Day :
- Sessions/Tracks:
Drug Discovery and Development | Patient-Centric Clinical Trials | Polymer–Peptide Conjugates | Medicinal Chemistry and Drug Discovery | Drug Delivery Systems | Patient-Centric Clinical Trials | Globalization of Clinical Trials
Chair
Edwin G Moore
University of Illinois, Urbana
Co-Chair
Panayiotis P Constantinides
Biopharmaceutical & Drug Delivery Consulting LLC, USA
Session Introduction
Siddhartha Chowdhury
Northeastern University, USA
Title: Planning and submitting clinical trial applications to Ex US countries
Time : 14:00-14:45
Biography:
Sid Chowdhury has completed his Bachelors in Pharmacy at the age of 22 years from Mumbai University, Mumbai and Masters of Science (MS) from Northeastern University, College of Professional Studies, Boston, MA. He is the Study Start-Up lead for Alkermes, a premier pharmaceutical company based out of the Boston metro area. He has been managing Study Start-Up for global Phase III CNS studies for more than 3 years and has been serving as a Clinical Trial Manager, Global Clinical Services.
Abstract:
There is a lot of preparation and planning that goes into submitting Clinical Trial Applications (CTA) to Ex-US countries. Alkermes has performed CTA submissions to countries such as Italy, Spain, Germany, the UK, Ireland, Austria, Israel, Poland, Bulgaria, Ukraine, and Serbia recently for Phase III schizophrenia studies. A pharmaceutical sponsor company such as Alkermes can’t do this alone and therefore, CRO support is critical in this regard. Both the Sponsor Company and CRO need to understand the regulatory landscape, patient population, study design and treatment type, study drug etc. to plan for submissions and weigh in risks. The CRO plays a key role in being the in-country expert, shares intelligence on in-country submission requirements and dates for competent authority and ethics submissions and tentative approvals. Internally, it is key to delegate roles and responsibility for documents needed for CTA submission based on cross-functional expertise. A rapid response team for queries and aligning internally on expectations, roles, and deliverables during CTA submission will prevent additional delays when the regulators share queries or concerns on your study protocol. This presentation or workshop will allow for alkermes representative to discuss case studies on challenges faced during Ex-US submissions and ways to overcome them.
Brandon Furr
Atrium Health, USA
Title: Implementing strategic financial management for clinical research
Time : 14:45-15:05
Biography:
Brandon Furr, CCRP, is a Senior Coordinator of Sponsored Programs, at Neurosciences Institute-Neurology, Atrium Health. He has completed his B.S. in Finance from the University of North Carolina at Charlotte. He is a SOCRA-Certified Clinical Research Professional with six years of clinical research experience in both industry and federal grant projects. He is a member of the Executive Leadership Research Committee at Atrium Health’s-Neurology which is comprised of a variety of medical professionals who address higher level research-related issues and leverage resources across the enterprise. He has successfully negotiated budgets and contracts, managed revenues and billing for numerous Phase I-IV clinical trials. More recently, he has been focused on developing new applications with Atrium Health’s Sponsored Programs Administration to help strengthen the relationship between the research site and off-site financial administration offices.
Abstract:
Financial management of clinical research throughout its life cycle is comprised of various disciplines across the healthcare field. Leadership which utilizes the strengths of each of these areas can result in successful budgeting, and subsequently lay the foundation for the management of crucial milestones. A clinical trial’s life cycle can be separated into two phases: pre-award & post-award. The pre-award phase of strategic financial management requires the analysis of projected personnel salary costs and protocol-required procedures. Effective post-award management involves contrasting actual expenses with the original projected budget, and reporting it regularly to recognize discrepancies that may be negatively impacting financial accounts. Correcting these issues involves careful monitoring of fluctuations in salary costs, as well as an understanding of interim short-term deficits and whether any future budget amendments are necessary. It is also important to recognize the critical balance of a project’s assignment of administrative personnel versus clinicians, which can intrinsically create communication barriers and logistical difficulties. The identification of deficiencies along this workflow can only be obtained by implementing a strategic management approach that highlights the relationship between clinical practices/procedures and their financial counterpart. This session will identify common financial issues that occur during the life cycle of a clinical trial, and propose strategies to mitigate these issues in both the pre-award budgeting and negotiation phase, as well as the post-award project management phase. It will also provide tools necessary for the analysis of this data and discuss the application of this methodology across differing structural department arrangements.
- Workshop:
Planning and submitting clinical trial applications to Ex US countries
Session Introduction
Naoki Toyooka
University of Toyama, Japan
Title: Total syntheses and their biological evaluation of poison-frog alkaloids ent-cis195A and cis-211A
Time : 15:05-15:25
Biography:
Naoki Toyooka has done B. S. in Pharmaceutical Sciences from Kinki University, March 1984. He completed his Ph. D. in Pharmaceutical Sciences from Kinki University, March 1989. He earned his Postdoctoral Research in department of chemistry from North Carolina State University with Professor Daniel L. Comins, 1997. From April 1989-March 2001 he worked as Research Associate, Toyama Medical & Pharmaceutical University. From April 2001-March 2006, he served as an Associate Professor, Toyama Medical & Pharmaceutical University. From April 2006-March 2010, he joined as an Associate Professor, University of Toyama. Currently, he is the Full Professor in University of Toyama since April 2010. Also, he is the Dean of Graduate School of Innovative Life Science, University of Toyama since April 2017.
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Abstract:
To date, over 800 lipophilic alkaloids representing more than 20 structural classes have been detected from the skin extracts of neotropical poison frogs. The 2,5-disubstituted decahydroquinolines are represented one of the major classes, and the structural diversity and pharmacological activity associated with this class of alkaloids have stimulated synthetic activity in numerous groups. We report here the first total synthesis of the decahydroquinoline type poison-frog alkaloid cis-211A along with ent-cis-195A. The synthesis began with known piperidine 16, which was converted to aminoester 2 in 3 steps. Michael-type conjugate addition reaction of 2 provided the adduct 3 in high yield as a single stereoisomer. The ester 3 was transformed into the keto-aldehyde 4, which was subjected to an intermolecular aldol-type cyclization to afford the cis-fused enone 5 as a single isomer. The conjugate addition reaction of 5 followed by treatment of the resulting enolate with Comins’ reagent gave rise to the common and key intermediate of enol triflates 6. Synthesis of ent-cis-195A was achieved from 6 in 2 steps, and the first total synthesis of cis-211A was also completed from 6 in 5 steps as shown in Scheme1. Details of the synthetic process synthesis and their evaluation of the nicotinic acetylcholine receptors and inhibitory effect on [3H] nicotine uptake by TR-BBB13 cells of both synthetic alkaloids will be reported.
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