How to Metamorphose into Effective Leader

cat-564202_1280The quality of leadership within 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

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All You Need is a Career Manifesto

cocoon-209096_1920The Internet is crowded with an annoyingly large number of articles on career development. Everyone seems to have their suggestion on how to achieve your biggest career aspirations and ultimate happiness. I realize I am adding another piece to the already full space. Independently, I will share my career development experiences, assuming what has worked for me, can also work for many of you. Continue reading

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

The Silent Silo – How to Improve Team’s Communication?

silo-406957_1920-copyEffective communication builds trust, is critical to the success of any project and represents one of project management’s most important responsibilities. Excellent communication within the project team and between the project manager, team members, and all external stakeholders is essential and is correlated with a high team performance.  Continue reading

Diversity of Roles in Pharmaceutical Project Management

banner-1571998_1920_blog-pmPer 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: Continue reading

How to Fight the Loss of Exclusivity

beach-1238464_1920My previous post “A Secret Life of the Patent Attorney” 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. Continue reading