Bio Platforms
Agenus Enters Clinical Collaboration With Nelum for Zalifrelimab Combination
Agenus Inc. recently announced that it has entered into a clinical collaboration with Nelum Corp. to evaluate the safety and efficacy of zalifrelimab, Agenus’ anti-CTLA-4 antibody….
Vaxart Announces Additional Preclinical COVID-19 Oral Vaccine Data & Publication
Vaxart, Inc. recently announced additional results from its SARS-CoV-2 Hamster Challenge Study, as well as a peer-reviewed publication in Nature Medicine resulting from a collaboration…
Antios Therapeutics Completes Phase 1b Clinical Trial of Active Site Polymerase Inhibitor Nucleotide
Antios Therapeutics, Inc. recently announced it has completed the Phase 1b clinical trial of ATI-2173, an Active Site Polymerase Inhibitor Nucleotide (ASPIN), in patients with…
ViGeneron Announces Research Collaboration With Daiichi Sankyo to Evaluate Novel Ophthalmic Gene Therapy
ViGeneron GmbH recently announced a research collaboration to utilize its novel engineered adeno-associated virus (vgAAV) vectors with Daiichi Sankyo Company, Limited for delivering….
Clene Nanomedicine Receives Patent Notice of Allowance for using Gold Nanocrystals for Treating MS
Clene Inc. recently announced its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, was issued a Notice of Allowance from the US Patent and Trademark Office (USPTO) for its invention for….
Cognate BioServices & Its Gene Therapy Division Cobra Biologics Announce Major Expansion
Cobra Biologics, the gene therapy division of the Cognate BioServices’ group, recently announced a multi-phase augmentation of its plasmid DNA services as a continuation of…
Cocrystal Pharma Announces Further Development of Influenza A/B Antiviral Compounds by Merck Under Exclusive Worldwide License & Collaboration Agreement
Cocrystal Pharma, Inc. recently announced it has completed all research obligations under the Merck exclusive worldwide license and collaboration agreement, and that Merck is now…
Quantum Genomics Launches Phase 3 Pivotal REFRESH Study
Quantum Genomics recently announced the launch of its Phase 3 REFRESH study in difficult-to-treat or resistant hypertension. This new study is part of firibastat’s Phase…
Gritstone Advances Second-Generation COVID-19 Vaccine
Gritstone Oncology, Inc. recently announced it is advancing development of a second-generation vaccine against SARS-CoV-2, the virus that causes COVID-19, with potential for both prolonged…
Caladrius Biosciences Treats First Patient in the Phase 2b FREEDOM Trial
Caladrius Biosciences, Inc. recently announced it has treated the first patient in its Phase 2b FREEDOM trial of CLBS16 as a therapy for coronary microvascular…
DalCor Announces Launch of Dalcetrapib Clinical Trial for COVID-19
DalCor Pharmaceuticals recently announced the initiation of dal-COVID, a Phase 2 proof-of-concept study for dalcetrapib as a potential oral anti-viral treatment for COVID-19. The main…
Cara Initiates Phase 2 Trial of Oral Treatment for Pruritus in Patients with Notalgia Paresthetica
Cara Therapeutics, Inc. recently announced the initiation of a Phase 2 trial of Oral KORSUVA (difelikefalin) for the treatment of moderate-to-severe pruritus in patients suffering…
MULTI-PARTICULATE MANUFACTURING - How Does Experiment Design Affect Multi-Particulates Manufacturing?
Namrata Vora, MS, Danica Cartwright, Karthikeyan Selvaraj, MPharm, and Ryan Larmon, MS, discuss how the careful application of design of experiment studies is an invaluable tool in proving the design space of complex formulations and manufacturing processes.
EXECUTIVE INTERVIEW - BiologIC Technologies: The Future Microsoft for the Biorevolution
Richard Vellacott, CEO of BiologIC Technologies, discusses his company’s unique technology and its applications in the future of medicine and wider fields of synthetic biology.
BIOSIMILAR DEVELOPMENT - Biosimilars: The Process & Quality System Approach to Clinical Applications
Kaiser Aziz, PhD, addresses biosimilar developments and future innovations with an emphasis placed on quality system approaches to the development and availability of new biosimilar products.
SIRION Biotech GmbH Licensed LentiBOOST™ Transduction Technology to Cellectis
Through this recent license agreement, SIRION Biotech GmbH has granted Cellectis non-exclusive right under its proprietary lentiviral transduction….
Kite & Oxford BioTherapeutics Establish Cell Therapy Research Collaboration
Kite, a Gilead Company, and Oxford BioTherapeutics Ltd. recently announced the companies have entered into a research collaboration to evaluate five novel targets for a….
Argenx & Zai Lab Announce Strategic Collaboration
Argenx SE and Zai Lab Limited recently announced an exclusive license agreement for the development and commercialization of efgartigimod in Greater China, including….
Catalyst Pharmaceuticals Announces Strategic Plan for Product Portfolio Expansion
Catalyst Pharmaceuticals, Inc. recently announced an expansion in its strategic priorities related to portfolio planning and research and development. Catalyst also provided preliminary net revenues…
Silo Pharma Inc. Receives $1 Million in Up Front Licensing Deal
Silo Pharma, Inc. recently announced it has entered into an agreement to license technology covered by provisional patent applications filed by Silo Pharma with the…
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).