Do not run through life so fast. You may forget where you have been, but also where you are going…
Author: Monika Z. Rogozinska
I am a Boston-based biopharma executive. During my career, I have been developing new medicines and medical devices to improve patients health and quality of their lives.
In 2016 I started RedSnaeakersBlog, focused on biotech and pharma related topics, but in late 2018 I decided to close it. I am pulled in many exciting initiatives, and I am unable to continue blogging on a regular basis. I would like to thank you for reading. You can connect to me through Linkedin, where I remain active and will be posting.
The blog will be archived but still available as a webpage, so readers have access to previous posts. Some of them were read many thousands of times, so I do not want to take the precious resources from anybody who searches for the biotechnology and leadership topics.
Dear Readers, I would like to let you know that I decided to close the RedSneakersBlog. I am pulled into many exciting initiatives, and I am unable to continue it. I would like to thank you for reading. You can connect to me through Linkedin, where I still remain active and will be posting. Please see the Contact tab for details.
The blog will be archived but still available as a webpage, so readers have access to previous articles. Some of them were read many thousands of times, so I do not want to take the precious resources from anybody who searches for the biotechnology and leadership topics.
Change management is notoriously difficult. One of the reasons may be because the organizations are making the same errors all over again and they do not learn from good or bad experiences. I have seen the same pitfalls across the biopharmaceutical sector to various extent. The new executives coming in, big ideas are flashed out, and then everybody is asked to implement what they were told. The results: poor or just plain bad. Even if the initial implementation phases go pretty successfully, the sustainability of the change is usually short-lived.
Overwhelmed by the virtual world of infinite connections, we should never forget that non-virtual social network is of crucial importance to your professional and personal development. The strategic partnerships you form throughout your life are going to benefit you at every level. It is clearly advantageous for anyone to be surrounded with people who inspire, support you but also challenge you and help you to grow. Continue reading →
‘Enrepretonourship,’ seems to be one of the most overused terms in today’s business. If you own lemonade stand or similar enterprise, please stop calling yourself an entrepreneur. If you work for a corporation, bad news, you are not an entrepreneur either. If you wish to learn more about entrepreneurship, please continue to read. Below, I share my lessons learned from my GMP program at HBS.
Per update to the below post: Yoga, Neophobic Parrot, and Exciting News: the manuscript I wrote for the Clinical Pharmacology & Therapeutics journal was just accepted. It will be published in a special Jul 2018 issue focusing on the topic of intelligent design digital devices. It is intended for a clinical audience and discusses the impact of the smart devices on the productivity of drug development.🍾🥂🎆
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. The portfolio management is a dynamic process and methodologies used vary among companies. The size of the company and portfolio dictates the complexity and work intensity of the portfolio management. Relevant decisions are made according to a predetermined process and by evaluating multiple parameters. Some of the portfolio management components may be outsourced if there is a need for it. Final accountability for the portfolio decisions stays with the R&D executive team and board of directors. Continue reading →
Drug development can be described as the process of obtaining the relevant information necessary to be included in 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 →