Join us for a complimentary lunch seminar in Cambridge, MA
"Getting It Right Early: The Importance of Biopharmaceutics in Early Drug Development"
Thursday, April 21, 2022
11:30am - 12:00pm
12:00pm - 1:00pm
Watson Room - towards the back of the restaurant
Complimentatry validated parking available in the Technology Square Garage
Nominated candidates entering clinical development often have sub-optimal physicochemical, biopharmaceutic or DMPK properties for oral delivery. Development teams are challenged with how to understand the properties of new drug candidates, how to design the appropriate formulation strategy and how to move quickly and successfully into early phase clinical trials. Along the way, it is important to identify developability risks and take steps to mitigate these factors, balanced carefully against time and cost investments.
Join Dr. Aruna Railkar, Quotient Sciences' Senior Drug Development Consultant, as she discusses effective strategies being used by biotech and pharmaceutical companies to overcome biopharmaceutic challenges for small molecules in today’s drug development pipeline; and explores alternative approaches for accelerating your early development plan. Aruna will present case studies related to:
- Poorly soluble molecules
- Drugs with short half-lives
- Preclinical to clinical translation
Key learning objectives:
- The importance of salt and polymorph screening and prototype selection for pre-clinical assessment
- BCS or DCS assignment and developing a formulation strategy for poorly soluble molecules
- The role of physiologically based pharmacokinetic (PBPK) modelling and simulation (M&S) for rational formulation design
- Teasing apart the drivers of poor bioavailability - In-vitro testing / in-silico techniques / in-vivo preclinical studies / clinical assessment
- Choosing the appropriate dosage form for first-in-human trials
- Formulation optimization using adaptive clinical programs
After the seminar, enjoy appetizers and beverages while mingling with your peers.
About our speaker
Dr. Aruna Railkar has over 25 years of experience in the pharmaceutical industry working at the discovery – development interface, providing critical input for progressing compounds into clinical development, prodrug evaluation, understanding challenges in absorption/exposure of lead molecules and development of formulation strategies (conventional or enabling) based on compound properties.
During her career at Hoffmann-La Roche, Aruna led the group characterizing the physicochemical and biopharmaceutic properties of compounds to inform NCE selection and provided stage appropriate formulation development for preclinical and clinical studies collaborating with discovery and development teams in multiple therapeutic areas. Her recent experience also covers clinical formulation development of poorly soluble molecules using amorphous or lipid-based formulations, oral and injectable controlled release dosage forms.
Aruna's area of interest is in the development of novel dosage forms for existing drugs (as an alternate route of administration or improved delivery which can use the 505(b)(2) development pathway). She joined Quotient Sciences as a Senior Research Fellow in the scientific consulting group and supports the Business Development team in designing and scoping the studies for clients and assisting in scientific and technical discussions.