Michael Vincent Email & Phone Number

Delaware, United States

Founder, charting the business strategy, financing and implementation of infrastructure of the startup company.Steered the company's focus on rapid oral fluid toxicology tests to address the emerging public safety concerns with the legalization of recreational marijuana, the concerns about the lack of utility of the urine tests for THC and to address the unmet market need for oral fluid rapid tests that meet the SAMHSA screening guidelines.Responsible for the stringent lab like… Show more Founder, charting the business strategy, financing and implementation of infrastructure of the startup company.Steered the company's focus on rapid oral fluid toxicology tests to address the emerging public safety concerns with the legalization of recreational marijuana, the concerns about the lack of utility of the urine tests for THC and to address the unmet market need for oral fluid rapid tests that meet the SAMHSA screening guidelines.Responsible for the stringent lab like design specifications of the visually read oral fluid rapid test products. Worked closely with the Chief Technology Officer on the product development and transfer to manufacturing of the oral fluid collection device and associated proprietary ultrasensitive nanoparticle gold toxicology products. Show less

Pomona, California, United States

Responsible for delivering both visual read and instrument read rapid lateral flow tests, development and supply of rare reagents as well as development of lab chemistry analyzer-based toxicology immunoassay screens. Oversight of Toxicology R&D groups in Abingdon UK, San Diego and Pomona in California and Hangzhou China.Obtained FDA 510(k) clearances for the first split specimen oral fluid collection device for toxicology, updated the existing collection device claims with the FDA with… Show more Responsible for delivering both visual read and instrument read rapid lateral flow tests, development and supply of rare reagents as well as development of lab chemistry analyzer-based toxicology immunoassay screens. Oversight of Toxicology R&D groups in Abingdon UK, San Diego and Pomona in California and Hangzhou China.Obtained FDA 510(k) clearances for the first split specimen oral fluid collection device for toxicology, updated the existing collection device claims with the FDA with a new 510(k) clearance and obtained the next generation oral fluid PCP FDA clearance.Led the development of the next generation oral fluid assays to meet the proposed SAMHSA Federal workplace guidelines.Completed the development and launch of the urine ethyl glucuronide lateral flow colloidal gold assays along with 13 other drugs to eliminate the dependency on third party suppliers.Charted the strategy to reduce the dependency on external suppliers of critical biologics and protein drug conjugates.Represented the Rapid Diagnostics division on the Global Abbott Scientific Governing Board. Show less

Pomona, California, United States

Responsible for formulating the enterprise strategy for developing and delivering critical antibodies, antigens and proteins for the immunoassay and molecular platforms by working closely with the Global Business Unit (GBU) marketing and R&D leadership teams. Worked with the manufacturing sites in replacing critical reagents used in on market products to mitigate supply chain risk.

Pomona, California, United States

Responsible for the vertically integrated toxicology reagents within Global Business Unit (GBU). Steered the business to address the rapid changes in the US market by enhancing the product line to address the client laboratory needs to rapidly and efficient screen for opioids and other designer drugs. This resulted in offering laboratory clients the largest opioid testing panel to address the opioid crisis. Adopted a dual strategy of direct sales and channel partners to tackle different… Show more Responsible for the vertically integrated toxicology reagents within Global Business Unit (GBU). Steered the business to address the rapid changes in the US market by enhancing the product line to address the client laboratory needs to rapidly and efficient screen for opioids and other designer drugs. This resulted in offering laboratory clients the largest opioid testing panel to address the opioid crisis. Adopted a dual strategy of direct sales and channel partners to tackle different market segments in North America. The new product line and business strategy resulted in the reagents business tripling revenue over 5 years while delivering the best gross margins and operating margins percentages among all companies within the Toxicology GBU.Launched 20 new products over 48 months. Including first to market chemistry analyzer assays for Fentanyl, Meperidine, Carisoprodol and Tramadol.Obtained 12 FDA 510 (k) clearances for both illicit and prescription drugs of abuse assays.Developed unique recombinant antibodies utilizing the Alere critical reagent team.Negotiated, validated and launched a private labeled benchtop chemistry analyzer to place the opioid drug panel in pain clinics and substance abuse treatment facilities.Integrated an acquisition to address the pain clinic and substance abuse treatment facilities. Show less

Pomona, California, United States

Responsible for hardware agnostic business strategy, implementing unique toxicology assays on 3rd party open channel chemistry analyzers and ELISA equipment.Steered the company with 3 formats of lab immunoassay products to meet the market needs to test for illicit and prescription drug abuse with multiple biological matrices. Over 40 products were launched to meet the rapidly changing market needs. This resulted in 12 consecutive years of double-digit revenue growth.Developed… Show more Responsible for hardware agnostic business strategy, implementing unique toxicology assays on 3rd party open channel chemistry analyzers and ELISA equipment.Steered the company with 3 formats of lab immunoassay products to meet the market needs to test for illicit and prescription drug abuse with multiple biological matrices. Over 40 products were launched to meet the rapidly changing market needs. This resulted in 12 consecutive years of double-digit revenue growth.Developed and implemented an effective oral fluid specimen strategy as an alternative to the conventional toxicology matrices of urine and blood.Obtained multiple 510 (k) clearances for oral fluid and hair toxicology assays.Responsible for driving the implementation of ISO:13485 certification.Developed and managed the capital expenditure budgets to keep pace with the strong growth.Managed the P&L driving margin and net operating income improvements.Negotiated strategic partnerships to enter international markets and other domestic market segments.Successfully completed the sale of the company to Alere (NYSE:ALR) in August 2010. Show less

United States

Responsibility for manufacturing and quality control of the full line of in-vitro lab toxicology assays

Master Of Science - Ms, Industrial Engineering

Bachelor Of Engineering - Be (Hons), Mechanical Engineering