2018 Confirmed Speakers

Transcription

1 The leading clinical trial supply series delivering localised content to key biopharma clusters 2018 Confirmed Speakers Eyal Ron, Chief Technology Officer, Gelesis Michael Sparozic, Trial Supplies Operation Manager Leader, Sanofi Marco Afonso, Supervisory Import Specialist, U.S. Customs and Border Protection Georgia Mitsi, Senior Director, Search & Evaluation, Digital Healthcare, Sunovion Pharmaceuticals Doug Meyer, Associate Director Clinical Drug Supply, Biogen Chris Campbell, Clinica Supplies Specialist, Ironwood Pharmaceuticals Tom Skiendzielewski, Associate Director Business Process and Integration, Shire Pharmaceuticals Chad Presher, Associate Director, Clinical Drug Supply, Biogen Jennifer Truong, Clinical Trial Manager, Constellation Pharmaceuticals Katherine Mucci, Manager Clinical Supplies - Business Process & Integration, Shire Pharmaceuticals Christine Tosone, Executive Director, Clinical Operations, Allena Pharmaceuticals Maryam Ahmadi, Senior Director of Pharmaceutical Science, Achillion Pharmaceuticals Todd Smith, Director, External Operations Global Lead, Clinical Supply Packaging, Pfizer Craig Warden-Rothman, Senior Manager, Global Supply Chain & Logistics, Sarepta Therapeutics Melissa Morandi, Vice President Global Quality, Aegerion Pharmaceuticals Emily VanHassel, Director of Regulatory Affairs, CMC, Akebia Therapeutics Frank Leu, CEO, Novapeutics LLC Amanda Scott, Senior Manager, Clinical Drug Supply, Biogen Steven Kates, CSO & VP Reg Affairs, Lakewood Amedex Event Sponsors

2 Clinical Trial Supply New England th March 2018 I Programme Day One 07:45 AM Registration and refreshments 08:20 AM Chair s opening remarks 08:30 AM Keynote Presentation Exploring the Evolving Landscape of Importing Clinical Trial Materials and Products into the US Exploring free trade and its consequences for the clinical trial industry to better understand how to work within the system Evaluating the importance of working with customs brokers to effectively work within regulations and with government bodies Investigating the key facts all companies should know when importing to the US to clarify your obligations to tax, VAT and regulatory transgressions. Outlining the responsibilities for custom brokers and companies to work with governmental bodies on matters of economic and national security to reduce interference and promote uninterrupted trade Marco Afonso, Supervisory Import Specialist, U.S. Customs and Border Protection 09:00 AM Session reserved for PCI Clinical Services 09:30 AM Fault in the System: Hazards of System to System Communication and Mitigation of the Consequences Diagnosing data loss and identifying the issues of integration to better respond to data inaccuracies Working across multiple integrated systems and dealing with database controls in a multi-vendor scenario Exploring the prospects of collective development in vendor partnerships to ensure that established relationships continue to advance together to uphold the integrity of data entry Analysing the current standards of integration to evaluate if they are fit for purpose in an outsourced environment. Tom Skiendzielewski, Associate Director Business Process and Integration, Shire 10:00 AM Morning refreshments and networking Building successful partnerships 10:45 AM Vendor Alliance: Cultivating the Most Beneficial Vendor Relationships Proposal and protocol: how to procure the perfect partnerships Early engagement: exploring vendor engagement timeframes to ensure adherence to established schedules Case Study: exploring model relationships in clinical trial supply outsourcing Outsourcing overload: identifying methods to find your ideal vendor number to improve results 2

3 Eyal S. Ron PhD., Chief Technology Officer, Gelesis Inc 11:15 AM Session reserved for SensiTech 11:45 PM Panel Discussion on Vendor Alliance Panelists: Eyal S. Ron PhD., Chief Technology Officer, Gelesis Inc Maryam Ahmadi, Senior Director of Pharmaceutical Sciences, Achillion Pharmaceuticals Todd Smith, Director, External Operations Global Lead, Pfizer 12:15 PM Lunch and networking The world we live in 1:45 PM Agenda Highlight Thinking the Unthinkable: Contingency planning for natural disasters Exploring the implications of hurricane Harvey on clinical trials to better prepare responses to ensure trial supply reaches the site Plan for the worst, hope for the best: investigating procedures for dealing with disaster to identify best practice approaches Mitigating the risks from Black Swan events in the clinical supply chain Be prepared: case study examples of dealing with disaster Chad Presher, Associate Director, Clinical Drug Supply, Biogen 2:15 PM Session reserved for Catalent 3:15 PM A Global Industry: Conducting Multi-National Clinical Trials (panel discussion) Understanding site needs: outlining the strategy to working across multi-national, multi-cultural, and multi-lingual clinical trial sites to best mitigate barriers in running trials International regulation compliance: evaluating best practice approaches to working with numerous national guidelines within a single clinical trial to ensure global compliance Investigating the challenges in technology when running simultaneous international trials to safeguard the integrity of data collection Exploring the obstacle of running multiple international clinical trials, strategizing for manufacturing compliance with multiple vendors and dealing with global regulations to minimize impact on trial cohesion Panelists: Craig Warden-Rothman, Senior Manager, Global Supply Chain & Logistics, Sarepta Therapeutics 3

4 Tom Skiendzielewski, Associate Director Business Process and Integration, Shire Doug Meyer, Associate Director Clinical Drug Supply, Biogen 3:45 PM Afternoon refreshments and networking 4:15 PM Session reserved for RxSolutions Working with Controlled Substances: an Investigation into the Possible Consequences of Working with Controlled Substances 4:45 PM Constructing a productive relationship with the right regulators when conducting trials with controlled substances Analyzing the latest regulations for the use of controlled substances to highlight how to move forward with your trial whilst meeting standards Exploring the protocol on certified controlled substance destruction to reduce additional cost Best practice examples of working with controlled substances in clinical trials Katherine Mucci, Manager Clinical Supplies - Business Process & Integration, Shire 5:15 PM Chair s closing remarks Clinical Trial Supply New England th March 2018 I Programme Day Two 08:15 AM Registration and refreshments 08:50 AM Chair s opening remarks Optimizing Supply Operations AM Reviewing the Riddles of Recruitment and Retention Evaluating the errors in enrolment estimates to better anticipate final retention Analyzing the flexibility of vendors to better respond to fluctuating enrolment figures and avoid wastage in supplies Exploring new methods of recruiting the right patients and trial sites to increase efficiency in enrolment and trial supplies Examining best practice techniques for enrolment to maximize patient retention ensuring patients receive trial drugs on time 4

5 Christine Tosone, Executive Director, Clinical Operations, Allena Pharmaceuticals 09:30 AM Working together: Supply and Operational Clinical Team Partnership Investigating the significant increase in efficiency and accuracy through cooperation in supply chain planning Exploring approaches to this team work and unpacking best practice to get the answers you need from clinical colleagues Case study: the perfect partnership of clinical and operational teams and how you can achieve this too Amanda Scott, Senior Manager, Clinical Drug Supply, Biogen 10:00 AM Failure to Communicate? Traversing the Evolving Relationships with Vendors An analysis of the transforming relationship between sponsors and vendors in a changing industry Evaluating the flaws in communication to understand why communications breakdown and the steps for successful vendor relationships Outlining strategic approaches to improved vendor relations and increase coherence in trial management Analyzing the effects of outsourcing on established communication methods in the clinical trial industry Methodical approaches to ending a substandard vendor relationship to minimize the effect on clinical trials and ensure future working relationships Jennifer Truong, Clinical Trial Manager, Constellation Pharmaceuticals AM Morning refreshments and networking Advancing industry standards 11:00 AM Mobile Technology in Monitoring Success in Clinical Trials Outlining the possibilities of the use of mobile technology in managing clinical trial data Creating patient-centric strategies in the implementation of mobile technology to better understand the needs of patients and help with patient retention Examining the limitations of user-friendly interfaces in achieving accurate data collection Investigating trial data security concerns when working through cloud technology Georgia Mitsi, Senior Director, Search & Evaluation, Digital Healthcare, Sunovion Pharmaceuticals 11:30 AM Direct to the Door: Analyzing the Potential of Direct-to-Patient Clinical Trials Trial friendly: How to ensure the direct-to-patient model is right for your trial Trial by error: identifying and evaluating the risks related to direct-to-patient to better forecast for this 5

6 new model Increased enrolment: evaluating the potential for elevated recruitment and retention, changing estimation protocol to better forecast within the direct-to-patient model Delivering the delivery: exploring the possibilities for distribution direct-to-patients to maximize efficiency in clinical trials Regulation review: implications of GCP regulations on direct-to-patient data management to ensure compliance Michael Sparozic, Trial Supplies Operation Manager Leader, Sanofi 12:00 PM Lunch and networking 1:00 PM An Exploration of the Possibilities Available for Dealing with Restrictions within a Clinical Trial Site Evaluating the implications of capacity restrictions at trial sites to better forecast for the needs of such a site Outlining strategic alternatives to long term on site storage to offer maximum flexibility to every trial Exploring feasible strategies for dealing with short-life products at trial sites Investigating the complications of a restrictive trial site to better prepare for the implications on trial integrity Frank Leu, CEO, Novapeautics LLC Regulatory Review: Best Practice for Compliance and Streamlined Trial Supply (panel discussion) 1:30 PM Resources, recording and reporting: to understand the principals of protecting data integrity Recommendation to requirement: identifying, evaluating, controlling, reviewing and reporting risks in QMS to meet new GCP requirements. Exploring sponsors accountability to comprehend new responsibilities towards trial management, data handling and record keeping Evaluating the amendments to understand how GCP amendments will improve standards of clinical research Panelist: Melissa Morandi, Vice President Global Quality, Aegerion Pharmaceuticals Emily VanHassel, Director of Regulatory Affairs, CMC, Akebia Therapeutics 2:00 PM Afternoon refreshments and networking 2:30 PM Speaker Hosted Roundtables Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each roundtable session lasts for 45 minutes, and delegates may attend up to 2 roundtables 6

7 Roundtable 1 Discussing the implications of regulation changes in the US Steven Kates, CSO & VP Reg Affairs, Lakewood Amedex Roundtable 2 Future of technological innovation in the supply chain Doug Meyer, Associate Director Clinical Drug Supply, Biogen Roundtable 3 4:00 PM Communicating communication: large/small pharma and vendors discuss their relationships Chris Campbell, Clinical Supply Specialist, Ironwood Pharmaceuticals Chair s opening remarks 7