Bio Platforms
Biogen Announces Results from Phase 3b NOVA Study Evaluating Every 6-Week Dosing With Natalizumab in Relapsing-Remitting Multiple Sclerosis
Biogen Inc. recently announced results from the 2-year prospective, randomized, interventional, controlled, open-label Phase 3b NOVA study (NCT03689972). NOVA was designed to estimate a potential…
CatSci & Argonaute RNA Partner to Expedite Oligonucleotide Manufacturing for Gene-Silencing Therapeutics
CatSci Ltd and Argonaute RNA recently announced a chemistry, manufacturing, and control (CMC) development collaboration focused on novel therapeutic oligonucleotides…..
Lantern Pharma & Allarity Therapeutics Enter Into Agreement for Future Clinical Development of Irofulven
Allarity Therapeutics A/S and Lantern Pharma Inc. recently announced they have entered into an exclusive agreement under which Lantern will reacquire global rights to Irofulven (LP-100) and assume full….
AC Immune Acquires AFFiRiS’ Specific Active Immunotherapy (SAIT) Anti-Alpha-Synuclein Programs Targeting Neurodegenerative Diseases
AFFiRiS AG recently announced that AC Immune SA is acquiring AFFiRiS’ anti-alpha-synuclein programs targeting neurodegenerative diseases caused by misfolded forms of human self-proteins. All acquired…
Dyadic Announces Technology Transfer & Licensing Agreement With South Africa’s Rubic Consortium
Dyadic International, Inc. recently announced it signed a COVID-19 vaccine technology transfer and licensing agreement with the Rubic Consortium, a South African-based company whose mission…
ValenzaBio Partners With ProBioGen to Maximize Cell Line Productivity & Licenses GlymaxX
ProBioGen and ValenzaBio recently announced the initiation of a cell line development project involving the application of ProBioGen's proprietary GlymaxX technology. ValenzaBio's VB119 is a…
LEXEO Therapeutics Receives Rare Pediatric Disease Designation & Orphan Drug Designation
LEXEO Therapeutics recently announced that the US FDA has granted Rare Pediatric Disease designation and Orphan Drug designation to LX1004 for the treatment of CLN2…
Catalent Plans Multi-Phase, $100 Million Expansion of Italian Facility to Increase Biologics Manufacturing Capabilities in Europe
SOMERSET, N.J. – July 21, 2021 — Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and…
Strathclyde University conclude that membrane technology could revolutionize vaccine and therapeutics production
Whilst paying tribute to to the hugely impressive efforts of those who reconfigured existing equipment at speed into a "Generation 1" manufacturing process for mRNA…
Collaboration Between AbbVie, Biogen & Pfizer Creates World’s Largest Browsable Resource Linking Rare Protein-Coding Genetic Variants to Human Health & Disease
Today, access to the world’s largest browsable resource linking rare protein-coding genetic variants to human health and disease was launched through a genetic exome sequence…
Cyclerion Therapeutics & Beacon Biosignals Announce Expanded Strategic Partnership
Cyclerion Therapeutics, Inc. and Beacon Biosignals recently announced an extended and expanded strategic partnership between the two companies. This collaboration is expected to identify disease-relevant…
Evaxion Biotech Reports Data From Phase 1/2a Trials of EVX-01 & EVX-02
Evaxion Biotech A/S recently announced results from both its Phase 1/2a trial of cancer immunotherapy EVX-01 in metastatic melanoma and interim Phase 1/2a trial of…
Valneva Awarded FDA Breakthrough Designation for its Single-Shot Chikungunya Vaccine Candidate
Valneva SE recently announced it has been awarded Breakthrough Therapy Designation for its single-shot chikungunya vaccine candidate, VLA1553, by the US FDA. Breakthrough Therapy Designation…
Akston Biosciences Announces Positive Phase 1 Data for Second-Generation COVID-19 Vaccine Candidate
Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, recently announced positive results from a 60-subject, open-label, Phase 1 trial of AKS-452, its…
BioAegis Awarded BARDA Contract to Advance Development of a Novel Host-Directed Human Protein for Patients With Sepsis & Severe Infection
BioAegis Therapeutics Inc. recently announced it was awarded a contract from Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, to further….
Apellis & Beam Therapeutics Enter Exclusive Research Collaboration
Apellis Pharmaceuticals, Inc. and Beam Therapeutics Inc. recently announced an exclusive 5-year research collaboration focused on the use of Beam’s proprietary base editing technology to discover new….
Encoded Therapeutics Partners With Genedata to Accelerate AAV-Based Gene Therapy Development
Genedata recently announced that Encoded Therapeutics has chosen Genedata Bioprocess to digitalize their proprietary gene therapy R&D technology…..
Atea’s Oral Antiviral Drug Candidate Reduces Viral Replication in Hospitalized Patients With COVID-19 in Phase 2 Interim Analysis
Atea Pharmaceuticals, Inc. recently announced positive interim results from the global Phase 2 study evaluating AT-527 in hospitalized patients with mild-to-moderate COVID-19. Roche and Atea…
Lyra Therapeutics Announces Positive Topline Results of Pharmacokinetic Study of LYR-210 in Patients With Chronic Rhinosinusitis
Lyra Therapeutics, Inc. recently announced positive topline results from the company’s pharmacokinetic (PK) study of LYR-210. Data obtained from the study are supportive of LYR-210’s…
OSE Immunotherapeutics Announces Manufacturing Agreement With Cenexi
OSE Immunotherapeutics and Cenexi recently announced the signature of an agreement whereby Cenexi will manufacture clinical batches of CoVepiT, OSE Immunotherapeutics' vaccine candidate against COVID-19 currently…
What are Bio Platforms?
Platforms (or asset-independent technologies to capture all kinds of capabilities that can be leveraged across many different drug candidate assets rather than just discovery tools that the term ‘platform’ immediately brings to mind) are ubiquitous in modern pharma. They are the product of an arms race, to secure access to the best capabilities in key areas.
Platform technologies are considered a valuable tool to improve efficiency and quality in drug product development. The basic idea is that a platform, in combination with a risk-based approach, is the most systematic method to leverage prior knowledge for a given new molecule. Furthermore, such a platform enables a continuous improvement by adding data for every new molecule developed by this approach, increasing the robustness of the platform.
But it has often been said that access to the latest technological platforms to aid efficient drug discovery and development is limited to Big Pharma, which can more easily justify the costs of creating and operating these platforms.
Benefits of Bio Platforms
Platform technologies have the ability to radically improve upon current products and generate completely novel products. In this sense, they open up new arenas for drug discovery and development, potentially increasing the number of therapeutic options for patients. Once a single compound or therapeutic has been generated and demonstrates a clinical benefit in patients, it is more likely this platform technology can successfully be applied to other therapeutic areas, derisking future compounds/products.
Complex drugs by their very nature are challenging and costly to manufacture. This, in turn, translates into higher costs for patients and other payers. In order to provide safe and effective therapies at a reasonable price, it is necessary for the industry to develop manufacturing technologies that reduce costs and provide a consistent product. While the initial investment may be larger, manufacturing costs will be lower over time as the manufacturing process is solidified.
Scale and Investment of Bio Platforms
Despite the initial upfront costs, platform technologies inevitably provide pragmatic solutions to production challenges, while yielding safer and more effective therapeutic products. It has often been said that one of the key features that distinguishes “Big Pharma” from biotech is access to the latest technological platforms to aid efficient drug discovery and development.
These platforms range from vast chemical libraries, ultra-high throughput screening and huge genetic databases in discovery, to predictive toxicology platforms, cutting-edge ‘omics’ and even deep-seated knowledge of particular therapeutic areas in development. All these platforms have two things in common: They can be used on any (or many) development candidate assets, and they cost huge sums to establish in the first place, and in a few cases each time they are used as well. Hence their restriction to the largest pharmaceutical companies (and a few of the so-called “big biotechs” that are, in many ways, indistinguishable from the old-guard pharma).
Only when you have hundreds of active projects can you justify the cost of creating and operating these platforms. Or so the mantra goes. It is access to these platforms that keeps the big companies ahead in the race to discover and develop the best medicines (or at least counterbalance the disadvantages of being large and slow-moving, depending on your point of view). But is that just an assertion? How much evidence is there to support the proposition that the efficiency gains due to these platforms outstrips the cost of creating and maintaining them?
Keeping these technologies “cutting edge” has become so expensive that increasingly we hear pharma companies talking of “pre-competitive” approaches to develop the next generation. A group of companies might develop a platform capability they then share. The principle goal of such initiatives is to access even grander and more expensive tools than individual companies could afford, rather than to dramatically cut costs (although sharing platforms rather than developing the same thing in parallel in each silo should at least keep a lid on rising costs).