Canyon Lake, Tonto National Forest Arizona, USA, October 2019.
Pharmalorax Consulting Company
is dedicated to change management
Our approach
Pharmalorax is fundamentally a scientific consultancy. Science and technology however, are human endeavors. Therefore, the scope of our blog is broad enough to include all aspects of human activity relevant to value creation for patients and other stakeholders in another man-made ecosystem: drug discovery and development.
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.
Remote and (eventually) in-person options.
Pharmalorax Consulting, located in Shrewsbury, Massachusetts, USA is prepared to conduct all business remotely until travel is considered a safe and effective option.
Pharmalorax Scope
Where are the Cutting Edges?
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 was the cutting edge of biopharmaceutical technology. Today the cutting edge of biopharmaceuticals is making transgenic people. In them, successfully-treated cells make/stop making a specific macromolecule which previously had to be provided as a medicine or counteracted with a different medicine because the endogenous macromolecule was a disease agent. Today, in contrast to 1990, protein biopharmaceuticals frequently qualify as "well characterized" meaning there are validated and robust means to ensure the product safety, identity, strength, quality and potency.
The genetic selection of patients in whom cancer genotypes match the susceptibility profile of a rationally designed drug is new and effective cutting edge in biopharmaceutical technology.
A third cutting edge is one which carried forward: the understanding and modification of immune responses so that a treated person's lymphatic system can more appropriately respond to agents at risk for the potential to cause illness.
The Drug Discovery and Development Ecosystem Dynamic
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.
When not pursuing scientific interests Louise enjoys family, reading, gardening, needle work, choral singing, and travel.
Contact Information
To initiate discusssion of a Pharmalorax Consulting project,
send email to : lgarone@pharmalorax.com
For additional information about Louise Garone see Linked in
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