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1rem

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.

 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

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

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

Through this global alliance, PackGene, Weill Cornell Medicine, and GC4K, an Australian non-profit, intend to deliver a custom-tailored gene therapy solution to treat hereditary spastic paraplegia type 56, a particularly rare neurological disease.

PackGene and GC4K Team Up Along with Weill Cornell Medicine for Gene Therapy to Treat Rare Neurological Disease

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. 

Videos

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

PharmTech News

Behind the Headlines: 2024 Year in Review

Behind the Headlines, Episode 8

 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 8, we’re joined by Dr. Vanessa Almendro, PhD, MBA, VP, Head of Science & Technology Innovation at Danaher Corporation; Elliot Berger, Board of Directors and Strategic Advisor at Orientation Marketing; Benjamin McLeod, founder at Convey Bio; and Turna Ray, managing editor, Precision Medicine Online, who wrap up the year in pharmaceuticals by outlining pivotal trends in 2024, as well as discussing some of the more surprising or unpredicted outcomes that deviated from earlier expectations. 

 was by and large considered the most pivotal trend for 2024, with its technology playing an increasing role throughout the pipeline, from novel drug discovery to reduced batch loss in 

. An increasingly politicized climate, fueled by a lapse in public trust and social media, made for a contentious year, especially for the FDA. 

 was considered an important trend in the gene therapy space, as were advances in drug delivery broadly, and tissue cell type targeting more specifically. Additionally, the group called out both the Human Cell Atlas Project and also the Innovative Genome Institute, upending the traditional for-profit drug model as companies progress toward commercial-scale genomic medicines.

Law changes affecting pharma’s position of influence in the provider space were discussed as a potential obstacle, with general political uncertainty appearing to complicate this picture in hard-to-predict ways.

Vanessa Almendro, Elliot Berger, Benjamin McCloud, and Turna Ray go behind the headlines to discuss 2024’s biggest trends in the pharmaceutical industry, as well as the unforeseen outcomes that took us by surprise. 

Business News

PharmTech Videos

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

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

Brian Feth and Jonathan Grinstein go behind the headlines to discuss the impact of a Republican administration on Federal Trade Commission actions, tax relief, and Health and Human Services (HHS) leadership; as well as advancements in CAR-T.

Behind the Headlines: What the US Election Results Mean for Industry, In Vivo CAR-T Applications, and more

 is a bi-weekly panel discussion examining the latesttrends, 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 seekingto highlight the more enduring lessons that hide behind the headlines.

In episode 6, Brian Feth, CEO atXcell Biosciences, and Jonathan Grinstein, North American Editor, 

, go behind the headlines to understand how a recently elected Republican administration in the U.S. might spur investment into the biopharmaceutical industry, particularly through tax breaks and loosening of certain regulations. They also discuss how stem cell research might be slowed and how nontraditional leadership of HHS might influence vaccine policy and pandemic preparedness.

FDA approval of Autolus Therapeutics' obecabtagene autoleucel

 (Aucatzyl) for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) (1). This autologous CAR T-cell therapy, targeting CD19-positive B-cells, has shown promising results in the FELIX trial, with a notable complete remission rate. However, in line with FDA’s current warnings for treatment-related secondary cancer, “The approval includes a boxed warning for risks of cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome (ICANS), and potential T-cell malignancies.”(1) The panel also noted Autolus’ other updates, including the first dosing of patients in their phase 1 CARLYSLE trial of obecabtagene autoleucel in refractory systemic lupus erythematosus (SLE)(2).

Sticking to CAR-T breakthroughs for B-cell abnormalities, the panel also pointed out that Interius BioTherapeutics dosed the first-ever patient with an in vivo CAR gene therapy for the treatment of B-cell malignancies. This is a possible game-changer for advanced therapies as in vivo therapies remove many of the lengthy and expensive manufacturing steps currently required for cell and gene therapies. Interius president and CEO, Phil Johnson, MD, said, “This milestone marks the first time that a durable in vivo CAR therapy has been used in the clinic. INT2104 has the potential to overcome ex vivo CAR therapy challenges with a single-dose, off-the-shelf, widely accessible therapy for the treatment of B cell malignancies enabled by Interius’ programmable platform.” (3)

1. FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. FDA. November 8, 2024. Accessed November 8, 2024. 

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-obecabtagene-autoleucel-adults-relapsed-or-refractory-b-cell-precursor-acute

2. Autolus Therapeutics reports third quarter 2024 financial results and business updates. Press release. Autolus Therapeutics. November 12, 2024. 

https://autolus.gcs-web.com/news-releases/news-release-details/autolus-therapeutics-reports-third-quarter-2024-financial

3. Interius BioTherapeutics doses first patient with in vivo chimeric antigen receptor (CAR) gene therapy for B-cell malignancies. Press release. Interius BioTherapeutics. October 23, 2024. 

https://interiusbio.com/2024/10/interius-biotherapeutics-doses-first-patient-with-in-vivo-chimeric-antigen-receptor-car-gene-therapy-for-b-cell-malignancies/

Behind the Headlines: What the U.S. Election Results Mean for Industry, In Vivo CAR-T Applications, and more 

Leaders in pharmaceutical industry discuss the latest news making waves in the pharmaceutical industry. 

Behind the Headlines, Episode 5: GLP-1 Shortage, Nobel Prize, RNA Editing, and More

In episode 5, panelists Laks Pernenkil, Principal Life Sciences at Deloitte; Brian Feth, CEO at Xcell Biosciences; and Alex Philippidis, Senior Business Editor at Genetic Engineering & Biotechnology News, go behind the headlines to understand why FDA felt it was time to remove 

 from the drug shortages list (1) and how Catalent’s sale of a small molecule manufacturing facility (and incidentally its own headquarters) to expanding European company Ardena might affect future drug availability (2).

The panel also discussed Nobel Prize awards being given in the 

 field (3) and what that might mean in terms of growth, given a series of false starts and hurdles including the shelving of a hepatitis C therapy due to fears that microRNA might not compete commercially with traditional therapeutic approaches (4). The Nobel Prize in physics awarded to recognize advancements in artificial intelligence (5) was likewise considered from the perspective of how AI will bolster drug discovery and drug formulation, as well as help optimize drug manufacturing. 

Lastly, panelists discussed the emerging potential for novel protein replacement therapies on the heels of Wave Life Sciences’ positive clinical data for RNA editing to combat AAT protein deficiency (6), and how temporary and reversible RNA-editing approaches may confer additional benefits that further support this novel approach in the marketplace.

FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. FDA Drug Safety and Availability. October 2, 2024. 

https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize

Catalent signs agreement to sell Somerset, NJ oral solids facility. Catalent. October 14, 2024. 

https://www.catalent.com/catalent-news/catalent-signs-agreement-to-sell-somerset-nj-oral-solids-facility/

The Nobel Prize in physiology or medicine, 2024. 

https://www.nobelprize.org/prizes/medicine/2024/press-release/

Sparmann A and Vogel J. RNA-based medicine: from molecular mechanisms to therapy. 

Laks Pernenkil, Brian Feth, and Alex Philippidis go behind the headlines to discuss the impact of recent news, including FDA’s drug shortage list update, Nobel prize winners in microRNA and AI, and a big-potential research win for RNA editing. 

Manufacturing, Gene Therapies

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