Cambridge Healthtech Institute’s 6th Annual

Improving Site-Study Activation and Performance

Strategically Implementing Process and Systems for Rapid Study Start-Up and Improved Site-CRO-Sponsor Interactions

February 20-21, 2019

 

Clinical trial site activation and efficient study start-up are critical to drug development programs, in terms of time, cost and quality of data. To improve start-up times and outcomes, one needs an experienced clinical research investigator, motivated and capable team members and efficient communication by all. Everyone (Sponsor, CRO, Site) must communicate and execute effectively in order to improve: the study feasibility process, contract and budget negotiations, standardization of source documents and other study-related materials, development of patient and staff educational materials, and development of patient recruitment and retention programs. CHI’s 6th Annual “Improving Site-Study Activation and Performance” will cover the topics one should consider when strategically implementing a process for rapid study start-up.

Final Agenda

Arrive early and attend Part 1 (Tues-Wed): Protocol Development, Global Site Selection, Feasibility and Site Management

Wednesday, February 20

11:30 am Registration Open

12:30 pm BRIDGING LUNCHEON PRESENTATION: Metrics, Standards & Technology: How to Harness Digital to Transform Protocol Creation

Bob Brindle, Venture Leader, Life Sciences, Cognizant

How much effort do you waste during clinical trial protocol creation? How do you know? How do you fix it? In this increasingly digital world, it’s frustrating to be constrained by traditional word processing tools, but making the shift to a digital process can be daunting. Join this session to discover the practical steps that will set you up to transform your process – and get a peek at what a digital protocol will enable.

1:10 Coffee and Dessert Break in the Exhibit Hall

2:10 Plenary Keynotes

3:20 Booth Crawl & Refreshment Break in the Exhibit Hall, Last Chance for Exhibit Viewing

UNDERSTANDING THE LATEST CHALLENGES FOR STUDY START-UP AND SITE ACTIVATION IN US, EU AND ROW

4:05 Chairperson’s Remarks

John Makowski, Head, Clinical Operations, Audentes Therapeutics

4:10 New EU-Clinical Trials Regulation: Industry Preparation via Pilot Procedures

Ruppert_ThorstenThorsten Ruppert, MD, Senior Manager, Research, Development and Innovation, Association of Research-Based Pharmaceutical Companies (vfa)

The Regulation (EU) No 536/2014 on clinical trials in medicinal products for human use (EU-CTR), which will apply from 2020, will fundamentally change the procedures for approving and evaluating applications for clinical trials in Europe – e.g. a purely electronic application via an EU portal or a joint assessment between EU-Member State with involvement of national-level authorities and ethics committees. In preparation for the approach introduced by the EU-CTR, different pilot phases have been started in Europe with the aim of fundamentally testing this new process. The presentation will describe the experience of industry and learnings made for the preparation for the new authorization system in Europe.

4:40 Study Start Up Practices and Cycle Times among Sponsors and CROs

Lamberti_MaryJoMary Jo Lamberti, PhD, Professor, Associate Director, Sponsored Research, Tufts CSDD

Tufts CSDD conducted a comprehensive survey among over 400 pharmaceutical and biotechnology companies and contract research organizations examining the processes of site identification, site selection and study start up. The survey examined site selection practices and decision-making, study start up timelines, and site feasibility, and also explored the implementation of specific tools and resources that impact cycle time, cost, and performance. Tufts also assessed those factors contributing to poor site selection; and improvements made to the site selection and start up processes. Key performance metrics (e.g. cycle time) were gathered for site selection, site identification and study start up activities, and comparisons were made between those companies using new vs. repeat sites, sponsors and CROs, and those companies with varying investment levels in technology.

Chung_Jae_SSUJae Chung, President & Founder, goBalto

Workflow-based technology coupled with executive authoritative power encourages process optimization in the clinical trial continuum, helping to break down silos, enhance operational performance and ensure quality in the electronic trial master file.


5:25 Accurate Patient Enrollment Forecasting Using EnForeSys®: Case Studies and Lessons Learned

Liu_CharlesCharles Liu, Senior Product Manager, Cytel


5:40 CASE STUDY: The Sites First Initiative: Understanding Patients and Site Relationships to Improve Trials

Rackley_MarisaMarisa Rackley, Director, Clinical Development Execution, Vertex Pharmaceuticals

This presentation will share Vertex’s site-focused initiatives and our journey to put sites first. How did the initiative start? What were the obstacles? In addition to describing the other parts of the initiative, the talk will focus on the installation of our new Regional Site Advocate group and share data from the sites on how this role has helped to bring value to the sites.

 

6:107:10 Networking Reception (Sponsorship Opportunity Available) or Close of Day

Thursday, February 21

7:15 am Registration Open

7:45 BREAKFAST PRESENTATION (Sponsorship Opportunity Available) or Morning Coffee

8:15 Session Break

IMPROVING START-UP TIMES: UNDERSTANDING SITE INVESTIGATORS’ EXPERIENCE, INFORMED CONSENT, PAYMENTS

8:20 Chairperson’s Remarks

Chairperson to be Announced

8:25 Re-Defining the Site Investigator Experience

Moneymaker_LisaLisa Moneymaker, CTMS Process Architect, Amgen

Imagine a world where Site Investigators could use a centralized point of access for all study-related tasks and study information, rather than many portals and platforms, to access studies with every Sponsor they work with. Imagine if Sponsors could quickly search for and download their latest study documents, and easily access a registry of Investigator profiles to assess feasibility for new studies. The Shared Investigator Platform (SIP) was launched with these goals in mind and continues to evolve with new functionality. This session will provide real-world observations and learnings from the SIP’s first major wave of adoption.

8:45 Site Management Approaches in Gene Therapy & Rare Disease Clinical Trials: A Collaborative Approach to be a Sponsor of Choice

Makowski_JohnJohn Makowski, Head, Clinical Operations, Audentes Therapeutics

There is significant complexity, sensitivity and timely logistics to most effectively execute gene therapy, rare disease clinical trials. The importance of a Clinical Operations organization to have a well-established collaborative approach with Investigators, Internal Medical Science Liaisons and Advocacy Groups is key to successful execution of these complex studies. The ability to simplify and innovate around a sponsor’s Site Management approaches can increase your ability to be a sponsor of choice in this competitive and exciting area of drug development. We will review several different approaches and strategies to consider to position a team for success in this space.

9:05 Transforming Informed Consent: Current Landscape and Tools to Enable the Future of eConsent

Smith_CassandraCassandra Smith, MBA, Associate Director, Investigator and Patient Engagement, Janssen

While the shift to digital technologies is pervasive across multiple industries, the informed consent process for clinical trials remains primarily paper-based. Further, the increasing complexity in clinical trial-informed consent language and longer paper consent forms are increasing the importance of efforts to enhance patient comprehension, which may in turn contribute to increased study compliance, and fewer withdrawals from a study. TransCelerate’s eConsent initiative stands to transform the informed consent process by using an array of patient-focused, multi-media components to improve understanding of a study and create process efficiencies for sites and sponsors. This session will share how the initiative has created the first cross-industry perspective, developed over a period of 2 years with input from over 14 global pharmaceutical companies.

9:25 CO-PRESENTATION: Improving Site-Study Activation and Study Timelines through Harmonizing Budgeting, Contracts, Data, and Payments

Karich_BillBill Karich, Strategic Business Operations, CSL Behring


Farmer_TrentonTrent Farmer, Contract Manager, Attorney, CSL Behring

Site activation timelines and site payments both remain key industry issues. Simplifying and streamlining processes provides benefits for both sites and sponsors. This session covers how approaching the budgeting and contracting phases with both data and payments in mind can improve site activation timelines while creating a better foundation for prompt, accurate, and timely site payments.

9:55 Presentation to be Announced

10:25 Networking Coffee Break (Sponsorship Opportunity Available)

BUILDING CAPABILITIES FOR IMPROVED SITE ACTIVATION AND CYCLE TIMES

11:10 Chairperson’s Remarks

Chairperson to be Announced

11:15 CASE STUDY: GSK’s Journey of Launching a Formal Study Start-Up Department

Crandall_ChristineChristine Crandall, Head of Strategic Clinical Planning, Study Start Up, R&D Projects Clinical Platforms & Sciences, GSK

In mid-2018, GSK established a Study Start Up Department bringing together core functions: Clinical Planning, Investigator Contracts & Benchmarking, Technology & Innovation and Study Start-up Leads. This Case Study will provide insight to our vision, capabilities and delivery methodology of providing subject matter expertise to enable quicker and more efficient study start-ups in a complex, global environment.

11:45 Transforming Study Start-Up: The Next Big Step

Davidson_AshleyAshley Davidson, Director, Vault Study Startup, Strategy, Veeva

Research shows that today’s clinical technology landscape is siloed, prompting an industrywide move to unify clinical trial systems and streamline end-to-end processes for better study execution. In a recent industry survey, 99% of respondents report the need to unify clinical applications, and 84% say their organizations are taking action to unify and streamline study start-up processes. In this, Ashley will share how organizations are transforming study start-up on a global basis.

12:15 pm Transition to Shared Sessions

OPTIMIZING SITE-CRO-SPONSOR INTERACTIONS: UNDERSTANDING PATIENTS, SITES, PROCESS & TECHNOLOGY TO IMPROVE TRIALS (SHARED SESSION)

Chairperson’s Remarks (continued from morning session)

Chairperson to be Announced

12:20 CASE STUDY: Topic to be Announced

Shelly Barnes, Patient Experience and Implementation Lead, UCB

This abstract will be posted soon.



12:50 INTERACTIVE PANEL: Moving from Technology Indigestion to Workable Solutions

Vulcano_DavidModerator: David Vulcano, MBA, Vice President, Research Compliance & Development, HCA


Abbott_StephanieStephanie Abbott, PharmD, Clinical Research Program Director, Western Washington Medical Group


Perera_JeewaJeewa Perera, CEO, Champ IT Solutions


Yanak_BrendaBrenda Yanak, Former Global Head, Specimen Strategy and Innovation, Q2 Solutions a Quintiles Quest Joint Venture; Former Precision Medicine Lead, Pfizer


Moyer_MattMatt Moyer, MBA, Director, Clinical Supply Technology, Merck

Multiple technologies are advancing healthcare delivery each and every day. This not only pertains to better utilizing both data at rest and data in motion, but also pertains to communication technologies breaking down the traditional boundaries of medicine. As clinical trial site operations are often dwarfed by the larger healthcare delivery ecosystem, how can pharma leverage that already-developing ecosystem so that they don’t have to recreate the wheel?

  • What technologies are out there right now that are underutilized by pharma in clinical trials?
  • What regulatory or operational issues need to be either “myth busted” or challenged to make this happen?

1:20 Transition to Lunch

1:25 LUNCHEON PRESENTATION (Sponsorship Opportunity Available)

1:55 Closing Remarks

2:00 SCOPE Summit 2019 Adjourns

Arrive early and attend Part 1 (Tues-Wed): Protocol Development, Global Site Selection, Feasibility and Site Management

Register!

“SCOPE Featured Author”
Emmanuel Fombu, MD,
Director, Digital Health Solutions
Novartis


Signature Sponsors

IQVIA

Medidata


Premier Sponsors

Appian
Axiom

BBK-Worldwide

Bioclinica_new

ClinicalInk

Covance

DrugDev

ERT
Mendel Health
Oracle-Health-Sciences

PRA Health Sciences 
Saama-Technologies

Syneos Health

UBC_new

Veeva