8:50 am Chair Opening Remarks

Darrell Panich
Former VP, Clinical Affairs
RepliCel Life Sciences
9:00 am Keeping Pace with Washington State’s Fast Growing Life Science Industry: Opportunities and Challenges
- 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?

Leslie Alexander
President, Life Science Washington
9:30 am Overview of FDA’s Real World Evidence Program and implications for the future of product development
- Brief review of FDA’s framework and associated recent draft guidance documents issued in late 2018 and throughout 2019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

Darby Thompson
President, Emmes Canada
10:00 am Exploring how Small Trial Sponsors can Engage their CRO to Gain Access to Valuable Resources
- 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

Maria Jeleva
Associate Director, Clinical Operations, Impel NeuroPharma Inc
10:30 am Online Patient Recruitment: Best Practices and New Developments
• 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

Paul Ivsin
Managing Director, Clinical Trial Strategy
Seeker Health
11:00 am Morning Refreshments & Networking
11:30 am Q&A Panel: FDA Meeting Advice and Lessons Learned
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.

Jill Herendeen
VP, Regulatory Affairs, Silverback Therapeutics

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

Patrick Martin
VP, Clincal and Regulatory Affairs, Mirabilis Medica
12:00 pm Accelerating Clinical Trials in Asia-Pacific
- 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

Alex Ireland
Business Development Manager, Novotech
12:30 pm The Power of Social Media to Support Patient Recruitment and Retention
- 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

Lawrence Romel
SVP Clinical Operations, Brickell Biotech

Victoria Donovan
Founder, Clinically Media
1:00 pm Lunch & Networking
2:00 pm CASE STUDY: Controlled Human Malaria Infection (CHMI) Clinical Trial Design
-
- Malaria – Exploring the Public Health Problem
- CHMI History and Underlying Rationale
- Recent CHMI Trials and Prospects for Vaccine to Prevent Plasmodium falciparum Infection

James Davie
President & CEO, MalarVx
2:30 pm Regulatory and Clinical Considerations in the Development of Cannabinoid Therapeutics
• 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

Michael Kong
Director Medical Science Liaison, Altasciences
3:00 pm How Biomarkers Can Improve Your Clinical Trial Success: NSCLC As a 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)

Anthony Marotta
Medical Director, North America, AmoyDx
3:30 pm Afternoon Refreshments & Networking
4:00 pm Present and Discuss: Exploring Various Approaches to Monitoring your Vendor
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

Darrell Panich
Former VP, Clinical Affairs
RepliCel Life Sciences

Heather Hughes
Director, Clinical Operations Programme Management, Juno Therapeutics

Christina Lorentz
Senior Scientist and Project Manager, Aronora

Norah Verbout
Senior Scientist and Project Manager, Aronora
5:00 pm Chairman’s Closing Remarks & Drinks Reception
8:50 am Chair Opening Remarks

Darrell Panich
Former VP, Clinical Affairs
RepliCel Life Sciences
9:00 am 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 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

Darrell Panich
Former VP, Clinical Affairs
RepliCel Life Sciences

Janet R. Rea
Vice President, Regulatory, Quality and Clinical Affairs, Atossa Genetics
10:30 am Morning Refreshments & Networking
11:15 am PANEL DISCUSSION: Working with the Military in Medical Device Development and Clinical Research
- 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

Ronald W. Schutz, MD, FACC,
CMO, Co-Founder & Director, Sonivate Medical

Jonathan Monti
President and Co-Founder, SPOCUS

Eric Hanson
Founder and CEO, Tier 7
12:00 pm Deep Diving into Patient Centric Trial Design to Improve Retention Rates
- 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

Theresa Deisher
CEO, AVM Biotechnology
12:30 pm Lunch & Networking
1:45 pm Discussing Strategy and Tactics for A Successful Pre-Submission Meeting With the FDA
- 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

Patrick Martin
VP, Clincal and Regulatory Affairs, Mirabilis Medica
2:15 pm Maintaining Data Privacy to Stay Ahead of Regulations and Ensure Worldwide Compliance
- 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

James Schneider
Director of Global Compliance Operations and Data Privacy, Seattle Genetics
2:45 pm Personalized Medicine - Current Status and Impact on CROs
- Personalized / Precision Medicine – Hype, Hope and Reality
- Clinical Trial Experience – Strategic and Operational Issues
- Lessons learned and summary conclusions

Ramani Aiyer
Senior Vice President, TheraBiologics
3:15 pm Close of Conference
SPONSORSHIP OPPORTUNITIES
To enquire about sponsorship opportunities for the conference, please contact:
Paul Adams
Healthcare Director
E-mail: PaulAdams@arena-international.com
CONFERENCE ENQUIRIES
To enquire about the program, speaker opportunities for the conference, please contact:
Chloe Roberts
Portfolio Manager, Clinical Trial Events
E: Chloe.Roberts@arena-international.com
T: +44 0207 936 6822