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Category: Product Development
Manuscript Accepted!
Per update to the below post: Yoga, Neophobic Parrot, and Exciting News: the manuscript I wrote for the Clinical Pharmacology & Therapeutics journal was just accepted. It will be published in a special Jul 2018 issue focusing on the topic of intelligent design digital devices. It is intended for a clinical audience and discusses the impact of the smart devices on the productivity of drug development.🍾🥂🎆
Pharma Basics: Portfolio Management
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
Budget Management in R&D Projects
Finance is a broad term describing the management of money and other valuables, which can be easily converted into cash to achieve economic objectives of the given organization. The usual structure of the financial department in large, mature pharmaceutical company includes Tax Group (scope: tax declarations & optimization, transfer pricing), Accounting (scope: external reporting, financial data management), Corporate Finance (scope: treasury & capital markets, M&A, investor relations), Controlling (scope: internal reporting, budgeting & planning, business valuation), plus potentially additional groups. Continue reading
Creation of Drug Development Plan
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
Pharmaceutical Portfolio Management
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
Loss of Exclusivity & Preservation of Product Value
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.
Patent & Regulatory Exclusivity in Pharma R&D
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
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
