HOW WE ARE GOING TO GET THERE
Continue to discover pharmacological chaperones aiming at novel targets involved in protein misfolding diseases.
We will continue to leverage our core scientific expertise and proprietary technology to develop innovative pharmacological chaperone drug candidates for the potential treatment of a range of diseases.
Continue to formulate against inflammation pathways and drug- target interaction to design drugs/products with higher efficacy and lower adverse effect reactions potency including patent properties.
We will continue to leverage our core scientific expertise and proprietary technology to develop formulations that work against inflammation pathways and drug-target interaction.
Translation of our research discoveries into clinical development.
Once we establish in-vivo proof of concept for our pharmaceutical cosmeceutical products formulated or reformulated with Lactoactive®, we identify potential clinical candidates to launch manufacturing and preclinical testing.
Strategically collaborate or use in- and out-licensing select programs.
We intend to collaborate or make use of in- and out-licensing for certain potentially therapeutic candidate products to biotechnology or pharmaceutical companies for preclinical and clinical development and commercialization.
Highly leverage external talent and resources.
We plan to maintain strong talent internally, having expertise in our core areas of focus to execute efficiently on our R&D and business objectives. We operate by conducting in-house R&D on critical elements in our drug discovery pipeline, while forming strategic alliances around novel technologies and outsourcing generic research activities to established contract research organizations. We plan to continue to rely on the very extensive experience of our management team to execute on our objectives.
Collaborate with scientific and clinical experts in areas of interest related to disease.
We collaborate with highly regarded scientists having expertise in our disease areas of interest to test and characterize our pharmacological properties and targeting therapeutic inflammation related diseases. We also collaborate with leading clinical experts in our disease areas of interest for feedback and guidance on our programs. In addition, we engage a number of consultants who have specific functional expertise to execute our preclinical and clinical development programs.
Evaluate commercialization strategies on a product-by-product basis to maximize the value of our product candidates or future potential products.
As we move our drug candidates through development toward regulatory approval, we will evaluate several options for each drug candidate’s commercialization strategy. These options include building our internal sales force; entering a joint marketing partnership with another pharmaceutical or biotechnology company, whereby we jointly sell and market the product; and out-licensing our product, whereby another pharmaceutical or biotechnology company sells and markets our product and pays us a royalty on sales. Our decision will be made separately for each product and will be based on several factors including capital necessary to execute on each option, the size of the market to be addressed and terms of potential offers from other pharmaceutical and biotechnology companies. It is too early for us to know which of these options we will pursue our drug candidates, assuming their successful development.
In abidance with the law
We protect our proprietary therapeutic product candidate assets and associated technologies that are important to our business consisting of seeking and maintaining domestic and international patents.
These may cover products, compositions, methods of use, manufacturing processes, and other inventions that may be important to our business strategy. We also rely on trade secrets to protect aspects of our business.
Our competitive position depends on our ability to obtain patents on our technologies and our potential products, to defend our patents, to protect our trade secrets and to operate without infringing valid and enforceable patents or trade secrets of others. We seek licenses from others as appropriate to enhance or maintain our competitive position.
In connection with our programs under Topical Drug, Systemic Drug & Supplement, and Cosmetics we hold a worldwide, perpetual, non-exclusive, license, with the right to sublicense, all the intellectual property related to the composition of matter of Topical Drug, Systemic Drug & Supplement, and Cosmetics and plan to file U.S. and international patent applications.