• FULL PROGRAM
  • DAY 1
  • DAY 2
  • PROGRAM AT A GLANCE
  • Show All
  • Biologics
  • Technology & Innovation
  • Small Molecules
  • Device Development
Day 1 – (11/09/2018)
7:30-8:20AM
Registration & Refreshments

8:20-8:25AM
Chair’s Opening Remarks
8:25-9:00AM
Keynote
Technology & Innovation
In What Direction is the Drug Delivery Technology Space Moving?

medimmune logo

  • 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?

Anand Subromony,
Vice President New Product Technologies,
MedImmune

9:00-9:05AM
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9:05-9:40AM
Keynote
Small Molecules
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
Keynote
Biologicals
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

9:40-9:45AM
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9:45-10:20AM
Case Study
Small Molecules
Physiologically based pharmacokinetic (PBPK) modelling of oral absorption

Pfizer

  • Application in early pharmaceutical development
  • Role of physicochemical characterization
  • Relating physicochemical characterization to early pharmaceutical development

Dr. Tao Zhang
Principal Scientist-Research Enabling Group, Drug Product Design- Pharmaceutical Sciences Small Molecules
Pfizer

Case Study
Biologicals
Combination treatment of multidrug resistant tumors with stimuli-sensitive nanocarriers co-loaded with siRNA and drugs
  • Combination of siRNA and drug can be used to treat multidrug resistant tumors
  • 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
10:20-11:00AM
Meetings
iSolve & Networking Refreshments

iSolve-logo

11:00-11:35PM
Solution Spotlight
Small Molecules
Session TBC

quotient-sciences

Solution Spotlight
Biologicals
Session TBC
unchained-labs
11:35-11:40PM
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11:40-12:15PM
Case Study
Small Molecules
Maximize the Potential of Discovery: Early Utilization of Enabling Technology
CurisDelivery of poorly soluble compound has become a major challenge in the pharmaceutical industry, especially in discovery. Many enabling formulation technologies can help to improve the solubility of these drug candidates. However, every compound/project is unique. Take away the best formulation strategy and technique to use that is compound value appropriate, development phase appropriate.

Lieyu (Richard) Hu
Sr. Formulation Scientist
Curis Inc

Case Study
Device Development

    • Bridging between device types
    • Role of devices during drug development programmes
12:15-1:15PM
Networking Lunch
Networking Lunch logo
1:20-1:55PM
Case Study
Small Molecules
Trojan horse formulations for tumour drug delivery
      • Improving stability of microparticle internalised chemotherapy
      • Potential to minimise systemic toxicity with new formulations
Case Study
Biologicals
Characterization of adsorbed vaccine formulation
Sanofi Pasteur

      • Characterization of combination vaccines comprised of several antigens in a single formulation.
      • Scanning electron microscopy (SEM) and X-ray photoelectron spectroscopy are showcased to examine morphology and size
      • Use of nanoDSF and FTIR spectroscopy for lean material characterisation
      • Studying structure and stability of adsorbed vaccine formulation

Marina Kirkitadze
Deputy Director, Head of Biophysics and Conformation Unit, Analytical R&D Biochemistry
Sanofi Pasteur

1:55-2:00PM
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2:00-2:35PM
Solution Spotlight
Small Molecules
Session TBC
Dow
Solution Spotlight
Biologicals
Session TBC
Albumedix
2:35-3:15PM
Meetings
iSolve & Networking Refreshments

iSolve-logo

3:15-3:50PM
Case Study
Small Molecules
Ophthalmic drug delivery
  • Avoiding drug loss through thermoresponsive polymer formulation in vitro evaluation of ophthalmic drug release
  • Performance characteristics of ophthalmic drug delivery systems
Case Study
Biologicals
Continuing challenges for mAb formulations
Amgen

  • Stabilising protein formulations
  • Designing formulations with environmental and chemical weaknesses in mind

Rahul Rajan Kaushik
Director of Drug Product and Formulation Development and Functional Area Head
Amgen

3:50-3:55PM
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3:455-4:30PM
Solution Spotlight
Small Molecules
Session TBC
Foster
Solution Spotlight
Biologicals
Bringing efficiency to biologics and large molecule pharmaceutical formulation
  • Improving light scattering biophysical screening
  • Aiding drug discovery through better molecule selection and purification
4:30-4:35PM
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4:35-5:10PM
Case Study
Small Molecules
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
Case Study
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 the FDA.
5:10-5:15AM
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5:15-5:50PM
Keynote
Biologicals
Challenges & Opportunities for Delivering Biologics Drugs Orally and by Inhalation
  • Unmet medical needs of patients with chronic use biologics
  • Transforming the chronic delivery of biologics
  • Opportunities of delivering oral biologics: innovations in technologies
  • Inhaled biologics: scientific and technological challenges and innovations

Rakesh Dixit,
Vice President, Research & Development, Global Head, Biologics Safety Assessment-Translational Sciences,
MedImmune

6:25-6:30PM
Chair’s Closing Remarks
6:30-7:30PM
Evening Drinks Reception

Day 2 – (11/09/2018)
8:00-8:30AM
Registration & Refreshments

8:30-8:35AM
Chair’s Opening Remarks

8:35-9:10AM
Keynote
Technology & Innovation
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
9:10-9:15AM
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9:15-9:50AM
Case Study
Small Molecules
Application of High Throughput and Automated Workflows to Large Molecule Formulation and Process Development
Case Study
Device Development
Challenges and opportunities in combination product design, development and use
shire

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

Steve Bowman
Device Program Lead
Shire

9:50-09:55AM
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09:55-10:30AM
Solution Spotlight
Small Molecules

Capsugel-Lonza

Solution Spotlight
Biologicals
Choosing the correct self-injection system for large molecule
  • Combining human factors engineering with drug formulation for patient benefit
  • How can device manufacturers work closer with formulation scientists
10:30-11:10AM
Meetings
iSolve & Networking Refreshments

iSolve-logo

11:10-12:45AM
Case Study
Small Molecules
Challenges and opportunities of development of salts of weak bases
genetech

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

Dr. Helen Hao Hou
Scientist Small Molecule Pharmaceutical Sciences, Research and Early Development
Genentech

Case Study
Biologicals
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 factor engineering approach optimized for combination products
  • Best practices for meeting regulatory expectations for human factors engineering
12:45-12:50PM
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12:55-01:30PM
Solution Spotlight
Small Molecules
Roquette
Solution Spotlight
Biologicals
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?
01:30-02:30PM
Networking Lunch
Networking Lunch logo
02:30-03:05PM
Case Study
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
Case Study
Technology & Innovation
Use of Nano Biosystems in therapeutic drug targeting and cell specific delivery
03:05-3:10PM
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03:10-3:45PM
Case Study
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
Case Study
Biologicals
Formulating vaccines for microneedle delivery
genetech

  • Benefits of delivering vaccines via microneedle
  • Challenges of designing vaccines for microneedles
  • Effects on bioavailability

Ajit Narang
Senior Scientist
Genentech

3:45-3:50PM
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3:55-4:25PM
Keynote
Device Development
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
4:25-5:00PM
Panel Discussion
Technology & Innovation
How big data and artificial intelligence can revolutionize pharmaceutical R&D
  • Integrating all data
  • Collaborating internally and externally
  • Employing IT-enabled portfolio-decision support
  • Leveraging new discovery technologies
5:30-5:35PM
Chair’s Closing Remarks