Testimonial from Others

Transcription

1 Testimonial from Others Good in several aspects; learning more about clinical trial details networking with other companies meeting new potential suppliers - Director Supply Chain, Zosano It was very informational and informative, the information provided within the presentations where priceless and beneficial to my career and furthermore to the patient - Clinical Supply Manager, Inovio Pharmaceuticals An excellent event with a good cross-section of large and small companies, service providers, manufacturers and staff - Thoughtful presentations and an engaged audience - Clinical Supply Director, Crescendo Biosciences 2018 Speaking Faculty Anthony Zuccarello, Associate Director, IRT and Global Clinical Supply Strategy, Amicus Therapeutics Michael Sparozic, Lead Trial Supply Operations Manager, Sanofi Shell Lee, Global Logistics & Operations, Melinta Therapeutics Jennifer Rose, Sr. Manager, Clinical Supplies, Array BioPharma Joseph Ivan, Logistics provide an overview of the TransCelerate elabel initiative and communicate what TransCelerate is doing to assist with industry uptake and influencing health authorities. Manager, Pfizer Alain Frix, CT Supply Chain Design and Management, Chorus, a division of Eli Lilly Jole O. Rodriguez, Principal Research Scientist, Global RA Chemistry Manufacturing and Control, Eil Lily & Company Gowri Sukumar, Associate Director, CMC and Regulatory Affairs, ESSA Pharmaceuticals Henri Sauk, Senior Logistics Manager, Lundbeck Catherine Hall, Director of Operation Excellence, Sunovion Pharmaceuticals Heather Hermann, Research Compliance Officer, OSF Healthcare Kellie Bodeker, Clinical Research Regulatory Manager, University of Iowa Hospitals & Clinics Tom Gottschalk, Vice President, Clinical Business Development, Rx Solutions Elisabeth Lackner, CEO, GBA Pharma Michael Gazda,Vice President,Bexion Pharmaceuticals Peter Southerland, Supply Chain Manager, Astellas Pharma Allen R. Ritter, Vice President of Chemistry, Manufacturing and Controls, On Target Laboratories James Stout, Vice President of Quality Systems, Excorp Medical Hans von Steiger, Group Leader, Clinical Supply Chain Management, Pfizer/ TransCelerate Frank Leu, CEO, Novapeutics Terry Noel, Sr. Clinical Research Specialist, Medtronic Further Information For sponsorship opportunities please contact: Paul Adams PaulAdams@arena-international.com Tel: For programme enquiries please contact: Jisong Seo jisong.seo@arena-international.com Tel:

2 Conference Name: Clinical Trial Supply Midwest 2018 Conference Date: 12 th 13 th September Programme Day One 08:15 Registration and refreshments 08:50 Chair s opening remarks Establishing best practice for assessing supply costs accurately to reduce wastage and cost of your study 09:00 Exploring options for planning and forecasting technologies to determine how best to monitor clinical supply costs Evaluating options to predict alternative outcomes aided by forecasting tools when designing supply methods Determining specific regulatory guidelines regarding locations to ensure accurate forecasting for clinical trial shipment Establishing quality control system in global trial supply to reduce impact on bottom line and timeframe delays Anthony Zuccarello, Associate Director, IRT and Global Clinical Supply Strategy, Amicus Therapeutics An Innovative Approach To Simplify The Clinical Supply Process For Unblinded Medication and Supplies 09:30 Current Clinical Supply Trends And Issues Case Studies: Practical Applications Of An Innovative Approach Clinical Supply Process Cost Comparisons Utilizing Real World Data The Pharmacy Adjudicated Process Solution Explained Tom Gottschalk, Vice President, Clinical Business Development, Rx Solutions Analysing benefits and challenges of Direct to Patient(DtP) from GMP perspective 10:00 Determining most suitable studies for DtP in terms of patient recruitment and retention Steps for adhering to GMP regulations and ensuring standards are met in the delivery chain From door to door to central pharmacy steps for reducing the cost of DtP Investigating DtP availability in remote locations and navigating strategies to implement it Michael Sparozic, Lead Trial Supply Operations Manager, Sanofi 10:30 Morning refreshments and networking Exploring the challenges of clinical manufacturing from a small company perspective 11:00 Reviewing strategies for in-sourcing manufacturing processes to ensure that deadlines are consistently met Establishing what is needed to set up in-house clinical manufacturing processes in an efficient and cost-effective manner Evaluating methods for continuous improvement in clinical manufacturing processes to maintain quality

3 Gowri Sukumar, Associate Director, CMC and Regulatory Affairs, ESSA Pharmaceuticals Uncovering movements towards Extemporaneously Prepared Supplies, using innovation in drug development 11:30 Exploring the benefits that EPS has on shipping to multiple sites moving your supply at an accelerated rate Overviewing regulatory landscape in regards to EPS Ensuring correct GMP s and SOP s are covered for EPS, enabling sites are able to navigate this approach to supply Jole O. Rodriguez, Principal Research Scientist, Global RA Chemistry Manufacturing and Control, Eil Lily and Company Working with QPs: How to ensure a smooth import into Europe 12:00 The QP declaration, QP release and import licence Strategic planning: How can project managers and other non-qps effectively plan QP activities for their projects Brexit: What are the consequences, what contingency plans should a sponsor have and how it will be possible to continue to run trials in Europe Elisabeth Lackner, CEO, GBA Pharma 12:30 Lunch and networking Focusing on technology as a solution to streamlining the clinical supply chain Technology Demo Showcase The showcase will include a shortlist of leading technology providers revealing their disruptive and targeted technologies. The selected providers offer solutions to current challenges being faced by both small pharma and big pharma companies within the clinical supply space. Particular focus will be placed on illustrating how these technologies can be implemented within existing processes that are both rigid and flexible, 13:30 To include technologies such as: 222 documentation tracking VIP shippers as a form of reusable packaging Temperature controlled packaging Forecasting tools E-labels IVRS system Each innovative supplier will have 15 minutes to showcase their solution. The audience will have the opportunity to question and probe the benefits and challenges each innovation offers. Delegates will leave with new ideas on how to implement digitalisation in the their clinical supply chains.

4 E-labelling: future technology? real world technology! 14:30 Providing an overview of the TransCelerate elabel initiative and communicate what TransCelerate is doing to assist with industry uptake and influencing health authorities. Hans von Steiger, Group Leader, Clinical Supply Chain Management, Pfizer/ TransCelerate 15:00 Afternoon refreshments and networking Addressing challenges of managing the return and reconciliation process to ensure your study is compliant 15:30 Examining regulatory requirements, what has been and what will be including variations in regional and local requirements. Investigating the challenges of returns and increased pressure on industry to ensure reverse supply chain protocols will affect your clinical trials Discuss new trends including use of IRT systems to improve drug accountability accuracy and enable sponsors to manage returns effectively Encourage sponsors and sites to integrate systems to avoid task duplicity and reduce human errors Comparing centralized and trial-site specific ways to carry out drug destruction and assess their costeffectiveness 16:00 Catherine Hall, Director of Operation Excellence, Sunovion Pharmaceuticals [Case Study] The way we integrated our clinical study needs as an integral part of it Quality Management Systems TBC James Stout, Vice President of Quality Systems, Excorp Medical 16:30 Chair s summary and close of conference Conference Name: Clinical Trial Supply Midwest 2018 Conference Date: 12 th 13 th September Programme Day Two 08:15 Registration and refreshments 08:50 Chair s opening remarks Navigating vendor selection and incorporating necessary regulations for accurate forecasting in global supply chains Understanding key communication points for timely distributor performance of shipment and supply Highlighting regulations, licensing fees and ensuring processing is completed within supply timelines Defining SOP s with both international and US GMP audited manufactures ensuring quality standards in supply production Recognizing IMPD requirements required for review of by regional authority to allow import and export of clinical drug supply

5 Navigating unforeseen changes in regulations restricting access of supply to clinical sites Shell Lee, Supply Chain & Logistics, Melita Therapeutics [Case Study] Key Aspects of Successful CMO Selection and On-Going Relationships 09:30 Selection of CMOs based on company strategies and circumstances, and on a sound technical and contractual diligence process Early-on in the technical work: Key points to ensure robust technical transfer and initial execution On-Going efforts to maintain quality and quantity of product: communication, continuous diligence, and contingency planning Michael Gazda,Vice President,Bexion Pharmaceuticals Engaging your CMO for your specific manufacturing needs whilst ensuring product quality 10:00 Accounting for the differences in CMO-small pharma relationships and CMO-big pharma relationships to identify the best way to achieve collaborative success Highlighting potential hiccups be-tween the CMO and sponsor to ad-equately have a pre-emptive solution Conducting an audit conducive to the alignment of CMO capabilities and the task in question to ensure the best outcome Allen R. Ritter, Vice President of Chemistry, Manufacturing and Controls, On Target Laboratories 10:30 Morning refreshments and networking Engaging your clinical supply chain partners to meet study timeline and assure product quality 11:00 Debating effective oversight strategies to maintain quality of your product in multinational clinical sites Engaging your suppliers early to enhance joint study ownership Creating effective communication systems with your partners and ensure clear understanding of study supply needs Implementing mobile technologies to enhance data collection from remote sites Jennifer Rose, Sr. Manager, Clinical Supplies, Array BioPharma 11:30 Academic medical centers: Considerations to assess costs and timelines accurately and reduce budget overruns Assessing billing corrections when trials overrun and how to manage the impact this has on forecasted costs of supply Developing strategies to oversight on spending at sites in real time to prevent overruns Saving contingency funds for unpredictable disasters and minimising study delays Exploring forecasting systems that can streamline your budget planning and forecasting costs Heather Hermann, Research Compliance Officer, OSF Healthcare Kellie Bodeker, Clinical Research Regulatory Manager, University of Iowa Hospitals & Clinics

6 12:30 Lunch and networking Analysing changes brought to clinical supply by controlled ambient shipping requirements and the impact on temperature excursion 13:30 Deconstructing new requirements of tracking room temperature of drugs and the impact on your study Developing centralised data monitoring of temperature excursions between you and shipping companies Exploring cheaper phase-change materials (PCMs) options to maintain your room temperature products safely Making sure your suppliers are familiar to CRT procedures and refrigerants to avoid temperature excursion Frank Leu, CEO, Novapeutics Establishing best practice for getting through Chinese customs faster and smoothly 14:00 Understanding regulatory changes of cfda similar to FDA what are the updates and challenges for conducting trials in China Learning Chinese standard for import valuation and preparing proper documents to bring API into China Exploring potential amendments in documentation to enable flexible planning Finding local partners specialised in Chinese customs to keep your products refrigerated in customs area Joseph Ivan, Logistics Manager, Pfizer [Panel Discussion] A Global Industry: Conducting Multi-National Clinical Trials 14:30 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 Terry Noel, Sr. Clinical Research Specialist, Medtronic 15:00 Afternoon refreshments and networking Reflection Sessions 15:30 Delegates have the opportunity to take part in a deep dive discussion with their peers and speakers on what we ve discovered on the day and what tangible, actionable information they can take away from the event.

7 Attendees my attend up to 2 reflection sessions which lasts for 45 minutes. Roundtable 1 Roundtable 2 Roundtable 3 Cultivating most beneficial relationship with vendors to get flexible resources Alain Frix, CT Supply Chain Design and Management, Chorus, a division of Eli Lilly Establishing strategies to ensure smooth transition through US customs on time Henri Sauk, Sr. Logistics Manager, Lundbeck Comparing commercial supply strategies vs clinical supply strategies to save time and cost on supply chain Peter Southerland, Supply Chain Manager, Astellas Pharma 17:00 Chair s summary and close of conference