At Pharma’s Almanac, while COVID-19 and vaccines undoubtedly dominated the publication and inspired the most content during 2020, the pandemic had to cede space to the dominant topic of 2021, cell and gene therapy. While the field has been a constant presence in these pages for many years –– and while some of our more traditional topics, like APIs, process development, bioprocessing, drug discovery and development, clinical trials, and logistics, remain well represented here –– we definitely saw a surge of contributions and interest from readers across all aspects of cell and gene therapy, from R&D through manufacturing, regulatory concerns, clinical studies, the supply chain, and facility design.
Given my own training in genetics and molecular biology, it was very exciting and fulfilling to work with so many experts in the field to develop powerful thought leadership to support this evolving and innovative field.
Going into 2020, it appears that cell and gene therapy will retain its dominance, but it will have stiff competition from the emerging modality of focus, RNA. However, the industry is full of surprises, and a single innovation, approval, or success can change everything.
JANUARY
- Ratish Krishnan of MilliporeSigma assesses the current state of the gene therapy field and looks ahead toward the future. [READ]
- In this Q&A, EXUMA Biotechnology's Gregory Frost, Ph.D., and Sid Kerkar, M.D., discuss early experiences with cell therapy, logic gates, and the promise of rapid point-of-care CAR-T therapy. [READ]
MARCH
- IPS's Brian Peasley compares horizontal and vertical approaches to cell therapy facility design. [READ]
- MilliporeSigma discusses strategies for cell and gene therapy development to help facilitate and improve process development so that product yield, quality, and patient safety are successfully balanced and to accelerate progress against critical milestones. [READ]
- MilliporeSigma shares insights for navigating within the novel and complex regulatory environment facing cell and gene therapies, mitigating risks posed by raw materials, and implementing proper risk assessments during manufacturing. [READ]
APRIL
- Mariah Baltezegar, Panteli Theocharous, Ph.D., Patrick Bennett, and Tim Rich of PPD discuss how decentralized protocols and digital tools can help minimize the patient burden in cell and gene therapy clinical trials. [READ]
- In this excerpt from Nice Insight’s 2021 Cell and Gene Therapy Report and Pricing Study, Jason Rahal assesses the challenges and opportunities within the markets for gene therapies and CAR-T cell therapies. [READ]
MAY
- Catalent's Maribeth Donovan Janke, Ph.D., discusses strategies to build quality into processes early and reap rewards for gene therapy programs. [READ]
- WuXi Advanced Therapies (ATU) CEO David Y. H. Chang discusses the past, present, and future of cell and gene therapy and how WuXi ATU is building a platform to support forthcoming innovations. [READ]
JUNE
- BioAnalytix examines the six analytical strategies to consider before submitting your cell and gene therapy application. [READ]
JULY
- Pharma's Almanac's Editor in Chief examines the therapeutic potential of gene-edited mesenchymal stem cells and some of the inherent challenges in transfection and transduction and highlights the benefits of RoosterBio's RoosterGEM medium in optimizing transduction. [READ]
AUGUST
- Pharma’s Almanac Scientific Editor in Chief David Alvaro met with Andelyn’s Mayo Pujols and Wade Macedone to discuss the challenges facing gene therapy developers and how Andelyn’s history and unique perspective help drive innovation in the sector. [READ]
SEPTEMBER
- Chris McClain of Be The Match BioTherapies® discusses how the company is leveraging its extensive experience and well-established infrastructure to help speed novel cell therapies into the clinic and the market. [READ]
- Jennifer Cheung of WuXi Advanced Therapies explores the evolving quality and regulatory challenges facing cell and gene therapy developers and the progress toward widely applicable solutions. [READ]
- Dr. Ashish Patel, of The NIHR Guy’s and St Thomas’ BRC, discusses his work on a new engineered monocyte therapy for the treatment of fibrotic interstitial lung disease in patients who have recovered from COVID-19. [READ]
- Ratish Krishnan, David Loong, Ph.D., and Nargisse El Hajjami, Ph.D., of MilliporeSigma discuss the challenges to gene therapy development and manufacturing created by the pandemic and lessons learned from the rapid vaccine development efforts that can be applied to transform the gene therapy field going forward. [READ]
OCTOBER
- Andelyn Biosciences' Wade Macedone, Jonathan Rush, Samir Acharya, and Philip Vermilion discuss the challenges associated with process changes for locked-in gene therapy manufacturing processes, and solutions to overcome the challenges. [READ]
- Drew Brennan, General Manager, Viral Vector Technologies, at Avid Bioservices, discusses the drivers motivating the company’s entrance into the viral vector space and the unique and differentiating values Avid can offer cell and gene therapy developers. [READ]
- Cyrill Kellerhals and Sarah O’Reilly of Andelyn Biosciences discuss unique solutions to the cell and gene therapy sector’s ubiquitous challenge of finding and retaining talent from a limited pool and how Andelyn is overcoming the challenge to build an innovative company and culture. [READ]
- In conversation with Pharma’s Almanac Editor in Chief David Alvaro, Ph.D., Mike Nicholson, Ph.D., Inceptor Bio’s Chief Scientific Officer, explains what to expect from the company and how he envisions the broader cell and gene therapy field over the next decade. [READ]
- Andreas Neubert, Ph.D., Former Chief Science Officer at IDT Biologika, discusses how viral vectors are relatively new to the industry but their value has become more apparent as pharmaceutical technologies and capabilities have evolved. [READ]
NOVEMBER
- Yourway's Leandro Moreira discusses how the evolving temperature-controlled requirements for cell and gene therapies have created a need for specialized logistics solutions. [READ]
- Wade Macedone and Adam Lauber of Andelyn Biosciences discuss the supply chain and capacity issues facing the gene therapy sector and how Andelyn is leveraging strategic partnerships and its own unique legacy to overcome these challenges. [READ]
- Philip Gialenios, President and Chief Operating Officer of Kineticos Life Sciences, explains how the company is helping to advance novel therapies by working directly with companies and offering potential support through its investment activities to identify, establish, and execute effective growth strategies. [READ]
DECEMBER
- Pharma’s Almanac explores the evolving cell and gene therapy hub in the Greater Philadelphia area. [READ]
- Tim Kelly, the new Chief Executive Officer at RoosterBio, discusses Rooster’s standardized stem cell product platforms that enable rapid clinical and commercial translation and its commitment to industrializing regenerative medicine supply chains to accelerate innovation. [READ]