The Lilly COI API and TrialReach: A Story of Innovation 19

tomThe following blog post is by Tom Krohn. Tom is the Chief Development Officer for TrialReach and is responsible for business development including clinical trial sponsor relationships, patient advocacy groups and research institutions. He has 25 years of experience across different sectors in health including large pharma, hospital & retail pharmacy, and the developing world. Most recently, Tom led the Clinical Open Innovation team at Eli Lilly with a focus on patient engagement, open data and business transformation. Tom is passionate about serving patients from their point-of-view while building sustainable and highly effective organizations.

Everyone Has a Story

Everyone has a story.  You.  Me.  Innovation.

About four years ago, a small group of Lilly employees started work on open innovation with a focus on improving public information to accelerate medical innovation. Barry Crist and I wrote a whitepaper that outlined a vision for clinical knowledge generation becoming participatory for all in the clinical research ecosystem, especially patients.  Participatory—that is the essence of an open network. It is at the core of open innovation.

With executive sponsorship and a case for action, we took these ideas and developed an open API which launched in 2012. We put Creative Commons copyleft licensing on the API to remove the friction that is the norm of the life-science industry. Then, open innovation happened.

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Patient and Caregiver Insights Are Key to Improving Adherence 4

Lilly employee Coleman Gerstner presents a concept for improving adherence at the Adherence Summit.

Lilly employee Coleman Gerstner presents a concept for improving adherence at the Adherence Summit.

 

Savin Pic a 8-2-13The following post is by Ken Savin, Advisor, Clinical Innovation at Eli Lilly and Company. Ken received his Ph.D. from the University of Utah in 1996 and came to Lilly in 1998 from the Memorial Sloan Kettering Cancer Research Center as a senior organic chemist. He worked on several projects as a medicinal chemist in the areas of anxiety, depression and inflammatory disorders, and he has been involved in many cross-functional Lilly research collaborations. Some of Ken’s recent efforts include the NASA – Lilly collaboration, an outgrowth of the InnoCentive program and a recent Innovation Day event. Through these programs, he continues to reach out to other organizations internally and externally as part of a broader open innovation effort.

Every day we see some evidence that the culture of medicine is changing. Paternalistic approaches to providing healthcare are becoming less and less acceptable as patients have begun to make good use of the medical information and community support networks available on the Internet. If we, as drug developers, want to provide the best possible care and the best possible medicines, it just makes good sense for us to listen to people and carefully consider what works best from their standpoint.

Adherence, the idea of whether or not a patient is following a treatment regimen as directed, is one of many complex issues within drug development for which we could use more insights from patients and caregivers. It has been estimated that three out of four Americans do not take their medications as prescribed. Even in clinical trials, where adherence rates tend to be relatively high, investigators report average adherence rates of only 43 to 78 percent among patients receiving treatment for chronic conditions. This can lead to poor health outcomes for patients, and unreliable results in a clinical trial.

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A Win-Win Situation: Lilly and Clinical Research Site Professionals Explore Innovation 5

NSheetzThe following post is by Nicole Sheetz, Advisor of Clinical Development Innovation and Innovation Adoption at Eli Lilly and Company. Nicole is a 15-year pharmaceutical industry professional with broad clinical development experience.  She has held leadership positions in clinical project management, data sciences, scientific communications, data disclosure, clinical operations, and competitor intelligence.  Nicole currently leads clinical development innovation programs that span various functions, and she is specifically responsible for implementation of innovation projects that are ready for global production and scale-up at Lilly.

 

I’ve been working in and around clinical trials for most of my career, and I’ve learned that all voices – the patient, the site, and the sponsor – are vital when trying to improve how we conduct research.

Patients’ views are invaluable, as they help us to understand what makes participation in trials important and feasible for them. Clinical research site professionals (investigators, site directors, study coordinators, and pharmacists) are also critical, and they play a very important role in shaping the patients’ clinical trial experience. They serve as the primary bridge between the sponsor’s goals for a trial, the healthcare provider’s care for the patient, and the patient’s needs and wishes. As a result, site professionals are able to share plenty of great insights based on their day-to-day experiences interacting with patients and conducting trials.

I work on Lilly’s Clinical Development Innovation team, and we are focused on reducing the amount of time it takes to bring innovative medicines to patients while maintaining the highest standards of patient safety, ethical practice, and data quality. We know that we cannot reach this goal alone; we need input from the people involved in all facets of the clinical trial process in order to understand what we can improve upon and how. Hearing feedback and suggestions for improvement from site professionals who are “on the ground” every day will surely help us to develop the kinds of solutions that will make a real difference for patients and for the entire clinical development process.

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NASA Visits Lilly for Innovation Day 1

Savin Pic a 8-2-13

The following post is by Ken Savin, Advisor to Special Projects and Innovation Small Molecule Design and Development at Eli Lilly and Company. Ken received his Ph.D. from the University of Utah in 1996 and came to Lilly in 1998 from the Memorial Sloan Kettering Cancer Research Center as a senior organic chemist. He worked on several projects as a medicinal chemist in the areas of anxiety, depression and inflammatory disorders, and he has been involved in many cross-functional Lilly research collaborations. Ken is currently in the Small Molecule Design and Development organization working on special projects around technology and innovation. The latest efforts he has engaged in include the NASA – Lilly collaboration, an outgrowth of the InnoCentive program and a recent Innovation Day event. Through these programs, he continues to reach out to other organizations internally and externally as part of a broader open innovation effort.

It’s been understood for quite some time that drug development has become too costly and too uncertain. It takes too long and doesn’t meet the needs of patients well enough. Traditional models of innovation—where managers are responsible for coming up with ideas and employees carry out those programs—are not sustainable. It doesn’t allow us to take advantage of the wide breadth of knowledge and talent that scientists, patients and citizens both inside and outside of Lilly possess. That’s why Lilly is working to uncover more opportunities for innovation through initiatives like Innovation Day (I-Day).

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