Webinar Date/Time: Thu, Oct 22, 2026 11:00 AM EDT
Oral delivery of peptides and complex molecules is moving from aspiration to possibility. Discover strategies to improve bioavailability, reduce risk, and accelerate the path to clinic.
Register Free:
Event Overview:
Oral delivery offers significant advantages in patient convenience, acceptance, and adherence, but peptides, macromolecules, and other complex molecules face formidable barriers, including enzymatic degradation, poor solubility, low permeability, and variable gastrointestinal conditions. Advances in formulation science are expanding oral-delivery opportunities for peptides, macromolecules, and complex beyond-Rule-of-Five compounds, including certain targeted protein degraders. This webinar will explore enabling approaches, such as lipid-based formulations, permeation enhancers, localized pH modification, and engineered delayed-release softgels. Scientific examples and formulation case studies will demonstrate how these technologies can address molecule-specific barriers and improve oral bioavailability. The session will also examine next-generation permeation and in vitro–in vivo correlation (IVIVC) methodologies for translating the in vitro performance of lipid-based formulations into meaningful bioavailability insights. Attendees will learn how an integrated approach to developability assessment, formulation design, and performance prediction can strengthen candidate and formulation selection, reduce development risk, support regulatory readiness, and increase the probability of clinical success.
Key Learning Objectives:
Who Should Attend:
Speakers:
Amruta Mhashilkar, MD, PhD, MBA
Director, Formulation and Process Development
Catalent
Amruta Mhashilkar, MD, PhD, MBA, is director of formulation and process development at Catalent in St Petersburg, Florida. She is a well-rounded and enthusiastic professional with a strong background in the scientific and technical aspects of pharmaceutical development. Her expertise includes ANADA, ANDA, and NDA submissions, as well as the development and launch of prescription and VMS products. Mhashilkar is proficient in CMC writing, oral drug delivery, and process development, with hands-on experience in pilot and scale-up cGMP manufacturing. She specializes in enteric and controlled-release delivery systems and has a solid foundation in technology transfer and new product development. Her prior experience encompasses cell and tissue culture, protein purification, western blotting, PCR, transcriptomics, and gene editing techniques. In her current role, she manages over 40 pharmaceutical product development programs, guiding them from pre-IND studies through to commercial launches. She has direct oversight of formulation and process development activities and leads a team of more than 8 scientists.
Sandip Tiwari, PhD, FAAPS
Head of Technical Services–Pharma Solutions
BASF
As head of technical services for BASF Pharma Solutions in North America, Sandip Tiwari, PhD, FAAPS, leads strategic scientific and customer-facing initiatives supporting innovators, generic companies, and CDMOs across formulation design, excipient selection, bioavailability enhancement, in vitro performance testing, IVIVC, process development, scale-up, and regulatory-relevant CMC decision-making. His work reflects global leadership in formulation and drug delivery innovation, helping translate scientific concepts into practical, regulatory-relevant, and commercially meaningful solutions.
Tiwari is a 2026 Fellow of the American Association of Pharmaceutical Scientists (AAPS), recognized for his scientific leadership in translating formulation and drug delivery science into regulatory-relevant, practice-changing solutions, with demonstrated impact from early development through commercialization. He currently serves as chair of the AAPS Formulation & Delivery Community and has held leadership roles in the AAPS IVDRT Community, the Society for Pharmaceutical Dissolution Science, and the American Association of Indian Pharmaceutical Scientists.
An active scientific contributor, editor, speaker, and mentor, Tiwari has authored more than 100 publications, presentations, book chapters, abstracts, and patents. He serves as chief editor of the Desk Book of Pharmaceutical Dissolution Science and Applications and is an adjunct professor in the Department of Translational Science and Medicine at the University of Alabama, supporting academic-industry collaboration and mentoring future pharmaceutical scientists.
Karunakar Sukuru, PhD, RPh
Segment Vice President, Global Product Development & Innovation
Catalent
Karunakar (Karu) Sukuru, PhD, RPh, is a distinguished leader in the pharmaceutical industry, with over 3 decades of expertise in drug product and technology development. At Catalent, he oversees the development of small-molecule prescription products, guiding a team of over 1000 scientists across 14 sites on 4 continents. His role involves managing a robust pipeline of several new molecules, utilizing diverse drug delivery technologies to support successful product launches. Sukuru has a proven track record in product development and technical oversight of numerous contract development and manufacturing organizations globally. He is renowned for pioneering innovative controlled-release platform technologies in softgel dosage forms. He holds more than 12 issued patents and has over 20 pending patent applications, particularly in modified shell, fill technologies and lyophilization techniques for biologic products. Before joining Catalent in 2016, Sukuru held key positions at Endo Pharmaceuticals, Banner Pharmacaps (in India and the US), and Natco Pharma in India, demonstrating his extensive leadership in the field. He is actively involved in professional organizations, including the American Association of Pharmaceutical Scientists, Controlled Release Society, and the Society for Pharmaceutical Dissolution Science, and has served as an expert committee member at the United States Pharmacopeia, for 10 years, where he contributes to setting pharmaceutical standards
Register Free:
