Tuesday, March 6, 2012

#PCT 2012: How can understanding genomes and sponsor/CRO relationships make for a better industry?

Disruptive Drug Development: Driving the Necessary Innovation and Change to Pioneer the Next Frontier
J. Craig Venter, Founder, Chairman, and President, J. CRAIG VENTER INSTITUTE; Founder and CEO, SYNTHETIC GENOMICS INC

Technology is changing rapidly, last year celebrating the 10th Anniversary of the human genome. Technology has changed; it’s getting simpler, faster and cheaper. Sequencing clinically will change significantly. These machines generate so much data; it’s faster and cheaper to send data via FedEx rather than over optical wires. There is much more genetic diversity within Africa than Africa versus other parts of the world. We have 22-23 million genes. How do all these affect human health?

Stem cells can be a means to studying diagnostic features. Where do mutations develop and why do they develop? Can we understand changes and prevent them, if not, can we repair them. Can we make genetic corrections based on isolated cell lines?

We can now write the genetic code. The implications for science and medicine are now able to be observed.

Industry Sit Down: Seismic Shifts in Clinical Development—The Move Towards Tailored Therapeutics and Personalized Medicine
Moderator: Bernard Munos, Chief Apostle, Breakthrough Innovation, INNOTHINK CENTER FOR RESEARCH IN BIOMEDICAL INNOVATION
Peter Mueller, PhD, CSO & Executive Vice President, Global Research & Development, VERTEX PHARMACEUTICALS
Felix Frueh, PhD, President, Medco Research Institute, MEDCO HEALTH SOLUTIONS, INC.
J. Craig Venter, Founder, Chairman, and President, J. CRAIG VENTER INSTITUTE; Founder and CEO, SYNTHETIC GENOMICS INC.

Venter: There’s a big gap of time between the science breakthrough and it’s permeation into the clinical market. With genetics in clinical trials, it’s not likely to happen anytime soon.

Mueller: We have the beginning of the new field beyond genomes. It’s the translation of the genome into the phenotypically situation. He points to cystic fibrosis as an example with 1800 mutations. You know the information, but it’s hard to start immediately. What does the genomic information in this setting? In cystic fibrosis, it’s beyond the lungs; it affects the whole body system.

Ventor: How can you address these inefficiencies? There’s no substitute to understand the mechanisms of the diseases themselves. When starting to sequence the genome, the effort to find the gene was a 1-2 decade process. At that process, it would have taken 2-3 centuries to use this information. But data process has now changed and it’s quicker. The whole basis of research has changed. Most diseases have multiple genetic outputs. Understanding the fundamentals and complexity from understanding the whole genotype will lead to truly solving the problem. A disease is not a one drug approach. It’s important to bring everyone together to understand the impact of all systems. Research must be done in a different way & bring clinicians in up front to identify not just one biomarker but a set of biomarkers. If it’s done right, the research is translated from the lab into the clinic.

Frueh: The question is once you have this information, how can you get information for payers to understand the evidence. There is a dynamic in the payer community. The ones that say “No” to development are the ones that have formulary decisions and a finite budget over time. They’re working with the payers to find where the opportunities are over time, and looking for alternative options. How much can we pay for drugs that cost $10,000+ a year? So we should look at how much we can pay as a society before it breaks down.

Strategies to Overcome Internal resistance to Change: Tools to Beat Organizational Challenges when Moving to New Outsourcing Models
Frances Grote, Senior Director, Clinical Outsourcing, MILLENNIUM
Kimberly Glen, Vice President, Strategic Programs, ICON CLINICAL RESEARCH
Rhonda Henry, Executive Director, PPD, INC
Michael Massaro, Global Operations Head, Quintiles

In this session, Millennium came together with their CROs to discuss how to optimize their relationships and create the most productive work environment for all involved.  Here are a few of the key ideas to come out of the session:

Rhonda Henry, PPD: Managing the budget is a very challenging part of research. Ops minded individuals are not trained to think financially, but they must be worked with so that they understand. It’s important to talk with the team constantly to communicate changes and accommodations to work with that.

Michael Massaro, Quintiles: Through continuing dialogue with the CRO, constant communication is important. Continuing dialogue is a great strategy to overcome the resistance to change.

Kimberly Glen, ICON Clinical Research: Set up expectations for the partnership at the beginning of conversations for projects. Lay the fundamental groundwork. Agree to the success factors upfront. At Icon, taking the information gained at the beginning, so that those in the field can be train, including  project managers.

Q: Need and ability to impact and be the voice for Millennium (Sponsor)?

Henry: She’s an agent of change for the relationship between the two companies. She’s the voice of PPD to Millennium and shares the expectations on both sides. They employees need to have a clear view of what they’re doing for Millennium.

Glen: Ensuring that things get done internally and work cross divisionally, working with these people to execute and ultimate success for the studies.

What is the best way to manage the success of the team?
- Train, train & Train, it’s unique at Millennium. New skills needed.
- What to measure. People love metrics, but often it’s jumbled. Find key indicators.
- Celebrate success. It’s much more motivating to do it this way.





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