Testimonials from OCT Attendees: 2018 Speakers Include:

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1 Exploring innovative strategies in clinical outsourcing and operations to optimise trial outcomes Testimonials from OCT Attendees: At OCT, I greatly value the opportunity to reconnect with old friends/colleagues in the industry, as well as make connections with new colleagues and service providers who may be able to help us conduct our clinical trials even more effectively --- Howie Mai, Senior Director, Strategic Clinical Sourcing, BeiGene USA Arena International has been delivering for years great conferences on important aspects of pharmaceutical clinical trials. The participants are well informed. The conferences have been very helpful to our own Phase 2a trial planning and execution. David Larwood, CEO, President, Valley Fever Solutions 2018 Speakers Include: Alexandra Massoud, Director Clinical Affairs, Exact Sciences Corporation Amy Crary, Sr. Director Clinical Trials, Mallinckrodt Pharmaceuticals Angie Shumaker, Clinical Project and Evidence Planning Manager, Hollister Inc. B. Woun Seo, Associate Director of Medical Affairs, Pinnacle Biologics Beth Robinson, Exec Dir Clinical Compliance and Operations, Horizon Pharma Bruce Riser, CEO, BLR Bio Caryn Barnett, Senior Director, Clinical Operations, Endocyte Daria Wicks, Director Clinical Operations, Vericel Corporation Jeff Wagner, Advisor Clinical Information and Process Automation, Eli Lilly and Company/ Transcelerate Jessie Coe, Global Project Director, Global Clinical Operations, Abbott Joe Gotowko, Assistant Director Quality Systems, Abbvie Kenneth Olovich, Chief Financial and Procurement Officer Chorus Division, Eli Lilly Krista Emmons, Senior Portfolio Relationship Manager, Astellas Pharma Kristina Rodriguez, Manager, Procurement and Vendor Management, Horizon Pharma Larry Crow, Director Regulatory Compliance, Genzada Pharmaceuticals Minji Bae, Assistant Director, Vendor Operations, Abbvie Mukesh Kumar, Director Regulatory Affairs, ResQ Pharma Rama Sashank Madhurapantula, Co-Founder Director R&D, Great Lakes Neurosciences Sai Prashant, President, Great Lakes Neuroscience Further Information For sponsorship opportunities please contact: Nicholas McCudden NicholasMcCudden@arena-international.com For programme enquiries please contact: Anne-Marie Mongan Annemarie.Mongan@arena-international.com Tel:

2 Conference Name: Outsourcing in Clinical Trials Midwest 12 th September 2018 Programme Day One 08:15 Registration and refreshments 08:50 Chair s opening remarks Managing change: Developing partnerships in a rapidly-evolving clinical trial environment Overcoming the challenges of change management in large pharmaceutical companies to increase flexibility and drive innovation 09:00 Establishing common gaps and pitfalls in the typical change management strategy to determine how it can be made more comprehensive Devising value indicators to show internal groups evidence of increased quality when considering the change from doing work in-house to outsourcing to win Executive support Highlighting the importance of creating a Change Manager role for the project to ensure follow-through Encouraging sharing of feedback and best practices among team members to guarantee consistent improvement of the change strategy Considering how to be mindful of cultural differences when implementing change management in an international organization to devise a change strategy that works on a global level Krista Emmons, Senior Portfolio Relationship Manager, Astellas Think-Tank: Addressing how to breakdown internal silos to enable all stakeholders in your clinical trial to align timelines and goals Think-Tank Session 09:30 In this session, the audience will be split into small groups. The hosts will share current practices and compile creative ideas from the audience to determine how the various departments involved in the running of a clinical trial can better communicate. Identifying current challenges in aligning timelines between the clinical operations, data management and clinical supply departments to address common issues Assessing the benefits of working with internal stakeholders outside of the clinical study as well Highlighting the importance of getting input from all stakeholders involved in the trial during the planning phase to ensure proposed timelines are realistic Defining a communication framework which enables departments to effectively report on milestones reached or missed, changing trial parameters and raise issues Providing examples of how breaking down silos enables creative problem-solving in the event of unforeseen challenges Reviewing the current tools available to facilitate better internal communication between functions Larry Crow, Director Regulatory Compliance, Genzada Pharmaceuticals Angie Shumaker, Clinical Project and Evidence Planning Manager, Hollister Inc 10:15 Session Reserved for Lead Sponsor 10:45 Morning refreshments and networking Refining your outsourcing strategy 11:15 Lightning round: Debating the benefits of full, functional and other outsourcing models to assess which provides the best balance of quality, time and cost for your clinical program

3 This session will consist of 4x 15 minute case study presentations, each dealing with a different outsourcing model, followed by an audience Q&A Determining what internal resources are required for each model to assess which choice is realistic in terms of the budget and man-power you have available Evaluating the correct level of oversight trial sponsors should have of their CRO s 3 rd party vendors when engaging in the full-outsourcing model to ensure they are minimizing operational risk Discussing whether it is always preferable to work with technology solution providers directly rather than through your CRO to ensure you have access to the best expertise Highlighting the procurement perspective to assess why working with one CRO is more time and cost-efficient Exploring opportunities to consolidate technology providers and other partners into one package to avoid multiple applications and transfer of data Defining the hybrid model to discover whether it offers the perfect balance of access to expertise, tailored services and potential for scale-up Case Study 1: Daria Wicks, Director Clinical Operations, Vericel Corporation Case Study 2: Jessica Coe, Global Project Director, Global Clinical Operations, Abbott Laboratories Case Study 3: Minji Bae, Assistant Director, Vendor Management, Abbvie Case Study 4: Amy Crary, Senior Director, Clinical Trials, Mallinckrodt Pharmaceuticals 12:45 Lunch and networking Discussing strategies for improving financial transparency in clinical trials to strengthen vendor-sponsor partnerships 1:45 Assessing tools and methodologies for better predicting trial costs as studies are becoming more global and complex Determining how to centralize financial data and trial activities to enable automated tracking of this information Evaluating how to best overcome a perceived mismatch between work completed and work charged for to settle discrepancies efficiently and without damaging the partnership Suggesting how the change order process can be streamlined to minimize impact on trial timelines Highlighting current available tools and interfaces which allow sponsors and vendors to view and share financial data Alexandra Massoud, Director Clinical Affairs, Exact Sciences Corporation 2:15 Session Reserved for Sponsor Developing strategies for accurate budget forecasting and tracking to enhance teamwork and transparency 2:45 Discussing how the application of budgetary and invoicing models can lead to increased trust between partners. Discovering what sponsors really need to help them manage CRO and trial related expenses Considering the increased effort that certain budgetary models require to set up to evaluate whether they are worth the investment Highlighting the importance of considering timing and accurate projection of spend as well as total spend to find the balance between them Kenneth Olovich, Chief Financial and Procurement Officer Chorus Division, Eli Lilly 3:15 Afternoon refreshments and networking Looking Beyond Clinical Operations

4 3:45 Developing a dedicated procurement function to maximize efficiency when selecting and working with vendors Assessing how clinical and procurement departments can best work together to ensure a balance between operational and commercial expertise Highlighting how having a dedicated procurement function can ensure you get the best price for vendors work output Underlining how a dedicated procurement function can help speed up the contracting process when integrating vendors into your organization Considering how to best give your procurement team air-time to ensure they are viewed as a strategic partner within the company Exploring how to ensure procurement works as a consultant/ expert rather than simply a facilitator to enable you to draw on the department s commercial insights to improve relationships with trial partners Kristina Rodriguez, Manager, Procurement and Vendor Management, Horizon Pharma Defining your oversight obligations for post-market research to determine how to best manage these studies 4:15 Considering differences in perspective between EU and US regulators to ensure you are meeting global requirements Assessing whether post-market studies should be held to the same standards as Phase III trials to determine alternative, more pragmatic models Underlining key considerations to take into account when outsourcing your post-marketing study to ensure it is appropriately designed and can navigate a complex regulatory landscape Highlighting the benefits of replacing COA with ecoa to improve data quality Exploring strategies for generating real-world evidence early in development to reduce costs and delays in postmarket research requirements Mukesh Kumar, Director Regulatory Affairs, ResQ Pharma 4:45 Chair s summary and close of conference

5 Outsourcing in Clinical Trials Midwest 13 th September 2018 Programme Day Two 08:15 Registration and refreshments 08:50 Chair s opening remarks Early phase development and beyond Panel Discussion: Making connections as a small start-up company in the Midwest to achieve quality partnerships, funding and more 09:00 Considering how to engage CROs when you are not fully-funded Discovering how to make the most of your existing network to get ahead Exploring how to best reach out to KOLs and what intellectual resources they can offer you Assessing different routes to funding for your clinical program Panellists: Bruce L. Riser, CEO, BLR-Bio LLC Sai Prashant, President, Great Lakes Neuroscience 09:30 Session Reserved for Sponsor Determining the outsourcing wants and needs of Preclinical CROs and Start-up companies 10:00 Considering what start-up companies should look for when recruiting a preclinical CRO Discussing end points we want vs. end points they offer to evaluate how to reach a middle-ground Evaluating how to best handle pricing discussions to ensure you are getting the most for your money Developing best practices for attaining live deliverables during your study, data tracking and exchanges Rama Sashank Madhurapantula, Director R&D, Great Lakes Neuroscience 10:30 Morning refreshments and networking Working effectively with partners, patients and investigators Workshop: Developing best practices for working with your vendors to project, detect and manage risk in clinical trials Workshop Session 11:00 This is a small group session facilitated by a host who will support the audience in defining and creating a comprehensive risk management strategy Reviewing ICHE6 R2 to determine the specifics of sponsor responsibility as outlined in the addendum Developing a comprehensive framework to identify risks at sites prior to study start-up Determining how you can ensure your providers understand what risk is and how to best communicate it Defining a clear issue escalation pathway to ensure risk is managed and dealt with quickly during your trial Highlighting the importance of providing time and budget for vendors to become sufficiently familiar with trial protocol and other critical processes Caryn Barnett, Senior Director, Clinical Operations, Endocyte Beth Robinson, Exec Dir Clinical Compliance and Operations, Horizon Pharma

6 Providing an update on the success of Transcelerate s Shared Investigator Platform (SIP) to evaluate tangible benefits and next steps 12:00 Exploring industry use-cases of SIP to determine real examples of how it has improved site-sponsor relationships Evaluating the benefits for sites, sponsors and regulators to assess how the platform has the potential to radically improve efficiency in clinical trials Considering the opportunities for CROs and other vendors to have greater involvement in SIP Revealing future plans for the platform to consider how the technology can be further leveraged to reduce the administrative burden of clinical trials Jeff Wagner, Advisor Clinical Information and Process Automation, Eli Lilly and Company 12:30 Lunch and networking Aligning internal departments to achieve results Exploring the role of Medical Affairs and how cohesive work with Clinical Operations can lead to successful execution of clinical trials 1:30 Considering the role of medical affairs in a successful investigator initiated study program Describing the use of the field based medical affairs group within the initiation of clinical trials Impacting clinical trial recruitment with direct medical affair involvement Ensuring appropriate compliance between medical affairs within a clinical trial program B. Woun Seo, Associate Director of Medical Affairs, Pinnacle Biologics 2:00 Session Reserved for Sponsor 2:30 Afternoon refreshments and networking Interactive Roundtables 3:00 R1 R2 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. All roundtable session run twice, for 45 minutes, allowing delegates to attend up to 2 roundtables. Developing best practices for risk management when outsourcing to vendors in emerging markets Host: Joseph F. Gotowko, Assistant Director, R&D Quality Systems, Abbvie Establishing how to increase transparency between vendors and sponsors to foster trust and ensure trial goals are met without delay R3 Establishing best practices for developing the Master Service Agreement to provide consistency and transparency when outsourcing Host: Jessica Coe, Global Project Director, Global Clinical Operations, Abbott Laboratories 4:30 Chair s summary and close of conference

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