White Paper: Moving Clinical Development Forward in 2023

2023-07-24T21:05:36-04:00Cell & Gene Therapy, News, Thought Leadership|

In today’s cell and gene therapy landscape, there are over 1,400 companies striving to move their products forward into clinic—a critical step in commercializing these groundbreaking treatments. Clinical development is a complex endeavor and the path to market requires careful consideration of factors ranging from chemistry, manufacturing, and controls (CMC) and regulatory strategy to study design, CRO selection, and clinical trial diversity.


White Paper: The Price is Right: Cell and Gene Therapy Approvals and Market Access in 2023

2023-07-24T21:06:01-04:00Cell & Gene Therapy, News, Thought Leadership|

Starting health economic evidence development and market access planning as early as possible in clinical development for a cell and gene therapy is important demonstrating the value to payers and health technology appraisal (HTA) organizations. In a dynamic regulatory and market access landscape, balancing the requirements of regulators and the expectations of payors can be challenging since there is no one-size-fits-all approach.


White Paper: The Future is Now: Cell and Gene Therapy Innovation, Challenges, and Perspectives

2023-07-24T21:06:29-04:00Cell & Gene Therapy, News, Thought Leadership|

Cell and gene therapies have the potential to revolutionize treatment of a wide range of diseases. With six new therapies approved in 2022, including the first allogeneic T-cell therapy, and at least as many slated for approval this year, the sector is poised for rapid growth. This innovation comes with challenges, though, and many consider 2023 to be a seminal year for establishing a strong foothold for advanced therapies in mainstream medicine.


Executive Summary: State of the Industry

2023-07-24T21:06:57-04:00Cell & Gene Therapy, News, Thought Leadership|

Tim Hunt, CEO of the Alliance for Regenerative Medicine (ARM), kicked off the event with a briefing on the state of the cell and gene therapy development landscape. With 475 members worldwide, ARM focuses on convening the sector, providing data and analysis, engaging with stakeholders, and enabling the development of advanced therapies. One of their key initiatives is modernizing healthcare systems to enable access to these novel therapeutics. Highlights of this briefing are provided in this summary.


Webinar: Driving Successful Therapeutic and Diagnostic Development: Effective Practices for Integrating Biomarkers, Biospecimens, and Science from Concept through Clinic to Cloud


In the rapidly evolving world of precision medicine, the successful integration of high-quality biospecimens and well-defined biomarkers is a fundamental aspect. Together with robust scientific methodologies and validation procedures, they drive discovery, clinical development, and the advent of Artificial Intelligence (AI)-driven diagnostics.

This webinar delves into the practical application of biospecimens in critical areas like neurodegeneration, immuno-oncology, and oncology. It outlines the development of assays for clinical application, the creation of multiplexed Immunohistochemistry (IHC) assays, and the use of sequenced biospecimens in the development and diagnosis of targeted therapies.

Key topics will also highlight the value of Tissue Microarrays (TMAs), the advantage of accessing diverse disease indications, the necessity for substantial tissue cohorts for clinical trial assay validation, and the role of tissue images (Hematoxylin & Eosin (H&E), IHC) and related sample data (Next-Generation Sequencing (NGS)) in shaping AI-based diagnostics.


Webinar: Maximizing Efficiency in Your Next State of the Art Facility Build

2023-06-20T11:58:00-04:00Cell & Gene Therapy, Events|

Sponsored by Project Farma, a Precision for Medicine Company, this panel will feature insights from industry leaders on their organization’s risk-based approaches, strategies, and regulatory, manufacturing, and commercial needs to maximize efficiency in their facility build.

This discussion will be moderated by Chad Salisbury: SVP (Project Farma), and include insights from Adam Barlow: CEO and Founder (Baseline Controls), Antinea Chair: VP, Technical Operations (Cellares), Steve Marr: Head of Capital, Real Estate, and Facilities (Spark), Matthew Smith: Head of Project Delivery (Novartis), and Sarah Stoll: Sr. Director (Project Farma).


White Paper: Gene Editing Breakthroughs: A New Hope for Patients

2023-06-20T14:19:37-04:00Cell & Gene Therapy, News, Thought Leadership|

Gene editing technology has rapidly evolved over the past decade. From the initial breakthrough of sequencing the first human genome to researchers today having the ability to create genetically modified mice in as little as four weeks. CRISPR Cas-based gene editing, which acts as a pair of genomic scissors, is at the core of these innovations. The revolutionary technology has enabled rapid genome sequencing and editing to spur advancements in disease research and treatment.

In this white paper, Anshul Mangal President of Project Farma and Precision ADVANCE and Cynthia Pussinen, Advisor & Executive Consulting Partner share how the latest breakthroughs in gene editing technology have the potential to dramatically improve outcomes for patients.


White Paper: Moving CGTx Clinical Development Forward in 2023

2023-06-20T14:21:24-04:00Cell & Gene Therapy, Thought Leadership|

Clinical trials are foundational to developing innovative, life-saving treatments and cures for patients. For developers of cell and gene therapy (CGTx) products, the path to clinical success is fraught with vast and complex challenges. The CGTx field is becoming more crowded, with increased clinical trial volume and an influx of less-experienced sponsors contributing to an increase in clinical holds in the category. Such challenges intensify the pressure to succeed in a fiercely competitive environment.


White Paper: Market Trends and Expectations for Advanced Therapies in 2023

2023-07-06T11:12:25-04:00Cell & Gene Therapy, Thought Leadership|

The cell and gene therapy space has undergone transformational change in the last few years, driven by the promise these modalities have demonstrated in addressing rare and intractable diseases. Achievements in the CAR-T therapy space – there are now six approved CAR-T treatments on the market – in conjunction with breakthroughs in gene therapy and viral vector drugs, have signaled a new era of innovation aimed at furthering cell and gene therapies within the greater healthcare landscape.


Conference: 3rd Gene and Cell Therapies: CMC, CGT & Vector Manufacturing Summit

2023-06-15T15:58:07-04:00Cell & Gene Therapy, Events, Thought Leadership|

Precision will be at this year’s 3rd Gene and Cell Therapies: CMC, CGT & Vector Manufacturing Summit, June 20-21, 2023, in Vienna, Austria. Connect with our team of experts as they lead meaningful presentations and discussions throughout this event providing insights into the development for cell and gene therapies.

Connect with our Advanced Therapy experts!

  • Schedule a meeting with one our our experts
  • Be sure to attend Precision’s own, Houria Bachtarzi’s presentation on June 20, 2023, at 10:10 AM CEST

You can register for the 3rd Gene and Cell Therapies: CMC, CGT & Vector Manufacturing Summit below:



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