Outsourcing in Clinical Trials Southern California 2018 September 26 th 27 th La Jolla

Transcription

1 Outsourcing in Clinical Trials Southern California 2018 September 26 th 27 th La Jolla This year s conference has a solid range of emergent topics, a variety of subject matter expert speakers and excellent networking opportunities! - James Wabby, Executive Director, Regulatory Affairs Device/Combination Products 2018 Speakers Confirmed: Jeff Knight, Vice President, Clinical Operations, Clinical Outsourcing & Project Management, Halozyme Therapeutics Lei Zhang, Vice President, Global Clinical Development and Operations, Zensun USA James Wabby, Executive Director, Regulatory Affairs - Device/Combination Products, Allergan Dov Gal, Vice President Regulatory and Clinical Affairs and Quality Assurance, ClearFlow Rod Saponjic, Vice President, Global Development Operations, Greenwich Biosciences Harri Jarvelainen, COO, DrugCendR Mary Syto, Director, Clinical Operations, Celgene Diane Fortune, Director, Development Outsourcing and Contracts, Vir Biotechnology Ramani A. Aiyer, Executive Vice-President, Therabiol Brian J. Byrnes, Senior Director, Clinical Projects, La Jolla Pharmaceutical Company Nagesh Uppuluri, Senior Director, Global Medical Affairs, Medtronic Christopher J. Nardo, PhD, Senior Vice-President, Development, Dermata Brian Dempster, Director, Clinical Operations, Vital Therapies Ken Wilson, Director, Sourcing Operations, Pfizer Rosh Vora, VP, Clinical Affairs, PhysioCue Raj Nihalani, Chief Technology & Business Development Officer, Reshape Life Sciences Jacqueline Blem, Director, Clinical Operations, Triphase Accelerator Andreza Oliveira, Director of Clinical Operations, Evofem Biosciences Vlad Bogin, Chief Executive Officer, Nobilis Therapeutics Peter Stiegler, Senior Director Clinical Affairs, Progenity Kenneth Kleinhenz, VP, Regulatory Affairs, Avelas Biosciences Sarah Wheeler, Associate Director, Clinical Operations, effector Therapeutics Roberta Alton, Director, Clinical Operations, Halozyme Therapeutics Joseph Djan, Director, Clinical Operations, Dart Neuroscience Constance Crowley, Senior Clinical Program Leader, Roche

2 Outsourcing in Clinical Trials Southern California Day 1 September 26 th :15 Registration and refreshments 8:55 Chair s opening remarks Mary Syto, Director, Clinical Operations, Celgene 9:00 KEYNOTE Moving beyond the contract: Identifying strategies for maximizing CRO engagement and building relationships to strengthen collaboration and achieve goals Demonstrating to your CRO the importance of your trial to get buy-in and instill the wider significance of their work Promoting frequent meetings and reporting metrics to promote open communication Exploring best practices for establishing good communication between internal teams and vendors to minimize delays Pinpointing the challenges of having a singular ClinOps representative to understand how best to manage vendor relationships and leverage the emotional component Using real life case study examples to demonstrate how CRO-sponsor partnership can add value to multiple aspects of the trial Mary Syto, Director, Clinical Operations, Celgene 9:30 Session reserved for Premier Research Agenda Highlight 10:00 LIVE DEBATE The mismatch with innovative thinking: There is a lack of clinical innovation seen with big CROs and strategic alliances NEW 10:00 Moderator Opening Remarks 10:05 Initial Audience Vote 10:10 Arguments For 10:15 Arguments Against 10:20 Interactive Debate/Q&A 10:40 Final Audience Vote Discussing the idea that large CROs are less supportive of innovation and new trial technology to determine how this may impact your study Weighing up the benefits of utilizing smaller CROs for more novel technologies Exploring whether strategic partnerships can lead to complacent vendors and reduced

3 innovation Debating the impact vendor size has on your strategic model to ensure you have the most suitable one Moderator: Ken Wilson, Director, Sourcing Operations, Pfizer Confirmed Panelists: Ramani A. Aiyer, Executive Vice-President, Therabiol (DISAGREE) Rod Saponjic, VP, Global Clinical Development Operations, Greenwich Biosciences (DISAGREE) Sarah Wheeler, Associate Director, Clinical Operations, effector Therapeutics (AGREE) Vlad Bogin, Chief Executive Officer, Nobilis Therapeutics (AGREE) Constance Crowley, Senior Clinical Program Leader, Roche (AGREE) 10:45 Morning refreshments and networking 11:15 Developing an internal management strategy for multiple vendors to ensure effective use of time and resources Highlighting the importance of determining what internal expertise is needed for effective vendor oversight to ensure you are meeting your requirements as a trial sponsor Exploring the benefits of having one point-of-contact in-house for all vendors to ensure successful integration Determining how to balance under-performing and over-achieving vendors to meet deadlines Investigating what current systems and tools exist to aid management of vendors in a cost and time effective way Diane Fortune, Director, Development Outsourcing and Contracts, Vir Biotechnology 11:45 Implementing the 2018 FDA draft guidance for Developing Drugs for Treatment in Early Alzheimer s Disease: Diagnostics and Endpoints Reviewing the significant changes from the draft guidance issued in February 2013 Discussing the diagnostic criteria and the selection of patients into trials as recommended by the FDA Presenting the relationships between cognition and daily function in normal aging, Mild Cognitive Impairment, and Early AD Why choosing the right clinical endpoint to assess neuropsychological performance and impairment in daily function is important, and various measures commonly used in the literature Discussing recommended strategies for implementation in clinical research Lovingly Park, Director of Scientific Affairs, PAREXEL 12:15 Evolving clinical trial outsourcing models and considerations - What really matters

4 Assessing your internal expertise to identify which aspects to outsource making the most of your in-house abilities Exploring pros and cons of the hybrid vs full outsourcing models to identify the most suitable option Addressing the risks of both outsourcing models to understand who is ultimately responsible for all aspects of the trial Having awareness beyond the clinical group to further understand financial aspects before considering what to outsource Lei Zhang, Vice President, Global Clinical Development and Operations, Zensun USA 12:45 Australia's 43.5% R&D refund and simplified regulatory environment as a gateway to Asia Australia s scientific talent, excellent medical infrastructure and lucrative 43.5% R&D cash refund scheme makes it a preferred destination for early phase clinical trials. Patient availability makes Asia a key region to accelerate later phase development, at lower costs. The partnership between regional specialists, an alternative to large global CRO to manage complex global trial while keeping the flexibility required for Mid-size Biopharma companies. Aditya Kotta, Business Development Manager, Novotech 1:15 Lunch and networking 2:30 Considering a small company s perspective on etmf management to encourage effective running of your clinical trial Agenda Highlight Exploring the current trends in streamlining clinical trials with etmf adoption Highlighting the specific challenges faced by smaller companies when implementing an etmf management strategies to make the most of limited resources Identifying what internal resources you have to manage etmf and what can be outsourced Pinpointing the advantage of allocating a member of your team with internal authority to be the TMF owner to ensure you are inspection ready Identifying how etmf can quicken study start-up timings to improve overall trial efficiency Jeff Knight, Vice President, Clinical Operations, Clinical Outsourcing & Project Management, Halozyme Therapeutics Roberta Alton, Pharm D, Director, Clinical Operations, Halozyme Therapeutics 3:00 Session reserved for Synteract

5 3:30 In an era of patient centricity Investigating how to operationalize the grass roots of a patient-led movement to increase awareness and optimize recruitment Developing relationships with local physicians and specialists to develop effective referral pathways for patients Creating pathways for patients to find relevant clinical trials themselves reducing the pressure on internal teams Engaging patients in the protocol design phase to identify the best enrolment strategy Adopting the use of social media to increase the level of interest in a patient population and accelerate recruitment Ramani A. Aiyer, Executive Vice-President, Therabiol 4:00 Afternoon refreshments and networking 4:30 Developing strategies to enable your vendor to become an extension of your clinical trial team to improve collaboration and engagement Evaluating how to best gauge cultural compatibility during vendor selection to ensure you are acquiring a long-term partner Developing the right management approach to ensure your partner becomes an extension of self Highlighting the importance of stressing how your vendor s work plays into your overall clinical objectives to ensure engagement throughout the partnership Brian J. Byrnes, Senior Director, Clinical Projects, La Jolla Pharmaceutical Company 5:00 Evaluating recruitment and engagement strategies to develop a successful rare disease drug development model Highlighting the key challenges associated with rare disease trials and how collaboration with other sponsors can be beneficial Outlining your CRO selection process including how to evaluate their level of experience Pinpointing best practices for rare disease patient recruitment and engagement in order to prevent study start-up delays Recognising the need for effective site and investigator engagement to ensure extensive knowledge of inclusion/exclusion criteria Rosh Vora, VP, Clinical and Regulatory Affairs, PhysioCue

6 5:30 Chair s summation and close of conference Outsourcing in Clinical Trials Southern California Day 2 September 27 th :15 Registration and refreshments 08:50 Chair s opening remarks Ramani A. Aiyer, Executive Vice-President, Therabiol Biopharmaceutical Stream Chair: Ramani A. Aiyer, Executive Vice-President, Therabiol Medical Device Stream Chair: Dov Gal, Vice President Regulatory and Clinical Affairs and Quality Assurance, ClearFlow Key considerations for executing rapid study start-up with multiple vendors across various regions: A small company perspective Developing an internal strategy for vendor management during start-up to meet deliverables and ensure correct specification Promoting strong vendor communication plans with weekly calls and regular faceto-face meetings Assessing the protocol feasibility aspect of start-up to ensure an efficient site selection process Highlighting technologies available for tracking multiple moving pieces during start-up Jacqueline Blem, Director, Clinical Operations, Triphase Accelerator Addressing challenges with international trials in different cultural and regulatory environments to overcome barriers Pinpointing the importance of international sites generating greater outreach to recruit the right patient population Recognizing the benefit of a remote contact for studies abroad to maximize local knowledge and country-specific regulations Exploring exactly how involved the sponsor should be with international trials to encourage efficiency Appreciating good relationships with international site coordinators to solve issues quickly despite time zone differences Nagesh Uppuluri, Senior Director, Global Medical Affairs, Medtronic Neurovascular 09:30 Session reserved for ERT Session reserved for Event Sponsor 10:00 PANEL DISCUSSION Overcoming hurdles presented when outsourcing trials internationally to develop the PANEL DISCUSSION Are you prepared for the new EU Medical Devices Regulation (MDR)? Agenda Highlight

7 best competitive approach for going global Ensuring the correct criteria is used to pinpoint a knowledgeable provider with a global presence and experience with specific regulatory bodies Identifying effective tools and plans with all parties to overcome language barriers and avoid delays Discussing best practices for performing feasibility tests with emerging markets to identify the best location for your study Setting out clear objectives with your international CRO early on to make sure your priorities align Moderator: Ramani A. Aiyer, Executive Vice-President, Therabiol Confirmed Panelists: Ken Wilson, Director, Sourcing Operations, Pfizer Raj Nihalani, Chief Technology & Business Development Officer, Reshape Life Sciences Understanding what has changed between the existing MDD and the new MDR Discussing what is required in terms of clinical evaluation of legacy devices to identify if new data is needed Revisiting risk management processes to ensure compliance with the new regulation Addressing quality management systems and economic operators to maintain the effectiveness of current processes Highlighting the advantages of post-market surveillance for continuous feedback and maintain a high standard of product quality Confirmed Panelists: James Wabby, Executive Director, Regulatory Affairs - Device/Combination Products, Allergan; Kenneth Kleinhenz, Vice President, Regulatory Affairs, Avelas Biosciences Premier Research Sponsor 10:45 Morning refreshments and networking 11:15 Session reserved for Celerion Developing clinical trials and human factor validation studies for complex devices or combination products to ensure regulatory requirements for device and pharma are met Highlighting the importance of developing a core team with both a clinical and nonclinical component in order to map out all aspects of the trial in the early stages Integrating human factors and usability into design controls in order for the clinical trial to yield optimal trial results Emphasizing that ClinOps should be part of design validation and design control Enhancing trial management through effective use of design control ensuring the

8 team have full oversight of deliverables James Wabby, Executive Director, Regulatory Affairs - Device/Combination Products, Allergan 11:45 Discussing having partner relationships in China to join the emerging market before embarking on a clinical trial Exploring a practical perspective relevant for early stage companies who have not yet entered China A case study from a company with practical China experience A regulatory perspective: Highlighting the regulatory changes set out by cfda and what this means for future clinical trials Harri Jarvelainen, COO, DrugCendR 12:15 Session reserved for Invicro Operational issues in a clinical trial with an easily unmasked investigational product Ensuring that shipping, packaging and deployment of IP maintains study blind Carefully drafting a consent that fully informs patients of study risks, without unmasking treatment Operational issues in drug preparation and administration to maintain the study blind Drug accountability activities that will not unmask treatment Christopher J. Nardo, PhD, Senior Vice-President, Development, Dermata REGULATORY UPDATE Addressing the MDSAP Certification and ISO 13485:2016- Two major quality and regulatory changes which intersect with clinical affairs 12:45 PANEL DISCUSSION Determining whether Risk Based Monitoring (RBM) methods along with CRO collaboration is a realistic approach for smaller companies Pinpointing the advantages of implementing RBM into clinical trials to identify key areas to focus on Highlighting the main aspects of ISO13485:2016 to further understand the regulation encouraging compliance Examining the medical device single audit (MDSAP) program to allow a single regulatory audit of a device manufacturer that satisfies the regulatory authorities Pinpointing the implications on clinical affairs within human resources, infrastructure and finance gap analysis Dov Gal, Vice President Regulatory and Clinical Affairs and Quality Assurance, ClearFlow PANEL DISCUSSION Discussing best approaches to vendor partnerships to effectively manage medical device trials Identifying vendors that meet the need without breaking the bank Pinpointing the importance of building trust with your vendors early on Assessing how sponsors can take back

9 Promoting the collaboration with a RBMexperienced CRO to ensure effective and compliant data collection Assessing ways to integrate RBM strategies into your study protocol without negatively impacting trial timelines Debating cost-effective methods for internal RBM training to improve inhouse expertise Peter Stiegler, Senior Director Clinical Affairs, Progenity Brian Dempster, Director, Clinical Operations, Vital Therapies Andrew Schachter, Founder & CEO, Axiom Real- Time Metrics control Encouraging CROs to be more flexible with their outsourcing model to accommodate your ideas Addressing site training methods to familiarize site personnel with device functions Confirmed Panelists: Raj Nihalani, Chief Technology & Business Development Officer, Reshape Life Sciences Nagesh Uppuluri, Sr. Director. Global Medical Affairs, Medtronic Neurovascular 1:15 Lunch and networking 2:15 PANEL DISCUSSION Delving deeper into protocol and trial designs to achieve optimal patient engagement and retention in long-term clinical trials Agenda Highlight Using past experiences to identify when the best time is to get patients involved with the clinical trial process Ascertaining the specific needs of your wider patient pool based on treatment area to decide which aspects of your protocol will be most challenging Discussing novel approaches to become more patient-centric through small changes in the study that will have a positive effect on the patient s life Collaborating with Patient Advocacy Groups to ensure all the study info is available online and further develop your recruitment strategies Confirmed Panelists: Lovingly Park, Director of Scientific Affairs, PAREXEL; Raj Nihalani, Chief Technology & Business Development Officer, Reshape Life Sciences; Rod Saponjic, Vice President, Global Clinical Development Operations, Greenwich Biosciences 2:45 Exploring strategies for smaller companies to work with the most appropriate CRAs to ensure the A- team for your trial Specifying the individuals you agreed to work with during the vendor contract stage in order to avoid losing valued team members Evaluating the vendor team proposed for your study to determine experience early on

10 Working with your CRO to identify solutions if a CRA moves on to ensure minimal disruption Assessing the advantages of a small-medium sized CRO to ensure your trial is a top priority Andreza Oliveira, Director of Clinical Operations, Evofem Biosciences 3:15 Afternoon refreshments and networking 3:45 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 RT 1 RT 2 RT 3 RT 4 Considering a small company s perspective on etmf management: challenges and lessons learned Roberta Alton, Pharm D, Director, Clinical Operations, Halozyme Therapeutics Vendor management: How do you build trust with your partners? Brian Dempster, Director, Clinical Operations, Vital Therapies Which country should you run your clinical trial next? Sarah Wheeler, Associate Director, Clinical Operations, effector Therapeutics Discussing how to strike the balance between outsourcing and using in-house resources Joseph Djan, Director, Clinical Operations, Dart Neuroscience, LLC 5:15 Chair s summation and close of conference