Bio Platforms
OliX Pharmaceuticals Enters Agreement With Pharmaron to Advance Non-Clinical Toxicology Testing for Hepatitis B Candidate
OliX Pharmaceuticals, Inc. recently announced it has selected Pharmaron, a leading contract research organization based in China, to conduct non-clinical toxicity studies to evaluate the…
Emergent BioSolutions Announces Initiation of Pivotal Phase 3 Study Evaluating the Safety & Immunogenicity of Its Single-Dose Chikungunya Vaccine Candidate
Emergent BioSolutions Inc. recently announced the first participant dosed in its pivotal Phase 3 study evaluating the safety and immunogenicity of the company’s investigational chikungunya…
CEL-SCI’s Multikine Immunotherapy Produces Significant Survival Benefit in the Group Receiving Surgery Plus Radiotherapy in a Landmark Head & Neck Cancer Phase 3 Study
CEL-SCI Corporation recently announced results from its 9.5 year pivotal Phase 3 study for its immunotherapy Multikine (Leukocyte Interleukin, Injection)* in the treatment of advanced…
Viridian Therapeutics Submits IND Application for an IGF-1R Antibody for the Treatment of Thyroid Eye Disease
Viridian Therapeutics, Inc. recently announced the submission of an investigational new drug (IND) application to the United States Food and Drug Administration (FDA). The company…
Omega Therapeutics Announces Strategic Research Collaboration With Stanford University School of Medicine
Omega Therapeutics, Inc. recently announced a strategic research collaboration with researchers at the Stanford University School of Medicine to explore the therapeutic potential of Omega Epigenomic…
Progenity Announces Several Patents Granted by USPTO, Strengthening the Company’s Intellectual Property Position in Ingestible Therapeutics Technologies
Progenity, Inc. recently announced the United States Patent and Trademark Office (USPTO) has issued four patents related to its ingestible technologies for delivery of therapeutics…
LEXEO Therapeutics & FUJIFILM Diosynth Biotechnologies Announce Collaboration to Support Development & Manufacturing of Gene Therapies for Genetic Diseases
LEXEO Therapeutics and FUJIFILM Diosynth Biotechnologies recently announced a strategic collaboration to support the development and manufacturing of LEXEO’s AAV-mediated gene therapies. FUJIFILM Diosynth Biotechnologies…
Centogene & Twist Bioscience to Develop Advanced Sequencing Tools to Make Genetic Testing Rapidly Accessible for More Patients With Rare Diseases
Centogene N.V. and Twist Bioscience Corporation recently announced they have signed a contract to collaborate on the development and commercialization of custom assay kits for rare diseases…..
Acumen Announces First Patient Dosed in a Phase 1 Clinical Trial of Monoclonal Antibody
Acumen Pharmaceuticals, Inc. recently announced dosing of the first patient in INTERCEPT-AD, the Phase 1 placebo-controlled, single- and multiple-dose clinical trial of ACU193, a monoclonal…
Albireo Announces Exclusive Licensing Agreement With Jadeite Medicines
Albireo Pharma, Inc. recently entered into an exclusive licensing agreement with Jadeite Medicines, Inc. for the development and commercialization of Bylvay (odevixibat) in Japan for…
Agenus to Receive $20-Million Milestone Payment From Bristol Myers Squibb With Dosing of First Patient
Agenus Inc. recently announced it has triggered the first development milestone payment under its global licensing agreement with Bristol Myers Squibb for AGEN1777, an Fc-enhanced bispecific….
Metrics Contract Services Enters Partnership to Develop Oncology Drug
Metrics Contract Services, the US-based contract pharmaceutical development and manufacturing division of Mayne Pharma, recently announced the signing of a development and manufacturing agreement with….
Avacta Group Announces Achievement of Preclinical Development Milestone in LG Chem Life Sciences Partnership
Avacta Group plc recently announced a preclinical development milestone has been achieved in the multi-target therapeutics development partnership with LG Chem Life Sciences, the life sciences division of the South Korean LG Group, triggering an….
Boehringer Ingelheim & OSE Immunotherapeutics Announce First Patient Dosed in Phase 1 Expansion Trial of SIRPα Antagonist Monoclonal Antibody BI 765063 in Combination With Anti-PD-1 Antibody Ezabenlimab, in Patients With Advanced Endometrium or Colorectal Tumors
Boehringer Ingelheim and OSE Immunotherapeutics SA recently announced that the first patient has been dosed in the expansion phase of the Phase 1 clinical trial…
Castle Creek Biosciences Expands its Innovative Gene Therapy Platform for Rare Genetic Connective Tissue Disorders Through Research Collaboration With Mayo Clinic
Castle Creek Biosciences, Inc. recently announced a research collaboration with Mayo Clinic to advance discovery and preclinical development of investigational gene therapy candidates for the…
Adaptive Biotechnologies Launches Enhanced clonoSEQ Assay Reports for Patients With Chronic Lymphocytic Leukemia, Now Featuring IGHV Mutation Status
Adaptive Biotechnologies Corporation recently announced the launch of an enhanced version of its clonoSEQ B-cell Clonality (ID) report, which will now feature the immunoglobulin heavy…
Starton Therapeutics Announces Successful Results in STAR-LLD Toxicology Study: No Myelosuppression & Excellent Tolerability
Starton Therapeutics Inc. recently announced the results of a preclinical toxicology study for STAR-LLD. STAR-LLD is a continuous delivery system of lenalidomide in development for…
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.
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).