Poor drug solubility continues to be one of the most significant challenges in small molecule drug development, impacting bioavailability, formulation design, clinical performance, timelines and overall development risk. With an estimated 80-90% of molecules currently in development exhibiting poor solubility characteristics, sponsors are increasingly seeking integrated strategies that can accelerate decision-making while reducing the risk of costly reformulation and scale-up challenges.
In this webinar, expert speakers will explore how a connected development strategy can help sponsors successfully navigate solubility challenges from early development through clinical supply. The session will examine how understanding a molecule’s physicochemical properties and biopharmaceutic profile, coupled with a flexible clinical development plan and objectives, can guide the selection and optimization of the most appropriate formulation approach and enabling technology.
Attendees will gain insight into the key considerations for selecting between approaches such as hot melt extrusion (HME), spray dried dispersions (SDD), lipid-based formulations and particle size reduction technologies, while also learning how early formulation decisions can influence future scale-up, manufacturing robustness, regulatory strategy and commercial readiness.
The webinar will cover amorphous solid dispersion development considerations, including stable ASD development through HME and spray drying pathways. It will also examine how scalable development strategies can support formulation continuity from first-in-human studies through later-stage clinical development. Real-world examples will illustrate how integrated development models can help accelerate formulation optimization, generate clinically relevant data earlier and support informed decisions throughout the product lifecycle.
The session will provide practical guidance for evaluating formulation options, planning clinical supply and developing a fit-for-purpose strategy that balances scientific, clinical and commercial considerations.
Register for this webinar to learn how drug solubility strategies can reduce formulation and scale-up risk throughout small molecule development.
Speakers
Robert Cornog, Senior Director, Product Development, Quotient Sciences
Robert Cornog has over 26 years of experience in product development and process design. Across a broad range of dosage forms and technologies, Robert has focused on advancing pharmaceutical manufacturing through science and technical innovations.
Through application of a deep understanding of manufacturing sciences and risk- based methodologies, he has successfully driven the adoption of new technologies and expanding manufacturing capabilities.
Within the Integrated Development services team at Quotient Sciences, Robert provides technical and scientific support to operational and business development teams for the successful transfer of late-stage and commercial drug product programs.
Message Presenter
Mark A. Krook, PhD, CMC & Early Drug Development, NGT Biopharma Consultants
Mark is a Pharmaceutical Executive with more than 35 years of experience, covering all aspects of small molecule CMC research and development, from early drug development through commercial manufacturing.
Mark began his pharmaceutical career at The Upjohn Company (later Pfizer) as a Process Chemist working on API process development for clinical and commercial needs, eventually moving into the leadership of global, multi-site, chemical process R&D organizations with responsibilities for both laboratory and pilot plant facilities. From there, he transitioned to portfolio management, providing broad technical, strategic and governance oversight for cross-functional CMC activities within a highly diversified portfolio of development projects.
Upon joining Johnson & Johnson (Janssen), he had responsibility for the API development group in the US and took over leadership of the global CMC Portfolio Management function with accountability for CMC activities across the entire small molecule development spectrum (pre-clinical to life cycle management). His most recent role was in Janssen Supply Chain, leading End-to-End Strategy, where he helped orchestrate the lifecycle management of commercial products via improved strategies, oversight and governance, with an emphasis on delivering the best product possible.
Since retiring from J&J, Mark has joined the leadership team of NGT BioPharma Consultants and is also an Independent Consultant.
Message Presenter
Andrew Parker, PhD, Executive Drug Development Consultant, Quotient Sciences
Dr. Andrew Parker has over two decades of experience in the pharmaceutical industry, spanning from preclinical development, through early clinical formulation development into late-stage development, scale-up and commercialization. At Quotient Sciences, Andrew’s focus is on Translational Pharmaceutics® and the acceleration of drug candidate progression provided through the integration of formulation development, clinical drug product manufacture and clinical dosing activities.
Andrew is interested in enabling technologies for bioavailability enhancement, characterization of all delivery formats, innovative technologies and understanding drug product structure and function relationships. Additionally, he has advised clients in all types of clinical pharmacology study objectives, including first-in-human, drug-drug interaction studies, relative bioavailability, bioequivalence, TQT and studies where various types of PD biomarkers and PD bio-responses (such as EEG) are part of exploratory endpoints in healthy volunteer studies.
Before joining Quotient Sciences, Andrew worked at Cooper Surgical and Healthcare as a Program Director and at Catalent as an Open Innovation Director covering two business units. Andrew also spent 15 years at Juniper Pharma Services and Molecular Profiles CDMOs in a variety of roles combining technical and commercial knowledge, sitting at the operational and business interfaces with external clients.
Andrew holds a PhD in Physical Chemistry from the University of Bristol.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Formulation Scientists and Senior Formulation Scientists
- Drug Product Development Scientists
- Pharmaceutical Development and CMC Leaders
- Clinical Pharmacology and Translational Medicine Teams
- Preclinical-to-Clinical Development Scientists
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- Biopharmaceutics and Bioavailability Specialists
- Drug Product Manufacturing and Technical Operations Teams
- Process Development and Scale-Up Scientists
- Regulatory CMC Professionals
- Program Managers overseeing development strategy and outsourcing partnership
- VP CMC
- Head of Manufacturing
- Head of External Manufacturing
- Director of Technical Operations
- Head of Quality
- Director of Supply Chain
- Head of Development Strategy
- Head of Lifecycle Management
- VP, Asset Strategy
- Head of Chemistry, Manufacturing & Controls
- Head of Manufacturing Sciences & Technology (MSAT)
- Head of Supply Chain & CMC Strategy
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What You Will Learn
Attendees will gain insights into:
- How to assess poorly soluble molecules and develop a fit-for-purpose formulation strategy aligned with clinical objectives
- Key considerations for selecting between HME, spray drying, lipid-based and particle size reduction approaches
- ASD Science and challenges for developing stable ASDs
- How to reduce scale-up and technology transfer risks through early formulation and manufacturing planning
- The value of integrating formulation development, manufacturing and clinical testing to accelerate decision-making and development timelines
Xtalks Partner
Quotient Sciences
Quotient Sciences brings 35+ years of trusted scientific insight, quality, and control to drug development with a mission to help our customers bring new molecules to patients faster. We provide a full range of drug product (CDMO) and clinical (CRO) services, which can be tightly integrated with Translational Pharmaceutics®—a disruptive platform to enable greater efficiency, better outcomes, and reduced timelines in development.
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