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

Phama 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 in 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

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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It is Scary Out There

 

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When I was a kid, the world seemed to be so enormous and overwhelming. Adult life appeared to be so interesting and complicated. As the time went by, in my mind, the world has shrunk substantially, the adult life stopped being so glamorous. One day I suddenly realized: I became a pretty fearless grown-up. Continue reading

PM 20/20: PROJECT MANAGEMENT ADOPTION IN LIFE SCIENCES COMPANIES

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Hello All,  I do not do this usually, but I want to bring your attention to a great article by John Todd, Project Management Insitute. I had a pleasure to work with John, who is very thorough PMI researcher, as one of the respondents. I shared some of my pharma R&D project management experiences that served as a base for the article below.

PM 20/20: PROJECT MANAGEMENT ADOPTION IN LIFE SCIENCES COMPANIES – PILOT

If you are in a company which would like to participate in the above program/interviews, please let me know and I will connect you with John!

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