Wednesday, March 7, 2012

#PCTUS 2012: Innovation in Clinical Trials

Day 2 of Partnerships in Clinical Trials kicked off with a focus on innovation and how the Pharma industry can look to the future with success.

Changing Your Game—How Clinical executives Can Succeed by Increasing Global Competitiveness and Driving revenue with Innovation

Innovate or die. If you don’t grow, you will die and lack of innovation will contribute. Everyone in an organization needs to be a part of an innovation team. It builds organizational muscles and opens the mind. Make change friendly, it’s a good thing for innovators. Innovation is beyond the prototype – reach out and find new markets. Invention and innovation are two different things. Invention is creating an idea. Innovation is converting an idea into life.

What are a few things to help you evaluate the value of an innovative idea? Will it lead to more revenue, give you a competitive advantage, bring you into a new game, and does it give your customers a better brand appreciation? Innovation is the social process from the time you select an idea to the delivery. If you can figure out the “secret sauce”, you can then institutionalize that idea. What are the tools that are used and can be modified so that they can be institutionalized? In innovation, focusing is critical.

Capacity of the organization to handle more than four products well is nearly impossible. Charan encourages companies to focuses on a few core competences, and observe the differentiation when they’re successful. Integrators to build these things in your company, often diverse disciplines, are able to integrate new ideas into companies.

Focus and integration are two pivotal steps to bring innovation to the. Building trust in human beings come from frequency of practice. Each of us is responsible for our own grown, and innovation is the key to this. If individuals learn by doing, you’ll build a string of innovations.

The government is driving the game change in the financial industry. Look at the phenomenon from a different angle.

Industry Sit Down: Aligning to Innovate—Sponsors & CROs Partnering to Significantly Improve Success Rates for Clinical Trials
Moderator: Ram Charan, Author, GAME CHANGER
Rene Sluijter, Global head Outsourcing, ABBOTT LABORATORIRS
Daniel Perlman, Chairman and CEO, RPS
William Sharbaugh, Chief Operating Officer, PPD, Inc.
Meryl Wiernik , Senior Director Strategic Outsourcing, TEVA 

There are no techniques to properly integrate a CRO in to the Sponsor. This is the place the integrator comes in. Once they’re integrated and incorporated, nothing can replace their success. Bill Sharbaugh at PPD is a big Pharma guy but moved to CROs. There are two solutions to confront the problem of innovation: Scientific innovation and business model innovation. The lines of innovation, both scientific and business, are now being blurred as opposed to CROs and business innovation and Pharma with scientific innovation.

We need to open our minds to find the new ideas. Meryl Wiernik of Teva points out that growth through acquisition is how TEVA has grown over the past few years. As a company, they want to globally standardize. It is about building communications and relations through suppliers and innovation together. The power of simultaneous dialogues throughout different stakeholders in the organization is key.

Why is it taking so long for Pharma/Life Sciences that many countries in other industries learned 20 years ago. Dan Perlman of RPS believes the number one problem is too much money. Pharma would give money to any project, but other industries have always been financially controlled. Also, the outsourced vendors, who are coming from an overflow, therefore there was no forced innovation. It was all heading towards a patent cliff, creating panic. This will lead to better models and efficiency. Sharbaugh believes Pharma has realized they need the right kind of leadership and Pharma, and they’re experimenting to do this. GMs are moving into scientific organizations to solve this problem. Scientific professionals should be moving into learn a little about commercial leadership.

Most companies that are integrating don’t spend enough time discussing and identifying cultural differences and how to merge them. Individual companies have capacity for innovation depending on their culture. Leadership drives innovation. The best partnerships come through cultural alignment. Seek advice from others who have outsourced. Be laser focused on what separates you from everyone else. Bring data driven examples of where you can excel to stand out in the eyes of Pharma. With an RFP, sponsors and CROs should do the research. The vendor’s structures should show how they meet the cost and the deliverables.

Point, Counterpoint: The R&D Path Going Forward: How do we Re-Invigorate Drug Research?
John Lamatina, Former President of R&D, PFIZER INC
Kenneth Somberg, Chief Medical Officer, Covance 

The clinical trial industry is facing extinction and fast because of the money. The money is being wasted. If this industry can’t conduct clinical trials, it will soon be extinct. The system is broken – including sponsors and CROS, but much broader including legislators and society. The fact that drugs are approved the way they are is questionable – after a trial one size fits all.

Is the industry doing enough to change the system? There’s quite a bit of inertia in the system. Change happens only under duress. That’s not enough. A different vision has to be articulated. Some companies have that leadership, but many are not. No matter how many biomarkers, long-term monitoring is needed. Companies with limited budgets should take shots at the big players. Sablinski believes clinical trials cost too much per patient. In order for CROs to thrive, they need to figure out the best way they can do that. A lot of money is spent identifying patient – but with an electronic system, this could change. If we accept that clinical research is unaffordable, someone’s revenue line is going get hit, and no one wants that is to happen. The cost pressures being put upon the industry in Europe will eventually travel to the US as well. The industry needs to soul search and reconcile the fact that innovation is disruptive and maybe the Pharma industry needs to destruct itself.

How realistic it t for drug development to change in light of the FDA? The FDA is a great excuse for intellectual laziness. The FDA is a great excuse for intellectual laziness. It’s easier to sit and say “I can’t do it” with someone to lay the blame on. One panelist believes they are encouraging innovation. Today’s FDA is willing to embrace change.

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