Program 2019

7:30 AM - 8:20 AM

Registration & Refreshments

8:20 AM - 8:30 AM

9:10 AM - 9:15 AM

Move to your next Session

9:15 AM - 9:50 AM - Case Studies

Small Molecules

Right Time, Right Place; Exploiting Micro and Nano Particulates for Drug Delivery

  • Development of sustained release of small molecule and peptide APIs to shift treatment from daily to monthly or longer
  • Delivery of hard-to-formulate actives for complex and novel applications
  • Poly-lactide microspheres for the treatment of eye diseases
  • Organ-selective delivery of cytotoxic payloads
  • Targeting of tumour cells

Biologics

Limitations and problem solving of polysorbate

  • Polysorbate degradation
  • Impact of polysorbate degradation on drug stability
  • Improving stability of polysorbate

Technology & Innovation

Innovations in Creating Drugs for CNS Diseases

  • Potential routes to crossing the BBB (Blood Brain Barrier)
  • S1P1inhibitors as a potential companion drug
  • Formulating CNS drugs with built in S1P1 inhibitors

Device Development

Combination treatment of multidrug resistant tumours with stimuli-sensitive nanocarriers co-loaded with siRNA and drugs

  • Combination of siRNA and drug can be used to treat multidrug resistant tumours
  • Drug and siRNA can be loaded on the same delivery nanosystem
  • Such co-loaded nanopreparation could be made stimuli-sensitive
  • Nanopreparations can also target intracellular organelles

9:50 AM - 9:55 AM

Move to your next Session

9:55 AM - 10:30 AM - Case Studies

Small Molecules

Nanoparticle Formulation Development: A Closer look at Pharmaceutical Fabrication Methods

  • Nanoparticle formulation for drugs with poor aqueous solubility
  • Comparison of polymer nanoparticle fabrication methods and composition
  • Effect of nanoparticle fabrication method and composition on nanoparticle physical properties

Biologics

QbD and Process Scale Up Considerations

 

  • Biological continuous manufacturing
  • Making sense of regulatory guidelines
  • Formulating drugs with manufacturing in mind

Technology & Innovation

Ultra-High Drug Loading in Micelles

  • Drug release timing, uniformity of colloidal dispersions, drug stability colloidal uniformity and formulation stability
  • Triggering drug release based on oxygen levels in cancerous cells

Device Development

In What Direction is the Drug Delivery Technology Space Moving?

  • Evaluating how fast the delivery technology field has evolved until now – are there limiting factors to its continued development?
  • What is the potential of less-traditional delivery routes such as nasal and ocular delivery?
  • Discussing the future of evolving areas including polymer technologies, auto injectors, microneedles etc.
  • Looking retrospectively, has the industry done all it can until now to maintain the R&D paradigm?

10:30 AM - 11:30 AM

iSolve & Networking Break

11:35 AM - 12:10 PM - Case Studies

Small Molecules

Advances in Supersaturating Drug Delivery Systems

  • What are Supersaturating Drug Delivery Systems (SDDS)?
  • Advances in developing and characterizing SDDS?
  • Complexity in in-vitro and in-silico characterization of SDDS?
  • Benefits and limitations of SDDS characterization tools and methods

Biologics

Designing formulations for enhanced bio-availability

  • Studying lipid based delivery systems for poorly water-soluble drugs
  • Studying applicability of lipid based excipients

Technology & Innovation

Challenges and opportunities in combination product design, development and use

  • Importance of coupling device design with drug formulation
  • Main challenges of designing user friendly devices

Device Development

Compatibility studies for administration devices materials: A long journey

  • How do compatibility studies fit into the formulation journey?
  • Selecting the correct plastics: infusion systems vs syringes
  • Thinking about shelf stability

12:10 PM - 12:15 PM

Move to your next Session

12:15 PM - 12:50 PM - Solution Spotlights

Small Molecules

Session TBC

Biologics

Session TBC (2)

Technology & Innovation

Session TBC

Device Development

Session TBC

12:50 PM - 1:50 PM

Networking Lunch

1:50 PM - 2:25 PM - Case Studies

Small Molecules

Challenges and opportunities of development of salts of weak bases

 

  • Effect of physicochemical properties of API and excipients
  • Implications of disproportionation on oral bioavailability
  • Alternative formulation approaches

Biologics

Emerging opportunities in biologics delivery

  • Changing regulatory landscape (include Paediatrics)
  • Demand in the market
  • Challenges in the industry to be addressed
  • The changing landscape of collaboration

Technology & Innovation

Optimizing Conventional Formulations for Continuous Manufacturing

  • Improving material science, API and process robustness for continuous manufacturing
  • Ensuring you have fully automated controls to realize true end-to-end pharma production
  • Breakthrough technologies poised to revolutionize formulation and manufacturing

Device Development

Implementing human factors engineering and user-centered design: Practical guidance for combination products

  • Introduction to human factors engineering and user-centered design
  • Suggestions for involving users throughout the development process
  • Tips for planning and implementing a human factors engineering approach optimized for combination products
  • Best practices for meeting regulatory expectations for human factors engineering

2:25 PM - 2:30 PM

Move to your next Session

2:30 PM - 3:05 PM - Solution Spotlights

Small Molecules

Solution Spotlight By Hovione

Biologics

Solution Spotlight By Unchained Labs

Session TBC

Technology & Innovation

Solution Spotlight By Dow

Session TBC

Device Development

Solution Spotlight By Confinis

3:05 PM - 4:05 PM

iSolve & Break

4:05 PM - 4:40 PM - Case Studies

Small Molecules

Co-amorphous Materials, Discovery and Design

  • Can co-amorphous formulations be the answer to Amorphous solid dispersions ASD shortcomings
  • Improving solubility of Co-amorphous formulations

Biologics

Oral delivery of hydrophobic drugs using mixed micelles

  • Improving bioavailability through mixed micelle formulations
  • PEGylation stabilisation of mixed micelles
  • Mucus penetration through endothelial cells by PEGylated mixed micelles

Technology & Innovation

Enhancing Drug Formulation of Challenging Compounds Using Supercritical Fluid (SCF) Technologies

  • SCF technologies to streamline development
  • 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

Device Development

Foundational research on subcutaneous injection physiology to improve biologics delivery systems and patient experience

  • Developing better delivery technology for biologics based therapies
  • Factors affecting drug absorption after SC injection
  • Improved knowledge of SQ anatomy, physiology and the biomechanics of injection to better inform formulation

4:40 PM - 4:45 PM

Move to your next Session

4:45 PM - 5:20 PM - Case Studies

Small Molecules

Challenges and Opportunities of Developing Paediatric Drug Formulations

  • Different capabilities for drug administration, medicine-related toxicity, and taste masking
  • suitable dosage forms unique to paediatric oral formulations
  • Review of new regulations and research initiatives

Biologics

Can biosimilars and generics be treated as if they are one and the same?

  • Can biosimilars be used the same way generics are
  • Switching patients from originator to biosimilar
  • NOR-SWITCH and similar case studies

Technology & Innovation

Overcoming Barriers of Acetylcholinesterase Inhibitors for Alzheimer’s Disease

  • Reasons for the continued success of Acetylcholinesterase inhibitors as NCE
  • Most common issues with solubility and low bioavailability
  • Crossing the Blood Brain Barrier

Device Development

Dealing with the Changing Regulatory Landscape around Combination and Medical Devices

  • Challenges of developing combination products through a changing regulatory landscape.
  • Working across boundaries to achieve common goals.
  • Case study on the review of human factors protocols by regulators.

5:20 PM - 5:25 PM

Move to your next Session

5:25 PM - 6:00 PM - Keynote

Biologics

Keynote Panel Discussion: Ensuring Biosimilar Approval Processes are Quick, Fair and Safe

  • What companies can do to expedite their biosimilar’s approval
  • Regulators and industry working together to ensure speedy and safe biosimilar approval processes
  • Collaboration between regulators

6:00 PM - 6:05 PM

6:05 PM - 7:05 PM

Drinks Reception

8:00 AM - 8:30 AM

Registration & Refreshments

8:30 AM - 8:40 AM

Chair's Opening Remarks

8:40 AM - 9:15 AM - Keynote

Small Molecules

Future Trends in Pharmaceutical Development

Olaf Queckenberg, Head of Chemical & Pharmaceutical Development, Bayer

 

Abstract TBC

9:15 AM - 9:20 AM

Move to your next Session

9:20 AM - 9:55 AM - Case Studies

Small Molecules

Targeting Cancers with Nano Drug Delivery Systems

  • Understanding passive and active targeting strategies
  • Main problems with nanoparticle formulations
  • Instability of nanoparticles

Biologics

Current Research on GLP-1 with a Special Focus on Semaglutide Oral Delivery

Jesper Lau, Vice President, Protein and Peptide Chemistry, Novo Nordisk

 

Abstract TBC

Technology & Innovation

Nanotechnology Application in Drug Design and Delivery

  • Aiding drug discovery through use of nanobiotechnology
  • Limiting effects on healthy cells

Device Development

Ophthalmic Drug Delivery

  • Avoiding drug loss through thermoresponsive polymer formulation
  • in-vitro evaluation of ophthalmic drug release
  • Performance characteristics of ophthalmic drug delivery

9:55 AM - 10:55 AM

iSolve & Networking Break

10:55 AM - 11:30 AM - Case Studies

Small Molecules

Improving Absorption of Poorly Soluble Compounds

  • Highlighting the main obstacles to oral delivery
  • Formulating drugs with solutions to identified obstacles in mind

Biologics

Oligonucleotides, the Small Large Molecules

  • Challenges with formulation
  • Challenges with analytics (methods and stability)
  • What are the expectations of health authorities?

Technology & Innovation

Carbon Nanotube Composites for Drug Delivery

  • Overcoming biological barriers
  • Nanotube interactions with subcellular structures

Device Development

Wearable Insulin Delivery Devices

  • Sweat based glucose monitoring
  • Closed loop systems for glucose measurement and dosage setting
  • Data collection and deep learning

11:30 AM - 11:35 AM

Move to your next Session

11:35 AM - 12:10 PM - Solution Spotlights

Small Molecules

Solution Spotlight By Foster Delivery Science

 

Session TBC

Biologics

Solution Spotlight Roquette

Session TBC

Technology & Innovation

Solution Spotlight ShinEtsu

Session TBC

Device Development

Solution Spotlight Session TBC

Session TBC

12:10 PM - 12:15 PM

Move to your next Session

12:15 PM - 12:50 PM - Case Studies

Small Molecules

Formulating with Tissue Distribution and Toxicity in Mind

  • Problems with nanoparticle inadequate tissue distribution
  • Avoiding toxicity from drug build up in targeted cells

Biologics

Practical Lessons on Making QbD an Essential Step in Biologics Production

  • Overview of the latest QbD guidelines and best practices
  • QbD methodology: Quality Target Product Profile

Control strategy for QbD

Technology & Innovation

Design, Translation and Development of Polymeric Nano-Medicines

Harivardhan-Reddy Lakkireddy, Head of Drug Delivery Technologies & Innovation - Nanotechnologies, Sanofi

  • Review the basics of translation and development for polymeric nano-medicines
  • Design of delivery nanocarriers for cancer therapies

Device Development

Nano-structured Films for Ocular Drug Delivery

  • Patient non-compliance with traditional glaucoma treatment
  • Automatic sustained release of drug via intraocular devices
  • Monitoring drug release kinetics

12:50 PM - 1:50 PM

Networking Lunch

1:50 PM - 2:25 PM - Solution Spotlights

Small Molecules

Solution Spotlight Adare Pharmaceuticals

 

Session TBC

Biologics

Solution Spotlight Albumedix

 

Session TBC

Technology & Innovation

Solution Spotlight DFE Pharma

 

Session TBC

Device Development

Improving COPD treatment with ‘Smart Inhalers’

  • Adherence interventions categories that can be targeted
  • Measuring cost effectiveness of treatment through smart devices- eg smart inhaler

2:25 PM - 2:30 PM

Move to your next Session

2:30 PM - 3:05 PM - Case Studies

Small Molecules

Accelerated Stability Testing of Biopharmaceutical Excipients

Ellen Verheyen, Senior Scientist - Stability Expert, Janssen 

 

  • Accelerated vs Real-Time testing techniques
  • Humidity and pH accelerated effects prediction
  • Current regulations for accelerated shelf life assessments

Biologics

Technology & Innovation

Penetrating the Blood Brain Barrier (BBB) Using Novel Nanoplatforms

  • Developing nano-delivery vehicles capable of targeting the CNS
  • Comparing formulations using organic vs inorganic nanoparticles, liposomes and micelles

Device Development

Human Factors Engineering for Medical Device Development

Rémy Vomscheid, Director, Device Development & Technologies, Ipsen

 

  • Human Factors Engineering: overview & regulatory framework
  • Patient-centricity in Device Design and Development
  • Case study

3:05 PM - 4:05 PM

Networking Break

4:05 PM - 4:40 PM - Solution Spotlights

Small Molecules

Solution Spotlight W.L. Gore

Abstract TBC

Biologics

Solution Spotlight Session TBC

Session TBC

Technology & Innovation

Solution Spotlight Grace

 

Abstract TBC

Device Development

Solution Spotlight Session TBC

Session TBC

4:40 PM - 4:45 PM

Move to your next Session

4:45 PM - 5:20 PM - Keynote

Biologics

Personalised Immunotherapies Based on mRNA Drugs

  • Overview of the obstacles created by RNA degradation and the effects on stability and delivery
  • Potential for better drugs by modifying RNA structure to promote self-amplification

5:20 PM - 5:30 PM

Chair’s Closing Remarks and End of Day 2

Mostafa Nakach, Head of Pharmaceutical Engineering, Sanofi

8:00 AM - 8:30 AM

Registration

8:30 AM - 8:35 AM

8:35 AM - 9:10 AM - Keynote

Device Development

Innovating Medical Devices Cost Effectively

  • Blending multiple ideas with streamlined management to innovate more effectively
  • How much is pharma losing today through R&D that does not result in product?
  • Accelerating product design and testing to reduce R+D cost of devices and combination products

9:10 AM - 9:15 AM

Move to your next Session

9:15 AM - 9:50 AM - Case Studies

Small Molecules

Local Delivery for Enteric Coated Drugs

  • Advances in Colonic delivery
  • Enteric coating for sustained release
  • Enteric coating targeting

Biologics

Limitations and Problem Solving of Polysorbate

  • Polysorbate degradation
  • Impact of polysorbate degradation on drug stability
  • Improving stability of polysorbate

Technology & Innovation

Bringing Drugs to Market Sooner

  • Advanced screening to reduce the number of compounds wasted in discovery phases
  • Advanced predictive modelling to reduce costs per drug brought to market
  • Saving most time and money can happen at pre-clinical and clinical tests

Device Development

Development of Inhalers That Guide Patient Technique

  • Setting out the problem with improper inhaler use
  • Can we reduce the amount of medication lost from inhalers?
  • Programming smart inhalers to inform patients of medication adherence
  • Integrated sensors to warn patients of environmental asthma triggers

9:50 AM - 9:55 AM

Move to your next Session

9:55 AM - 10:30 AM - Solution Spotlights

Small Molecules

Solution Spotlight By Merck Group

Abstract TBC

Biologics

Solution Spotlight Session TBC

Technology & Innovation

Solution Spotlight Session TBC

Session TBC

Device Development

Solution Spotlight Session TBC

Session TBC

10:30 AM - 11:30 AM

Networking break

11:30 AM - 12:05 PM - Case Studies

Small Molecules

Control Strategy approaches in Continuous Manufacturing of Oral solid dosage forms

Jacqueline Maximilien, Senior Scientist, Janssen 

Abstract TBC

Biologics

Molecular Modelling Techniques to Aid Drug Stability Studies

  • Understand the mechanism of drug delivery
  • Receptor site geometric modelling
  • Data analysis case study using advanced computing

Technology & Innovation

Approaching IVIVC for Nanoformulations: Challenge Accepted!

  • PBPK
  • Drug release
  • Dialysis
  • Controlled release
  • Liposomes
  • Nanoparticles

In silico

Device Development

Micro-Injector for solid micro-dose Injections: Regulatory Considerations for Pharmaceutical and Device Development

Dr Faz Chowdhury, Chief Executive Officer, Nemaura Pharma

The field of drug delivery using microneedles to deliver solid dosages through the skin is buoyant with products entering clinical trials for vaccines and small molecules alike. These systems provide commercial, clinical and end-user advantages. These include enhanced stability of compounds at ambient conditions, and the improvement of patient compliance. However, there are multiple challenges that must be addressed from a regulatory perspective including accuracy and reproducibility of dosing, and human factors considerations. This presentation discusses the benefits and regulatory challenges and methods of addressing them using novel device formats.

12:05 PM - 12:10 PM

Move to your next Session

12:10 PM - 12:45 PM - Solution Spotlights

Small Molecules

Solution Spotlight Session TBC

Session TBC

Biologics

Session TBC

Session TBC

Technology & Innovation

Solution Spotlight Session TBC

Session TBC

Device Development

Solution Spotlight Session TBC

Session TBC

12:50 PM - 1:50 PM

Networking Lunch

1:50 PM - 2:25 PM - Case Studies

Biologics

PS80 Oxidation Case Study: Any Impact on mAb Stability

Heloise Audat, Head of Late Stage Formulation Development Unit, Biologics, Sanofi

 

Abstract TBC

Technology & Innovation

Release Testing of Nanoformulations

  • Review of real-time test methods for nanoparticulate drug release
  • Advances in voltammetry and turbidimetry
  • Mathematical modelling for drug release

Device Development

Industry Effects of EU MDR and IVDR Regulations

  • Independent testing prior to EU marketing: Criteria to test
  • What are the extra responsibilities to be taken by ‘Notified Bodies’
  • Timeline to conform to EU MDR
  • What is covered by EU MDR 117

Small Molecules

Challenges with Oxidation Sensitive Drug Substances

  • Which antioxidants, acceptability by authorities, how to control their level throughout shelf life?
  • Available packaging solutions: oxygen scavengers and new technologies (e.g. bottles coated with oxygen scavengers
  • In addition: use of desiccant in blisters for moisture sensitive drug products

2:25 PM - 2:30 PM

Move to your next Session

2:30 PM - 3:05 PM - Case Studies

Small Molecules

Modelling and Control of Fluid Bed Granulation Processes

Sophie Martin, Process Engineer in Pharmaceutical Development, Sanofi

Fluidized bed processes are a complex equilibrium between thermodynamics, hydrodynamics and atomization.

A simple model based on mass and heat balances on the equipment is proposed to find the perfect alchemy to control granulation, coating and drying processes in Fluidized bed.

3 cases studies:

  • Application to a granulation process
  • Application to a coating process
  • Application to a drying process

Biologics

Chemistry, Manufacturing and controls (CMC) strategies for Cell Therapies

  • Efficient and safe T-Cell Processing for CAR-T therapies
  • Maintaining stability testing standards in compressed development timeframes

Technology & Innovation

Ultra-high Drug Loaded Micellar Drug Formulation and Solid Dispersions

Device Development

Software Applications (Apps), the New Medical Devices?

  • When do mobile apps become devices? The regulations.
  • Allowing apps to make recommendations on treatments or medical consultations
  • Role of AI and responsibility of app designers vs medical clinicians

3:05 PM - 4:05 PM

Networking Break

4:05 PM - 4:40 PM - Case Studies

Small Molecules

Disproportionation of Salts in Solid Oral Dosage Forms

  • Drug efficacy deterioration as a result of salt dissociation
  • Dissolution changes
  • Disproportionation case studies

Biologics

Regulatory Considerations of Nanomedicines

  • Licensed medicinal products exploiting nanotechnologies – current guidelines
  • Challenges of regulating ‘nanomedicines’
  • Considerations of the information required for development / licensing

Nanotechnology has greatly advanced in the past decade and provides immense potential for the development of improved therapeutic and diagnostic tools for the treatment, prevention and diagnosis of various diseases of the central nervous system, cardiovascular system and cancer.  Due to their small size in dimension, it is believed that nanoparticles are able to interact with cells at the molecular level more efficiently and provide better targeting ability towards desired cells and tissues with greater precision and efficacy. Nano-based delivery systems using polymers (e.g. polymeric micelles and polymer-drug conjugates) and lipids (e.g. liposomes, and solid lipid nanoparticles can help:  i) increase solubility; ii) improve tumour targeting; (iii) decrease toxicity; (iv) overcome drug resistance, and v) prolong circulation half-life by modifying the surfaces of these nanoparticulate drug delivery systems and increasing drug payload to the target cells. The complexity of nanomedicines requires a holistic assessment of the quality, safety and efficacy of the product. This talk will focus on the challenges of developing these advanced drug delivery systems to match with the current regulatory expectation.

Technology & Innovation

Nanomedicines - Are We Ready for The Market?

  • Nanocarrier production
  • Scale-up
  • Critical quality attributes
  • Process parameters
  • IVIVC

Device Development

Benefits of Early Integration of Human Factors: A BYDUREON® BCise case study

James Meehan, Associate Principal Scientist – Human Factors , AstraZeneca

 

  • This presentation will provide a case study of a HF program for the development of a combination product used to treat type II diabetes
  • This product was initiated in 2009 and has therefore been developed during a period of evolving HF guidance. The presentation will discuss evaluations that were conducted at multiple design stages with representative users, as well as iterations to the design user interface to mitigate observed performance issues
  • This presentation will include an overview of interactions with regulators as well as the importance of having a dialogue with regulators throughout the development process.

4:40 PM - 4:45 PM

Move to your next Session

4:45 PM - 5:20 PM - Keynote

Small Molecules

Injectable Drug formulation depots with sustained release

  • Reducing relapse rates amongst all patients including non-complying patients
  • Achieving sustained release drugs through physiochemical alteration

5:20 PM - 5:25 PM

Chair’s Closing Remarks