Advancing Pharmaceutical Development: Compaction Simulation, Regulatory

Expectations, and AI Integration

Location: Gilead, 333 Lakeside Dr, Foster City, CA
Date: June 9th, 1 PM to 5 PM

Join us for an immersive workshop designed for pharmaceutical scientists, engineers, and regulatory professionals seeking to deepen their understanding of compaction simulation and its pivotal role in regulatory submissions. Hosted as a prelude to the Compaction Simulation Forum, this workshop bridges scientific innovation and regulatory compliance, offering insights into the integration of advanced tools and methodologies in pharmaceutical development.
We will explore how regulatory agencies, including the FDA, evaluate compaction simulation data and its alignment with USP standards. Learn how to effectively incorporate compaction simulation results into FDA filings, enhancing the scientific robustness of your submissions while meeting regulatory expectations. Participants will gain a clear understanding of the role of compaction simulation in de-risking formulations, process optimization, and ensuring product quality.
The workshop will also delve into the transformative potential of artificial intelligence in pharmaceutical development. Discover how AI is reshaping the landscape of pharmaceutical processes, from predictive modeling in formulation and process development to the analysis and interpretation of complex datasets. We will discuss best practices for leveraging AI to ensure regulatory compliance, improve decision-
making, and advance drug development timelines.
By participating in this workshop, attendees will:

1. Gain a comprehensive understanding of compaction simulation and its relevance to regulatory submissions.
2. Explore practical approaches for aligning compaction simulation data with USP standards and FDA requirements.
3. Understand the role of AI in pharmaceutical process modeling and data analytics, and how it can enhance regulatory submissions.
4. Participate in hands-on discussions and case studies that illustrate the integration of AI and compaction simulation in real-world pharmaceutical scenarios.
5. Engage with industry experts to address common challenges and solutions in utilizing these technologies effectively.

This workshop offers a unique opportunity to stay at the forefront of regulatory science and innovation, equipping you with the knowledge and tools to navigate the complexities of modern pharmaceutical development. Don’t miss this chance to advance your expertise and contribute to the future of our industry!

First Section: Applying Compaction Simulation Experimental Data and Analysis in Regulatory Filings and Its Use in Quality by Design
Speaker: Bhavishya Mittal, PhD
The compaction simulator is a powerful tool for analyzing material properties. Another critical application of a compaction simulator is evaluating the manufacturability of a drug substance under different formulation and process conditions. Such experimental approaches can establish a baseline for scale-up.
The interpretation of data from a compaction simulator varies depending on the stakeholder’s role in pharmaceutical development. This presentation will provide insight from multiple perspectives, including that of an FDA reviewer, an innovator drug development scientist, and a CDMO manufacturer. While the data remains consistent, its application and regulatory significance differ across these domains.
This presentation will discuss the following case studies:

1. Constrained mixture designs where the formulation-process design space is simultaneously evaluated.
2. An experimental study conducted on a compaction simulator to establish scalability to a large-scale rotary tablet press. These case studies will illustrate how experimental data generated from a compaction simulator can be leveraged to develop robust drug product sections of regulatory
   submissions.

Second Section: USP GC <1245> Compaction Simulation – Origin, Key Contents, and Future Outlook
Speaker: Professor Calvin Sun, PhD
Compaction simulation technology has emerged as a critical tool in pharmaceutical development, providing insights into material behavior, formulation optimization, and process scalability. The recently published USP General Chapter <1245> addresses the scientific foundation and practical applications of compaction simulation.
This presentation will provide an overview of the development of this publication, followed by a discussion of its key topics, including:

1. Fundamental principles of compaction physics.
2. Different types of instruments used for simulating powder compaction.
3. Potential benefits of compaction simulation in formulation and process development.
4. Limitations and challenges associated with the technology.
5. Practical applications of compaction simulation in pharmaceutical manufacturing and regulatory submissions.
   
   The presentation will conclude with insights into the future of compaction simulation
   technology and its evolving role in advancing tablet formulation and manufacturing processes. By integrating compaction simulation into modern pharmaceutical workflows, the industry can improve drug product performance, enhance process efficiency, and strengthen regulatory compliance.

Third Section: AI Applications in Pharmaceutical Development – Streamlining Cocrystal Design and API Route Optimization
Speaker: Aaron Johnson, PhD
Artificial intelligence (AI) is revolutionizing pharmaceutical development by enhancing data organization, integration, and application, leading to accelerated decision-making and process optimization. This presentation examines two AI-driven implementations that streamline drug development and manufacturing workflows, improving efficiency and regulatory compliance.
The first case study focuses on the use of machine learning to optimize pharmaceutical cocrystal design. By employing binary classification models integrated with ADMET Predictor features, this approach enhances coformer selection to improve active pharmaceutical ingredient (API) properties efficiently. The second application highlights an AI-powered retrosynthesis planning platform that leverages advanced algorithms and Monte Carlo Tree Search methodology to map optimal synthetic pathways. By integrating proprietary supply chain intelligence with predictive modeling, this system enables rapid route optimization based on real-world material availability.
These case studies illustrate the critical role of AI in pharmaceutical data management, from characterization and formulation to synthesis planning and regulatory submissions. The discussion will provide insight into how AI-driven methodologies align with regulatory expectations, ensuring data integrity and submission quality.
By demonstrating AI’s ability to drive data-driven decision-making and accelerate pharmaceutical innovation, this presentation underscores the transformative potential of AI in drug development and manufacturing.

Interactive Roundtable Discussion: Bridging Insights and Innovation.
Moderator: Kevin J. Bittorf,PhD PEng
Following the presentations, participants will have the opportunity to engage in an interactive roundtable discussion. This session will provide an open forum for attendees to share their perspectives, raise questions, and explore ideas related to compaction simulation, regulatory applications, and AI-driven pharmaceutical advancements. The discussion will foster collaboration among industry professionals, regulatory experts, and researchers, offering valuable insights into challenges, emerging trends, and innovative solutions in pharmaceutical development.

About Our Speakers
Professor Changquan Calvin Sun, PhD – University of Minnesota
Dr. Sun is Distinguished McKnight University Professor of Pharmaceutics in the Department of Pharmaceutics, University of Minnesota. Dr. Sun’s research focuses on formulation development of tablet products through appropriate application of materials science and engineering principles. Two areas of current research are 1) crystal and particle engineering for superior pharmaceutical properties and 2) fundamental understanding of pharmaceutical processes. He has published 270 peer-reviewed papers in these areas with H-index = 69.
Dr. Sun currently serves on the editorial boards of CrystEngComm and Frontiers in Chemistry. He also serves on the editorial advisory boards of Int. J. Pharm., J. Pharm. Sci., Mol. Pharmaceutics, AAPS Open, and Pharm. Res. He has served on the Expert Committee in Physical Analysis of the United States Pharmacopeia since 2010. Dr. Sun is a Fellow of the American Association of Pharmaceutical Scientists (AAPS), the Royal Society of Chemistry (RSC), and the American Association for the Advancement of Science (AAAS). He received the 2019 Ralph Shangraw Memorial Award from the International Pharmaceutical Excipient Council (IPEC) and the 2022 David J. W. Grant NIPTE Distinguished Scholar Award in Basic Pharmaceutics.

Bhavishya Mittal, PhD – Vice President, Product Development and Manufacturing,
BioDuro (Formerly Staff Fellow, FDA)
Bhavishya Mittal is the Vice-President of Product Development and Manufacturing at BioDuro-Sundia (Irvine, CA), where he leads the strategy and operations for drug product development of all small molecule client-owned assets within the portfolio. Before BioDuro, Bhavi worked at Kronos Bio, AbbVie, US FDA, Takeda, and Astellas Pharmaceuticals. Bhavi is also an adjunct faculty at the Keck Graduate Institute’s Henry E. Riggs School of Applied Life Sciences (Claremont, CA).
He has a Ph.D. in Materials Engineering from the Pennsylvania State University and a BS in Chemical and Bio Engineering from the National Institute of Technology, Jalandhar (India).
Bhavi has 22+ years of industrial experience in formulation design, process development, and project management of numerous drug products of small therapeutic molecules. He is the Chair for AAPS’s Manufacturing Sciences and Engineering (MSE) community. He is the author of 3 published books, 4 granted US patents, 11 peer-reviewed manuscripts, and numerous conference papers and posters published/presented in various international journals and conferences.

Aaron Johnson, PhD – R&D Cheminformatics Data Scientist, Lonza
Dr. Johnson combines expertise in chemistry and computer science with a focus on data-driven innovation. After earning a PhD in Inorganic Chemistry and completing postdoctoral research in nuclear forensics at Idaho National Laboratory, he pursued a Computer Science degree to bridge scientific research with computational methods. At CAS, he developed machine learning models for scientific literature analysis before joining Lonza, where he now leads the cheminformatics and data science team. His work focuses on applying ML and AI technologies to advance pharmaceutical R&D, positioning him as a leader in the digital transformation of chemical sciences.

Keivn J Bittorf, PhD, MBA, PEng – Founder of SCxCMC Solutions and President of
the CSF
Kevin J. Bittorf is a seasoned executive and consultant specializing in pharmaceutical development, technical innovation, and regulatory strategy. With extensive experience in GMP compliance, business development, contract manufacturing, and long-term strategy, Kevin collaborates with CEOs and executives to drive pharmaceutical advancements by evaluating strategic approaches, securing regulatory approvals, and implementing emerging technologies that improve the drug development lifecycle.
As the Founder of SCxCMC, LLC, Kevin provides expert consulting to small and medium-sized pharmaceutical and biotechnology companies, focusing on pharmaceutical development, process chemistry, formulation, regulatory affairs, quality assurance, supply chain, and packaging. His work ensures that companies efficiently navigate CMC challenges, optimize manufacturing strategies, and successfully transition from early development to commercialization.
Kevin has also played a key role in fostering industry collaboration through the formation of multiple non-profit conferences:

• Advancing Drug Development Forum (www.AdvDrug.org) – Focuses on the
  journey from scientific innovation to regulatory approval, engaging key opinion
  leaders in biotech and pharma.
• Compaction Simulation Forum (www.CompactionSimulation.com) – Examines
  how formulations perform at an industrial scale using minimal material, helping
  pharmaceutical companies optimize manufacturing processes and reduce costs.
• Continuous Manufacturing Forum (www.ContMfg.com) – Showcases best
  practices for improving pharmaceutical manufacturing efficiency through
  continuous processing.

A forward-thinking innovator, Kevin played a pivotal role at Vertex Pharmaceuticals, where he justified the transition to continuous manufacturing using financial modeling and technical innovation, reducing costs and accelerating time-to-market. He later co-founded Trek Therapeutics, a biotech company focused on HCV treatment in emerging markets, where he led business development and CMC strategy, licensing five new chemical entities (NCEs) and preparing materials for clinical trials in under a year.
Now a full-time consultant and industry advocate, Kevin continues to support companies in optimizing their CMC strategies, leveraging innovative technologies, and navigating regulatory complexities to ensure success in pharmaceutical development.