CLINICAL TRIALS SUPPLY NEW ENGLAND

Transcription

1 CLINICAL TRIALS SUPPLY NEW ENGLAND 26 TH -27 TH MARCH BOSTON, MASSACHUSSETS Developing best practices and incorporating novel technologies to meet the demands of a more complex, international clinical trial supply chain VALUE FROM ATTENDING Clinical Trial Supply New England is a strategic event targeted at those who have clinical, technological and regulatory responsibility for the supply of clinical trials. The key outcome of this meeting will be to balance supply chain delivery to overcome current operational challenges in clinical trials. Year on year this conference brings together the leading thought leaders from both big and small pharma to debate discuss and learn best practice from one another in an intimate and relaxed setting. Learning and networking are key outcomes of this meeting SPEAKING FACULTY Peter Shapiro, Ph.D., Editor in Chief, GlobalData PharmSource Troy Petrillo, Supervisory Consumer Safety Officer, FDA Sean Smith, Supervisory CBP Agriculture Specialist, Customs and Border Protection Elliot Ortiz, Chief CBP Agriculture Specialist, Customs and Border Protection Barrett Glasser, Director, Supply Chain Integrator, Takeda Tom Skiendzielewski, Associate Director Business Process and Integration, Shire Pharmaceuticals Melissa Morandi, Vice President Global Quality, Aegerion Pharmaceuticals Janel Kelly, IRT Specialist, Clinical Supply Capabilities, Biogen Abizer Harianawala, Senior Director, Product Development & Technical Operations, TARIS James Krupa, Director, Clinical Supplies Team Lead, Shire Lucia Ayra, Director, Clinical Supply, Acorda Therapeutics Doug Meyer, Associate Director, Clinical Drug Supply, Biogen Susan Marlin, President and CEO, Clinical Trials Ontario Kelsey Kern, Clinical Trial Supply Specialist, CSL Behring Paul Larochelle, Senior Manager, Clinical Asset Planning, Biogen Maria Vilenchik, Chief Executive Officer & Founder, Felicitex Matthew Leets, Transportation and Trade Management Analyst, Sanofi FURTHER INFORMATION For sponsorship opportunities please contact: Paul Adams, Healthcare Director PaulAdams@arena-international.com Tel For program enquires please contact: Charlie Abrines, Senior Conference Producer charlie.abrines@arena-international.com Tel

2 Clinical Trial Supply New England th March 2018 I Programme Day One 07:45 Registration and refreshments 08:20 Chair s opening remarks Global clinical trials These sessions will give sponsors the opportunity to further their knowledge on the global landscape affecting clinical trials to ensure compliance and reduce delays 08:30 Outlining challenges in the import and export of IMP s to guarantee drugs reach their destination and avoid delays at border control Reviewing current import and export requirements for IMP s into and from the US to ensure you are up to date with sponsor obligations Outlining a clear customs process with your broker to prevent hold-ups at the border which can potentially compromise your drug and delay your study Providing low cost alternatives to large-scale shipping companies when dispatching your drug supply for your global clinical trials Harnessing the knowledge provided by the US Borders and Customs Centers of Excellence to guarantee on-time delivery Troy Petrillo, Supervisory Consumer Safety Officer, FDA Sean Smith, Supervisory CBP Agriculture Specialist, Customs and Border Protection Elliot Ortiz, Chief CBP Agriculture Specialist, Customs and Border Protection 09:00 Session reserved for PCI Clinical Services 09:30 Conducting clinical trials in Canada; what you need to know to make this a reality Reviewing what sponsors need to know to begin successfully running trials in Canada Considering potential cost savings associated with Canadian trials vis-à-vis the US Highlighting Canadians engagement in clinical trials to improve recruitment and data collection Susan Marlin, President and CEO, Clinical Trials Ontario 10:00 People bingo This is the perfect chance to network and meet your peers. In this session, delegates will all be assigned a number and tasked to find 3 other numbers in the room. Ask them their name and top challenge and reason for attending the conference. The delegate who completes this the fastest will win a bottle of champagne. 2

3 10:15 Morning refreshments and networking Clinical Quality and Monitoring These sessions will seek to unpack best practice in quality management to ensure sponsors are compliant with regulatory requirements 10:45 Designing and implementing a quality management system to improve how your clinical supplies are administered Reviewing which quality systems are currently available Implementing the right quality management system for your organization Providing the appropriate training and messaging to ensure consistency across and within teams Considering key stakeholders and affected systems and processes Melissa Morandi, Vice President Global Quality, Aegerion Pharmaceuticals 11:15 Session reserved for Catalent 11:45 IMP lessons learned during GCP regulatory authority inspection Content TBC James Krupa, Director, Clinical Supplies Team Lead, Shire 12:15 Lunch and networking Logistics These sessions will focus on clinical supply logistics and showcase ways that companies can get their drugs to patients quickly and efficiently 13:45 From theory to practice; how can biopharma leverage technology to design a functioning Direct to Patient (DtP) supply chain Appreciating the complexities of transforming current supply chain management systems to effectively incorporate DtP Highlighting regulators concerns with implementing DtP into your clinical trial strategy Considering patients storage capabilities and additional costs which will affect your trial design Maximising current technologies to improve patient adherence and prevent drop-offs through DtP Lucia Ayra, Director, Clinical Supply, Acorda Therapeutics 3

4 An innovative approach to simplify the Clinical Supply Process for unblinded medication and supplies 14:15 Unpacking current clinical supply issues and trends Case Studies: Practical applications of an Innovative Approach Presenting cost comparisons for the clinical supply process utilizing real world data Explaining the pharmacy adjudication process and how you can benefit Speaker from RxSolutions 14:45 Discovering how to incorporate gene therapies within your supply chain Highlighting current technologies available in the transportation and storage of these therapies Showcasing what changes are needed to incorporate gene therapies into your supply chain Reviewing differences in regulation across the US and EU; how to meet quality, safety and efficiency standards Considering the commercial risks associated with gene therapies and what is needed to make this a success Peter Shapiro, Ph.D., Editor in Chief, GlobalData PharmSource 15:30 Afternoon refreshments and networking Brand new 2019! Think Tank sessions offer delegates the possibility of delving into a topic and unpacking this in a thoughtful and constructive manner. Each speaker is a subject matter expert in their field and comes prepared with questions which will allow delegates the chance to debate and discuss in detail. Each session lasts 45 minutes and delegates will be able to attend 1 session these work on a firstcome first serve basis 16:00 Think tank 1 Brexit is here now what do we do? Doug Meyer, Associate Director, Clinical Drug Supply, Biogen Think tank 2 Ancillary supplies and clinical trials what you need to know Kelsey Kern, Clinical Trial Supply Specialist, CSL Behring Think tank 3 Reserved for Recro Gainesville Think tanks 4 Unpacking the complexities of carrying out trials in China from a supply chain perspective 4

5 16:45 Chair s closing remarks and end of day one 27 th March 2018 I Programme Day Two 07:45 Registration and refreshments 08:20 Chair s opening remarks Tech focused morning The following presentations will aim to showcase some of the innovative content which is being trailed by sponsors and solution providers alike to improve supply chain management 08:30 Blockchain: a discussion of practical applications for clinical supply chain and life-sciences Unpacking what blockchain is and its usefulness for supply chain Showcasing if and how blockchain can be implemented within your current supply chain strategy Highlighting the benefits blockchain could bring by improved traceability, accountability and compliance Determining potential costs savings which the blockchain can offer sponsors Barrett Glasser, Director Clinical Supply Integration, Takeda 09:00 Integrating different IRT systems across your internal CMS to reduce error and wastage Showcasing ways through which system integration can improve forecasting, planning and logistics monitoring Determining whether building internal IRT systems vs purchasing off-the-shelf is more beneficial for your business Overcoming the complexity of connecting systems together through actionable examples Outlining ways specialized IRT vendors can offer technical expertise which can save time and money Tom Skiendzielewski, Associate Director Business Process and Integration, Shire Pharmaceuticals 9:30 Session reserved for Recro Gainesville 10:00 Transitioning IRT vendors and systems post acquisition Content TBC 5

6 Janel Kelly, IRT Specialist, Clinical Supply Capabilities, Biogen 10:30 Morning refreshments and networking 11:00 Speaker hosted takeaway sessions Interactive takeaway sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry. Hosted by industry experts and each focused on a single issue, takeaway sessions are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each session lasts for 30 minutes, and delegates may attend up to 2 roundtables Takeaway 1 Assessing future technologies which could further your budget and improve your clinical trails Takeaway 2 Sponsor-vendor relationship management: don t let a communication breakdown negatively affect your trial Paul Larochelle, Senior Manager, Clinical Asset Planning, Biogen Takeaway 3 Managing importation on tight schedules Matthew Leets, Transportation and Trade Management Analyst, Sanofi 12:00 Interactive Q&A Bringing it all together; what have we learnt? Each speaker will have 5 minutes to present the findings of their round table and share this with the audience. After this there will be 10 minutes of Q&A for the audience to explore these issues further. Paul Larochelle, Senior Manager, Clinical Asset Planning, Biogen Matthew Leets, Transportation and Trade Management Analyst, Sanofi 12:30 Lunch and networking Global clinical trials These sessions will give sponsors the opportunity to further their knowledge on the global landscape affecting clinical trials to ensure compliance and reduce delays 6

7 13:45 Panel Discussion Looking beyond Brexit; the future of clinical trials in the EU Considering the UK s future regulatory status and its impact on current trials Presenting alternative countries through which to release IMP into EU Reviewing how your suppliers are preparing and what best practice can be adopted across industry Doug Meyer, Associate Director, Clinical Drug Supply, Biogen Maria Vilenchik, Chief Executive Officer & Founder, Felicitex Panel Discussion Conducting trials on a global scale; key tips for success 14:15 Evaluating regulatory differences across key clinical supply regions; EU, LATAM & Asia Outlining ways global inhouse teams can operate better together to avoid delays and errors in planning and delivery Designing KPI s to track and report external partners and drive a continuous process improvement Determining which technologies can allow sponsors to better manage global trials and reduce costs Abizer Harianawala, Senior Director, Product Development & Technical Operations, TARIS Biomedical 14:45 Chair s closing remarks and end of conference 7