scholarly journals Perspectives on the draft ICH M10 guidance: an interview with Kelly Dong

Bioanalysis ◽  
2019 ◽  
Vol 11 (22) ◽  
pp. 2025-2026
Author(s):  
Kelly Dong

Kelly Dong, PhD, Chief Executive Officer, United-Power Pharma Tech Co., Ltd Kelly Dong obtained her PhD degree from McGill University, Canada. Kelly has nearly 25 years of multinational industry experience working for pharmaceutical companies and CROs in Canada, the UK and China. Her scientific expertise encompasses drug metabolism and pharmacokinetics (DMPK) in drug discovery and regulated bioanalysis for preclinical and clinical development. After 20-year overseas experience, she joined GlaxoSmithKline R&D China in August 2009. She was the Director of DMPK for CNS drug discovery and Head of Bioanalysis, Immunogenicity and Biomarkers, overseeing more than 40 preclinical and clinical studies across different therapeutic areas. She joined United-Power Pharma as the Chief Executive Officer in February 2018. She is also a research fellow at the National Engineering Research Center of Protein Drugs. She is one of the founders and a steering committee member of China Bioanalysis Forum. She is also an active contributor to the scientific community, with numerous scientific publications, invited presentations and organizing scientific conferences. This interview was conducted by Sankeetha Nadarajah, Managing Commissioning Editor of Bioanalysis.

2020 ◽  
Vol 72 (12) ◽  
pp. 18-20
Author(s):  
Stephen Rassenfoss

A British independent bet its future on proving that fractured basement formations could produce large amounts of oil and gas. Based on its first two wells, the proposition that these highly fractured layers of awful-quality reservoir rock can produce billions of barrels of oil is looking very unlikely, but there might be something of value down there. Last April, Hurricane Energy predicted those two development wells could easily produce 17,000 B/D of oil from rock it said held “half a billion barrels of oil.” Now Hurricane’s ambitious plans and its identity as “basement reservoir specialists” are in tatters. The initial wells were productive but much of what was coming out of the lower one - 205/21a-7z - was water. After 8 months of production the water cut reached 46% from a well that was supposed to be hundreds of meters above the boundary between the oil and water aquifer. That was not the only evidence suggesting there was something wrong with the plan to develop discoveries in the Lancaster field along Rona Ridge in the West of Shetland area. On 8 June, Hurricane’s founder and Chief Executive Officer Robert Trice, a geologist with a keen interest in fractured basement rock, resigned, and the company launched a review of the technical work underlying the plan. Experts were added to the subsurface team, which then made major changes. The most significant change pushed up the depth of the contact point between the oil and water levels by around 300 m, within 1 m below the toe of the lower well. In other words, three-quarters of the reservoir in the original plan was under water. The presentation by Beverley Smith, the company’s interim chief executive officer, was a reminder of how a long-term production test can change a reservoir model, even one based on years of work and the drilling of multiple wells. “Let me start by reminding everyone that we are dealing with a unique and challenging reservoir that was always subject to great uncertainty and where data acquisition has long been problematic,” Smith said. Lowered Expectations Hurricane’s remaining Lancaster well (205/21a-6) is producing more than 12,000 B/D, providing critical cash flow for the company, whose future looks altogether different than it did in the days when it predicted its discoveries could potentially produce 2.6 billion bbl of oil, making it the largest undeveloped resource base in the UK Continental Shelf (UKCS).


2020 ◽  
Vol 13 (1) ◽  
pp. 63-84
Author(s):  
Danquah Jeff Boakye ◽  
Gabriel Sam Ahinful ◽  
Randolph Nsor-Ambala

Purpose: This article investigates the relationship between executive compensation and financial performance for Alternative Investment Market (AIM)-listed firms in the UK. While most studies have looked at the impact of executive compensation on financial performance, this study argues that the issue of reverse causality cannot be ignored even if it is controlled and therefore investigates the extent to which financial performance can also impact on executive remuneration. Design/methodology/approach: The study relies on a sample of 201 AIM-listed firms in the UK from 2011 to 2016 to examine the relationship between executive compensation and financial performance. It draws on agency and tournament theories to model the relationships between executive compensation and financial performance using various panel regression models. Findings: The findings from the study revealed that the chief executive officer (CEO) remuneration impact on both accounting- and market-based measures of financial performance. It also showed that while performance-based incentives like bonus and other long-term incentives linked to performance significantly impact on financial performance, salary, a cash-based non-performance-related compensation rather negatively affects performance. It was also discovered that financial performance can also influence the level of executive compensation and not always vice versa. Value/originality: The study adds novelties to the existing literature by introducing tournament theory to the studies on the relationship between executive compensation and financial performance. Most of the existing studies have been one sided and emphasise only on the influence of executive remuneration on financial performance. However, based on the tournament theory, the study argued that the issue of reverse causality between the two should not be overemphasised even if it is controlled.


2013 ◽  
Vol 29 (2) ◽  
pp. 337-348
Author(s):  
Randal J. Elder ◽  
Diane J. Janvrin ◽  
Paul Caster

ABSTRACT In July 2012, Peregrine Financial Group filed for bankruptcy following the discovery that $215 million in customer balances had been embezzled. Investigation revealed that its Chief Executive Officer, Russell Wasendorf, Sr., fooled auditors and regulators for 20 years by preparing fictitious bank statements and cash balance confirmations to hide the theft of cash. The fraud was uncovered when Peregrine's regulator, the National Futures Association (NFA), demanded that Peregrine participate in an electronic confirmation process for verification of customer accounts. This case discusses how the fraud was allowed to go undetected for 20 years, the importance of auditing cash, and how new electronic confirmation technology improves the ability to authenticate confirmation responses. The case is suitable for use in both auditing and accounting information system courses.


2020 ◽  
Vol 28 (6) ◽  
pp. 406-436 ◽  
Author(s):  
Michael A. Abebe ◽  
Pingshu Li ◽  
Keshab Acharya ◽  
Joshua J. Daspit

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