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Xi Hu is a principal scientist working in Pfizer’s BioTherapeutics Pharmaceutical Sciences organization. she received B.S in chemistry from Peking University in China and Ph.D in bioorganic chemistry from Duke University. she have over 10 years of bio-pharmaceutical industry experience in process research and development of bioconjugates, including vaccine conjugates and antibody drug conjugates. My expertise includes late phase process development, quality by design/DOE, control strategy, technology transfer, process validation and regulatory filing.
As antibody drug conjugates (ADCs) move through clinical development, from phase 1 to pivotal studies, supported by clinical efficacy and appropriate safety, the development of late stage and commercial-ready processes and methods becomes a priority. During the development of commercial-ready processes, several key activities have contributed to the successful advancement of the inotuzumab ozogamicin program to late-stage development. Among these are the development of a control strategy that focuses on the control of quality attributes from raw materials through drug product, attention to proper scaling of unit operations, detailed understanding of the product through application of appropriate analytical tools, and studies of the effect of process parameters on quality attributes. In addition, planning for the complex supply chain and facility requirements for handling cytotoxic materials has been crucial. This ADC is particularly complex, but the approaches used are applicable universally
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Dr. Qureshi has extensive (30+ years) working experience, as a research scientist, with a regulatory agency (Health Canada). He is an internationally known expert on the subject and maintains a full command in the areas of drug dissolution testing, pharmacokinetics, biopharmaceutics and analytical chemistry as related to animal and human studies for developing and evaluating pharmaceutical products. Specifically: (1) Quality assessment of pharmaceutical products based on pharmacokinetic studies (e.g. bioavailability/bioequivalence) in humans and animals, including validation of in vitro results with in vivo (bioavailability) studies. (2) In vitro drug release characterization of pharmaceutical products in particular oral and dermal using dissolution and/or diffusion (absorption/penetration through skin) techniques. (3) Analytical methods development/validation for drug disposition evaluation in humans and animals using chromatographic (e.g. HPLC, GC, TLC) and spectroscopic (e.g. UV, MS) techniques. (4) Data analysis using sophisticated (SAS) and general-purpose (e.g. MS Excel) software.
Dr. Qureshi has extensively published in peer-reviewed journals and given numerous national and international presentations on the subject. Dr. Qureshi is very well known for his innovative but simple and practical ideas. Since 2010, he has been contributing and moderating a weblog (www.drug-dissolution-testing.com) which has become a popular source of new and thought provoking ideas for addressing the issues of product evaluations.
It is important to note that patients and consumers need drugs or medicines but buy products such as tablet/capsule. In this respect, one must first clearly differentiate between the two – drugs/medicines from products. The capability of releasing or delivery of the drugs from the products as expected then becomes a quality attribute of the products from a patient’s perspective. A formal or regulatory recognition of this critical quality attribute (CQA) is lacking at present, at least in a measurable terms which causes significant hurdles in developing and manufacturing of the pharmaceutical products. This presentation will explain scientific rationale for defining the CQA for pharmaceutical products so that the development process for such products becomes effective, objective and efficient. Unlike the current practices and requirements, which lack scientific basis, the approach or technique for the assessment of quality, thus CQA, must be product independent for an unbiased assessment. Such a product independent evaluation approach is not only a scientific requirement but will hugely simplify product evaluations thus their development and manufacturing. Considering solid oral dosage forms (tablet/capsule) as an example, a new and simple approach based on a universal drug dissolution test will be presented for monitoring CQA. Scientific validity, simplicity and superiority of such an approach in comparison with the current practices will be highlighted.