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Developing Successful Drug Delivery SystemsFormulation Development from Pre-Clinical to Clinical Supply & Beyond

מק"ט: 218004
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מקוון - בזום

in collaboration with

Each year only a few dozen new drugs get licensed for use, but in their wake, there will be tens of thousands of candidate compounds that have fallen by the wayside. The research and development stages of...המשך קריאה

in collaboration with

Each year only a few dozen new drugs get licensed for use, but in their wake, there will be tens of thousands of candidate compounds that have fallen by the wayside. The research and development stages of those few new drugs that make it to market will have taken around 12-15 years and cost of the order of $1.5 billion.
Deciding whether a drug is ready for clinical trial involves extensive pre-clinical studies and formulation strategies.
These webinars will thus focus on how to fast track formulation development, so as to provide a cost-effective solution to advance to early phase clinical trials and GMP manufacture of clinical batches.

The webinar is followed by videos of manufacturing operations and case studies.

סגור
תאריכים: 
  • 19/05/2021
  • 02/06/2021
  • 09/06/2021
מיקום הקורס: הקורס יועבר באמצעות Zoom
משך הפעילות: 3 מפגשים של שעה וחצי
שעות: 12:00 - 10:30
נקודות זכות: 1
שפת הקורס: English

עלות הקורס: ₪965 + מע"מ
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מה תכני הקורס?

May 19th
Lipid Delivery Systems
An overview with respect to the rationale for selection and design of lipophilic delivery systems.  Including considerations for in vitro methods and techniques to characterise lipid based formulations.
Case study: lipid strategies that have been used in pre-clinical studies to maximise API exposure.
Formulation options and analytical challenges associated with oral delivery of lipidic dosage forms for first in human studies.
Understanding the potential and limitations for lipid formulations, subject to requirements of the target product profile (TPP) and physicochemical properties of the API.
Case study: Practical considerations and time-lines associated with a typical Phase I drug product development programme.

June 2th
Paediatric Product Development
Scientific and regulatory overview, including paediatric investigation plan (PIP) & paediatric-use marketing authorisation (PUMA).
PK/PD considerations compared to adults.
Dosage form selection considerations for neonates to adolescents, Excipient & Tox considerations.
Basics for Pre-formulation – Physiochemical characteristics of API and influence on dosage form design.
Setting a TPP.
Formulation route selection – solids, liquids, powders for reconstitution.
Taste masking, antioxidants, osmolality, product specs.
Analytics – Chromatographic considerations for preservatives, specificity, antioxidants, batch to batch consistency.

June 9th
Live Biotherapeutics
Overview – Definitions, Growth over last decade, Clinical progress, Mechanisms of action
Understanding the drug substance – Fecal Microbiota for Transplantation (FMT), Strains, Consortia, Phages, New modalities
Drug substance development process – Isolation, fermentation, purification, drying. Characterisations methods, specifications. Development risks and challenges.
Drug product development process – TPP, preformulation, robustness, technology selection for target delivery, capsule filling, tabletting, characterisation methods, specifications, packaging.

למי זה מתאים?

  • Start-ups and companies seeking for
    • development solutions and CDMO to develop a pre-formulation or a formulation for their NCEs, APIs, biologics, or biotherapeutics
    • to develop products for paediatric use
    • developing live-biotherapeutic products
  • Researchers, developers and Personnel
    • involved in R&D & CMC in drug discovery
    • seeking to improve the solubility, permeability and bioavailability of their formulated products
    • monitoring preclinical testing or early-phase clinical trial performance with newly developed formulations
    • handling early phase small scale production

מה אקבל מכך בפועל?

At the end of these three sessions the participants will have an intensive overview and an understanding of:

  • The challenges and pitfalls involved in the development of preformulations for preclinical trials, drug delivery systems for early stage clinical trials, and manufacturing for clinical and commercial supply.
  • The role of a Contract Development and Manufacturing Organization (CDMO) and the benefits of outsourcing the development to a third party that specialise and has the knowledge, experience and scientific capabilities to successfully developing novel, effective, safe and robust drug-delivery systems

About the Presenters:

Professor Mike Rubinstein, BPharm, PhD, MIChemE, CEng, MRPharmS, QP
Chairman & Founder

Mike is the Chairman and founder of Quay Pharma. A chemical engineer and pharmacist with Qualified Person (QP) status, he has over 30 years of experience in solid dosage form design, development and manufacture. Before founding Quay Pharma, he was Professor of Pharmaceutical Technology and Director of the School of Pharmacy and Chemistry at Liverpool John Moores University. He is the author of five books on pharmaceutical technology, owns two patents and has published more than 200 research papers and articles. His experience includes work with AstraZeneca and GlaxoSmithKline in both R&D and productionproduction 

Mike Frodsham,MSc, PhD
Chief Technical Officer (CTO)
Mike has over 20 years’ experience in drug product development. For over 15 years he has been responsible for development activities at Quay Pharma before which he was Principal Scientific Officer with SSL International and Development Projects Manager at Galpharm International.
Mike has overseen over 200 non-sterile development projects; predominantly taking NCE’s through to first in man studies and beyond. His background is in formulation science with a PhD in liquisolid dosage forms and he is cited as an inventor on multiple oral formulation patents.


 Professor John Collett, PhD, DSc
Chief Scientific Officer (CSO)

John is Quay Pharma’s Chief Scientific Officer and Emeritus Professor in the Faculty of Medicine; University of Manchester at the University of Manchester. He has over 30 years of experience in formulation science and is the author of more than 250 research papers. His areas of expertise include the formulation of solubilised and modified release drug delivery systems.


Alison Foster, BSc, PhD
Head of Technical – Pre-Clinical

Alison is the Head of Technical for Pre-Clinical Services at Quay. She has a wide breadth of experience having worked previously for Unilever in their cross-category research unit focused on Oral Care and Hair projects, to being one of the founders of a small nanotechnology start-up company focused on improving bioavailable of poorly soluble drugs. Alison gained Post-Doctoral experience in medicinal chemistry from the School of Pharmacy, University of Manchester following a Ph.D. in synthetic chemistry. She is co-author of 25 patents and 9 papers


Audrey Vardy, BSc, PhD
Head of Business Development – Pre-Clinical

Audrey is the Head of Business Development for Quay’s Pre-Clinical Services. She has 15 years’ experience within the pre-clinical contract research world holding both Operational and Commercial positions during that time. Spending 6 years at CXR Biosciences, Audrey was laboratory team leader, before joining the sales team as BDM, then Sales Manager. She then joined BD Biosciences as their European Key Account Manager being responsible for both contract services and drug-metabolism research products. Before joining Quay Pharma in 2018, Audrey returned to CXR (then Concept Life Sciences) for 4 years as Principal Scientist and Head of Operations. Audrey also has a Ph.D. in Neurosciences.


Ryan Wilson MSc
Head of Live Bio-therapeutic Program

Ryan Joined Quay Pharma as Strategic Projects Manager in Sept 2014 and in Jan 2016 moved on to lead our Live Biotherapeutic Program. Prior to joining Quay, Ryan was Head of Program Management at Oxyrane for 6 years and before that he worked for SSL International for 13 years as Innovation Manager and 5 years as Project Manager
Ryan has headed development of a number of phages and at least 50 strains of living organisms both as single strains and consortia consisting of BSL class 1 & 2; most being moisture sensitive anaerobes, therefore requiring careful handling and processing. He has developed products for Phase I to III dealing with only Pharma-grade LBTs. Further to the above, since Quay doesn’t possess an IP we don’t have an interest in shoehorning our clients’ projects into a patented delivery system of our own.
Ryan holds an MSc from The University of Manchester in Pharmaceutical technology and an MSc in Project Management from Leeds Metropolitan University.


Tom Pointon, BSc, PhD
Microbiology Technical Expert

Tom supports the microbiological technical and hygiene needs across the business. He has worked a range of microbiology roles within FMCG, pharmaceutical and clinical industries including leading Unilever’s home and personal care preservation and applied microbiology programme and managing Source Bioscience’s serology department.


 Michael Kruidenier
Head of Business Development
Michael joined Quay Pharma in Sept 2013 and he is responsible for all global Live Biotherapeutic business and for all other business outside Europe. Most of Michael’s career has been spent in commercial roles. He has over 30 years of Sales and Marketing experience, including 20 years in the pharmaceutical industry with Proctor & Gamble and SCA followed by working for leading contract service organisations.


David Blum BPharm, MBA, QP, QPPV, Appointed Pharmacist
Managing Director (Israel)

David joined Quay as Managing Director of the company’s Israeli subsidiary to expand its presence providing CDMO services in Israel. He holds a degree in Pharmacy from the Hebrew University of Jerusalem and an MBA from the University of Leicester and is certified by the Israeli Ministry of Health as Appointed Pharmacist, QP & QPPV. He has about 30 years of experience working with at least a dozen companies dealing in pharmaceuticals, drug discovery and medical device development and has held positions of influence spanning business development, plant management, supply chain management, manufacturing, CMC development, quality assurance, regulation & pharmacovigilance.

About Quay

Quay Pharmaceuticals is experienced in providing a comprehensive out-sourcing service for formulation and analytical development with subsequent clinical trials and commercial manufacturing for pharmaceutical and biotechnology companies worldwide.
Working as a dedicated, pro-active part of your team, we apply strong project management and technical expertise to take products quickly and cost effectively under IP free conditions, thereby freeing the client of any consideration for a royalty baggage, from late stage preclinical through to the end of phase III clinical trials and commercial manufacturing under MHRA, EMA & FDA GMP certified conditions.

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