#DDPEvent 2012: A morning of change, personal medicine and regulation

To kick off DDP 2012, Chairperson,Lee Shorter, Director, GlaxoSmithKline, looked at a few things that are going to impact the Drug Delivery World in the next few years:

The industry, in light of new challenges, are looking into new therapeutic areas that make financial sense, such as cancer. Biologics are the future, as well as the human genome. Big Pharma is looking at new delivery systems for emerging markets. Drug delivery technologies need to add value when they are to be used by the patients and insurances.

Adapt to the New Rules for Profitability— The New Role of Drug Delivery in the Changing Drug Development Paradigm
John Baldoni, GlaxoSmithKline

Baldoni believes knowledge is becoming more and more of a commodity, and it will be transformational in human health. Electrons will be a key part in the future of medicine. What are the key healthcare stakeholders? The six key groups who have interest in healthcare are patients, physicians, payers, pharma, politicians, and policy makers. In order to make their best investments possible, they are differing investment until the last possible moment in order to make the best decisions.  GSK won’t invest with anyone unless they have presented their proof of the hypothesis, thus only investing in highly probable ventures.

Why is Pharma a key part to the world? Baldoni believes that the professionals take ideas that their employees have and translate them into meaningful medicines that help people feel better and live longer. The focus is on the better life of the human.

At GSK, to reinforce this, they have a patient visit each month to share about their disease. The patients that come bring their inspiring stories to those who are developing the drugs to make those lives better. Some of the best developments through this industry has been to the in targeting the lung, liver, absorption of medicine into in the gut and more. Better molecules are entering the pipeline and that will directly impact drug delivery partnerships. Where are the proteins that you see in a disease eliminated by the drug? This is one of the ways these better molecules are being developed for the drug delivery process. The capitalization cost is hindering drug development – is there an opportunity for drug companies to work together to share these?

Will it Help or Hurt? The Impact of Healthcare Reform on Drug Delivery Innovation, Reimbursement, and Patient Compliance
Mark McClellan, Engelberg Center for Healthcare Reform, Brookings Institute, Centers for Medicare and Medicaid Services

The healthcare world is anxiously awaiting the the decision from the Supreme Court as to whether or not the ACA is legal. McClellan believes that some of the Act will be overturned, but not the whole thing. No matter the individual mandate to buy healthcare insurance will be delayed or repealed entirely. A lot of the other aspects are directly impacted by the 2012 Election. Since it is unpopular, Congress will delay the implementation. McClellan believes that this whole process will take longer and won’t be implemented on schedule in 2014. What won’t change? The insurance market will change, and those with chronic conditions will be covered. Republicans can’t repeal the whole law should they win the 2012 Election. The challenge is how to figure out how to cover more and more people who aren’t covered by insurance.

Rising healthcare costs that are coupled with a lot of rules to restrict spending means it will be very difficult to find a way balance the budget.
 As for FDA Drug Approvals, they are up. This includes more personalized treatments. The process of developing new treatments is very long and uncertain. So success rates are still running around 11-13% for approval. Pharma is moving towards targeting therapies and innovative develop methods require new ways for the FDA to approve them.

Quick approval methods currently from the FDA: Fast track, Priority review, Accelerated approval. There were 8 drugs over the past few years approved this way. It’s hard to set up post approval success measures to get the drugs approved as well.

In the future, McClellan believes that there will be an evidentiary standard (Progressive approval), Targeting , better regulatory guidance and premarket development science

McClellan believes that personalized medicine will have a huge impact on health care in the future, but only if the reimbursement structure is changed from its current structure.