Outsourcing in Clinical Trials Pacific Northwest 2019

• New economic impact data show impressive growth across Washington state’s life science sectors.
• Continued industry growth is challenged by workforce needs ranging from entry-level technical workers through PhD scientists.
• Located at the epicenter of biomedical research, machine learning/AI, cloud computing and big data, Seattle is becoming a global leader in convergence-based technologies.
• These “disruptive” technologies will present a wide array of regulatory challenges; is the CRO industry ready?

• Brief review of FDA’s framework and associated recent draft guidance documents issued in late 2018 and throughout 2019
• Learn what is RWE, how could it contribute to assessment of efficacy, and why it should be considered for most development programs
• Understand FDA’s sensitivities including the standards for data quality and thoughtful study design
• Consider skills necessary to design, collect, review, compile RWD

• Championing the potential of your drug to drive enthusiasm for its success within your project team
• Contract Creation: forming an outcome based agreement as opposed to an activity based one to avoid the incurrence of high costs
• Building interpersonal relationships with your CRO to leverage a better position
• Best practices for negotiating a contract that will ensure the allocation of the dream team to your trial

• Patient interest in clinical trial information continues to grow rapidly
• Online platforms such as Google and Facebook are evolving and require new approaches
• An online referral is a valuable asset: provide both online and offline support for the process

This session will take on an interview style format, our chair will ask our speaker a series of questions for 15minutes, and this will be followed by 10minutes audience Q&A which will allow attendees to ask burning questions about FDA meetings and pre-submissions to experience Regulatory Affairs professionals.

• Australia’s scientific talent, excellent medical infrastructure and lucrative 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

• Using social media to promote a better understanding of your clinical trial in a user-friendly way
• Leveraging data from social media to find and recruit your target groups more efficiently
• Discussing the benefits and limitations of using social media to engage with potential patients worldwide
• Understanding the limitations of social media: exploring data privacy and demographic restraints

• • Malaria – Exploring the Public Health Problem
  • CHMI History and Underlying Rationale
  • Recent CHMI Trials and Prospects for Vaccine to Prevent Plasmodium falciparum Infection

• Understanding the current regulatory landscape for conducting clinical trials on cannabinoid-based drugs
• Types of clinical pharmacology studies relevant during clinical development
• Lessons learned from an early development case study

• How early should biomarkers be included?
• How do biomarkers increase the likelihood of clinical trial success
• What markers should be considered as part of the trial design for new therapies in NSCLC (non-small cell lung cancer)

During this session, delegates shall hear from two different speakers (20mins each) who will share their experiences of monitoring their vendors, highlighting what has/hasn’t worked. The speakers will then join to together in a panel to discuss their approaches with the audience (15mins).

Moderator:  Darrell Panich, Former VP, Clinical Affairs, RepliCel Life Sciences

Presentation 1: Using Regular Check Ins to Successfully Manage Partnerships in a Phase I Clinical Trial

• Christina Lorentz, Senior Scientist and Project Manager, Aronora; Norah Verbout, Senior Scientist and Project Manager, Aronora

Presentation 2: Tips and Tricks for Managing Multiple Vendors to Ensure you Trial Runs Smoothly

• Heather Hughes, Director, Clinical Operations, Juno Therapeutics a Celgene Company

 Panellists: Heather Hughes, Director, Clinical Operations, Juno Therapeutics a Celgene Company; Christina Lorentz, Senior Scientist and Project Manager, Aronora; Norah Verbout, Senior Scientist and Project Manager, Aronora

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 runs for 45 minutes and delegates have an opportunity to take part on 2 roundtables.

RT 1- Corporate Culture and its Impact on Forming Strong Sponsor-CRO Teams- What Can We Do About It?

Darrell Panich, Former VP, Clinical Affairs, RepliCel Life Sciences

RT 2- Deep Diving into the most Efficient Methods of Tracking sites’ Documentation and Records

Janet R. Rea, Sr Vice President, Regulatory, Quality and Clinical Affairs, Atossa Genetics

RT 3- Understanding how to work with CROS in the East Asia Region to Reduce Trial Costs

Ramani A. Aiyer, Principal, Shasta BioVentures

RT 4- Debating Best Practices for Measuring the Health of your Vendor Partnerships to Fix Issues Early

• Case study overview of Sonivate’s experience working with the military
• Outlining possible collaboration opportunities with DoD resources and other military assisting Federal Agencies
• Exploring the design and implementation of clinical research protocols within the U.S. Army framework

• Conduct Research at site level to understand the potential study burden before designing your trial
• Utilising patient profiles to guide the design of your trial and increase retention rates
• Leveraging existing online social data to monitor opinions and understand patients concerns
• Simplifying informed consent through providing study information in user friendly formats to make enrolment easier

• Understand what Pre-Submission process can and cannot provide your company
• Dispel common misconceptions of Pre-Submission meetings
• Optimize your submission and presentation
• What to expect during the Pre-Submission process

• Understanding the global variation in data privacy rules to ensure worldwide compliance
• Developing an understanding in the contracting phase of a CRO into data privacy expectations
• Maintaining oversight of your CRO to ensure all documents released are in line with your data privacy
• Approaches for managing clinical trial data flows

• Personalized / Precision Medicine – Hype, Hope and Reality
• Clinical Trial Experience – Strategic and Operational Issues
• Lessons learned and summary conclusions