Outsourcing in Clinical Trials East Coast 2017 King of Prussia, PA, May 23-24 2017 Outsourcing in Clinical Trials East Coast brings together the clinical operations and outsourcing community from pharma, biotech and medical device companies from Pennsylvania, New Jersey, New York and beyond to discuss the latest challenges in clinical operations and outsourcing. Speakers include: Mitchell Katz, Head of Clinical Research & Drug Safety Operations, Purdue Pharma Ken Getz, Director, Sponsored Research Programs, Tufts CSDD Doug Schantz, Executive Director, Clinical Operations, AstraZeneca Bari Kowal, Head of Clinical Trial Management, Regeneron Pharmaceuticals Richard Robinson, Director, Clinical Operations Lead, Pfizer Susan Lubin, Director, Clinical Pharmacology Medical & Operations Group, Bristol-Myers Squibb Frank Leu, Chief Executive Officer, Novapeutics Sameer Tandon, Head of Strategic Alliances, Novartis Ratan Ratnesh, Director, Clinical Outsourcing, Otsuka Stuart Halasz, Associate Director, Clinical Quality Management, Merck Charlotte French, Senior Director, Service Provider Management, EMD Serono Debora Araujo, Associate Director, Clinical Contracting Services, Boehringer Ingelheim Michelle Stonier, CRO Infrastructure Lead, Bristol-Myers Squibb Rick O Hara, Associate Director, Project Management and Business Operations, Endo Michael Snyder, Director, Clinical Operations, ContraVir Pharmaceuticals Rosalie Filling, Senior Director, Head of Clinical Operations, Lupin Inc. Beth A. Soffer, Senior Director, Quality Preformance & Risk Management, Pfizer Inc. Terrence Tormey, Vice Chairman, Prevention Pharmaceuticals Carrie Lewis, Associate Director, Clinical Operations, Lupin Pharmaceuticals Craig Coffman, Executive Director, Clinical Business Operations & Outsourcing, Nektar Therapeutics Evan Tzanis, Senior Vice President Clinical Development and Clinical Operations, Paratek Pharmaceuticals Ramzey Odetalla, Sr. Director, Clinical Research, Noven Pharmaceuticals Sponsors include:
Outsourcing in Clinical Trials 2017 Day One May 23 2017 Programme Day One 7:50 Registration and refreshments 8:20 Chairman s opening remarks 8:30 Opening Keynote: Developing lean models for outsourcing of clinical development to meet the demands of recent trends within the industry Exploring experiences, thoughts and lessons learned from companies that have employed lean models to identify the use of such strategies Discussing the decision paradigms that led to the need to use lean sourcing strategies Considering the nature of the models employed to investigate their benefits, challenges and key success factors Investigating key decision that need to considered to ensure successful lean outsourcing Mitchell Katz, Head of Clinical Research & Drug Safety Operations, Purdue Pharma 9:00 Session reserved for Acurian 9:30 Panel Discussion: Exploring how sponsors can use KPIs to measure quality to identify where time and resources need to be allocated to solidify the partnership Defining what is truly meant by KPIs and highlighting the differences between KPIs and metrics to ensure this language is being used correctly Emphasizing the need to simplify the KPI process to measure quality in a quantitative way to allow for comparison of vendors Considering which internal teams should be involved in developing KPIs for vendors to allow quality to be measured effectively Working transparently with vendors to develop effective and realistic KPIs whilst promoting accountability for tasks Considering the option of vendors providing KPIs to sponsors to encourage a true partnership that puts onus on both partners Evaluating how KPIs should change depending on project and vendor category and size Doug Schantz, Executive Director, Clinical Operations, AstraZeneca Bari Kowal, Head of Clinical Trial Management, Regeneron Pharmaceuticals Ramzey Odetalla, Sr. Director, Clinical Research, Noven Pharmaceuticals
10:00 Session reserved for Atlantic Research Group 10:30 Morning Refreshments & Networking Mid-Sized to Big Pharma Stream Small Company Stream 11:00 Developing oversight strategies to ensure effective management of CROs and other vendors and avoid trial delays Exploring the need to tailor your oversight strategies depending on vendor and sponsor size, past experience and location Dealing effectively with missed deliverables to ensure accountability whilst maintaining a solution oriented focus Developing well established specifications alongside pre-agreed milestones to clearly measure partnership success Considering who internally should be managing the outsourcing relationship to ensure the required resources are assigned Evaluating how best to go about portfolio-level reporting and analytics for more effective oversight Susan Lubin, Director, Clinical Pharmacology Medical & Operations Group, Bristol-Myers Squibb Exploring key aspects that need to be addressed as a start-up company moving from the preclinical to clinical space to make this transition as smooth as possible Highlighting differences when selecting and working with pre-clinical and clinical CROs to identify the best outsourcing model Considering how to go about launching international trials to highlight the reliance on CROs for smaller companies Prioritising resources and budgets to ensure costs are allocated in the most productive way Preparing in-depth trial timelines with appropriate required actions to ensure any new vendor services are identified as early as possible Appreciating the need for extra internal resources that may be required to manage additional vendors Frank Leu, Chief Executive Officer, Novapeutics 11:30 Session reserved for SynteractHCR Session reserved for RxSolutions 12:00 Panel Discussion: Considering strategies to overcome issues with staff turnover both Panel Discussion: Debating what should be considered at the start of a trial to build
internally and externally Evaluating what can be done to encourage CRA and investigator buyin into your trial to reduce likelihood of turnover Encouraging the CRO to involve the sponsor in the selection of replacement staff to ensure they are the right fit for the trial Investigating the option of using retention bonuses as way of saving costs in the long term Assessing the option of working with consultants to avoid dealing with staff turnover on the same scale Recognizing the need for pharma leadership teams to match what is provided to employees at CROs Richard Robinson, Director, Clinical Operations Lead, Pfizer Terrence Tormey, Vice Chairman, Prevention Pharmaceuticals effective partnerships Identifying what should be included in a typical RFP to facilitate the comparison of bids Emphasizing the need for a concise but thorough Scope of Work to be provided to ensure suitable responses are received Using the questions posed by vendors in responses as an indicator of vendor knowhow and experience Exploring key preparation aspects to consider before the Bid Defense Meeting to ensure the right partner is found for your trial Considering who should be present at the meetings to ensure a streamlined approach whilst obtaining the required input Rick O Hara, Associate Director, Project Management and Business Operations, Endo Michael Snyder, Director, Clinical Operations, ContraVir Pharmaceuticals Rosalie Filling, Dr. Director, Head of Clinical Operations, Lupin Pharmaceuticals 12:30 Networking Lunch 2.00 Investigating the state of feasibility assessments and strategies to improve your methodology Case Study: Exploring how working with large scale CROs can be the key to international trial management Considering why, despite technological improvement and realtime access to date, the industry continues to be plagued by common errors and oversights Defining two distinct steps to feasibility; Medical and Operational feasibility to identify the differences between both Ensuring you plan in due time for international trial growth in order to guide your vendor selection process Recognizing the need for an increased spend on a global CRO at the outset to avoid incurring extra costs as your trial expands Considering how best to capitalize on a vendors global reach to ensure you are
Investigating time and resources into improving feasibility assessments to meet the demands of more complex protocols Exploring different tools that can support the feasibility processes and streamline this proves getting what you paid for Overcoming any issues with being seen as a second class customer by large scale CROs Michael Snyder, Director, Clinical Operations, ContraVir Pharmaceuticals Sameer Tandon, Head of Strategic Alliances, Novartis 2:30 Session reserved for INC Research Session reserved for Rho 3:00 Panel Discussion: Ushering in the next stage of outsourcing models for big pharma to promote flexibility Building effective management strategies when working with third party vendors to secure oversight across all aspects of the trial Exploring creative partnership models that allow for faster selection and quicker partnership starts Optimizing re-examination processes for long-standing partners to ensure a successful re-bid process Investigating forming strategic partnerships with functional vendors to allow for more agile relationships Considering best practices for seeing out current relationships to completion and anticipating next steps Evaluating how large pharma companies can take a small/virtual approach to improve flexibility with partners Setting out clear expectations of any third party vendors with a full service CRO at the outset Defining metrics to clarify when sponsors should interfere to ensure quality standards to not slip Ensuring roles are accurately and transparently defined to avoid duplication of efforts and costs from multiple parties Considering the benefits of allowing CROs to centrally manage other vendors to promote the idea of a true partnership Debating whether CROs will negotiate effectively to ascertain whether they can maintain required level of costs Carrie Lewis, Associate Director, Clinical Operations, Lupin Pharmaceuticals 3:30 Afternoon Refreshments & Networking 4:00 Recognizing what can be done by all partners, staff and stakeholders to improve inspection
readiness Promoting the idea of being in a constant state of preparation rather than preparing for a one-off inspection Emphasizing the need for effective TMF management; ensuring data is not only collected in the right way but also accessible when required Debating what senior management within both sponsors and CROs need to do to ensure a culture of compliance Questioning whether electronic TMF can be a solution or an obstacle in future trial management Ensuring all required staff, internally and externally, locally and globally are aware of requirements and are reachable to improve response times Exploring other technological solutions to improving trial management and improving success rates during inspection Stuart Halasz, Associate Director, Clinical Quality Management, Merck 4:30 Taking a risk-based approach using advanced analytics to oversee vendors and investigative sites- A Case Study Ensuring the health of investigative sites requires a more evolved approach in the way we deploy recourses, manage risks and quality issues, and identify trends Building the story with analytical tools ensures effective oversight of quality and performance to prevents poor outcomes Considering the importance of the new ICH E6 addendum which is helping to drive the approach to ensuring quality in clinical trials Beth A. Soffer, Senior Director, Quality Preformance & Risk Management, Pfizer Inc. 5:00 Chairman s closing remarks and close of Day One Outsourcing in Clinical Trials 2017 Day One 24 th May 2017 Programme Day Two 8:15 Registration and refreshments Biopharmaceuticals Stream 8:50 Chairman s opening remarks
9:00 Establishing an end-to-end approach to business operations for clinical research to allow for more effective forecasting and budgeting Promoting the idea of business operations and outsourcing teams being under the same management to avoid any knowledge being lost Considering how best to build links between project management and business operations to improve forecasting and budgeting processes Ensuring specific plans and processes for each team when change order occurs to minimize their impact Developing plans for forecasting strategies as the trial grows to international levels or takes different avenues Charlotte French, Senior Director, Service Provider Management, EMD Serono 9:30 Session reserved for George Clinical 10:00 Case Study: Developing strategies for when it all goes wrong; considering how to maintain relationships when challenges occur Recognizing what the sponsor can do as soon as red flags are raised to reduce the impact of any issues Creating effective escalation strategies within the contract in case of any issues to facilitate quick solutions Re-establishing communication with vendor business development teams in case of under delivery Does the end mean the end; ensuring bridges aren t burnt in the event you need to change CROs mid-trial Learning from past lessons to highlight what must be thought about from the outset to avoid issues midway through the trial Evan Tzanis, Senior Vice President Clinical Development and Clinical Operations, Paratek Pharmaceuticals 10:30 Morning Refreshments & Networking 11:00 Implementing investigator site payment strategies for success in outsourced trials Identifying opportunities before and during Clinical Trial Agreement negotiations for site payment success regardless of outsourcing model Automation, transparency and centralization for improved overall site payment experience
Engaging sites early to avoid potential bottlenecks during the site payment stage Customizing the site payment approval process for improved payment cycle times Exploring the implementation of site feedback mechanisms as a way of constantly improving site payment relationships Debora Araujo, Associate Director, Clinical Contracting Services, Boehringer Ingelheim 11:30 Session reserved for ResearchPoint 12:00 Panel Discussion: Evaluating the future of off-shoring and outsourcing to emerging markets to identify how best to capitalize on these regions Highlighting the key advantages of working in markets such as Asia and Latin America as a way of reducing costs Identifying the risks of working in less experienced and less regulated markets to develop strategies to monitor the high risk aspects Debating whether to work with global CROs with remote affiliates in emerging markets or with niche local CROs to find the best fit Ensuring you are capitalizing on vendor contacts and knowledge when working in new markets as a key route to success Considering the current political landscape and potential pressures on companies to work with US-based companies 12:30 Networking Lunch 1.45 Considering how best to engage with all stakeholders to develop trial strategies that fit the needs to all parties and is most beneficial to patients Recognizing what different stakeholders can stand to gain from your trial to allow for a more targeted approach to engagement Evaluating how best to work with patient groups to develop patient-centric trials to improve patient retention and recruitment rates Considering how to find sites that are looking to engage, and developing processes that simplify tasks for trial to ensure effective collaboration Highlighting the benefits of working with CROs that have their own site networks whilst being sure to not be influenced by this when developing site relationships Developing communication routes between senior level sponsor executives and sites to ensure they are aware of the specific trial and sponsor needs Craig Coffman, Executive Director, Clinical Business Operations & Outsourcing, Nektar Therapeutics
2.15 The Changing Outsourcing Landscape and its Impact on Drug Development Operating Conditions Review new data characterizing the structure of the market for outsourced services Highlight major trends and M&A activity driving consolidation and operating change Discuss strategies anticipating landscape change to drive development performance Ken Getz, Director, Sponsored Research Programs, Tufts CSDD 3:00 Afternoon Refreshments & Networking 3:30 Speaker Hosted Roundtables Each roundtable session lasts for 40 minutes, and delegates may attend up to 2 roundtables Roundtable 1 Developing best practices for outsourcing in rare disease trials Roundtable 2 Roundtable reserved for George Clinical Roundtable 3 Investigating the true value of Risk Based Monitoring Roundtable 4 Developing effective infrastructures for effective management of CROs Facilitator: Michele Stonier, CRO Infrastructure Lead, Bristol-Myers Squibb 4:50 Chair s summation and close of conference