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MedPharma Partners in Pharmaceutical Executive
Wednesday, September 24, 2008 - 02:07 PM - 3 months, 2 weeks ago - Blog - Health Business Blog My fellow MedPharma Partners co-founder Patrick Kager and I have an article in this month’s Pharmaceutical Executive magazine entitled How Do You Solve a Problem Like Manufacturing? Pat is our pharma manufacturing guru at MedPharma Partners and the article reflects his deep experience in consulting to big pharma, biotech and contract manufacturers. Manufacturing isn’t well understood within pharmaceutical companies. Top management and board members typically have little background in manufacturing and the head of manufacturing usually reports to someone in the commercial organization rather than directly to the CEO. It’s unusual for the head of manufacturing to sit on the executive committee at big pharma companies. When top management does examine manufacturing –usually at the behest of the CFO– they are surprised to find how much capital is invested and how low capacity utilization is. “Why don’t we just outsource it?,” they ask. Especially in these times of cost cutting, moving to a fully outsourced model seems like a good solution. But actually, there are good reasons not to rush down that path: It’s hard to dispose of the existing assets. Unlike in consumer electronics there are few companies capable of buying and running the facilities. Exceptions –like Catalent (formerly Cardinal) and Patheon –are subject to acquisition by private equity funds or to screwing up their operations and getting into trouble with the FDA. Owning manufacturing plants can yield tremendous tax advantages, which are difficult to replicate in a purely outsourced model (though there are ways to achieve some of the benefits through tolling) There are increasing opportunities for tight integration between pharmaceutical development and manufacturing, and the interfaces between the two can be much more robust in an in-sourced model. Truly new drugs are rare within pharmaceutical company pipelines. New combination products and modified release formulations require advanced manufacturing knowledge Manufacturing costs are a very low percentage of revenue for pharmaceutical companies. Even in these tighter times it makes good sense to keep spare capacity and go overboard on spending on quality and support services. However contract manufacturers look at the world differently. What represents a mere 5 to 20% cost of goods sold for the pharma company is 100% of the contractor’s revenue. They are more prone to squeeze out spare capacity and take shortcuts elsewhere simply because they have a greater economic incentive to do so. That can lead to trouble Recent troubles in China and India reveal the dangers of losing control of the supply chain That doesn’t mean pharma should use a purely insourced model either. In general, pharmaceutical companies should make greater use of third-party manufacturers. Left to their own devices, manufacturing divisions will look to keep everything in house. And with top management not understanding the fundamentals of the business, it’s easy for the manufacturing folks to exaggerate the dangers of third parties and present unfair cost comparisons. A favorite approach is to compare the marginal costs of in-house production with fully loaded third-party costs, something we explore in greater depth in the article. Pat and I are available to discuss this topic at greater length so if you’re interested please send us an email . |
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New Report Calls for More Formal Training of Patient Caregivers
Wednesday, September 24, 2008 - 01:17 PM - 3 months, 2 weeks ago - Newspaper & TV news - Medscape Business of Medicine Headlines The report both outlines the knowledge and skills needed by the caregiving professionals and suggests ways to develop them. It also lays out an agenda for future research on family caregiving. Medscape Medical News |
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Cavalcade of Risk is up at American Consumer News
Wednesday, September 24, 2008 - 12:56 PM - 3 months, 2 weeks ago - Blog - Health Business Blog The latest edition of the Cavalcade of Risk is up at American Consumer News. |
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Expenses May Cause Cancer Patients to Decline Clinical Trial Enrollment
Wednesday, September 24, 2008 - 11:27 AM - 3 months, 2 weeks ago - Newspaper & TV news - Medscape Business of Medicine Headlines Cancer patients insured by Medicare's HMO plans might not be able to participate in cancer clinical trials because of prohibitive costs. Medscape Medical News |
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Thyroid Hormone Analog Fails in the Treatment of Heart Failure
Wednesday, September 24, 2008 - 10:38 AM - 3 months, 2 weeks ago - Newspaper & TV news - Medscape Business of Medicine Headlines The phase 2 study was stopped early because the compound worsened heart-failure symptoms, although it did have a positive effect on weight and lipid profiles. Heartwire |
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Gene Targeted Drug Therapy for Heart Failure
Tuesday, September 23, 2008 - 03:04 PM - 3 months, 2 weeks ago - Newspaper & TV news - GLG News(sm): Healthcare -Another step towards invididualized medicine -Proves that old drugs can be reinvented for useful purposes -Advances pharmacogenetics forward |
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EHR versus EMR
Tuesday, September 23, 2008 - 02:53 PM - 3 months, 2 weeks ago - Blog - Health Business Blog The terms Electronic Health Record (EHR) and Electronic Medical Record (EMR) are usually used interchangeably these days and I’ve basically decided to stop worrying about it. I used to use EMR but now mainly say EHR. I’ve figured it’s kind of a like the shift from Disease Management to Care Management –takes the edge off by shifting to a more benign –if less descriptive– term. But I do cringe when EHR is used interchangeably with Personal Health Record (PHR), as I often do. In any case, Software Advice has an excellent column explaining the difference and documenting the confusion. |
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FDA accepts iCardiac Technologies’ highly automated ECG analysis tools for QT submissions
Tuesday, September 23, 2008 - 12:20 PM - 3 months, 2 weeks ago - Blog - Health Business Blog As part of its program to prevent drugs with cardiac safety problems from reaching the market, FDA requires products in development to be tested for their tendency to lengthen the heart’s QT interval. This guidance (ICH E14 ), issued in 2005, adds substantial costs and time to clinical trials. Drug developers must collect ECGs from trial participants and then hire expensive cardiologists to perform the QT measurements by hand. That’s changing now thanks to an innovative approach from iCardiac Technologies, Inc . The company has completed the industry’s largest validation study for an automated ECG analysis technology. The FDA has reviewed the data and told the company that it would consider such analyses acceptable as part of drug approval submissions. According to the press release (iCardiac Completes Industry’s Largest Validation Study of Highly Automated QT Analysis; Represents First Automated Approach to Comply with Regulatory Guidance ): In the validation study, conducted with leading pharmaceutical companies and academic partners, iCardiac’s highly automated QT method has demonstrated results equivalent to manual measurements performed independently by U.S. board-certified cardiologists. iCardiac’s highly automated QT method was shown to reliably detect the effect of the drug moxifloxacin. Moxifloxacin is used as a positive control in cardiac safety studies and is included in the FDA’s E14 industry guidance. “iCardiac’s highly automated QT analysis provides drug developers with the cost advantages of automation – which are significant – without compromising the rigor of drug safety testing,” said iCardiac’s Co-Founder and Executive Vice President Sasha Latypova. “We leverage validated algorithms and keep cardiologists involved at critical decision points. This principle has been successfully applied in many fields where safety is of paramount concern, such as air traffic control systems and energy generation.” The results of the completed validation study were presented at the FDA’s interdisciplinary review team (IRT) meeting in August and will be published by iCardiac and its partners over the coming months. This study is part of iCardiac’s broader validation program that aims at both reducing the cost of cardiac safety studies and developing the next generation of ECG biomarkers that are more predictive than the QT interval for characterizing arrhythmia risk associated with novel medicines. If the pharmaceutical industry is to get back on track it needs to embrace technologies like this one, which reduce costs and speed up trials. For more information you can contact Sasha Latypova at (617) 359-7088. I am a board member of iCardiac Technologies. 536 |
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Grand Rounds is up at KevinMD
Tuesday, September 23, 2008 - 04:48 AM - 3 months, 2 weeks ago - Blog - Health Business Blog Dr. Val Jones hosts Grand Rounds this morning. Since she’s temporarily blogless, the post appears on KevinMD . I understand it is also due to appear on Emergiblog but it’s not there yet. |
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Working with Silcione Hydrogels is not easy!
Monday, September 22, 2008 - 03:17 PM - 3 months, 2 weeks ago - Newspaper & TV news - GLG News(sm): Healthcare This article mentions two major contact lens manufacturers, CooperVision and Vistakon (a subsidiary of Johnson & Johnson), with difficulties actually making silicone hydrogel contact lenses that can be sold successfully. |
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