2025 Summit on Innovations in Controlled Release, Bioavailability Enhanceme: Full Schedule

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9:00am EDT

Chairperson’s Welcome & Opening Remarks

Thursday May 8, 2025 9:00am - 9:05am EDT

Brunswick Ballroom

Thursday May 8, 2025 9:00am - 9:05am EDT
Brunswick Ballroom

9:05am EDT

Excipient Reactivity and Drug Stability in Formulations

Thursday May 8, 2025 9:05am - 9:45am EDT

Brunswick Ballroom

Speakers

Masih Jaigirdar, PhD

Former Senior Product Quality Reviewer, FDA

Mashuddin Jaigirdar is a retired pharmaceutical scientist with over 35 years of global experience in formulation development, process technology transfer, and manufacturing for brand and generic pharmaceuticals. He served as a Senior Quality Reviewer at the U.S. FDA, contributing... Read More →

Thursday May 8, 2025 9:05am - 9:45am EDT
Brunswick Ballroom

General Session

9:45am EDT

Lipid-based formulations: Maximizing the delivery of the poorly soluble drugs

Thursday May 8, 2025 9:45am - 10:15am EDT

Brunswick Ballroom

Speakers

Yogesh Bachhav, PhD

Associate Director, AiCuris

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... Read More →

Thursday May 8, 2025 9:45am - 10:15am EDT
Brunswick Ballroom

General Session

9:45am EDT

Osmotic-Controlled Release Oral Tablets: Technology and Functional Insights

Thursday May 8, 2025 9:45am - 10:15am EDT

Brunswick Ballroom

Speakers

Kenneth Ogueri, PhD

Senior Researcher, Drug Product Design and Process Manufacturing, Pfizer

Dr. Kenneth S. Ogueri is currently a researcher in drug product design (DPD), Pfizer worldwide R&D. Kenneth does research in materials engineering, polymer science, formulations and their applications in oral therapeutic drug delivery, regenerative engineering, and other biomedical... Read More →

Thursday May 8, 2025 9:45am - 10:15am EDT
Brunswick Ballroom

General Session

10:15am EDT

Strategies for ASD Formulation Development

Thursday May 8, 2025 10:15am - 10:50am EDT

Brunswick Ballroom

Speakers

Erica Schlesinger, PhD

Vice President of Technical Development, Seran Biosciences

Erica Schlesinger has over 12 years of professional experience in technical development, research and development, formulation development, drug delivery, process chemistry, education, engineering, and teaching. In 2018, they served as VP Technical Development and Director, R&D for... Read More →

Thursday May 8, 2025 10:15am - 10:50am EDT
Brunswick Ballroom

General Session

11:20am EDT

Enhanced Bioavailability of Small Molecules, Peptides and Proteins by Nanoparticle Formation using Scalable Flash NanoPrecipitation

Thursday May 8, 2025 11:20am - 11:50am EDT

Brunswick Ballroom

Thursday May 8, 2025 11:20am - 11:50am EDT
Brunswick Ballroom

General Session

11:50am EDT

Using PBPK Modeling for Risk Assessment in Drug Product Development

Thursday May 8, 2025 11:50am - 12:20pm EDT

Brunswick Ballroom

Speakers

Siddharth Kesharwani

Director, Small Molecule CMC Development, AbbVie

Ph.D. (Pharmaceutical Sciences) with 5+ years of experience in fast-paced pharmaceutical industry, management consulting, and higher education with 25+ publications, 15 awards, 5 grants, and >50 invited seminars and presentations at national/international meetings.Certificate in Healthcare... Read More →

Thursday May 8, 2025 11:50am - 12:20pm EDT
Brunswick Ballroom

General Session

1:30pm EDT

Consumer-Centric Nasal Bioavailability Enhancement Formulation Development

Thursday May 8, 2025 1:30pm - 2:00pm EDT

Brunswick Ballroom

Speakers

Shabbir Lobo, PhD

Staff Scientist, Global Innovations and Product Development, Bayer

Shabbir is a skilled formulator in Transdermals, Modified Release oral Dosages and Topicals for Abbreviated New Drug Application (ANDA) and 505 b2 submissions. Attuned to current FDA regulations for a QbD based product development. dFMEA through the development of dosage form and... Read More →

Deb Das, PhD

Senior Associate Director & Science Fellow, Research and Development, Bayer

Debanjan (Deb), is a drug delivery scientist and an innovation-driven technical manager with over 19 years of product development experience in driving projects from concept to commercialization. He has marketed more than 40 commercial products in US (small molecules & biologics... Read More →

Thursday May 8, 2025 1:30pm - 2:00pm EDT
Brunswick Ballroom

1:30pm EDT

Exploring Diverse Routes for Parenteral Delivery via PK profile; Subcutaneous Oil Formulations

Thursday May 8, 2025 1:30pm - 2:05pm EDT

Brunswick Ballroom

Thursday May 8, 2025 1:30pm - 2:05pm EDT
Brunswick Ballroom

2:00pm EDT

The Rise of Continuous Manufacturing: Melt Granulation and Melt Extrusion in Pharma

Thursday May 8, 2025 2:00pm - 2:30pm EDT

Brunswick Ballroom

Speakers

Richard Steiner, PhD

Head of Sales & PCM Practice Lead, Pharmatech Associates

Richard Steiner, a seasoned professional with over 30 years of experience in sales, currently leads the sales efforts at Pharmatech Associates as the Head of Sales and Practice Lead for Pharmaceutical Continuous Manufacturing. Richard's extensive career includes notable leadership... Read More →

Thursday May 8, 2025 2:00pm - 2:30pm EDT
Brunswick Ballroom

2:35pm EDT

Overcoming Bioavailability Barrier to Deliver Protein Degraders

Thursday May 8, 2025 2:35pm - 3:10pm EDT

Brunswick Ballroom

Speakers

Chong-Hui Gu, PhD

SVP Head of CMC, LifeMine Therapeutics

Chong-Hui Gu, currently working at LifeMine Therapeutics as the Head of CMC and QA, has an extensive background in the pharmaceutical industry. Prior to joining LifeMine Therapeutics, Chong-Hui held roles at Foghorn Therapeutics, Agios Pharmaceuticals as the Head of CMC and DHODH... Read More →

Thursday May 8, 2025 2:35pm - 3:10pm EDT
Brunswick Ballroom

3:10pm EDT

Long-Acting Injectables Product Development: Opportunities and Challenges

Thursday May 8, 2025 3:10pm - 3:35pm EDT

Brunswick Ballroom

Speakers

Pratik Saha

Director, Biopharmaceutics, Drug Product Development, GlaxoSmithKline

Thursday May 8, 2025 3:10pm - 3:35pm EDT
Brunswick Ballroom

3:35pm EDT

Chair’s Closing Remarks and End of Summit

Thursday May 8, 2025 3:35pm - 3:40pm EDT

Brunswick Ballroom

Thursday May 8, 2025 3:35pm - 3:40pm EDT
Brunswick Ballroom

Morning Networking Break