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| robin_smith [2022/12/04 06:12] pamela | robin_smith [2022/12/05 08:18] (current) pamela | ||
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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 | + | ==== Orig3n |
| - | EUA200068 - Trade/ | + | EUA200068 - Trade/ |
| * April 10, 2020 | * April 10, 2020 | ||
| * Robin Y. Smith, | * Robin Y. Smith, | ||
| * President and Chief Executive Officer | * President and Chief Executive Officer | ||
| - | * Orig3n, Inc. | + | * [[:Orig3n]], Inc. |
| * 27 Drydock Ave., 3rd Floor, | * 27 Drydock Ave., 3rd Floor, | ||
| * Boston, MA 02210 US | * Boston, MA 02210 US | ||
| + | |||
| + | |||
| * Re: EUA200068 | * Re: EUA200068 | ||
| * Trade/ | * Trade/ | ||
| Line 42: | Line 65: | ||
| Dear Robin Smith: | Dear Robin Smith: | ||
| - | This letter is in response to your request that the Food and Drug Administration (FDA) add your test as an | + | 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 Emergency Use Authorization (EUA), pursuant to Section 564 of the Federal | + | authorized test to the March 31, 2020 [[:Emergency Use Authorization]] (EUA), pursuant to Section 564 of the Federal |
| Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3). | 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 SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test). As such, your test is hereby added to Appendix A1 as an authorized test. | + | 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 [[:SARS-CoV-2]] (Molecular LDT COVID-19 Authorized Test). As such, your test is hereby added to Appendix A1 as an authorized test. |
| Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am | 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 | + | **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 | 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 | authorized laboratory to detect SARS-CoV-2 in specimens collected from individuals suspected of COVID-19 by their | ||
| Line 65: | Line 88: | ||
| Office of Product Evaluation and Quality | Office of Product Evaluation and Quality | ||
| Center for Devices and Radiological Health | Center for Devices and Radiological Health | ||
| - | 1 Appendix A is available at, h | + | 1 Appendix A ((https:// |