In a classical set-up of an early clinical development program, studies are performed in a sequential order: Single Ascending Dose (SAD) followed by Multiple Ascending Dose (MAD) and Proof of Concept (POC). Every trial is considered a stand-alone trial, and the design of each subsequent trial is adapted to the results of the previous one. By combining these trials in a single combined protocol, it is possible to achieve a substantial gain in total time and hence make a go/no-go decision much earlier.

 

This presentation will focus on the advantages and difficulties of these combined protocols, and present some examples.

In today’s market it is critical to optimize drug development programs through better and faster go-no-go decisions. Obtaining more information about a drug candidate, in less time, is the driving force behind many clinical trial decisions. In the same vein, more First-In-Human (FIH) clinical trials are being conducted in-patients, and recruitment of targeted populations further compounds the challenges of meeting development timelines.

Experience shows that efficiencies can be found in the early stages of clinical trials, by implementing subject recruitment strategies at the very start of the project planning, through proper country and site allocation and selection. For instance, conducting early phase trials, FIH and Proof-Of-Concept (POC), as multicentre studies can provide significant advantages for finding the right target population and improving recruitment.
Using recent experience and case studies, this webinar will detail the specific benefits of coordinating sites in Central Eastern Europe (CEE) countries with sites in Western European countries for early phase trials. For example, the extremely fast authorisation time lines in Western countries for FIH and complex study protocols, combined with the high recruitment rate of CEE countries (frequently 5 to 10 times higher than average) for in-patients early phase studies, provides strong evidence for the benefits of this multicentre, multi-country approach.

In countries such as the Czech Republic, that joined the European Union five years ago, the legal and regulatory environments have been fully harmonised for conducting clinical trials in accordance with ICH-GCP standards. In the Czech Republic and other CEE countries, also outside the European Union, high quality early phase trials in patients are becoming increasingly common and an integral part of successful drug development plans.

Following long delays and much anticipation from industry and health campaigners alike, the European Commission finally adopted the new Pharmaceutical Package on 10 December 2008. The proposed Pharmacovigilance legislation therein, is announced to be the most significant redesign of the EU’s Pharmacovigilance system in the last 40 years.

Discussed in multiple sessions throughout the DIA, it has become clear to all parties involved, that the new measures are necessary to improve the way the EU rules operate on the pharmacovigilance of medicinal products. The package is part of currently ongoing multiple processes of collaboration, driving the industry and regulators towards EU and international PV harmonization. However, some disquiet regarding the PV Package remains. Is this proposal really going to simplify things?

In today’s market, it’s critical to utilize every avenue possible to optimize your drug development pathway. One of the key components to an efficient and successful marketed drug is a close collaboration with Regulatory Affairs experts. The full development of a new medicinal product, from discovery research to the submission of the marketing authorisation application and the post-marketing developments, should be monitored by Regulatory experts to ensure full compliance with the Health Authorities’ requirements.

This webinar will describe in detail how and where in the drug development process Regulatory expertise can add the necessary insight and key information to ensure improved efficiency and success.

This webinar will be useful for individuals working in the biotech and pharmaceutical industries concerned with regulatory issues at any step in the drug development process.

In the last two years, significant progress was made to increase the number of new HIV compounds available to patients. In this webinar you will learn more about: HIV epidemiology, HIV drugs in research, and recent approved drugs and implications on HIV treatment.