|
|
home > ebr > spring 2020 > transforming cell and gene therapy trial design and execution |
 |
 |
PUBLICATIONS |
European Biopharmaceutical Review
|
The success of cell and gene therapies (CGT) has transformed the delivery of clinical trial services, requiring the design of new workflows, processes, and tools to address the vast differences in how CGT trials are executed compared to traditional trials. Martin Lachs, Vice President and Head of the Oncology and Cell Therapeutics Project Management Group at ICON, an Irelandbased clinical research organisation, understands the difference from first-hand experience. “As an early pioneer in CGT trials, we quickly realised that we couldn’t use our traditional tools and resources. We formed a dedicated solutions group to focus on addressing the nuances and complexities of CGT trials,” he notes. “In the early days, there weren’t any handbooks or standards to rely on. We learned from our mistakes, forcing us to become more agile and flexible. Our ability to regroup and change processes has been extremely important as our work with emerging biotechnology companies continues to grow. We literally become an extension of their teams.”
ICON formed an internal training programme, the ICON CGT Academy, to address the procedural, operational, and technological complexity of CGT trials. “Initially we were learning along with the industry and knew we needed to capture these important lessons. Today, with over 60 CGT trials in our portfolio that encompass multiple therapeutic areas, from cancer to rare and orphan diseases, we’ve captured our experience-based best practices and documented the tools we created to deliver these trials in rigorous curricula. With over 300 ICON CGT Academy members, it serves as a true value add for our clients,” notes Lachs.
The demand for robust best practices will only increase over the next decade. Recent market intelligence projects the global CGT market will grow at a compound annual growth rate of 36.25% between 2019 and 2025 (1). The ever-increasing focus on rare diseases (cardiovascular, ophthalmic etc.) only emphasises the importance of developing innovative and accelerated ways to deliver CGT trials and address the challenges of scaling to commercialisation while optimising the journey for all involved.
|
Read full article from PDF >>
|
 |
 |
 |
Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | |
|
|
Martin Lachs, Vice President, Project Management, Oncology and Haematology, Clinical Research Services, ICON plc.
ICON is a global provider of outsourced drug and device development commercialisation services to pharmaceutical, biotech, medical device, and government and public health organisations. The company specialises in the strategic development, management, and analysis of programmes that support clinical development – from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently operates from 97 locations in 40 countries and has approximately 14,650 employees.
|
|
 |
Martin Lachs |
 |
|
|
 |
 |
 |
|
 |
News and Press Releases |
 |
Catalent Signs Commercial Supply Agreement with Blueprint Medicines Following FDA Approval of GAVRETOT (pralsetinib)
Catalent, the leading global provider of advanced delivery technologies,
development, and manufacturing solutions for drugs, biologics, cell and
gene therapies, and consumer health products, today announced that it
had entered into a commercial supply agreement with Blueprint Medicines
following FDA approval of GAVRETO™ (pralsetinib). Developed by Blueprint
Medicines, GAVRETO is a new therapy indicated for the treatment of
adults with metastatic RET fusion-positive non-small cell lung cancer
(NSCLC) as detected by an FDA approved test.
More info >> |
|

 |
White Papers |
 |
New Temperature Profiles from a Global Study
Laminar Medica
Recently there has been an influx of temperature
mapping studies to collect sufficient ambient data to develop temperature
profiles. Solid temperature profiles on
specific shipping routes are required to ensure streamlined packaging and robust
lane qualification.
The most reliable method to develop
temperature profiles is to capture the actual reading from shipments, as well
as using the historical and meteorological data to increase the confidence
level.
More info >> |
|
 |
Industry Events |
 |
12th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology
8-11 February 2021, Vienna, Austria
In continuation of the very successful scientific meetings in Budapest, Paris, Berlin, Florence, Geneva, Barcelona, Malta, Istanbul, Lisbon, Glasgow and Granada, the 12th PBP World will be held in Vienna from 8-11 Feb 2021. This every two year held conference has gained an ever increasing impact among the pharmaceutical scientists: With up to 1000 submitted abstracts and about 1300 participants it has become a well-established major meeting, attracting scientists from all over the world.
More info >> |
|
|