Comments on: Industry should consider combination http://blog.pharmtech.com/2010/02/18/industry-should-consider-combination/ The blog of Pharmaceutical Technology magazine Tue, 07 Feb 2012 17:25:13 -0500 http://wordpress.org/?v=2.8.4 hourly 1 By: Christian Ahlmark http://blog.pharmtech.com/2010/02/18/industry-should-consider-combination/comment-page-1/#comment-29053 Christian Ahlmark Mon, 22 Feb 2010 18:20:52 +0000 http://blog.pharmtech.com/?p=2493#comment-29053 Its not only medical devices, but also fixed dosage combination products that are on the rise. I recently attended a Combination Product Conference put on by CHI (Cambridge Healtech Institute), in which many expert speakers addressed the unique challenges of combination products. With dwindling pipelines, limited resources, & expiring patents, now, more that ever, combination products are being considered in drug development portfolios. However, regulatory hurdles, physician acceptance, and market strategy, are just a few considerations that one should think about before heading down the path. Here is a brief overview of the discussions, that will cover specifics regarding fixed dosage combinations (FDC’s), and will hopefully give your company a better understanding to the challenges ahead. http://www.corerxpharma.com/resources/white_papers.html In terms of the industry, revenues for combination products, as a whole, are expected to reach $11.4 billion by 2010ˡ. Further, some sources estimate that 30% of new products under development are combination products². With technology advances (nanotechnology, genomics, molecular diagnostics, tissue engineering etc.), combination products may offer us a promising future. Its not only medical devices, but also fixed dosage combination products that are on the rise. I recently attended a Combination Product Conference put on by CHI (Cambridge Healtech Institute), in which many expert speakers addressed the unique challenges of combination products. With dwindling pipelines, limited resources, & expiring patents, now, more that ever, combination products are being considered in drug development portfolios. However, regulatory
hurdles, physician acceptance, and market strategy, are just a few considerations that one should think about before heading down the path. Here is a brief overview of the discussions, that will cover specifics regarding fixed dosage combinations (FDC’s), and
will hopefully give your company a better understanding to the challenges ahead. http://www.corerxpharma.com/resources/white_papers.html

In terms of the industry, revenues for combination products, as a whole, are expected to reach $11.4 billion by 2010ˡ. Further, some sources estimate that 30% of new products under development are
combination products². With technology advances (nanotechnology, genomics, molecular diagnostics, tissue engineering etc.), combination products may offer us a promising future.

]]> By: Andrew Luk http://blog.pharmtech.com/2010/02/18/industry-should-consider-combination/comment-page-1/#comment-29039 Andrew Luk Mon, 22 Feb 2010 06:41:23 +0000 http://blog.pharmtech.com/?p=2493#comment-29039 I totally agree that there are many untapped opportunities in the drug-device combination areas. Many of such product concepts will add values to patients and doctors. However, I felt that pharmaceutical companies are concerned with the non-conventional hurdles to be encountered with such combo product, and their business model has led them to stay with what they know best. On the other hand, most medical device companies are not financially set up for supporting extra clinical, technical, and regulatory requirement for combo device development, even if the device serves as the primary mode of action. For similar reasons, companies shy away from novel local delivery concepts, which the drug serves as the primary mode of action, with anticipated high clinical and regulatory requirements. All of these combination product concepts are thus perceived as high uncertainties/high risks projects rather than improved safety/efficacy opportunities, and this perception drives internal decision to avoid rather than adopt. In our industry, it will take time to change this tide until a few more courageous companies come up with successful stories. I totally agree that there are many untapped opportunities in the drug-device combination areas. Many of such product concepts will add values to patients and doctors. However, I felt that pharmaceutical companies are concerned with the non-conventional hurdles to be encountered with such combo product, and their business model has led them to stay with what they know best. On the other hand, most medical device companies are not financially set up for supporting extra clinical, technical, and regulatory requirement for combo device development, even if the device serves as the primary mode of action. For similar reasons, companies shy away from novel local delivery concepts, which the drug serves as the primary mode of action, with anticipated high clinical and regulatory requirements. All of these combination product concepts are thus perceived as high uncertainties/high risks projects rather than improved safety/efficacy opportunities, and this perception drives internal decision to avoid rather than adopt. In our industry, it will take time to change this tide until a few more courageous companies come up with successful stories.

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