Outsourcing in Clinical Trials Southern California 2017 September 27 th 28 th La Jolla, California

Transcription

1 Outsourcing in Clinical Trials Southern California 2017 September 27 th 28 th La Jolla, California 2017 Speaking Faculty Larn Hwang, CSO, Autotelic Inc Mathias Schmidt, CEO, ArmaGen Dr. Vlad Bogin, CEO, Nobilis Therapeutics Gary Lain, Senior Director, Sourcing Operations, Centre of Excellence, Pfizer Rod Saponjic, SVP, Clinical Operations, Patara Pharma Tinna Kwan, Sr Director, Clinical Research, Avanir Pharmaceuticals Uyen Nguyen, Director of Clinical Research, Avanir Pharmaceuticals Cindy Croissant, Sr Director, Clinical Operations, LumiThera Lisa Latven, Director, Clinical Operations, Ambrx, Inc. Dov Gal, Vice President RA, CA, QA, ClearFlow, Inc. Michael Lauw, Director, Clinical Operations, Heron Therapeutics Jin Jean Wang, Co-Chairman and Co-Founder, CARDIX Therapeutics Kelly L. Smith, Contracts and Budgets Manager, Celgene Corporation/Receptos Dr. Roberta Alexander, Director of Clinical Research and Medical Affairs, Exagen Diagnostics Brian Dempster, Director, Clinical Operations, Vital Therapies Inc Barry Murphy, Director, Business Development, Novotech Dr. Bronislava Gedulin, Chief Medical Officer, Satiogen Pharmaceuticals Miriam Cruz, Director, Clinical Research, Oncology, Halozyme Therapeutics Dr. Zhongling Feng, Director of Clinical Development, ACEA Biosciences Raj Nihalani, Founder & CEO, Onviomed, Inc Julius Kusserow, Head of PAREXEL Data Standards, PAREXEL James Wabby, Director, Strategic Regulatory Intelligence and Compliance, Allergan Peter Stiegler, Director Clinical Operations, Prometheus Laboratories Sridhar Prasad, Vice President, CalAsia Pharmaceuticals Dave Conway, Vice President, Clinical Operations, Terra Biological Kenneth Kleinhenz, VP, Global Regulatory Affairs and Quality, Cytori Therapeutics Sean Xie, Director, Pharmaceutical Operations, Spectrum Pharmaceuticals Melissa Castillo, Senior Manager, Safety Surveillance, SynteractHCR Deborah Schmalz-Kern, Executive Director, Medical Device, Medpace

2 Outsourcing in Clinical Trials Southern California Day 1 September 27 th :45 Registration and refreshments 08:20 Chair s opening remarks 08:30 Assessing the best outsourcing strategy for a small biotech when choosing between a small, mid-sized or large CRO to determine how best to invest your resources for the greatest return Reviewing the needs of the trial and the capabilities of potential partners to decipher which model suits your needs Deciphering opportunities afforded to smaller biotech and start-up companies in gaining access to the wealth of resources of large CROs Establishing strategies to ensure your small clinical study is not overlooked by a large CRO through effective contracting and trial management Outlining perceived positives in working with small and mid-sized CROs as a small biotech to weigh if the reduced resources available through such partnerships diminish your study significantly Dr. Zhongling Feng, Director of Clinical Development, ACEA Biosciences 09:00 Optimizing in-house employment and retention of core talent to ensure outsourcing is a choice and not a necessity Implementing novel strategies for attracting long-term talent to your company in a fast-paced and competitive job market Outlining benefits to your trial in attracting and retaining long-term staff members instead of utilizing consultants or CRO staff Communicating mutual benefit for organization and staff in developing a long-standing working relationship through continued employment Highlighting financial gains enjoyed through reliable, long-term engaged staff Tinna Kwan, Sr Director, Clinical Research, Avanir Pharmaceuticals Uyen Nguyen, Director of Clinical Research, Avanir Pharmaceuticals 09:30 Seamless datatflow with a clinical Meta Data Repository Explaining how a clinical Meta Data Repository (MDR) integrates the spokes of a hub design containing generic variables and practical use for data managers, programmers and statisticians Presenting challenges in designing meaningful concepts to provide a seamless understanding and execution of transformations between all the spokes Demonstrating how the protocol specific application of standards will improve quality during collection, tabulation and analysis Discussing how Study Instance Metadata (SIM) will provide better planning and execution of the

3 data transformations to avoid bottleneck situations around database lock Examining the benefits of the Clinical MDR and SIM for both large and small/mid-size Biopharmaceutical clients Julius Kusserow, Head of PAREXEL Data Standards, PAREXEL 10:00 Interactive Debate Is outsourcing the best option for you and your trial? In this session our panelists and audience will share their personal experiences of outsourcing and delve into both the positives and the negatives of working with outsourced resources so you can decide if this really is the best option for your clinical trial. Points for discussion include: Why did you decide to outsource for your trial and did it meet your expectations? What model did you use and how effective was it? What would you change moving forwards? Was outsourcing the right decision for you and your trial? Panelists include: Gary Lain, Senior Director, Sourcing Operations, Centre of Excellence, Pfizer Rod Saponjic, SVP, Clinical Operations, Patara Pharma Peter Stiegler, Director Clinical Operations, Prometheus Laboratories 10:30 Morning refreshments and networking 11:00 Navigating the best outsourcing strategy for a small biotech through a case study of due diligence Recognizing the need to transition a vendor, in order to improve capability Selecting your new vendor pool and using due diligence to choose the best new candidate Highlighting reasons for choosing a relatively small vendor Uncovering challenges faced after making the decision to establish what in retrospect could have been avoided Presenting lessons learned and future strategy to ensure that your next vendor decision is the right one Brian Dempster, Director, Clinical Operations, Vital Therapies Inc 11:30 Session reserved for Worldwide Clinical Trials

4 12:00 Determining how small companies can make a big impact with site engagement to connect effectively for successful trial execution Considering challenges encountered in site engagement as a small company to establish changes required in management strategy Building site engagement into the process from the initial contracting stage to start as you mean to go on Presenting innovative site engagement strategies to generate ideas for increasing site investment in your trial Leveraging limited resources to engage sites beyond financial incentives to build creative strategies Modifying the approach dependent on the site to ensure you are tailoring to each sits capability Larn Hwang, CSO, Autotelic Inc 12:30 Lunch and networking 14:00 Panel Discussion Looking at the future of clinical trials to decipher how technology available now can be incorporated in your next trial Defining available technology through handheld devices and wearables and the impact they can have on your trial Deciphering your technology need based on the size and structure of your study to ensure the most economical approach to technology adoption Overcoming the first hurdle - practical advice on how to incorporate a new technology into your next study Appreciating the opportunities created through an increase in clinical technology use to reduce costs and timelines and to free up a wealth of resources Panelists include: Rod Saponjic, SVP, Clinical Operations, Patara Pharma Julius Kusserow, Head of PAREXEL Data Standards, PAREXEL 14:30 Session reserved for Premier Research 15:30 Afternoon refreshments and networking

5 16:00 Battling patient enrolment challenges when conducting trials in increasingly niche specialties Outlining challenges in patient identification and recruitment when conducting studies in specialized therapeutic areas Juggling the option of an unmanageable number of sites with high expectations on patient travel to decipher where to locate your sites Establishing the need for patient centricity and defining what is expected here when working with limited patient pools in international studies Working with vendor partners and local centers of excellence to create protocol to work for the trial and to reach a large enough patient pool Dr. Bronislava Gedulin, Chief Medical Officer, Satiogen Pharmaceuticals 16:30 Considering trial design and protocol when looking for optimal patient engagement and retention in longterm clinical trials Moving beyond the buzzword of patient centricity to truly identify your patient needs and expectations Accepting the limitations in your study where data collection must be top priority for the integrity of the trial data Addressing the specific needs of your wider patient pool based on treatment area to best ascertain which aspects of your protocol will be most challenging Searching for new and novel approaches to increase engagement of patients through small tweaks or little gestures which will have big impact on a patients life Miriam Cruz, Director, Clinical Research, Oncology, Halozyme Therapeutics 17:00 Chair s summation and close of conference

6 Outsourcing in Clinical Trials Southern California Day 2 September 28 th :15 Registration and refreshments 08:50 Chair s opening remarks Biopharmaceutical Stream Medical Device Stream Maximizing CRO engagement in your clinical trial Considering your needs as the trial sponsor from your CRO team to enter the relationship with clear communication Maintaining communication throughout the trial to ensure effective oversight of CRO ensuring they meet your expectations at every stage Implementing strategies to keep your trial a priority when financials are restricted Exploiting positive relationships with CROs to move forward with new trials and ensure vendor engagement Knowing when to move on - highlighting trigger signs for damaging relationships and effectively managing this difficult scenario Sean Xie, Director, Pharmaceutical Operations, Spectrum Pharmaceuticals Utilizing design control in combination product trials to ensure all regulatory requirements for device and pharma are met Highlighting practical approaches to design control and design change to determine best practice for trial management Integrating human factors and usability into design controls and the clinical trial to yield optimal trial results Balancing the approach to design control to ensure preparedness for audits and inspection while minimizing the burden and paperwork for your clinical team Enhancing trial management through effective use of design control ensuring the clinical team have full oversight of deliverables Pinpointing effectiveness of procedures and templates, training and understanding in balancing the pendulum James Wabby, Executive Director, Regulatory Affairs (Device & Combination Products), Allergan 09:30 Presenting key considerations for selecting a safety services provider Beware the hidden costs in conducting clinical trials understanding landmines and how to avoid them Sharing an overview of considerations for your evaluation Highlighting pitfalls of outsourcing to the wrong vendor Showcasing benefits of outsourcing to the right vendor Reviewing several case studies to identify Highlighting critical areas requiring expert oversight and management to ensure your timelines and costs are not derailed Mitigating later unexpected costs by investing early into medical, regulatory and operational experts, rather than hurrying through trial design

7 patterns and strategies for getting it right Pinpointing best practices for transitioning safety work to another vendor mid trial Evaluating considerations through the product lifecycle Melissa Castillo, Senior Manager, Safety Surveillance, SynteractHCR Making smart site selection decisions to avoid a lengthy start-up, lack-lustre recruitment and quality issues and eventually time delays and higher costs Ensuring data is processed expeditiously and reports are generated without delays to ensure not lost revenue through data management/biometrics/medical writing Deborah Schmalz-Kern, Executive Director, Medical Device, Medpace 10:00 Interactive Session This session will be run by a moderator and the audience are actively encouraged to bring ideas, examples and questions to stimulate lively discussion and debate Managing and delivering successful international clinical studies Points for discussion include: Who are your best partners when working abroad? How can you best manage international multi-site studies? Success stories and lessons learned Moderator: Michael Lauw, Director, Clinical Operations, Heron Therapeutics Interactive Session This session will be run by a moderator and the audience are actively encouraged to bring ideas, examples and questions to stimulate lively discussion and debate Selecting and managing the best CRO for a medical device clinical study Points for discussion include: What capabilities to look for when selecting your CRO? How to ensure they understand the application of your device? Success stories and lessons learned Moderator: Raj Nihalani, Founder & CEO, Onviomed, Inc 10:30 Morning refreshments and networking

8 11:00 Implementing a service-level agreement and quality agreement in the vendor contract to ensure return on your investment Defining the need for a service-level agreement and quality agreement with your vendor from a small company perspective Utilizing CRO metrics to minimize timelines for contract negotiation Managing the trial through a service-level and quality agreement to gain optimal results for your trial Sharing best practice examples of servicelevel and quality agreements made and the positive trial results yielded Incorporating service-level and quality agreements into your next vendor contract to ensure you get the A team Kelly L. Smith, Contracts and Budgets Manager, Celgene Corporation/Receptos Implementing effective data monitoring systems into your clinical trial as a small company to remain compliant Ascertaining your needs from a data monitoring system as a small company to decipher which database would be most effective Building the data monitoring strategy around FDA standards and clearly communicate with all teams to ensure clearly demonstrability of compliance Sourcing the optimal data monitoring technology for your needs to ensure ease of use and compliant results Accepting record keeping as greatest cause of cgcp error to promote real time data analysis for you trial Looking to the future to determine advancements to be made to best aid small companies in compliant and cost-effective data monitoring Dov Gal, Vice President RA, CA, QA, ClearFlow, Inc. 11:30 Conducting Clinical Trials in Asia the why, how and when Presenting common challenges of conducting clinical trials in USA and Europe Discussing opportunities and solutions in Asia- Pacific recruitment, access to treatment naïve patients, prevalence of certain indications, quality, cost Exploring challenges and considerations when conducting clinical trials in Asia regulatory, cultural, language considerations Selecting the right partners for success Session reserved for event sponsor Barry Murphy, Director, Business Development, Novotech 12:00 C-Level Panel Three CEOs share their highs, lows and experiences of running a biopharmaceutical company during the clinical trial stage Outlining personal drivers for building Quick Fire Case Studies Two 15 minute case studies will be presented giving an insight into challenges and opportunities in a different region, followed by a 30 minute panel. Which country should you run your Medical Device

9 biopharma companies Sharing case study examples of challenges in finances, outsourcing and trial management to determine strategies to overcome the hard times Highlighting trial achievements and success stories to outline accomplished approaches Jin Jean Wang, Co-Chairman and Co-Founder, CARDIX Therapeutics Dr. Vlad Bogin, CEO, Nobilis Therapeutics Mathias Schmidt, CEO, ArmaGen trial in next? Assessing in-country regulations for medical device trials Exploring approval barriers and opportunities Pinpointing ease of access for trial resources incountry 12:00-12:15 Japan Kenneth Kleinhenz, VP, Global Regulatory Affairs and Quality, Cytori Therapeutics 12:15 12:30 Canada Cindy Croissant, Sr Director, Clinical Operations, LumiThera 12:30 13:00 Panel Discussion Panelists: Cindy Croissant, Sr Director, Clinical Operations, LumiThera Kenneth Kleinhenz, VP, Global Regulatory Affairs and Quality, Cytori Therapeutics 13:00 Lunch and networking 14:00 Interactive Discussion Planning and executing safe, secure and compliant clinical trials in international political uncertainty In this interactive session the panel of speakers and audience will debate, discuss and deliberate the current international political sphere and the impact this has had and may have on your clinical trials Points for discussion include: The impact of Brexit on European and UK clinical trials The impact of Trump s policies on clinical stage pharma, biotech and medical device companies The impact of political instability and uncertainty internationally when choosing your next international clinical study destination Kelly L. Smith, Contracts and Budgets Manager, Celgene Corporation/Receptos James Wabby, Executive Director, Regulatory Affairs (Device & Combination Products), Allergan 14:45 Afternoon refreshments and networking

10 15:15 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 30 minutes, and delegates may attend up to 2 roundtables Roundtable 1 Roundtable 2 Roundtable 3 Roundtable 4 Roundtable 5 Staying up to speed on the EU data transfer agreements to ensure your European trial goes without a hitch Lisa Latven, Director, Clinical Operations, Ambrx, Inc. Producing an RFP to actively support your winning vendor selection Cindy Croissant, Sr Director, Clinical Operations, LumiThera Assessing the need for outsourcing to determine when it is time to make the step as a small company Dr. Roberta Alexander, Director of Clinical Research and Medical Affairs, Exagen Diagnostics Navigating a successful pre-clinical trial to achieve your IND submission and reach Phase I efficiently Sridhar Prasad, Vice President, CalAsia Pharmaceuticals Delving into digital era patient recruitment and engagement to ascertain how to use social media in clinical trials Dave Conway, Vice President, Clinical Operations, Terra Biological 16:15 Chair s summation and close of conference