38 LAWYER MONTHLY JUNE 2024 slightly forbidden territory, as agreed between me and the lawyers. I also learned that, unlike in the US, in Canada, it is allowed for the witness to speak back to the opposing attorney and correct deliberately inaccurate statements and assertions. The judge was Scots-Irish, and she had quite a temper. She started to get angry with me about the nature of my post-lunch testimony (described above) very quickly. On the stand, I could see her face getting redder and redder, and the tension between us was palpable. Instead of addressing me, she addressed my attorney with extreme hostility and barely contained rage, and then softly turned to me and very sweetly and quietly asked me to exit the courtroom! I left both confused, intimidated, and more than a little worried that I was going to be disqualified; after a short recess, we were called back. My lawyer and his associate raced toward me, and he told me “you were perfect – you’ve done nothing wrong, and you’re not being disqualified. Now, go back in there and finish strong!” My testimony resumed, with me talking directly to the jury, as (before). The last question my attorney had for me was a touchy one – “how much would the decedent have made in a year of consulting, on average?” The defense attorney had just gotten to his feet (but hadn’t verbally objected), and I was able to give my answer just before the judge tried to cut me off – the figure made it into the trial transcript, and the plaintiff won the case! Very dramatic and exciting!!!!! Here I was before that, in the anteroom of the courtroom, thinking that things had totally tanked, and they did not. What are the most exciting areas in chemical and pharmaceutical development? The Confluence of Increase in Flow Chemistry’s Capability, Process Analytical Technology (PAT), Big Data, and AI, to Expand Flow Chemistry’s Utility in the Pharmaceutical Industry This has already been occurring, and has resulted in highly controlled, real-time monitored chemical and pharmaceutical processes that can be adjusted as they occur and Proven Acceptable Range (PAR) and Normal Operating Ranges (NOR) boundary limits are approached. Ultimately, this ongoing R&D and manufacturing will expand the thinking of regulatory agencies about the meaning of quality by design (QBD), design of experiments (DOE), and control of unit operations and entire processes. The confluence of physical chemistry of materials, advances in and further refinement in the development of existing and emerging modalities in enabling technologies for drug product intermediate and finished drug product R&D, production and manufacturing Chemical Space, a region in which new, unique molecules emerge, had, for a long time, been relegated mostly to” theoretically interesting” molecular classes, e.g., highly strained, energetic molecules or molecules that violated well-established scientific rules, e.g., aromaticity and anti-aromaticity, etc. The pharmaceutical industry has recently (2005-2024) made significant inroads in chemical space, and now probably dominates that realm, due to enhanced (see third most exciting area below) capabilities to accomplish chemical transformations that were previously impossible, extremely difficult or impractical due limits in equipment and energy sources required. As a result, conventional approaches to preformulation, formulation development, and drug product production and manufacturing was confronted with the need to render these new drug candidates into tractable, efficacious dosage forms that could navigate, intact, the often circuitous, challenging route to the appropriated tissues and sites of action. The issues being addressed currently involve increasingly lower aqueous solubilities of drug candidates, to the point that an increasing proportion of
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