PPD opens drug safety center in Bulgaria

According to Pharma Times, PPD has officially opened a pharmacovigilance and medical communications office in Sophia, Bulgaria. With this new office, in addition to the one currently in Athlone, Ireland, PPD can now better provide regional support for pre and post approval in drug safety trials. For more, read the full article here.

Partnerships Latin America Session Spotlight: Meet the Demands and Expectations for Patients in Latin American Trials: Ethical Challenges to Consider

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

Presented by:
Luis Pliego, MD, Regional Medical Affairs and Regulatory Manager, JANSSEN AND CILAG – ARGENTINA
Daniel Ciriano, Medical Director, ROCHE – ARGENTINA
Ana Rodriguez Castelli, MD, Clinical Research Manager PIERRE-FABRE – ARGENTINA

About the session:
Regulatory authorities in Latin America may approve a drug that patients may not be able to access due to lack of coverage – a serious consideration for sponsors contemplating marketing a
drug in the region. For patients participating in clinical trials, law dictates in that trial sponsors must continue to provide drugs to those in need even after the trial ends which is a huge cost factor for sponsors. These are critical ethical concerns, as is informed consent translating into risks to sponsors of trials in Latin America that must be fully considered.

• Formularies/Access – how does reimbursement impact a sponsor’s decision to conduct a trial and/or commercialize a product in the region?
• Language barriers and informed consent – are these documents easily understood by study participants?
• Post-Study Drug Provisions – must pharmaceutical companies be able and willing to market drugs in the countries in which the patients are enrolled in trials?

Creating a “VALUE” added position

Eyeing strategic deals in India has been the major focus of the global pharma companies who are stepping their feet in India particularly Pfizer and Glaxo.

Pfizer has gone south in establishing licensing cum marketing deal for its 30-40 products in 2009. Further, Glaxo last year has had strategic stake investment in Dr. Reddy laboratories. This deal gave the UK drug giant exclusive access to the latter's portfolio and future pipeline comprising more than 100 branded pharmaceuticals across areas such as diabetes, cancer and pain management, in emerging markets. In July 2008, the firm linked up with South Africa's Aspen and its Indian joint venture partner Strides Arcolabs to sell branded generics in emerging markets.

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

Partnerships Latin America Session Spotlight: Get Your Study Approved: Current Regulatory Requirements and Timelines for Conducting Clinical Trials

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

Presented by:
Eduardo Motti, MD, Regional Head Clinical Operations, Pfizer – Brazil
Silvio Klimovsky, MD, Head of Clinical Research, Argentina and Uruguay, Pfizer – Argentina

About the session:
What do Latin American regulatory authorities expect from pharma/clinical research submissions and what can pharmaceutical companies expect from the review process?

Gain an understanding of the regulatory environment and its impact on the future of clinical development in Latin America with an overview of Brazil, Argentina, Mexico, Peru, Colombia and Chile.

• Individual regulatory authorities and their role in the approval process
• Barriers and solutions: understanding the regulatory challenges in the various Latin American countries
• How much of a deterrent is elongated regulatory timelines in certain counties for sponsors wishing to conduct trials in this region?
• What are the unique challenges around commercialization and approval?
• Understanding the protocol approval process including timelines

Generics: Acquisition specialists- TEVA

Teva, the world's biggest generic drug maker has blanket coverage in its presence especially in USA and Canada. The company with acquisitions before 2005 had managed to place itself in the European market of Italy. After the takeover of Barr in 2008 only which brought Teva, the European assets of Pliva (which Pliva took over form Merck), it has been the sole objective of this generic drug giant to strengthen its position in the largest European generics market of Germany.

Nothing could have been better than Ratiopharm takeover for Teva. With Global Majors like Pfizer and generic drug giant, Actavis in the fray for the Ratiopharm, the stakes for this acquisition were definitely higher.

Ratiopharm businesses were facing problems after the suicide of Adolf Merckle. They were up for sale since the last 9-10 months and were on the lookout for a suitable buyer.

All indicators were pointing at the largest market for generic drugs in Europe- i.e. Germany but also India…………

And that requires no guesswork…..

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

Partnerships Latin America Session Spotlight: Uncover the Advantages, Risks and Key Factors in Conducting Successful Clinical Trials in Latin America

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: Uncover the Advantages, Risks and Key Factors in Conducting Successful Clinical Trials in Latin America
Presented by: Carlos Caparros, MD, Senior Director, Global Clinical Trial Operations, Latin America, MSD – ARGENTINA
Jose Eduardo Neves, MD, Medical Director, ASTRAZENECA – BRAZIL
Matilde Damian, MD, Associate Director, Regional Clinical Operations, BRISTOL-MYERS SQUIBB - Mexico

About the session:
Research conducted in Latin America can support successful global drug development programs. This session provides an overview of the opportunities – and the obstacles – of the region. Argentina, Brazil, Mexico, Peru and Chile are covered.

Panelists will be looking at:
• Who are the key players and what are their capabilities?
• What is the level of infrastructure in the region?
• What is the scale of Latin America investigators?
• What are the opportunities this region has to offer?
• What are the risks of running trials in the region and what impact might they have on studies?
• What are the cultural differences that need to be considered?
• What are the therapeutic area focus and incidences in each region?

Outsourcing Clinical Research

What will happen to the world of outsourcing?

The Pharma world space of 3 major global players has united to form the world's FIRST cancer group to focus towards the emerging markets of Asia to target Stomach and Lung cancer. The news release has got flashed at 6-7 major web sites. An individual news clip was flashed by Elli Lilly in the late evening hours yesterday as well which spoke of its initiatives to start the research work form Singapore. There were mentions of mainly the people from Elli Lilly in Singapore and China in the News release.

The world of the Pharmaceutical Industry has changed. The drug majors are uniting themselves with the changing times, have decided to "mutually share" database s for cancer drug development and move in unison towards the emerging markets.

If this is so, then what should be the subsequent strategic initiatives at the CRO's (the outsourcing providers) in the emerging markets?

Should the CRO's "act" in a similar manner as the Pharma companies or prepare to understand the market on their own with individual capabilities?

This is question which can be answered only when the outsourcing market takes a DECISIVE turn in a direction which today many forecasting experts are trying to understand.

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

Clinical trials getting harder to conduct

A recent report by the Tufts Center For the Study of Drug Development looks at how hard it is becoming to conduct clinical trials. Not only is it getting hard to get them off the ground, but, as we've seen in many articles throughout the Partnerships Blog, it's very hard to maintain patients throughout the process.

The article at the Boston Globe does point out that one of the reasons for this is the complexity of the trials that are now being treated. As the more rare and complex treatments get for certain diseases, the harder it will be find the right patient population. What do you think about the findings of the studies?

The Indian Oncology Market

The Indian Oncology Market
Key Cancer Statistics for India


Cancer accounts for 29% of the main causes of deaths in India. It is becoming the leading cause of deaths in India.


The number of deaths is increasing in India due to various types of cancers such as lung cancer, breast cancer, ovarian cancer, pancreatic cancer and so on.

Prevalent cases - 24 lakhs

1. New cases witnessed every year - 8 lakhs
2. 80% of patients reach hospitals only in advanced stages of the disease
3. 5.5 lakhs people die annually due to cancer
4. Higher incidence of the disease is found among women than men
5. Cancers of oral cavity and lungs in males and cervix and breast in females account for over 50% of all cancer deaths in India
6. More at-

http://blogs.veedaoncology.com/Lists/Posts/Post.aspx?ID=42