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In this episode of the Drug Solutions podcast, Jill Murphy, Editor, speaks with Dr. Graziella Piras, senior director of Strategic Marketing at 908 Devices, about drug development, specifically related to monitoring bioprocess parameters and other important technologies important to moving the process forward.

Graziella has over 15 years of experience in developing products, applications, and solutions for upstream bioprocessing. Before joining 908 Devices, she held various positions in marketing and R&D at Thermo Fisher Scientific, leading projects to support the Cell Culture and Cell Therapy business.

Graziella obtained her Ph.D. in Biochemistry & Molecular Biology in Belgium. She did her postdoc studying the role of epigenetic regulation on cancer and development at the National Cancer Institutes in Maryland.

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

Podcasts

Drug Solutions Podcast: Breaking Through the Barriers of Drug Development

Cell therapies are a hot topic in the bio/pharma industry today. In this episode of the Drug Solutions Podcast, Meg Rivers, senior editor, Andrew Scharenberg, CEO, Umoja Biopharma, and Ryan Crisman, co-founder and chief technical officer, Umoja Biopharma, discuss:

The greatest advancements in cell therapy to date

The biggest trends in cell therapy development

The pros and cons of developing cell and gene therapies

In the discussion, one thing that came up a few times was that one of the major challenges in developing cell therapy is retention. This issue, according to the speakers, has led to the current trend for some biopharma companies to insource development rather than outsource to contract development and manufacturing organizations (CDMOs). The speakers also discussed scale up vs. scale out and various challenges and opportunities for autologous and allogeneic therapies.

 is the CEO of Umoja Biopharma, an MPM portfolio company. He also serves as an executive partner at MPM Capital and chairs the scientific advisory boards at Generation Bio, Genti Bio, and Alpine Immune Sciences. Prior to founding Umoja, Scharenberg co-directed the program in cell and gene therapy at Seattle Children’s Research Institute, working to translate cell and gene therapies for the treatment of inherited immunologic and blood diseases. This work led to the development of a program in engineered regulatory T-cells, partnered with Casebia Therapeutics, for the purpose of developing gene-edited cell therapeutics for type 1 diabetes and other inflammatory diseases. Previously, he was the chief scientific officer of Cellectis Therapeutics, where he initiated the development of an allogeneic CAR T-cell platform, and was the co-founder of Pregenen Inc., a gene-editing and cell-signaling technology company that was acquired by bluebird bio in 2014.

PhD, is the co-founder and chief technical officer of Umoja Biopharma. Before starting Umoja in 2019, Crisman served as the executive director for the Gates biomanufacturing facility, where he was responsible for building out and staffing this protein and cell therapy CDMO. He was instrumental in growing the facility’s current good manufacturing practice capabilities and delivering many first-in-human therapeutic products to patients. While at Juno Therapeutics, Crisman led the JCAR017 chemistry, manufacturing, and controls program and was the head of late-stage process development. He has also held scientific leadership positions at Zymogenetics and CMC Biologics.

Experts from Umoja Biopharma dive into cell therapy development in this episode of the Drug Solutions Podcast, including the greatest advancements in cell therapy to date, areas for improvement, the biggest trends in cell therapy development, and retention as a pain point. 

Drug Solutions Podcast: Cell Therapy Development: Advances, Trends, and the Challenge of Retention

In this discussion, Feliza Mirasol, science editor for 

, explores innovative approaches, such as plant-made pharmaceutical manufacturing technology and organ-on-a-chip technology, that have been successful in enabling the development and manufacturing scale-up of biologics as well as some emerging therapies. Mirasol also discusses industry challenges, including cost considerations and development timelines, with Barry Holtz, PhD, Chief Scientific Officer of Phylloceuticals, and Professor Yaakov Nahmias, founder and chief scientific officer, Tissue Dynamics and founder and president, Future Meat Technologies.

In this episode of the Drug Solutions Podcast, Feliza Mirasol, Pharmaceutical Technology’s science editor, discusses technologies enabling biologics and emerging therapies manufacturing and development with Barry Holtz, PhD, chief scientific officer of Phylloceuticals, and Professor Yaakov Nahmias, founder and chief scientific officer, Tissue Dynamics and founder and president, Future Meat Technologies.



Drug Solutions Podcast: Biologic Drug Development and Manufacturing

In this episode of the Drug Solutions Podcast, Meg Rivers, senior editor, interviews Joy Aho, senior product manager at Be The Match BioTherapies, about sourcing autologous and allogeneic cell therapies, including discussions on:

Current sourcing options for biopharma companies in the cell therapy space

Key considerations when deciding what sourcing method is best for an individual therapy

Considerations for donor identification and cell collection

Potential collection network strategies for cell therapy, and how these strategies impact quality, agility, and scalability

Vendors for cell therapy and supply chain impacts

Joy Aho, PhD, is the senior product manager at Be The Match BioTherapies, where she develops innovative products and services for the cell and gene therapy industry.

In this episode of the Drug Solutions Podcast, Meg Rivers, senior editor, interviews Joy Aho, senior product manager at Be The Match BioTherapies, about sourcing autologous and allogeneic cell therapies.

Drug Solutions Podcast: Sourcing Autologous and Allogeneic Cell Therapies

Global scale-up requires developing replicable processes that work the same no matter where they are performed. This can be accomplished with smart factories that utilize fully automated manufacturing platforms.

Ushering in Industry 4.0 with the IDMO Model to Solve the CGT Manufacturing Bottleneck

The move towards “pharma 4.0” requires a major shift, both ideologically and technologically, to adapt current processes to a framework that will automate much of today’s manufacturing.

Pharma 4.0: What are Industry Leaders Prioritizing in the Modernization of Pharmaceutical Manufacturing? 

With a completed €40 million (US$43 million) investment in Slovenia, Novartis has opened its first specialized viral vector production facility in Europe, following earlier significant investments in R&D that has led to the growth of Slovenia’s workforce.

Novartis’ Steady Investments in Slovenia Result in New Viral Vector Manufacturing Facility and a Growing Work Force

The collaboration will combine fully automated and digitalized technologies to reduce CGT manufacturing timelines to 2.5 days. 

Trenchant BioSystems Partners with Autolomous to Form Integrated Automated CGT Manufacturing Platform

Cytiva will combine its CGT manufacturing technologies with Cellular Origins' robotic manufacturing platform.

Cytiva Collaborates with Cellular Origins to Deliver Automated Manufacturing for CGTs

Industry Outlook 2025: Cell Therapy Advancement

Edwin Stone, CEO of Cellular Origins, sees two themes having the biggest impact to the bio/pharma industry: the expansion of glucagon-like peptide-1 (GLP-1) and the growth of cell therapies from fourth- and third-line treatments to second-line treatments. “It really opens up that question of, when do we start to see first line treatments? And of course, part of that comes down to not just the safety and efficacy profiles, but the cost of goods, which still no one has a good answer to,” Stone says. “So, I think that really links the two parts that we've seen through this year, the GLP-1 and advanced therapies really all come down to that manufacturing piece.”

“The other big thing on cell therapies that I think has been really important this year, and I think really hopefully points to future … moving now into new indications, particularly solid tumor. Again, we don't have to go back that far for there to be real questions with Iovance’s approval in that space and then later Adaptimmune. Solid tumors now are right [on] the cutting edge of where cell therapies are at, and I think that gives great excitement for their potential. Again, we're going to need to make sure we can show that we can manufacture those,” Stone adds.

Stone also sees messenger RNA, the diversity of biologics, and new biological mechanisms as areas to pay attention to for the future of the industry. “I think the thing … we're perhaps just at the start of now, is being able to really broaden our ability to harness biology to go after diseases that we previously haven't been able to tackle. And of course, that's incredibly exciting,” Stone says.

Click the video above to watch the full interview.

Videos

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about the bio/pharmaceutical trends from 2024 that continue to impact the industry in 2025.

PharmTech News

PharmTech Videos

Behind the Headlines Episode 12–Cell and Gene Therapies, New Genomics Tools, and Recent Partnerships

 is a bi-weekly panel discussion examining the latest trends, readouts, and other factors that drive pharmaceutical news and innovation. Each episode features consultants, venture capitalists, scientists, patient advocates, and journalists discussing the prior weeks’ top news while seeking to highlight the more enduring lessons that hide behind the headlines.

In this episode of Behind the Headlines, Brian Feth, CEO and founder of Xcell Biosciences; Thomas Heathman, chief commercial officer of Ori Biotech; and Matthew Lauber, Sr director of BioSeparations, Waters Corporation, discuss commercialization challenges in the cell and gene therapy (CGT) space and advances in new genomics tools from Roche, Illumina, and Eikon. In addition, the panelists review Biogen’s and Stoke Therapeutics’ collaboration for the development and commercialization of zorevunersen, a therapy for Dravet’s syndrome (1); Thermo Fisher Scientific’s purchase of Solventum’s purification and filtration business (2); and Eli Lilly’s $27 Billion plant expansion in the United States due to tax breaks extensions and tariffs threats

Pfizer said the discontinuation of its last remaining cell therapy program was due to several reasons, including “limited interest in gene therapies for the bleeding disorder…However, the company said it will redirect its time and resources towards Hympavzi, an injectable drug approved in October to prevent or reduce bleeding episodes in hemophilia A or B patients aged 12 years and older” (3). Our panel pointed out that a good amount of business process and commercialization rationale went into this decision. This coincides with the Carlysle groups purchase of a CGT Pioneer bluebird bio, for only $30 million (4), and illustrates investor wariness and strong commercial headwinds for the CGT field. 

Recently, new genomics tools have been introduced into the market. Roche has unveiled a new class of next-generation sequencing with its novel sequencing by expansion technology (5), while at the same moment Illumina unveils first-of-its-kind spatial transcriptomics technology (6). In the same moment, Eikon has released novel single-molecule tracking technology, demonstrated through “clinical studies now operating in 28 countries, across five continents, we are accelerating the development of much-needed therapies while continuing to expand our research and development capabilities,” said Roger M. Perlmutter, MD, PhD, CEO and Board Chair of Eikon Therapeutics, in a press release (7).

Biogen. Biogen and Stoke Therapeutics Enter into Collaboration to Develop and Commercialize Zorevunersen for the Treatment of Dravet Syndrome, a Rare Genetic Epilepsy Associated with Refractory Seizures and Neurodevelopmental Impairments. 

Thermo Fisher Strikes Deal for Solventum’s Filtration Unit

Santhosh. C. Pfizer Stops Commercialization of Hemophilia Gene Therapy Beqvez, 

Carlyle. bluebird bio Announces Definitive Agreement to be Acquired by Carlyle and SK Capital. 

Roche. Roche Unveils a New Class of Next-generation Sequencing with its Novel Sequencing by Expansion Technology. 

Illumina. Illumina Unveils First-of-its-kind Spatial Transcriptomics Technology. 

Genetic Engineering News. Eikon Therapeutics Raises $350 Million to Support Clinical Stage Programs, Pipeline Development. 

Brian Feth, Xcell Biosciences; Thomas Heathman, Ori Biotech; and Matthew Lauber, Waters Corporation go behind the headlines and discuss commercialization challenges in the cell and gene therapy space; advances in new genomics tools from Roche, Illumina, and Eikon; and the latest development and manufacturing partnerships. 

Behind the Headlines

Behind the Headlines: Sana's Type 1 Diabetes Breakthrough, Drug Price Negotiations, and More

 is a bi-weekly panel discussion examining the latest trends, readouts, and other factors that drive pharmaceutical news and innovation. Each episode features consultants, venture capitalists, scientists, patient advocates, and journalists discussing the prior weeks’ top news while seeking to highlight the more enduring lessons that hide behind the headlines.

In episode 10, we’re joined by Brian Feth, CEO and Founder, Xcell Biosciences; Jonathan Grinstein, PhD, North American Editor, Inside Precision Medicine; Beth Willers, Principal and Founder, White Matter Communications; and Laks Pernenkil, Principal, US Life Sciences Product, Supply and Manufacturing Operations Practice Leader, Deloitte Consulting, who discuss recent headlines from the pharmaceutical industry, including major announcements from the JP Morgan Healthcare Conference as well as changes arising from the change of administration in US government.

The group discussed Sana Biotechnology’s early trial results showing that allogeneic treatment without immunosuppression might be possible in type 1 diabetes. “The clinical data are highly promising for patients and provide the first evidence in humans for overcoming allogeneic and autoimmune rejection with pancreatic islet cell transplantation in type 1 diabetes with no immunosuppression,” said Per-Ola Carlsson, MD, principal investigator and senior physician and professor at the Clinic for Endocrinology and Diabetology at Uppsala University Hospital. (1)

Also discussed was the interconnected topic of proteomics, which appear to be having a moment thanks to the UK Biobank choosing the Olink platform for a major set of initiatives going forward. (2)

In addition, the participants weighed in on the latest round of Medicare price negotiations, with the medications listed encompassing a large percentage of overall drug expenditure, including Ozempic, Rybelsus, Wegovy, Trelegy, Ellipta, Xtandi, Pomalyst, Ibrance, Ofev, Linzess, Calquence, Austedo, Austedo XR, Breo, Ellipta, Tradjenta, Xifaxan, Vraylar, Janumet, Janumet XR, and Otezla. (3)

Sana Biotechnology Announces Positive Clinical Results from Type 1 Diabetes Study of Islet Cell Transplantation Without Immunosuppression. , Press release. Sana Biotechnologies. January 7, 2025. 

https://www.globenewswire.com/news-release/2025/01/07/3005841/0/en/Sana-Biotechnology-Announces-Positive-Clinical-Results-from-Type-1-Diabetes-Study-of-Islet-Cell-Transplantation-Without-Immunosuppression.html

Thermo Fisher Scientific’s Olink Platform Selected for World’s Largest Human Proteome Study. Press release. Thermofisher Scientific. January 9, 2025. 

https://ir.thermofisher.com/investors/news-events/news/news-details/2025/Thermo-Fisher-Scientifics-Olink-Platform-Selected-for-Worlds-Largest-Human-Proteome-Study/default.aspx

HHS Announces 15 Additional Drugs Selected for Medicare Drug Price Negotiations in Continued Effort to Lower Prescription Drug Costs for Seniors. Press release. Centers for Medicare and Medicaid Services. January 17, 2025. 

https://www.cms.gov/newsroom/press-releases/hhs-announces-15-additional-drugs-selected-medicare-drug-price-negotiations-continued-effort-lower

Brian Feth, Jonathan Grinstein, PhD, Beth Willers, and Laks Pernenkil go behind the headlines to discuss major news announcements made during the JP Morgan Healthcare Conference, a wave of new Medicare drug price negotiations, and more. 

Behind the Headlines: Sana’s Type 1 Diabetes Breakthrough, Drug Price Negotiations, and More

Edwin Stone, Bernard Sagaert, and Khaled Yamout go behind the headlines to discuss what the ongoing measles outbreak in the UK means for pandemic preparedness and anti-vaccination trends; new mRNA approaches; and what Roche’s acquisition of Poseida means for complex cell therapies. 

Behind the Headlines, episode 7: Pandemic Preparedness, Novel mRNA Applications, and More 

In episode 7, Edwin Stone, CEO of Cellular Origins; Bernard Sagaert, CEO of etherna and senior consultant and CEO, Inphacon BV; and Khaled Yamout, founder and CEO of Yamout Chem Consultancy, go behind the headlines to discuss the ongoing 

, and what the troubling trend means for vaccination acceptance and overall pandemic preparedness, including the need for improved public health messaging and narratives to combat anti-vaccination movements globally.

The panel also discussed takeaways from arguably the two most important mRNA conferences of the year, with the Alliance for mRNA Medicines’ (AMM) 1st annual conference, 

, both of which took place in Boston. New mRNA approaches, novel therapeutic applications, and a presentation about a promising branched polyA tail were of great interest for discussion.

Lastly, the panel commented on Roche’s acquisition of its collaboration partner Poseida Therapeutics in an arrangement worth up to $1.5 billion (1), betting on complex immune cell therapies against several types of blood cancer to boost its development pipeline, with Poseida’s non-viral delivery method opening up new avenues in terms of cargo payloads.

Reference: 
1. Poseida Therapeutics, Inc. announces agreement to be acquired by Roche Holdings, Inc. News Release. Poseida Therapeutics. November 26, 2024. https://www.prnewswire.com/news-releases/poseida-therapeutics-inc-announces-agreement-to-be-acquired-by-roche-holdings-inc-302316189.html

Business News

Behind the Headlines: Pandemic Preparedness, Novel mRNA Applications, and More

Experts in cell and gene therapy weigh in on hot topics in a quick-hitting buy, sell, hold format before expanding their thoughts on complex questions. 

Buy, Sell, Hold: Cell and Gene Therapy - Part 2

 is a rapid-fire expert panel covering a single topic, such as lipid nanoparticle delivery, supply chain resilience, 

 (CGT), or aseptic filling. Panelists first respond to quick-hit questions with a buy, sell, hold format before being allotted more time to share more considerate responses to complex topics.

While finance and investment perspectives flavor the discussion, science and pragmatism are the main ingredients driving these dynamic panel discussions.

“Episode 1: Cell and Gene Therapy” features the expertise of Fabian Gerlinghaus, co-founder and chief executive officer of Cellares; Dr. Claudia Zylberberg, board chair and co-founder of Arscience Biotherapeutics, and board chair and co-founder of Akron Biosciences; and Benjamin McLeod, director, Cell & Gene Therapy Segment, at NanoMosaic.

In the first 2 segments, the panelists share quick thoughts on CGT topics, including: The merits of focusing on orphan diseases; training new staff versus re-training existing staff; machine learning, artificial intelligence, and quantum computing; existing supply chain functioning; government investment into CGT; using traditional CDMOs for CGT production; facility retrofits for CGT; and CGTs as first-line treatment.

In the final segment, panelists had up to two minutes each to weigh the advantages and disadvantages of gene editing (CRISPR), gene augmentation, and gene-silencing approaches. Panelists also discussed their technology or engineering wish lists, as well as how to best to sync up regulations to current technology progress. Lastly, they exchanged ideas about the key missing piece(s) to lowering cost and improving accessibility.

Click here for more episodes of Buy, Sell, Hold

Fabian Gerlinghaus, Co-Founder and CEO, Cellares

Fabian Gerlinghaus is Co-Founder and Chief Executive Officer of Cellares. He is driven by a strong sense of purpose and is passionate about building the future of cell therapy manufacturing. With 10+ years of experience as an innovator and a leader, Fabian has established a track record of assembling top-performing teams to successfully drive novel bioprocessing technologies from ideation to commercial readiness. Prior to co-founding Cellares, Fabian served as Chief Innovation Officer at Synthego, where he co-invented the company’s proprietary RNA synthesizer technology and helped grow the company from five to more than 230 employees. He successfully led the interdisciplinary team that took synthesizer technology from whiteboard sketch to production-ready instruments within two years, enabling the company to be the first to market with its CRISPR/Cas9 product portfolio. He earned a master’s degree in aerospace engineering from the Technical University of Munich, and an honors degree in technology management from the Center for Digital Technology and Management, Munich

Dr. Claudia Zylberberg, Board Chair and Co-Founder Arscience Biotherapeutics, Board Chair and Co-Founder Akron Biosciences

With over 30 years of experience in the regenerative medicine industry, Dr. Zylberberg has established herself as a leader in her field. For nearly 15 years, she led Akron Bio as its founder and CEO with leadership, foresight, and expertise in advanced therapies manufacturing. Her passion for pushing the industry forward in the development and commercialization of safe novel therapies also led her to co-found the Standards Coordinating Body and serve as an active member of numerous industry boards and advisory committees. Claudia co-founded AssureImmune, an adult stem cell bank, and worked with Nabi Pharmaceuticals, specializing in human plasma-derived products. Her experience in product development and protein manufacturing was instrumental in the development of key materials to accelerate the regenerative medicine industry. She holds numerous patents and developed several patent-pending platform technologies in cryopreservation, novel formulations, and others. Claudia received her PhD from the University of Buenos Aires, where she studied Immunology, and conducted her doctoral research at the University of British Columbia. She also authored a children’s book called You’re Full of Genes to introduce the younger generation to genetics. Claudia is a member of the Forum on Regenerative Medicine at the National Academies of Sciences, Engineering, and Medicine.

Benjamin McLeod, Director, Cell & Gene Therapy Segment, NanoMosaic

Currently Benjamin helps many related researchers become more familiar with CGT concepts by translating complex processes into digestible bites on social media platforms such as LinkedIn and X. At OmniaBio he was product manager, collaborating with technical stakeholders to develop clear and actionable messaging around OmniaBio’s manufacturing services. At Virica Biotech he was Technical Lead, for a company whose viral sensitizer technology, increased viral yield in manufacturing, and potency in viral therapeutic products.

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT. 

Manufacturing, Cell Therapies

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