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.
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 →
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 →
Biotechnological and Pharmaceutical companies are usually very different entities. Biotech exists primarily for the innovation and discovery. Pharma companies mainly aim to develop, commercialize and sell their own or acquired products. Therefore, those two types of companies usually take on a very different business model. Continue reading →
Per definition of PMI (Project Management Institute), project managers across different industries are assigned by the performing organization to achieve the project objectives. This is a challenging, high-profile role with significant responsibility and shifting priorities. It requires flexibility, good judgment, strong leadership and negotiating skills, and a solid knowledge of project management practices. A project manager must be able to understand project detail but manage from the overall project perspective. As the person responsible for the success of the project, a project manager is in charge of all aspects of the project including, but not limited to:
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 →
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 →
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 →
The quality of leadershipwithin the organization is critical from a business perspective. Yet, according to Gallup’s research, the majority of leaders are not equipped to take on the leadership roles. This status quo hurts not only employees but also decrease the performance of the organizations. Much could be achieved by providing relevant training and development opportunities to the managers and leaders. Many companies though do not invest in leaders’ training and poor management comes at the expense of U.S. economy, costing $398 billion annually. Continue reading →
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.