Transcript
1. VIBpharma Wednesday 17 and Thursday 18 March 2010, New Brunswick, New Jersey Optimizing your outsourcing strategies to maximize the quality and cost efficiency of your clinical trials HEAR FROM KEY INDuSTRY SPEAKERS: KEY REASONS TO ATTEND: ● Great new case studies from key biotech • Molly Rosano, Director • oss Pettit, R and pharmaceuticals companies Clinical Research, Vice President, Clinical Learn the latest new approaches that can help Operations, ARIAD ● PulMATRIx INC you increase the efficiency of your outsourcing PHARMACEuTICAlS program • onathan Guerriero, J • ashieda Gluck, R Participate in expert led panel discussions to Program Director, ● Head of Clinical get your questions answered RADIuS Operations, • Katie Wood, VIFOR PHARMA Clinical Trial Head TOP COMPANIES REPRESENTED: Translational Medicine • isa Kaufman MS, l ● PFIZER ● RADIUS Oncology, NOVARTIS Director, Clinical ● NOVARTIS ● CELTIC PHARMA Operations, PHARMACEuTICAlS ● SOLACE ● EISAI STROMEDIx ● ROCHE ● ASTRAZENECA • Maureen Hynes, • ary- Callahan-Squire, M Director, Strategic Executive Director, Sourcing, MIllENNIuM Clinical Programs, PHARMACEuTICAlS ASTRAZENECA FREE* for vice presidents • hris Houchins, C and directors from biotech VP Clinical Operations, ARNO THERAPEuTICS and pharma companies Silver sponsors: europe REGISTER NOW: Online: www.vibpharma.com/outsourcing/nj Tel: +44 (0)20 7753 4268 Email:
[email protected] Fax: +44 (0)20 7915 9773 2. Program day one Wednesday 17 March 2010 08:30 Registration 11:30 Developing an effective strategy to maintain multiple contracts successfully and improve time and cost 09:00 Opening remarks from the Chair efficiency ● Establishing an optimal model for your clinical trial department to 09:10 Evaluating recent and ongoing changes in the world of ensure that your protocol produces the best possible partnership every outsourcing in order to plan for future partnerships time ● Assessing developments taking place in the CRO marketplace in order ● Achieving a balance between over dependence on too few providers, to establish a more effective decision making strategy and an unmanageable number of vendors ● Understanding the implications for sponsors and the opportunities ● Incorporating offshore CROs into your global strategy in order to that have been created by a more integrated CRO/Sponsor climate promote good interaction and reduce the likelihood of error ● Overcoming the challenges presented by a more CRO reliant ● Reviewing supervisory strategy to improve your working relationships environment to exploit potential advantages without sacrificing and increase efficiency autonomy Jonathan Guerriero, Program Director, RADIuS ● Uncovering developing trends and what they mean for the future of clinical trials outsourcing 12:00 Panel Discussion: The tender process: how can you Mitchell Katz, Vice President Clinical Operations, EISAI GlOBAl ensure that the proposal you receive is realistic and ClINICAl DEVElOPMENT informative in order to avoid unnecessary change orders ● The Request For Information: ensuring that your request is sufficiently Identifying the optimum vendor for your business to specific to allow the CRO to provide a comprehensive and informative response ensure a successful partnership ● Understanding the optimal level of detail in order to make efficient use 09:30 Achieving clarity on how to identify the type of CRO that of time without compromising the bid process best meets the needs of your company profile to help ● The Request For Proposal: analyzing key questions to maximize the accuracy and relevance of the proposals you receive you maximize ROI ● Developing best practice reviewing the bids to identify the CRO who ● Establishing the needs of your trial in order to more effectively best meets your needs streamline the selection process ● Re-evaluating bid-grids and the need for negotiations to be based on a ● Assessing the capabilities and specialities you require of your CRO common language: avoiding all barriers to communication ● Understanding whether a full service or function service model will ● Comparing ‘apples to apples’ to make sure that the cheapest bid really offer the best return on the investment of your time and financial outlay is the best value ● Achieving a balance between price and quality by involving both the Katie Wood, Clinical Trial Head Translational Medicine Oncology, clinical and outsourcing teams in the selection protocol NOVARTIS PHARMACEuTICAlS ● Revealing key strategies to make the right choices first time, every time lisa Kaufman MS, Director, Clinical Operations, STROMEDIx Maureen Hynes, Director, Strategic Sourcing, MIllENNIuM PHARMACEuTICAlS Jonathan Guerriero, Program Director, RADIuS 10:00 Size matters: matching your CRO to the phase, drug, location and business model in question to maximize 01:00 Lunch efficiency ● Finding a CRO that can offer both the security of a large corporation, Optimizing the bid process to streamline procedure and and the personal partnership of a smaller provider ● Assessing the true benefits of using a large CRO: can it save you time expedite trial start-up and money? 02:30 Employing comprehensive and well researched ● Developing a strategy that incorporates specialist, smaller vendors in order to take advantage of a closer working relationship and the contracts to reduce the risk of change orders and resulting efficiency missed milestones ● Optimizing results in early phase trials by selecting a well suited ● Achieving maximum CRO buy-in in order to share risks and benefits vendor and reduce the likelihood of vendor-led over-run ● Evaluating small and large CROs to establish the most price-efficient ● Identifying potential areas of risk to better prepare for them approach ● Reducing the need for time-consuming and financially draining Ross Pettit, Vice President, Clinical Operations, change-orders by establishing a water-tight contract ARIAD PHARMACEuTICAlS ● Understanding whether a one-off contract or a long term partnership will be most effective for your trial 10:30 Morning Refreshments and Networking ● Using a long-term partnership to reduce the likelihood of costly mistakes and develop a sense of shared responsibility Mary- Callahan-Squire, Executive Director, Clinical Programs, Putting in place the best possible vendor and ASTRAZENECA in-house team to ensure a successful, timely, and cost efficient trial 03:00 Establishing a workable contract that delivers on promises 11:00 Case Study: learning what virtuals require of CROs and ● Optimizing the speed of your trial by identifying potential problems at the lessons that more traditional business models can the outset take from a fully outsourced format ● Asking the revealing questions: pinpointing unrealistic promises ● What does the ideal CRO offer the virtual biopharma? ● Defining effective due diligence procedure to ensure that your vendor ● Establishing a self managing format which reduces the need for is offers what you need constant oversight from the sponsor ● Ensuring that the bid is realistic and all-inclusive to minimize the ● Successfully ensuring that your project is given adequate resource and chance of over-spending attention so that quality is maintained ● Clearly defining responsibilities and expectations in order to minimize ● Securing excellent the vendor staff your trials require to enable you to oversight and achieve key milestones focus on core competencies Katie Wood, Clinical Trial Head, Translational Medicine Oncology, ● Overcoming challenges specific to virtual pharma and identifying NOVARTIS PHARMACEuTICAlS tailored strategies to maximize efficiency Chris Houchins, Vice President, Clinical Operations, 03:30 Afternoon refreshments and networking ARNO THERAPEuTICS 3. day one Wednesday 17 March 2010 Program day two Establishing a relationship which optimizes quality 08:45 Registration and refreshments and reduces error 09:10 Chairman’s opening remarks 04:00 Maximising transparency and reliability through metrics and SlAs to develop an efficient and reliable working Developing effective CMC outsourcing strategy relationship ● Enhancing the quality and reliability of your trial through the 09:40 The Role of CMC in Early and late Phase Clinical Trials ● CMC strategies for early-phase clinical studies deployment of effective metrics ● Risk-managed CMC regulatory compliance strategies ● Matching the CRO to your KPI requirements in order to create a ● Effective collaborations with CMOs for CMC development activities harmonious partnership that meets your needs of external partner and clinical trial supplies ● Measuring and bench-marking your pre-agreed metrics: how to ● Coordination of clinical operations, quality and regulatory functions effectively assess your progress against key goals to ensure adherence to standards and on time clinical trial supplies ● Minimizing trial duration through the use of an effective monitoring ● Effective interactions with international regulatory bodies to gain protocol timely approval of regulatory submissions ● Adapting your strategy to take account of offshore trials: factoring in Angelos Dovletoglou, Director, Small Molecules, CMC, BIOGEN IDEC potential obstacles 04:30 Chairman’s summation and close of day 1 Developing an offshore strategy that minimizes risk while taking advantage of potential efficiencies 10:10 Case Study: Outsourcing clinical trials to India Overcoming cultural and language differences in order to optimize the reliability of your clinics ● Successfully conducting essential initial research to establish the requirements of your location of choice ● Developing protocol that enables you to select a vendor that can fulfil those requirements ● Ensuring that your CRO has sufficient in-country support from a local vendor in order to reduce the likelihood of time-consuming misunderstandings ● Assessing the availability of qualified investigators who can deliver your data on time and to an FDA compliant standard ● Understanding India’s regional languages and their implications your you trial: avoiding surprises 10:40 Working effectively with CROs in the uK to increase the efficiency of Phase I clinical trials ● Highlighting the UK regulatory landscape to better understand the necessary process and maximize efficiency ● Clarifying REC and CA submission to guarantee regulatory expectations are met ● Explaining the MHRA accreditation system for Phase I CROs to ensure the selection of an appropriate facility Moira Burke, Managing Director, BIO-KINETIC EuROPE 11:10 Morning refreshments and networking 11:40 Running a high quality trial through careful management of international partnerships ● Identifying the technology required to ‘watch’ an off-shore trial ● Overcoming key challenges when monitoring the progress of a geographically distant trial ● Taking account of the hidden costs of managing your relationship in order to create a more realistic budget ● Minimizing the likelihood of misunderstandings by creating effective and clearly defined chain of command 12:10 Evaluating the role of China in the future of clinical trials ● Assessing the business challenges of operating in China today: determining the political and economic landscape ● Analyzing the potential benefits to patient recruitment and time savings ● Delving deeper into the challenges: uncovering the current status of infrastructure, personnel and supply systems in order to gauge whether developing operations in China would benefit your business ● Ensuring patient care and safety standards through careful evaluation of likely obstacles ● Establishing the true financial efficiencies over a more traditional location register online now! ● Sourcing a CRO with specialist skills in this geographical area the www.vibpharma.com/outsourcing/nj challenges associated with it 01:10 Lunch 4. day two Thursday 18 March 2010 02:40 Keynote Presentation: How to ensure that your trials comply with both local and FDA regulations Who should attend ● Exploring the progress of key global clinical trial locations against The audience will be made up of Vice Presidents, Directors FDA requirements to identify the most proficient and Managers within pharmaceutical and biotech ● Pinpointing key challenges as the FDA become increasingly manufactures from the following areas: demanding on safety data and patient numbers ● Using local knowledge to ascertain in advance what is required ● Outsourcing ● Clinical Research of your trial and how best to satisfy in-country regulations and ● Clinical Operations ● R&D guidelines ● Procurement ● Project Management ● Reviewing the requirements and the implications for your key milestones and budget targets ● External Alliances ● Contracts ● Acquiring sufficient local expertise and guidance to ensure that your ● Clinical Trials ● Legal Counsel trial runs smoothly ● Identifying common pitfalls and how they can be overcome going forward How you will benefit from attending Outsourcing Maintaining a partnership that reduces your exposure in Clinical Trials New Jersey to risk and maximizes efficiency • articipate in cutting edge debate on how to choose the P 03:10 Optimizing communication in order to expedite the perfect vendor delivery of product to market • aximize your productivity by learning new technique to M ● Ensuring that communication is part of your protocol: building it into your strategy manage your contracts and relationships ● Overcoming language and cultural barriers to achieve effective • nalyze the impact of merger and acquisition activity in the A communication in an increasingly global market market place and how it may affect your trials ● Developing a communication strategy that avoids the possibility of misinterpretation and time-consuming errors • evelop a deeper understanding of how to overcome the D ● Ensuring that your relationship does not suffer as a result of the challenges presented by offshore outsourcing pressure to cut costs ● Learning from past mistakes: analyzing errors and their solutions to • Hear the latest case studies and learn from their outcomes help build a fool-proof system • inimizing costs by benchmarking your metrics and SLAs with M Rashieda Gluck, Head of Clinical Operations, VIFOR PHARMA industry best practice 03:40 Afternoon refreshments and networking 04:10 learn what steps to take to improve communication About the Conference and performance with your existing CRO and when and Optimizing your outsourcing strategies to maximize the how to move part or all of your project to a new CRO quality and cost efficiency of your clinical trials. ● What are the warning signs that a project needs to be rescued? ● Deciding whether you should work with your current CRO to make Following the enormous success of our San Francisco changes and if so what you need to do and Boston. Outsourcing in Clinical Trials events earlier ● Pinpointing how best to change CROS once the decision has been this year, VIBpharma is proud to announce the launch of made Outsourcing in Clinical Trials New Jersey. ● What do you look for in a new CRO? ● Evaluating whether you should have the new CRO take over all of The New Jersey conference comes at a crucial time the study or just certain functions for outsourcing clinical trials as pharma and biotech Kate Didio, Sr. Director, Clinical Operations, SuRFACE lOGIx companies pursue cost-reduction strategies. Outsourcing Molly Rosano, Director Clinical Research, PulMATRIx INC to a specialized provider is an effective and highly popular method for minimizing financial outlay and maximizing 04:40 Closing remarks from the Chair time-efficiency. VIBpharma's Outsourcing in Clinical Trials New Jersey will 05:00 End of conference bring major pharma and biotech manufacturers together to debate potential solutions to these complex challenges. Located in New Brunswick this event will cover topics such as the vendor selection, the effect of merger and acquisition on the outsourcing marketplace, offshoring, and relationship management. By debating and discussing the latest solutions to shared challenges, the conference will help you get the most out of your outsourcing strategy for the coming year. This event is FREE* to attend for a limited number of biotech and pharma manufacturers. Register your place today! 5. Sponsors and Media Partners Silver Sponsor C0 Sponsor Medpace is a full-service, global contract research organization (CRO) that partners with biopharmaceutical companies to bring innovative drugs to market. Medpace, based in Cincinnati, Ohio, manages global studies and regulatory submissions, providing clinical trial support in all phases of development up to and including submissions to regulatory agencies. In addition to full-service CRO functionality, Medpace has international operations that include Media partners bioanalytical and pharmacology capabilities, central laboratory, and core imaging services. Pharmaceutical Technology is used daily as a means of creating Medpace physicians have extensive experience conducting clinical partnerships and as a point of trials and understand the issues from the perspective of the clinical reference by professionals within the investigator, the scientific leader, and the reviewer at the regulatory pharmaceutical industry. This comprehensive resource supplies the agencies. Medpace brings these perspectives to each clinical trial that latest news releases, detailed information on industry projects, white we conduct. www.medpace.com papers, event information and a thorough breakdown of products and services. www.pharmaceutical-technology.com Bio-Kinetic Europe – Consistency in Clinical Excellence. An independent Phase I-II Clinical Drugdevelopment-technology.com: Pharmacology Unit based in Belfast, Northern is a procurement and reference europe Ireland, we have experience in 400+ clinical resource providing a one-stop-shop trials across all therapeutic areas and trial designs. We have a GCP & for professionals and decision makers within the drug development GMP accredited 40-bed clinic, a 11,500 volunteer database and a Phase and medicines industry. They provide a comprehensive breakdown I CTA approval timeline of 14 days that provides further incentive for our of drug development contractors and suppliers, up-to-date news and clients. www.biokineticeurope.com press releases, white papers and detailed information on current industry projects and trends. Their recruitment area provides career BioClinica is a leading global provider of information and the latest job vacancies in the field. integrated, technology-enhanced clinical www.drugdevelopment-technology.com trial services. BioClinica supports pharmaceutical and medical device innovation with imaging core lab services, internet image transport, Pharmaceutical Business Review: The Business electronic data capture, interactive voice and web response, and clinical Review websites are your number one stop supply chain design and optimization solutions. www.bioclinica.com for all the latest news, comment and industry information. Each Business Review website offers content that is produced by a dedicated team Clinical Resource Network, LLC is a leading of journalists and global industry experts.In addition to the free content provider of specialized in-home and alternate-site made available on the sites an intelligence store will provide you with nursing, pharmacy and phlebotomy services for premium market analysis reports from the leading global suppliers of phase I-IV studies conducted in the US, Canada, market research and industry analysis.Pharmaceutical Business Review is UK, Europe and Israel. These services decrease the world's leading pharma website, being used by over 100,000 visitors development time by accelerating patient recruitment and improving every month. For further information contact jsharp@industryr
