https://www.pharmalorax.com/blog daily 0.75 2024-04-01 https://www.pharmalorax.com/blog/philosopy-of-education-n3tye monthly 0.5 2024-04-01 https://images.squarespace-cdn.com/content/v1/5f56653a4097795014e94e15/8aea34df-70f4-486a-a349-e40eeb8732f0/EdPhiloFig1.jpg Pharmalorax Blog - Philosopy of Education (Updated 26 July 2022) - Make it stand out Figure 1. Overview of Translational Science to Educate for Careers in Health and Community Care https://www.pharmalorax.com/blog/black-lives-matter monthly 0.5 2024-04-01 https://images.squarespace-cdn.com/content/v1/5f56653a4097795014e94e15/1599525249035-C6M08ZNRA19HC6A28HMR/Whatie+Fragility_flow.jpg Pharmalorax Blog - Black Lives Matter https://www.pharmalorax.com/blog/books-are-important monthly 0.5 2022-02-21 https://www.pharmalorax.com/blog/the-cutting-edge monthly 0.5 2020-09-09 https://images.squarespace-cdn.com/content/v1/5f56653a4097795014e94e15/1599656120167-4FIFVOYU9V0NQ5U6ULO6/Amaranth%2Bseeds.jpg Pharmalorax Blog - The Cutting Edge - The photograph at left shows freshly-harvested amaranth seeds. The cutting edge in my garden's technology is improving efficiency of the gravity separation used to separate amaranth seeds from the chaff and stems. Thirty years ago producing a human blood protein in the milk of transgenic goats, and establishing its pharmaceutical safety and efficacy, was the cutting edge of drug discovery and development. https://www.pharmalorax.com/blog/2020-garden monthly 0.5 2020-09-08 https://images.squarespace-cdn.com/content/v1/5f56653a4097795014e94e15/1599530514871-YA0KU8KCHXNTVXVRHCU8/20200730_123003.jpg Pharmalorax Blog - 2020 Garden https://images.squarespace-cdn.com/content/v1/5f56653a4097795014e94e15/1599530549104-CPVY4PQUAOMSKBD2V9X2/20200804_160621.jpg Pharmalorax Blog - 2020 Garden https://images.squarespace-cdn.com/content/v1/5f56653a4097795014e94e15/1599530574249-FATFGMMMN7L93QSYVKZD/20200801_150419.jpg Pharmalorax Blog - 2020 Garden https://images.squarespace-cdn.com/content/v1/5f56653a4097795014e94e15/1599530591422-0ESQELK7FAHHPK945DRB/20200705_141222.jpg Pharmalorax Blog - 2020 Garden https://images.squarespace-cdn.com/content/v1/5f56653a4097795014e94e15/1599530618460-VANBG58EMW43SZOLLGQT/20200730_122802.jpg Pharmalorax Blog - 2020 Garden https://images.squarespace-cdn.com/content/v1/5f56653a4097795014e94e15/1599530638548-RBOJK334Y43PISB2P0E8/20200727_081512.jpg Pharmalorax Blog - 2020 Garden https://images.squarespace-cdn.com/content/v1/5f56653a4097795014e94e15/1599530225802-UVP5UHCTI8QL5TYEE5F9/20200614_131456.jpg Pharmalorax Blog - 2020 Garden - My garden was not perfectly rectangular… https://images.squarespace-cdn.com/content/v1/5f56653a4097795014e94e15/1599527621568-Y06OOB36NI2IBWTD9FL1/20200727_074020.jpg Pharmalorax Blog - 2020 Garden …but it has been productive https://www.pharmalorax.com/our-approach daily 0.75 2020-09-07 https://www.pharmalorax.com/contact daily 0.75 2022-02-21 https://www.pharmalorax.com/team daily 0.75 2023-05-09 https://images.squarespace-cdn.com/content/v1/5f56653a4097795014e94e15/1599534964473-K8J3OABJDQ9DZNB0FRKR/20190507_210341.jpg Team Louise Garone A biopharmaceutical project team comprises colleagues with expertise in Research, Analysis, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, Clinical Development, Compliance, and Marketing. Trained to contribute and lead as an analytical biochemist, Louise worked on products at all lifecycle stages from Discovery through Commercial Manufacturing during her 29-year tenure in the industry. Whether your product is at a cutting edge or aspiring to be well characterized Pharmalorax Consulting may be able to help your company organize and manage change. I am strongly committed to transparent interdisciplinary conversation on all scientific topics as well as to those in “soft” areas like group dynamics and individual performance. I am a lifelong ally of diversity, equity, inclusion, and respect. https://www.pharmalorax.com/home2 daily 1.0 2023-05-09 https://www.pharmalorax.com/home daily 0.75 2020-09-08 https://images.squarespace-cdn.com/content/v1/5f56653a4097795014e94e15/1599508378172-H4L3H3GZC0CMGKERO1Q8/20170507_143036.jpg Home Innovation, Failure, and Discovery Innovation means seeing an entity, problem or process differently and using using that novel insight to make or do something in a new and more functional way. Innovation usually happens at the individual or group level of humanity. About three years ago I lost footing and fell while hiking on a glacier. My husband turned and captured (shown at left) the embarassed shout out "I am fine". Nevertheless our guide halted the group, came to me, and documented the event to the base camp. Walking with crampons on their boots was a new experience for most so I was the first, but not the last person, to fall on that tour. Although uninjured, I moved more carefully thereafter because I wanted to complete the trail. This vignette illustrates how the misstep that results in Failure (falling down) can, and did, motivate a productive behavior change. Aggregate levels of humanity (groups, families, companies, societies) also experience failures that motivate conscious adjustment of behavior to achieve the group’s goals. Discovery means seeing, making, or doing something not observed, made or done before. Discovery occurs at all levels of human organization and ranges from simple breakthroughs in understanding by an individual to the formulation and endorsement, by large groups, of a science and technology paradigm-shifting idea. Each path converging in a company's change management system traces back to some innovation, failure, or discovery. Nevertheless, these take quite different routes to implementation under the same industry guidance, compliance documents, quality procedures, and processes. The mission of Pharmalorax Consulting is to help companies make appropriate changes efficiently. https://images.squarespace-cdn.com/content/v1/5f56653a4097795014e94e15/1599510647781-FIE1CKRXPU3OWBQRUAD2/20190507_210341.jpg Home - Dr. Louise Garone formed Pharmalorax to keep a hand in the community of which she has been a member for the past 29y, after having retired as a professional biochemist. The company goal is to provide access to change management consulting services, should those be needed. Louise retired from Takeda Pharmaceuticals (d.b.a. Millennium Pharmaceuticals) as Associate Director of Commercial Quality Control Analytical Development . During her five-year tenure with Takeda Louise supported the campaigns to transfer noncompendial tests and verify compendial analytical methods to new manufacturing sites. Those campaigns ran in conjunction with scope expansion or full process transfer for two major commercial products, and her work was conducted in close collaboration with R&D, Operations and Quality Assurance colleagues. It included design strategy, finances, reporting and ownership of relevant change controls in accord with the interacting companies’ policies and procedures. Louise also served as lead author and/or matrix reviewer for selected CMC sections, and for QC response to questions which arose during global regulatory filing for these and other projects. A lifelong ally of diversity, equity and inclusion, Louise is strongly committed to open and transparent quality conversations on topics but performance, in paarticular. Prior to Takeda Louise held USA-based positions with Enterprise System Partners, a serialization and ERP consulting firm based in Cork, Ireland, with Lonza Biologics (Visp, Switzerland), with Merck Serono (Darmstadt, Germany) and with Genzyme. She is a member of the American Association for the Advancement of Science, the American Chemical Society, the Protein Society, the Biophysical Society and the American Society for Mass Spectrometry. hand-drawn empty pill bottle icon https://images.squarespace-cdn.com/content/v1/5f56653a4097795014e94e15/1599509843453-CN8DTKZ90D2DBY02EHKJ/Amaranth%2Bseeds_big.jpg Home - The photograph at left shows freshly-harvested amaranth seeds. The cutting edge in my garden's technology is improving efficiency of the gravity separation used to separate amaranth seeds from the chaff and stems. hand-drawn armchair icon https://www.pharmalorax.com/services daily 0.75 2024-09-07 https://images.squarespace-cdn.com/content/v1/5f56653a4097795014e94e15/1600125963153-ITNMJE3TSWG3V0IIZ5SK/Change+Drivers.jpg Services https://images.squarespace-cdn.com/content/v1/5f56653a4097795014e94e15/1600125465756-H2J3FHKXJX7POIEKBLHC/20170507_143036.jpg Services My Opinions on Discovery, Innovation, and Failure