Bio Platforms
Minerva Neurosciences Announces Study Results Demonstrating Bioequivalence of Phase 2b, Phase 3, & Planned Commercial Formulations of Roluperidone for Treatment of Negative Symptoms of Schizophrenia
Minerva Neurosciences, Inc. recently announced results from a pivotal bioequivalence study comparing the roluperidone formulations used in its late-stage Phase 2b and Phase 3 trials,…
EXECUTIVE INTERVIEW - Emergent CDMO: Making the Impossible, Possible for Biopharma Innovators
Catherine Hanley, Vice President & Interim CDMO Business Unit Head at Emergent BioSolutions, discusses the company’s plans for current and future CDMO operations and client partnership opportunities.
ARTIFICIAL INTELLIGENCE - Attempting to Speed Up Vaccine Development to Combat the Next Pandemic
Lars Wegner, MD, in the wake of the huge impact Covid-19 has had around the world, presents a state-of-the-art mathematical modelling and algorithms approach to vaccine development to prevent the next pandemic.
Novigenix & Radbound University Medical Center Discover the First Blood-Based ImmunoTranscriptomic Biomarkers for Response to Anti-PD-1 Therapy
Novigenix SA recently announced release of the article Whole Blood Transcriptome Profiling Identifies DNA Replication and Cell Cycle Regulation as Early Marker of Response to Anti-PD-1 in Patients with Urothelial Cancer. Immune checkpoint inhibitors (ICIs) have become….
Genetron Health & IMPACT Therapeutics Announce Partnership to Drive Development of Synthetic Lethal Product Pipeline
Genetron Holdings Limited recently announced a partnership with IMPACT Therapeutics in which the two parties will cooperate together on research and development for synthetic lethal inhibitors that are based on….
Evelo Biosciences Announces Positive Phase 2 Clinical Data With EDP1815 in Psoriasis
Evelo Biosciences, Inc. recently announced positive data from its Phase 2 study evaluating EDP1815 versus placebo for the treatment of mild and moderate psoriasis. A statistically significant reduction in the….
Soligenix Announces Accelerated Publication Demonstrating Efficacy & Broad Neutralizing Activity of its COVID-19 Vaccine in Non-Human Primates
Soligenix, Inc. recently announced publication of preclinical immunogenicity studies for CiVax (heat stable COVID-19 vaccine program) demonstrating durable broad-spectrum neutralizing antibody responses, including against the…
First Wave BioPharma Begins Patient Screening for Phase 2b Clinical Trial Evaluating Niclosamide in Patients With Ulcerative Proctitis & Ulcerative Proctosigmoiditis
First Wave BioPharma, Inc. recently announced it has begun screening patients for enrollment in a Phase 2b clinical trial investigating a topical formulation of FW-UP…
BioXcel Therapeutics to Highlight Novel Approaches in AI-Based Drug Candidate Discovery & Development & Advances in Neuroscience Portfolio
BioXcel Therapeutics, Inc. recently hosted a virtual R&D Day that discussed new applications of the artificial intelligence ecosystem to augment and accelerate its drug candidate…
FDA Approves Samsung Bioepis & Biogen’s BYOOVIZ (SB11), LUCENTIS Biosimilar (ranibizumab-nuna)
Samsung Bioepis Co., Ltd. and Biogen Inc. recently announced the US FDA has approved BYOOVIZ (ranibizumab-nuna), a biosimilar referencing LUCENTIS (ranibizumab) for the treatment of neovascular….
AVEO Oncology Announces Ficlatuzumab Granted Fast Track Designation by US FDA for the Treatment of Relapsed or Recurrent Head & Neck Squamous Cell Carcinoma
AVEO Oncology recently announced the US FDA has granted Fast Track Designation (FTD) to ficlatuzumab for the treatment of patients with relapsed or recurrent head…
Carrick Therapeutics Debuts Data for First-In-Class Oral CDK7 Inhibitor Samuraciclib
Carrick Therapeutics recently presented encouraging initial clinical data on samuraciclib (CT-7001), an oral and first-in-class inhibitor of CDK7, at the 2021 European Society of Medical…
Cue Biopharma Granted US Patents on Lead Clinical Program Novel Drug Product Candidate CUE-101
Cue Biopharma, Inc. recently announced the issuance of two new United States Patents Nos. 11,117,945 and 11,104,712 from the United States Patent and Trademark Office.…
Veru Announces Positive Updated Data from Phase 1b/2 Sabizabulin Study in Men With Metastatic Castration-Resistant Prostate Cancer
Veru Inc. recently announced that updated clinical data from the positive Phase 1b/2 study of sabizabulin (VERU-111) in 80 men with metastatic castration-resistant prostate cancer…
Excision Receives FDA Clearance of IND for Phase 1/2 Trial of EBT-101 CRISPR-Based Therapeutic for Treatment of HIV
Excision BioTherapeutics, Inc. recently announced the US FDA has accepted the Investigational New Drug (IND) application for EBT-101, a CRISPR-based therapeutic candidate in development as…
SomaLogic Announces Strategic Collaboration With UPMC to Tailor Clinical Care Through Proteomics Technology
SomaLogic recently announced a strategic collaboration with leading health system UPMC to explore how the large-scale study of proteins and….
ProQR Announces Axiomer RNA Editing Licensing & Research Collaboration With Lilly
ProQR Therapeutics N.V. recently announced a global licensing and research collaboration with Eli Lilly and Company (Lilly) focused on the discovery, development, and….
Longeveron Partners With Kinesiometrics to Create & Implement Cutting-Edge Smart Phone App to Measure Physical Responses to Cell Therapy
Longeveron Inc. has entered into an agreement with Kinesiometrics Inc., to provide a cutting-edge, digital data-driven solution for objective real-time measurement of functional capacity and quality….
AzurRx BioPharma Announces Acquisition of First Wave Bio & its Proprietary Niclosamide Formulations Targeting Multi-Billion Dollar Inflammatory Bowel Disease Indications
AzurRx BioPharma, Inc. recently announced it has entered a definitive agreement to acquire First Wave Bio, Inc. in a stock and cash transaction valued at….
Denali Therapeutics Announces Initiation of Phase 1b Study of EIF2B Activator DNL343 in ALS
Denali Therapeutics Inc. recently announced that dosing recently commenced in a Phase 1b study of DNL343, its brain-penetrant small molecule activator of EIF2B, in participants diagnosed…
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).