President of Consulting Services, OSD Pharmaceutical Solutions
Firouz Asgarzadeh, Ph.D. is founder of OSD Pharmaceutical Solutions LLC (an independent consulting firm) which provides formulation and process development services to pharmaceutical companies. Dr. Asgarzadeh has over 29+ years of global R&D and commercial experience in leadership... Read More →
The pharmaceutical industry is undergoing a profound transformation, shifting from traditional batch processes to continuous manufacturing. This evolution is partly propelled by advances in Process Analytical Technology (PAT) and the foundational principles of Quality by Design (QbD). Transitioning to a SMART factory mode of operation, however, requires technological innovation, significant professional development, and the maturity of regulatory and management systems. The issue of data integrity breaches (BAD-I), with its historical implications and current prevalence, serves as a critical backdrop for understanding how to balance technological progress with the necessary professional and systemic maturity. This balance is essential to ensure the successful guidance of pharmaceutical manufacturing through this revolutionary phase. In this presentation, we will introduce a SMART framework designed to provide a common-sense foundation for navigating the complexities of pharmaceutical manufacturing’s evolution. This framework will offer ways to ensure that data integrity, technological advancements, and professional maturity move in concert toward a more efficient and compliant future.
Consultant & Fmr Deputy Director Office of Pharmaceutical Science, FDA
Dr. Ajaz S. Hussain is a highly accomplished pharmaceutical scientist with adistinguished career spanning academia, industry, and regulatory affairs. Currently serving as anadvisor to technology companies, he brings expertise from extensive leadership roles. Dr.Hussain was the President... Read More →
Nima is a consultant on advanced manufacturing and modeling and simulation in pharmaceutical and fine chemical industries. His area of expertise covers modeling and simulation and digitalization, process design and scale-up, and advanced manufacturing.With more than 20 years of diverse... Read More →
Assistant Professor, Pharmaceutics & Drug Delivery, University of Texas at Austin
Feng Zhang is an associate professor at the Division of Molecular Pharmaceutics and DrugDelivery at College of Pharmacy at The University of Texas at Austin. He received his Ph.D. in pharmaceuticsfrom the University of Texas at Austin. He worked in the industry for 14 years prior... Read More →
Amorphous solid dispersions (ASDs) are supersaturating formulations that enhance both the apparent solubility, and the bioavailability of poorly water-soluble drugs following oral administration. Upon dissolution, ASDs can generate nano-sized amorphous droplets of ∼100- 200 nm, when the concentration of the molecularly dissolved drug exceeds the amorphous solubility, thereby maximizing the diffusive flux during the supersaturation window. In this research, two poorly soluble drugs were prepared as ASDs with hydroxypropyl methylcellulose acetyl succinate (HPMCAS), to characterize supersaturation and crystallization kinetics in simulated and aspirated intestinal fluids. For each ASD, the onset of nucleation was found to be highly medium dependent. Moreover, membrane flux was attributed to the resulting phase behavior and remained high as long as supersaturation was maintained, whereas desupersaturation, induced by drug crystallization, was coincident with a noticeable decrease in flux. Importantly, it was shown that ASD dissolution in aspirated fluids led to the formation of drug-rich nanodroplets, confirming same observations made in simulated fluids. These observations provide insights into better understanding of the intraluminal supersaturation potential of ASDs as well as the selection of appropriate dissolution media to improve biopredictability for ASD formulations.
Glatt Pharmaceutical Services develops and produces solid pharmaceutical dosage forms. Our focus lies on multiparticulate systems such as pellets, micropellets and granules. Whether you are looking for optimal bioavailablity or taste masking, improved solubility or stabilization of... Read More →
One of the many lessons that the SARS-CoV-2 pandemic has taught the world is the vulnerability of supply chains. When factoring in wars, tit-for-tat tariffs, and safety recalls, an actionable plan needs to be in place to swiftly adapt to rapidly changing supply demands. In response, a call for more flexible manufacturing is desired to address such challenging geographic, economical, and political climates. One aspect of flexible manufacturing is the ability to quickly transfer product between manufacturing locations. When production of a specific product cannot meet supply additional manufacturing lines, not previously utilized for said product, could be implemented to meet the additional supply demand. One such instance where this procedure would have been extremely useful during the recall and subsequential lack of supply of baby formula in the United States, which resulted in the import of product from foreign entities. In the current practice of transferring between one manufacturing route, or site, to another, the procedure is to perform multiple designed experiments and perform statistical analysis on the results. While scientifically beneficial, practically this leads to significant waste in material with little to no actionable items. This methodical approach is not suited to respond to a crisis. Therefore, an approach is needed to focus on critical quality attributes of the existing drug product and methods in which to reproduce the key attributes. One step that is universal in making tablets is the compaction step. Whether it is roller compaction, wet granulation, direct compaction, batch manufacturing, or continuous manufacturing, a tablet press is utilized to bring punches together and compress the final blend into a desired thickness, shape, and mass. Therefore, if the material entering the dies of the press has the same properties (bulk packing, flow, etc.) similar tablet properties should be obtained for both processes. With this understanding, the research presented here is focused on how shearing of powder that occurs in different manufacturing lines can be utilized to generate blend with similar properties. Utilizing three different blenders and two different tablet press feed frames, an IR shear sensitive formulation was blended in three different manufacturing routes, under different shearing profiles, number of rotations, throughput, and RPM, to prove that the final product can be manufactured on different lines.
Ruchit Trivedi is a Director, CMC Pharmaceutics at Eli Lilly based in Indianapolis, Indiana. Previously, Ruchit was a Director of Formulation at BioDuro-Sundia and also held positions at Pfizer, Banner Life Sciences, CU Denver, Northeastern University.
Dr. Shahab Kashani Rahimi is the lead principal scientist in the product development team at Ardena. Shahab has 7 years of experience in pharmaceutical oral solid and liquid formulation and manufacturing process development, and his work focuses on solubility/bioavailability enhancement technologies including hot melt extrusion and spray drying, development of immediate and modified release dosage forms and novel complex drug delivery systems. His experience spans all stages of product development, from pre-clinical development and proof of concept to scale-up, clinical and registration manufacturing. Shahab holds a PhD in polymer science and engineering and has previously worked as a formulation principal scientist at Catalent Pharma Solutions and BioDuro and as a postdoctoral research fellow at molecular pharmaceutics and drug delivery department at University of Texas at Austin.
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 →
Principal Scientist Principal Scientist, Microsize
Jason Riggs is the Head of Research and Development at Microsize and a PrincipalScientist at The Solubility Company. He has over 15 years of Pharmaceutical Sciencesexperience in biopharmaceutical assessment, solid-state characterization, formselection, formulation development, and... Read More →
Microsize specializes in Particle Size Reduction, Powder Classification, and Analytical Services, catering to a diverse clientele, including small biotechs, Big Pharma, CDMOs (API, Dosage Form, Integrated), and Functional Excipient Companies. Our expertise in milling and micronization... Read More →
Business and Technical Consultant, Evolve Consulting
Eduardo Jule earned his PhD in Materials Engineering from the University of Tokyo, where he specialized in designing polymer-based nanoparticles as cytotoxic payload carriers. He later transitioned to a Business Development role at NanoCarrier. Following that, he joined Capsugel and... Read More →
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 →
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 →
Lipid excipients offer tremendous in vivo performance benefits for oral drug delivery by improving solubility/bioavailability, enhancing absorption, and mitigating food effect. While lipids are typically employed in capsule formulations such as soft gels and liquid-filled hard capsules, there is growing interest in incorporating the benefits of lipid excipients into oral solid dosage forms, such as tablets.
In this presentation, we will provide an overview of how lipid excipients enhance bioavailability and discuss unique approaches to formulating oral solid dosage forms using well-known lipid chemistries.
Senior Global Marketing Manager - Pharmaceuticals, Gattefossé
Nick DiFranco, MEM, is the Senior Marketing Manager at Gattefossé Pharmaceuticals USA. In this role, he isresponsible for developing and executing a strategy to grow our North American market presence.Most recently, Nick was the Global Market Segment Manager for Oral Treatments at Lubrizol Life Science Health (LLS Health). In his role, Nick coordinates a multi... Read More →
Since 1880, Gattefossé has developed and manufactured high-quality lipid excipients for human and animal health. Our oral excipients offer solubility/bioavailability enhancement, sustained release, lubrication, and taste-masking. We also provide solubilizers, penetration enhancers... Read More →
Tatiana is a principal scientist in the oral solid development team of Johnson and Johnson Innovative Medicine. Tatiana holds a master of science in Pharmaceutical chemistry and technology from the University of Bologna (Italy) and she is an industrial PhD candidate at Gent University... Read More →
Melanie Marota is a director at Merck and has over 15 years of experience in oral drug product development. She has made substantial contributions to Merck’s pipeline culminating in multiple commercial products including Belsomra, Zepatier, Welireg, and Lagevrio. Melanie has successfully... Read More →
Modified release (MR) drug delivery systems play a critical role in optimizing therapeutic outcomes, improving patient compliance, and extending product lifecycles. This presentation explores a comprehensive, science-driven approach to MR formulation development, integrating modern modeling tools, robust technology platforms, and strategic development methodologies. The session will highlight the role of physiologically based pharmacokinetic (PBPK) modeling in assisting formulation design, enabling prediction of in vivo performance and supporting accelerated development with minimal pharmacokinetic study iterations. The use of biorelevant and predictive dissolution methods to establish in vitro-in vivo correlations (IVIVC) that reduce development time and risk will also be discussed. A broad spectrum of modified release technologies will be discussed, including matrix-based systems (erodible and diffusion-controlled), multiparticulates, bilayer tablets, osmotic tablets, and controlled-release of amorphous solid dispersions. Each technology will be evaluated in terms of its ability to meet specific pharmacokinetic profiles, align with the Quality Target Product Profile (QTPP), and fulfill therapeutic goals. The presentation will explore how to select the most cost-effective technology without compromising performance, guided by a Quality by Design (QbD) framework that ensures a scientifically sound and risk-managed development strategy. Attendees will gain insight into rational technology selection, efficient formulation pathways, and how MR systems can be leveraged not only to improve patient outcomes but also to strategically position products throughout their lifecycle.
Steve has 11 years of industrial solid oral formulation development experience,including complex controlled release formulations and solubility enhancementtechniques. He joined Ardena (formerly Catalent Somerset) in 2021 as Manager ofProduct Development and works to provide clients... Read More →
Wesley Tatum is a Principal Engineer in the Process and Product Development department at Serán. Heleads a team of scientists and engineers in characterizing new API and identifying shortcomings forbioavailability. He and his team then screen and select drug product intermediates... Read More →
At Serán, Our mission is to provide optimized drug development and manufacturing services for our clients, from discovery to the clinic. Our science-driven approach utilizes predictive design tools, novel chemistry, analytical tools, enabling delivery technologies, and a thorough... Read More →
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 →
Dr. James DiNunzio has over 12 years of oral solid dosage drug product development experience and currently serves as an Associate Principal Scientist at Merck & Co. Dr. DiNunzio received his Ph.D. in Pharmacy (Pharmaceutics track) from The University of Texas at Austin, and holds... Read More →
Pharmaceutical salts are a commonly used strategy to improve the bioavailability of poorly water-soluble active pharmaceutical ingredients (APIs). The selected salt form is expected to have high solubility to obtain optimal supersaturation and sufficient physical stability for adequate shelf life. In this presentation, we aim to develop equations to describe critical parameters of salts, including pH-solubility profile and pHmax. The equations serve as a valuable tool to aid in the calculation of salt solubility at pH below the pHmax in the presence of common counter ions. This provides the knowledge to assess the risks of pre-selection of the salt formers without the necessity of salt synthesis. The solubilities calculated by this model demonstrate good agreement with experimental solubility results reported in the literature. Compared to the conventional approaches for salt solubility and pHmax calculation, our model stands out, especially for poorly water-soluble bases with low pKa values, which benefit the most from salt formation. Moreover, the equations are used to support the concept that salt selection should focus on finding salt forms with sufficient solubility, rather than the most soluble salt, as excessively high solubility could be detrimental to physical stability.
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 →
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 →
With about 20 worldwide approvals and almost a decade of commercial applications, CM is fertile ground for the next generation of implementation. Progress in the next few years will be fueled by major competitive advantages of CM: - The faster speed in development of new products and processes enabled by CM will make it a central technology in pharmaceutical reshoring. - The greater ability to model and control CM processes and improve quality control provides a major opportunity for the implementation of advanced manufacturing methodologies aligning closely with the FDA AMT designation program, enabling faster review of NDAs, ANDAs, and PAS. - New formulation methods for continuous direct compression enable major reductions in the effort and materials required to develop or transfer manufacturing processes
Professor Callegari is an expert in the physical behavior of granular materials, particularly their interactions with liquids (such as wettability and dissolution) and with other particles (such as flowability and electrostatics). His research contributes to pharmaceutical product... Read More →
President of Consulting Services, OSD Pharmaceutical Solutions
Firouz Asgarzadeh, Ph.D. is founder of OSD Pharmaceutical Solutions LLC (an independent consulting firm) which provides formulation and process development services to pharmaceutical companies. Dr. Asgarzadeh has over 29+ years of global R&D and commercial experience in leadership... Read More →
Led by Dr. James Scicolone, will tour the first pioneering full-scale continuous direct compression tablet manufacturing line. This line is spread across a 3-floor equipment train including excipient dispensing, continuous blending, and tablet compression, all monitored by advanced process analytical technology (PAT) for real time content uniformity and near-instant release testing. This facility served as the prototype for Janssen Pharmaceuticals' continuous manufacturing line in Gurabo, Puerto Rico, developed in collaboration with Rutgers. In 2016, the FDA approved this line for producing PREZISTA (darunavir), marking it as J&J’s first commercial product manufactured using continuous processes. The transition to continuous manufacturing, supported by a myriad of pharmaceutical companies and FDA , helps to enhance efficiency, reduce waste, and accelerate time-to-market for medications .
