Scientific program

Nov 25-26, 2020    New York, USA

Global Summit on Drug Discovery, Design and Development

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Wasfi AlAzzam,
09:30 AM-10:00 PM 1

Wasfi AlAzzam,

TechnoPharmaSphere LLC United States

Title: Industrial Practices for Determining Biopharm Products’ Critical Quality Attributes (CQAs)

Abstract:

Analytical methods have been playing a major role in creating in vitro and in vivo product characterization packages. Compiling both sets of data helps in-depth understanding of product’s quality attributes (QA) and helps in the determination of product’s CQAs. It is proven that some CQAs have impact on the product’s safety and biological profiles. Biopharm industry is now revising their testing strategies to accelerate product development. This talk will connect analytical, CQAs, and clinical outcomes in product’s development.      Analytical methods have been playing a major role in creating in vitro and in vivo product characterization packages. Compiling both sets of data helps in-depth understanding of product’s quality attributes (QA) and helps in the determination of product’s CQAs. It is proven that some CQAs have impact on the product’s safety and biological profiles. Biopharm industry is now revising their testing strategies to accelerate product development. This talk will connect analytical, CQAs, and clinical outcomes in product’s development.      

Manoj Jadhav, PhD, FCP.
10:00 AM-10:30 AM 1

Manoj Jadhav, PhD, FCP.

CRC Pharma, LLC United States

Title: Drug repurposing: Key strategic considerations

Abstract:

In this presentation, Dr. Jadhav will elaborate on the importance of having the right drug development strategy (clinical, formulation, TPP) for drug repurposing and specific formal interactions with the different divisions of the US FDA. Setting the right path can fulfill the aim of getting maximum benefits/waivers from the Agency. Dr. Jadhav will also cover specific case studies to illustrate this point.

Biography:

Dr. Jadhav is responsible for strategic, scientific planning and business functions for the organization. He also act as an expert and contribute to the clinical development plans, target product profile for the  clinical and scientific development projects e.g. NCE, 505(b)(2) across different therapeutic areas e.g. infectious diseases, oncology, autism, Huntington disease, CV, CNS etc. He has supported 08 pre-IND meetings, IND compilations for US-FDA communications for small molecules, synthetic peptides and biological.

Dr. Jadhav brings in his experience of over 10+ years in industry and academia. He is a trained clinical pharmacologist with extensive experience in planning, designing, execution and interpretation of clinical studies (prospective, retrospective, interventional and observational) in the area of cancer, cardiovascular and infectious diseases.

He was part of successful team which developed first Indian liposomal amphotericin B (FungisomeTM) and launched in Indian market. Dr. Jadhav has over twenty-five peer-reviewed publications, co-edited a book, have made numerous posters and oral presentations internationally.

Dr. Jadhav received his PhD in Pharmaceutics from Bombay College of Pharmacy and KEM Hospital, University of Mumbai, India and did his Post-Doctoral fellowship at the Colleges of Pharmacy and Medicine Univ. of Florida, Gainesville, Florida.

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