Who We Are
We use the fundamentals of physics and chemistry as an integral part of our approach to problem solving, as even the most challenging problems will unravel under this scrutiny.
At Amgen, acted as in-house consultant for multiple departments, such as Clinical Development, Process and Product Development, Drug Delivery (devices) and Biologics Optimization. Was sought after for expertise, trouble shooting strengths and detailed technical engagement.
Consultation in drug delivery systems, biomaterials, formulations, program design and planning, technical due diligence – literature and patents, polymers, physical chemical methods (with fundamental theory), rheology, light scattering, etc.
What We Do
- Drug delivery systems. We carefully evaluate the target product profile, providing guidance on selecting the drug delivery carrier and fabrication method, which is typically but not necessarily polymeric in nature. This selection will be made in conjunction with stability assessment of the drug in the carrier, as well as the effect of the drug on the carrier subsequent to analytical method development. Next, we usually follow with in vitro release and in vivo release in an appropriate animal model. Optimization is conducted by iterative methods. In addition, we can provide our expertise in organic/polymer synthesis to assist in polymer design and characterization.
- Biomaterials: Establishment of target product profile. Literature/patent/market search of possible polymeric systems. If search does not yield suitable candidates, we then explore synthetic options, including surface modification. Depending on the application, thermomechanical studies may be warranted.
- Formulation: Early and late stage formulation and stability/robustness studies using, where appropriate, statistical designs. Key factors taken into account in an aqueous environment include concentration, pH, temperature, time, excipients, preservatives etc. Analytical methods include HPLC (especially SEC-HPLC for proteins), LC-MS, and amino acid analysis for peptides. Detailed analytical assays would depend on the species—protein, antibody, peptide, etc. Drafting CMC drug product development sections of IND.
Technical Due Diligence: Will perform extensive literature and patent searches evaluating external and internal technologies, as well as assisting in the drafting of the patent application covering the examples, disclosures ( generic formulae) and claims. This is best done working closely with patent lawyers/agents. Will also work with patent professionals in drafting responses/arguments to decisions from patent agencies, including U.S., Europe, Japan, China etc.
Case Studies
Advised venture capital firms on the subtleties of various drug/device combination products and about future trends.
Advised biopharmaceutical company on methods to increase the delivered dose of a highly insoluble drug.
The Right Idea, LLC
Address: Thousand Oaks, CA 91360
Phone: (805) 551-6253
Fax: (805) 241-8184
Email: info@therightideaconsulting.com