TPP導向藥品開發計畫之關鍵數據統計考量及FDA審查案例分析【工作坊】

【課程簡介】
藥品開發乃基於target product profile (TPP)的思維，針對適應症開發具有療效之安全藥品，從非臨床研究到臨床試驗，為目標產品擬定開發計畫Clinical Development Plan (CDP)，本工作坊將邀請Boehringer Ingelheim資深統計主管及哥倫比亞大學兼任教授，Fundamental Concepts for New Clinical Trialists一書作者Dr. Naitee Ting說明就各階段相關之數據及統計關鍵考量，如何支持Clinical Development Plan 之前期規劃與執行，也將就開發過程中利用案例分析，說明如何運用Subgroup Analysis 來評估臨床試驗數據。 本工作坊也將就近期法規單位如FDA的審查案例，由前任FDA審查員人員，曾任職於BMS，Regeneron ，現任SDC副總裁之Dr. Helen Li以Substantial Evidence in Drug Development and Evaluation為主題，說明審查之重點，以促進藥品開發之進展。

【上課日期】 2023/07/24-25 (週一及週二)
【上課時數】9小時
7/24 (週一)  下午 13:30-16:30 
7/25 (週二)  全日 09:30-16:30 (午休: 12:30-13:30)
 
【上課地點】台北市中正區思源街18號（台灣大學，水源校區）
【上課人數】上限 45 人, 額滿為止
【報名方式】線上報名<---- 
【課程費用】
1. 非團體會員每人:15,000元
2. 本會團體會員每人:12,000元
3. 早鳥優惠價 (2023/07/17前完成報名及繳費) 每人: 10,500元
4 同公司或機關;3人以上同時報名,即享有優惠價: 每人9,600元
 
【課程主題及授課講師】
7/24 13:30-16:30 (週一下午開始)
 
1.Substantial Evidence in Drug Development and Evaluation
 
 
 Abstract
The FD&C Act requires substantial evidence for demonstrating drug to be effective and safe. The interpretation of the substantial evidence by the FDA has been laid out in the Guidance for Industry, Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products.  The substantial evidence requires at least two adequate and well-controlled clinical investigations, each convincing on its own. Despite the guidance, what are considered as substantial evidence may vary in practice, depending upon factors, such as unmet medical need, safety concerns, multiplicity issues, etc. In this discussion, I will use several case studies to illustrate the various considerations in drug evaluation.
 
Biography of Speaker
Helen has close to 25 years of experience in the field of biostatistics and worked on a wide range of therapeutic areas. She currently works for Statistics & Data Corporation (SDC). Prior to SDC, she worked at BMS and Regeneron and was an experienced statistical reviewer in FDA and NIH before joining pharmaceutical industry. She received her doctoral degree in Biostatistics from Harvard School of Public Health, master degree from Purdue University, and undergraduate degree from Tsinghua University.
 
 
7/25 (週二) 09:30-16:30 (午休: 12:30-13:30)
 
2. Clinical Development Plan (CDP)
 
Most drugs start out as a simple chemical compound.  Chemists and biologists study a certain disease process, and synthesize many compounds in the laboratory with the hope that some of these compounds can help patients with this disease.  If a compound demonstrates good efficacy and low toxicity, this compound will progress into animal testing (non-clinical studies) and human testing (clinical studies).  Clinical trials are broadly divided into 4 Phases – Phases I, II, III, and IV.  A clinical development plan starts with a draft drug label, known as the target product profile (TPP). Each phase of clinical development is planned according to this TPP.  In this presentation, we will discuss how statistical thinking is applied in supporting the CDP.
 
 
  
3. Subgroup Analysis in Clinical Development of New Drugs
 
In clinical development of new medicinal products, it is common to perform subgroup analysis after trial results are available.  There are many reasons for performing subgroup analyses.  However, most of these analyses are post hoc in nature and hence clinical findings simply from these analyses may not be thought of as confirmatory evidence.  In this presentation, a few case studies are used to clarify some of the considerations in performing subgroup analysis.  In recent years, a new topic is known as subgroup identification becomes popular.  This topic will also be covered in this presentation.
 
 
  
Biography of Speaker
 
Naitee Ting is a Fellow of American Statistical Association (ASA). He is currently a Director in the Department of Biostatistics and Data Sciences at Boehringer-Ingelheim Pharmaceuticals Inc. (BI).  He joined BI in September of 2009, and before joining BI, he was at Pfizer Inc. for 22 years (1987-2009).  Naitee received his Ph.D. in 1987 from Colorado State University (major in Statistics).  He has an M.S. degree from Mississippi State University (1979, Statistics) and a B.S. degree from College of Chinese Culture (1976, Forestry) at Taipei, Taiwan. 
 
Naitee published articles in Technometrics, Statistics in Medicine, Drug Information Journal, Journal of Statistical Planning and Inference, Journal of Biopharmaceutical Statistics, Biometrical Journal, Statistics and Probability Letters, and Journal of Statistical Computation and Simulation.  His book “Dose Finding in Drug Development” was published in 2006 by Springer, and is considered as the leading reference in the field of dose response clinical trials.  The book “Fundamental Concepts for New Clinical Trialists”, co-authored with Scott Evans, was published by CRC in 2015.  Another book “Phase II Clinical Development of New Drugs”, co-authored with Chen, Ho, and Cappelleri  was published in 2017 (Springer).  Naitee is an adjunct professor of Columbia University, University of Connecticut, and Colorado State University.  Naitee has been an active member of both the ASA and the International Chinese Statistical Association (ICSA).
 
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