Bio Platforms
Samsung Bioepis Announces US Launch of Oncology Biosimilar for Early & Metastatic HER2-Overexpressing Breast Cancer & Metastatic Gastric Cancer
Samsung Bioepis Co., Ltd. recently announced today that ONTRUZANT (trastuzumab-dttb), a biosimilar of the reference biologic medicine HERCEPTIN (trastuzumab) for the treatment of….
Biomarkers Heavily Used as Diagnostic Tools in COVID-19 Trials
Biomarkers are a beneficial tool in the search for a COVID-19 vaccine and will help speed up clinical trials, reduce costs of development, guide subject…
Celsion Reports Sufficient Events Have Been Reached for the Second Interim Analysis of the Phase 3 OPTIMA Study
Celsion Corporation recently announced the prescribed minimum number of events of 158 patient deaths has been reached for the second pre-specified interim analysis of the…
7 Hills Pharma Announces COVID-19 Vaccine Program Targeting At-Risk Elderly
7 Hills Pharma, a clinical stage immunotherapy company focused on development of drugs for the treatment and prevention of cancer and infectious diseases, recently announced…
Vir Biotechnology Announces VIR-2218 Demonstrates Dose-Dependent & Durable Reductions of Hepatitis B Surface Antigen in Phase 1/2 Trial
Vir Biotechnology, Inc. recently announced additional interim data from the ongoing Phase 2 trial in patients and results from the Phase 1 trial in healthy…
Precision BioSciences Announces Dosing of First Patient in Phase 1/2a Clinical Trial
Precision BioSciences, Inc. recently announced the initiation of patient dosing in a Phase 1/2a clinical trial of its second off-the-shelf (allogeneic) chimeric….
OncoSec Collaborates With Providence Cancer Institute to Conduct First-in-Human Trial of Investigational Vaccine to Prevent COVID-19
OncoSec Medical Incorporated recently announced that Providence Cancer Institute, a part of Providence St. Joseph Health, is pursuing a first-in-human Phase 1 clinical trial of OncoSec’s novel….
Leading BioSciences Announces Potential for Investigational Drug to Treat Multiple Organ Dysfunction Syndrome in COVID-19 Patients
Leading BioSciences recently announced it has developed a potential approach to treat COVID-19 patients suffering from acute respiratory distress syndrome (ARDS) and multiple organ dysfunction syndrome (MODS) using its….
Beam Therapeutics Licenses SIRION Biotech’s LentiBOOST Technology
SIRION Biotech GmbH recently announced that Beam Therapeutics licensed rights to use SIRION Biotech’s LentiBOOST for use in….
Cytovia Therapeutics & Macromoltek to Develop Dual-Acting Natural Killer Immunotherapy Against SARS CoV2 (COVID-19)
Cytovia Therapeutics recently announced it is expanding its programs to help urgently address the current SAR CoV2 (COVID-19) crisis. Natural Killer cells are a first…
Antiviral Drugs Market to Foresee Tremendous Gains Over 2020-2026
The global antiviral drugs market was valued at $56 billion in 2019 and is expected to accrue phenomenal gains over the forecast period. The spread…
NeuBase Therapeutics Announces Positive Preclinical Data
NeuBase Therapeutics, Inc. recently announced positive preclinical data from its pharmacokinetics studies in non-human primates (NHPs) and in vitro pharmacodynamics data in patient-derived cell lines.…
Oxford BioTherapeutics Announces Second Oncology Drug Candidate Selected to Advance Into Formal IND-Enabling Studies From Boehringer Ingelheim Collaboration
Oxford BioTherapeutics Ltd. recently announced that Boehringer Ingelheim has selected a second asset to advance into formal IND enabling studies. The asset discovery was enabled…
Aravive Announces AVB-500 Improves Anti-Tumor Effects When Combined With Anti-Angiogenic Bevacizumab or PARP Inhibitor Olaparib
Aravive, Inc. recently announced that AVB-500 improves anti-tumor effects when combined with the anti-angiogenic bevacizumab or the PARP inhibitor olaparib in preclinical uterine cancer models.…
Horizon Discovery & Pharmahungary Report Positive Early Stage Results for Novel Micro-RNA Therapeutic
Horizon Discovery Group plc and Pharmahungary Group recently announced positive early stage results for a novel micro-RNA therapeutic for…………..
Altimmune & the University of Alabama Collaborate on Development of Single-Dose, Intranasal COVID-19 Vaccine
Altimmune, Inc. recently announced it is launching a collaboration with the University of Alabama at Birmingham (UAB) on the development of its single-dose…..
THERAPEUTIC PEPTIDES - Continuous Manufacturing of Peptides Could Speed Up Development, Reduce Costs & Improve Quality
Jens Bukrinski, PhD, MSc, says the high-quality, high-process consistency between manufacturing runs and the in-line PAT analytics of the μLOT platform will enable unprecedented robustness of the manufacturing process, significantly retiring the risk of failure to supply due to non-scalability of the manufacturing process.
Lonza Launches New TheraPEAK SfAAV Medium to Boost & Optimize the Production of AAV in Sf9 Insect Cells
Lonza recently announced the launch of the TheraPEAK SfAAV Medium, the first chemically defined, non-animal origin medium designed specifically for the production of….
Akers Biosciences Acquires Licenses to Coronavirus Vaccine Candidate From Premas Biotech
Akers Biosciences, Inc. recently announced it has acquired a licensing agreement with Premas Biotech, under which Akers will in-license a novel coronavirus vaccine candidate under development by…..
WPD Pharmaceuticals Partners With CNS Pharmaceuticals on Drug Development for Coronavirus & Other Antiviral Indications
WPD Pharmaceuticals Inc. recently announced it has entered into a development agreement with CNS Pharmaceuticals, Inc. for the development of……
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).