spacer
home > ict > spring 2018 > essential steps
PUBLICATIONS
International Clinical Trials

Essential Steps

ICT:What are the main obstacles currently being faced within oncology research?

Clinipace: One is the competition for patients and site resources due to the plethora of oncology studies currently being conducted. Therefore, including a large number of sites is necessary to achieve a realistic timeline for study completion. The difficulty in obtaining insurance coverage and the need for sponsor companies to pay for expensive background therapy and/or comparator agents in combination therapy trials are also obstacles.

How are clinical trials improving research results in this area?
New trial designs in oncology such as basket studies – testing therapies that target a specific genetic mutation found independent of the underlying tumour type regardless of where the cancer originated – have led to more rapid drug or biologics development and, even now, FDA approvals. Also, the use of expansion cohorts in patients with biomarkeror genetic-mutation-expressing tumours can accelerate moving promising molecules from Phase 1/2 to pivotal studies or even quicken FDA approval via the breakthrough therapy pathway.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Peter Langecker offers medical expertise at Clinipace and externally, often acting as Chief Medical Officer or Medical Monitor for sponsor companies and clinical studies. He provides drug development and regulatory strategy, feasibility assessments, monitoring and medical oversight, and agency advice for select clients. Peter has more than 25 years of experience in clinical oncology and oncology drug development and specialises in the planning and execution of Phase 1-4 oncology trials, EMA, and FDA interactions and submissions. He has served in senior leadership roles at several pharmaceutical and biotechnology companies including Coulter, SUGEN, Intarcia, DURECT, and OXIGENE.

Brian Travers leads Clinipace Asia-Pacific business. Prior to joining Clinipace, he served as General Manager, Greater China at InVentiv Health, overseeing both the clinical and commercial segments. Brian also served as Vice President of Finance at Pharmalegacy Laboratories in Shanghai, China, and, before that, held the dual roles of Senior Manager of Finance and Administration at the International Clinical Diagnostics operations at Thermo Fisher Scientific and Regional Manager where he was responsible for overseeing the administrative activities of the operations outside of the US, as well as managing and developing the distribution business in the Middle East and North Africa region.

Barb Geiger
has more than 25 years of experience in the conduct and management of Phase 1-4 clinical trials and overseeing project teams in multiple therapeutic areas. She has global expertise, having run clinical trials in over 30 countries on six continents. Prior to founding an oncology CRO, Worldwide Clinical Research in 2000, Barb spent 10 years in leadership roles at global CROs. She also spent eight years at a major pharma company and began her career in clinical research in a Phase 1/2 private research unit. Barb is a clinical operations professional and serves clients as an executive liaison to project teams and sponsors. An oncology nurse by training, she has extensive experience in oncology, CNS, and cardiovascular drug development.

spacer
Peter Langecker
spacer
spacer
spacer
Brian Travers
spacer
spacer
spacer
Barb Geiger
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

PPMA Group Industry Awards 2019

PPMA Group is today issuing a ‘Final Call for Entries’ to the 2019 PPMA Group Industry Awards. All companies within the packaging and processing sector are invited to submit their FREE submission by the deadline of 17 July 2019.
More info >>

White Papers
 
Industry Events

Clinical Innovation Partnerships

11-12 September 2019, Hotel Palace, Berlin

Clinical Innovation Partnerships is the only event for senior clinical operations and procurement professionals driving innovation in their clinical trials. It is where the pharma, CRO and vendor clinical trials ecosystem meet to drive innovation in digitalisation, tech and partnering to improve patient experience and reduce trial cost and time.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement