NERDG 2026
Abstracts for Round Table (RT) Session 1: Emerging Technologies - DS and DP
Presentation 1
Breaking the Barrier: Resolving CMC Challenges with DS–DP Co‑Processing
Dr. Bing-Shiou Yang, Boehringer Ingelheim
Abstract:
The growing complexity of new chemical entities (NCEs)—including intrinsically amorphous compounds, cohesive crystalline APIs, and poorly soluble BCS II/IV molecules—has intensified CMC challenges that often exceed the capabilities of traditional Drug Substance (DS) and Drug Product (DP) toolkits. Established approaches such as spray‑dried dispersions (SDD) and hot‑melt extrusion (HME) commonly struggle with limitations in crystallization control, flowability, density, scalability, and facility readiness, resulting in development bottlenecks. DS–DP co‑processing offers a transformative alternative by engineering API physical properties at the interface of DS and DP. Through polymer‑assisted, non‑covalent co‑precipitation, this approach enables conversion of problematic particle morphologies into robust, high‑performance materials while retaining or enhancing solubility‑enabling amorphous states.
A central example is the Controlled API–Polymer Solidification (CAPS) platform, an emulsion‑based co‑processing method that uses standard DS equipment to generate amorphous solid dispersions with superior physical properties—including high bulk density, narrow PSD, spherical morphology, and excellent flow and compression behavior. These enhanced material attributes simplify downstream DP operations, often enabling direct compression and reducing process complexity. Case studies with a late‑stage development compound demonstrate bioequivalent in‑vitro and in‑vivo performance relative to SDD, supporting CAPS as a scalable and robust technology suitable from early development through commercial readiness.
Abstracts for Round Table (RT) Session 1: Emerging Technologies - DS and DP
Presentation 1
Breaking the Barrier: Resolving CMC Challenges with DS–DP Co‑Processing
Dr. Bing-Shiou Yang, Boehringer Ingelheim
Abstract:
The growing complexity of new chemical entities (NCEs)—including intrinsically amorphous compounds, cohesive crystalline APIs, and poorly soluble BCS II/IV molecules—has intensified CMC challenges that often exceed the capabilities of traditional Drug Substance (DS) and Drug Product (DP) toolkits. Established approaches such as spray‑dried dispersions (SDD) and hot‑melt extrusion (HME) commonly struggle with limitations in crystallization control, flowability, density, scalability, and facility readiness, resulting in development bottlenecks. DS–DP co‑processing offers a transformative alternative by engineering API physical properties at the interface of DS and DP. Through polymer‑assisted, non‑covalent co‑precipitation, this approach enables conversion of problematic particle morphologies into robust, high‑performance materials while retaining or enhancing solubility‑enabling amorphous states.
A central example is the Controlled API–Polymer Solidification (CAPS) platform, an emulsion‑based co‑processing method that uses standard DS equipment to generate amorphous solid dispersions with superior physical properties—including high bulk density, narrow PSD, spherical morphology, and excellent flow and compression behavior. These enhanced material attributes simplify downstream DP operations, often enabling direct compression and reducing process complexity. Case studies with a late‑stage development compound demonstrate bioequivalent in‑vitro and in‑vivo performance relative to SDD, supporting CAPS as a scalable and robust technology suitable from early development through commercial readiness.
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Bio:
Bing-Shiou Yang is a distinguished Chemical Engineer with a Ph.D. and over 24 years of experience in the pharmaceutical industry, specializing in API isolation development, solid-state, engineering technologies, and leading non-clinical development as a project leader. Currently, he serves as the Director of Material & Analytical Sciences at Boehringer Ingelheim in Ridgefield, CT, where he lead the Solid-State Science & API Engineering driving scientific leadership and innovation in areas such as crystallization, separation technology, continuous processing, process engineering, and process analytical technology (PAT).
Bing-Shiou's expertise extends to streamlining Drug substance and Drug product CMC development interfaces, leveraging solid form, API isolation process, and material science profiling. His team has been instrumental in the development of all new chemical entities in Boehringer’s portfolio, a testament to their dedication and expertise. Bing-Shiou's direct contributions to the Ph III assets Icelpertin and Nerandomilant are particularly noteworthy. His leadership in resolving DS-DP challenges earned him a prestigious President’s award from Boehringer. As an active member of the pharmaceutical community, he represents BI in the International Consortium for Innovation and Quality (IQ) and Enabling Technology Consortium (ETC), also serving as a Board of Director for ETC.
Before joining BI, Bing-Shiou worked at Bristol-Myers Squibb (BMS) as a crystallization and particle engineering specialist, making significant contributions to portfolio compounds, including ELIQUIS® (Apixaban). He holds B.S. and M.E. degrees from National Taiwan University and a Ph.D. in Chemical Engineering from Princeton University. Throughout his career, Bing-Shiou has co-authored over 75 publications, patents, book chapters, and presentations, showcasing his dedication to advancing the field of pharmaceutical process development.
When he's not at work, Bing-Shiou loves to lose himself in the beauty of photography and the thrill of exploring new places. But the highlight of his day is undoubtedly the precious moments he spends with his two teenage kids, soaking in the joy of their musical performances. Bing-Shiou also dedicates his time to volunteering, holding a board member position at a local Chinese Language School. He also mentors young Taiwanese professionals who are embarking on careers in the US pharmaceutical and biotechnology industry.
Bing-Shiou Yang is a distinguished Chemical Engineer with a Ph.D. and over 24 years of experience in the pharmaceutical industry, specializing in API isolation development, solid-state, engineering technologies, and leading non-clinical development as a project leader. Currently, he serves as the Director of Material & Analytical Sciences at Boehringer Ingelheim in Ridgefield, CT, where he lead the Solid-State Science & API Engineering driving scientific leadership and innovation in areas such as crystallization, separation technology, continuous processing, process engineering, and process analytical technology (PAT).
Bing-Shiou's expertise extends to streamlining Drug substance and Drug product CMC development interfaces, leveraging solid form, API isolation process, and material science profiling. His team has been instrumental in the development of all new chemical entities in Boehringer’s portfolio, a testament to their dedication and expertise. Bing-Shiou's direct contributions to the Ph III assets Icelpertin and Nerandomilant are particularly noteworthy. His leadership in resolving DS-DP challenges earned him a prestigious President’s award from Boehringer. As an active member of the pharmaceutical community, he represents BI in the International Consortium for Innovation and Quality (IQ) and Enabling Technology Consortium (ETC), also serving as a Board of Director for ETC.
Before joining BI, Bing-Shiou worked at Bristol-Myers Squibb (BMS) as a crystallization and particle engineering specialist, making significant contributions to portfolio compounds, including ELIQUIS® (Apixaban). He holds B.S. and M.E. degrees from National Taiwan University and a Ph.D. in Chemical Engineering from Princeton University. Throughout his career, Bing-Shiou has co-authored over 75 publications, patents, book chapters, and presentations, showcasing his dedication to advancing the field of pharmaceutical process development.
When he's not at work, Bing-Shiou loves to lose himself in the beauty of photography and the thrill of exploring new places. But the highlight of his day is undoubtedly the precious moments he spends with his two teenage kids, soaking in the joy of their musical performances. Bing-Shiou also dedicates his time to volunteering, holding a board member position at a local Chinese Language School. He also mentors young Taiwanese professionals who are embarking on careers in the US pharmaceutical and biotechnology industry.
Presentation 2
Phase understanding to guide process control for patient centric microsphere formulations
Dr. Heather Frericks Schmidt, Pfizer, Inc.
Abstract:
Wax based microspheres offer a versatile, patient centric dosage form for oral delivery of solids pharmaceuticals. A melt-spray-congeal (MSC) process is used to prepare microsphere. This manufacturing process can cause the drug substance or formulation components to undergo phase changes that impact the product performance. In the case of the drug substance, the high temperatures of melting step can result in change to its solid form. A pre-formulation test and development protocols were created to assess risk of process induced transformation and to set temperature limit that would retain the desired solid form. During the MSC process the wax components themselves can undergo phase changes which impact drug release. A thorough investigation of the microstructure after manufacturing and storage revealed changes in the overall microsphere porosity that impacted drug release. This was followed up with study on the thermal behavior and miscibility of the wax to identify control strategies for modified release microspheres. By understanding of the phase space for all formulation components process changes were made to maintain control throughout the manufacturing.
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Bio:
Heather Frericks Schmidt is a Senior Principal Scientist at Pfizer, Inc. with 17 years of experience developing of solid oral dosage forms. She earned her Ph.D. in Physical Chemistry from University of Illinois at Urbana-Champaign. At Pfizer, she is team leader in Drug Product Design and Supply and leads the development of DP for pharmaceutical candidate to treat metabolic diseases. Her research focuses on chemical and physical stability of drug products and how their phase behaviour influences performance.
Heather Frericks Schmidt is a Senior Principal Scientist at Pfizer, Inc. with 17 years of experience developing of solid oral dosage forms. She earned her Ph.D. in Physical Chemistry from University of Illinois at Urbana-Champaign. At Pfizer, she is team leader in Drug Product Design and Supply and leads the development of DP for pharmaceutical candidate to treat metabolic diseases. Her research focuses on chemical and physical stability of drug products and how their phase behaviour influences performance.
Presentation 3
Liquid-Liquid Phase Separation in Formulation and Crystallization Development
Prof. Na Li, University of Connecticut
Abstract:
Liquid-liquid phase separation occurs in solution when the solute concentration exceeds its miscibility gap with the solvent. In oral formulations, liquid-liquid phase separation can lead to the formation of amorphous drug nanoparticles, promoting drug absorption across the intestinal mucosa. However, in crystallization development, undesired liquid-liquid phase separation may cause encrustation, extended process times, or even completely prevent crystallization altogether. In this presentation, we will discuss liquid-liquid phase separation and its implications for both formulation design and crystallization development.
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Bio:
Na Li is an assistant professor in the Department of Pharmaceutical Sciences at the University of Connecticut (UConn). Her research interests focus on integrating biopharmaceutics, formulation sciences, and engineering principles to guide drug substance and product development.
She received her bachelor’s degree in Food Science and Engineering from South China University of Technology, and Ph.D. degree in Food Chemistry at Purdue University, followed by postdoctoral training in Industrial and Physical Pharmacy at Purdue. Prior to joining UConn, she also worked at Crystal Pharmatech Inc. specializing in solid-state chemistry and crystal form selection of small molecule drugs. She joined UConn in 2019, shortly before the onset of COVID pandemic. Despite these challenges, she quickly established a productive research team and made significant research progress while securing $3 million in research support since starting at UConn. She has received the 2021 IPEC (International Pharmaceutical Excipients Council) Foundation Patrick DeLuca Emerging Researcher Award, the 2022 PhRMA (Pharmaceutical Research and Manufacturers of America) Foundation Research Starter Grant, and the 2025 NIPTE (National Institute for Pharmaceutical Technology and Education) Rising Star Scholarship Award. Currently, she serves on the Editorial Advisory Board of Molecular Pharmaceutics and Pharmaceutical Research.
Na Li is an assistant professor in the Department of Pharmaceutical Sciences at the University of Connecticut (UConn). Her research interests focus on integrating biopharmaceutics, formulation sciences, and engineering principles to guide drug substance and product development.
She received her bachelor’s degree in Food Science and Engineering from South China University of Technology, and Ph.D. degree in Food Chemistry at Purdue University, followed by postdoctoral training in Industrial and Physical Pharmacy at Purdue. Prior to joining UConn, she also worked at Crystal Pharmatech Inc. specializing in solid-state chemistry and crystal form selection of small molecule drugs. She joined UConn in 2019, shortly before the onset of COVID pandemic. Despite these challenges, she quickly established a productive research team and made significant research progress while securing $3 million in research support since starting at UConn. She has received the 2021 IPEC (International Pharmaceutical Excipients Council) Foundation Patrick DeLuca Emerging Researcher Award, the 2022 PhRMA (Pharmaceutical Research and Manufacturers of America) Foundation Research Starter Grant, and the 2025 NIPTE (National Institute for Pharmaceutical Technology and Education) Rising Star Scholarship Award. Currently, she serves on the Editorial Advisory Board of Molecular Pharmaceutics and Pharmaceutical Research.
