Cell &
Gene Therapy
Strategies
At Precision, we understand that you can’t run a cell or gene therapy development program using conventional clinical development processes. From regulatory strategies to product handling logistics to reimbursement, there are different challenges at each stage that you need to overcome—challenges we know how to plan for. Whether you just need strategic support or a full clinical development partner, we have the experience and expertise to help you succeed.
Precision cell & gene therapy development strategies
Put our logistics and cell and gene therapy expertise to work for you
Leverage Precision’s cell & gene therapy experience
Our team has extensive first-hand experience working on all aspects of cell and gene therapy trials, including several first-generation autologous cell therapeutics.
- We have processes, procedures, and forms that are unique to cell and gene therapy trials
- We have an internal Adoptive Cell Therapy Working Group that keeps our Precision teams informed on industry advances and the current Cell Therapy-specific aspects of:
- The regulatory environment
- Manufacturing and logistics management
- Site selection
- Start-up materials and plans
- Staff training
- Data considerations
- Patient safety management
Plan with Precision’s cell & gene therapy experts
Our team understands cell therapy & gene therapy studies from all angles—translational science, clinical development, and clinical trial operations, especially product handling logistics.
- Our experts have worked on all aspects of cell and gene therapy clinical trials, including
- Protocol review and development
- Biomarker strategy development and implementation
- SAP review
- Clinical/project management
- Logistical coordination through product lifecycle
- Medical monitoring
- Pharmacovigilance
- Data management
- Regulatory and site start-up
- Biometrics oversight
- Medical writing
- Statistics & statistics programming
Delivering on the promise of cell therapy: Challenges and trends
Are you familiar with the nuances of EU regulations?
What constitutes a GMO can vary from country to country
One nuance of the EU regulatory landscape is the existence of two different risk classifications for GMOs-contained use (Directive 2009/31/ EC) and deliberate release (Directive 2001/18/ EC)-which may impact the development of cell therapy products. Contained use is defined as any activity with GMOs for which specific containment measures are used to limit their contact with the environment.1
Deliberate release refers to any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment.2 Sponsors must decide which category the cell therapy falls under and make justification for that decision, keeping in mind that in some EU member states any GMO is considered deliberate release by default, even in the context of a clinical trial.
- Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (Text with EEA relevance). EUR-Lex website. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32009L0041. Accessed August 29, 2019.
- Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC – Commission Declaration. EUR-Lex website. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32001L0018. Accessed August 29, 2019.
Case Study: Navigating logistical complexity in matched cellular therapy trials
Sponsors of cellular therapy trials face enormous complexities coordinating site and manufacturing schedules and standards. The challenges are multifold and include: disparity among sites, multiple
samples with unique collection requirements and pressure to coordinate collection timing. See the processes Precision implemented to help sponsors, manufacturing facilities and sites mitigate potential issues.
“We have decades of experience in clinical trials and how to think these through to minimize risks and increase chances of getting approval.”
Gerald Messerschmidt, MD, FACP
CMO and member of the Precision Adoptive Cell Therapy Working Group
“We have decades of experience in clinical trials and how to think these through to minimize risks and increase chances of getting approval.”
Gerald Messerschmidt, MD, FACP
CMO and member of the Precision Adoptive Cell Therapy Working Group
Tell us about your project requirements
Our cell and gene therapy experts are ready to provide guidance on your clinical development strategy. Start the conversation today.
Tell us about your project requirements
Our cell and gene therapy experts are ready to provide guidance on your clinical development strategy. Start the conversation today.
Clinical trial services
Global Clinical Trial Footprint
Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs.
Clinical Development Strategy
Tailored strategies consider the scientific, regulatory, and commercial factors that shape each trial, mitigating risk and advancing the development pathway.
Clinical Trial Design
Advanced trial-design approaches—including basket, umbrella, and adaptive trials—deliver biomarker driven clinical research. Deep experience in these highly complex trial designs maximizes both insights and efficiency.
Biostatistics
Seasoned biostatisticians and statistical programmers deliver insight into every trial phase, from study design to regulatory submissions, all backed by meticulous documentation and data monitoring.
Clinical Sample Management
Sample inventories from a global network of labs supply real-time processing in 55 countries; consolidated data from central labs, screening labs, and specialty labs with clinical data create actionable reports.
