new drug candidates require enabling technologies, and an increasing proportion of those are DCS 2b drugs (solubilitylimited drugs that are highly insoluble but permeable), on the border with BCS 4 drugs (neither soluble nor permeable nor soluble). This issue is being addressed to a very small extent via structural modifications to the drug candidate via synthetic chemistry, but the success rate of this strategy is often very low (>10%). The Development of New Chemical Reactions That Allow Access to Previously Impossible to Make or Impractical to Make Chemical Structural Motifs The advent of rediscovery and improvement of the performance of previously impractical chemical reactions has resulted in the aforementioned foray into chemical space, populating this realm with an increasing proportion of molecules that are truly structurally and physicochemically unique. This has been a double-edged sword, in that, while these new structures address previously undruggable targets in pharmaceutical medicinal chemistry, discovery, development and clinical realms, this has been accompanied by physicochemical challenges – extremely poor solubility, more complex syntheses, processes, characterization, rendering into a dosage form with acceptable performance (in vivo dissolution, distribution, delivery to the target, pharmacokinetics, metabolism, etc. All of the above are on balance very positive phenomena, but anything novel also presents technical and regulatory challenges that must be overcome. CDMOs with more conventional capabilities will need to continue to develop and shift their capabilities and technologies, in order to keep up with novel technologies discovered and invented in the academic and emerging industrial realms, as well as “boutique vendors” whose sole purpose is to innovate. What are the essential elements for an expert report? • Introduction - Context – clear, accurate descriptions and assessments of the theories of the case for both plaintiff and defendant • Tying the above to the parties’ contentions, arguments and conclusions, as they relate to their respective theories and contentions (also often part of the introduction) • Clear presentation of client’s position that is fact and data-based • Challenging/refutation of the opposing parties’ questionable contentions, again based on facts and data • If requested by counsel or a ruling by a judge, construct theoretical projections, based on facts and data as expected of one skilled in the art • Statement as to whether arguments made are more likely than not, citing arguments made and conclusions reached earlier in the report • Provision of a final opinion, entailing all aspects of the case that are at issue What makes a great expert witness? • An individual who is skilled in the art that is/are the areas of interest; ability, with the attorneys to present expert’s competence during Daubert Challenges or Voir Dire • High verbal ability – written and spoken, as it relates to the case subject matter and in general; ability to be concise and humble while teaching or explaining to a judge, jury, opposing counsel or one’s attorneys • Tenacity – usually the most important quality of both a scientist and expert witness • The ability to work diligently and carefully under time pressure and the watchful eyes of the client and attorneys • Soft skills – persuasion, diplomacy, judgement (knowing what to say and not to say, and how to say it), ability to navigate real-time conflict and uncomfortable situations arising from such events • Understanding of the fundamentals of the law, as it relates to the matter (this is, without exception, by the attorneys, but one must always read between the lines and ask clarifying questions) • Coachability and ability to be guided through the process by attorneys • 360⁰ thinking - all sides of an issue, including anticipation of challenges from the opposing counsel and client, so that both stipulations and challenges/refutations can be made as accurately/rationally and diplomatically as possible WWW.LAWYER-MONTHLY.COM 39 Stuart G. Levy, Ph.D. Principal SGL Chemistry Consulting, LLC 92 Fairmont St. Arlington, MA 02474 T: (781)316-2594 E: sglevy@sglchemistryconsulting.com www.sglchemistryconsulting.com The most difficult aspects come during the due diligence/ initial deep dive into the case file.
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