Understanding the Roles that Proposal Managers Play and How to Leverage Their Skill

Earlier this week, we looked at rare disease research in the broadest terms (read the article here). We explained that rare disease is a classification that is comprised of thousands of different conditions, but, collectively, the number of people with rare diseases is quite significant. Most of these conditions are caused by inheriting the right combination of genes to bring a recessive condition to the surface, but there are other possibilities, including illness and allergies. Understanding this root cause enables researchers to develop treatments.

Clinical research has grown in leaps and bounds. Researchers now have the tools to understand many of the world’s rarest diseases at a molecular level. At the same time, current legislation supports the development of treatments to address these rare conditions. However, challenges in this realm persist. A recent article in Nature reviewed the challenges in rare disease development as well as the opportunities that different rare disease development platforms present. 

In this post, we discuss elements and lessons learned from a recent BARDA funded Influenza A Phase II study.  The study’s purpose was to assess the efficacy of the Sponsors IP in treating severely ill and hospitalized Influenza A patients. Subject Detail: The study was targeted to enroll a subset of the general Influenza A global population.  The study inclusion criteria required that each patient be ill for a certain number of days which could not be exceeded. The subject must also be hospitalized and specifically on oxygen therapy.

Clinical Trials are large complex projects, and occasionally a sponsor may need to make a change to bring an underperforming project back on schedule. This type of change is not taken lightly by sponsors. Making such a transition takes time and a large investment in coordination and additional money. In this post, we will take you through a general scenario for a full-service contract research organization (CRO) transition. Our example will show when a sponsor fully transitions from the CRO currently running their study to a new CRO taking over and finishing it off. You may be wondering, “how long would that take?”. After reading this article, you will have the answer based on generally accepted timetables. 

When working on a rare disease program, there are far reaching benefits to conducting a natural history (NH) study. In this article, Pharm-Olam's Dr. Jovana Vlajkovic-Josic was interviewed by Melissa Fassbender from Outsourcing-Pharma.

Personal data privacy has taken another evolutionary step with the release of the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons, the General Data Protection Regulation (GDPR).  If you work for an organization that is not based in the EU, you may or may not be aware of the GDPR.  The GDPR, came into effect on May 25, 2018. 

Pharm-Olam specializes in the conduct of complex global rare disease clinical trials. Because Phase 3 trials are designed to assess the efficacy, effectiveness, as well as safety of a new drug, this is typically a difficult, costly and time-intensive process. The difficulty of Phase 3 trials rachets up even more when it is conducted in a rare disease population.