Bio Platforms
WuXi AppTec Completes Acquisition of OXGENE to Further Strengthen Cell & Gene Therapy Service Offerings for Global Customers
WuXi AppTec recently announced that it has completed the acquisition of OXGENE, a pioneering UK-based contract research and development organization that designs and develops scalable gene….
Qualigen Therapeutics Secures Option to Negotiate License for G-Quadruplex Anti-Cancer Technology
Qualigen Therapeutics, Inc. recently announced it has entered into a Material Evaluation and Option Agreement with the University College London (UCL) to advance development of…
Silo Pharma Enters Exclusive Option Agreement With the University of Maryland
Silo Pharma, Inc. recently announced it has executed an exclusive option agreement with the University of Maryland, Baltimore to explore a novel invention generally known…
NGM Bio Initiates Expansion of Ongoing Phase 1b Proof-of-Concept Study
NGM Biopharmaceuticals, Inc. recently announced it has dosed the first patient in an expansion of its ongoing Phase 1b proof-of-concept study of NGM120 in patients…
Aptamer Group Extends Collaboration With AstraZeneca to Explore Next-Generation Drug Delivery Approaches
Aptamer Group, the developer of Optimer reagents and therapeutics, recently announced the extension of its current agreement with AstraZeneca, a global biopharmaceutical company. This agreement…
CELL & GENE THERAPY - End-to-End Cell & Gene Therapy – From Development to Commercialization – Buy or Build?
Aldo Romano and Emily Moran, MBA, discuss how the life science industry must bring technology solutions to the table while at the same time securing the capacity to develop and manufacture groundbreaking cures so patients and society can tap the benefits of cell and gene therapies.
IMMUNE ACTIVATORS - Enhancing Cell Adhesion to Safely Improve Effectiveness of Vaccines & Cancer Immunotherapies
Siddhartha De, PhD, and Peter Vanderslice, PhD, present their research on the use of proprietary, orally available compounds that can activate the immune system to enhance the effectiveness of vaccines as well as immuno-oncology therapies for cancer, especially in patient populations that are most vulnerable to disease.
MICROFLUIDIC ENCAPSULATION TECHNOLOGY - Achieving Reliable siRNA Drug Delivery for Inflammatory Diseases & Tumor Targeting by Nanoencapsulation
Olivia Merkel, PhD, and Christoph Zimmermann, PhD student, discuss the benefits of microfluidic encapsulation technology for gene silencing applications in cancer immunology and inflammatory diseases, where siRNA can potentially be used to downregulate genes associated with these pathologies.
ORAL MUCOSAL IMMUNOTHERAPY - Oral Mucosal Delivery of Allergenic Proteins for Inducing Tolerance in Food Allergic Individuals
William R. Reisacher, MD, highlights some of the differences between food allergy immunotherapy via the oral mucosal route versus exposure through the stomach and intestines.
PRODUCT DEVELOPMENT STRATEGY - ESCP, Estimating Product Performance Part 1 - Playground Physics
Josef Bossart, PhD, introduces, in a series of short articles, a qualitative model to help understand and visualize the potential of a product with prescribers, patients, and payors. This simple model can help weed out product ideas that may at first glance seem attractive but offer little potential in the real world.
Vaccinex Announces Signing of Two Multi-Project Deals With Leading Pharmaceutical Companies
Vaccinex, Inc. recently announced the signing of multi-project deals with two undisclosed prominent pharmaceutical companies…..
SIRION Biotech & Sanofi Join Forces to Develop Gene Therapies for Multiple Life-Threatening Disorders
SIRION Biotech GmbH recently announced it signed a license and collaboration agreement with Sanofi to develop improved tissue-selective adeno-associated virus (AAV) vectors to realize….
Catalent to Acquire Delphi Genetics & Launch US Plasmid Manufacturing Site to Establish Global pDNA Development & Manufacturing Capabilities
Catalent and Delphi Genetics recently announced they have entered into a final and definitive agreement whereby Catalent will acquire 100% of the shares of Delphi Genetics. Catalent is also….
Mateon Therapeutics & Windlas Biotech Launch India's First Combined Lung Therapy & AI Telemedicine Solution
Mateon Therapeutics, Inc. and Windlas Biotech Pvt. Ltd. recently announced the launch in India of PulmoHeal, a first-of-its-kind integrated, consumer-centric solution for respiratory wellness. The…
Halberd Collaborates With GreenBioAZ for the Development of Its Patent Pending Radio Frequency Technology
Halberd Corporation has engaged GreenBioAZ, Inc. to conduct laboratory testing of Halberd’s patent-pending Radio Frequency (RF) extracorporeal treatment to eliminate infectious disease pathogens. The methodology…
Intra-Cellular Therapies Applies for FDA Approval of Bipolar Depression Treatment
Intra-Cellular Therapies, Inc. recently announced it has submitted supplemental New Drug Applications (sNDAs) to the US FDA for two indications for CAPLYTA (lumateperone): 1) as…
Celsion Corporation Receives FDA Fast Track Designation for GEN-1 in Advanced Ovarian Cancer
Celsion Corporation recently announced that it has received Fast Track designation from the US FDA for GEN-1, its DNA-mediated interleukin-12 (IL-12) immunotherapy currently in Phase…
SCYNEXIS Announces Licensing Agreement & Strategic Partnership With Hansoh Pharma
SCYNEXIS, Inc. recently announced it has entered into a licensing agreement and strategic partnership with Hansoh Pharmaceutical Group Company Limited…..
Biomunex Pharmaceuticals Signs Strategic License & Co-development Agreement With Onward Therapeutics
Biomunex Pharmaceuticals and Onward Therapeutics SA recently announced the signing of a strategic exclusive worldwide license and co-development agreement for a proprietary….
Altimmune Announces FDA Clearance of Single-Dose, Needle-Free, Intranasal COVID-19 Vaccine Candidate
Altimmune, Inc. recently announced the US FDA has cleared the company’s Investigational New Drug (IND) application for its Phase 1 clinical trial of AdCOVID….
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).