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
What is the meaning of the pharmaceutical market access? Market access is the process to ensure that all appropriate patients who would benefit, get rapid and maintained access to the brand, at the right price. 
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. 
PART 2: Partnering models for different types of biotech companies
During my career, I have been on the both sides of the financial partnership table. While at pharma, I have supported due diligence together with the rest of the development team. During recent months, I have been assessing various pharmaceutical assets regarding development risks for investors. I found that area fascinating from a personal growth standpoint. It came naturally to me that many of my blog readers may benefit from learning about investment partnerships models for pharma and biotech companies. 
Pharmaceutical drug development is generally complicated and expensive. I have no reason to believe this will ever change. In recent years, however, FDA makes an extra effort to help the industry to bring new promising treatments faster to the market. Despite that willingness to accelerate drug development, that is possible only in some cases, pharma and biotech still operate in a highly complex regulated environment, dealing with many issues that can surface out from the poorly predicted development and commercialization risks. Thus not all the drug candidates can and will reach the market. 
In recent few years, many of the pharma companies try to elevate the perspectives of the patients and caregivers and find best ways to respond to their priorities and needs. Pharma companies engage individual patients and advocacy groups in improving patients’ outcomes and experiences during the actual product development (clinical trials) and incorporates patients’ inputs into products, services, and integrated solutions. This is what buzzword “patient-centricity” is about. We read about it and hear about it a lot, especially from pharma executive leadership during official communications with mass media. 
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