Absence of Proof is not Proof of Absence

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Recently, I have been supporting a good friend who suffers from various health issues. During the process, we discovered that alternative therapies, not hard medicines, are often beneficial. Exercise, acupuncture, acupressure, meditation, herbal or dietary supplements often may come to rescue as prescribed medication alone may not resolve the health issues. In combination, however, they can reach the desired effect (cure or improvement of the condition). Continue reading

Know the Pharma Basics: INN and USAN

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An International Nonproprietary Name (INN) is an official generic and nonproprietary name given to a pharmaceutical drug or active ingredient. INN identifies pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name. The INN system is managed by the World Health Organization (WHO). The INN system has been coordinated by the World Health Organization (WHO) since 1953. Continue reading

Creation of Drug Development Plan

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Drug development can be described as the process of obtaining the relevant information necessary to be included on your drug prescribing information. Development Plan (DP) is the strategic document that guides the lifecycle of a new product from the pre-clinical lead compound stage through Lifecycle Management (LCM). LCM starts with the first approval of BLA/NDA (first Marketing Authorization) and encompasses development of new indications. In mature pharma organization, DP is approved by the governance bodies. Once approved, it can be regarded as the agreement between executive leadership/board of directors and the program team involved in the discovery, development & commercialization of the product. The DP is a living document and should be amended when the development strategy changes. 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

Getting Pre-Candidate Drug to First IND

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The 2016 analysis by the Tufts Center for the Study of Drug Development estimated the average cost to develop and gain marketing approval for a new drug is ~ $2.87 bln. Drug development is not only costly; it is a lengthy, laborious and usually, sequential process. Discovery phase can take 2-10 years. A drug discovery projects initiate because there is a disease or clinical condition without suitable medical products available and it is this unmet clinical need which is the underlying driving motivation for the project. 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

Continue reading

Know the Pharma Basics: Drug Development Plan

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Drug development can be described as the process of obtaining the relevant information necessary to be included on your drug prescribing information. Development Plan (DP) is the strategic document that guides the lifecycle of a new product from the pre-clinical lead compound stage through Lifecycle Management (LCM). LCM starts with the first approval of BLA/NDA (first Marketing Authorization) and encompasses development of new indications. In mature pharma organization, DP is approved by the governance bodies. Once approved, it can be regarded as the agreement between executive leadership/board of directors and the program team involved in the discovery, development & commercialization of the product. The DP is a living document and should be amended when the development strategy changes. 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