Arena International s Inaugural Outsourcing in Clinical Trials Southern California, La Jolla.

Transcription

1 Arena International s Inaugural Outsourcing in Clinical Trials Southern California, La Jolla. Program Day One September 24 th :45 08:20 Registration and refreshments Chair s opening remarks Sarah Carter, Executive Director, Planning and Platform Services, Amgen Contract Negotiation and Regulations 08:30 09:00 09:30 Presenting the latest developments in regulatory requirements to keep you up-to-date Updating you on ever-changing legal and administrative background to running clinical trials Analyzing GCP to ensure that you are applying it accurately based on the actual guidelines, rather than previous experiences Assessing FDA guidelines related to comparator studies to clarify how you need to approach this Appreciating potential for outsourced partners to clarify regulatory needs and stay on top of trial-related requirements Investigating progress in the FDA s Safety First initiative to keep you ahead of changes Connecting regulatory and operational teams to better understand how the theoretical decisions play out in reality Highlighting the importance of keeping regular contact with your local regulatory body to avoid being bogged down in timely delays later on Kenneth Kleinhenz, VP, Regulatory Affairs & Quality Assurance, Cytori Therapeutics, Inc. Negotiating your contract to prioritize and protects your core goals Making your key requirements obvious in contract negotiations so that they are not compromised Inviting the right members of your team into contract negotiation so that all needs of the trial are included Including risk-sharing and liability issues in your contract to avoid confusion at a critical time Safeguarding against change orders by including mitigation plans into your contract Utilizing your contract to ensure your vendor s A team is delivered as agreed Knowing the competitive landscape to compare prices and ensure you are not overpaying for services Michael Swit, Special Counsel, FDA Law Practice, Duane Morris LLP Interactive session: Exploring whether Risk Based Monitoring is right for your study & organization Connecting the dots in Risk Based Monitoring between the regulatory landscape, the clinical trial arena s readiness and the economic burden to do this right Navigating the upside of Risk Based Monitoring with a more defined approach to data visualization, quality and risk mitigation Understanding your theory on Risk Based Monitoring and uncovering what would this look like in your organization Brian Bollwage, Aimee Frazier, Mark Penniston and Alison Taber, Theorem Clinical Research

2 10:30 Morning refreshment break and networking Optimizing trial management 11:00 Planning for Murphy s Law: dealing with the unexpected when working with external service providers Closing the Gap: advantages and disadvantages of outsourcing and the role/impact of corporate governance Accurate forecasting of budgets and timelines that enable both parties to meet goals and prevent change orders from occurring Elucidating on good project management before beginning a trial and how outsourcing will optimize outcomes Developing a process around negotiations ahead of time, so you are aware of your own flexibility and restraints Noting lessons learnt from previous clinical trials so as to anticipate likely change orders and determine your flexibility around them should they arise Analyzing how a strategic partnership can mitigate changes Linda Strause, Executive Director and Head, Clinical Operations, Vical 11:30 12:00 Revealing the True Value of Patient Recruitment Discussing the steady decline of enrolment rates by evaluating industry trends Determining innovative patient recruitment options for enrolment shortfalls Comparing options in terms of cost efficiency to ensure that you are securing the best system for your company Analyzing the costs and value of different patient recruitment strategies Maximizing leverage through the use of data and making the business case Scott Connor, Vice President, Marketing, Acurian Building comprehensive management structures that bring adequate oversight of your trial Working with your CRO to create a level of management and oversight that is agreeable to both of you Addressing the potential conflict between respecting your CROs autonomy and asserting that a trial is conducted according to your SOPs Evaluating different management structures that successfully enable the degree of oversight that you require Generating best practice with regards to the frequency of face-to-face meetings and open communication Determining how a holistic overview of your trial enables greater operational efficacy all-round Navigating oversight issues when having to manage a trial remotely Sarah Carter, Executive Director, Planning and Platform Services, Amgen 12:30 Lunch break and Networking

3 New opportunities in trial models 1:30 2:00 2:30 Case Study on Pfizer s Outsourcing Models from FSP to Strategic Alliances The case for change Key elements of Alliance Partnerships Focus on Quality Challenges and successes Kenneth Wilson, Director, Business Operations, Pfizer Achieving successful CRO/Sponsor collaboration; how to work together effectively How Doing a Clinical Trial is Like Skydiving Establishing goals; ensuring clinical trial agreements between CRO and sponsor are clear and inclusive of all tasks Knowing your team; beginning with the kick off meeting, ensuring each primary contact is an integral part of study start up discussion Preparing for success; setting up expectations that are mutually agreed upon by both parties Assigning responsibilities; knowing who will be responsible for what or the effective use of a Gantt Chart Being accountable; following up before a task is due, not when it is due Expecting the unexpected; responding to the out of scope requests Knowing the end result; maintaining transparency between both parties throughout the course of the project to promote clear communication Barbara Ruby, Project Director, SynteractHCR PANEL: Investigating how different outsourcing models are appropriate to different types and sizes of companies through case study analysis Extracting advantages and disadvantages of full outsourcing compared to functional outsourcing to determine which model best suits your business strategy Analyzing whether the benefits of partnering with multiple specialized CROs outweigh the additional work that it involves for the sponsor Establishing minimum number of trials needed before retaining work in-house becomes cost-effective Reviewing whether smaller companies are limited in their approach to outsourcing models due to their size Assessing the extent to which full outsourcing reduces the level of oversight and control you have over your trial Unfolding benefits to establishing a preferred partnership for both sponsor and vendor companies Sharing insight into CRO perspective when partnering in a full outsourcing model to clarify expectations from both sides Linda Strause, Executive Director and Head, Clinical Operations, Vical Kenneth Wilson, Director, Business Operations, Pfizer Sarah Carter, Executive Director, Planning and Platform Services, Amgen

4 3:00 Afternoon refreshment break and networking 3:30 4:00 4:30 Pinpointing how to manage and maintain good relationships with the outsourcing partners that you are working with Examining factors that have been key in successful sponsor-vendor relationships Ascertaining how factors such as team composition, trial management, or sponsor oversight play a role in partner relationships Investigating to what extent you can work with almost any CRO as long as you know each others strength and weaknesses and work together to fill each others gaps Determining how to deal with under-deliveries and dissatisfaction on either side to prevent it damaging the relationship Establishing clear communication between all team members so that you are all working together Assessing effectiveness of involving CRO members/consultants into decision boards to increase transparency and respect Cathryn Bennett, Director Clinical Operations, MabVax Therapeutics Open Source for EDC, Infrastructure, and Reporting: Cutting Costs and Gaining Flexibility Selecting the best EDC solution to ensure productivity for your clinical trial Data management in house or outsourced, the benefits and pitfalls of each A survey of open source solutions: understanding open source and its current applications Working in open source communities to grow your people and your code Reviewing how to pick vendors that keep your process as lean and efficient as possible Liz Robertson, Director of Data Management and IT, TRACON Case Study: Exploring what it takes to conduct a stem cell clinical trials in Africa Highlighting distinct features of conducting trials in emerging markets to guarantee smooth trial delivery Assessing different geographical trends for trial location depending on therapeutic area Analyzing case studies of clinical trials that have been conducted in Africa, to understand practicalities of working in this region Recognizing varying roles and involvement of governmental bodies in different markets and how this may impact your trial Pinpointing differences in business culture so you approach negotiations in a manner that is profitable and conducive to local norms Exposing general risks that you may encounter, for example intellectual property disclosure, quality and/or safety Eyitayo Fakunle, Head of Translational Research, CalAsia 5:00 Chair s summation and close of day one Sarah Carter, Executive Director, Planning and Platform Services, Amgen

5 Arena International s Inaugural Outsourcing in Clinical Trials Southern California, La Jolla. Program Day Two September 25 th :00 Registration and refreshments 09:20 09:30 10:00 Chair s opening remarks Doug Lane, President and CEO, Applied Integrin Sciences, Inc Virtual Companies Generating strategies for dealing with a merger or acquisition so as not to disrupt ongoing clinical trials Safeguarding your project from unnecessary delays when adjusting to different strategies and protocols Navigating issues when adapting to a new SOP mid-way through conducting a trial Considering implications of moving location and/or changing staff on trial delivery Reviewing case studies of successful mergers and acquisitions within the area so you are able to combine forces effectively Generating best practice for streamlining different statistical, operational and management processes Assessing contingency plans for communicating all changes with any service providers or funders Joe Zimmerman, Sr. Director Clinical Operations, Amylin Pharmaceuticals Selecting the optimum EDC platform to support your clinical program Working with your outsourcing partner to identify the key drivers to consider when evaluating EDC platforms to match your program needs Developing a requirements-driven Chair s opening remarks Pam Lilly, Director of Clinical Operations, REDpoint International, Inc Medical Devices Clinical and Regulatory Strategies - A Small Company Perspective: Can a CRO be Successfully Integrated? Understanding the device regulatory pathways and how clinical studies are utilized Examining nuances of working with a small medical device company and the specific requirements they may have Identifying the critical components of the clinical study that are best suited to be outsourced Choosing between a CRO and strategic consultants - the key determinant factors Al Memmolo, Chief Operating Officer and VP Regulatory and Quality Assurance, Dallen Medical Experience with a Clinical Trial in India Using an Extracorporeal Device to Treat Hepatitis C Virus Outlining various positive aspects of working abroad that make your trial delivery a success Unfolding how to find and manage CROs in a region that is different to

6 checklist and conducting risk-benefit analysis to provide an objective framework for decision-making Assessing different platforms at some of the most critical thresholds during your clinical program to enhance productivity, cost efficiency and getting to decision points quickly Scrutinizing EDC systems to help biotech and pharma choose the most appropriate platform for their current and future development needs Toby Odenheim, Director, Clinical Technology Services, SynteractHCR that in which you usually source Providing an overview of key regulatory differences in different regions that you should be aware of Overcoming practical issues that can make your clinical trial delivery more challenging Richard Tullis, Chief Scientific Officer, Aethlon Medical 10:30 Morning refreshment break and networking 11:00 Pinpointing tactics to managing outsourcing partners that are relative to your company size Ensuring your vendors prioritize your clinical trial despite the fact you are much smaller than some of their other customers Avoiding having to retrain new groups of staff within your vendor when teams are changed, and how to do this training efficiently when necessary Building sufficient oversight when working remotely Highlighting limitations to not having a fixed base, and how these can be mitigated Exploring trials and tribulations of other companies to determine how their relationships have progressed Guy Boccia, Director of Clinical Operations, Sangart Optimizing trial outcomes/evaluation through building productive relationships with your medical device vendors Establishing transparency with your vendor regarding timelines so you are all working from the same page Outlining the optimum level of input you should maintain in a CRO s activities to achieve a healthy sponsor-vendor relationship Adhering to contractual agreements so that both sides feel there is consistency and honesty Allowing for strong visibility in trial progress by explaining your expectations regarding oversight from the beginning Analyzing the need for sponsors and vendors to monitor themselves and each other at the same time Sharing Key Performance Indicators to ensure meaningful CRO oversight with minimal internal resources Avoiding timeline extensions by having clear communication regarding any issues that occur Pam Lilly, Director of Clinical Operations, REDpoint International, Inc

7 11:30 12:00 Clinical Trial Run by Virtual Companies: Been There, Living That, Thriving Addressing challenges virtual and start-up biotech s have had and how they overcame them Outlining specific differences when working with Virtual Companies Keeping Communication Flowing Evaluating lessons learned from past experiences Highlighting success stories Shantal Feltham, President/CEO, Stiris Research PANEL: Exploring routes to company progression by evaluating industry trends Untangling how virtual companies make themselves amenable to partnerships with larger pharmaceutical companies Handling typical expectations of a larger company when partnering with virtual companies with regards to SOPs Outlining valuation points that VCs focus on to understand what it is that drives investment Outlining successful pathways to first market approval that have been taken by virtual companies Examining case studies of companies that have sold their products to larger partners so you know how to manage this process Shell Lee, Supply Chain Manager, Geron Corporation Shantal Feltham, President/CEO, Stiris Research Doug Lane, President and CEO, Applied Integrin Sciences, Inc PANEL: Optimizing your selection process to secure the best service provider for your trial Conducting thorough research of your potential vendors by acquiring a history and references about their previous work Carrying out inspections of vendor sites and services to check that everything is as promised Considering minimum number of bids needed to give you a holistic overview of competitors in the market and what they can each offer Scoping out niche boutique providers that deliver innovative and novel ways to assist you with your trials Evaluating typical selection processes and seeing how they can be improved Balancing particular device experience with specialized knowledge in, for example, data management, when selecting the most appropriate CRO Karin Hughes, Vice President Clinical and Regulatory Strategy, Astute Medical Rodney Kenley, President, Aethlon Medical Pam Lilly, Director of Clinical Operations, REDpoint International, Inc

8 12:30 Lunch break and Networking 12:15 Lunch break and Networking 1:30 2:00 Determining optimal team structure for a virtual company to ensure maximum efficiency Delegating specific roles across your team to ensure all aspects of trial delivery and management are assigned Looking into minimum team sizes for small companies running big trials to compare yourselves with others Recognizing how critical it is to choose the right vendor when you are a small team conducting a big trial Handling how to fit outsourcing into the responsibilities of other job roles, and exploring how you can acquire the knowledge and training to enable you to do this Overcoming potential sense of isolation when working as the solo representative for your departments, without someone to share or validate ideas Shaily J. Reichert, Executive Director, Pacira Pharmaceuticals, Inc Large company capabilities on start up company capital constraints: building effective and capable infrastructure for outsourcing clinical trials in the virtual company Appropriately prioritizing resources towards establishing infrastructure and stability Recognizing the importance of building up your systems to establish continuity and strength Balancing short term and long term needs with regards to resource allocation Resolving the tradeoff between 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. Both roundtable sessions will last for 45 minutes 1) Discussing operational challenges specific to medical device trials to ensure clinical efficiency Host: Sapna Hornyak, Vice President, Medical Device and Diagnostic Development, Theorem Clinical Research 2) Evaluating key differences between trials run within and outside of the US and the considerations to be made both operationally and with partner selection Host: Steven Kesten, Executive Vice President & Chief Medical Officer, Cytori Therapeutics

9 developing trials and having an established structure to support them Evaluating industry trends for when start-up companies develop their own SOPs Investigating how to set up your department when taking a function in house Doug Lane, President and CEO, Applied Integrin Sciences, Inc 2:30 Unlocking the secret recipe of trial execution success: Building and maintaining a strong relationship with your partner with clear communication of realistic expectations Ensuring your vendors prioritize your clinical trial despite the fact you are much smaller than some of their other customers Strategically building a strong relationship with your Partner s Project Manager on a personal level, therefore he/she is willing to take a leap for you Employing advanced communication skills to clearly communicate your realistic expectations Utilizing recurrence lessons learned for continuous process improvements to maximize win-win satisfaction for both parties Shell Lee, Supply Chain Manager, Geron Corporation 3:00 Chair s summation and close of conference Doug Lane, President and CEO, Applied Integrin Sciences, Inc Chair s summation and close of conference Pam Lilly, Director of Clinical Operations, REDpoint International, Inc