Speakers

Yogeshwar Bachhav is a pharmacist by training and has PhD in
advanced drug-delivery systems from ICT, Mumbai (India). He has around 16 years of post-PhD experience in Europe in the field of pharmaceutical development of investigational drugs. He has contributed to the success of the clinical candidates
ranging from preclinical to phase 1, 2, and 3 trials followed by commercial launch. Yogesh has worked as a Research Scientist for around four years on a collaborative project between Pantec Biosolutions AG (Lichtenstein) and University of Geneva,
Switzerland. After this, he has worked as a Formulation Manager at Debiopharm Group, Lausanne, Switzerland, for around four years in the capacity of a lab head, where he successfully developed preclinical and clinical formulations for oncology
indication. Currently Yogesh is working as a Associate Director (Consultant) at AiCuris Anti-infective Cures
AG Germany and responsible for pharmaceutical development of investigational drugs in the domain of innovative anti-viral and anti-bacterial drugs. Yogesh’s expertise in the field of advanced drug-delivery system comprises pre-formulation, formulation development of small molecules and/or peptides
for oral, dermal, and parenteral applications. Also, he has exposure to in-house development and outsourcing these novel dosage forms. Besides several publications in the targeted formulation field, Yogesh is a well-known expert with over 30 conference proceedings and has been named Wiley-VCH in the same book series titled Innovative Dosage Forms: Design and
Development at Early Stage. He is also serving as visiting faculty at reputed Pharmacy Schools in India.

Presentation Title: Hurdles to Develop a Parenteral Nanosuspension Formulation for Early Clinical Phase

Abstract: Majority of the NCEs display a poor solubility in aqueous environment and this presents a great deal of challenge to deliver the active at the site of action. The issue of poor solubility is also leads to the poor efficacy and failure of the compound to succeed the cycle of drug development.
It’s important to initiate the development of enabled formulations such as nanosuspensions at early stage so that sufficient exposures can be attained in the preclinical safety studies. Also, time required to optimize the Frist in human (FIH) formulation can be gained.
The current talk will cover overview of the practical limitations to develop parenteral nanosuspension formulations for early-stage clinical projects. Typically, issues such as stability constraints, identification of suitable CDMO partner and case studies will be discussed.

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