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| ===== Robin Smith ===== | ===== Robin Smith ===== | ||
| + | {{ :: | ||
| + | Robin Y. Smith brings over 20 years of startup, science, and entrepreneurial experience to [[: | ||
| - | + | As the global head of R&D for PerkinElmer, | |
| - | Robin Y. Smith brings over 20 years of startup, science, and entrepreneurial experience to ORIG3N. In his previous roles as founder of three successful enterprises, | + | |
| Bloomberg Profile ((https:// | Bloomberg Profile ((https:// | ||
| - | CEO/ | + | CEO/ |
| - | Global Head: | + | |
| + | Forner Global Head: | ||
| + | [[: | ||
| + | |||
| + | ==== ArtusLabs, Inc. ==== | ||
| + | |||
| + | References to [[: | ||
| + | |||
| + | |||
| + | === Perkin Elmer Buys Artus === | ||
| + | March 24, 2011 | ||
| + | |||
| + | WALTHAM, Mass.--(BUSINESS WIRE)--PerkinElmer, | ||
| + | |||
| + | ArtusLabs provides us with innovative technology enabling enhanced access to scientific knowledge, and is highly complementary to CambridgeSoft’s informatics solutions.” | ||
| + | |||
| + | He added, “These acquisitions combined with our existing offerings, particularly our OneSource® laboratory asset management services, make us uniquely qualified to enable highly efficient laboratory environments and increased scientific productivity.” ((https:// | ||
| + | |||
| + | Durham’s ArtusLabs sold to PerkinElmer - Triangle Business Journal by Monica Chen | ||
| + | Date: Thursday, March 24, 2011 | ||
| + | |||
| + | ArtusLabs, a business intelligence and data management company in Durham backed by [[:Hatteras Venture Partners]] and [[:Southern Capitol Ventures]] has been acquired by PerkinElmer. ((https:// | ||
| ==== Interview with Robin Smith, CEO of ORIG3N ==== | ==== Interview with Robin Smith, CEO of ORIG3N ==== | ||
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| I have an unusual background and history. My father was in the Air Force, and I was born in Korea. My mother is Korean and my father is American, so every three years of my life I ended up moving to a new place and having to learn new things and meet new people. When you have that background, the life of an entrepreneur is not much different. | I have an unusual background and history. My father was in the Air Force, and I was born in Korea. My mother is Korean and my father is American, so every three years of my life I ended up moving to a new place and having to learn new things and meet new people. When you have that background, the life of an entrepreneur is not much different. | ||
| - | I sold my last company to PerkinElmer and thought that would kind of be it. It was a tremendous opportunity to drive large scale innovation with a storied American research firm. At that time, I was working at PerkinElmer and was heading up their R&D group, and then my father got diagnosed with lung cancer. Because I was in a military family, I grew up in a different socioeconomic class than I am now. Today, I live in Boston, run a biotech company, and live downtown. I have a different lifestyle than my family when I was growing up, who now live in eastern North Carolina. When I went down to spent time with my dad at the hospital, I felt like I had walked into 1940 or 1950. ((https:// | + | I sold my last company to PerkinElmer and thought that would kind of be it. It was a tremendous opportunity to drive large scale innovation with a storied American research firm. At that time, I was working at PerkinElmer and was heading up their R&D group, and then my father got diagnosed with lung cancer. Because I was in a military family, I grew up in a different socioeconomic class than I am now. Today, I live in Boston, run a biotech company, and live downtown. I have a different lifestyle than my family when I was growing up, who now live in eastern North Carolina. When I went down to spent time with my dad at the hospital, I felt like I had walked into 1940 or 1950. ((https:// |
| + | |||
| + | {{ :: | ||
| + | ==== Orig3n 2019 Novel Coronavirus (COVID-19) Test ==== | ||
| + | |||
| + | EUA200068 | ||
| + | |||
| + | * April 10, 2020 | ||
| + | * Robin Y. Smith, | ||
| + | * President and Chief Executive Officer | ||
| + | * [[: | ||
| + | * 27 Drydock Ave., 3rd Floor, | ||
| + | * Boston, MA 02210 US | ||
| + | |||
| + | |||
| + | * Re: EUA200068 | ||
| + | * Trade/ | ||
| + | * Laboratory: Orig3n, Inc. Laboratory | ||
| + | * Dated: March 25, 2020 | ||
| + | * Received: March 25, 2020 | ||
| + | |||
| + | |||
| + | Dear Robin Smith: | ||
| + | This letter is in response to your request that the [[:Food and Drug Administration]] (FDA) add your test as an | ||
| + | authorized test to the March 31, 2020 [[: | ||
| + | Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3). | ||
| + | |||
| + | We have reviewed the EUA submission package and determined that your test meets the criteria for issuance under section 564(c) of the Act **because your test is eligible for authorization under the March 31, 2020 EUA for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid** from [[: | ||
| + | |||
| + | Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am | ||
| + | **adding this test to Appendix A as an authorized test**, as described in the Scope of Authorization (Section II) and | ||
| + | pursuant to the Conditions of Authorization (Section IV) of the attached letter of authorization2 for use by the | ||
| + | authorized laboratory to detect SARS-CoV-2 in specimens collected from individuals suspected of COVID-19 by their | ||
| + | healthcare provider. | ||
| + | |||
| + | Accordingly, | ||
| + | and the authorized Healthcare Provider and Patient Fact Sheets that must be used in conjunction with your | ||
| + | authorized test pursuant to the Conditions of Authorization (Section IV) of the Letter of Authorization. | ||
| - | ==== FDA COVID-19 Testing ==== | + | Sincerely yours, |
| + | ____________________________ | ||
| + | [[:Uwe Scherf]], M.Sc., Ph.D. | ||
| + | Director, Division of Microbiology Devices | ||
| + | OHT7: Office of In Vitro Diagnostics and Radiological Health | ||
| + | Office of Product Evaluation and Quality | ||
| + | Center for Devices and Radiological Health | ||
| + | 1 Appendix A ((https:// | ||
| - | EUA200068 - Trade/ | ||
| - | {{ :: | ||