What is Target Product Profile?

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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

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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

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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

Investing and Partnering in Drug Development

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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

Continue reading

Costs Management in Pharmaceutical R&D Projects

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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

Getting Busier…

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Just letting everyone know that I will be writing and posting less in upcoming months.

I have a lot of things going on professionally, which are very exciting but same time I can not keep up with all of my other engagements. I promise the next article on R&D costs will be published in early March.

Thank you for your interest and loyalty 🙂

 

How to Climb the Ladder in Red High Heels

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I am not a feminist in a traditional meaning. I like to think of myself as a woman supporting other women. I also do not believe that all men are misogynistic (a characteristic often associated with NPD).  I admit I met some passive-aggressive male colleagues who were not buying into the gender diversity concept if I can put this delicately. Research shows such men often suffer from certain psychological problems, but I am not going to focus on those aspects today. During my career, I certainly have been lucky enough to deal with many great, supportive and smart men who treat women as equals. Continue reading

Store, Discard or Recycle? – How to Own Your Schedule

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Efficient prioritization and planning should be the two critical skills of every business professional. Planning is a process of thinking about the tasks and goals one wishes to achieve in a given time. Prioritization is a process of ranking the tasks according to their importance and focusing on those which are the most critical or have the biggest potential impact on your goals. Proper planning and prioritization facilitate your and your team success. Continue reading