Bio Platforms
Novavax’s NanoFlu Achieves All Primary Endpoints In Phase 3 Clinical Trial
Novavax, Inc. recently announced positive top-line results of its pivotal Phase 3 clinical trial of NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate with its…
Rafael Pharmaceuticals Enrolls More Than 75% of Patients Needed for Pivotal Phase 3 Trial
Rafael Pharmaceuticals, Inc. recently announced it has enrolled more than 75% of the 500 patients needed for its pivotal Phase 3 clinical trial for metastatic…
Immunogenesis Contracts ProBioGen for Development & Large-Scale Manufacturing Services
ProBioGen AG recently announced that Immunogenesis, Inc., a spin-off of the MD Anderson Cancer Center, University of Texas, has signed a Service Agreement for Cell…
Enlivex Announces Positive Final Safety & Efficacy Data From Clinical Trial
Enlivex Therapeutics Ltd. recently announced positive final safety and efficacy data from the company’s completed Phase 1b clinical trial in patients with severe sepsis. The…
Arcutis Announces Inclusion of Children in On-going Pivotal Phase 3 Clinical Trials
Arcutis Biotherapeutics, Inc. recently announced that, at the request of the US FDA, it has submitted a protocol amendment to the FDA to include children…
CERo Therapeutics Announces Research Collaboration With Lyell Immunopharma; Completion of Financing
Under the terms of the agreement, CERo and Lyell will collaborate to pursue proof-of-concept studies for a new class of cell-based therapeutics directed against….
Evonik Achieves Major Biotech Breakthrough With a New Animal-Free & Fermentation-Based Collagen Platform
Evonik recently announced the development of an advanced collagen platform that is made via fermentation-based processes and devoid of animal- or human-derived materials…..
Nurix Therapeutics Closes $120-Million Financing to Advance Targeted Protein Modulation Drug Pipeline
With the funds raised in this financing, Nurix is well positioned to bring its targeted protein modulation therapeutics into the clinic…..
Zydus & XOMA Announce Exclusive Licensing Agreement
Zydus Cadila and XOMA Corporation recently announced they have entered into a licensing agreement to advance an IL-2-based immuno-oncology (IO) drug candidate that….
DEINOVE Passes Second Milestone of the AGIR Program
DEINOVE recently announced it has successfully completed the second key milestone of the AGIR program – Antibiotics against Resistant Infectious Germs – which is supported by……
BeyondSpring Files for Patent Protection on BPI-002 for the Treatment of Viral Infections, Including COVID-19
BeyondSpring Inc. recently announced the submission of a provisional US patent application for its pipeline asset BPI-002, for methods of treating viral infections, including COVID-19,…
Retrophin Announces Enrollment of First 190 Patients in Pivotal Phase 3 Study
Retrophin, Inc. recently announced that the first 190 patients have been enrolled in the pivotal Phase 3 DUPLEX Study evaluating the safety and efficacy of…
Emergent BioSolutions Initiates Development of Plasma-Derived Product Candidates for the Treatment & Prevention of Coronavirus Disease
Emergent BioSolutions Inc. recently announced it has initiated development of two product candidates for the treatment and prevention of coronavirus disease (COVID-19). These product candidates…
Beroni Group Advances Research & Development of Medical Solution for Coronavirus (COVID-19)
Beroni Group recently announced its development of a medical solution using nanobody technology for the novel coronavirus (COVID-19) in collaboration with Tianjin University in China…
Arcturus Therapeutics & Duke-NUS Medical School Partner to Develop a COVID-19 Vaccine
Arcturus Therapeutics and Duke-NUS Medical School (Duke-NUS) recently announced their partnership to develop a Coronavirus….
PDC*line Pharma Announces First Patient Dosed With its Therapeutic Cancer Vaccine
PDC*line Pharma recently announced the first patient was dosed with its innovative medicinal product candidate PDC*lung01 in a Phase 1/2 trial in….
zPREDICTA Enters Strategic Collaboration With LabCorp
zPREDICTA, Inc. recently announce it has entered into a strategic collaboration with LabCorpto to support the adoption of….
ADMA Biologics Highlights Expanded Intellectual Property Portfolio
ADMA Biologics recently announced that it has received another Notice of Allowance from the US Patent and Trademark Office (USPTO) for a patent application related to its…..
Evelo Biosciences Announces Biomarker Data Showing Drug is Orally Delivered Dual Cytokine Inhibitor for Inflammatory Diseases
Evelo Biosciences, Inc. recently announced biomarker data for EDP1815, its lead inflammation product candidate. Interim data from individuals in the ongoing Phase 1b clinical trial…
CN Bio Innovations Raises $9 Million to Strengthen Commercial Development
CN Bio Innovations recently announced it has raised $9 million investment, led by CITIC Securities Investment Co., Ltd., and supported by existing investor CN Innovations…
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).