Join our complimentary co-hosted lunch seminar with Nano PharmaSolutions at Divino Restaurant in Belmont, CA on May 18th
Seminar Title: "Tackling Solubility Challenges: Leveraging novel technologies & rapid clinical assessments to achieve clinical success"
Thursday, May 18th, 2023
11:30am - 12:00pm - Registration & Lunch
12:00pm - 1:00pm - Seminar and Q&A
Main conference room
968 Ralston Ave,
*Parking is available on the street or in the parking lot behind the restaurant.
Poorly soluble molecules (BCS/DCS Class II or IV) still remain prevalent in today’s development pipelines. Molecules that present solubility and bioavailability challenges tend to increase formulation complexity, raise failure rates, and drive-up development costs if not properly identified in the preclinical and candidate selection stages. Having a clear understanding of a compound’s biopharmaceutic properties early in development can greatly aid in identifying a successful promising candidate and suitable formulation and technology selection strategy that will achieve your target product profile (TPP) for these challenging molecules.
Assessment of a formulation in preclinical species is often not predictive of human performance. Preclinical toxicology formulations tend to use strong solvents and/or surfactants to solubilize otherwise insoluble drug candidates to achieve maximum exposure levels in animals to establish safety margins. These formulations are typically not suitable for human clinical trials due to their toxicity. For first-in-human (FIH) studies many companies look to use a fit-for-purpose simple format, such as liquid formulations, powder-in-bottle or powder-in-capsules with little solubility enhancement. However, this can be a risky approach if the compound has solubility-limited absorption, as these formulations may not provide adequate exposure and can ultimately fail in the clinic.
Join Quotient Sciences’ Senior Drug Development Consultant, Dr Vanessa Zann and Nano PharmaSolutions’ CEO, Dr Kay Olmstead as they share innovative development strategies and novel technologies that help to overcome the hurdles of poor solubility in early drug development. Through case studies, they will demonstrate the benefits of an integrated development and clinical testing approach and discuss how Nano PharmaSolutions’ NanoTransformerTM platform generates stable drug nanoparticles using no additives to improve solubility.
Key topics include:
- Biopharmaceutic properties of today’s NCEs – what are the challenges and risks
- BCS or DCS assignment and developing a formulation strategy for poorly soluble molecules
- Teasing apart the drivers of poor bioavailability - In-vitro testing / in-silico techniques / in-vivo preclinical studies / clinical assessment
- Choosing the appropriate dosage form for first-in-human trials
- The benefits of integrating real-time GMP manufacture and clinical testing
- Formulation optimization using adaptive clinical programs
- Fit-for-purpose formulations contribute to the failure rate of Phase 1 PK studies and slow down drug development due to formulation changes between clinical stages, which often lead to a need for bridging PK studies.
- Nano-granulation is a new approach for using essentially the same formulation for animal safety studies, first-in-human clinical studies, and late-stage clinical programs.
- Development of nano-granulation is fast and requires a very small amount of API
- GMP facility for nano-granulation is coming online in 4Q 2023.
About Nano PharmaSolutions
Nano PharmaSolutions developed the nanoformulation platform - NanoTransformerTM which generates stable drug nanoparticles using no additives. These highly soluble easy-flow nano-granules can be used for animal safety studies as oral gavage, and FIH clinical samples as a powder in capsule; without having to perform a bridging PK study between Phase 1 and 2 due to the clinical formulation changes. This stable nano-granulation with high drug loading (up to 25%) is fast to develop for a small molecule with a material requirement of fewer than 10 grams of API.
About Quotient Sciences
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
About our speakers
Dr Olmstead has over 30 years of experience in the pharmaceutical industry in both API (drug substance) and finished dosage form development. Prior to founding Nano PharmaSolutions, Dr Olmstead served numerous small to medium pharmaceutical companies worldwide as a CMC subject matter expert, especially in poorly soluble drug development. During the past 20 years, Dr Olmstead played a lead role in the development and the FDA approval and commercialization of five drugs. Dr Olmstead has published more than 12 manuscripts and has 12 issued patents and 4 pending patent applications. Dr. Olmstead received a Ph.D. degree in Organic Chemistry at Johns Hopkins University followed by a NIH post-doctoral fellowship at Stanford University under Professor Harry Mosher.
Vanessa has over 19 years of industry experience providing biopharmaceutics support to discovery, development and clinical programs. Vanessa has previous experience at AstraZeneca as a permeability expert working in the Pharmaceutical Development dept. where she lead the global Caco-2 facility for development, liaising with discovery scientists to ensure the selection of NCE with appropriate biopharmaceutical properties, introduced the IV microtracer technique and also provided biopharmaceutical support to both Discovery and Development programs. Vanessa joined Quotient Sciences in 2012 and has led the implementation of Modelling and Simulation and has been heavily involved in the Pharmaceutical Sciences in vitro characterisation strategy, as well as designing clinical studies and providing scientific support through clinical study delivery.