Final Keynotes #SCOPE2014

Previously Posted Re-caps

Day 1, February 4th, 2014
Day 2, AM sessions
Day 2, Part 2

Final Day of SCOPE: Thursday, February 6th, 2014

AM Keynote: Innovation

During the plenary keynotes at SCOPE I learned that “current public image ratings of pharma are worse than those of the tobacco industry.” Ouch. Andy Lee of Genzyme stepped us through a recap of the obstacles we face now in drug development, many of which were topics at the Summit for Clinical Operations Executives (SCOPE) conference this week. Among the challenges:

  • Rising costs of development of new drugs ($5-10 billion; $6m-13m per new drug on average)
  • Anemic product pipelines
  • Integration of disparate systems
  • Big Data: What will we do with all the operational and patient data (and the complexity it adds…possibly unnecessary noise)
  • Need for more collaboration and transparency

I cannot begin to capture all of his comments on innovation in this space; his team has been studying and publishing (see Jackie Fenn paper) on the topic much more intently so I’ll keep it brief.

The summary point I jotted down is this: “Innovation is really just restoring a process that we broke. It is an iterative cycle of continuous improvement.” I agree completely and I have a lot more to say in my newsletter about my personal experiences in over-complicating process by adding in all the flashiest tools so please sign up for the ClinOps Toolkit newsletter if you have not already. I’ll be covering this concept a few times in the 2014 editorial calendar and offline.

Forte accepts an award for Best Practices

Forte accepts an award for Best Practices

Clinical Informatics News Best Practice Awards

Allison from Clinical Informatics presented the first annual Best Practice Awards. Submissions were review by 7 judges and Clinical Informatics News editorial staff. Awards were given to Mytrus (ICF Collection as innovation in study start-up and design), Clinical Inc. (managing patient data via eSource for a tuberculosis trial), and Forte (Research Resonance Network). Read more in the Clinical Informatics News Press Release.

Pre-Competitive Processes: Transcelerate Update

Jackie Kent of Eli Lilly provided an update on Transcelerate initiatives to date and future directions. Transcelerate’s mission is to improve health by accelerating and simplifying drug development. There are now 14 companies that have joined the original 10 to collaborate with regulators and cooperate with one another to innovate. To join Transcelerate, a company makes a financial and resourcing commitment annually to the initiatives. Core tenants include transparency openness, quality, trust, courage, and collaboration.

In 2013, the group focused as follows:

  1. clinical data standards progress
  2. instituted a voluntary comparator drugs program to allow central-sourcing
  3. produced a risk-based monitoring whitepaper (that Lilly has implemented within their organization)
  4. formally recognize GCP training of other companies/orgs by agreeing to minimum key criteria
  5. work on a collaboration platform

Projects in 2014 will include development of common protocol template(s), an investigator registry (to keep contact info & training info), and the creation of a special populations trial participant registry (pediatrics, rare disease, etc.).

Craig Lipset Leads the Panel

Conference themes included: site activation & startup planning, using real-time data during study conduct and adapting trial operations, increasing transparency in clinical finance, leveraging big data for post-marketing trials, and logistics and precision medicine to better define sub-populations for clinical trials. Craig Lipset of Pfizer said we can’t continue to “turn the Lipitor crank from 7 years ago” pointing out the new investments in pipeline-generating collaborations and partnerships.

The panel included Craig, Jackie Kent, and Andy Lee. They kicked it off with the question “Must innovation be sexy?”. Clinical data standards are about as boring as it can get, but they represent a major deliverable of Transcelerate in 2013. Craig Lipset admitted (with perfect comedic-timing) that he loves data standards and is “glad other people make them.”

Andy spoke next about prioritizing initiatives and resourcing projects. Selecting and funding “innovation” can be done through crowd-sourcing and committee, but it is better to focus on ideas that are truly transformative. Revising business processes should create value and not just represent re-work, alternative tracking activities, or new inefficiencies. Each new project must be evaluated for ROI so that companies can put “muscle behind the best few.”  Putting only the best ideas forward truly requires discipline and Craig Lipset advised, “turn your critic into your project champion.”

Jackie spoke about success of new initiatives and cautioned to “align resources around the correct milestones”. Andy added that pharmaceutical companies must find a way to “measure health, not [just] data.”

Peter Ducker of UCB commented at the end of the talk that the site perspective cannot continue to be overlooked and he applauded the Transcelerate member companies for including SCRS as a member in the initiative.  At least one cynic in the audience challenged whether industry competitors would truly be able to invest together in driving quality and sustainability. One commenter suggested that if there were more supported clinical investigative sites in the future that could meet the trial needs, then basic site lists would no longer be considered competitive intelligence. If that were true now, I might not have spent nearly three full days on the Site Feasibility track.

In the next post I will summarize more take-aways from the final day of the conference.  Thank you for following along in the series and please provide your email in the sidebar to subscribe and be kept informed of new posts (at a current frequency of no more than twice per month).

More SCOPE summaries

Day 1 of SCOPE conference
Day 2, Part I
Day 2, Part II
Day 3, Final Sessions

About The Author

Nadia

Nadia Bracken, lead contributor to the Lead CRA blog and the ClinOps Toolkit blog, is a Clinical Program Manager in the San Francisco Bay Area.