Criterium Registers in Canada, Creates New Positions

By Sara Gambrill

Saratoga, N.Y.-based contract research organization (CRO) Criterium is planning to open an office in Toronto. The move was client-driven and will be where the company’s newly appointed director of global affairs, Lawrence Reiter, Ph.D., is based.

Reiter has worked for Criterium since 2003 and was formerly managing director. All global operations will report into Reiter. He will also be responsible for ensuring that operations in new offices that Criterium opens are standardized.

“We have a new position at the company called director of global affairs. What that means is that for the rest of the world, everything needs to be coordinated, everything codified for every office because we will continue to open offices. [Dr. Reiter] is one of the folks who have been with us for some time, and he’s coming to North America from overseas so that he’ll be in our time zone,” John Hudak, founder and chief executive officer of Criterium, told CWWeekly at IIR’s 17th Annual Partnerships with CROs conference in Las Vegas.

Criterium has three Canadian clients that have studies ongoing in Canada as well as other parts of the world.

Criterium was founded in 1991 and has 117 staff, including full-time equivalent (FTE) and permanent consultant staff. The company began conducting clinical trials globally in 1997. In 2003, the company opened its Johannesburg office; in 2005, it opened offices in Pune, India, and Berghem, The Netherlands; last year, the company opened offices in Boca Raton, Fla., St. Petersburg, Russia, and Gedera, Israel. The company has 21 active clinical trials.

Criterium’s trial management model employs technology flexibility and a centralized workflow process. “Wherever we do work around the world, it’s still the same process,” said Hudak. “The sites, wherever they sit, get the data directly to New York. And once we have them in New York, then we can start to make decisions with them. We process them, we query them and then incorporate them into reports so we can make decisions on the fly about how things are going in Russia and South Africa,” he said.

Criterium also discussed the different paradigm that it has employed for the past five years, requiring a new position to be named recently—clinical data liaison—to reflect that difference. “We really believe it’s a new paradigm. We feel that we’ve broken down the silos, and we have data management now blended very beautifully with what we call our clinical data liaisons, who are in-house monitors who assist the field monitors,” said Ronny Schnel, executive director, business development and client services for Criterium.

“The clinical data liaison in Saratoga is a kind of hybrid of a clinical monitor and data management, so we break down that traditional silo between the clinical team and the data team, and in-house they actually work on both. They’re the first line of data reviewing when it comes to New York directly from the site. They send the queries back directly to the site, then they instruct the monitors in the field which sites to go to and what work has to be done at the sites. So the field monitor goes into a site and knows what to expect. [The field monitor’s] primary job is to do source document checking and troubleshooting at the sites,” said Hudak.

The company plans to open more offices globally wherever sponsors want to conduct clinical trials.

“We went to areas where our sponsors asked us to and where we could have the Criterium style and do it. We’re doing it. In 2007, we were on the runway, and in 2008, we just took off,” Schnel said.

Sara Gambrill is senior editor at CenterWatch. She is also the author of The Emerging Markets of Clinical Research and Asia-Pacific’s Growing Role in Global Clinical Trials.

Parexel's Josef von Rickenbach On Phase I Activity

Parexel recently expanded its early phase operations in three of its phase I facilities. The move brings the company’s global phase I bed capacity to one of the largest in the industry, at 550.

Parexel also has phase I services in India through a partially owned venture with Synchron Clinical Research’s Ahmedabad-based facility, which has 86 beds. Last month, Parexel increased its ownership stake in that venture from 19.5% to 31% at a cost of $5 million. At the same time, Parexel sold its France-based bioanalytical and biomarker testing laboratory facility—owned since 1999—to a subsidiary of Synchron for approximately $6.7 million. The unit will now be called Synexel Research International and will stay within Synchron’s operational network.

ClinicalTrialsToday recently asked Josef von Rickenbach, Parexel's chairman and chief executive officer, to provide some additional insight into the CRO's recent moves within the burgeoning  phase I market.

Parexel Buys Larger Stake in India Venture and Expands Phase I Business in U.S., Europe

By Stephen DeSantis

Waltham, Mass.-based contract research organization (CRO) Parexel has grown its early phase operations with an expansion of three clinical pharmacology units (CPUs), located in Baltimore, London and Berlin.

The expansion brings the company’s total worldwide phase I bed capacity to 550, one of the largest in the industry, the company stated. Parexel also has CPUs in San Diego and Los Angeles, and two facilities in South Africa. Each of its phase I facilities uses its clinical trial management and electronic data capture (EDC) technology, ClinBase. The company’s early phase services include bioanalytical services, data management, biostatistics, medical writing, pharmacokinetic services and consulting.

Progenitor Grows Organically in Latin America, India

By Sara Gambrill

The opening of the Progenitor International Research’s new office in Buenos Aires, Argentina, a year ago signaled the beginning of a fundamental change to the company’s business model. Previously, Progenitor had worked exclusively as a CRO composed of teams in emerging markets who worked under a coordinated platform to deliver global development services. Progenitor’s office in Argentina represents the first organic growth of the company in an emerging market.

Progenitor International Research is an emerging market contract research organization (CRO) founded in 2005 with headquarters in Deidesheim, Germany. The company’s global management functions reside in Europe, and clinical research is conducted in 12 countries—Argentina, Chile, Peru, India, China, Korea, South Africa and countries in Southeast Asia.

Progenitor conducts clinical research in South Africa and in countries in Southeast Asia through partnerships, but the company is growing organically in the other countries in which it operates. The company has 800 clinical research professionals working together with Progenitor in emerging markets who have experience on more than 500 clinical trials.

CenterWatch caught up with three key members of the operations team at Progenitor International Research at the DIA EuroMeeting in Barcelona to find out how the new model was working and what plans the company had for growth in 2008 and beyond...

Project to Develop Guidelines for Health Research in Africa Launched

By Sara Gambrill

The “Clinical Trials Roundtable” attracted more than 70 participants during the “Science with Africa” conference organized by the United Nations Economic Commission for Africa and the African Union, which is an international organization that promotes cooperation among the independent nations of Africa. The conference was held in Addis Ababa, Ethiopia, and attended by more than 600 representatives, including representatives from health and science ministries, universities, non-governmental organizations and international organizations from Africa, Europe and North America.

Two representatives from industry were also in attendance—Dr. Richard C. Hubbard, senior director, External Medical Affairs, International, Office of the Chief Medical Officer, Pfizer, and a representative from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), which represents the global research-based pharmaceutical industry.

Much of the Clinical Trials Roundtable, chaired by Mrs. Avril Doyle, member of European Parliament, focused on identifying the needs of African countries for guidelines in clinical trials and other areas of health research. It also provided an opportunity for leading African and international partners to develop a consensus position on the organization of the project to develop guidelines for health research in Africa.

Francis Crawley, executive director of Brussels, Belgium-based Good Clinical Practice (GCP) Alliance, which he founded in 2005, was approached by organizers of “Science with Africa” in October to participate. Crawley has extensive experience in creating GCP guidelines and model bioethics laws in Eastern European, Asian and African countries. He was also asked to speak briefly at a meeting in the European Parliament in December and subsequently to write an abstract for the roundtable.

More than 70 attended the Clinical Trials Roundtable, which ran for four hours. About 80% of participants were from Africa and the rest were from Europe, the U.S. and Canada, according to Crawley. The industry representatives also participated. At a pre-meeting to the roundtable, African participants made it clear that, despite the existence of many international guidelines, Africa needed its own.

inVentiv Clinical Moves into Latin America

By Stephen DeSantis

inVentiv Clinical, the contract research organization (CRO) division of Somerset, N.J.-based marketing, communications and staffing firm inVentiv Health, has expanded its clinical services to Latin America with a new central hub in Sao Paulo, Brazil. The company stated it plans to bolster its operations in other countries throughout the region as well.

inVentiv Clinical has placed Ana Paula Ruenis, Ph.D., in charge as director of clinical operations in Latin America. Ruenis has more than eight years of experience managing trials in Latin America and has worked for top pharmaceutical companies in South America.

"Having already established full off-shore operations in India, the expansion of our clinical operations into Latin America is an important next step in our goals to become a global clinical services provider," said Mike Hlinak, inVentiv Clinical’s chief executive officer.

Latin America has proven to be an emerging market of choice of late. It poses less of a logistical challenge than do more remote regions such as China and India. The six major markets—Argentina, Brazil, Chile, Colombia, Mexico and Peru—have 425 million people, or 80% of the region’s population. That is equal to the population of the entire European Union but less than half the size of India or China.

PRA Relocates to Larger India Office

Raleigh, N.C.,-based PRA International has expanded its Mumbai, India, presence by moving into a larger facility. It is located in a new development in the Andheri East area of Mumbai. The new space can hold more than 20 clinical staff and allow for PRA to bring its total to 50 employees there by the end of the year. The company said this would potentially increase its service capacity by 150%. As the office grows, PRA will increase services in protocol development, medical writing and clinical consultation services in the region.

"This is an exciting time for PRA," said Dr. Sue Stansfield, executive vice president, Product Registration, Europe, Africa and Asia-Pacific. "The Mumbai team is a great example of PRA's global experience and therapeutic expertise.  Their success in earning client trust and delivering service excellence has been key to the growth we are experiencing in India."

Japan’s New Regulatory Attitude Evident at DIA EuroMeeting

By Sara Gambrill

One of the highlights of the DIA EuroMeeting in Barcelona certainly had to be the update from Japan’s regulatory agency, Pharmaceutical and Medical Devices Agency (PMDA). The session was introduced by Yoshiaki Uyama, Ph.D, a review director at PMDA, who  was wearing a PMDA T-shirt, instead of a suit and tie, which admittedly seemed too casual. He explained that his luggage hadn’t arrived at the same time he had, which produced knowing laughter.

What he went on to say was both surprising and refreshing, coming from a representative of PMDA. He said that he had wondered what he would wear if he didn’t get his luggage in time for the session. In the end, even though he had been reunited with his clothing in time, he decided to wear the PMDA T-shirt to foster an informal atmosphere for the session, which he hoped the audience would find acceptable. This last sentiment was met with an enthusiastic round of applause from the hundreds in attendance, many from big pharma.

Clearly the message PMDA wanted to send during its session was that the agency is striving for openness, cooperation and timeliness to promote Japan’s role in global drug development.

Both Uyama and Satoshi Toyoshima, Ph.D., executive director and director, Center for Products Evaluation at PMDA, discussed many objectives and initiatives to accelerate the drug process in Japan, but the initiative that will have the most immediate impact will launch in April. With the new Investigational New Drug Application (IND) Consultation Process, PMDA wants to increase the number of face-to-face meetings with sponsor companies and also meet with them in a more timely manner.

Uyama noted that in 2006 there were 473 sponsor applications for IND consultations with PMDA, with only 295 actually granted. PMDA wants to increase the percentage of consultations granted to those sponsors that apply and has a tentative plan that Uyama shared with the DIA EuroMeeting audience. From April forward, the new IND consultation process should have a predictable schedule of about five months, during which sponsors are able to submit an expression of intention, apply and submit documents to PMDA.

Five weeks prior to the face-to-face meeting, there will be an inquiry and response period between sponsors and PMDA. Four days prior to the face-to-face meeting, PMDA will give its opinion, which will be discussed at the meeting. Draft minutes will be drawn up and then finalized one month after the meeting.

Kendle Looking to Grow Phase I Business

Cincinnati-based CRO Kendle is expanding its phase I business with the appointment of Phillip Davies, a 20-year industry veteran in early stage research, and made another key hire to grow its Asia-Pacific operations.

The company stated that Davies will provide the leadership needed to grow its phase I units, which include a clinical pharmacology unit in The Netherlands and a bioequivalence facility in West Virginia. Kendle said Davies will focus on expanding its capabilities worldwide.

Prior to the appointment, Davies had roles within Kendle’s pharmacology business in Germany and the UK. Before joining Kendle, he spent six years with Eli Lilly in its pharmacology operations. Most recently, Davies was director of global exploratory and program phase medical operations. Davies, as vice-president of phase I, will report directly to Kendle’s chief executive officer, Candace Kendle, PharmD.

“Phase I is a rapidly growing area of opportunity and is an integral part of Kendle’s business plan, with the market to grow between 13.4 and 16% annually through 2010,” said Kendle.

Kendle also hired Ross Horsburgh, M.D. as vice president of global clinical development for the Asia Pacific region. Prior to joining Kendle, Horsburg was regional medical director for AstraZeneca’s Asia Pacific region. He will be based in Singapore and report to Martha Feller, senior vice president of global clinical development for phase I through III operations.

Quintiles Expands Central Lab in China; Consolidates Services

Quintiles has consolidated its China-based Global Central Laboratories and Clinical Development Services (CDS) businesses into a new, 17,000-square-foot facility in Sun Dong Ann Plaza in Beijing. The new site is larger than the CRO’s original laboratory located at the Peking Union Medical College Hospital (PUMCH). The CDS plans to grow to a staff of more than 60 in the next year.

The company stated that by consolidating these businesses its could improve coordination and efficiency for Quintiles’ customers

“The globalization of clinical research is continuing to increase, and China is just beginning to see the rapid growth we have experienced in India, Australia and throughout Asia Pacific,” said Lai Lee Tan, head of the Quintiles’ Clinical Operations and general manager in China.

Quintiles’ laboratories in China are certified by the College of American Pathologists (CAP) and the National Glycohemoglobin Standardization Program (NGSP).

ClinTech Relocates To Scotland

ClinTec International, a CRO based in the UK, is moving it global headquarters to Scotland from its current offices in Windsor. The office will be in Glasgow, Scotland.

The headquarters will house all of the company’s corporate functions including sales, human resources, IT, finance and marketing as well as clinical operations. The move is being assisted by a $2.7 million Regional Selective Assistance Grant from the Scottish Enterprise—an economic development agency funded by the Scottish government.

ClinTec has pledged to create 240 new jobs over the next three years. The company stated one of the incentives to relocate to the region is its highly skilled talent pool available due to the many universities and academic research institutes. More than a dozen CROs maintain operations in Scotland, including Quintiles, Aptuit, Charles River Laboratories and BioReliance.

In August, PPD obtained a $9.1 million RSA grant to the construction of a 34,000-square-foot office in Lanarkshire, Scotland to support its late-stage services.

Indian CRO Manipal AcuNova and ECRON GmbH Merge

Manipal AcuNova, a Bangalore, India-based CRO has acquired ECRON GmbH a of CRO based in Frankfurt, Germany. The new company will have a combined staff of 265 and will be known as ECRON AcuNova. It will provide services for phase I through IV global studies, including project management, data management, biostatistics, medical writing, central lab and BA/BE.

The new company will maintain both headquarters as well as operate a U.S. hub in Princeton, N.J. Kohkan Shamsi, M.D., will become chief executive officer of ECRON AcuNova and will be based in the U.S.

ECRON’s founder, K. D. Wiedey, M.D., will act as the company’s president in Europe. D.A. Prasanna, M.D. will lead the CRO’s Asia operations. “We are able to strengthen our expertise in clinical trials and data management from our Indian counterparts with faster patient enrollment in clinical trials, timely database lock, high quality early phase development as well as unique features like access to the central lab,” stated Wiedey.

AstraZeneca to Work with Keio University in Japan

AstraZeneca’s Japanese subsidiary, AstraZeneca KK, signed a Master Clinical Study Agreement with Keio University School of Medicine based in Tokyo. The university reported that due to Japan’s slow pace of drug research, it has taken steps to build up its own clinical trial capabilities and improve the efficiency of its research.

AstraZeneca and Keio University will collaborate on future studies and support the development of new compounds within the school.

Synergy Creates Alliance With Indian CRO Neeman Medical

Russian CRO Synergy Research Group (SynRG) has made its next move to create a global CRO alliance, forming a partnership with Neeman Medical International, an India-based CRO. The alliance will focus on providing international sponsors with monitoring and site and data management services. Neeman Medical was founded in 2001 and is headquartered in New Delhi.

The CRO has about 70 investigative sites in 17 locations across the country, with access to more than 600 trained investigators. In August, SynRG formed a similar alliance with Costa Mesa, Calf.-based Promedica International.

“Our next target is to find a partner in China. We’ve recently taken part in the Russian- Chinese Forum on Biotechnological and Pharmaceutical Industries, and have established a number of good promising contacts,” said Igor Stefanov, director of business development at SynRG.

Serbia Celebrates International Clinical Trials Day; Clinical Center of Serbia Joins ECRIN

By Dragana Maca Kastratovic, M.D.

In May, the celebration of the “International Day of Clinical Trials” was organized by the Center for Clinical Pharmacology, Clinical Center of Serbia, in the Polyclinic of the CCS. The International Day of Clinical Trials is May 20, which commemorates the first comparative trial conducted in 1747 on 12 sailors afflicted by scurvy.

On behalf of the Clinical Center of Serbia, the meeting was opened by Professor Dr. Svetozar Damjanovic, a Scientific Research Manager. His introductory lecture was called “The significance of clinical trials for the development of the Clinical Center of Serbia.”

Professor Damjanovic reported on past activities and results in respective fields, as well as the huge potential for the future. He emphasized that, by implementing the EU Directive for Clinical Trials, Serbia would have a chance to work in the same way as the best research settings in Europe and worldwide.

The European Union Clinical Trial Directive was passed by the Ministry of Public Health of the Republic of Serbia and incorporated in the Serbian Act, which encompasses the regulations governing clinical trials of drugs, procedures and contains the documents for approval of clinical trial, Official Gazette No 19/2007.

Thus, clinical trials in Serbia will be performed officially in the same way as in other EU countries. Dr. Vasilije Antic, senior consultant gave a presentation on this Act with a special focus on the part referring to inclusion of vulnerable populations into clinical trials of drugs.

India to Allow First-in-Human Phase I Studies of Molecules Developed Abroad Soon?

By Sara Gambrill

India may allow first-in-human phase I studies of molecules developed abroad in the near future. Currently, India only allows first-in-human studies developed in India—a boon to the burgeoning domestic clinical research industry, and a bane of the global clinical research industry.

A year ago, the then Drug Controller General of India, Mr. Ashwini Kumar, said at the DIA Annual Meeting in Philadelphia that India was not ready for these types of studies. Some wonder if India is ready now.

CenterWatch spoke with Navaneetha Rao for perspective. Rao has worked in India for many years and is currently head of clinical R&D at Vicus Therapeutics, a small U.S.-based biotech. Prior to that he worked for an India-based contract research organization (CRO), as head of clinical research services.

“Imagine if what happened in the UK with TeGenero were to happen in India. Not only would it have a huge negative and adverse impact on phase I studies, but it would have a very big dampening effect on clinical research in general. There are right things happening, there are right steps being taken, but is it sufficient to handle the load that is being placed on the industry?”

The Central Drug Standard Control Organization, India’s main regulatory agency headed by the DCGI, promulgated “Good Clinical Practices for Clinical Research in India five years ago, and it’s been two-and-a-half years since India upgraded its Schedule Y (equivalent to the U.S. Code of Federal Regulations) to harmonize it with U.S. and International Conference on harmonization (ICH) standards.

India’s participation in global clinical trials nearly quintupled between 2001 and 2005, but it is in competition with other emerging markets, all of which allow first-in-human phase I clinical trials for molecules developed outside their respective countries...

Criterium Opens Offices in Russia, Israel

By Sara Gambrill

Saratoga Springs, N.Y.-based contract research organization (CRO) Criterium has opened two new offices in St. Petersburg, Russia, and Yavne, Israel. Criterium made its announcement recently at the 43rd Drug Information Asociation (DIA) annual meeting in Atlanta, Georgia.

Criterium, founded in 1991,  has 91 employees. It has offices in New York, California, Florida, India, South Africa, The Netherlands, Russia and Israel. The company began conducting clinical trials in Asia, South America and Europe in 1997.

Its newest office in Russia has three full-time employees and the office in Israel has one, Ayelet Bar-Dov, clinical liaison/business development associate. Prior to joining Criterium, Ms. Bar-Dov worked as regional sales representative at Teva Pharmaceutical Industries.

Criterium’s trial management model, which employs technology flexibility and a centralized workflow process, makes its expansion into various emerging markets in clinical research possible.

“We’re tying it all together with our technology and our workflow. We fit the technology to the region. Technology is a tool, but workflow makes it work. Our hub is in New York. All data comes into it and goes back out to sites, then we manage the monitors using real data that comes in,” John Hudak, president and founder of Criterium, told CWWeekly at DIA.

Hudak’s first considerations when establishing a new office are the regulatory process, patient population and quality sites. Criterium has plans for further growth that include the Pacific Rim and South America.

“We have plans [to open offices in] New Zealand and South America. The regulatory process has to be reasonable. We’ve done work in Chile and just finished work in Ecuador,” said Hudak. “In today’s global studies, it is more important than ever to adopt an agile approach, which means finding the appropriate patients and combining various data collection tools with a standardized, centralized workflow, which allows timelines to stay on track and costs to be kept in line.”

Sara Gambrill, Senior Editor at Thomson CenterWatch and author of The Emerging Markets of Clinical Research.

Parexel Expands Global Reach with New Hub in India

By Stephen DeSantis

Waltham, Mass.-based contract research organization (CRO) Parexel International has opened a major clinical operations and data management office in Hyderabad, India. The office will serve as the company’s main hub in the region and will expand its presence in the emerging Indian clinical trials market. Although Parexel already operates an 86-bed phase I unit in Ahmedabad, through a joint venture with the CRO Synchron, this would be the company’s first late phase clinical operations office in the region.

During the Drug Information Association (DIA) 43rd Annual Meeting in Atlanta, Mark Goldberg, M.D., president of clinical research services and Perceptive Informatics at Parexel, discussed the company’s news with CWWeekly.

“One of the biggest challenges in running clinical trials today is patient recruitment and retention,” said Goldberg. “India provides a great opportunity to work with a vast population of patients, many of whom are interested in participating in clinical trials. Parexel will also be able to leverage its global footprint to perform appropriate tasks within a lower cost structure, such as data management.”

The phase I sector in India remains comparatively soft due to regulatory requirements on first-in-man studies. Goldberg stated he didn’t see that changing anytime soon but added that India will be a key later phase market for the company. About 7% of Parexel’s revenue comes from trials in Asia. And that business is projected to grow rapidly over the next few years. The U.S.-based consulting firm McKinsey has estimated that biopharmaceutical sponsors will spend $1.5 billion per year on clinical trials in India by 2010.

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.

Read our full coverage of the news in an upcoming CWWeekly article or for any other CenterWatch stories visit our publications area.

Bilcare To Create Research Academy in India and Asia

By Stephen DeSantis

India-based Bilcare Limited, a pharmaceutical packaging and clinical technology firm, together with the Association of Clinical Research Professionals (ACRP), have created the Bilcare Research Academy. The company will open 25 educational centers in India and Asia by 2010, investing $4.8 million. The first centers to open in India and Singapore, followed later by Thailand, Pakistan, Bangladesh, Sri Lanka, Indonesia and China.

Bilcare Research Academy will offer a one-year postgraduate diploma, accredited by ACRP, in clinical trials management to graduates of pharmacy, life sciences and medicine. The academy will also provide continuing medical education course for current industry professionals. Students also receive a year of free membership to ACRP.

ACRP and Bilcare have a common interest to enhance the capability, competency and expertise of the professionals engaged in developing, monitoring, conducting and supervising clinical trials in India and other Asian countries by way of specialized training programs," said Thomas Adams, chief executive officer of ACRP.

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.

Russia's Growth Potential

By Sara Gambrill

The growth of Russia’s clinical research market in the past five years has been impressive. Nearly double the number of clinical trials were approved in 2006 as were in 2000, and the number of patients participating in global clinical trials conducted in Russia more than tripled between 2002 and 2006. In addition, between 2001 and 2006, Form FDA 1572s were filed by more than three times the number of investigators in Russia.

The most distinguishing factor propelling Russia’s growth - attracting pharmaceutical and biotech companies and contract research organizations (CROs) from around the world - is the solid reputation for clinical research the country has built up over the past decade. Drugs developed with data coming from studies conducted in Russia have begun to be approved by the U.S. Food and Drug Administration and the European Medicines Agency—the most important quality marker an emerging market in clinical research could attain...

INC Research Expands Into India

By Stephen DeSantis

Raleigh, N. C.-based CRO, INC Research, has partnered with GVK Biosciences to launch business operations in India using GVK’s facilities in Gurgaon. The new venture will be called INC GVK BIO Private Limited. The plans to open the office were announced to CWWeekly earlier this month during an interview with John Potthoff, Ph.D, president and chief operating officer at INC. Potthoff said that because of increasing demand, INC would be opening up offices in India and Latin America before the end of the year.

“These are mainly driven by where our customers need us to be. And that is where they are leading us at this point,” he said. Given the country’s cost savings and the number of treatment-naïve subjects available, INC sees India as a small but fast growing segment of its current business.

“Our goal in India is really looking at it as an opportunity, a strategic expansion for access to patients and investigators. For us, India also will be a kicking off point for Asia,” said Potthoff.

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.

A New COG Model In Brazil

Posted by: Sara Gambrill

A new oncology-focused contract research organization (CRO) may have found an ideal way to tap into the large patient population participating in Brazil’s public healthcare system.

Oncopartners, a management-funded U.S. company with a wholly owned Brazilian subsidiary, has entered an exclusive worldwide partnership with Instituto Brasileiro de Pesquisa em Câncer (IBPC), a non-profit entity created to build a network of oncology clinical researchers from 18 public cancer hospitals in Brazil.

Oncopartners has funded and designed the IBPC infrastructure to support international clinical research in each of the public hospitals. Those sites treat more than 30,000 new incidences of cancer annually.

This is a brand-new CRO model for Latin America and an important one. Pharmaceutical and biotechnology companies usually have the option of outsourcing an entire clinical trial, and often do, so the model for a particular country, especially in an emerging region, can be all-important.

Enter Romania And Bulgaria

Posted by: Sara Gambrill

The European Union (EU) will have two new member states next month: Romania and Bulgaria. Both countries are ready to implement the EU Clinical Trials Directive, but their membership may have broader implications for clinical research than just harmonized regulations.

Fast patient recruitment - one of the biggest drug development bottlenecks in the West - has been Eastern Europe’s trump card. Clinical trials that take only weeks to recruit patients for in Eastern Europe can take months or even a year in Western Europe.

The major difference between Western and Eastern Europe is the structure of their respective healthcare systems. Eastern European countries have very large hospitals, each dedicated to one therapeutic area where all patients with that disease go to seek treatment. These countries also only have one national healthcare system in which all patients are identified...

Novartis Makes Big Play in China

Posted by: Sara Gambrill

Following in AstraZeneca’s footsteps, Novartis is investing $100 million in an R&D center in China. It’s a move I had alluded to in an earlier piece in this forum. Expect other big pharma companies to follow.

Those who look at a move like this as merely a cost-cutting measure are missing one of the more obvious reasons a drug company would go to China—it’s the largest potential market on the planet. China’s pharmaceuticals market grew 28.4% between 2003 and 2004 and is projected to grow another 18% this year, IMS Health estimates. In addition, the government has declared that biotechnology/life sciences make up one of China’s pillar industries.

Now is the perfect time to set up operations in China. The country adopted Good Clinical Practice in 1998 and became a member of the World Trade Organization in 2001, prompting it to tighten its intellectual property rights protection, which is still a concern. Most significantly, in 2003 China formed the State Food and Drug Administration (SFDA), a full cabinet-level agency, modeled after the U.S. Food and Drug Administration. That is when big pharma started taking a serious look at China for R&D.

Underwriting Investigator Training in China

Posted by: Sara Gambrill
 
Eli Lilly and Novartis have made substantial investments in investigator training in China recently. Both companies are planning to make a big play there. Novartis has already said that it’s opening an R&D center in Shanghai this year. Lilly has not made its plans public.

With a population of 1.3 billion and a centralized healthcare system with access to millions of treatment-naïve patients per day, China has certainly attracted the interest of top 20 pharmaceutical companies. AstraZeneca has by far the largest presence in China. The country’s pharmaceutical market has been growing at a double-digit clip, dwarfing the growth seen in Western markets.

To further their goals, Lilly and Novartis have each donated tens of thousands of euros to the Vienna School of Clinical Research (VSCR) to fund the organization of investigator courses. VSCR seeks funding from industry and government to fulfill its mission of raising the level of professionalism in clinical research in Central and Eastern Europe and developing countries...

In India, A Pairing Born Of Necessity

Posted by: Sara Gambrill

India’s clinical research market entered a new era in January 2005 with the signing of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. TRIPS requires the country to honor all product patents issued after 1995.

A paper published by the U.S.-based National Bureau estimates that in the antibiotic sector alone, TRIPS will result in a $713 million loss to the Indian economy; $50 million of this amount represents foregone profits of domestic drug companies. To avoid these losses, Indian pharmaceutical companies are looking for new revenue streams. Increasingly, large domestic—formerly generic—pharmaceutical companies are focusing on new drug development.

A partnership deal made last week reflects the changes going on in India’s domestic pharmaceutical market. A contract research organization (CRO) called ClinTec International, based in the UK with operations in 27 countries in Europe, South Africa, the Middle East and India, has formed a co-development partnership with Hyderabad, India-based Dr. Reddy’s Laboratories. The risk-sharing agreement involves co-development of DRF 1042, a topoisomerase inhibitor that has shown potential as an anti-cancer treatment.

Medical Device CROs Setting Up Shop in Emerging Markets

Posted by: Stephen DeSantis

Alquest, a medical device focused contract research organization (CRO) based in Minneapolis, Minn., has launched services in India. The company claims to be the first such CRO to expand medical device offerings into the emerging India trials market. Medical device companies are particularly afflicted by challenging patient recruitment rates, and Alquest feels many companies will head to India to shave costs.

Alquest was started by Linda Alexander in 1993, as a consulting company to the device industry. In addition to the company’s Minneapolis headquarters, Alquest holds an office in the San Francisco Bay Area. Earlier this month, Alquest announced the promotions of Ann Quinlan-Smith to president and Elizabeth Kempen to chief operating officer. It employees a staff of about 50 employees.

Stephen DeSantis, Senior Associate Editor, Thomson CenterWatch.

Fighting The Logjam In LatAm Drug Trials

Posted by: Sara Gamrbill

Clinical research in Latin America has grown significantly over the past 10 years but obstacles to continued growth still exist. In our first-ever survey of investigative sites in Latin America, we at Thomson CenterWatch found that bottlenecks at the site level continue to hinder growth of clinical research in the region as researchers strive to improve the system.

In the survey, 86% of respondents said that regulatory delays and bureaucracy were the biggest challenge to conducting clinical trials. Two of the largest markets, Brazil and Mexico, have the lengthiest and sometimes slowest moving regulatory approval systems. Both countries have said, though, that they are committed to streamlining their processes.

The six major markets—Argentina, Brazil, Chile, Colombia, Mexico and Peru—account for 425 million people, or 80% of the region’s population, equal to the population of the entire European Union but less than half the size of India or China.

Is India Ready For Phase I Studies?

Posted by: Sara Gambrill

India has come a long way as a center for clinical drug trials, but is the country ready for Phase I studies? I think the short answer - and others would agree - is “no”. Take, for instance, recent comments by Ashwini Kumar, the Drug Controller General of India (DCGI), who spoke recently at the Drug Information Association’s (DIA) Annual Meeting in Philadelphia. Kumar, head of the Central Drug Standard Control Organization (CDSCO), India’s regulatory agency, said that India needed to create an environment for the best quality assurance before embarking on phase I studies...

Wyeth Overhauling Phase II Program

Posted by: Sara Gambrill

Wyeth plans to make bold changes to its phase II program, cutting the number of sites participating and using more sites in China, India, Latin America and Central and Eastern Europe. Wyeth also plans to use more sites in emerging regions for its entire clinical program.

Wyeth has a robust pipeline of compounds entering phase II. While phase II clinical trials study a relatively small population of no more than a few hundred subjects, Wyeth uses 50 to 100 sites, 30% of which enroll zero to two patients for phase II trials. This practice is common among most large international pharmaceutical companies. Wyeth plans to reduce the number of sites in a typical phase II program to about 10-20 worldwide...

Clinical Research in India

Posted by:  Dr. Chandrashekhar Potkar

-Clinical Trials Today’s guest author, Dr. Chandrashekhar (Shekhar) Potkar, is the Director of Clinical Research & Regulatory Affairs at Pfizer LTD in Mumbai, India. Over the coming weeks, Dr. Potkar will explore India’s rapid expansion into the clinical trials arena through a series of posts highlighting on one of the hottest topics in the industry today.

Over the last three years, there has been an increase in clinical research activity in India. Rapid expansion of the clinical research activity has lead to number of questions, some with clear answers and others with not so clear answers. This is not necessarily country-specific but perhaps related to the clinical research field itself. As India is poised at a tipping point in this field, we offer a commentary on a range of key topics given below. There have been a number of pointers to this growth, as reflected in...

A New Era Begins for India’s Clinical Research Market

Posted by: Sara Gambrill

India’s participation in global clinical trials has nearly quintupled between 2001 and 2005, as investment in the country by large international and domestic pharmaceutical companies, small and medium-sized Western biotechs and the National Institutes of Health (NIH) has grown as well. The clinical research outsourcing market in India grew to $70.5 million last year and will continue to climb.

AstraZeneca Bets More Chips On China

Posted by: Sara Gambrill
 
AstraZeneca is investing $100 million more in China over the next three years to build the AstraZeneca Innovation Centre China, an R&D facility to study the benefits of new drugs to Chinese patients. Already one of the most heavily invested in China among big pharma companies, AstraZeneca is further distinguishing itself as the leader there with this new commitment.

The Innovation Centre, expected to open by the end of 2009, will focus on translational science by building knowledge of Chinese patients, biomarkers and genetics. Initially, research there will target cancer, a major cause of death in China. AstraZeneca’s lung cancer drug, Iressa, has proved more effective in Asian patients than it has in Caucasians, and China is becoming an important market for sales...