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. Continue reading

What is Target Product Profile?

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The Target Product Profile provides a structure for the scientific, technical, clinical, and market information, which is the basis for the product development strategy. The Target Product Profile (TPP) is the critical component of the Development Plan (DP), and its existence is necessary to achieve a desired commercial outcome for the particular product. TPP provides all stakeholders with a clear vision of the product objectives and guides for R&D actions and decisions. TPP is a dynamic document that should be reviewed and updated throughout the drug development process. The FDA has also published the guidelines on how to develop a TPP, and the agency encourages its use as a tool to better frame the technical details of the product at advisory meetings. Continue reading

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

Investing and Partnering in Drug Development

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During my career, I have been on the both sides of the financial partnership table. I have led ‘due diligence’ process together with my drug & business development teams at pharma. Currently, I represent the third party capital providers assessing development risks for various pharmaceutical assets.  Since this is an area of interest for many of my blog readers, this article will explain the basics of the investments and partnerships models for pharma and biotech companies. Considering that there are fundamental differences between the pharma and biotech organizations and how they manage their portfolio strategies, the article is split into two parts:

  • Part 1 will cover the basics of the large pharma partnering models with third-party capital providers
  • Part 2 will focus on partnering models for different types of biotech companies

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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

Know the Pharma Basics: Target Product Profile

pills-384846_1920-copyThe Target Product Profile provides a structure for the scientific, technical, clinical, and market information, which is the basis for the product development strategy. The Target Product Profile (TPP) is the critical component of the Development Plan (DP), and its existence is necessary to achieve a desired commercial outcome for the particular product. TPP provides all stakeholders with a clear vision of the product objectives and guides for R&D actions and decisions. TPP is a dynamic document that should be reviewed and updated throughout the drug development process. The FDA has also published the guidelines on how to develop a TPP, and the agency encourages its use as a tool to better frame the technical details of the product at advisory meetings. 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

Investing and Partnering in Drug Development (Part 1 of 2)

businessman-1106919_1920During my career, I have been on the both sides of the financial partnership table. While at pharma, I have supported due diligence together with the rest of the development team. During recent months, I have been assessing various pharmaceutical assets regarding development risks for investors. I found that area fascinating from a personal growth standpoint. It came naturally to me that many of my blog readers may benefit from learning about investment partnerships models for pharma and biotech companies. Continue reading