Pharma Basics: Portfolio Management

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The pharmaceutical R&D portfolio is usually formed by combining several assets. It can include discovery, pre-clinical and development stage small molecules and biologics (Phase I-IV) or medical devices. Less mature biotech companies, usually own either single project or platform and there is not yet a real R&D portfolio to manage. Large pharma or biotech organizations have actual and sometimes complex portfolios with numerous projects at various stages of development. Decisions around portfolio such as selection of the drug candidates, portfolio prioritization, and optimization are the most critical areas driving a total shareholder value for the organization. The portfolio management is a dynamic process and methodologies used vary among companies. The size of the company and portfolio dictates the complexity and work intensity of the portfolio management. Relevant decisions are made according to a predetermined process and by evaluating multiple parameters. Some of the portfolio management components may be outsourced if there is a need for it. Final accountability for the portfolio decisions stays with the R&D executive team and board of directors. Continue reading

Biotech’s Toughest Love

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Biotech companies are a critical element of the pharmaceutical business, delivering life-saving and quality-of-life improving medicines and medical devices to patients.  They can be considered a beating heart of innovation, filling up many of productivity and innovation gaps at pharmaceutical companies. A broad array of their novel products and discoveries brings hope for patients suffering from previously untreatable conditions and diseases. Small biotech organizations tend to operate with very few experts onboard, prioritizing clinical development and regulatory expenditures to reach their value creation goals: achieving proof-of-concept and obtaining regulatory approval. Historically, commercial aspects were not at the top of the biotech’s priorities. Now, more than ever, biotech needs to get commercial aspects of drug development right. Regulatory approval of the new drug is a significant milestone; however, without commercial/market access & pricing strategy in place, it may lead to a failure further down the road.

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Know the Pharma Basics: USA Healthcare

 

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The United States (US) has a population of over 324 million people and one of the most complex healthcare systems in the world. US health care system is in a constant state of change. The United States spends the most on health care per person — $9,237 – according to two new papers published in the journal The Lancet ($3.2 trillion total in 2015). For comparison, the global spending on health in 2014 was US$9·21 trillion. Continue reading

Loss of Exclusivity & Preservation of Product Value

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My previous post “Patent & Regulatory Exclusivity in Pharma R&D” I have indicated that the pharmaceutical company holding the original pharmaceutical product patent may attempt to fight the loss of exclusivity (LOE). The same article already covered the R&D aspects of the patent and regulatory exclusivity protection, leaving the commercial side to further analysis.

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Patent & Regulatory Exclusivity in Pharma R&D

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When one thinks about the role of the patent attorneys, it may not be obvious how paramount are they for the life science industry. Do we perceive them as the pharma’s secret agents on an ongoing, critical mission? If not, we should. They work behind the research and development scene, making sure the company can maximize the value of the drug candidates and related inventions. This article, in the form of Q&A, covers the patent and regulatory exclusivity topics in biopharmaceutical R&D. Continue reading

Drug Prices Issue & Pharma La-La Land

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Pharma business is complicated. It is a laborious task to explain it to anybody outside of the industry. Yet, the topic of the drug pricing seems to be relevant to everyone. We all deal with illness at some point in our life, either because we get sick or our family members or friends do. Recently some bad actors in the pharma industry (Turing, Mylan) caused a lot of discussions on the drug pricing and negativity around pharma business. Is that deserved?  Continue reading

How to Fight the Loss of Exclusivity

beach-1238464_1920My previous post “A Secret Life of the Patent Attorney” indicated that the pharmaceutical company holding the original pharmaceutical product patent may attempt to fight the loss of exclusivity (LOE). The same article already covered the R&D aspects of the patent and regulatory exclusivity protection, leaving the commercial side to further analysis. Continue reading

A Secret Life of the Patent Attorney

business-suit-690048_1920-copy-copyWhen one thinks about the role of the patent attorneys, it may not be obvious how paramount are they for the life science industry. Do we perceive them as the pharma’s secret agents on an ongoing, critical mission? If not, we should. They work behind the research and development scene, making sure the company can maximize the value of the drug candidates and related inventions. This article, in the form of Q&A, covers the patent and regulatory exclusivity topics in biopharmaceutical R&D. Continue reading

Short Guide to Pharmaceutical Portfolio Management

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The pharmaceutical R&D portfolio is usually formed by combining several assets. It can include discovery, pre-clinical and development stage small molecules and biologics (Phase I-IV) or medical devices. Less mature biotech companies, usually own either single project or platform and there is not yet a real R&D portfolio to manage. Large pharma or biotech organizations have actual and sometimes complex portfolios with numerous projects at various stages of development. Decisions around portfolio such as selection of the drug candidates, portfolio prioritization, and optimization are the most critical areas driving a total shareholder value for the organization. Continue reading