Clinical Trials in Emerging Markets


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VIBpharma’s Clinical Trials in Emerging Markets conference will bring together pharma and biotech companies to share solutions to strategic and operational challenges in setting up and conducting studies in new territories. Attendees will hear from experienced professionals who will share their knowledge on making the most of the opportunities and benefits of conducting trials in emerging markets. Attend this practical, insightful and solution led event to generate new cost and time saving ideas for your clinical trials.

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Clinical Trials in Emerging Markets

  1. 1. 2nd Annual VIBpharma Clinical Trials in Emerging Markets Maximising the opportunities for global clinical development Monday 1 – Tuesday 2 March 2010, Prague, Czech Republic DISTINGUISHED SPEAKERS INCLUDE: Anish Desai, Eric Hurden, Head R&D and Medical Director, Associate Director, Global Clinical BAyER HEALTHCARE INDIA Operations, BIOGEN IDEC Ramil Abdrachitov, Josemund Menezes, Clinical Research Manager, Clinical Clinical Project Leader and Medical Research Region Central and Eastern Advisor CRU – India, Europe – Russian Department, SANOFI AVENTIS ASTRAzENECA Eva Lapkova, Pavel Farkas, Clinical Monitoring Manager for Czech Senior Director, Biopharmaceutics, Republic, Slovakia and Hungary, PLIVA CROATIA MERCK Jörg Möller, Cem Ozesen, Senior Vice-President Head, Global Clinical Research Manager, Clinical Development, MERCK BAyER SCHERING PHARMA WHy yOU SHOULD ATTEND?: Attend to netw o • Improve your long-term clinical development over 50 rk with strategies by understanding how to maximise pharma leading opportunities in emerging markets an compan d biotech • Identify challenges with site selection and ies fro patient recruitment and discover e ective methods to overcome them around m the wor • Discover channels where you can improve ld your o -shoring strategy and make the most of opportunities for conducting trials in emerging countries • Uncover the pros and cons of importing and Sliver sponsor: exporting drugs and biological samples in order to save money on your operations REGISTER NOW: ■ Online: ■ Tel: +44 (0)20 7753 4268 ■ Email: ■ Fax: +44 (0)20 7915 9773
  2. 2. Programme day one Monday 1 March 2010 8:30 Registration ● Upgrading ethics committees to govern all local trial sites Site management organisation and maximising 9:00 Opening remarks from the Chair ● patient recruitment Eric Hurden, Associate Director, Global Clinical Operations, ● Retaining talent in an increasingly competitive BIOGEN IDEC trial environment PROJECT AND SITE MANAGEMENT SOLUTIONS ● Capacity building at the clinical sites and reducing FOR OFFSHORE TRIALS patient drop-out rates ● Overcoming infrastructure restrictions and identifying 9:10 Getting the site selection right to achieve the best strategy for advancing clinical trials optimal study outcomes Josemund Menezes, Clinical Project Leader and Medical ● Ensuring that sponsors understand the pros and cons Advisor CRU – India, SANOFI AVENTIS of each site location ● Determining ways to access to patient population and 12:10 Infrastructure challenges in conducting trials in India make the recruitment process easier ● Dealing with the lack of processes and systems in regards to ● Understanding the regulatory approval processes communication and conducting clinical trials abroad ● Establishing a relationship with local authorities ● Finding adequate clinical facilities and trained clinical ● Understanding the benefits of chosen sites for long term investigators trial sustainability and patient retention ● Overcoming regulatory barriers to entry in site selection Ramil Abdrachitov, Clinical Research Manager, ● Ensuring adequate record keeping on paper and available Clinical Research Region Central and Eastern Europe – electronic databases Russian Department, ASTRAzENECA Viraj Rajadhyaksha, Senior Manager, Operations, Planning and Management Clinical Research, PFIzER INDIA 9:40 Non-invasive monitoring and management of global trials 12:40 Lunch ● Giving CROs flexibility whilst ensuring the best use of resources are met and there are minimal delays PRACTICAL AND ETHICAL CHALLENGES IN Maintaining ongoing communication to identify EMERGING MARKETS ● problems early ● Ensuring key deliverables and timelines are met 14:00 Feasibility studies for informed decision making ● Understand the practicalities of vendor management in when conducting clinical trials in emerging regions offshore trial sites ● Adequate country selection and patient ● Making the decision for keeping project management recruitment projections in-house or outsource to a service provider ● Facilitating the decision making process through a Olav Flaten, Medical Director, GSK analysis of options Start up challenges and avoiding delays to study progress 10:10 Panel Discussion: Setting up metrics for ● Evaluating the benefits of emerging markets compared trials in emerging countries ● to developed countries ● Developing performance metrics that are appropriate to the ● The benefits of taking a non survey approach to feasibility circumstances and meet the challenges of the trial ● Cost benefit analysis to reveal the full extent of the pros ● Adapting existing measures once trial sites are chosen and cons ● Determining all variables that can affect a trial to assist with Eric Hurden, Associate Director, Global Clinical Operations, minimising risk BIOGEN IDEC ● Variations in metrics for different trial sites 10:40 Morning Refreshments 14:30 When and how to conduct a successful clinical trial in an emerging clinical research country Key decision drivers supporting the conduct of MAXIMISING OPPORTUNITIES AND OVERCOMING ● your trial abroad CHALLENGES IN INDIA AND ASIA-PACIFIC ● Managing cultural differences and minimising 11:10 Keynote presentation: Clinical development in risks of errors emerging markets: the case of the Asia-Pacific ● Ensuring that every site complies with both local region and global ethics board ● Understanding current regulatory and legal aspects ● Choosing trial partners through analysis of ethical of the region and GCP compliance ● Developing your strategy for complying regulations ● Patient recruitment considerations for building a and communicating with regulatory bodies sustainable trial environment ● Successfully navigating the approval process ● Sustaining local access to treatments found to be ● Determining the restrictions on importing and exporting safe and effective of drugs and biological samples Cem Ozesen, Clinical Research Manager, MERCK ● Dealing with ethics committees Jörg Möller, Senior Vice-President Head, Global Clinical 15:00 Panel Discussion: Choosing the right trial Development, BAyER SCHERING PHARMA partner through an efficient and thorough selection process 11:40 Maximising the benefits of the growing ● Setting a selection criteria to find the right quality partner market for trials in India ● Information gathering processes to determine partners ● The benefits of high quality medical staff and an increasingly capabilities and strengths professional regulatory framework ● Understanding competencies and track records in ● Development in regulations and reviewing the benefits of chosen trial sites setting up clinical trials in India ● Agreeing to robust contracts that cover all study areas
  3. 3. Programme day Two ● Minimising the time taken for partner selection to reduce 8:30 Registration overall cost of clinical trials ● Establishing a relationship of trust to get the trial off to the 9:00 Opening remarks from the Chair best start Pavel Farkas, Senior Director, Biopharmaceutics, PLIVA CROATIA 15:30 Afternoon refreshments 09:10 Delegates will be able to attend three one-hour CASE STUDIES FROM CENTRAL AND roundtable discussion groups from a selection of key EASTERN EUROPE topics. Each session will be chaired by an industry expert who will facilitate an exchange of opinions, 16:00 Making the most of clinical trial hubs in the Czech essential experiences and learning related to a Republic, Slovakia and Hungary current aspect of data management ● Strategic issues and consequences for key trial decisions ● Developing awareness of different regulations, licensing Roundtable 1 environments, patient populations and expectations Ethical considerations of conducting trials ● Building the expertise amongst clinical investigators to in emerging markets successfully set up and run trials ● Understanding local regulations and operating within ● Considerations for sponsors with limited experience in guidelines to ensure compliance ethical codes of conduct Central and Eastern Europe for setting up clinical trials Cem Ozesen, Clinical Research Manager, MERCK Eva Lapkova, Clinical Monitoring Manager for Czech Republic, Slovakia and Hungary, MERCK Roundtable 2 16:30 Overcoming cultural and communication barriers Advantages and challenges of conducting trials when conducting trials in Eastern Europe in Eastern Europe ● Tailoring project management and communication ● Navigating obstacles in trial set up and project management processes for offshore trials in core trial sites ● Matching patient expectations with recruitment Ramil Abdrachitov, Clinical Research Manager, Clinical processes for different sites Research Region Central and Eastern Europe – Russian ● The challenge of working with different bureaucratic Department, ASTRAzENECA bodies and regulatory processes ● Communication techniques to secure co-operation from Roundtable 3 authorities without delaying trial set up processes Maximising the benefits of clinical trials in Asia ● Agreeing clear and measurable outcomes, timelines, ● Identifying suitable locations and working with local costs and expectations with local trial partners and authorities to facilitate trial conduct recruiting adequately skilled staff Lesley Mathews, Strategic Sourcing Manager, Mikhail Putilovskiy, Clinical Operations Manager, BAyER HEALTHCARE ELI LILLy RUSSIA Roundtable 4 17:00 Closing remarks from the Chair and close of Day One Identifying opportunities in the Asia-Pacific region for cost effective clinical development ● Making the most of available resources and expertise in the region Jörg Möller, Senior Vice-President Head, Global Clinical Development, BAyER SCHERING PHARMA Roundtable 5 Developing and maintaining successful a relationship between trial sponsors and service providers ● Building trust and agreeing measureable outcomes for trials in unfamiliar territories Pavel Farkas, Senior Director, Biopharmaceutics, PLIVA CROATIA Roundtable 6 Managing patient expectations and implementing a successful patient recruitment and retention strategy ● Maximising the opportunity for patient recruitment and maintaining the long term viability and success of the trial Olav Flaten, Medical Director Norway, GSK 12:40 Lunch Register online now at:
  4. 4. PosT-conference workshoP Tuesday 2 March 2010 Successful CRO selection 14:00 The challenges and benefits of conducting trials in the Czech Republic and monitoring processes ● ● Reviewing the challenges of setting up trials Designing trial structures to take account of local when conducting trials in ● infrastructure and site constraints Understanding the regulatory issues emerging markets ● Making the most of patient recruitment opportunities wednesday 3 March 2010 ● Maximising drug development in the Czech Republic Petr Cypro, Medical Director, BRISTOL MEyERS SqUIBB led by: roger Joby, Managing director, 1to1to1 About the workshop: LONG TERM STRATEGIES FOR CLINICAL Choosing the right trial partner is a crucial step towards building a DEVELOPMENT successful clinical trial model but trial sponsors must have a clear vision of trial aims and communicate this effectively to partners throughout 14:30 Panel discussion: The sustainability of global the selection process and the conduct of the clinical trial. Knowing your studies in emerging markets goals makes it easier to make decisions on selection criteria and carry ● Determining the long term value of conducting out assessments of the strengths and capabilities of potential partners. trials in emerging countries ● Assessing outsourcing decisions on the basis of Having made the decision on your trial partner, the importance of quality, cost and measurable outcomes contract negotiation and subsequent project monitoring is paramount in order to achieve the goals of the trial on time and on budget. This ● Anticipating cost increases in a rapidly workshop provides a practical and interactive environment in which professionalising and competitive trial arena to engage with the challenges of CRO selection and monitoring. It ● Robust quality assurance frameworks to determine is intended to enable delegates to share experiences of selection value for money strategies, contract planning and trial monitoring. ● Ascertaining the long term effectiveness of offshoring strategies Workshop agenda: 15:30 Afternoon refreshments 9:00 Registration and coffee 9:30 Effective planning for making optimal INDIA: COMPETING IN A GROWING MARKET selection decisions FOR CLINICAL DEVELOPMENT ● Knowing your goals – balancing decisions on quality, 15:30 Recruiting trained CRAs and investigators in a timelines and trial costs competitive Indian market ● The impact of site selection on selection processes – ● Finding the most qualified professionals as the local expertise and availability of resources number of trials increase ● Developing study metrics and key deliverables of a trial ● Setting the criteria for staff recruitment to ensure appropriate levels of experience and expertise 10:15 The process of selection ● Working with clinical trial training institutes to supply ● Understanding candidates partners capabilities qualified professionals and strengths ● Staff retention in the face of intense competition ● Requests for information and requests for proposals between trial sponsors ● Due diligence and analysis of proposals ● Making the most of the professionalisation in the ● Matching trials to appropriate CROs industry to reduce trial errors 11:00 Refreshments ● The long term clinical trial strategy for emerging countries Anish Desai, Head Research and Development and 11:30 Contract negotiation and agreement Medical Director, BAyER HEALTHCARE INDIA ● Matching contracts to desired trial outcomes ● Choosing a fixed, fixed unit priced or variable contract 16:00 Conducting clinical studies for generic ● Protecting your trial against cost and time overruns pharmaceuticals in India: a global sponsor's view ● Dealing with the lack of processes and systems for 12:15 Project monitoring and evaluation communication and conducting clinical trials ● Planning the project management functions to ensure ● Finding adequate clinical facilities and trained clinical adequate oversight functions investigators ● Developing performance metrics for measuring conduct ● Overcoming regulatory barriers to entry in site selection and outcomes of the trial ● Ensuring adequate record keeping on paper and ● Earned value analysis available electronic databases Pavel Farkas, Senior Director, Biopharmaceutics, 13:00 Close of workshop PLIVA CROATIA About your workshop leaders: 17:00 Closing remarks from the Chair and close of Roger Joby B.Sc. MAPM is the Managing Director of 1to1to1. Roger has conference been involved in the pharmaceutical industry for over 30 years working for both CROs and pharmaceutical companies and now as an independent consultant. Roger’s experience includes project management, proposal generation, sub-contractor contacts and project finance. 1to1to1 is part of R. & N.R. Consulting specialising in project management consultancy in clinical research. The company was formed in March 2000 and has a range of clients that include large and medium sized pharmaceutical companies, bio-techs and CROs
  5. 5. Silver sponsor: About the Conference DOKUMEDS CRO VIBpharma is proud to announce the launch of our second Eastern Europe based Full annual Clinical Trials in Emerging Markets conference Service CRO operating since taking place in Prague on 1-2 March 2010. 1995 in Latvia, Lithuania, Estonia, Russia and Ukraine. Phase II-IV clinical R&D services including Project Management, In the current economic climate reducing costs and Regulatory Services, Contract and Finance Management, Data increasing efficiency during the clinical trial process is Management and Medical Consultancy. Member of CROs crucial to sustaining the long term development of new alliance (Acrossalliance) operating in East-Central and South treatments. There exists challenges, in setting up and Europe; ISO certified in International Project Management. running a clinical trial that must be overcome. A key factor in determining the effectiveness of your trial is Media Partners: recruiting the right types of patients at the right time. It is a complex and intricate area, requiring knowledge of human Pharmaceutical Technology is behaviour, marketing and management expertise, together used daily as a means of creating with scientific knowledge. partnerships and as a point of reference by professionals within the pharmaceutical industry. As more pharma and biotech companies look to emerging This comprehensive resource supplies the latest news releases, regions to conduct their studies the need for information, detailed information on industry projects, white papers, expertise, guidance and advice on managing the pitfalls of event information and a thorough breakdown of products and services. operating in new and unfamiliar countries becomes greater than ever. Emerging regions such as Eastern Europe and Biocompare is the most comprehensive, in-depth, and Asia, where large patient populations are available pose, objective website for life science product information. opportunities but also risks. Key challenges encountered Thousands of scientists use Biocompare daily to quickly find the right product for their experiments rather than looking by sponsors include: through multiple print catalogs. Visit www.biocompare. ● Obtaining regulatory approval in trial sites and com to find the products you need, stay informed of new working with national regulators in an ever changing technologies, read product reviews, watch product videos, bureaucratic landscape and keep up-to-date on life science news. ● Import licences and overcoming supply chain issues GlobalData GlobalData's Report Store features thousands of high ● Infrastructure and communications challenges in quality research reports across a broad range of industries. developing countries The reports draw on in-depth primary and secondary research, databases of proprietary in house data and high quality ● Choosing trials partners and outsourcing to local analysis from our expert teams. Data and analysis at the or global CROs - ensuring that the partnership is company, country and industry level includes competitors, effectively managed is paramount valuations, trends, forecasts and analytics. ● Recruiting adequately trained clinical investigators VIBpharma’s Clinical Trials in Emerging Markets conference Join our Linked-in group online. will bring together pharma and biotech companies to Name: Clinical Trials Arena share solutions to strategic and operational challenges in setting up and conducting studies in new territories. Attendees will hear from experienced professionals who Who should attend? will share their knowledge on making the most of the The audience will be made up of Vice Presidents, opportunities and benefits of conducting trials in emerging Directors and Managers within pharmaceutical and markets. Attend this practical, insightful and solution led biotech companies from the following areas: event to generate new cost and time saving ideas • Outsourcing • Clinical Operations • Procurement • External Alliances • Clinical Trials • Clinical Research • R&D • Project Management Do you wish to exhibit your products • Contracts and services at this exclusive event? • Legal If you want to be a part of this leading industry event, • Counsel please contact Jaz Sidhu in our sponsorship team. Tel: +44 (0) 20 7753 4259
  6. 6. Booking Form Clinical Trials in Emerging Markets, Monday 1 – Tuesday 2 March 2010, Prague, Czech Republic Yes, i would like To regisTer for The evenT: Before Before Before AfTer ■ Register online at 7.12.2009 4.1.2010 2.1.2010 2.1.2010 Pharma and Biotech attendees emerging-markets/register I would like the VIP attendees package to include the two day conference + the post-conference workshop + interactive CD-ROM €3,290 † €3,430 † €3,570 † €3,780 † ■ Email us at (saving €220) † I would like to attend the two day conference + €2,640 €2,780 €2,920 €3,130 the post conference workshop (saving €150) † ■ Tel +44 (0)20 7753 4268 I would like to attend the two day conference + €2,450 † €2,590 † €2,730 † €2,940 † ■ Fax +44 (0)20 7915 9773 interactive CD ROM (saving €70) † I would like to attend the two day conference only €1,820 €1,960 €2,099 €2,309 Venue Details I would like to attend the post conference workshop only €980 €1,120 €1,260 €1,470 The two day conference will take place in Prague, Czech Republic For further information contact our fees for all other attendees Operations department on +44 (o) 207 753 4201. I would the VIP Package attendees package to include the two day €3,450 † €3,590 † €3,730 † €3,940 † conference + interactive CD-ROM Are you registered? I would like to attend the two day conference €2,820 €2,960 €3,100 €3,310 You will always receive an acknowledgement of your I cannot attend the conference but would like to receive booking. If you do not receive anything, please call €700 † €700 † €700 † €900 † the interactive CD-ROM us on +44 (0) 20 7753 4268 to make sure we have † VAT where applicable received your booking. Total Discount code if applicable _________________________________ Discounts are at the discretion of VIBevents and are not cumulative All total fees are subject to a 2.5% service charge Arena International Conference Delegate terms and conditions 5 General: You, your executive/s or your agents may not transfer or assign any of the rights or obligations of this Agreement 1. 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