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In clinical research, every detail matters. More than ever, sponsors need to remove uncertainty and risk from clinical research. Spotting trial risks before they become problems means you can bring clinical treatments to patients quickly — and with confidence.

 Join us for a morning where you will:

  • Navigate regulations to run faster, more efficient trials
  • Improve collaboration across a geographically and functionally dispersed team
  • Leverage technology for optimizing Fast-Track early phase and rare disease studies

Agenda


Thursday, September 7, 2017

7:30 AM

REGISTRATION & NETWORKING

8:00 AM

WELCOME & INTRODUCTIONS

Make valuable new connections with other attendees.

Moderator:
Kristina Lowe, Vice President, Portfolio Sales West, ERT

8:15 AM

OPTIMIZING YOUR REGULATORY STRATEGY

Regulators are changing the landscape to drive faster more efficient drug development. This session will review strategies sponsors can take earlier in development to expedite development timelines, reduce cost, and make assets more attractive for partnering. 

Presenters:
Robert Kleiman, MD, Chief Medical Officer, ERT
Bruno Gagnon, Vice President, Development Operations, Eidos Therapeutics

8:45 AM

BEST PRACTICE APPROACHES TO CLINICAL TRIAL DATA COLLECTION

With regulations tightening, budgets closely managed and funding requirements become more stringent than ever, it’s critical that your trial is positioned for success from day 1.  Despite even the best planning, issues are bound to arise.  Learn the pros and cons of various data collection, safety & efficacy, patient engagement and trial management approaches that will help you proactively mitigate risk, collect higher quality data and enable better-informed decisions throughout the clinical development process.  This session will directly address the benefits of capturing clinical data digitally.

Presenters:
Brion Regan, Product Manager, ERT
Kelly Barnes, Data Integrity Manager, Genentech

9:30 AM

BREAK

9:45 AM

LEVERAGING TECHNOLOGY FOR FAST-TRACK EARLY PHASE & RARE DISEASE STUDIES

Global regulators enable sponsors to accelerate rare disease therapies with Fast-Track considerations, but don’t provide guidance on how to modify study designs to accommodate progressive disease states, rater changes, and other special considerations.  ERT experts will review current literature, highlight global regulations and ISPOR recommendations, and educate attendees on the parameters for using PRO/eCOA in fast track and rare disease studies.

Presenter:
Nadeeka Dias, PhD, Clinical Science Advisor, ERT

10:15 AM

IMPROVING COLLABORATION AND EFFICIENCIES

It takes a village to successfully execute a trial, with multiple vendors and partners involved in data collection and information management – and multiple opportunities for inefficiencies and errors along the way.  With so many players, data inputs and tracking systems in place, how can you truly optimize trial performance?  This presentation will share a real-world example of how sponsors and CROs are leveraging data, analytics and a cutting-edge CTMS to provide near real-time visibility into critical study trends, enable proactive operations, automate repetitive manual tasks across trials, and provide better visibility and collaboration across all trial stakeholders.

Presenters:

Helen Hall, Director, Biometrics, Accelovance

Christine Kanalis, Relationship Manager, ERT


10:45 AM

GROUP DISCUSSION & WRAP UP

We’ll summarize key takeaways of the day, review implications for early stage firms and wrap up the day’s proceedings.


11:30 AM

DEPARTURES/OPTIONAL LUNCH

REGISTRATION


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Location


Marriott San Francisco Airport Waterfront

1800 Old Bayshore Highway

Burlingame, CA 94010

United States

http://www.marriott.com/


                                

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