 mn in new business


Veeda Oncology®, a full service Oncology CRO with facilities in North America, Europe and India, has been awarded over $8.4 million of new clinical research programs over the past 30 days.




Veeda Oncology®, a full service Oncology CRO with facilities in North America, Europe and India, has been awarded over $8.4 million of new clinical research programs over the past 30 days.The awarded work will be conducted in India, Europe and the US and will include services for monitoring, data management and biostatistics, medical monitoring, safety, site management and project management.


http://www.blogs.veedaoncology.com/Lists/Categories/Category.aspx?Name=Veeda%20Oncology%20in%20the%20News

California Central Lab faces law suit

National Cardio Labs LLC will pay $3.6 million to settle a law suit do to the defrauding of government healthcare programs. According to the article, Stanman and Parsons, both from Laguna Niguel, are accused of knowingly submitting false healthcare claims for cardiac and blood pressure diagnostic testing between January 1998 and February 2004. Read the full article here.

Do you think that central labs are in need of more oversite?

Partnerships Poll: Social benefits of new drugs

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 July 30 for our results!

Security in medical devices

A recent article in the Boston Globe looks at medical devices and assesses the risks the security threat they present. Many of the medical devices rely on wireless signals, which could serve as a target for a security breech. Pacemakers and infusion pumps were singled out in the article, whose wireless signals put their private information and control of the device at risk of an attack. However, any of these sanctions fall outside the realm of the FDA's control. Read the full article here.

Are you concerned about patient safety in regards to security risk of medical devices? What are extra precautions that could be taken to ensure patient safety?

Partnerships Latin America Session Spotlight: Training Experienced AND Naive Site Investigators: Moving from a One Country Pilot Plan

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: Training Experienced AND Naive Site Investigators: Moving from a One Country Pilot Plan to a Full Implementation Approach across Latin America

Presented By: Glauce Nunes, Director Clinical Operations, Latin America, RPS, INC

About the session:
This session will characterize ways of creating an effective and customized training program with a true ROI for research sites in Latin America.

Social networks reach new audience for clinical trials

While we hear a lot of what social networks can do for clinical trials, Brandon at Healthcare Trends looks at what Facebook can do for clinical trials. He notes that 57% of all adults surf the web for health related information. In addition, 52% of Americans 18 to 64, and 75% of those 18-29, are on at least one social networking site.

This opens up a new pool of applicants for researchers. Brandon specifically looks at what Facebook can do in terms of marketing clinical trials to patients. With the Ads, researchers can reach their specific target market, from age range and gender to specific distances around an area. However, this should not be the only way researchers recruit their guests, but just another channel.

What do you think? Has your company recruited patients through a social media application? Were you able to reach more individuals?

Partnerships Asia Pacific Session Spotlight: Partnerships in Clinical Trials: East vs. West

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: Partnerships in Clinical Trials: East vs. West
Presented by: Mark Bach, PhD, Vice President, Head of R&D, Regulatory Affairs and Safety,
JANSSEN PHARMACEUTICALS KK, Japan

About the session:
Pharmaceutical companies are facing continuing pressure due to patent expirations, increasing regulatory constraints and other factors. These result in the need to increase productivity, increase speed to market and maintain quality. One approach to address these needs is strategic sourcing – CROs can bring value to sponsors through both strategic and tactical support for development. Sponsors headquartered in the US and Europe are entering into strategic partnerships with CROs, but the experience in Asia is more limited. How can the extensive experience in these markets inform and accelerate the development of such relationships in Asia?

Key issues include:
• How does the current APAC environment compare to the US/EU CRO industry 10 years ago?
• How is the Asia operation model different from US?
• What can be learned from the history of CRO and pharma partnership development outside of Asia?

Clinical setbacks in Clinical Development

Big Pharma like Pfizer is facing rising pressure from the easing generic competition, patent cliffs and investor pressures has made them conduct clinical studies for more than one indication. However clinical setbacks are increasingly becoming part of various company programs despite efforts to ensure that the relevant and suitable clinical endpoints are achieved.

One of the major concerns for various drug majors today is safety. A recent example of this is as follows: -Pfizer has suffered a clinical setback with the news that a late-stage trial of its oncology blockbuster Sutent as a potential treatment for liver cancer has been halted over safety concerns. The New York-based giant has discontinued the SUN 1170 Phase III study of Sutent (sunitinib) in advanced hepatocellular carcinoma following a review by an independent data monitoring committee. It has been halted because of a higher incidence of serious adverse events in the sunitinib arm of the trial compared to Bayer/Onyx' Nexavar (sorafenib).

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

Statement of Policy requested for orphan drug products

National Organization for Rare Disorders (NORD) has recently asked the FDA for a Statement of Policy regarding the approval and regulation of orphan drug products. They believe that this would encourage companies to invest more in research and development for rare disorders. At the current moment, there is no policy for the review of drugs and biologics for rare diseases.

Frank Sasinowski, chairman of the NORD board of directors, stated:
“What is not often heard is the companion portion that completes that statement. While the statutory standards are the same, the FDA interpretation and application of those same standards have historically been tailored by FDA to the unique facts of each particular medicine under FDA review”.

Read the full article here.

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