Apps and Clinical Trials?

In this electronic era it is just assumed that there are apps to assist with and to help improve the implementation and maintenance of clinical trials, to connect patients with a clinical trial, to connect the patient with the physician, to help physicians in finding the right clinical trial for their patient, to plan, forecast, as well as track patient enrollment in a clinical trial. Of course, there are apps that will do most of the aforementioned. As I am sure you are aware, there is an app for your iPhone, iPad, blackberry, and other mobile devices. Check out these articles. http://alturl.com/64z7j and  http://alturl.com\4tt3y. If you have not already done so,  you can  also find information on the U.S. National Library of Medicine website http://www.nlm.gov/mobile/. With regard to clinical trial management platforms such as Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and Microsoft SharePoint just to name a few, they have been around for years and are in need of redesign to address the functional gaps that exist.

As we work through this explosion of electronic information/aides, industry is looking for guidance from the Food and Drug Administration. However, there is not a guideline with regard to the management of clinical trials on mobile devices but hopefully FDA will be forward thinking and put something in place soon. There is a guidance that was proposed last year with regard to consumers and health information, the guidance can be found at http://alturl.com/ynjdf. In my opinion, the FDA should employ an expert who can focus solely on mobile device apps for the Life Science space specifically, the management of clinical trials, perhaps, they have a person(s) but I could not find such an expert on their staff.

The future of Healthcare is an open agenda ready for us to fill in the blanks. See an article in the Wall Street Journal titled A Doctor in your Pocket http://alturl.com/whruy. The Healthcare Industry is certainly taking the lead with regard to utilizing the latest technology; see reports in Technology Review magazine published by MIT. http://alturl.com/6s68p and  http://alturl.com/gdxcc

The Biotech/Pharmaceutical industry is trying to contain the rising cost of drug development; in my opinion, it would be quite impressive if industry could be innovative enough to propose a unique process particularly with regard to early stage clinical drug development that would dare all of industry to be different but of course,  insuring that CDER & CBER mission is not in conflict.

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Drug Development in 2012

In 2011 the primary focus with regard to drug development was the rising cost of drug development, increased development & sale of generic drugs, and drug patent expiration. “In Fiscal Year 2011 the FDA approved 35 drugs that offered important advances in treatment for hepatitis C, late-stage prostate cancer, lupus, drug resistant skin infections, pneumonia, and other serious and life-threatening diseases”. Go to http://www.fda.gov to obtain a complete list of 2011 drug approvals. In 2012 it will be great if the FDA can surpass the number of drug approvals that occurred in 2011. With regard to issues in the drug development space that perhaps were a threat in 2011, will remain a threat in 2012. However, I would like to add the need for greater innovation which will be a positive for drug development. Specifically, the need to have an innovation process in place/implemented at Biotechnology/Pharma companies including a dedicated budget. And of course,  top management’s ability to encourage innovation by their employees will be need to be successful. Check out an article in Forbes magazine titled “Innovation Resolutions 2012” http://alturl.com\yskhu. Forbes magazine also identified the best large Pharmaceutical companies of 2011 with regard to their top share price but it would be great if these Pharmaceutical companies were also recognized for their innovative practices; see Forbes article http://alturl.com/kv588. In addition, for the small biotech companies that are in the clinical space perhaps, we could tie innovation to the amount of financial backing that they receive from Venture Capitalists.  In my opinion, if we take this approach we may be able to better address the need for an innovative approach to drug development

  In an effort to keep the cost of drug development down  we saw partnerships with Contract Research Organizations (CRO) and Big Pharma. Will we see more partnerships between Pharmaceutical companies? See article in Fierce Biotech http://alturl.com/mzdzy. I think there will be increased collaboration between academia and industry, as well as, an increase in conducting basic research by academia in 2012. In my opinion, innovation will be an important part of development, we recognize that we cannot continue to develop drugs the way we have been doing so and contain costs. Will AstraZeneca’s misfortune force a change in the current drug development process? See the article in Business week. http://alturl.com/rqoii.

 The mission of FDA’s Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in this country are safe and effective. The current drug development and drug approval process can be found on the FDA website http://fda.com. In my opinion a change in the way drugs are developed will not affect CDER’s mission.

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