We offer a full range of technical and business services including:
- Product development and commercialization planning
- Bench-top through manufacturing technical assistance
- Regulatory compliance and document preparation
- Technology audits and competitive assessments
- R&D Program review, analysis and restructuring
- Identification of new applications and markets for products and technologies
- Strategic market overviews and market entry strategies
- Advertising campaign planning and implementation
- Graphic design and presentation of new products
- Identification and evaluation of partners and acquisition candidates
- Technical due diligence and company evaluations
- TCA On-Site Seminars on new and emerging technologies
- Patent examination and audits
- Expert Witness testimony and support
Please scroll down for examples of assignments we have carried out for clients.
Examples of Recent Assignments
For a start-up pharmaceutical company, we evaluated two new immunoassays being used to predict the metabolism of an orphan drug and allow calculation of individual patient dose administration. Our work resulted in significant simplification of the assays, requiring fewer reagents, controls and assay steps.
For an international clinical diagnostics company, we carried out a technical and management audit of their assay development program to identify critical areas of improvement. Our findings and recommendations resulted in a 40% reduction in assay development and transfer-to-manufacturing time, allowing new assays to reach the market sooner.
For a U.S. diagnostic company, we carried out the original audit and market analysis for a new diagnostic for septicemia developed by a start-up company. A partnership resulted and we remained involved through technical development, production, and clinical trials of the new assay. We also helped to design and produce a new instrument for the assay.
PHARMACEUTICALS & BIOPHARMACEUTICALS
For a major pharmaceutical company, we carried out a technical audit and valuation of a biopharmaceutical acquisition candidate. Our findings resulted in a favorable acquisition of the biopharma company by our client.
For a number of small diagnostic and biotechnology companies, we have carried out technical audits and suggested strategies to move their assays and drugs to the market. This included marketing and sales strategy, identification of strategic partners, and preparation of investor presentations.
For a major European separations and diagnostics company, we carried out a study to compare its biosensor-based high throughput screening technology to competitors, and to assess its application to primary and secondary drug discovery screening. We focused on markets in North America, Europe and Japan. After our report, the company moved forward and is currently marketing products based on the technology for drug discovery.
For a small U.S. company specializing in genomic products, we evaluated and then helped them to develop a fast throughput system for the rapid identification of SNPs (single nucleotide polymorphisms); and to identify markets for the technology including genetic screening, pharmacogenomics, and drug discovery.
For a new U.S. joint venture, we carried out a technical and competitive assessment of the company's new technology for the rapid and inexpensive manufacture of multiplexed microarrays, and have continued to help in the laboratory development of specific proteomic assays using the technology. We also identified and contacted potential partners and investors for the technology on behalf of the joint venture.
For a number of U.S. and international companies we have planned and helped to implement production and downstream processing of high value biologicals including recombinant hemoglobin, insulin, and new drug candidates from algae and microorganisms.
DIETARY SUPPLEMENTS; FOOD ADDITIVES AND COLORANTS
For a major producer of lycopene, a carotenoid and dietary supplement, we have carried out analysis and food formulation studies to characterize and standardize lycopene use in foods and as a dietary supplement. We wrote a Color Additive Petition (CAP), a New Dietary Ingredient Notification (NDIN) and a GRAS (Generally Regarded as Safe) Petition for the tomato lycopene. All have been accepted by the U.S. FDA.
For a major producer of astaxanthin, an algal carotenoid, we have written an NDIN and GRAS Petition. Both have been accepted by the U.S. FDA.
We have planned and directed the scale up of large fermentation production lines for carotenoids such as b-carotene, lycopene, zeaxanthin and astaxanthin; and for food additives such as fatty acids and peptides. In China, we helped establish algal production ponds for b-carotene in batches of over one million liters of culture.
EXPERT WITNESS SERVICES
Dr. Taylor has direct experience as an expert witness in cases related to in vitro diagnostics, biopharmaceuticals, toxic materials, and nutritional supplements. His experience includes writing expert and rebuttal reports, patent infringement and invalidity reports, claim construction (Markman Hearing), depositions, and trial testimony in both the U.S. and the U.K.
In Rentschler vs. Biogen and Penn, (Old Bailey,London, UK.) Dr. Taylor was an expert witness in biotechnology for Biogen (defense) as represented by Freshfields in a civil dispute regarding the value of a pharmaceutical intermediate and related patents. Dr. Taylor provided consulting, patent review, a written deposition, and trial testimony in the UK. Biogen won the case.
In Abbott Laboratories vs. Church & Dwight, Dr. Taylor was an expert witness for Abbott (plaintiff) in a patent infringement lawsuit regarding use of Abbott's immunochromatography patents by C&D in C&D's product line of home pregnancy kits. Dr. Taylor provided consulting, patent review, expert reports, review of other expert reports, assay market valuing, and a deposition. The case settled out of court to Abbott's advantage.
In Kaneka Corp. vs. Zhejiang Medicine Co., Ltd. et. al., Dr. Taylor was theexpert witness for ZMC (defendant) in a patent infringement lawsuit regarding the production and sale of Coenzyme Q10 (a dietary supplement). He was involved in multiple lawsuits in the U.S. and Europe including at the International Trade Commission in Washington, D.C. In the ITC case, the ITC ruled in favor of ZMC. In a trial before the US District Court in Houston, TX, ZMC was declared as non-infringing on the patent by summary judgment. In this work, Dr. Taylor provided consulting, patent review, expert reports, depositions, and trial testimony for both invalidity and patent infringement.
More examples of past work are available on request.