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  • small moleculess
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DAY 1, 9 February 2015

12:00-12:50
12:50-13:00
13:00-13:35

Pharmaceuticals 2050: Exploring the potential of 3D printing individualised medicines

Chemist Lee Cronin is working on a 3D printer that, instead of objects, is able to print molecules. An exciting potential long-term application: printing your own medicine using chemical inks.

 

  • Commercialising 3D printing technologies and "chemputer" platforms
  • Discussing the scalability of the technology and new opportunities for speciality products
  • Examining the University of Glasgow's printer that is able to print molecules
  • Navigating the regulatory pathway and roadblocks to success

Lee Cronin
Regius Chair of Chemistry
University of Glasgow

13:35-13:40
13:40-14:15
stream 1
workshop

  • The increasing prevalence of poorly soluble drugs in pharmaceutical industry pipelines has led to the development of a variety of enabling oral drug-delivery technologies. These technologies include amorphous-dispersion, attrition-milling, lipid, and liquid formulations.
  • This presentation will look at the rational selection of technologies for solubilisation using the compound’s physical properties (e.g., melting temperature, glass-transition temperature, log P, and solubility) and product specifications (e.g., dose, pharmacokinetics, permeability).
  • Maps and guidance surfaces will be used to identify formulation approaches with limited experimental work. A primary focus of this presentation will be the science behind the use of amorphous solid dispersions (“spray-dried dispersions” or SDDs) and related technologies to improve the oral bioavailability of hundreds of low-solubility drugs. 
  • This presentation will cover manufacturing process, stage-appropriate physical-stability models,  in vitro test methods that differentiate the species and activity of drug in biorelevant solutions and suspensions, and the formulation of the drug-product intermediate into conventional oral solid dosage forms.

Rod J Ketner, PhD
Director of Pharmaceutical Sciences
Bend Research

stream 2
workshop

 

  • Automated high throughput (HT) methods were applied to developability studies and early to late stage formulation development of biopharmaceuticals.
  • Automation integrated with instrumentation generated high quality data and led to highly efficient studies in terms of sample and resource utilisation.
  • Results of the case studies highlight the utility and flexibility of laboratory automation and integration with analytical devices such as spectrophotometers, liquid chromatography (HPLC and UPLC) and dynamic light scattering DLS.
  • Automated workflows demonstrate numerous novel HT methods including enhanced visual inspection (colour, turbidity, and particles), viscosity and pH.

Russell Burge, Ph.D.
Applications Scientist, Life Sciences
Freeslate, Inc.

stream 3
workshop

  • Dissolution has become a very important test to evaluate the performance characteristics of many types of pharmaceutical products throughout their life cycle.
  • As with any analytical equipment, the qualification of the dissolution apparatus is essential to ensure that it is capable of producing reproducible and therefore comparative dissolution results.
  • Modern technologies have enabled more sophisticated equipment to be designed specifically for the mechanical qualification of the dissolution tester itself.
  • This dedicated equipment, encourages more frequent qualification and use of a database to store the results, facilitates trend analysis and therefore provides early warnings of potential problems.

Terry Way
Consultant
TW Consulting
UK

14:15-14:20
14:20-15:35
14:20-15:05

This workshop is to be attended by all delegates in Group 1

The presentation will focus on case studies using the new product range developed for customers in need of excipients with enhanced capabilities for bioavailability enhancement. The first study will focus on high productivity Hypromellose Acetate Succinate (HPMCAS) and Hypromellose (HPMC) developed for increased solids loading in solutions used to prepare spray dried dispersions. In the second part, AFFINISOL™ HPMC Hot Melt Extrusion (HME) will be highlighted using a case study where the same polymer is used in small scale spray-drying and subsequently transferred to a larger scale hot melt extrusion.

  • Case study 1: High Productivity HPMCAS and HPMC polymers have significantly reduced viscosity that can result in an increase in solids loading in a spray solution by as much as 1.7-fold. In addition, high productivity polymers are capable of achieving the same level of supersaturation and nucleation inhibition as current marketed materials.
  • Case study 2: AFFINISOL™ HPMC HME is capable of being used for small scale spray drying studies for formulation screening/development in purely organic solvent systems. All studied formulations successfully transferred from small scale spray drying to hot melt extrusion without reformulation.

Dr. Meinolf Brackhagen
Senior Scientist
Dow Pharma & Food Solutions

15:05-15:35
15:35-16:05
stream 1
workshop

  • Exploring opportunities, challenges and applications of poorly soluble drugs and NCEs
  • Examining the fundamentals of bead mills for nanosizing
  • Overview of the clinical benefits of commercialised drugs utilising nanotechnology

Markus Maier
Business Development Manager, Pharma & Cosmetic
NETZSCH Vakumix GmbH

stream 3
workshop

 

  • Quality-by-design approach starts from drug degradation understanding.
  • Moisture protection offered by an active packaging can be customized to match identified product needs.

Valère Logel
Head of Development, Healthcare Packaging - BL Medical Specialities
Clariant Healthcare Packaging
France

16:05-16:10
16:10-16:45
stream 2
workshop

 

  • A highly mechanistic model framework for predicting oral absorption as a function of particle size and food effect in the absence of clinical trial data.
  • This approach enables a reduction in the number of clinical trials.
  • A single environment for correlating in-vitro (USP-II, ASD, etc.) experiments and predicting in-vivo performance.
  • Describes dynamics of transit of all species (not just API) and dynamics of changes between fed and fasted states.

 

Sean Bermingham
VP of Life Sciences at Process Systems Enterprise Ltd
PSE

stream 3
workshop

 

 

  • Drug delivery of special dosage forms
  • Biorelevant in-vitro [performance] testing
  • Pulmonal drug delivery
  • Relationship of particle properties and drug release

 


16:45-16:50
16:50-17:25
stream 1
workshop

  • Excipient reproducibility
  • Quality by Design
  • Multi-Variant Analysis
  • Pharmatose 200M

Dr Bastiaan Dickhoff
Senior Product Application Specialist
DFE Pharmaceutical

stream 2
workshop

 

 

  • From this workshop, you will gain valuable insights about how patient-centric drug formulations can help you overcome oral drug delivery challenges.
  • This workshop features 4 case studies and provides customised solutions for patients with diverse needs:
  1. Providing the most convenient dosage formulation for better patient adherence
  2. Taste masking drugs with an unpleasant or bitter taste
  3. Orally disintegrating tablet technology ideal for patients who have difficulty swallowing such as paediatric, elderly and dysphagic
  4. Demonstrating bioequivalence and achieving regulatory approval with new formulations
  5. Improving the safety profile of drugs and reducing health care costs 

Luigi Boltri, Msc
Director, Pharmaceutical Development & Analytical Sciences
Aptalis Pharmaceutical Technologies

Nadine Maalouf, PharmD
Director, Licensing
Aptalis Pharmaceutical Technologies

stream 3
workshop

  • Challenges in development of parenteral sustained release protein & peptide formulations

  • Biodegradable hydrophilic multi-block copolymers as a universal platform for delivery of proteins, peptides and small molecules 

  • Monodisperse microsphere as parenteral sustained release depot formulations with superior injectability 

  • Case-studies :

    • Treatment of ischemic heart disease via intra-coronary growth factor delivery with monodisperse microspheres
    • Intra-articular drug delivery with sustained release microspheres for the treatment of osteoarthritis

Rob Steendam
Chief Technology Officer
InnoCore Pharmaceuticals

17:25-17:30
17:30-18:05
18:05-18:15
18:15-19:00

Welcome reception


19:00-21:00

 

 The Old Town is the place to be. The famous Altstadt is a wondrous square kilometre that has more to offer than any other district in Düsseldorf. More than 250 pubs, restaurants and bars line the streets of the Old Town. Quaint breweries, trendy restaurants or student pubs with a friendly atmosphere - go for it and explore the variety!

WTG will be providing coaches to and from the hotel at no extra cost, leaving you free to enjoy the Old Town.

There will be one pick up from the Swissotel at 19:00 and a returning coach from the Old Town at 21:00.

 

 


DAY 2, 10 February 2015

07:30-08:00
08:00-08:50
breakfast briefing

 

  • Lipid Multiparticulate (LMP) technology offers a range of functionality applicable to many formulation challenges while also harnessing the benefits of the multiparticulate dosage format
  • Dependent upon the lipid excipients utilised to form the matrix multiparticulates, LMP formulations may be designed to provide controlled release, taste-masking and/or bioavailability enhancement.  The improved palatability offered with LMP formulations can also provide an optimal approach for dosing paediatrics, geriatrics and other specialised patient populations
  • This workshop will present LMP technology, covering excipient options, the manufacturing process and representative case studies

Dr. Jan Vertommen
Senior Director Product Development and Manufacturing
Capsugel

breakfast briefing

 

  • Continuous production of water soluble granules via Twin Screw Granulation
  • Smeets has developed, in collaboration with Ghent University, a technique to produce watersoluble granules containing poorly water soluble drugs of Class II (poorly soluble, highly permeable) or Class IV (poorly soluble, poorly permeable) of the Bio Classification System (BCS)
  • The granulation technique – in combination with suitable excipients as polyethyleneglycols and maltodextrins – improves the extent but mainly the rate of dissolution of the poorly water soluble drug. The faster release of the API results often in an improved bioavailability and consequently a decreased intake of API to obtain the same clinical effect
  • The technique can be applied for the production of human and veterinary medicines.  Nowadays, the technique is used for the production of  granules administered via drinking water to treat large groups of animals (poultry, pigs, …). The produced granules can also be filled in capsules or can be used as intermediates for the production of tablets
  • The main advantages of the technique are the continuous process, no grinding necessary after extrusion, low temperature process (50 °C),  limited problems of upscaling and the absence of solvents by which no drying step is necessary; supersaturation possible based upon formulation

Jef Verplaetse
Managing Director Owner
Laboratoria Smeets

08:50-08:55
08:55-09:05
09:05-09:40

SMALL MOLECULES

  • What methodology should be used in dissolution qualification?
  • Enhancing bioavailability and increasing manufacturing processes, can both be done?

 

BIOLOGICS

  • A world without injections, changing biologics paradigm
  • Exploring lipid based delivery systems

 

TECHNOLOGY & PARTNERSHIPS

  • Using the latest MJR technology to improve performance

  • Improving delivery systems by using shelf pens and auto injectors

 

 


09:40-09:45
09:45-10:20
stream 1
small molecules

  • Pharmaceutical co-crystals are an emerging class of crystals which can enhance the solubility, bioavailability, and/or stability of API crystal forms
  • Our group has developed a scalable continuous extrusion co-crystallisation process for indomethacin - saccharin (IND–SCH) co-crystals following co-crystal filling in gelatine capsules. The process is coupled with PAT tools such as in-line NIR and spatial filter velocimetry for real time monitoring of the co-crystal quality and particle size distribution respectively
  • The continuous extrusion processing produced stable high quality co-crystals with enhanced dissolution rates

Dennis Douroumis
Director of Centre for Innovation in Process Engineering and Research
Greenwich University

stream 2
biologics

  • Case studies: stability and stabilization of protein, adjuvanted glycoprotein, and lived attenuated virus

  • Stabilisation strategy for early and late product stage

  • Dedicated predictive models developed for complex biomolecule systems (bio-therapeutics and vaccines) useful for formulation and stabilisation strategies.

  • Use of dedicated accelerated stability studies and modeling as a de-risking approach for vaccine from chemical entities, biomolecules to attenuated microorganisms.

  • Simulation and experimental design as an optimal  stability strategy

Olivier Brass
Scientist
Sanofi Pasteur

stream 3
technology & partnerships

 

  • Analysing inhalation technology for pulmonary drug delivery
  • Using exemplifying inhalation technology for the treatment of pain
  • Applying ultra-rapid drug delivery technology by incorporating Technosphere dry power formulations
  • Using powder inhalation with small, breath-powders by applying pre-metered single use cartridges

Philippe Rogueda
Monash University
Adjunct Senior Lecturer
UK

10:20-10:25
10:25-11:00
stream 1
workshop

  • Reducing the attrition rate of New Chemical Entities (“NCE’s”) in today’s shrinking drug development pipelines has become an issue of paramount importance. A significant number of NCE’s offer therapeutic promise for patients, but exhibit limited physico-Chemical attributes for conventional, solid oral dose delivery.

  • Recent estimates are that as many as 40% to 50% of NCE’s are poorly water soluble and, as a consequence, prone to oral bioavailabilty problems (BCS Type II and IV). The human gastrointestinal track (“GIT”), a complex biological system, may work for, or against, a formulator’s best intensions to deliver efficacious doses of BCS Type II and IV NCE’s.

  • Today’s formulation scientist must have a sound working knowledge of how to develop orally-delivered, lipid-based systems that can be used advantageously to improve the bioavailability of these classes of compounds.

Vincent Plassat
Scientific Affair Manager
Catalent

stream 3
workshop

 

  • Improved quality of life for cancer patients' by changing administration routes, eliminating food-effect and making dose reduction possible
  • General introduction of the validated, scalable continuous flow chemistry based approach for the production of viable novel formulations from early discovery phase to cGMP production scale through a case study: cGMP production of Phase 1 Super-API formulation
  • Pre-clinical Super-API formulations providing clinically meaningful benefits for the treatment of multiple myelanoma, myelogeneous leukaemia and prostate cancer
  • Assessing the potential opportunity of pH independent absorption to significantly reduce the disadvantageous food effect and overall variability of compounds associated with it
  • Converting parenteral cancer drugs into orally available high-value pharmaceutical Super-API products - Case study: Phase 1 Super-API formulation for the treatment of breast cancer

Genoveva Filipcsei
Chief Scientific Officer
DRGT

11:00-11:05
11:05-12:20
11:05-11:50

This workshop is to be attended by all delegates in Group 2

The presentation will focus on case studies using the new product range developed for customers in need of excipients with enhanced capabilities for bioavailability enhancement. The first study will focus on high productivity Hypromellose Acetate Succinate (HPMCAS) and Hypromellose (HPMC) developed for increased solids loading in solutions used to prepare spray dried dispersions. In the second part, AFFINISOL™ HPMC Hot Melt Extrusion (HME) will be highlighted using a case study where the same polymer is used in small scale spray-drying and subsequently transferred to a larger scale hot melt extrusion.

  • Case study 1: High Productivity HPMCAS and HPMC polymers have significantly reduced viscosity that can result in an increase in solids loading in a spray solution by as much as 1.7-fold. In addition, high productivity polymers are capable of achieving the same level of supersaturation and nucleation inhibition as current marketed materials.
  • Case study 2: AFFINISOL™ HPMC HME is capable of being used for small scale spray drying studies for formulation screening/development in purely organic solvent systems. All studied formulations successfully transferred from small scale spray drying to hot melt extrusion without reformulation.

Dr. Meinolf Brackhagen
Senior Scientist
Dow Pharma & Food Solutions

11:50-12:20
12:20-12:55
stream 1
small molecules

 

  • Successfully delivering poorly soluble compounds by taking advantage of the thermodynamic properties of NCEs
  • Using the optimal precipitation inhibitor and solubilisers for commercial products
  • Improving solubility of systematic dispersal oral forms to reduce the challenging amorphous state
  • Investing in solid dispersal hydrogens HME interactions to increase stability

Harpreet Sandhu
Former Principal Scientist, Sterile Formulation, Pharmaceutical Sciences & Clinical Supply
Merck
US

12:55-13:55
13:55-14:30
stream 1
workshop

 

                                           

 

 

 

  • Using the power of automation to improve repeatability, data quality and knowledge retention
  • An introduction to automation followed by case studies in:
  1. Hot melt extrusion
  2. Lipotropic nanoparticle dispersions
  3. Polymorph and salt screening
  4. SMEDDs


stream 2
workshop

  • Protein therapeutics often require frequent dosing due to short-half life, yet the repeat injections can be a barrier to patient compliance and greater market uptake.  
  • Depot formulations of biologics require very precise control of dosing with tight control over initial burst release
  • Octoplus’s Polyactive technology for controlled release of proteins and mAbs addresses these two challenges and provides a platform for development of more effective biologics therapeutics
  • Considerations for matching a protein to the delivery technology will be discussed along with case studies of preclinical and clinical stage projects.

Syed Reza, MD, PhD
Director, Business Development
Octoplus

stream 3
workshop

By any measure, transdermal drug delivery (TDD) is a successful controlled release technology. Over the last 30+ years, a steady state flux of transdermal products have received regulatory approval and reached the market. For the right compound, TDD is an effective and preferred route of administration; for others, delivery across the skin makes no sense at all. Currently the “rules” that govern (passive) TDD feasibility are clearly understood. In addition to potent pharmacological activity, the transdermal candidate must be “small” of molecular weights not greater than 500 Da and with balanced lipophilicity, logP, ideally around 2 to 3.
The maximum steady state flux across the skin given by Fick´s 1st law of diffusion was predicted for 18 drugs presently approved for TDD. The predicted maximum skin flux was compared with the labeled in vivo delivery rates of the transdermal products on the market. The ratios of the in vivo delivery rates to the predicted maximum fluxes were in the range between 0.01 and 29.


For most transdermal products the ratio was within an order of magnitude of 1, which means that the transdermal systems were formulated to provide maximum thermodynamic driving force for passive diffusion across the skin. For ratios below 1, for example for Nicotine, it is clear that the delivery system itself rate controls delivery to prevent a potentially excessive exposure to the patient. The cases in which the in vivo delivery rates exceed the estimated maximum flux, can more often than not, be attributed to the presence in the patch formulation of skin penetration enhancers. However, the extent of such skin penetration enhancement is limited due to an increased incident of skin irritation. In fact, there is a direct correlation between the efficacy of an enhancer to improve permeation and its inherent ability to elicit irritation.


Nevertheless, assuming that a suitable potent drug candidate has been identified for which a convenient oral dosing regimen proves impossible (e.g., due to high first-pass effect, short biological half-life), then the feasibility of transdermal delivery requires an assessment of the compound`s skin penetrability. Predicting the candidate`s maximum skin flux can be used to evaluate whether this value is sufficient to satisfy the anticipated dose with a reasonable patch size and whether TDD is feasible.

Dr. Sandra Wiedersberg
R&D Project Leader
LTS Lohmann Therapie-Systeme AG
Germany

14:30-14:35
14:35-15:10
stream 1
biologics

 

  • Overcoming the challenges of developing protein formulations and finding solutions to these approaches
  • Exploring different protein formats and formulations 

Senta Voss
Senior Scientist
Merck Serono

stream 2
biologics

 

  • Proteins and peptides play unique roles in human physiology and are thus excellent templates for drug discovery
  • However, endogenously secreted proteins/peptides have many limitations when translated directly into pharmaceuticals
  • Poor half-life, bioavailability, pharmaco-dynamics, chemical and biophysical stability are common parameters that need to be significantly improved in order to transform a protein/peptide into a convenient drug
  • Tailored engineering of GLP-1 will be discussed based on Novo Nordisk case stories

Jesper Lau
VP Protein & Peptide Chemistry
Novo Nordisk
Denmark

stream 3
technology & partnerships

 

  • Formulation design of nano-vectors
  • Commercial process development of biotech products
  • Development and adaptation to pharmaceutical regulation of new manufacturing processes (nanotechnologies, amorphisation, spray drying, freeze drying
  • Identification of critical steps and relevant monitoring to manufacture a product exhibiting the expected quality attribute
  • Implementation of a pharmaceutical engineering tool box that will contribute to the implementation of QBD approach
  • Modelling scale down and scale-up rules
  • Design and set-up/qualification/validation of equipment and pilots aimed at manufacturing nanotechnology-based product

 

Mostafa Nakach
Head of Pharm Eng
Sanofi
France

15:10-15:15
15:15-15:50
stream 1
workshop

Quotient Clinical Logo

  • Integration of formulation development, real time adaptive manufacturing and, clinical testing
  • Acceleration of first in human to proof of concept project timelines
  • Efficient optimisation of drug formulations prior to later stage development
  • Case studies demonstrating achievable time and cost savings

Dr Alyson Connor
Director, Exploratory Clinical Pharmacology
Quotient Clinical Ltd.

stream 2
workshop

 

  • Dissolution testing has been and still is the key technique when developing conventional and/or innovative formulations
  • The ability of this technique to discriminate between products with different Critical Quality Attributes (CQA) is very helpful when using QbD-based development
  • This approach however, can be demanding with regards to the amount of data to be generated. Hence, automation can be a great tool to achieve and overcome such demanding challenges
  • Automation can add value by:
  • Increaseing productivity and reducing cost per analysis
  • Producing large volumes of data within a short timeframe to reduce time-to-market
  • Ensuring greater safety for analysts by reducing the exposure to highly potent drugs
  • The presentation will discuss the various cases, with the related automated solutions and the parameters to be considered

Samir Haddouchi
Managing Director
SPS Pharma Services

stream 3
workshop


  • Inorganic Controlled Release Technology (iCRT) platforms will overcome oral formulation challenges and reduce manufacturing costs
  • Through fundamental control of the process parameters, drug release profiles can be tailored for purpose using iCRT (from minutes to hours from the same material)
  • Control of physical properties can remove obstacles associated with solubility and bioavailability of small molecules, and allows versatility of the final form (powders, tablets, films, etc.)
  • Ease of prototyping and cost-effective manufacture make inorganic carriers an excellent alternative delivery technology for generic and branded products for lifecycle management
  • Partnering with technology companies with the associated know-how to control and define the optimal process for each compound has significant benefits for IP protection – patents are not always sufficient

Dr. Mark Cresswell
Senior Scientist, Healthcare
Lucideon

15:55-16:30
stream 1
small molecules

Case story 1: Fast release of antacid for treatment of heartburn

Case story 2: Modified release of nicotine for smoking cessation

Bruno Provstgaard Nielsen
Senior Principle Scientist
Fertin

stream 2
biologics

 

  • 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

Robert Gurny
Professor
University Geneva
Denmark

stream 3
technology & partnerships

 

  • Striking a balance between what is expected and what the industry/CDMO is willing to support
  • Surviving the regulatory Catch-22 - balancing cost reductions with increasing regulatory demands for more measurements and analysis
  • Better medicines vs. reduced costs - which do we want more?
  • Deploying strategies that satisfy industry, regulatory & consumer demands
  • End of the 'Perfect Therapy' - should society be expected to support an ever-ageing population or is the investment better spent elsewhere?

Tomas Landh
Director
Novo Nordisk
Denmark

16:30-17:30
17:30-18:05
keynote

 

  • Designating clear responsibilities throughout an outsourcing relationship
  • Applying penalties if crucial deadlines are not met
  • Successfully terminating contracts with partners
  • Achieving excellence in supplier management by creating a solid contract

Andrew Lewis
Director
Ipsen
France

Barry Heavey
Head of life Sciences
IDA

Dennis Douroumis
Director of Centre for Innovation in Process Engineering and Research
Greenwich University

18:05-18:15
18:15-19:15

DAY 3, 11 February 2015

08:40-09:10
09:10-09:20
09:20-10:00
keynote

SMALL MOLECULES

  • What methodology should be used in dissolution qualification?
  • Enhancing bioavaliability and increasing manufacturing processes, can both be done?

 

BIOLOGICS

  • A world without injections, changing biologics paradigm
  • Exploring lipid based delivery systems

 

TECHNOLOGY & PARTNERSHIPS

  • Using the latest MJR technology to improve performance

  • Improving delivery systems by using shelf pens and auto injectors


10:00-10:05
10:05-10:40
stream 1
small molecules

 

  • Types of animal studies in human DP development
  • Formulation types vs route of administration
  • Standard vs specialised formulation types
  • Local vs systemic drug delivery - several case studies
  • Challenges in formulation evaluation in early development

Dr Iidiko Terebesi
Head of Early Formulation Development
Bayer

stream 2
biologics

 

  • Unmet needs for novel drug delivery systems to enhance patient care

  • Drug delivery technology opportunities and solutions

  • Alternative routes of delivery and their advantages

Andrew Lewis
Director
Ipsen
France

stream 3
technology & partnerships

 

  • Utilising collaborative relations to ensure long-term agreements and developmental success
  • Different models of outsourcing and external cooperations
  • Analysing the three cornerstones of appropriate partnerships - technology, quality and finance
  • Success factors for outsourcing drug development 

Holger Memmesheimer
Director
Boehringer Ingelheim Pharma
Germany

10:40-11:20
11:20-11:55
stream 1
small molecules

Successfully developing and commercialising combination products, turning problems into solutions

  • Patient requirements from combination products - ease-of-use and organoleptic  requirements
  • Formulation challenges for parenteral combination products
  • Sourcing devices for combination product development
  • Strategies to prevent drug-drug interactions
  • Future prospective and opportunities

Daniel Bar-Shalom
Associate Professor
University of Copenhagen

stream 2
biologics

 

 

  • Expected benefits of oral peptides versus injectable sustained-release formulations
  • Formulating peptides to enhance oral bioavailability
  • Discussing the pros and cons of the oral peptide technologies in regards to:
    •  Stability
    •  Bioavailability
    •  Safety and efficacy
      • Impact on CoGs and manufacturability
      • Case studies: Examining clinical results and models for oral peptides in development
      • Oral pharmacokinetics versus subcutaneous injection
      • What technologies can overcome food effects?

Dr Joël Richard
VP, Peptides
Ipsen
France

11:55-13:30
13:30-14:05
14:05-15:05
keynote

 

  • Understanding how to accelerate regulatory procedures
  • Applying for MA in EU, Lichtenstein, Ireland and Norway can be frustrating and complicated, mostly because of the amount and complexity of the directives and guidelines that are to be followed. There are not only international but also national directives and guidelines that the MA applicants must follow in order to get the MA application validated and approved.
  • All countries in EU/EEA have generally the same approval procedure and the MA application must be valid and accepted in all the relevant countries before the approval procedure starts.
  • Beside of submitting a correct application and documentation, the product must have an approved name in every applicable country in order to avoid delaying an approval.  Other common factors that may delay the approval of a procedure ar: wrong legal basis, lack of a cover letter, Risk Management Plan or Pharmacovigilance system etc.
  • Nowadays, the MA applicants have the opportunity to send an electronic Application Format (eAF), which will become mandatory as of July 2015 for CAPs and will become mandatory for all procedures as from January 2016.

Ornela Ademi
Higher Executive Officer
Norwegian Medicines Agency
Norway

15:05-15:15