Webcast Slides are Available for Your Convenience
Seventh Street Development Group now offers free webcast slides of presentations on polymorphs, cocrystals, amorphous dispersions, screening, crystallization, and more! Slides and information available when you need them. See the list below and check back regularly for new presentations.Amorphous Systems
Using Thermal Analysis to Characterize Amorphous Pharmaceutical Materials
An increased interest in using amorphous solid forms in pharmaceutical applications to increase solubility, dissolution, and bioavailability has generated a need for better characterization of key properties, such as the glass transition (Tg) temperature. Although many laboratories measure and report this value, the details around these measurements are often vague or misunderstood. Issues that directly impact the Tg, such as instrumental parameters, sample preparation methods, data analysis, and “wet” vs. “dry” measurements, will be discussed. Thermal methods used to investigate miscibility of multicomponent systems, such as amorphous solid dispersions (ASDs) and coamorphous materials, will be presented and compared with other techniques.
Presented by Ann Newman, Seventh Street Development Group
Hosted by Rigaku
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The Use of Amorphous Solid Dispersions to Enhance Dissolution, and Oral Bioavailability of Poorly Water-Soluble Pharmaceutical Compounds
This one hour presentation discusses the structural, thermodynamic and dynamic properties of amorphous solids and how they relate to desired material properties for an amorphous solid dispersion, including miscibility, stability, dissolution, and supersaturation.
Presented by George Zografi, University of Wisconsin-Madison
Hosted by Seventh Street Development Group
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Mesoporous Phases as Supports for Amorphous Material
Silicate scaffolds with 2-50 nm pores (mesopores) provide support for the amorphous state of drugs and drug-like compounds. The amorphous state in these mesopores is thermodynamically stable against recrystallization. In fact, it has been observed that crystalline drug loads itself into silicate mesopores by vapor phase transfer. Mesoporous silicates are being used by at least two pharmaceutical companies to improve drug exposure in tox studies and as a formulation in Phase I studies.
Presented by Dr. Robin Bogner, University of Connecticut
Hosted by Seventh Street Development Group
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The Formulator's Toolbox: Designing and Developing Disordered Systems
During this session, we will discuss the various tools that can be used by formulators faced with developing a challenging BCS II drug candidate. The tools discussed will include those specific to the goal of designing and developing amorphous solid dispersions and include: characterization of the drug candidate, selection of excipients (selecting a “parachute”), identifying formulation compositions, and understanding early development challenges. The scientific understanding gained by using these tools can contribute to the development of a pharmaceutically acceptable product with biopharmaceutical properties typically associated with BCS I drugs over the residence time in the body. There are multiple examples in the literature that demonstrate how these concepts have been utilized and a few of these examples will also be discussed.
Presented by Jayne Hastedt, JDP Pharma Consulting
Hosted by Seventh Street Development Group
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Amorphous Materials and Dispersions in Pharmaceutical Development
Amorphous drugs provide a promising route for enhancement of bioavailability in pharmaceutical development. A solid dispersion of an amorphous material is a delivery technology applied extensively at different development stages. Relevant concepts and fundamentals on amorphous dispersions will be introduced and explored. Industrial approaches and procedures on amorphous formulation development will also be discussed.
Presented by Jun Huang, Crystal Pharmatech
Hosted by Seventh Street Development Group
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Characterization Techniques
Solid-State NMR Spectroscopy of Pharmaceuticals: Form Identification and Quantitation of API and Drug Products
Solid-state NMR spectroscopy (SSNMR) is a powerful analytical technique for the analysis of both drug substances and drug products. In this webinar, examples of how SSNMR can be used to analyze drug substances, such as polymorphs, solvates, and co-crystals, will be presented. For drug products, amorphous solid dispersions are uniquely suited for analysis by SSNMR. Phase separation, detection of low levels of crystallinity, and drug-polymer examples will all be highlighted. Finally, examples of signal to noise enhancement using dynamic nuclear polarization (DNP) of drug substances and drug products will be presented.
Presented by Eric Munson, University of Kentucky
Hosted by Seventh Street Development Group
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In Process High Resolution Microscopy, Particle Focused Raman, Particle Size & Shape in One Probe
This one hour webinar will provide information on applications utilizing single probe acquisition of simultaneous microscopy and Raman spectroscopy. Case studies outlining the utility of the probe in various applications will be presented.
Presented by Gregor Hsiao, Blaze Metrics
Hosted by Seventh Street Development Group
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Cocrystals
Engineering Cocrystal Solubility and Streamlining Cocrystal Early Development
This one hour presentation provides an overview of meaningful characterization methods to guide cocrystal and additive selection and key indicators of cocrystal solubility and thermodynamic stability.
Presented by Nair Rodriguez, University of Michigan
Hosted by Seventh Street Development Group
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Crystallization
Synthonic Engineering: Tools for the Rational Design of High Quality Pharmaceuticals
This talk gives an overview on using molecular scale (synthonic) tools in process R&D to improve quality, shorten lead times, and cut costs. The use of available software in predicting physical properties of crystals and the potential impact on drug product formulation will be discussed.
Presented by Kevin Roberts, University of Leeds
Hosted by Seventh Street Development Group
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Effective Development of API Crystallization Processes During Drug Development
This webinar presents crystallization approaches to support drug development needs including examples involving polymorphic purity control, purity upgrade, crystal morphology alteration, and stability enhancement.
Presented by Jian Wang, Crystal Pharmatech
Hosted by Seventh Street Development Group
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Beyond Salt and Polymorph Screening and Selection: Tackling Scale-Up Challenges
This one hour webcast discusses how to scale-up your desired form for GLP toxicology/First in Humans (FIH) clinical trials interface.
Presented by JP Mobele, Okapi ChemTech
Hosted by Seventh Street Development Group
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Effective Chemistry Outsourcing for Emerging Pharmaceutical Companies
This webinar covers preparation for, interactions with, and management of chemistry contract research, development, and manufacturing organizations (CDMOs) to ensure the best technical and cultural fit with smaller sponsor companies. Mitigation of the risks associated with chemistry outsourcing and building strong working relationships with vendors are critical to success. An effective stepwise approach to chemistry outsourcing addressing these issues will be presented.
Presented by Stuart Levy, SGL Consulting, LLC
Hosted by Seventh Street Development Group
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Form Screening
Integrated Phase and Formulation Selection to Support GLP Toxicology and First in Human Studies
This one hour talk covers selecting physical forms such as salts and cocrystals jointly with formulation strategies to ensure sufficient stability and exposure for safety and clinical studies. Creative short cuts in early development will be discussed that will fuel studies leading up to decision points followed by a more rigorous investment once success has been established.
Presented by Nathalie Toussaint and Annette Bak, Merck Research Laboratories
Hosted by Seventh Street Development Group
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Rational Formulation Development through Solid Form Selection, Modeling, and Automated Formulation Screening
Recent developments in solid form technology, biopharmaceutics modeling and automation can enable the design of formulation properties to obtain the desired pharmacokinetic profile in vivo. This presentation will introduce the applications of modeling to understand the controlling factors for oral absorption and the use of solid form selection and automated formulation screening to optimize these factors in drug product.
Presented by Chong-Hui Gu, Agios Pharmaceuticals
Hosted by Seventh Street Development Group
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Specialized Screening: How Do I Deal with Difficult Compounds?
This one hour webcast covers special techniques used in polymorph screens, including stable forms, hydrates, processing stresses, ionic liquids, and highly solvating compounds. Access a free copy of our paper on specialized screening published in Organic Process Research and Development.
Presented by Ann Newman, Seventh Street Development Group
Hosted by Seventh Street Development Group
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Drug Development
The Drug Development Process from Discovery to Commercialization- An Overview
Once a new molecule with the desired biological and pharmacological properties is discovered and declared a “development candidate” many disciplines must swing into action; preclinical development, CMC, regulatory and clinical research to name a few. Whether the company is a large, integrated pharmaceutical company or a small biotech with no or limited development expertise, the activities must be well coordinated since many of them run in parallel. This presentation will highlight the complex processes and activities and their interdependency. Ultimately the development activities must result in a safe, well tolerated, efficacious and commercially viable therapeutic product.
Presented by Elizabeth Vadas, InSciTech Inc
Hosted by Seventh Street Development Group
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Crystal and Particle Engineering for Expedited Development of High Quality Tablet Products
The development of tablet products is often faced with challenges of poor flowability, tabletability, and bad taste of active pharmaceutical ingredients (API). In contrast to empiricism, the development of successful tablet products requires the employment materials science and engineering from solid form selection to formulation design. In this talk, recent examples of successful development of challenging APIs based on crystal and particle engineering will be discussed to illustrate the usefulness of such an approach of tablet product development.
Presented by Calvin Sun, University of Minnesota
Hosted by Seventh Street Development Group
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Preclinical Studies
Enabling Poorly Soluble Weak Bases for Improved Bioavailability: Why a Salt May Not be the Best Choice
While making salts is a well known strategy to increase exposure of ionizable drugs, it may not be the best strategy. For many weak bases, the potential for disproportionation of the salt back to the free base can lead to precipitation or crystallization of the free base in vivo. The factors which govern disproportionation will be discussed as well as alternative approaches for improving exposure for weakly basic drugs.
Presented by Dr. Sheri Shamblin, Pfizer
Hosted by Seventh Street Development Group
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Enabling Role of Pharmaceutical Sciences in Early Stages of Drug Development
Fundamental understanding of the drug absorption phenomena coupled with firm knowledge of physicochemical and solid-state properties of drug molecules are necessary for successful development and application of enabling formulation technologies that address drug development challenges. These concepts and a toolbox of enabling pharmaceutical technologies are explored. High-level overview of strategies for preclinical formulation development and form selection are also presented.
Presented by Dr. Roman Shimanovich, Amgen
Hosted by Seventh Street Development Group
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Polymorphism of Drugs - Can We Exploit Physical Form in the Development of Low Solubility Molecules?
This one hour presentation discusses the selection and use of solid forms in early and late formulation development.
Presented by Elizabeth Vadas, InSciTech
Hosted by Seventh Street Development Group
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Efficient Preclinical Formulation Development for Poorly Soluble Compounds
The challenge of providing adequate exposure of highly lipophilic BCS II compounds from a preclinical toxicology/safety perspective while maintaining an eye on formulation stability presents formulators with a mjor hurdle in formulation design. This presentation covers oral, preclinical formulation strategies to provide efficient formulation development with emphasis on solid form and preclinical study design to inform human dosage forms.
Presented by Christopher Lindemann, Focus Pharmaceutics
Hosted by Seventh Street Development Group
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Polymorphs
What Are Polymorphs and Why Do We Care?
A one hour webcast on solid-state polymorphs and how they impact on drug development.
Presented by Ann Newman, Seventh Street Development Group
Hosted by Seventh Street Development Group
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Disappearing Polymorphs
This one hour webinar will discuss crystalline solid forms of an active pharmaceutical ingredient (API) and what happens when you can no longer produce the form you need. Learn more about this phenomenon, known as disappearing polymorphs- what are they, how do you deal with them, and can you get them back?
Presented by Dr. Greg Stephenson, Pharma Form Finders, LLC
Hosted by Seventh Street Development Group
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Stability
Drug Degradation Mechanisms: Why Are They Important?
Developing an understanding of the degradation pathways available to drug substances and associated formulated products is an important part of establishing the “intrinsic stability” characteristics of a drug. This talk will focus on several case studies of degradation mechanisms, highlighting the importance of a “chemistry-guided” approach that includes structure elucidation of degradation products, utilization of kinetics, analytical tools, and experiments that are designed to uncover critical mechanistic root causes. The mechanistic insights gained from this approach will be used to illustrated how such understanding can reveal the reactive sites in the drug molecule, potential physical issues and analytical pitfalls, and implications for stabilization through formulation design and packaging.
Presented by Steve Baertschi, Baertschi Consulting, LLC
Hosted by Seventh Street Development Group
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Accelerated Stability Testing
This one hour webinar covers accelerate chemical stability testing for drug substance and drug product.
Presented by Scott Smith, Gilead
Hosted by Seventh Street Development Group
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