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2012 Conference Programme
Technology Day | day
one | day two
Programme - Focus Day16thJanuary 2012
Experimental Methods for Investigating and Modifying Supersaturation to Enhance Drug Bioavailability
Techniques for identifying whether or not drugs are capable of forming supersaturated solutions
- The use of supersaturation to increase bioavailability of drugs for GI absorption
- Fast experimental techniques for assessing the extent and duration of supersaturation
- How supersaturation can be enhanced using additives and excipients
- GI Dissolution assays for exposing small pellets of API to changing pH conditions and lipids to simulate passage of drugs through the GI tract
Enhancing Drug Formulation of Challenging Compounds Using Supercritical Fluid (SCF) Technologies
Supercritical fluid (SCF) technologies to streamline development
RightSize™ Particle technology-
RightSize™ Particle technology-
- RightSize™ Particle technology - Improving dissolution rates for poorly soluble compounds
- Processing conditions
- Using a broad range of excipients
- Particle and crystal property selection
- Amorphous, crystalline and co-crystals
Addressing the Formulation Data Management Challenge
- Addressing the formulations scientific data challenge by administering high volumes of information from multiple sources – presented in one, secure and compliant environment
- Utilizing a single data management platform across the whole research to commercialisation lifecycle - Reducing IT footprints & maintenance burden whilst promoting sharing and collaboration
- Combining a solid data management platform with powerful searching and reporting to enhance visibility of data assets, secure IP and enable better decision making
High Throughput Nanoactive™ Technology Platform in Improving Drugability
Transforming Class 2 and Class 4 compounds into drugable Class 1 compounds in a high throughput fashion
- Reducing transformation parameters including amount of required API and formulation time with the automated High Throughput NanoActive™ Technology
- Integrating the platform into discovery and early drug development R&D
- Scalability in GMP production
- Utilizing the technology in life-cycle management
Lipids: A Smart Strategy for Sustained Release
The vast majority of drug release retardant technologies and/or matrices rely on hydrophilic cellulose based polymers. For drug developers, this means that opportunities for the development of proprietary drug release systems and formulations are increasingly limited
The vast majority of drug release retardant technologies and/or matrices rely on hydrophilic cellulose based polymers. For drug developers, this means that opportunities for the development of proprietary drug release systems and formulations are increasingly limited
Specialty lipid excipients provide numerous advantages in this challenging market place including
- High compatibility with API’s and other excipients.
- The formation of robust matrices capable of minimizing the effects of pH changes, ethanol and hydrodynamic stress.
- Effective sustained release for highly water soluble API’s
- Taste-masking properties
- High versatility in processing techniques including hot melt extrusion, spray cooling, prilling, nanoparticle technologies.
New Inorganic Glass-Ceramic Controlled Release Technology for Pharmaceutical Applications
- Advantages of Inorganic CRT compared to organic polymeric systems
- Materials characterisation and drug loading capacity
- Effect of the compositional and non compositional parameters during synthesis on drug release and matrix degradation.
- Conclusions and future investigation on the new technology
Leverage Advanced Analytics and Informatics to Accelerate Formulation Development of Small and Large Molecules
- Harnessing Advanced LC Technology for Increased Sample Throughput
- Integration of Advanced LC Technology with Automation Platforms
- Understanding Structural Changes in Biologics with New MS Technology
- Sharing Information Across the Organization with Advanced Informatics
Jeff Mazzeo
Late Stage Development Director, Pharmaceutical and Life Science Business Operations
Waters Corporation
Novel Encapsulation and Delivery Methods for Topical Formulations
- Deploying new methods to encapsulate hydrophobic actives and to release them on to skin Example 1
- Utilizing patented polycaprolactone polymers blended with Seppic surfactants to form small nano capsules
- Case study Chlorhexydine - rate of release, efficiency & mechanisms of action
Agilent Solutions for Pharmaceutical Analysis, Purification and Dissolution Testing
- Purification and Purity Analysis
- Impurity Analysis
- Dissolution Testing Systems (automated and manual)
- Automation Solutions
Andreas Wasserburger
Sales Manager Germany and Austria, Life Sciences Solutions
Agilent Technologies Germany
Integrated Formulations Management System within an Electronic Notebook
- Effectively documenting experiments and leveraging knowledge from historical experiments
- Quickly accessing commonly used excipients and other ingredient databases
- Multi-step formulations
- Using screening experiments for quick set-up of multiple formulations in a single experiment
- Tracking and linking formulations testing
- Live demonstration of formulations and testing management system
Innovative Approaches to Formulation of Biologics
- Outlining innovative approaches to formulation of biologics resulting in improved stability profiles compared with conventional optimised formulations
- Utilizing improved formulations to allow the use of therapeutic proteins or vaccines outside the cold chain or as a liquid composition instead of a powder for reconstitution
- Demonstrating novel approaches on several data driven case studies using relevant therapeutic proteins, describing the specific formulation features employed to achieve superior stability.
- Explaining the nature of the formulation changes, and possible mechanism of action of the stabilising excipients suggested via their effects on different processes affecting protein stability.
Technology Day | day
one | day two
Programme - Day One17thJanuary 2012
Maximizing integration of form with formulation in early phase development
- Technical & Business Success Factors for Drug Delivery Programmes
- Fighting the growing trend to outsource in an effort to maintain core skill sets
- Minimizing initial investment to reduce risk and reduce costs later on
- Integrating form with formulation in early development to maximise their values mutually
- Developing a true understanding of both form and formulation for efficient development
Applying predictive and simulation modelling in formulation and delivery
- Utilizing particle engineering and predictive pharmaceutical modelling to predict form and performance
- Exploring how best to capture early phase data, analyse and forward screen to assess risk
- Readily accessing necessary tools for data comparison in development - The Cambridge Crystal Database
- Balancing the challenge of becoming smarter & faster whilst maintaining compliance
- Setting up later stage predictive parameters
Enhancing Solubility & Bioavailability for Existing and Emerging Therapies
Exploring new and novel technologies coming to market and their implications on poorly soluble drugs
- Lessons learned from the past - How far have we come?
- Generating successful formulation and delivery strategies to overcome barriers tp bioavailability and solubility
- Exploring potential forecasted technologies and emerging approaches & the challenges they present
Biological Characterization
Exploring Key Aspects and Potential Pitfalls in Future Vaccine Development
- Establishing more in-depth characterisation tools for multi-component protein-based vaccines
- Understanding to what extent a vaccine can be characterised
- What is the demand for characterisation, in each product case?
- Selecting which product features should be evaluated and characterised
- Characterization in deepening our understanding of antigen starters
- Evaluating expected results using varying techniques
Simulation Software in Early Development
Utilizing simulation technology in deciding on the correct formulation strategy
- Deploying SIMCYP simulation software from clinical only to early stage development
- Gaining advanced knowledge from API through to clinical development
- Boosting inter-departmental communication and thus pre-empting developmental challenges
- Generating accurate physicochemical properties in response to a range of conditions to test viability as a therapy
- Learning from the past – Case studies, facts & figures of such software application
- Next generation software - Applying simulation software to biological development
Rationale Formulation Design for Poorly Soluble Compounds
A holistic view from excipient, material science and process perspectives
- How to choose suitable formulation technologies for poorly soluble APIs: Conventional vs. non-conventional formulation approaches
- What needs to be considered when selecting an excipient to maximize formulation performance: Physicochemical properties, processibility, regulatory considerations and beyond
- When should formulation process be considered and how does this impact formulation selection: Understanding advantages and limitations of different process technologies
Enhanced Albumin Half-life Extension Platforms
Improving compliance and reduced healthcare costs
- Understanding the increasing pressures facing pharmaceutical companies due to patent cliff and regulatory constraints
- Exploiting FcRn binding to ‘recycle’ IgG and albumin molecules & increase serum half-life
- Exploring the potential of half-life extension to deliver competitive advantage through improved dosing and reduced side-effects
- Demonstrating the extended circulatory half-life of modified albumin variants, and protein drugs linked to such variants with new pharmacokinetic data
Emulsion Technology for Micro Encapsulation (ET4ME)
Revolutionizing drug delivery formulation
- Innovative technology platform for controlled particle engineering
- Product differentiation by applying uniform and reproducible PLGA microsphere formulations for sustained release of APIs
- Non-invasive therapeutic and preventive vaccination by chitosan mucosal delivery systems.
Significantly Improved Successes for Oral Modified Release Dosage Forms In Vivo using an Orally Swallowable Programmable Mini Pump System
- Understanding why colonic absorption is important for the successful development a modified release formulation
- Intellicap Technology - Exploring the orally swallowable programmable drug delivery capsule
- IntelliCap: Real-time monitoring of pH & temperature along with pre-determined drug release in vivo
- Quantifying a new drug's colonic absorption
- Utilizing man and dog models in optimizing MR formulations
- Case studies -Analysing the benefits of the Intellicap device technology during MR drug product development
Enhancing Macromolecule Delivery
Advancing promising technologies in the oral delivery of macromolecules
- How are peptides currently being converted from injectables to oral therapies?
- Reviewing some promising & emerging technologies -Nanotechnology to permeation methods
- Why are some technologies being held up in the clinical trial phases?
- Exploring aspects of chemical conjugation - As which formulations can peptides be absorbed?
- Assessing the facts & figures - Drawing from personal research and industry findings
Prof. David Brayden
Professor, Drug Delivery; Director, SFI Irish Drug Delivery Research Network SRC
Drug Delivery Network
Maximising Drug Release Control with Polymer Technologies
Using polymer technologies to enhance drug solubility
- Considerations in API insolubility
- Exploring structure manipulation vs polymer technologies
- Controlled-release potentials of polymer technologies
Hot Melt Extrusion - From API to Finished Dosage Form
Led by BASF
- Opportunities of HME
- Hurdles and Challenges of Implementing HME in Pharm. Industry
- Extrusion process at a Glance
- Downstreaming possibilities - role of polymers for the process and formulation
- Case Study : Hot Melt Extrusion vis a vis NanoCrystal® technology
Approach to Design
In-vitro characterization,Stability Evaluation
In-vivo Evaluation in Beagle Dogs
Summary of key findings
Protein Drug Delivery Technologies and Controlled Release
Unique solutions in protein delivery
- Advancing technologies to facilitate the controlled release of biologically active therapies
- Utilizing microsphere delivery technologies
- Enabling development of tailor-made controlled release formulations for all classes of injectable protein drug compounds
Your GMP One Stop Shop from Formulation Solutions to Drug Delivery Compounds for Parenterals
- Towards 350 years of Merck
- Merck’s EMPROVE® concept for formulation solutions
- Selected specialty grade lipids addressing your needs
- Functionalized PEGs to unfold the therapeutic potential of proteins
Recruiting Academics in Meeting the Needs of the Industry
- Understanding the academic psyche - Difficulties of strategy generation & deployment
- Exploring the Pros & Cons of working with academics and spin-out businesses
- Truly understanding the dynamics and relationship of an industry-academia interface
- What are the key motivating factors & incentives for academics?
- What can academics contribute to LCM?
- Ensuring the commercialization process is complimented by, often advanced, science
Parenteral Delivery of Poorly Soluble Drugs
- Characterizing the parenteral solubilization challenge
- Finding the right platform for highly concentrated formulations
- Relating drug substance properties and technology platform
- Nanomedicine as advanced technology option
Bernd Riebesehl
Principal Fellow, Parenteral Dosage Forms, Pharmaceutical and Analytical Development
Novartis Pharma AG
Utilising Integrated High Throughput Research Tools to Accelerate Successful Biologics Formulation Development
The development of robust formulations for biologics requires the screening and analysis of a comprehensive matrix of formulation compositions and stress conditions
- The Biologics Formulation Workflow is a fully-automated workflow for building array based formulations, stressing formulations, assessing their stability through a range of integrated analytics, and managing the data generated to drive informed decision making
- Case studies will be presented that outline how utilising high throughput research systems in a strategic way can lead to a better understanding of the impact of pH and excipients on API stability ultimately resulting in a better final formulation
Controlled Release Formulations: Strategies for successful protection of Life Cycle Products
- Exploring the importance of controlled release formulations in terms of life cycle management
- Utilising Released Formulations as LifeCycle Management Tools - An overview
- Exploring Platform Technologies deployed by originators
- How have generic companies overcome patent protection? – Protecting formulations that have unique characteristics
- Formulation concepts – Exploring successful & unsuccessful case studies: In vivo/in vitro data, applied models & proof in bioequivalence studies
- Lessons learnt and future outlooks in the development of formulations with unique characteristics: Delivering best chance of protection
Advances and Applications of Nanotechnology Platforms in the Delivery of HIV Therapies
Combating bioavailability of poorly water soluble drug molecules
- Evolving technologies in the generation of nanoparticles
- Consolidating nanotechnology with high-throughput systems as opposed to traditional milling
- Exploring key challenges and benefits of this technical collaboration over traditional methods
- Merging Material Scientists and Pharmacologists to test cytotoxicity and toxicology profiles of all dispersions together
- Building predictive models to evaluate therapeutic potential and application
Implementing cultural change to strengthen drug development pipelines
- Centralizing new technology and innovation strategies across the therapeutic delivery & formulation space
- Re-defining how best to reach out and engage in a changing economical and regulatory environment
- Centralizing functions to ensure efficient use of resources while enabling innovation and creativity
- How best to invest in the right technologies across the company portfolio
- Finding and engaging the best partners and building beneficial relationships with them
- Carrying out strategic partnerships with optimum technical execution
Technology Day | day
one | day two
Programme - Day Two18thJanuary 2012
Multi-Purpose OSD Facilities: Design Solutions for Specific Challenges
Deploying highly sophisticated engineering strategies in designing a World Class & cost effective facility
- Forcing extreme design vision and innovation in attaining World Class status
- Benchmarking against existing development and manufacturing facilities in selecting and enhancing preferable technologies and processes
- Producing maximally contained unit operations in the development of highly potent compounds
- Highlighting enhanced process engineering technologies
- Smoothening tech transfer knowledge and technologies
- PAT applications & drivers in optimising containment
Jerry Parker
Former Associate Director, Global Pharmaceutical and Analytical Sciences (Retired)
Abbott Laboratories
Making Patient Centricity a Fundamental Driver in Pharmaceutical Development
Successful product design & development strategies from paediatrics to geriatrics
- Understanding patient centricity fundamentals and the role of special patient groups - from children to the elderly
- Patient choice - Enabling a patient-focussed strategy through successful data collation
- Exploring the similarities and differences between paediatric and geriatric development
- Utilizing more advanced delivery systems and approaches to enhance our knowledge of product
- Increasing product adherence, safety and compliance with emerging technology implementation
Dr Norbert Rasenack
Team Lead, Downstream Solids, Continuous Manufacturing Unit, Global Pharmaceutical Development/Technical R&D
Novartis Pharma AG
Generating Successful Formulation Strategies
Choosing the appropriate avenue in preventing wasted efforts on compounds that end up being poorly absorbable, soluble and bioavailable
- Developing a successful formulation strategy during pre-clinical and clinical development
- Flagging compounds early on to prevent those with insufficient biochemical properties from reaching late stage development
- Modifying formulation strategies to assess what can be done in vitro, in vivo & in silico to biologically challenged but promising candidates
- Moving upstream earlier to allow for formulators and medicinal chemists to collaborate in producing highly developable compounds
Applying QbD Strategies to Protein Stabilisation in Preformulation
Industry stability case study
- Applying QbD approach to the creation of the stability design space
- Characterizing protein stability over a range of process parameters using different stress platforms
- Exploring the current and potential applications of the QbD platform in pre-formulation and screening
Applying Drug Delivery Principles to Existing Medical Devices
Overcoming common challenges in the development of drug-eluting devices
- Analyzing primary mode of action of combination products using drug delivery principles
- Identifying common bottlenecks and discussing real life challenges in the development of drug-eluting devices
- Recommending mitigation approaches to address interdisciplinary challenges
Hot Melt Extrusion at Micro-scale: Fast Forward Screening in Drug Development
- DSM Xplore pharma micro extruder
- End user case study: ‘Hot melt extruded polyester amide fibers as degradable platforms for drug delivery: an ophthalmic example’
- Fiber preparation and processing
- Polymer characteristics
- In vitro degradation
- In vivo biocompatibility: Subconjunctival and intravitreous
Deploying Successful Product Lifecycle Management Strategies
Improving Efficiency and Compliance from Lab to Launch through Agile Product Lifecycle Management
- Product development challenges facing the pharmaceutical industry
- How Agile Product Lifecycle Management (PLM) for Pharma can accelerate product innovation and better drug pipeline execution through synchronized project and global clinical supplies management
- Improving outsourcing coordination by incorporating change management across the entire drug development process to improve collaboration
- Successful approaches to achieve greater levels of regulatory compliance through adherence to strict quality and risk management processes
Transdermal Drug Delivery Systems
P.L.E.A.S.E. ®, The breakthrough device for transdermal drug delivery
- Novel diode pumped laser microporation devices
- Precise deposition of large molecular weight drugs into selected skin layers
- Preclinical and clinical applications of P.L.E.A.S.E. based drug delivery
Pharmaceutical Applications of Solid Dispersion & Cyclodextrin Technologies
- Automated screening approaches to solid dispersion analysis
- Solid dispersion characterization
- Exploring the importance of amorphous forms in the generation of dispersions for development and commercialization
- Manipulating membrane permeation, oral bioavailability and stability with cyclodextrin technology
Transdermal Immunotherapy for Allergy Treatment
Painless Transdermal Immunization Against Allergy – Preclinical proof of concept
- Characterizing the uptake of protein antigens -Processing, cell presentation & activation
- Determining the strength & polarization of the resulting immune response
- Understanding the mechanisms of transdermal immunization to enable the development of rational approaches
- Deploying the P.L.E.A.S.E.–based skin poration methods of Pantec to ensure efficient delivery
- Generating data of pre-clinical proof of concept for Specific Immunotherpy with the P.L.E.A.S.E.–based skin poration method in a mouse model
- Comparing transcutaneous immunotherapy using the P.L.E.A.S.E. platform to subcutaneous injection as used in conventional SIT
Enhancing Targeted Delivery Using Lipid-based Oligonucleotide Formulations
- Understanding key processes in the formulation of oligonucleotides with lipids
- Winning strategies in formulation development
- Case Study: Initial results & findings in a Phase I product study
Simplifying Inhaled Drug Delivery, Formulation and Device
- Providing ultra rapid drug delivery using Technosphere dry powder formulations
- Powder inhalation with small, breath-powered inhalers using pre-metered, single use cartridges
- Exemplifying inhalation technology using several drugs with a focus on peptides for the treatment of pain
Successfully refiling a product patent in a substantially meaningful manner
- Selecting meaningful features to enhance - Efficacy, specifcity, potency and toxicity
- Proving perceivable benefits to the consumer - Novelty and commercial value
- Assessing the regulatory environment - How far has the pass bar been raised?
- Successful strategeis in formulation, delivery and business development
- Avoiding failure - Preventing unnecessary time and cost losses
Successfully Responding to the Development Demands of Paediatrics
A Regulator's Overview
- What have been the impacts of EU regulations on paediatric development to date? - Early, late & clinical
- Opportunities for paediatric drug delivery and tying these into current requirements
- How has the MHRA been impacted by the regulations - Internal perspectives & industry response
- Formulation aspects from the Paediatric Commitee of EMA and PFormulation Working Group
- The Paediatric Investigation Plan - Filing approaches in regards to quality, safety & efficacy
- How are PIP's assessed, incentivized and rewarded?
Supporting the Pharmaceutical Industry to successfully deliver studies under the EU regulations
- Demonstrating the Children’s Research Network achievements to date
- Understanding the involvement of families and children in the support of paediatric research
- Reviewing the performance management structure
- Highlighting opportunities for early engagement with the network
- Streamlining study data acquisition & controls in making R&D faster & of higher quality
Dr William vant Hoff
Co-Director, National Institute for Health Medicines for Children Research Network
NHS
How is the industry & academia meeting the demand?
- Examining the pitfalls of non patient-centric approaches in terms of prescribing, dispensing, compliance and concordance of medicines for children
- The place of a patient-centric approach to QbD in paediatric development
- Example of a prospective approach of defining age-specific dosage form requirements for paediatric medicines
Dr William vant Hoff
Co-Director, National Institute for Health Medicines for Children Research Network
NHS
Benefit from additional networking and in-depth discussion on a topic of particular interest to you - join an informal topical discussion hosted over a networking lunch. Look out for sign-up sheets at the event so you can select which table you want to join. Topics for you to share knowledge and best practice will be led by:
Solid Solution Drug Dissolution Technology-overcoming roadblocks to the clinic
The Role of Advanced Analytical Tools in Accelerating Formulation Development and Aiding Formulation of Challenging Molecules
Jeff Mazzeo
Late Stage Development Director, Pharmaceutical and Life Science Business Operations
Waters Corporation
Are you satisfied with your supplies of GMP-grade bulk lipids and activated PEGs for parenterals?
Solutions for bioavailability enhancement of poorly soluble and poorly permeable compounds
Increasing productivity with fully integrated single source solutions for drug discovery - High throughput spectroscopy, chromatography and dissolution techniques
The Relevance of Solid State Research in Formulation Development
Moving Forward & Meeting the Demands of the 'Year of Active Ageing' and 'Solidarity between Generations' of the EU commission
Perspectives from a Geriatrician
- Analysing the increasing continental life expectancy and understanding the contributing factors
- Identifying clusters of morbedities that contribute to a common biology in target selection
- Realising the importance of including the elderly population in clinical trials
- Deploying a more integrated method of therapy to treat chronic, multi-morbid illness
Lessons from a Pharmacist
- Identifying key age-related limitations to self-medication - Cognitive & sensory impairment
- Overcoming these hurdles in managing dosing regimes and compliance
- Establishing the most appropriate delivery routes for the patient whilst balancing technological requirements
- What are the key issues in treatment of geriatrics vs. those in younger adult groups?
- Manipulating medications in a more patient centric appraoch to formulation & delivery
An Academic's remarks
- Understanding the issues related to the formulation pf paediatric therapies
- Overcoming the challenges of patient reconstitution
- Deploying existing & emerging technologies to improve formulation & delivery strategies
Prof Andreas Zimmer
Senior Research Head, Pharmaceutical Technology, Nanotechnology, Drug Delivery & Biotechnology
University of Graz Austria
Prof Andreas Zimmer
Senior Research Head, Pharmaceutical Technology, Nanotechnology, Drug Delivery & Biotechnology
University of Graz Austria
Quality by Design: A Wasted Investment?
Bridging the gap between QbD on paper and QbD in practice
- How advanced is the pharmaceutical industry in implementing QbD?
- What challenges have been observed during the implementation of QbD?
- Can we expect clinical evidence for Critical Quality Attributes and Critical Process Parameters?
- Realizing the potential of QbD: Quality increase and cost reduction
- What is your experience in accepting QbD and related data by regulatory bodies?
Nanotechnology - A Revolutionary Technology or a Wasted Investment?
Applications of nanotechnology and particle size reduction to combat issues of bioavailability
- What does nano really mean in formulation and drug delivery?
-Focusing on nanoformulation of actives and biological materials
-Advantages delivered by nanostructured actives
-Importance of size vs. specific interactions
- Regulatory perspectives
- Differences between the structures and thus, the safety profiles of the nanoparticle actives
-Factors controlling pharmacokinetics of nanodrugs
-What safety/toxicity measures should be applied for compounds whose original safety assessment (not nanoformulated) has already been established?
- Nanotechnology as a life cycle extension tool
- Generating relative NCEs
- Allowing alternative administration roots and providing means for new indications
Evaluating how a product will behave during commercial production
- Gaining an early awareness of product behaviour in small scale equipment and scale-down models
- Exploring the extent of interaction between product and manufacturing equipment and space
- Taking fill/finish factors into account during the formulation stages of development
- Bridging the communication gap between product formulation and process engineering
- Evaluating how the product will respond to the standard manufacturing platform used
Patient & Technical Considerations for Self-Injection Device Design
- Ensuring an effective balance between drug and device is established and maintained
- Exploring patient-centric design of each therapeutic product
- Can all global regions support the combination product?
- Ensuring that development moves from a technology-driven focus to a patient focus
- Exploring the principles for self-injection device design - Challenges & benefits
Dr. Beth Hill
Head, Drug Delivery & Device Development; Sr Director, Biologics Delivery
Johnson & Johnson
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