Biopharmaceuticals And Medical Devices: A General Overview III (Medical Devices)

Drugs Part I

Drugs Part II

(Note:  As with Drugs above, this is a very high level view of a very complex and multi-year process and is only intended as an overview.)

A proposed Medical Device definition is "A contrivance designed and manufactured for use in healthcare, and not solely medicinal or nutritional".  A more "conventional" regulatory definition is here: in short if your item is intended to treat, cure, mitigate, or prevent disease and is intended to impact a human or animal system not using a chemical action internally and/or not activated via metabolic systems, it is a device.

So to answer the question, lots of things are a medical device.  A tongue depressor counts.  So does a scalpel.  So does a hospital bed.  So does an MRI machine.

But, all devices are not created equal and so there are classifications for devices.  In the United States, there are three classes (Class I, Class II, Class II) which are identified based on their risk to patient and user.  Class I is the "least" risky, Class III is the "most' risky.

There are distinct steps for designing a medical device - perhaps unlike Drugs, the process is a lot more standardized.  These steps are found in the US Document CFR 21 Part 820 (Quality System Regulations) and in the ISO Standard 13485 (Medical Devices - Quality Management Systems).

Design

All devices start with identifying User Needs:  what does the end user (patient, medical personnel, even marketing) need the product to do or be?   This is much more of an activity that it may seem, as it can involve getting input from a great many sources.   The User Need will be phrased in the form of a statement - for our purposes today, we will identify a User Need as "The product casing should be blue".

User Needs are then usef to generate Design Inputs, which are "The physical and performance requirements of a device which are used as a basis for device design" (21 CFR 820.3 (f)).  Each Design Input must be individually identified and must be clear, unambiguous, and non-conflicting with any other Design Input. As you can imagine, this will lead to hundreds or even thousands of Design Inputs.  Our example above will be translated into "The product casing must be Pantone Classic Blue Part Number #19-4052".   That may seem very specific - and it is intended to be.  Each input must be able to be objectively verified.

At this point a Design Review Team will be called together.  This will consist of personnel from all concerned departments - R&D, Engineering, Quality, Regulatory, Marketing/Business Development, Manufacturing, Supply Chain - and an Independent Reviewer who is not directly involved in the project but has the educational and scientific basis to assess the project.  All will be reviewed, unclear inputs corrected, additional needs identified.  When all agree on the User Needs and Design Inputs, the project will move to Design Output/Design Verification.

Design Outputs are "the results of a design effort at each design phase and at the end of the total design effort" (21 CFR Part 820.3 (g)).  The outputs will form the basis of the final design documentation - batch records, testing, labeling, etc.).  Each Design Input will have a Design Output which will need to be independently verified.  All of these Design Outputs will be putting into a Design Verification Protocol - again for our example, the Design Output would need to be "Product casing color is verified as Pantone Classic Blue Part Number #19-4052" - likely pulled from the manufacturing documentation for the casing in this case.

Another Design Review will take place to ensure that there are no new User Needs or Design Inputs, that all Design Inputs have Design Outputs, and that the Design Outputs are verifiable.  If approvable, it moves to Design Verification.

Design Verification is (rather straightforwardly) ensuring the Design Input meets the Design Output.  Personnel will move through the Design Verification protocol and verify and/or test every single Design Input.  Each Design Output will be recorded as meeting the Design Input, partially meeting the Design Input, or not meeting the Design Input.  At the end of this process the Design Verification Protocol will be reviewed and those Design Outputs which are found to not fully meeting the Design Inputs will be reviewed for additional clarification, correction, and testing.  In our example, if the manufacturing paperwork could not verify that Pantone #19-4052 was used on the casing, this would need to be resolved by an investigation and perhaps a remanufacture of the part - or, the User Need could be re-examined to see if that shade of blue is really needed, or just any "blue".

Assuming all items have been identified, a Design Verification Report is generated, to be presented to the Design Review Committee for approval. 

As you can imagine, there is a lot of documentation (physical or electronic) generated by this.  One of the most critical items is the Design Trace Matrix, which traces each User Need to Design Input to Design Output to Design Verification Result.  This document allows complete traceability up and down the design process.

A note:  This process takes place for each major component of the system.  For a system that has hardware/instrumentation, software and firmware, and consumables/reagents, every item will have a design history.  

The product is ready to move to Clinical Validation.

Risk Management

As noted above, the consideration of risk is a primary factor in determining the classification of product.  A risk - in Medical Device terms - is the combination of the probability of the occurrence of harm (injury or damage to people, property, or the environment) and the severity (measure of the consequences of a hazard) of that harm.  The ISO standard 14971 defines the risk management standard and is really the gold standard for all risk management (and largely a universal consensus standard).

A very short definition (for a very long process) is that intended use of the device and its use conditions are identified, along with what safety would look like and potential hazards and harms identified (including not just impact on the patient, but on the user (electrical hazards, chemical hazards) and the environment (spills, disposal of reagents)).  Using a numerical system, the risk are graded and evaluated.  Where risks exceed an acceptable level due to impact or frequency, risk mitigation and/or controls will need to be introduced, which may very well impact the Design Inputs/Design Outputs/Design Verification which in turn may then require another Design Review Meeting.

Another useful tool is the Failure Mode and Effects Analysis (FMEA) or the Failure Mode Effects and Criticality Analysis (FMECA).  Every potential failure mode is identified and evaluated against probability of occurrence, severity of that occurrence, and impact of the occurrence (for the FMECA, criticality of the failure is also evaluated).  Again, a rubric is used to evaluate unacceptable levels of failures.

The point of this entire exercise is to identify all risks and move them to acceptable risk levels (sometimes called "residual risk levels").  Like drugs, all medical devices entail some kind of risk; the goal is to remove as much risk of failure as possible and control the rest. 

Using our example above, the risk would be assessed under "What is the impact if the casing is not Pantone #19-4052"?  Possibly nothing - but perhaps in a clinical lab setting, that shade of blue may be not be able to be discerned for certain vision issues and could conflict with other similar pieces of equipment.

As with the Design Process, there are multiple iterations of the Risk Management Process.  The final documents will be held in a Risk Management File, which should contain every known risk for the product.  When a new risk is uncovered (either in development or in use), it should get added to the Risk Management file and assessed - in some cases, it may entail a  redesign.

(A note for general use:  Risk can only be avoided, mitigated, transferred or shared (to someone/something else), or accepted. True in real life as well as in medical devices.)

Validation

Validation (or as it is often known "Clinical Validation") is the use of the product in the potential use environment.  The difference between verification and validation, if helpful is:

Verification:  Did we make the thing right (e.g., per the Design Inputs)?

Validation:  Did we make the right thing (e.g. per the User Needs)?

A protocol will be developed and clinical sites engaged as well as all items approved by the Design Review Board.  Similar to the clinical process as identified in Drug Overview Part II, there is a whole set of processes involved to insure patient safety and control of the clinical trial. 

At the conclusion of the Clinical Validation, a final report will be generated. The results of the Design Verification will be added to the Design Trace Matrix so there is complete transparency up and down the design chain from User Need to Design Validation.  Any Design Issues or new Risks will need to be addressed, and possibly a second Clinical Validation conducted  Once all issues have been resolved and the report issued, the product will be ready for regulatory submission.

Quality Systems

Underlying all of this, of course, are Quality Systems. Just as with Drugs, there needs to be a system which ensures that all products are documented, manufactured, and released per written procedures and per the approved Design Documents. Just as with drugs, one needs a Quality Manual (corporate statement and discussion of the systems to ensure Quality), Standard Operating Procedures to cover systems like documentation, manufacture, material receiving and testing, product testing, and release.  Materials have to purchased and verified per specification.  Manufacturing facilities need to be maintained for cleanliness and environmental control.  Manufacturing equipment has to be purchased, qualified, and maintained.  Records have to be retained.  The individual Device History Records (batch records for manufacture) need to be created, approved, and executed.  The Device Master File, including the Design History, the Risk Management File, and all documents need to make the product, needs to be controlled and maintained.  Personnel need to be qualified and trained.  Variances like deviations and nonconformities need to be captured and assessed.  Improvements in the form of Corrective Actions and Preventive Actions need to be identified, investigated, and executed.

In short, everything that was done for Drugs is effectively also done for Medical Devices.

Tomorrow, we will discuss Intellectual Property, Regulatory Submissions, and Commercialization.

Biopharmaceuticals And Medical Devices: A General Overview II (Drugs)

 In Biopharmaceuticals And Medical Devices: A General Overview I, we looked at the underlying basis of all drugs (pharmaceuticals and biologics) and discussed the development of a compound from initial discovery to the completion of Non-Clinical Laboratory Studies and the decision to move forward.  Today, we are picking up with starting clinical manufacture and clinical trials.

There are really three streams here:  clinical trials, clinical manufacture, and regulatory submission.  I am going to defer the regulatory submissions to later in the week as there are some small similarities with the Medical Device process.

Clinical Manufacture

Clinical manufacture is the manufacture of a drug to support a clinical trial.

Typically, clinical manufacture is divided into two phases, the manufacture of the actual compound (called an "Active Pharmaceutical Ingredient" for pharmaceuticals and "Drug Substance" for biologics) and the manufacture of the finished form of the product such as pills, capsules, filled liquid vials, lyophilized solutions, etc. called the  Drug Product.

The work done in the investigatory and pilot plant manufacture will be scaled up in volume to support the clinical trial, for example from a 5 L fermentation to a 50 L fermentation to a 600 L or 1000 L fermentation.  Process Development will work to find the ideal conditions for manufacture and all required buffers, medias, or reagents.  Process Sciences will develop criteria to evaluate the product - called "specifications" - which will allow testing during manufacture ("in process"), after manufacturing ("release"), or over time to evaluate how long the drug product remains "good" ("stability").  They will also identify tests to support these criteria.  

At some point, the developed process and associated tests and specifications will be transferred to the Operations Group.  Here, a variety of operations - Manufacturing, Quality Assurance, Purchasing and Supply Chain, Quality Control - will purchase and test incoming raw materials, write and approve manufacturing records for every part of the process, write and approve testing documents for all identified tests, and create final release documents so the product can be evaluated and made available for clinical trials.  The facility to be used will have to demonstrate that the meet the required regulatory and physical conditions for manufacture including temperature and humidity control, air particulate control, and micro-organism control. The equipment to be used - both manufacturing and testing - will need to be qualified to verify it is installed correctly, works correctly, and works for the process. Likewise, all quality control testing will have to be qualified to verify that the tests are repeatable, give verified data, and can be performed by multiple personnel potentially in different labs.

One note: development of the manufacturing process and manufacturing may be conducted in-house at the company or outsourced to a third party vendor, called a Contract Manufacturing Organization ("CMO") or Contract Development and Manufacturing Organization ("CDMO").  There are trade-offs between time and money; for many small companies they have no choice but to use a CMO as building out and qualifying an in-house manufacturing plant can be expensive and time consuming.

In the background of all of this (and by regulation), every company has a Quality System, which is the System put in place to guarantee that all product manufacture is conducted in such a fashion to ensure the identity, strength, purity, quality, and safety of the product.  This includes instructions on how to do things ("Standard Operating Procedures", or SOPs) for every aspect of the organization that is regulated, how to evaluate issues and failures (Deviations or Nonconformities), how to make improvements (Corrective Actions and Preventive Actions), how to manufacture and test the product (as above), and how to release the product. For all of these documents, evidence of training must exist.

Assuming all of this is in place, manufacturing will start.

Manufacturing will often start with a "non-GMP" batch, sometimes called an Engineering Batch.  This lot cannot be used for clinical trials but can demonstrate that the process can generate the Drug API/Drug Substance/Finished Product at sufficient scale and with sufficient quality.  If successful, manufacturing will move into GMP/ Clinical Trial material mode.

As trials advance (see below) the manufacturing and testing will progress as well.  As more is known about the product, tighter controls will need to be put in place.  Sometimes a problem only reveals itself over time through stability, which may mean going back to development.  Better and more extensive testing will develop.  And the process size will scale up as well to support commercial manufacture; for biological products, up to 20,000 L fermentation vessels exist for manufacturing

Clinical Trials

Clinical trials for Drugs in the U.S. (and largely, the world) are divided into three phases.  Each phase gathers information about the product and its impact on patients, but each phase also has a primary goal:

Phase 1 (also Phase I or P1) evaluates safety, or "Is the product (at a high level) safe?"

Phase 2 (also Phase II or P2) evaluates efficacy, or "Does the product do what we think it should do?"

Phase 3 (also Phase III or P3) evaluates dosing range, or "What is the best dosing level that maximizes benefit and minimizes patient impact?"

The primary concern of all Clinical Trials is ultimately the safety of the patient (this largely derives from World War II, where live in human testing was conducted (Read up on the testing in concentration camps and Unit 731 of the Imperial Japanese Army.  It is horrifying.).  To this end, 21 CFR Part include items specifically around the involvement of patients, physicians, and companies (Parts 50, 54, 56, and 312) as well as the International Committee on Harmonization document E6.  In short, patients must be fully informed and able to withdraw at any time.  Physicians cannot have a significant financial interest in a company for which they are testing a Drug Product.  An Independent Review Board ("IRB") must review all documents associated with a trial and make sure it protects patients, is ethical, and is scientifically justified.

To use an unapproved Drug Product ("investigational drug" in the regulated world) in humans, the company ("Sponsor")  is governed by 21 CFR Part 21 Part 312, Investigational New Drug Application.  In short, one has to provide an Investigational New Drug Application (called an "IND") and have it approved by the US FDA prior to starting the trial.

The IND will provide a description of the product, a history of its development, proposed release and stability criteria,  a summary of the Non-Clinical Laboratory Studies (GLP and non-GLP Compliant), and the proposed Clinical documentation.

Leading up to the IND, the company is developing documentation for the Clinical Trial:  an Investigator's Brochure, to explain the product and the trial to physicians and site staff; a Pharmacy Manual to explain how to prepare the product for patient use; an Informed Consent which explains to the patients about the trial and their potential participation and potential risks; a Clinical Protocol, which explains how the trial is to be conducted, what is to be tested, how patients should be included or excluded based on criteria, and the endpoints of the trial; the Statistical Analysis Plan created, which ensures that the study has the minimum of number of patients to power the study statistically and can deliver definitive data; and the Clinical Trial Documentation, which is used to record all data for the trial (often this is now electronic).  All of the documents are reviewed and approved internally by the company, by the IRB and by the FDA upon submission of the IND.  Any of these parties can require changes to any of these documents, which then need re-approval.

At the same time, the company is also identifying sites which would be willing to conduct the clinical trial. This is a lot more work that it may sound like:  there are always more trials than sites and some sites are more desirable than others.  For each site a contract must be written and signed, a budget prepared and approved (sites are paid to conduct these trials), all the documentation above provided, and supporting supplies provided.

Conduct of the Clinical Trial

Assuming all the product is manufactured and approved, all clinical documentation is approved, clinical sites have been identified and initiated, and the IND has been approved (or revised and approved as needed), the clinical trial can start.

Clinical trials escalate in size and scope as they progress.  A Phase 1 trial can have as few as 20 patients and 3 sites; a Phase 3 trial can have as many as 7,000 patients and multiple sites in multiple countries.  Study progress is based on the ability to enroll subjects - and have them complete the program.  Not all patients can be evaluated.  Patients may be rare, depending on the inclusion criteria.  If an Unexpected Adverse Event or Serious Adverse Event happens - something that causes transient, partial, or permanent damage to the patient including death or disablement - the trial may be stopped temporarily or permanently. 

During the trial, company personnel from the Clinical, Medical Affairs, Regulatory Affairs, and Quality Assurance departments work intensely with the sites.  Clinical Trial Monitors or Clinical Trial Associates contact and/or visit sites frequently to check up on the trial and audit documentation and product.  Medical Affairs personnel assess data and answer questions.  Quality Assurance evaluates potential complaints.  Regulatory Affairs reports any Unexpected or Serious Adverse events to the Regulatory Authorities.  Meanwhile as needed, Manufacturing, Purchasing and Supply Chain, Quality Assurance, Facilities, and Quality Control continue to do their jobs to ensure that Drug is available for the study.

Periodically the trial may be evaluated by statisticians to evaluate the data.  There may be a reason to cut the trial short, either because the data is overwhelmingly indicative of the endpoints or the data demonstrates no progress to the endpoints or is even risky.

Thoughts

As you can hopefully see, there is a lot to "testing the product in a person".

Perhaps unsurprisingly, a main factor is cost - not just of the all the work to make the product and get to the clinical trial, but for the clinical trial itself.  I would hesitate to provide a number for even the most basic of clinical trials, but it is easily in the millions of dollars for a Phase 1 trial - and goes up from there.  

And the cost escalates of course.  Phase 2 trials are more expensive than Phase 1 trials, and Phase 3 trials are even more expensive.  And the cost of scaling up manufacturing and testing increases as well.  

The funding of a company really determines its future at these stage. Most companies have enough funding to complete a Phase 1 clinical trial.  The hope is that the data from that Phase 1 trial will support getting additional funding to continue to Phase 2, then Phase 3.  Obviously, a failed Phase 1 trial pretty much can spell doom for an early stage company and many layoffs occur after a "setback" in the Phase 1 trial.

But it can happen at any step.  Phase 2 trials fail as well, and Phase 3 also.  The cost of those failures is significantly increased in terms of money as well as prestige:  a Phase 3 trial means that at some point, some signal was missed in an earlier trial.  This can reflect poorly on the company's executive management and scientific basis.  Established companies with commercial products can survive this; most non-commercial companies cannot.

And we have still not arrived at the ability to sell a single Drug Product and thus generate any revenue for all of the work done to date.

Tomorrow we will turn our attention to Medical Devices and how they reach this same point of pre-submission.

Biopharmaceuticals And Medical Devices: A General Overview I (Drugs)

FOTB (Friend Of This Blog) Leigh from Five Acres and A Dream made the following comment in my update on Week 4 of Hammerfall 3.0:

"Being in the "retired category of folks myself, I feel really out of the loop in understanding such things, but I have to ask why your particular industry seems to be struggling so.  I mean (probably naively), it's in the medical/health care arena, and people always need these things, so it would seem that the demand for the supply should keep the industry thriving.  I'm guessing the answer is extremely complicated but it's one of those things that just doesn't make sense."

It is a fair question - after all, the Pharmaceutical/Biotechnology/Medical Device Industry impacts almost everyone at some point (if you have used an aspirin or a bandage, you have participated).  Hopefully I can shed some illumination.  

For reference how I know about this: I have over 25 years of experience in the industry in Manufacturing, Quality, and Project Management had have worked for almost every type of manufacturer (pharmaceutical, biologic, medical device) for products being developed, products in the approval process, and approved products.

I will start with Biopharmaceuticals and then move to Medical Devices.

(Note 1:  This is a very generalized description of the process.  There is a lot of underlying details and processes which, while important, would rapidly spiral of control.)

(Note 2:  For the purposes of this discussion,  I will just use "Drugs" to describe both pharmaceuticals and biologics.)

The most important thing to remember about all of this is that all Drugs in the U.S., be they small molecule (e.g., generated by chemical or "pharmaceutical") or large molecule (generated by biologic process,  or "biologics") are regulated by U.S. Law.  The history of how we got here is long, but suffice it to say in our day, the US Food and Drug Administration (FDA) is responsible for ensuring that all drugs are safe and effective.  The origins of this authority are found in the 1938 Food, Drug, and Cosmetic Act (FD&C Act) and have been expanded ever since.  The regulations for drug manufacture (and much of biologic manufacture) is found in the Code of Federal Regulations (CFR), Title 21, Parts 210 and 211 (and part 600 for certain biologics).  

Unlike International Standards like the International Standards Organization (ISO) or the International Committee on Harmonization (ICH), these regulations must be complied with (as opposed to the standards, which must be conformed to) - unless the standards have been taken into U.S. law as a consensus standard (which many have been).  Every nation has their own set of regulations that must be complied with:  for example, if you are going to sell products in the U.S. and Europe, you have two sets of regulations to comply with.  Often these are similar, but sometimes there are differences which can be significant and must be planned for.

Thus everything that has to do with drug development and drug manufacture is regulated.  The closer one gets to submission for approval, the more regulated things become.

The second most important thing to remember is that all Drugs have side effects.  Every single one.  Drugs are thus evaluated on a risk/benefit basis: does the benefit of a drug outweigh the risks and impacts?  Everyone is familiar with the impact of chemotherapy on the individual in terms of visible impacts (loss of fast growing cells like hair follicles) and not quite as visible impacts (loss of appetite, nausea, loss of ability to taste, lowered immune resistance).  In this case, the benefit (fighting cancer) outweighs the impacts and risk (all the physical impacts above and, frankly, dying of an infection due to a lowered immune system).

Drugs all start in a lab.  There is a promising compound or a significant unmet need that drives scientists to look for a solution.  After going through hundreds or even thousands of compounds (via lab screening or computer models), they discover one which (maybe) has an effect on a condition on a medical condition.  Most likely it is perceived as a novel impact, as "me-too" drugs have a higher bar to succeed in the market.  Also, multiple labs may be working on the same condition, so the development becomes a race to be first (for a novel compound) or a race to be more effective (where a drug already exists for a condition).

Once a compound is identified, it has to be tested to verify that it has the effect that scientists think it has.  This is done in several ways - in silico ("in silicon", or using computer models). in vitro (literally "in glass", or under controlled laboratory conditions with the target cells or molecules), in vivo ("in the living" or using live animals (only, at this point - live humans come later),  Generally the progression is from in silico (where available) to in vitro (cell studies) to in vivo (animal testing).  At the same time as the product is being tested, a basic manufacturing process is being designed:  what conditions, what medias and buffers, what manufacturing steps have to be in place to make "the compound".  Not only does the compound need to have an effect, it needs to be able to be manufactured.

Assuming we now have the compound, it has to be put through some level of paces to make sure it is worth moving forward with.  Typically the product will be characterized (to learn all they can about it) and placed against a set of criteria that will define if the product meets the anticipated needs of the criteria identified (sometimes called "Target Product Profile") and can be manufactured.  If it meets both criteria, it will move forward (if not, of course, it gets discontinued).   At the point (or slightly before), small scale lots (pilot lots) will be manufactured and animal testing starts.

No-one I know of in the industry is fond of animal testing (also called "Non-Clinical Laboratory" Testing), but the other option at this stage is "testing straight in people", which for some pretty strong historical reasons is a bad idea.  A species which simulates the human system or condition to be tested is selected (typically starting with mice and ending with non-human primates, but other species animals may be used based on the nature of the disease or condition being evaluated) and the product tested per a protocol.  Often, necropsy is performed and the data reviewed, looking for 1) Efficacy and 2) Impact to to the physical systems.  Pharmacokinetics (the movement of the drug through the body) and Pharmacodynamics (the biological, physiological, and molecular impact of the drug on the body) are measured.  For this testing, the controlling regulation is 21 CFR Part 58, Good Laboratory Practice for Non-Clinical Studies (also referred to as GLP).  These test can be either non-GLP (for general data generation or proof of concept) or GLP (required to move the product into clinical trials).

All of this does not come cheaply, of course.  Scientists require labs, and labs required equipment and reagents and personnel to run them.  Small manufacturing lots need a pilot plant internal to the company or an external contract manufacturing organization (CMO) to manufacture them.  And Non-Clinical laboratory studies need to be conducted:  as of last year, a small mouse study ran $250,000 at a minimum and a non-human primate study $1.3 million.  Generally there is more than one mouse study and a minimum of one major animal study (such as non-human primates).   Add to that that scheduling for these studies is anywhere from 4 months (for mice) to 9 months or more (for non-human primates).

If helpful for reference, products that I have worked on to get to this point - not including internal overhead for personnel, lab space, equipment, etc. - have cost between $2 million and $4 million.  Just to get to the point of possibly using it in an early clinical trial.

Assuming all of this data indicates 1) There is some benefit; and 2) The benefit outweighs the impact, and 3)  The compound can probably be manufactured,  the compound will likely be moved to scaled manufacture and clinical trials of the compounds in humans (which we will review tomorrow).

Obeying In Absence

 

Obedience to God is itself a challenge at times.  Obedience to God when there seems to be no evidence of God, even more challenging.

As I read this quote of Lewis', I ask myself how often this has impacted me:  How often I have been in a universe where I have seen no evidence of God actively out there and continued on?   The reflection is not a good one: more often than not, I can barely obey God (or have failed to obey Him) when I am quite aware of His presence (and what He expects of me).  

Have I ever been completely bereft of the presence of God?

A hard question.  That I can consciously think of, no.  Even when there situations where I felt that I was completely abandoned (due to existing circumstances), there was never that sense that there is no God.  But that probably speaks more to the ease of my own life rather than any real circumstance that I found myself in.

Which likely says one of two things:  Either it really has never happened, or God really does not trust me to do so in such circumstances due to my weakness of belief.

Hammerfall 3.0: Week Four Report

 Period:  06 January to 12 January

Positions applied to:  I applied to 25 positions this week.  Total jobs applied to/opportunities investigated are 56 unique positions.

Rejections:  I was rejected for three positions, two within a week of submitting to the position.  The third one was a six hour turnaround, which is my new record.

Conversations:  I had  one phone interview and one phone screen.

The phone interview was an initial interview with the hiring manager for a position in New Home consisting of 30 minutes.  I should know soon if I advance to the next round.  I will confess I am ambivalent about the position.  Based on what I heard, it sounds there is a tangled mess of overdue actions they expect the position to come in and sort out.

The second was for a 1 year contract position.  It was with recruiters - recruiters are always gamble as they are super excited and hurry-hurry to get you interested and in line, and then you may never hear from them again.  I always take it with a large grain of salt.

Job losses:  This week in my industry, job loses were announced at Organon, Affimed (German company), Exelixis, C4 Therapeutics, and Nevro:  283 Job losses confirmed plus "percentages" of others.  Possible layoffs were announced at Lifescan.  Angiodynamics announced closure of their Queensberry, and Glen Falls NY plants in Q2 2025 with up to 350 workers impacted - interestingly, they are closing down a corporate owned site and moving to a outsourced manufacturing site, something which I suspect will become more widespread this year..

Mood:  Although I have had my down periods this week (Thursday afternoon was bad), on the whole it has been an okay week.  Partially, of course, being up here at The Ranch has been therapeutic and seeing "my people" has been refreshing (as I often joke, 90% of my in-person social group is here, not in New Home).

Sending things off into the InterWeb sphere is not a very rewarding process.  Things go off and the feeling that nothing is happening is oppressive at times.  Things are happening of course; it is just that I cannot see them going on.  Sometimes just waiting for the process to work and trusting God feels like the bigger struggle than just not having a position.

On Using A Wood Stove and Independence

 During my stay here at The Ranch, I had a bit of a problem to deal with.  The dryer had gone out.  I had arranged for a visit by the local repairman (Sears seems to be the one in the area).  Sure enough, the heating element was gone and it has not been upgraded like many other parts (I suspected the heating element, but after watching some Tube of You videos, suddenly there were a lot more possibilities).  

The part was ordered.  Sure enough, it was a three day turnaround which might get here but turned out to be a 7 day turnaround (so after the part arrives, I will ask Uisdean Ruadh to open the house up and then lock it back down).  Which meant I had a week's worth of laundry that needed doing before I left

Enter the wood stove.

T-shirts and socks on ironing board; skivvies (not pictured) on hearth

It is not an ideal system of course; things will take a while to dry and likely will be drying until tomorrow.  But it was a ready solution to a problem.

Which got me to thinking about something like the wood stove.

It has a multitude of uses.  It heats the house of course - well, mostly the living room and the office and to a lesser extent, the dining room and the kitchen (bedrooms, you are out of luck).  And I use it to heat water when I am here for tea (ideally if I had a french press, for coffee as well).  When the power went out last year, I used it to make dinner (noodles) and used it just for fun while I was here to make ramen.  And now, I have found another (albeit not completely ideal) use.

It represents independence, the ability to make do for one's self.  As long as there is the stove and a supply of wood (and an occasional chimney sweep), one is not dependent on the larger system for several things.

The drier is a great convenience of course, and I do love the way clothes feel coming straight out of it.  And so is the central heating that we have here.  But I can make do (at least during my visits) without both). 

A useful thing, that wood stove.  But more useful still for what it represents.

It is freedom.

It is freedom from a lot of things.  Freedom from dependence on the power grid.  Freedom from dependence on the company that runs the power grid and the governments (local, state, federal) that are somehow involved with overseeing the power grid.  Freedom from fear in the event of a power failure.  Freedom from freezing at night.  Freedom from being unable to cook anything.

Freedom to roast a marshmallow if I desired as well, I suppose.

It strikes that this freedom, this lack of dependence, is what Our Political And Social Betters (OPASB) hate.  They hate the idea that people can live their lives without oversight.  They hate the fact that people can provide for themselves instead of relying on the social constructs, companies, and government.  They especially hate the fact that those who do such things are not "leaning in" to the idea of centralization but are "leaning out" - sometimes as quickly as they can.

Perhaps, someday, someone will make a flag for the independent lifestyle.  Might I suggest we plant a wood stove in the middle of that?  It is a symbol of both independence and independent living.

The Collapse CXXXII: Sorting

 28 June 20XX+1

My Dear Lucilius:

I awoke to the smell of bacon – dear Lord, actual frying bacon. It smelled heavenly. Crawling of my sleeping bag and freshening up to the best of my ability, I wandered around inside the circle of cars surrounding the combination post office/general store to find the bulk of the party there, watching a someone had a grill frying bacon. Apparently, somewhere, there was at least one tank of propane.

Ox shoved a foam cup into my hand of...what was this? Actual coffee, that now-become rarest of delights of which hoarded the single can remaining to me with a miser’s eye. He then pushed a plate into my hand, with something resembling a pancake like substance with something that smelled vaguely of maple. He went and added on some bacon.

As God is my witness, Lucilius, it was as if I had manna to eat.

The explanation, said Ox as I continued to wolf down this miracle of a meal, were our now dearly departed Looters – and the 40 odd Summer homes that sat right outside the improvised barrier, homes that were likely never reached by their inhabitants. Likely the looters had not only what they brought with them, but the pickings of the end of a modern economic system.

As we all finished up our meals and dabbed our faces and hands with water removing any residual stickiness, the Colonel called us all around.

There had been now signs of any Looters in the night or early in the morning; if they had other parties out in wild they either were still out there or had kept going. A guard would continue to be maintained – not just here in the now named compound, but along the houses at each edge of the development. The rest of us would spend the day sorting through the goods here and organizing them for later retrieval – this was a gold mine, not just for the town we were most closely defending but to all of the towns within the somewhat self proclaimed Garnet Valley association that had come to defend this place.

A voice popped up from the back of the crowd. It was all well and good, it said, to have defeated the Looters and to find this treasure trove. But everyone that was here had put in time and effort and resources and the time here was not the time spent back at their homes, feeding their families and taking care of the property. What was the split to be?

The crowd, seemingly jovial after a fine breakfast, tensed almost at once. It was an uncomfortable question, but a logical one and eminently practical: if the response was “nothing”, likely such a force would not be able to be gathered again so easily. If it was “everything”, we would have become no better than the looters themselves.

The Colonel, it appeared, had already thought of a solution.

One of the things found inside was at least two lock boxes; the Looters had apparently hit at least one precious metal shop on their way here. In it was a hoard of silver, junk and silver dollars. He was prepared to offer the equivalent of one dollar for every two days we had come out: counting our likely return, that would be rounded up to $5. Whatever food we had used would be replaced from what was here; whatever ammunition had been expended, the same. Other items would be on a case by case basis but in no case was there to be more than three items leaving with each person. Someone would check; woe betide the individual that disregarded that rule.

There was a moment of uncomfortable silence, then someone broke out that it even less than the last time he earned minimum wage. Laughter broke out, and the moment was broken.

With that, we were organized into work parties and went to work.

My group – With Ox and Young Xerxes – was assigned to one of the six or seven small sections that the site consisted of. Once inside, it was a mess. Things had just been randomly piled in with any real sense of order or even similarity. Some of it was old and broken, some of it looked as if it had recently come out of the houses that were outside the auto palisade. It was not getting organized any faster by us looking at it, so we started in.

Tools, both sets and the “emergency car kits” one used to find. A Barb-be-cue. A box of what may have been useful dishware at one time but was smashed into a thousand pieces by rough placement on the floor. Sectional rugs. Chairs. Flatscreen TVs – apparently the takings of all the homes around us had made their way into this place.

What was not here? Food. Drugs. Firearms of any kind, although Ox found random shells scattered about.

We made three piles, the first everything that definitively did not have a use in the world we now lived in. In the second, things which possibly had a use. In the third, the things that definitely had value. I am sure you can imagine the way the piles sorted out.

At the lunch break – beef jerky, dried fruit, water, and stale Oreos, the Captain mentioned that based on what they had found, it was likely this group had come from the nearest large city, about 50 miles away. That had a certain sense to it, especially with what we found horded away in our case – likely a group that had survived in the relatively urban environment of a college town, then started making their way out, driven by hunger and perhaps a fear of what was left behind them. When they made it here, they must have thought they had reached the promised land: houses and houses of unplundered goods, isolated ranches for the taking, and a reasonably sized town that they could use as a continual “golden goose” when their own goods ran out.

After lunch, we were assigned to a different area. Here we made out better: at least two first aid kits with unexpired supplies, a complete (and fairly fancy) socket wrench set, and five boxes of 12 gauge ammunition were the best finds. And an actual case of coffee in 16 ounce cans, along with dried packages of rice mixes and ramen.

Sadly and surprisingly, Lucilius, there was not a single book except a Road Atlas.

The “useful now” piles were brought out at the end of the day, everyone suspecting this only represented a partial amount of what was actually there, but likely what we could find in a single day – to the nameless voice’s comment, we were all away from out homes and families and work. Medical supplies, a very small pile of weapons matched with a small pile of ammunition, knives, jewelry in the form of rings and necklaces and bracelets, food such as we had discovered, some tools manual and mechanical, a smattering of Winter coats and boots.

With that, we lined up for pay.

My pay was given to me in the form of 3 Silver dollars, four silver quarters, and two silver half dollars. I always like the Walking Liberty motif; it was nice to see it again. And then, we had our choices. Mine was a can of coffee, a box of 12 gauge ammunition (mine own caliber was not going to be there), and a solid winter coat that would fit Pompeia Paulina.

Dinner that night was mostly a repeat of lunch, with a different round of stale cookies thrown in for good measure. The mood was relatively upbeat, considering the fact that only 24 hours earlier a different group had sat in this camp, a group that was now dead.

Sitting over at the edge of the palisade, watching the sun sink and the stars come out, the monumental nature of the change in society hit me. A year previous I still had access to modern living; I paid for everything with paper or electrons. Things were readily available. Now I was paid in coin from men that I had likely killed, men that had liked to have kill me and take my things if the situation was reversed. There was no shopping expedition, just a few items from a world rapidly vanishing which were in turn likely taken from the homes around us from people that were now long gone and likely never to return.

Was it theft? Was it recovery? Was it the law of the jungle? Is this, this situation – sitting in the stronghold of our enemies having slain them, enjoying the spoils of battle – the place where all civilization crumbles to?

The sunset and stars did not have answers, Lucilius. They never do.

Your Obedient Servant, Seneca

(Author’s note: I may accused of “creating” the situation described, where a number of homes are just outside of the local post office/general store. In point of fact for the location on which this is based it is absolutely true. A housing development has developed there (long after my first visits there of course, or even my most recent one). The idea that these are largely vacation homes is not supported by any data, but a reasonable guess on my part given the rather severe Winters and overall lack of industry in this region – a slight author’s invention on my part, but not too much of one.) 

Glorious Sunset

 One of the things which are sadly missing to the extent that I could see them at The Ranch are sunsets.  This is no-one's fault really:  for all of the beauty of The Ranch, we are also surrounded by tall trees which does many things.  Blocking the view of the sunset is generally one of them.

(Picture taken this morning of writing, towards where the sunset should be.  One can see the issue.)

Thus, I often miss out on the magnificence of the sunsets here in their full glory.

However, when I am headed down the hill to civilization, it can be a different story:

Sometimes I just get lucky and leave at the right time.  In this case I was so lucky I pressed my luck and drove down a bit to get to pull off to take another picture. I was not disappointed.

I have done nothing to the color of these photos - if anything, they fail to do justice to the full rich range of colors.

The world in all of its glory is there for our viewing, if only we will look.

Antler Fencing

 Yesterday morning when I looked out the back door there was a surprise for me:

And not one, but two:

And then, probably more for their own pleasure than mine, they started fencing:

I think this is first time I have can remember seeing this in such a proximity to the house.

Frozen Wonderland

Driving up to The Ranch after arriving on Saturday, I started to see snow on on the tops of cars.  The Ranch is usually below the average snowline; I was pleasantly surprised to see this when I arrived:

It was much less than an inch and had stopped by my arrival.

The magic happened overnight though, when everything froze:

The snow was gone by the middle of the afternoon, but made for a beautiful arrival gift.

Sunlight breaking over the trees:

 

The views here never get old.

Situation And Selves

 

I know it is fair to say that saying "I cannot change a situation" can be a bit of a cop out - at least for myself, I am too often ready to throw in the towel based on an unwillingness to put in effort, especially when I perceive things are "hard".

And yet, there are situations that reach a point that I no longer have the ability to change.  At that point, I can either continue to be miserable in them (I have, more often than I care to admit) or I can make a decision to change myself in the context of them.

And remind myself, of course, that almost no situation is really "forever".

Hammerfall 3.0: Week Three Report

 It occurs to me that I might as well make some hay out of my current job situation as well as provide an ongoing update to the ongoing ripples of Hammerfall 3.0.  The "hay to made" is, of course, working on a different kind of documentation as well as hopefully providing some kind of historical record to myself at least (if not others) for the next time this happens (as I assume it will at this point).

In general, the report will run from the previous Saturday to Fridays (when I am writing this).

Period:  29 December 2023 to 05 January 2024

Positions applied to:  I applied to 16 positions this week.  Total jobs applied to/opportunities investigated are 31 unique positions.

A note on the number of positions applied to:  "applied to" is not the equivalent of "screened".  At this point I am applying for positions that I think I have a reasonable chance of getting, which are 90% in Quality Assurance, mostly in biopharmaceuticals.  Project Management jobs in this field are not forthcoming at the present time.  At the moment, I am applying for positions that are on-site, remote, or hybrid in Old Home and here in New Home or remote in general as a move is really not in the cards at this point beyond Old Home (as it gets me farther away from where I want to end up, not closer).  Currently I am applying for titles ranging from Site Head/Director to Manager.  My thought is that if at this point I go much below Manager to Supervisor or level of individual contributor, selling myself as staying "in place" without looking for another position will be tough.  It is easier to make that sale if you have been "out of work" for a bit longer.

Rejections:  I was rejected by five companies I had applied to. In three cases the rejections came within two weeks of my CV submission and two came within 24 hours, which is actually pretty quick and somewhat surprising.

I assume with the use of AI and application management platforms (as we used at my company), these will get weeded out a lot more quickly. Also, as was pointed out to me by a friend, likely the HR departments are back from the holiday and catching up on these matters.

Conversations:  I had two phone conversations.

Conversation 1:  My impression was that it was going to be a phone screen for a defined position; it turned out to be an introductory call for a position that is pretty early in the process and was actually a contact point for the recruiting firm.  I suppose the best outcome is that I am "in their system" now.  We will see if it amounts to anything, although I am not terribly hopeful.

Conversation 2:  This was with an actual company employee for an actual company position I applied for (In New Home).  It actually turned into potentially a discussion for another position (if the first one does not work out).  I should know more by next week.

Job losses:  This week in my industry, job loses were announced at Intellia and Aera, (If anyone is interested, dailyjobcuts.com provides a daily list of companies that have announced layoffs or closures.  For biopharmaceuticals, FiercePharma and Fierce Biotech have handy updates on such things).  I mention this because, perhaps self-evidently, these are all now potential competitors (as will be the December college graduates that were just launched into the world, to be followed by the next wave in May/June 2024).

For historical purposes, I will note that Fierce Biotech has an article dated 02 January 2024 noting that 2023 layoffs were up 57% year over year from 2022; per the article of 187 workforce reductions, only 60% of companies reported actual numbers (at 9,150) with the remaining 40% only reporting percentages of total employees or not reporting numbers at all(e.g., we do not really know the final count; I know for Hammerfall 3.0 this was not publicly reported).  

My completely uneducated opinion is that it will be this bad or worse in 2024, due largely to a combination of loss of capital markets and the economy.

Mood:  I will be frank:  this was not a great week.  

I cannot point to any particular item: being that we are coming out of the holiday season, I had already anticipated that responses would very likely be slim to none.  The fact that they were slow, though not surprising, was too easy to dwell on.

I am already running through the "what ifs" in my mind.  Like my friend the Dog Whisperer pointed out, at some point one has to start to go for the positions one is likely to get as well as the ideal ones even if they are less desirable.  Yes, one can (and should) keep looking, but that really goes against one of my beliefs that if I accept a job, I commit to it at least as long as it is feasible (or, apparently, they lay me off).

It is pretty easy to let myself get mired in "no-one is ever going to call".  

I am continuing to work on creating a structure for my day.  Part of that structure is that I have a set aside time every morning to job hunt - honestly, it can be done in about an hour.  After that, I turn my attention to other matters.  I perhaps check in one more time but if one is searching for "positions updated within the last 24 hours", it becomes a pretty quick activity.

As part of this activity, I am working on actively studying/training.  No reason to let the moss grow.

Career Advice

 During the course of the Hammerfall 3.0, a young woman with whom I had worked a bit reached out to me in the aftermath.  Would I be interested in having coffee to talk about careers?  We had a bit of back and forth on the scheduling, but the meeting finally happened this past week.

I interacted with her most directly just before everything fell apart. She was memorable to me at one point because she made the comment about this being her first "grown-up" job.  That comment made me laugh (out loud, as it turned out) as it was exactly the sort of thing I would say.

Since I had a lead up to the meeting, I had some time to think about the nature of the conversation.  Beyond the sorts of questions that I thought I could predict, what could I actually bring to the conversation?  I tried to think back on similar times in my own life when I, in turn, had asked questions of others.

Oddly enough, I do not remember getting any specific advice in those sessions.  So then I took a different tack with myself - given where I was now, what do I wish I would have known or asked back in the day?  This turned out to be an easier question to answer.

For our coffee based meeting (all good career meetings should be coffee based), we exchanged information on what we knew, each from our side of the situation, about our layoff events and who else we knew that was laid off.  We talked about careers a bit - what it was like to work in Quality, how to "break into" Quality (as if any sensible person wants to break into a form of prison), and the industry in general.  I did throw in a couple of question as well that I hoped would generate some thought longer term down the road:

1)  "What do you really want to do?" - In this case, it was her first job in the industry.  But was it really what she desired to do, or was it convenient and was it something she could see herself doing for a longer period of time.  It is one thing to try something and realize that it is not for you; it is another thing to stick with something and then 20+ years in realize that you are trapped without a way out.  Now was as good a time as any to really consider this question as the opportunity to redirect would be much easier than if one is long invested in a career and skill set that needs to be completely changed.

2)  "Are you thinking outside the box?" - It turns out there are a lot of things that involve what we do, but in ways that people do not generally think of.  For example, if one's interest is in process engineering, it is not just chemical and oil companies (or biotechnology) that uses these skills.  Distilleries, breweries, wineries - they all use the same basic principles.  Sometimes looking at our skills in an industry blinds us to looking at the skill set we bring and the industries we could apply it to.

Ultimately, of course, I can do very little to influence the course of another's job search or life journey.  What I can do - what any of us can do, especially those of who are a bit more "senior" - is to gently ask the sorts of things that, 20 or 30 years ago, we might have benefitted in hearing and thinking about.

Because, at least in my case, if I can save one person from being trapped in a career they see no way out of, I will have done a good thing.

The Collapse CXXXI: Aftermath

27 June 20XX+1

My Dear Lucilius:

The post-battle let down did not arrive immediately – even as we had removed the immediate threat, there remained the third group which was assumed to have remained at the building be used as a base, as well as any roving bands. Any chance of surprise was gone at that point, washed away in a hail of gunfire and shouting. It was apparent, even to me, that if the third mission – the commando with the Captain – had failed or even been late, there was still a difficult boil to lance that would be beyond our abilities to do easily.

A group under the Colonel – perhaps twenty or so – continued up the mile or so of road to reach the remains of McAdams. The rest of us at our station, perhaps 5 or so remaining, faced both West and East for a threat we did know would come. Then, from a distance, we heard three short horn blasts, as if from an air-compressed horn.

The Leftenant, who remained with us, slumped a fraction. That was the signal, she said. The mission was successful.

We remained on heightened guard until we saw figures approaching with armbands, the Colonel and that team returning. He and the Leftenant spoke for a minute or two as the walked by, then they carried on.

We received our next set of orders: strip the bodies.

I am assuming (after the fact of course) that those remaining at the decoy had started to process there and, as the saying goes, many hands make light work, even at such a gruesome task at this.

Someone passed around a box of Neoprene gloves, the proverbial “one size fits no-one” – bloodborne pathogens, we were reminded. Then small groups of us assembled around the bodies strewn around and began salvage operations.

I have seen a dead body or two in my time, mostly relatives that had passed away. Their skin was an odd feeling to the touch, their eyes staring wide into the great beyond. This was different: the bodies were holed with bullet wounds, pieces of muscle and organ and bone exposed. The odor of blood and some undefinable scent I can only characterized as “body insides” filled the air.

Moving as quickly as we could, we pulled shoes and boots from bodies – the clothes were almost completely a loss. Pockets were emptied, any jewelry pulled off, weapons and bullets put to the side as next to each body an inventory of goods collected.

The irony of Looters reduced to piles of items that had likely been looted was not lost on me.

I suppose that in some places and times it would be of interest the sorts of individuals that had become Looters: what did they look like, what did they evidence about themselves as we reduced them to their constituent elements? I honestly did not pay attention Lucilius, as it did not matter. Call it exhaustion, call it disgust, call it war weariness. The bodies looked like bodies. Dead bodies. More, I cannot recall.

And then, in one of those moments of immediate understanding, I suddenly grasped the difficulties of post-battles events throughout history. I was exhausted as to some extent was everyone, likely: even with the last year of practicing using our bodies much more than before, none of us likely were soldiers. There were the bodies here; there were likely bodies where the decoy was – even more, by all accounts. The thought of digging holes or even a single hole for them was tiring just to think about, let alone having shovels or even other equipment to do it.

A motorized rumble startled all of us from our stripping – it was the Looters truck, now driven by our side, an Toyota Tacoma that slowly ground up and to a halt.

Into the back the bodies went.

10 bodies is a lot for a truck bed (in case you were wondering), so the truck ended up making two trips. As we waited between the first and second, the items were pulled into bags, the weapons distributed out for carrying.

On the return trip, most of the remaining group came up with the truck, a small rearguard waiting for the decoy to return. I was thrilled – as thrilled as one can be, exhausted – to see Young Xerxes in the group uninjured – in fact, beyond some bandages from what seemed to be flesh wounds, there seemed to be no-one else significantly injured. The surprise apparently, was complete.

The faces looked exhausted as well, with looks of exhaustion or disgust or even the thousand yard stare on them. We were retirees, ranchers, former small business owners and workers, mechanics, graphic artists and technologists.

Now, we were all blooded militia. And it showed. Even Young Xerxes looked haggard and almost did not recognize me for a moment, until he suddenly came to and gave me an uncharacteristic hug.

While this reunion was happening in small groups, the Colonel pulled some men over. Before long the sound of shoveling filled the murmuring air, a slow sound that had a mournful cadence all its own.

The hole was dug to this side of the small bridge at the stream bed where we had made our stand and where Blazer Man had fallen. We gathered around as Blazer Man was carefully placed into his grave, arms folded and eyes closed. The Colonel bent down and from where I could see, placed two silver coins, one over each eye. He got out; someone – I had no idea whom – prayed. Two men remained behind to finish the burial as the rest of us slowly marched back to McAdams, leaving Blazer Man on Eternal Guard at the bridge.

Of the rest of the day up to this entry, I can tell you little enough Lucilius. I was as tired as I had ever been in my life and barely remember entering the palisade of cars or finding a place to cast my sleeping bag. I crashed as soon as I hit the ground, waking only twice: once at the urging of Young Xerxes to eat some soup, and then to wake up to write this in the waning evening light. After this, I will sleep again, the Leftenant having excused me from any guard duty this eve.

My dreams were strange, Lucilius. In them Blazer Man was alive and we sat as we had that day, talking of history as if we were two old friends merely out on a day’s hike.

I would say I slept the sleep of the dead – but having seen the dead that day, I know theirs to be a different kind of sleep.

Your Obedient Servant, Seneca

In The City

 On New Year's Eve, for the first time in over 25 years, The Ravishing Mrs. TB and I went to a New Year's social event out in the public.

As it turned out, it was a bit of a fluke:  my sister and her family had come to New Home to celebrate an anniversary and gave us tickets to the event as our Christmas gift (they were attending as well).  Not necessarily the sort of thing I attend (regularly or otherwise), but even I am open to a new experience once in a while.

The event, for the record, was pretty much what I expected it to be. On the bright side, it was a 1920's themed event and people definitely dressed up for it, which was pleasant.  Also rather cool to behold were couples in their 60's and 70's out dancing and obviously enjoying themselves (and in love).  The music was loud to start with and got louder.  Our tickets included all the alcohol one could drink (for the record, I had one glass of cabernet and a glass of champagne at midnight) and a rather sad trickle of snacks that was...well, at least they warned us it was "while supplies last".

I may or may not have even danced a bit.

But to go to this event, of course, we had to go downtown.

My images of "downtown" and "The City" were rather blurry growing up. My memories very early on were mostly the song from Petula Clark, "Downtown" (perhaps obviously in its post release days as part of a Reader's Digest music compilation), which included lines like "Listen to the music of the traffic in the city" and "Linger on the sidewalks where the neon lights are pretty".  Old Home was a small town (which had an actual downtown back in the day, sans neon lights and traffic), but sometimes we would go to Capital City.  

Capital City consisted (in my childhood world) mostly of the Capital grounds, where we would go and feed squirrels, and the zoo, and historical sites and very occasionally, a shopping mall.  Every year as well for a number of years growing up we would to to The Big City for a medical appointment (I had a condition where I just walked on the balls of my feet; it is better, but you can now always tell by my wear patterns on my shoes), which would include a visit to A Major Tourist Site or a very cool museum and park.  In those days I was hazy about the environment of the cities themselves; my memories are mostly of the experiences, not the surroundings.  

Except people. I remember a lot of people.

New Home is one of those "up and coming places" which is in a race to destroy itself and its uniqueness in order to be fashionable and relevant to the world around it.  Even in our time here, skyscrapers have soared into downtown, bringing apartment buildings and condos and upscale stores.  Land is actually so valuable that older buildings sell and are torn down, replaced by large squares of apartments with chic upscale restaurants and stores underneath, wedged in between older buildings that somehow manage to cling to their location out of nostalgia or sheer spite.

This started in downtown, but the "improvement" is working its way west to the upscale housing and meeting upscaling working down from the North. Only the eastern half of the city "remains" in its pre-center of the universe status and even there, pockets of "the future" are now emerging.

The Eastern half, of course, is where we stayed.

Human urine is a smell that, much like marijuana, once you know it you never forget it.  And that was the smell that greeted us as we walked from the parking lot to our hotel and then to the restaurant to dinner.

This part of the city is right on the razor's edge between new and old:  on one side - a clear, demarcating invisible line, is "the future".  On the other side are buildings - bars, tattoo parlors, low end restaurants, the occasional unique store - in buildings that for the most part are clearly from early in the previous century.  In some cases the word "crumbling" is as kind characterization.

The homeless are here, wedged in between bars and restaurants:  sleeping in doorways, sitting on corners, rolled up in blankets with carts nearby. Some speak up, asking for change, others just watch you go by.  

Patches of marijuana smell rise up like isolated rain clouds, vendors demonstrating the value of hemp in ways legal and not-so legal.  Music spills over from walls of enclosed patios or from open windows of bars.  We are still early: the roving bands of the younger set, coming for drink or amusement or to be seen will be out long after we have gone to our party.  But the street is even now blocked off and people are moving up and down lanes that saw traffic earlier in the day; luckily if they are weaving, there is far less danger.

It is not that I ever felt unsafe:  the sun was up, the lights were on, and I am aware enough and wary enough that I am at best a troublesome mark if perhaps an underweight easy one.  And certainly given the season, it is unlikely our local politicians or local law enforcement are interested in having high profile issues on New Years; The police were out and in force.

It is always a problem, of course.  Cities and counties bemoan the fact of development that wipes away their unique qualities even as they greedily stick out their hands to gain the income from increase property taxes and higher end taxes that come with increased tourism and sales.  They placate their inner guilt with development projects that in theory are civic minded but never seem to actually preserve the uniqueness of what they had; parks and community centers and monuments to their own glory are pale reflections of what used to be.

Culture, once unmade, can only rarely be recaptured.

It is not often that I go to any city or downtown, and there is a high likelihood that I will not see this downtown - at least at night - for the rest of our time here.  Not just because of the public safety, although that is a legitimate concern.  It is the reality that, hidden behind the rising towners and shining spires and self-congratulatory plaudits of the modern city lies the decay of modern life, pushed off to the sides and quietly tolerated as the cost of relevancy.

I do not remember this in the cities of my childhood; perhaps it was there and I simply missed it.  But I surely cannot see any city - at least any American city - with anything but this lens now.  The rot - but really the smell of old urine, all of the failures of urban life contained - is not something one hurries back to see.

The Forty-Five 2024 Edition: A Primer

 Greetings and welcome to 2024!

As has become a practice, one of the first posts in the New Year (this one, obviously) is intended as a primer to this blog.  I think, or at least perceive, that some level of individuals drift in each year, so this is offered as guide for the people and places that inhabit this world - which is (for the most part) based on the real world, or at least my perception of it.

I am your host, Toirdhealbheach Beucail ("Toridhealbheach" is a version of my name in Old Irish Gaelic; "Beucail" means "booming or roaring", as in the sound of a cannon. If you ever met me in person, you would find I have only two volumes:  silent and "ON").  I have been manning this rampart of the InterWeb, writing about this and that for what will now be my 19th year and am up to over 4900 posts on a variety of topics.

A very brief history: I grew up in a small town, the same town my parents and my mother's parents had grown up in. I went away to college for two degrees that have nothing to do with what I ended up actually doing, then came back home and lived in and around that area (referred to here uncreatively as "Old Home") until 15 years ago, when due to a layoff we had to move (to the also uncreatively named) "New Home".    Due to an unexpected health issue with both of my parents (see here, Moving TB The Elder And Mom), I now spend about one third of the year at Old Home, and the other time working to get back there on a more permanent basis to The Ranch (see below).  As more recent events have occurred (Hammerfalls 2.0 and 3.0), I once again find myself looking for work.

I have a variety of interests.  I am a practitioner of Iaijutsu, a Japanese martial art which is (crudely but correctly) defined as the "quick draw" of sword techniques (my style has existed since the 16th century).  I make cheese and other dairy foods.  I train with weights.   I garden.  I write (perhaps somewhat obviously).  I hike, mostly in the Sierra Nevadas but have also been down into the Grand Canyon.   I study languages, both current as well as the dead ones.  I read voraciously - primarily history and theology, but also philosophy, agricultural books and "old style" (say pre-1985) science fiction and fantasy.  I do some travel, although I am more of a homebody.

Dramatis Personae:

        - The Ravishing Mrs. TB:  To whom I have been married for over 30 years now and who actually makes sure the trains run on time and things get done.

     - Nighean Gheal: Number one daughter, a college graduate with a degree in International Business now living in The Big, Big City.

    - Nighaen Bhan: Number Two daughter, also a college graduate with a degree in Communications and pursuing a Master's level program in Speech Disorders (a.k.a., Speech Therapist).

     - Nighean Dhonn: Number Three daughter, currently studying Anthropology and Archaeology.

     - The Director:  One of my two best friends from High School and still currently one of my best friends.  Lives in Old Home, one of the most intelligent people I know.  Currently working on his Ph.D.  On an unusual note, he is practicing Quaker.

    - Uisdean Ruadh: The other of my two best friends from High School and still currently one of my best friends.  Also lives in Old Home, currently living in The Cabin at The Ranch with his mother  A Mhathair na hUisdean Ruadh, who turned 96 in December.  Deeply Catholic, loves traditional Catholicism, planes, and history.  

  - The Berserker:  My weight training coach.  I have trained with him for 8+ years now.  I live in fear of his weekly training regimes, although they have been very successful.

- The Shield Maiden:  A friend I met throw Highland Games many years ago.  She lives much farther away than she used to (Picture the border of Canada and then move down.  Slightly.).  We chat via the InterWeb every day.  She is a reservoir of wisdom and the much needed lectures I will get from no-one else.

-La Contessa: My very good and old friend (post high school, so not quite as long as The Director and Uisdean Ruadh, but almost as long).  We regularly have dinners once a month when I am in Old Home.

-The Outdoorsman:  My brother-in-law and hiking partner in crime.  What started as lark of an idea (hiking the Grand Canyon) has turned into 3-4 smaller training hikes and a single big hike a year.

- The Cowboy/The Young Cowboy:  A father and son team, they have kept cattle at The Ranch for almost 20 years now.  They are regularly present there and help to keep an eye on the place when I am not present.

- The Brit:  My niece's fiancée who has also become a hiking partner in crime.

- Rainbow:  One of the earliest people involved with this blog, she lives in the larger vicinity of Old Home.  She and I speak more or less weekly about life, mostly disguised as a two person writer self-help group.

- The Dog Whisperer:  Another refugee from Hammerfall 3.0 looking for a new job.  Loves dogs (and animals of all kinds).  

Important Places:

- Old Home:  Where I grew up and lived up to 15 years ago.  Originally a combination of the small town I actually grew up in  as well as the larger areas there which we lived in before moving to New Home, I use it more now to indicate my hometown.

- New Home:  Where I currently live. An urban area located in a state not where I grew up.  One might argue "where I am currently trapped", in some senses of the phrase.

- The Ranch:  The Ranch is the property my parents own and live on in <insert yet another undisclosed location here>.  It is approximately 90 acres of land in the mountains which has been our extended family for over 60 years.  You will see plenty of pictures from here.  This is where I am ultimately trying to get back to.

What do we do here?

(Note:  This is word for word from last year.  But I still believe it.)

Like most budding bloggers, when I started this blog I had great visions of this being a mighty bulwark of discussion and thought that would be a beacon of light (and, coincidentally, would let me write full time). It only took about 10 years to realize that neither of these things were going to happen.  Either because of obstinance or foolishness (I am guilty of both) I persevered.

What I did find - and what I still believe in - is that blogging represents the Social Internet (not a phrase that I came up with, but one I love): the ability of people to read, think, and discuss things on the InterWeb (as opposed to Social Media, which I detest).  What has become critically important to me  s creating a sort of InterWeb agora, a place where we can discuss subjects - some deep, some completely shallow - in a way that hopefully encourages thought and helps to build connections in a society which values neither thought nor connections except of the most shallow kind (otherwise known as Social Media).

What you find here most days is a combination of personal on-line journal, thoughts or concepts that have run through my mind, book reviews, occasional fiction, things that are just "going on" in my life, ruminations, and the occasional meme.  It is a smorgasbord of my existence (there are literally times I sit down to write with no idea what will be written, and no-one is more surprised than I am when it shows up).

Important Pages:

Ichiryo Gusoku Philosophy:  My overall guiding policy on my philosophy is here.

Ichiryo Gusoku Goals:  My overall goals are here (and they literally are aspirational at this point).

The Collapse:  A rather long running fiction series (in a series of letters) about a man watching society slowly collapse is here.  

Moving TB The Elder And Mom:  As mentioned, my parents suffered a series of health reversals in 2021.  This page pulls together the experience in hopes that others that have or will have the same issues will benefit.

What are the rules?

There are only four.

1)  Be kind in your comments:  In all my years of writing here, I have had to not publish only a handful of comments because, frankly, they were mean.  You can certainly poke holes in my theories or my writing or the responses of others.  I just ask you do it kindly.  Everyone you are responding is going through something.

2)  No profanity:  My mother was an elementary school teacher and a lovely Christian woman, so comment as if you were speaking directly to her.  Any profanity will simply not make itself a visible comment, no matter how relevant or good the comment is.

3)  We do not argue current politics:  Politics as it is practiced currently is simply an exercise in "It is your fault!  No, yours!" followed by vulgarity and crudeness.  Political Science (the practice of forming political societies and their functioning) is far more useful to actually reach a solution.

4)  We do not argue religion:  I state up front I am Christian (useful background for some of what I write) and will happily discuss my own trials and travails and thoughts.  What we do not debate is the nature of religion or different religions.  Again, see the previous comments on kindness.

Thanks!

Reading anything is an investment; taking the time to comment is more so.  Thanks so much for taking the time to spend a few moments of your precious time (a commodity which we cannot make more of) with me.

Happy New Year 2024

 

Perhaps not the usual New Year's quote, but given the past year and what the New Year might actually bring, perhaps the most fitting quote for the season.

Happiest of New Year's to all!