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FDA Veteran Paz Vellanki, MD, joins Precision to become one of 3 ex-FDA oncology leaders supporting clients

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Cell & Gene Therapy Strategies

Navigating complexities of cell and gene therapy development, with Precision
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.
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Leverage Precision’s cell & gene therapy experience

Precision has extensive first-hand experience working on all aspects of cell and gene therapy trials, including several first-generation autologous cell therapeutics. Our processes, procedures, and forms 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

  • Site selection

  • Start-up materials and plans

  • Staff training

  • Data considerations

  • Patient safety management

Nuances of EU regulations

What constitutes a GMO can vary from country to country

In the EU regulatory landscape there are 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.

References

  1. 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. Directive - 2009/41 - EN - EUR-Lex 
  2. 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. Directive - 2001/18 - EN - EUR-Lex 
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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.

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Insights from Precision’s experts

Stay ahead with the latest insights from Precision’s team of experts. Discover valuable perspectives, updates, and strategies to navigate cell & gene therapy development.

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Specialized capabilities in every stage of clinical development

Leverage an integrated infrastructure that reduces the inefficiencies inherent in complex development. Integrate lab and trial execution to accelerate speed to market. Precision can customize and converge our capabilities to meet your program's unique needs—driving efficiency, agility, and success from start to finish.

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