Effective 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
Category: Pharmaceuticals
Diversity of Roles in Pharmaceutical Project Management
Per 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
My 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
A Secret Life of the Patent Attorney
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
Short Guide to Pharmaceutical Portfolio Management
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. Less mature biotech companies, usually own either single project or platform and there is not yet a real R&D portfolio to manage. Large pharma or biotech organizations have actual and sometimes complex portfolios with numerous projects at various stages of development. Decisions around portfolio such as selection of the drug candidates, portfolio prioritization, and optimization are the most critical areas driving a total shareholder value for the organization. Continue reading
Investing and Partnering in Drug Development (Part 2 of 2)
PART 2: Partnering models for different types of biotech companies
Cont. from Part 1 Continue reading
Investing and Partnering in Drug Development (Part 1 of 2)
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. Continue reading
Technical vs. Team Leadership in Drug Development
Every drug development program is led by some type of the team leader. Such position may have different names in every organization (e.g. asset, team, program, project lead, etc.). The primary accountability of that individual in all pharma organizations is yet similar: to deliver the program to support the R&D strategic goals and direction. Continue reading
Insanity of Drug Development
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. Continue reading
Pharma Employees & Patients
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. Continue reading
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