Article: Innovations in Gene Therapies

2023-07-12T12:12:27-04:00Cell & Gene Therapy|

Despite innovation to date in gene therapy, safety concerns with adeno-associated virus (AAV) vectors and uneasiness around cost and affordability has brought into focus the need for even more advancement in the field. In this Pharma Live article, Precision’s Phil Cyr discusses some of the innovations that are occurring to address these issues.


Article: The Future of Gene Therapies: Three Trends

2023-06-06T14:38:00-04:00Cell & Gene Therapy|

Since the first gene therapy procedure more than 30 years ago, the field has seen significant advances and development, but also setbacks and issues. What is the future direction for gene therapies? Precision’s Phil Cyr, Richard Macaulay and Andy Kinley identify three future trends and how they might impact safety, manufacturing development, and reimbursement and payment.


Article: The FDA and AAV-Based Gene Therapy Safety: What You Should Know

2023-07-11T09:35:59-04:00Cell & Gene Therapy|

Over the last couple of years, we have witnessed the tremendous potential of adeno-associated virus (AAV)-based gene therapies. However, there have been a few high-profile safety issues that have occurred, including deaths associated with AAV vector gene therapies that have raised safety concerns among the public and regulators. Don’t miss this great primer on AAV-based gene therapies by Precision’s Deb Phippard and Phil Cyr, including basic background on the vectors, safety concerns, strategies to mitigate safety issues, and recent FDA safety meetings.


Article: Weathering the Storm: Cell and Gene’s Economic Downturn

2023-02-21T15:29:48-05:00Cell & Gene Therapy|

After record-setting milestones in fundraising over the past two years, the advanced therapy investment landscape is experiencing a natural correction. Precision’s Anshul Mangal and Dr. James M. Wilson outline in this The Medicine Maker article how industry leaders can ensure the advancement of innovative treatments for patients with #rarediseases by consolidating investments and prioritizing partnerships with patient advocacy organizations.


New Tech on the Rise: The Future of Cell and Gene Therapies Is Here

2023-01-19T07:10:40-05:00Cell & Gene Therapy|

Recent headlines suggest that the biotech industry as a whole is experiencing a downturn, yet in spite of this narrative the momentum for advanced therapies continues to persevere. Many companies in the cell and gene therapy space are dedicated to bringing these novel therapies to the patients who need them. In this article for PM360 Magazine, Precision’s Anshul Mangal explores the breakthroughs taking place in autologous cell therapies, non-viral delivery methods, and gene editing technologies that may improve patient access for life-saving treatments.


Article: Early Health Economic Models in Gene and Cell Therapy to Inform Clinical Trial Design and Optimize Commercialization Efforts

2022-12-14T10:08:22-05:00Cell & Gene Therapy|

Since the early 2000s, early economic models have been used by many developers as a best practice to maximize development through clinical trial design and commercial success. Early economic models are similar to HTA models in that they assess the direct and indirect costs and consequences of using a new therapy. Based off experience, early health economic models have been particularly useful in three major areas.

  • Assessing commercial viability
  • Developing clinical trial design and evidence-generation strategy
  • Planning for launch preparedness

Ivar Jensen (VP, Precisionheor) is joined by Phil Cyr (SVP, Precision Value & Health) to provide insight on this in “Early Health Economic Models in Gene and Cell Therapy to Inform Clinical Trial Design and Optimize Commercialization Efforts“.


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