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Small Molecule Compounds -
Accelerating Drug Development
Streamlining Development and Adopting a More Lean Approach in Keeping up to Date with Industry & Consumer Demands
- Managing drug development with scarce resources
- Adapting to more stringent investor expectations in a post financial crisis environment
- Comparing must have vs. nice to have
- Understanding the status of early stage development in Big Pharma vs. virtual biotech
- Maximising process value via lean implementation
Dr. Stefan ProniukVP, Product DevelopmentArno TherapeuticsUSA | Biologics -
Oral Protein Delivery
Understanding & Developing the Science Behind Oral Protein Delivery
An academic case study
- Understanding why multiple promising oral drug candidates were not carried forward in development
- Strategies to protect the protein from the acidic conditions of the GI tract
- Identifying the epithelial barriers to poorly absorbable macromolecules throughout the GI tract
- Gaining a greater understanding of the physical, chemical & biological barriers and potential ways to overcome them
- Exploring the role of excipients and/or technologies in overcoming poor absorption
Prof. Randy Mrsny PhDProfessor, Epithelial BiologyUniversity of BathUK/USA | Delivery Devices & Technology -
Device Design & Development in Lifecycle Management
IPAC-RS - A Risk-based Approach to the Management of Device Design Changes through the Product Lifecycle
- Understanding the role of the IPAC-RS (International Pharmaceutical Aerosol Consortium on Regulation & Science)
- Exploring industry survey findings with regards to how companies manage device changes and how they notify the respective regulators
- Realising that the device change process is not standardised and what the implications of this are on re-approval
- Development of a risk-based approach for the management of device design changes through the product lifecycle, aligned with ICH Q8, Q9 and Q10
- Opportunity - applicability of the process described across different therapeutic targets/mechanism for drug delivery
Andy DundonDirector, Innovative Drug Delivery TechnologyGSK R&DUK |
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Nanotechnology in Tumour Targeting Utilising Nanotechnologies in the Enhanced Treatment of Cancer
Applying a novel concept to optimise the delivery of existing anticancer drugs
- Innovative nano strategies - assembling the nanostructure within the drug itself vs. the delivery system
- Exploring the broad platform of potential applications to multiple drug candidates
- Understanding the therapeutic and clinical benefits of novel nano-structure assembly
- Tackling unfavourable PK profiles
- Enhancing safety & efficacy
- Maximising targeted delivery of anticancer therapies
Ajay KhopadeSenior GMSun PharmaIndia | Characterisation Characterising Biological Molecules to Improve Formulation Success
- What are the key parameters when determining stability of biopharmaceutical products?
- What are the stressors in biologic processing and formulation and what impact do they have on stability and aggregation?
- Developing key analytical assays for characterisation of biophysical, physical and chemical characteristics of biologic compounds
Michele PallaoroHead, Vaccines & DiagnosticsNovartisItaly | Quality by Design Productivity Improvement through Quality by Design (QbD)
- Addressing the transfer of the spray drying process of a large volume excipient between CMOs
- Understanding why the process could only run for 8-10 hours before requiring shutdown and cleaning
- Defining critical quality attributes and potential critical process parameters following a QbD approach
- Performing a set of exploratory and optimisation design experiments
- Utilising PAT methods to aid process understanding and determining a design space in a multivariate manner
- Generating, testing and then refining a model as an example of continuous improvement
- Developing and validating a robust process to eliminate the need of constant process interruptions and to increase product throughput by 70%
Dr. Conrad WintersDirector of Drug Product DevelopmentHovionePortugal
Sune Klint AndersenPrincipal Scientist - Drying ProcessesNovo Nordisk ASDenmark |
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Interactive Workshop Increasing quality of solid dispersions made by optimised hot-melt extrusion
- Solid dispersion - where are the challenges?
- Hot-melt extrusion - how can the process be characterised and optimised?
- Residence time distribution as a key parameter example
- Introduction of a process parameter chart capturing both the process and the formulation aspects
Andreas GryczkeManager Global Marketing New Products BASFGermany | Interactive Workshop From Idea to Pre-clinical Tool on its Way to the Market: Is there a Standard Way of Matching Biotechs with Big pharmaceuticals?
- Presentation of Nanologica and our porous silica
- Case study: Improved dissolution of Atazanavir
- Workshop: How to test and take on a technology as a drug carrier
Andreas BhagwaniCEONanologicaSweden | Interactive Workshop Introducing Second Generation Protein Formulations
- Insulin products: from prandial insulin to insulin combo’s
- Monoclonal antibodies: high concentrations, low viscosity, highly stable mAb formulations
- Regenerative medicines: biologics in wound healing
- Client case study: Formulating high concentration, low-viscosity mAbs
Dr. Olivier SoulaVice President, R&D DirectorAdociaFrance |
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Supergenerics Exploring the Forecasts and Implications of a Growing Supergeneric Market
- What qualifies as a supergeneric therapy? - clearing up the definition debate
- What are the regulatory, IP and commercial challenges of launching a supergeneric therapy in Europe?
- Incorporating patient requirements into supergeneric development
- Case studies: facts, figures, benefits and challenges of a supergeneric line
- Identifying novel supergeneric opportunities
- What are the future implications of a supergeneric market?
Dr Deepak MurpaniVP, Global R&D (Generics)Synthon BVThe Netherlands | Peptide Delivery Optimising the Delivery of Peptide Therapeutics
Understanding the challenges & opportunities of emerging delivery technologies
- Exploring the importance of this drug class and why it is a prime focus in formulation and delivery
- What developments are being made currently in the injectables field with regards to long sustained release forms?
- What is the next generation of peptide delivery? – oral, transdermal & buccal opportunities
- Exploring the global picture of peptide delivery and it’s implications
- Applying Ipsen’s technology platform to support long acting formulations
- Case study: Injectable self-assembling lanreotide
Dr Joël RichardVP, PeptidesIpsenFrance | Nano-Based Liposomal Delivery Utilising Nano-based Liposomal Carriers for Enhanced Targeting and Delivery
- Enhancing drug product targeting using nano-based liposomes
- Using thermosensitive technology in liposomal delivery to enhance sustained release and to trigger heightened uptake
- Improving bioavailability and efficacy of therapy using short-chain sphingolipids
- Therapeutic implications of image-guided drug delivery using MRI
Gerben KoningAssistant ProfessorErasmus Medical CenterThe Netherlands |
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Overcoming the Stability Constraints of Oxidation Generating and Deploying an Oxygen Control Strategy in Preformulation of Injectable Forms
Overcoming stability constraints of highly unstable formulations
- Utilising analytical testing to identify the mechanism of oxidation degradation
- Establishing the degradation pathway on paper
- Deploying preformulation testing to identify the most suitable excipients
- Formulating a development strategy to introduce the excipient(s) and remove the oxygen
- Applying a process and formulation strategy to support heightened stability
- From formulation to production – transferring the process & molecule to a manufacturing platform
Anne PetitLab Manager, Formulation & Process DevelopmentIpsenFrance | Controlled Release of Peptide & Protein Therapeutics Exploring an Innovative Approach to the Sustained Release of Biologicals
- Developing injectable biological products with novel polymeric carrier systems
- Understanding why earlier attempts were abandoned
- Re-designing the approach to achieve a simple and realistic model that can be translated to industry
- Exploring the physiological role of the polylactic acid-based carrier in prolonged release
- Case studies: Understanding the implications of this carrier system on the intra-ocular delivery of proteins and systemic delivery of peptides
Professor Robert GurnyProfessor, Department of Pharmaceutics & BiopharmaceuticsUniversité de GenèveSwitzerland |
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Themed Luncheon 1 Dissolution Qualification – which way to go? USP Performance verification Test or ASTM Mechanical Qualification?
| Themed Luncheon 2 Overcoming the challenges of the Oral Delivery of Macromolecules with Softgel Lipid Based Delivery Systems
| Themed Luncheon 3 Changing the Paradigm of Biologics Delivery: A World Without Injection?
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Themed Luncheon 4 Supporting QbD Initiatives
Technologies to streamline range-finding and robustness studies for drug substance and drug product development
| Themed Luncheon 5 Towards improved therapies by using MJR technology
| Themed Luncheon 6 Functional Excipients
Can enhancing bioavailibility and increasing the effectiveness of the manufacturing process go together?
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Themed Luncheon 7 Off the shelf pens and auto injectors
How confident can we be that these will satisfy the customer’s and FDA’s requirements for Human Factor Studies?
| Themed Luncheon 8 Size and shape analysis for formulators
How can we gain a greater understanding of our particles?
| Themed Luncheon 9 Today's and future challenges in managing data and information in the drug delivery and formulation laboratory
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Human vs Animal Product Development Lessons to be Learnt from Animal Development
- How is data efficiently gathered to meet consumer needs?
- What are the parameters that animal product formulators have to reach? How much of a concern is toxicity vs achieving a working PK profile?
- What levels of risk can be adopted when moving a drug product through development?
- What is demanded by the regulators?
- Investing in technologies vs keeping costs low
- Are all delivery routes considered for novel products?
Dr. Martin FolgerHead, Pharmaceutical DevelopmentBoehringer IngelheimGermany | Visibility in the OTC Market What Patient-centric Lessons Can be Learnt from the OTC Market?
- Understanding that in pharma the API is the priority and the dosage form and packaging are somewhat afterthoughts
- Utilising the increased number of sales channels for OTC products through which to gain consumer feedback
- Establishing a greater visibility of what all consumer populations want and require as opposed to only the extreme groups
- Utilising the data from previous products to formulate a more patient-centric strategy and product for novel ones
- Transferring these learnings from OTC to prescription drugs - is it possible?
Gerry McNallyVP, OTC TechnologyMcNeil, Johnson & JohnsonUSA |
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QbD in Development A QbD Case Study - From Principle to Practice
Successful implementation of QbD in the development of solid dosage forms
- Realising the implications of modifying a manufacturing process for solid dosage forms in late stage development on timelines, resources and the entire clinical programme
- Minimising the risk behind QbD implementation as underlined in the ICH Q8, 9 and 10
- Understanding the roles of risk assessment, DoE and PAT in supporting QbD implementation
- Case Study: Improving process understanding and enabling a significant change in the manufacturing process in late stage development by:
- defining Critical Quality Attributes (CQAs) and Critical Process Parameters (CPP)
- applying statisitical analysis (DoE) and PAT
- Validating 'design spaces' in light of a worldwide submission
Dr. Matthias FischbachHead, Drug Product Development & Lifecycle ManagementMerck SeronoGermany | Transdermal Drug Delivery Safety and Quality of Transdermal Drug Delivery Systems (TDDS)
Utilisation of state-of-the-art analytical methods to optimise performance of TDDS in vitro & in vivo
- Taking a Quality by Design approach to optimizse key safety relevant quality criteria
- Addressing challenges caused by drug polymorphism for TDDS with NCEs
- Exploring the implications of raw material quality and viscoelasticity on adhesion properties of TDDS
- Reviewing the draft EMA Guideline on Quality of TDDS
- Key formulation considerations: misuse, temptation of abuse, hazard of discarded patches for children, inappropriate treatment of the skin application site, handicaps and handling problems in specific patient groups
- Case study – data collection using a combination of SEM (scanning electron microscopy) and EDX (energy dispersive X ray spectroscopy)
Dr. Hans Michael WolffDirectorUCB BiosciencesGermany |
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