Monday, January 25, 2010

DDP 2010: DDP Event Kickoff Panel Discussion in Grand Ballroom: Enabling Drug Delivery technologies: Improving Current Therapies

Moderator: Lee Shorter, Director, Biophysical Sensors and Nanomaterials, GSK Pharmaceuticals
Robert A. Baughman, PharmD, PhD, Vice President, Experimental Pharmacology, Mannkind Corporation
Randolph M. Johnson, PhD,Vice President and Chief of Technology Development, Molecular and Integrative Pharmacology, KAI Pharmaceuticals, Inc.
Timothy S. Nelson, President and CEO, MAP Pharmaceuticals
Riccardo Panicucci, PhD, Global Head of Chemical and Pharmaceutical Profiling, Novartis Institutes for BioMedical Research Inc.
Eric Tomlinson PhD, DSC, President and Chief Executive Officer, Altea Therapeutics Corporation
Mary Gardner, Director, Technology Assessment, Hospira, Inc.

As we move through 2010, what will be the effect of the US healthcare plan? There will be an increased and continued financial pressure on emerging biotech and drug delivery. Mergers and acquisitions will continue. Two companies that were major players just last year are no more. There will be a continued pressure of Pharma on the stock market.

The Panel discussion is now open. The first question they’re addressing is: What are some of the key developments from drug deliverers in technology platforms?
Rick: In the future, we’re not going to be able to rely on innovative molecules. Molecular innovations need to be coupled with innovative delivery technologies. It would be great for a platform to fit in as many of the platforms as possible.

Randy: What’s important form a small biotech’s perspective is the new opportunity for growth and differentiation. The convergence of new technologies with more new chemical entities can lead to success in the future. There is pricing restrictions and pressure on the Pharma industry, but the blockbuster could still come with new technologies coupled with chemical entities. If we have a enw drug delivery company, maybe they’ll go after a drug that’s already proven. There is a double risk when tehse two things are combined. The regulatory pathway may be a little different, but the merging of technologies could bring new blockbuster drug products to the market.

What is the current value for paring current molecules with new delivery methods?
Novartis: Just coming up with blockbusters is not a model going forward. They’re looking at patient-centric ways to move forward. They’re going to look at every good opportunity to find something new to get it into their pipeline across their network. They haven’t always thought this way. They need to have a few game changers that will change up the way they do business, and at the same time, they’re working on many exciting things that will change the way they do business.

How does a company address reimbursement issues for more costly technology?
-It has to be attached to patient outcomes. It has to cost less to treat patients effectively. We can better plan clinical trials, so overall, there is a benefit. And Pharma can subsequently getting reimbursed for those things.

Mary: It comes down to a cost/benefit analysis.

What are some of the new opportunities to the developer once one has already successfully transferred a drug to a new delivery platform?
-That drug delivery can be enabled. You can develop the product, it’s highly differentiated, the delivery system a higher degree of compliance, you can grow the market and the clinical use of the drug. There is an opportunity for price premium if there is a benefit.

What is the best time to partner on a new technology? When do you need to go to big Pharma?
Novartis wants to be part of the development process. For good technologies, they want to make sure they’ll get to the finish line together. Some in Pharma believe that can’t do that anymore, but, they are trying to be more like a biotech company. Their future depends on it. At Novartis, they believe that the earlier the better. It’s on a one by one basis, but if there is an opportunity, Novartis will work on making it a technology.

How can we show insulin you show inhaled insulin taken for a lifetime is safe without a clinical trial that takes a life time without a clinical trial that takes a lifetime?
You cannot demonstrate lifetime safety until you’ve had a lifetime. But there are techniques and probability that can change this. Your pulmonary system is constantly fighting off other systems, such as smoking and smog. If someone said that an effective lifetime use of inhaled insulin, we must do everything we can and use all appropriate models, and do a study for the safety of the product. We look at small segments to determine the safety. There is no guarantee, but use all available processes to make the assessment.

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