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
Qualitative & Behavioral Characteristics of Great Leaders
The 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
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.
What is Target Product Profile?
The 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
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
Karma, Time and the Unexpected
In Hinduism and Buddhism, karma is the sum of a person’s actions in this and previous states of existence, viewed as deciding their fate in future existences. Informally, we consider karma as our destiny or fate, connecting the effect and cause. 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
Preview of April Gallery
Investing and Partnering in Drug Development
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
Life is like a box of macarons
I just received an elegant and delightful gift, straight from Paris. Box of macarons, from #1 ‘best in Paris macarons’ boutique, Carette. It was also a gift from somebody very special to me 💝 Continue reading
