Tag: Biotechnology

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 average cost to develop a new drug according to Deloitte is $2.2 billions.. 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

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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 →

Do Not Panic: How to Achieve Inspection Readiness

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pills-1569173_1920-copyInspection Readiness (IR) is a proactive process. It is a process of ‘getting ready’ for an inspection by a regulatory authority (such as FDA), which is conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority to be related to the clinical trial.  Continue reading →

Risk Management in Drug Development

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Risk Management is the continuous process of identifying, analyzing and responding to risk factors throughout the life of a project. The risk management starts at the beginning of the project and continues throughout the life of the project. At each stage of the project’s life, new risks will be identified, quantified and managed. Proper risk management is proactive rather than reactive and reduces the likelihood of an event occurring and the magnitude of its impact. Reactive risk management is often called as crisis management. The right balance in risk contingency is necessary; too much may make the project uncompetitive; too little contingency increases the chance of failure. Risk management is a responsibility of the project team and is driven by the project manager. In short, risk management is about anticipating uncertain events that are inherent to a project to optimize them for project success. Continue reading →

Know the Pharma 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 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 →

How to Metamorphose into Effective Leader

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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 →

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

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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 →