Aboutus

As with all global operations, operating under different regulatory guidelines, under-standing different cultural and ethical values, negotiating regional operational procedures and finding the right partner in Emerging Markets has remained a challenge for the research and development based, pharma-ceutical, bio-pharmaceutical and medical devices companies.

JCS with its uniquely selected editorial advisory board will provide you with regional and country by country information on the emerging markets. Information that will enable you to prepare for, and avoid any last minute glitches on Pre Clinical and Clinical Management, Trial Design, Regulatory, Validatory and Submission Issues, Subject Recruitment and Retention, Site management, Data capture and Data collection, Logistics and Patient Information and Compliance. JCS uniquely brings you experiences in trials for Vaccine Development and emerging market diseases.

Nermeen Varawala Vice President, Scientific & Medical Affairs, PRA International.

Wholehearted thanks to our readers, contributors and advertisers for the enthusiastic welcome given to the launch issue of Journal for Clinical Studies. Your response has validated our belief that there is a real place for a journal that addresses the operational, regulatory, clinical and scientific issues related to the conduct of clinical trials in emerging countries. The utilisation of emerging countries for new drug development has been proven to deliver cost and time savings.

In addition it holds the promise to assist with the development of products able to meet huge unmet medical need within both developed and emerging countries. It will be the endeavor of the editorial team at JfrCS to enable our readers to achieve their emerging country clinical trial objectives by providing a forum for the sharing of experiences, highlighting of best practices, updating of regulatory information and discussion of the unresolved scientific questions.

In keeping with our objectives this second issue of JfrCS covers a wide and relevant range of topics. Given the attention that India and China continue to receive, this issue includes numerous points of view on them. Dr. Zeng, of Incrom China explains how the Clinical Trial Approval and Clinical Site Certification process in China so markedly differs from other countries and Stefan Astrom of Astrom Clinical Research presents a survey of domestic CROs in China, arguing that they will increasingly participate in the provision of global pharmaceutical services. Whilst Kamal Sahani, Cliniminds echoes the call of India’s recent but fast growing clinical research sector for education and training initiatives and Ajita Kondalkar of iGATE Clinical Research International explains why the world’s leading pharmaceutical companies are conducting their diabetes mellitus clinical trials in India. Examining the uncharted territories of international clinical research; Maha Al-Farhan of ClinArt International asks whether there is any point in considering the inclusion of Saudi Arabia while Simon Adriensen of Medilingua discusses how to overcome language related hurdles in Africa.

To address the global regulatory matters; Jane Ricciuti, Thomson Reuters reports on the FDA ruling about the acceptance of foreign data from trials not conducted under an IND; whilst Oscar Podesta, Chiltern International and Ezequiel Klimovsky remind us that the regulatory environment in Latin America is steadily evolving and that access, relationships and collaboration with regulatory agencies in the region remains key. Dario Tanziani, Adams & Adams provides an overview of the South African regulatory and intellectual property environment and Francis Crawley brings us up-to-date with regulatory changes in Africa.

On the technology front, Mark Wren, Maria Sumner and Rob Nichols of PhaseForward describe the successful adoption of EDC -electronic data capture- in emerging countries and the ensuing benefits. This is complemented by Darah Ryan of CMED, experiences of setting up Really Remote EDC in Sub Saharan Africa. Ian Davidson of HMD Clinical makes the case for internationalization of clinical trial IT systems from the ground up to overcome the need for redeveloping systems for each country or language on a case by case basis. In addition, Stanley Tam of CRL Medinet describes how Asia has built “fit for purpose” Central Laboratory capabilities – an important facilitator of clinical research in the region and Gbolahan Fatuga of Caligeo Clinical OneVision articulates the unusual idea that public education and encouragement to participate in international clinical trials within emerging countries could assist with combating the huge problem of counterfeit drugs in these countries. We hope that this array of information and ideas will prompt you to send us your feedback and perhaps even write an article sharing your own experiences with our community of professionals engaged in emerging country clinical trials.

Hermann Schulz, MD, CEO, INTERLAB central lab services worldwide GmbH

Welcome to the first issue of JfrCS

Yes, on behalf of the editorial board I want to give a promise to our readers: you will enjoy reading the Journal for Clinical Studies due to it offering a completely different view of clinical research.

Having looked into other journals which are already available both to the pharmaceutical, biotechnology and medical devices industry and to CROs, JfrCS will provide country by country objectives on the various diseases and “hands-on” assistance. You will receive a practical insight for planning multisite clinical studies in developed and emerging countries especially if remote locations or naïve patients are involved. Selected articles will address issues of vehement importance to investigators and patients.

This very first issue of JfrCS gives you a colourful picture of clinical research in Russia (Igor Stefanov, SynRG), Ukraine and Moldova (N.M. Tsvitbaum, INNOPHAR), China (Kelli Bravo, ADOBE) and Africa (Alan Eggleston, CMED), defining the culture shock when dealing with different mentalities and operational procedures. Diseases covered this time include mental disorders (Lars Schmiedeberg, Cognitive Drug Research), cholera (Catherine Lund, OnQ) and infections (Janet Jones, Kendle). Patient safety is specifically taken care by Devrim Dogam, Encorium, in early phase studies and by Mike Blume and Susan Boyle, Spacelabs (ambulatory BP monitoring). Five articles focus on central labs (Hermann Schulz, INTERLAB), cross-border logistics in emerging countries (Alain Eudaric, Parexel), IMP supplies (Claudio Lorck, Temmler Werke), medical devices (Art Gertel, Breadsworth, and Nancy Stark,

Clinical Device Group) and, last but not least, on women participation in clinical trials (Rajam Jaishankar, Quest Life Sciences).

Our promise given above is strongly underlined by the high quality of all these papers and the support of their authors. You as the reader of this new journal can help the JfrCS team by giving your feedback on our content, quality, design and vision. We look forward to your feedback.

Dr. Stefan Astrom, Founder and CEO, Astrom Research International

A good 2009 to all of our readers, contributors and advertisers! The January issue of JfrCS covers a variety of topics and aspects of clinical trials in emerging countries. In line with the mission of the journal, a number of articles contain countryspecific information from emerging markets as to challenges and obstacles, while others cover areas of current interest.

The country-specific articles include procedures for import of drugs in connection with clinical trial applications in China (Xunting Zeng, InCrom China). Two interesting articles describe some challenges of clinical trials in India. Kamal Sahani of CLINIMINDS describes the initiatives of Indian regulatory authorities to restructure regulatory procedures, while Dr. Janet Jones of Kendle examines efforts to maximise the potential for clinical trials in India.

Francis Crawley (GCP Alliance Reviews) describes a joint initiative by the Good Clinical Practice Alliance – Europe (GCPA) in collaboration with the UN Economic Commission for Africa (UNECA) and the African Union (AU), to jointly develop Guidelines for Health Research in Africa (Afroguide). Nigeria is a country that may contribute to the access of patients in international clinical trials. Globahan Fatuga of Calegio Clinical One Vision and Ifeoma Okoye from AGCPN highlight the importance of GCP training in Nigeria and explain the experience gained working with the Train the Trainer Programme.

The clinical trials arena in the United Arab Emirates is developing rapidly. Maha Al-Farhan of Clinart International analyses demographics

and other factors of importance in this process. Two articles pinpoint initiatives by the FDA to engage in clinical research in foreign countries outside the US. Joseph M. Pickett of EXPERTBRIEFINGS depicts the FDA Watch compilation of international laws and regulations while Jerry Boxall of ACM Pivotal describes the impact of FDA opening offices in China and India.

Best practices in the clinical supply chain are focused on in two articles. Claudio Lorck of Temmler AG explains why depots of intermediate storage are often necessary in emerging countries’ settings, and Sean Smith & Ian Hunter of Fisher Scientific discuss the best practices for the clinical supply chain in China and India. Insurance as an overlooked area in trial planning is described by Chris

Tait of CHUBB INSURANCE.

Does the current economic slowdown affect clinical trials in emerging countries? This is discussed by Dr. Nermeen Varawalla of ECCRO, while another aspect is brought forward in an interview with Hermann Schulz, CEO of INTERLAB, as to why central labs are the best choice in complex trials including specialised tests.

Clinical Trials in Rapidly Developing Economies such as the BRIC area (Brazil, Russia, India, and China) is depicted in clear context by Georg Mathis (Appletree GMBH). Elisabeth Moench (Medici Global) stresses the fundamentals of effective pre-study planning when one wants to avoid study delays and poor patient enrolment.

This January issue covers two important therapeutic areas. Karl M. Eckl, of INNOPHAR GmbH, stresses the significance of QTc intervals being recorded under highly controlled settings, while Edward Mukwaya and Catherine Lund of ONQ Consulting contribute with an essential review on malaria: statistics, control and treatment. Adaptive trial design is a new tool for implementing efficient trials.

How and why is explained by Richard Young of CMED. Finally, Jean-Pierre Tassignon (Crossover CRI AG) looks into an area of significant importance to the entire R&D community, namely fraud and misconduct in scientific research.

We welcome all suggestions as to areas of interest to be covered in future issues of the Journal, and hope you will benefit and enjoy the

January volume of the JfrCS.

Patricia Lobo, Managing Director & Senior Consultant, Life Science Business Consulting

I’m delighted and honoured to be invited to join the Editorial Advisory Board of JCS. We have some interesting articles in this issue covering drug development and clinical research in China, India, Israel, Russia, Australia and New Zealand, as well as other articles such as cold chain logistics, IT, distribution and logistics of medicines to remote parts of the world, and outsourcing pre-clinical discovery.

In this Spring issue there is an article by James Vornor of Parexel, who reviews the current state of global efforts to improve stroke treatment (page 52 - 55). Every year an estimated 150,000 people in the UK have a stroke. Of all people who suffer from a stroke, about a third are likely to die within the first 10 days, about a third are likely to make a recovery within one month and about a third are likely to be left disabled and needing rehabilitation. Stroke has a greater disability impact than any other medical condition. A quarter of a million people are living with long-term disability as a result of stroke in the UK.

Stroke in low-to middle income countries has doubled in 40 years according to a recent article published in The Lancet Neurology (Feb 2009). New figures show that stroke mortality rates and burden vary greatly by country and between regions, with low-income countries being the most affected. However, known risk factors for stroke, including diabetes and alcohol consumption, are poor predictors of national stroke mortality and burden and do not explain the greater burden in low-income countries.

These are the conclusions of an article to be published online first and in the April edition of The Lancet Neurology, and presented at the International Stroke Conference in San Diego, by S Claiborne Johnston from the University of California, San Francisco, which coordinated the study with the World Health Organization (WHO).

A second study shows that, over the past forty years, the incidence of stroke in low-to-middle income countries has increased by more than 100%, and people living in these countries face a 20% greater risk of stroke than those living in high-income countries, where the incidence of stroke has declined by 42%. These are some of the main findings of a Review by Valery Feigin from the National Research Centre for Stroke in New Zealand and international colleagues, published Online First and in the April edition of The Lancet Neurology. Currently stroke is the number two killer in the world and if the number of incidents in developing countries continues to rise at the same rate, it will be number one within 20 years.

In the UK, ACT F.A.S.T. (recognizing signs in Face, Arms, Speech and Time to call the emergency services) is a new national Government campaign aimed at helping people to recognize the signs of stroke, and to act to save the lives and reduce the damage caused.

Meanwhile, Scientists have developed a tiny scaffold of stem cells to fill holes in the brain caused by stroke damage. So far tested in rats, the biodegradable balls loaded with stem cells were able to replace brain tissue in damaged areas within a week. The team, who report the results in Biomaterials, are now planning to add in a protein to encourage new blood vessel growth in the treated areas. But there is still a long way to go in stem cell therapy for stroke survivors. Previous research in injecting stem cells into rats with stroke damage has had some success but, because they lack structural support, the cells end up migrating into surrounding healthy tissue, the researchers said.

Enjoy our March issue of JCS and I look forward to meeting you at the DIA Spring 2009 in Berlin.

Mark A. Goldberg, M.D., Chief Operating Officer, PAREXEL International

The theme for the 45th Annual DIA Meeting to be held in San Diego, California is “Better Medicines: Improving Safety with Every Step.” This seems an apt theme, particularly against the backdrop of the Obama administration’s likely focus on safety and comparative effectiveness in drug development. Safety will remain paramount in the global search for effective new therapies.

With the knowledge that many potential adverse events will not emerge until much larger populations of patients are exposed, proactive pharmacovigilance planning is a growing focus for the biopharmaceutical industry. Voluntary reporting of adverse events is being replaced by registries and newer forms of non-interventional studies that will better characterise the profiles of marketed treatments. Technology has a key role to play in this area. An example is the potential that electronic medical records hold to mine data for safety signals, with the requisite protection of personal information, without having to use either specially designed studies or to rely on physician reporting. The approach to safety concerns is also evolving as companies implement new Risk Evaluation and Mitigation Strategies (REMS).

In early phase studies, a goal will be to generate more comprehensive safety profiles of compounds. This will be facilitated by innovative trial designs, including the use of adaptive studies. In addition, the role of biomarkers will continue to evolve as a tool to better predict potential safety issues as well as efficacy.

It is anticipated that medications that more specifically target the underlying mechanisms of disease will also have more attractive safety profiles. While the emergence of personalised medicine and the pairing of treatments and diagnostics may be progressing more slowly than some had expected, this area remains an inevitable evolution for the biopharmaceutical industry.

This year’s Annual Meeting will bring representatives of the biopharmaceutical industry together at a time of heightened uncertainty. The industry faces pressures due to global economic challenges, patent expirations, and decreased R&D productivity among other factors. In the U.S., the direction of the new administration, beyond the safety considerations mentioned earlier, is still emerging and includes such considerations as drug importation, pricing, and reimbursement. With large mergers and acquisitions changing the landscape, the industry will likely experience additional shifts in drug development priorities.

Combined with these market dynamics are a few key trends that continue to shape the biopharmaceutical industry, including increased globalisation of drug development, continued adoption of eClinical technologies, and the growing importance of strategic partnerships between CROs and pharmaceutical companies.

• Increased globalisation of drug development is being driven by several factors, including the ability to access diverse patient populations and the lower cost of conducting quality clinical research in emerging geographies. Another major driver is the increasing importance of new end markets for biopharmaceutical products in a number of geographies, including India and China.

• The use of technology has progressed from the adoption of a disparate set of tools from various vendors to the increasing availability of integrated technology suites. These suites offer the potential to meaningfully decrease cost and ease system interoperability. Combining these technology platforms with clinical expertise will help to bring greater productivity to development programs.

• Evolving strategic relationships among service providers and sponsors will lead to new operating models and the emergence of best practices in partnering. These enhanced partnerships, which will create new expectations of CROs in the areas of expertise and relationship management, promise to bring greater innovation and efficiencies to the drug development process.

Since change creates opportunities, it is likely that many of these emerging and ongoing trends will be favourable for the biopharmaceutical services industry, despite the current economic environment. The hope is that industry challenges will further drive innovation and enhance the performance of R&D investments. Service providers have an important role to play, in partnership with sponsors, to fulfil that promise. Given the many significant and evolving dynamics, this year’s meeting promises to foster an interesting dialogue among industry participants.

Mr. Jerry Boxall Managing Director, ACM Global Central Laboratory, Europe

I would like to extend all of our readers, contributors and advertisers a warm welcome to the latest edition of JCS.

As always, we have a wide variety of interesting and thought-provoking articles, this time with a clear focus on the emerging markets.

FDA Watch, compiled by Joseph Pickett of Expertbriefings. com, highlights the toughening stance on enforcement now being adopted by the FDA, backed by the Obama administration, as well as the growth trend now being seen in post-market studies. Continuing on the FDA theme, Alexandra Muntanola of Thomson Reuters highlights new guidance from the FDA that is intended to ensure that complete data sets are retained for FDA-regulated clinical trials.

In Australasia Watch, Russell Neal of CNS Pty. Ltd explores the development of genetically modified organisms (GMOs) in the region, and in China Watch, Dr Xunting Zeng of INCROM China explains the basic requirements for clinical trials in China and takes a look at Drug Administration Law.

Looking at new emerging markets in our ever-changing global landscape, Ebru Oncu of Encorium provides an update on the emergence of Turkey as a market for conducting clinical trials, and the drivers encouraging growth in clinical trials there. Kyung Won Jang of the Korea Health Industry Development Institute provides a report from the Asia-Pacific region on the launch of the APEC Harmonisation Center (AHC) in June, with an inaugural workshop on multi-regional clinical trials, while Dr Claudio Lorck of Temmler AG looks at the temperature-controlled shipment of investigational products to clinical centres.

Continuing the emerging markets theme, our regulatory section takes a look at regulation of data generated in emerging countries, with Prof. Anthony Woodman of ICRI Global Research exploring the potential concerns over such data. Tom Konopka of Medmarc Insurance and Frederic Nouaille of Biomedic Insurance look at insurance considerations for global clinical trials and highlight some of the risks that need to be covered, as well as the need for an understanding of the insurance requirements for all of the countries involved in a trial. David Maughan of MESM contributes an article on the issue of equipment maintenance in evolving markets, and the challenges this can present.

In our market analysis section, Dr Anthony Ikeme of Clintriad Pharma Services looks at clinical trials in Africa, and encourages collaboration with specialist CROs on the ground to identify and monitor the best trained GCP-compliant sites in the region.

Looking at therapeutic studies, John D’Souza of ACM Global Central Laboratory submits a report highlighting the role of the pathologist in the diagnosis and management of breast and prostate cancers, while Denis Miller of Parexel International looks at the particular challenges in cancer diagnosis and management in the emerging markets. Focusing on technology, Trudy Madden of Phase forward encourages the use of web-integrated interactive response technology (IRT) to automate the key processes involved in drug accountability, while Steve Heath of Medidata solutions takes a look at the importance of continued eClinical investments for small and mid-sized pharma and biotech companies.

I am sure you will agree that we have again compiled an impressive range of articles covering many topical areas of discussion, and looking closely at the developing growth within new regions and markets around the world. I hope that there is something here of interest to everyone, and that you enjoy reading this edition of the JCS.

Mr. Mark Barker Publisher Journal For Clinical Studies.

We have reached the end of 2009, and what a year it has been. I think we are all going to look back at 2009 and notice that the world has changed. We are all looking at the broader picture. From US, India & China pledging to reduce Carbon Emissions to the Pharmaceutical Industries endeavouring to find cure for many forgotten diseases, and diseases still prevalent in many developing countries, I think we will make this into a better world. When we launched Journal For Clinical Studies in 2008, we wanted to encourage Sponsors & CROs alike to venture out and utilise the vast pool of treatment naive population in the world, to find cure for diseases, and make health care available to all.

We wish to thank all our readers, contributors and advertisers for the enthusiasm with which the Journal for Clinical Studies has been welcomed and adopted as a must read journal. We would especially like to thank our editorial advisory board for the dedication and commitment they have given to this unique journal, and sourcing out information that are crucial to the modern drug discovery and development world.

In this latest issue we bring you another selection of valuable information. Trends in Clinical Trials and CT Supply Management – what happened in 2009, what may be expected in 2010 is an area covered by Dr Claudio Lorck of Temmler AG. While Walter Chalkley of Thomson Reuters writes on The FDA-EMEA Good Clinical Practice Initiative and the need to harmonise and eliminate

duplicate activities. Russell Neal focuses on how Australia and New Zealand offer proven solutions for helping SMEs with exciting novel products, While Francine Hakim of Caribbean Clinical Research Associate writes on the need for a good solid community education campaign to educate local communities, where clinical trials are being introduced for the first time into a region. Eastern Europe and the Baltic regions are relative new comers in the Clinical Trials field. Dr Janis Skards of Documeds provides a quick guide on what is happening in these newer European economies. Dr. Xunting Zeng of INCROM CHINA looks in to the important developments in China, the compilation of the Pharmacopoeia of China (2010 Edition) and the issue of the Regulation for National Essential Drugs List. The Korea Food and Drug Administration released a report on approval status of clinical trials in Korea last July, and Do Hyun Cho of KHIDI looks into this issue. Our India Watch, is on “The glorious metamorphosis: Compelling reasons for doing clinical research in India” is a joint initiative by FICCI and Ernst & Young, and is an outstanding initiative to portray the clinical research landscape in India. Dr. Ranya Shahrouri of ClinArt analyses Jordan for the first time in JCS and Francis P. Crawley of GCP Alliance examines China. Stephen Gunnigle of Kinapse looks at ways in which clinical trials can be run more effectively. The hot topic of Pharmacovigilance is explained by Sanjay Motivaras of 4G Pharmacovigilance, especially with new medicinal products

Dr. Nermeen Varawalla, President & CEO of ECCRO gives you a detailed overview of DIA Clinical Forum, Nice 2009: Improving Clinical Development Together. Heinrich Klech, CEO of Vienna School of Clinical Research reflects on improving people’s skills in Emerging Countries while Kohei Wada of Daiichi Sankyo, Co Ltd & JPMA representative of ICH Steering Committee explains the Role of the ICH-GCG (Global Cooperation Group) in facilitating the roll-out of ICH in non-ICH regions and countries. We have a focus on South Africa where Dr Lynn Katsoulis, Chairperson of SACRA discusses the regulation of device studies and practical issues encountered when conducting clinical trials on devices in South Africa. Dr Patricia Lobo interviews Dr. Dave Clark of Aurum Institute for Health Research on THIBELA a preventive study into TB in the gold mining industry, and finally Dr Jessica Trusler of BARC explains how various partnerships will define a new reality for Africa’s disease burden and a legacy of good health for its people.

We wish you all happy holiday season and see you in January 2010. “Happy New Year!”

Patricia Lobo, Managing Director & Senior Consultant, Life Science Business Consulting

A happy New Year to you! As our first issue of JCS 2010 goes out to you readers, we hear that the UK economy has come out of recession, after figures showed it had grown. The UK’s had been the last major economy still in recession, as Germany, France, Japan and the US emerged from recession last year. According to official data from the Office of National Statistics (ONS), the UK economy grew by just 0.1% in the last three months of 2009, compared to the previous quarter. During the 18 months of recession, public borrowing increased to an estimated £178bn, while output slumped by 6%. Some commentators are less jubilant on the ONS figures as they recognise that there’s more than a good chance that the 0.1% growth in Q4 will end up being revised downwards. Would it be tempting to predict a positive outlook for the life science industry for 2010? Reductions in health spending and industry job cuts could have an impact on the market, but an ageing population and a health service under pressure will guarantee an increasing demand for pharmaceuticals. According to Epsicon (The Pharmaceutical Market – January 2010), the UK pharmaceutical market is set to experience moderate growth over the coming years, tempered slightly by the effects of the economic recession. Public spending cuts are likely, as public debt continues to increase, and health expenditure is set to suffer as a result. I was particularly impressed by the 8th Annual Partnerships in Clinical Trials Congress and Exhibition by Informa, held in early November 2009 in Rotterdam. The meeting is an annual review of the industry’s best practice clinical partnerships between sponsors, CROs and other service providers. The conference Chair, John Sergeant, investigated the topic of how much the recession has impacted on clinical partnerships. Anatole Kaletsky, Associate Editor and Principal Economic Commentator of The Times, presented with great clarity an examination of the economic downturn and its impact on the pharmaceutical industry. The case study presented by Eli Lilly and Covance about risk-sharing in a successful clinical partnership was very well received. Jeffrey P. McMullen, President and Chief Executive Officer, PharmaNet Development Group, Inc., gave a detailed analysis of CRO growth opportunities in a more challenging market environment.

One of the major challenges facing globalisation of clinical trials is the recruitment of patients into clinical trials. As the demand for larger patient pools grows, countries with less experience are quickly emerging as clinical trial sites. The most prominent emerging regions include CEE, Latin America, and Asia. This globalisation trend is introducing new challenges in conducting clinical research, including language and cultural barriers. These create significant barriers to patient recruitment, especially in obtaining informed consent. In addition, regulatory approval processes and timelines in each country vary considerably. Lynn Katsoulis discusses improvements in the regulatory standards, timelines and enrolment potential in South Africa, whilst Rajam Jaishankar reviews the latest from the DCGI (Drugs Controller General India) (see pages 12 and 14 respectively) and Ryan Simper looks at the demand for language services providers in the changing clinical development world (page 52). On the patient recruitment front, my colleague Keith Thrower assesses the benefits and problems in emerging markets (page 38), whilst Oscar Podesta and Matthew McLoughlin focus on clinical research in Latin America (pages 16 and 27 respectively), Anna Ravdel on Russia (page 24), Rabinder

Buttar on Diabetes in India & the Gulf Region (page 42) and Rayna Shahrouri on Tunisia (page 18).

I am looking forward to meeting visitors to the forthcoming meetings listed on our events page, where you can pick up a copy of Journal for Clinical Studies hot off the press for hours of interesting reading. Thank you for your support, and keep the

articles rolling in.