Catalent

Articles

The Role of Forced Degradation in Method Development, Manufacturability, and CMC Strategy 

Get ready to elevate your expertise and gain actionable insights at our upcoming webinar, Optimizing Adaptive Trials: The Role of On-Demand Manufacturing and Derisking in Accelerating Early Clinical Trial Success.

https://www.pharmtech.com/pt_w/adaptive-trials

Small pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility.

This webinar will explore how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations. Attendees will gain insights into the integration of oral small-molecule manufacturing technologies and collaborative strategies necessary to ensure compliance and success in this dynamic environment.



Understand the strategic importance of on-demand manufacturing in adaptive trials where early data can guide real-time modifications of dose adjustments.

Explore how Catalent’s on-demand manufacturing approach ensures compliant production processes, enabling faster responses to the regulatory requirements of adaptive trials and ensuring seamless compliance across various regions.

Discover how implementing on-demand manufacturing reduces timelines and optimizes resource utilization, and how smaller companies can benefit from this approach.


Director, Scientific Advisory, Oral
Small Molecules, Europe
Catalent


Stephen Tindal is the Director, Scientific Advisory, Oral Small Molecules, Europe, Catalent. His work is largely focused on preclinical to phase 1 development and is based on assessing preclinical data to help define any challenges to dosage form development. Tindal has more than 36 years of experience at Catalent, where he has held roles of increasing responsibility and has demonstrated expertise in root cause investigation, technology innovation, and supporting business development. He holds a bachelor’s degree in chemistry and analytical science from Loughborough University in England.




Head of Clinical Project Management and Regulatory Affairs, UK
HMR

Karen Chalk, BSc, rejoined HMR as head of clinical project management and regulatory affairs in 2023. Her first appointment with HMR was as a research technician in 2001. She undertook secondments with our training department and pharmacy before leaving HMR in 2003 to continue her career in clinical research. In the 20 years between her appointments here, Chalk worked for both blue-chip pharma companies and small contract research organizations (CROs). Chalk has written about 70 protocols covering all phases, multiple therapeutic areas, and devices, and has acted as a quality consultant to several small biotech companies. She has also run a large multicenter, multicountry, EU-funded study with more than 1000 participants, and a research project on regulatory requirements in sub-Saharan Africa. As head of clinical project management and regulatory affairs, Chalk now oversees clinical project management, regulatory affairs, and quality functions. She is a visiting lecturer in clinical pharmacology, Barts Hospital Medical College and Queen Mary University, London, England, for the MSc course in early drug development.




Director of Global Regulatory Affairs
Catalent

Judith Jones is a director of global regulatory affairs, as part of the Catalent corporate regulatory affairs group. Jones has an honors degree in chemistry and is a Fellow of Royal Society of Chemistry and a member of TOPRA. Jones has over 25 years of experience working at Catalent and has been involved in the pharmaceutical industry for her entire career; she has worked in regulatory affairs for more than 20 years. She has extensive experience of the different Catalent dosage forms and technologies, such soft gelatin capsules, Zydis orally disintegrating tablets, sterile injectables, as well as solid oral dosages and medical devices. Her submission preparation experience includes CTAs/INDs/MAAs/NDAs/ANDAs/WHO applications, as well as full submission management and health authority liaison. Jones can provide regulatory assessment and advice for preapproval development projects and postapproval commercial projects, regulatory strategy at all stages of development, and full support for submission execution.



Webcasts

Webinar Date/Time: Wednesday, April 2, 2025 11:00 AM EST

Optimizing Adaptive Trials: The Role of On-Demand Manufacturing and Derisking in Accelerating Early Clinical Trial Success

Join us to discover how to drive innovation and deliver impactful solutions in this rapidly evolving field. This session will provide actionable insights and a forward-looking perspective on evolving opportunities in nasal drug development and delivery.

https://www.pharmtech.com/pt_w/nasal-drug-delivery

Nasal drug delivery is rapidly becoming a transformative approach in the pharmaceutical industry, offering unique advantages for both patients and drug developers. With applications spanning small molecules, biologics, and vaccines, nasal delivery systems are being leveraged to overcome challenges in drug administration, enhance therapeutic efficacy, and improve patient adherence.

In this webinar, experts will provide a comprehensive overview of the nasal drug delivery market, highlighting key trends and the evolving landscape driving innovation. Attendees will gain insights into pipeline advancements, the growing adoption of nasal delivery for biologics, and the rise of nasal powder formulations as a stable and patient-friendly solution. Additionally, the speakers will discuss future innovations, including cutting-edge devices and emerging technologies that promise to redefine the field.

Join us to discover how to drive innovation and deliver impactful solutions in this rapidly evolving field. This session will provide actionable insights and a forward-looking perspective on evolving opportunities in nasal drug development and delivery.



Understand the current market landscape for nasal drug delivery, including key trends and pipeline developments

Explore the unique advantages of nasal delivery for biologics and nasal powders in enhancing drug stability and patient adherence

Discover future innovations in nasal delivery systems, including advancements in device design and formulation technologies


Director, Innovation and Partnerships – Nasal Delivery
Catalent

Mark Ignaczak, director of innovation and partnerships for nasal delivery at Catalent. Ignaczak leads strategic growth initiatives and partnerships for Catalent’s nasal liquid and powder business and has an extensive background in nasal spray product development and commercialization. He holds a bachelor of science in biochemical engineering from Rutgers, New Brunswick, New Jersey. Mark has 21 years of pharmaceutical experience and over 17 years of direct experience with nasal spray products. In that time, he has worked on 75+ nasal programs in varying stages within the project lifecycle, ultimately launching 10+ NDAs, some considered first-of-their-kind and best-in-class therapies. Throughout his career, he has fulfilled various roles within bioprocess engineering, product development, supply chain, packaging, and all aspects of nasal delivery program management and strategy.




Vice President, Technical Services
Kymanox

Ryan Doxey, with over 20 years of industry experience, Ryan Doxey is a seasoned, strategic leader in the areas of CMC-regulatory and pharmaceutical/biologics development. Doxey’s expertise includes pharmaceutical and biopharmaceutical product development (formulation, process, analytical), US and ROW/global CMC regulatory strategy, technology transfer (pre- and post-approval), CDMO/CMO selection and management, program and portfolio management, and clinical supply manufacturing, labeling, and distribution. He has a specialty and passion for identifying, developing, and delivering practical and innovative solutions for complex, nonconventional product formulations and drug delivery systems from concept to pivotal clinical studies. Doxey has supported numerous clients in nasal drug delivery development, including considerations for device selection, manufacturing process design and development, and regulatory compliance.

Webinar Date/Time: Tues, March 4, 2025 11:00 AM EST


Nasal Drug Delivery on the Rise: What’s Next for Pharma?

Unlock the true potential of your biologic via extended stability studies Join our webinar to explore advanced forced degradation techniques and optimize your chemistry, manufacturing, and controls (CMC) strategy with insights from industry expert Brent Kennedy.

https://www.biopharminternational.com/bp_w/forced-degradation

Join us to discover the critical role of forced degradation studies in method development, manufacturability, aggregation, and other essential quality attributes. This session will delve into the analysis of an IgG1 antibody subjected to various forced degradation pathways, utilizing advanced techniques such as SV-AUC, SEC-MALS, and DLS. Gain valuable insights into sedimentation coefficients, molecular weight, polydispersity, and particle size analysis, and understand how these factors help optimize the CMC strategy of your monoclonal antibody therapeutics.



Understand the importance of forced degradation studies in the development and quality assessment of biotherapeutics.

Learn how advanced techniques help to understand and evaluate stability and critical quality attributes.

Explore how data from forced degradation studies inform method development and manufacturability decisions.

Individuals involved in the development, manufacturing, and quality control of biopharmaceutical products.


Manager
Biologics Analytical Services
Catalent Biologics



has over 24 years of experience in biophysical and biochemical analytics. He leads a team of scientists dedicated to the characterization of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs). He also oversees method development and collaborates with clients to address analytical challenges in both GMP and non-GMP contexts. Brent holds a BA in Cell Biology from the University of Northern Colorado and is highly skilled in advanced analytical techniques, including SEC-MALS and SV-AUC technologies.



Webinar Date/Time: Wednesday, February 12th at 11:00 AM EST


The Critical Role of Forced Degradation in Method Development, Manufacturability, and CMC Strategy

Join this webinar to explore the latest innovations in pregastric absorption. Learn more about advancements in buccal and sublingual delivery systems, the impact of permeation enhancers, and the role of physiologically based pharmacokinetic (PBPK) modeling in predictive formulation design.

https://www.pharmtech.com/pt_w/pregastric-absorption

In today's competitive pharmaceutical landscape, drug developers are continually seeking innovative strategies to enhance bioavailability, improve patient compliance, and expedite therapeutic outcomes. Pregastric absorption has emerged as a critical pathway to achieve these goals by enabling drugs to bypass gastrointestinal degradation and first-pass metabolism.

Join us for an insightful webinar as we explore the latest innovations in pregastric absorption. Learn more about advancements in buccal and sublingual delivery systems, the impact of permeation enhancers, and the role of PBPK modeling in predictive formulation design.

This session will provide a deep dive into how rapid-dissolving orally disintegrating tablets (ODTs) are transforming the landscape of drug development. Experts will also discuss how these trends are influencing the development of patient-centric formulations, all with the goal of improving therapeutic efficacy and patient experience.

Explore the latest formulation strategies, including the use of permeation enhancers and advanced ODT technologies, to improve the pregastric absorption of difficult-to-formulate drugs

Learn how to apply PBPK modeling tools to simulate and predict drug absorption through the oral cavity, accelerating formulation development

Understand how to create ODTs that are not only effective for pregastric delivery but are also more palatable and easier to administer, enhancing patient compliance


Associate Director DMPK Advisory Services
Catalent

Jan Neelissen, PhD, serves as the associate director of DMPK advisory services. He has over 25 years of pharmaceutical industry experience in the field of DMPK. In his current role, he advises drug innovators in developing new therapeutics and designing tailored formulation, delivery, and manufacturing solutions. Neelissen is a trained biologist and holds a doctorate in pharmaceutical sciences from Leiden University.




Formulation Section Head Product Development
Catalent

Emilie Kimberley is a Formulation Section Head at Catalent in Swindon, United Kingdom. In her role, she supports formulation development for Zydis orally disintegrating tablets from feasibility studies to clinical supply at bench scale. With over 16 years’ experience within the pharmaceutical industry, she plays a key role in supporting the successful development of new Zydis products. Kimberley holds a BSc in pharmaceutical and chemical industries from the University of Paris Descartes and an MSc in industrial pharmaceutical sciences from the University of Manchester.




Professor of Pharmaceutics
Aston University

Afzal Mohammed, PhD, is a renowned professor of pharmaceutics and head of pharmaceutics at Aston University. He is an expert in particle engineering and paediatric formulation development, with funding from various bodies including INNOVATE UK, MRC, EPSRC, BBSRC and NC3R. He has presented research findings at major national and international conferences and was awarded a fellowship at the Academy of Pharmaceutical Sciences in 2017. His group has published over 100 publications and he serves as an associate editor for the International Journal of Pharmaceutics and BMC Pharmacology and Toxicology.



Webinar Date/Time: Thu, Feb 13, 2025 11:00 AM EST


Innovations in Pregastric Absorption Drug Delivery and Orally Disintegrating Tablets

Join our panel of experts as they explore how spray drying can be applied to enhance the stability, bioavailability, and manufacturability of various molecules, including peptides, oligonucleotides, small molecules, monoclonal antibodies, and nutraceuticals.

https://www.pharmtech.com/pt_w/beyond-amorphous-solid-dispersions

Developers of innovative drug products dealing with protein formulations, nucleotide-based drugs, peptides, and poorly soluble molecules, face significant challenges in achieving efficient and scalable manufacturing solutions. Spray drying has emerged as a powerful and versatile manufacturing technology. It offers significant advantages for stabilizing complex and sensitive drug molecules while optimizing production processes.


Join our panel of experts as they explore how spray drying can be applied to enhance the stability, bioavailability, and manufacturability of various molecules, including peptides, oligonucleotides, small molecules, monoclonal antibodies, and nutraceuticals. This session will cover the latest innovations in spray drying technology, and provide valuable insights into formulation development, process parameters optimization, and large-scale production. Attendees will also learn how to maintain molecular integrity during the spray drying process and leverage in-silico tools to streamline commercialization.


Whether you’re working with small-scale experimental formulations or preparing for commercial manufacturing, this webinar will equip you with actionable strategies needed to optimize your development pipeline and succeed in spray drying applications.

Discover how spray drying extends beyond amorphous solid dispersions to tackle the stabilization and manufacturing challenges of complex compounds, including peptides, oligonucleotides, and biologics

Learn effective strategies for scaling up spray drying processes from lab-scale to commercial production, while ensuring product consistency, cGMP compliance, and regulatory adherence

Gain insights into advanced methods for analyzing spray-dried powders, including their particle size distribution, morphology, and flow properties, to ensure optimal performance of diverse pharmaceutical formulations beyond ASDs


Senior Director, Scientific Advisory
Catalent

Lisa Caralli is senior director of scientific advisory at Catalent, overseeing small molecule and peptide scientific support for North America. She has over 30 years of industry experience in pharmaceutical research and development, with a focus on early-phase approaches to the chemistry manufacturing and control of small molecules and peptides. Caralli has held previous product development positions at Ionis Pharmaceuticals, Amylin Pharmaceuticals, and the Immune Response Corporation. She holds a bachelor of science in biochemistry from the University of California, Davis.




Director, Scientific Advisory
Catalent

Nathan Bennette is the director of scientific advisory at Catalent. He is also a member of Catalent’s small molecule advisory team for North America. In this capacity he works directly with partners to understand the key drug delivery objectives for their specific molecule, collaborate on the target product profile, and define a strategy for the development program. He has over 15 years of experience in pharmaceutical development and delivery with an emphasis in bioavailability enhancement. Bennette is particularly interested in the application of the scientific method early in the design and development process, along with improving clinical outcomes by bringing a ‘right the first time’ approach to formulation and process design. He holds a master’s degree in inorganic and organometallic chemistry from the University of Washington.




Senior Process Scientist and OSD Manager
GEA

Andrew Birkmire is a senior process scientist and OSD manager at GEA. His responsibilities include all internal and on-site process testing and development for North American pharmaceutical applications. Birkmire’s background includes extensive experience in coating, drying, and granulation technologies, with a focus on continuous manufacturing processes.




Principal Consultant
Procegence

Nima Yazdanpanah is a consultant on advanced manufacturing and modeling and simulation applications in bio/pharmaceutical and fine chemical industries. His area of expertise covers process design and development, continuous manufacturing, process simulation, particulate matters, digitalization, and regulation. Prior to starting Procegence, his consultancy firm, Yazdanpanah was a research scientist with the US Food and Drug Administration. He was appointed as a member of an expert team for advancement of emerging technologies to modernize pharmaceutical manufacturing. With 20 years of diverse experience in different industries—including petrochemicals and specialty chemicals, food, and pharmaceuticals—he has worked in R&D, process design, and MSAT sections. At Procegence, he helps companies with process development, scaling-up, optimization, and tech transfer. He aims to bring his clients’ product to market faster, better, and at lower cost.




Director Global Sales and Marketing, Head of Sales, Americas
PolyPeptide

Trishul Shah is the Director of Business Development and Head of North American Sales for the PolyPeptide Group. He is involved in industry peer groups such as the TIDES Advisory committee, Boulder Peptide Symposium Scientific Board, a member of the PolyPeptide Group’s Executive Strategic Team in the US and member of the Global Management Group at PolyPeptide. Trishul joined the PolyPeptide Group as a peptide chemist in 2005 and in 2007 joined Allergan as a pre-formulation chemist. Upon returning to PolyPeptide in 2009, Trishul joined the Business Development group.

Webinar Date/Time: Wed, Feb 5, 2025 11:00 AM EST
