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  • small moleculess
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FOCUS DAY, 9 February 2015

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

Chair's welcome address


13:00-13:35
keynote

 Retuning R&D strategies to address: generic competition, challenging molecules coming through discovery and continual pressure of producing cost effective drugs

  • Analysing how the current  M&A have affected investment in the R&D sector and predicting future M&A trends to stay ahead in an uncertain climate
  • Investigating in emerging areas such as: oncology delivery systems, implantable drug delivery devices, implanted  wafers and nanoparticles
  •  Identifying a concrete strategy for supergenerics and the role they have in the future of the pharmaceutical market


14:10-14:50
stream 1
small molecules


stream 2
biologics

 

Highly Automated Procedures for the Assessment of Protein Formulations

  • By automating preparation, screening, and stability studies of drug formulations, companies can expand their productivity by increasing throughput without the need of additional resources.
  • Applications of the Biologics Formulation System (BFS) for formulation screening and stability studies of protein drug products were evaluated.
  • The BFS prepared all formulations and then measured their viscosity, color, visible particles, turbidity, protein concentration, protein aggregation, and protein purity.
  • Formulations were subjected to stresses (heat, shaking, and freeze-thaw) both on and off the BFS. Post stress, formulations were analyzed to qualify their performance.
  • By applying automation, an estimated 4x-6x reduction in scientist time was realized as compared to performing the study manually


14:50-15:10
15:10-16:00
16:00-16:35
stream 3
small molecules


stream 2
biologics

How glass-forming polymers improve bioavailability?


stream 3
technology

 

Adequate protection system for moisture sensitive formulations

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

 

 

 


16:35-17:10
stream 1
small molecules


stream 2
biologics


stream 3
technology

17:10-17:45
stream 1
small molecules

stream 2
biologics

workshop 3
technology

17:45-18:00
keynote

Successfully applying QbD to: DOE, PAT and design space for both macromolecules and APIs

  • Carefully defining crucial factors such as CQAs and CPP and applying it for statistical analysis for DoE and PAT
  • Investing in the right resources and tools for design spaces to minimise risk behind implementing QbD
  • Improving the processes by establishing a good dialogue with regulators from the onset and implementing the ICH guidelines (Q7-Q10)

 

James Sutter
Lead Downstream
Merck Serono

18:00-18:10

Chair's closing remarks


DAY 1, 10 February 2015

07:50-08:30
08:55-09:05

Chair's welcome address


09:05-09:40
keynote

Forecasting the impact of the growing market of supergenerics and biosimilars

  • Recognising opportunities available in the development of generics by gaps in the market in the delivery of oncology and CNS treatments
  • Carefully analysing patient requirements, IP, qualifications of generics and regulatory environment
  • Weighing both opportunities and challenges of generic markets and looking into the future implications of investing in generics


09:40-10:15
stream 1
small molecules

Using mini pump systems to improve the success rates of oral modified release dosage forms

  • Successfully monitoring temperature, pH and pre-determined drug release in in-vivo compounds by using real-time monitoring and using Intellicap technology
  • Applying orally swallowable technology by looking into Intellicap technology
  • Overcoming the challenges of colonic absorption by investing time to develop a modified release formulation
  • Exploring the different  types of molecules coming from different routes of administration 

Claudia Stark
Vice President
Bayer
Germany

stream 2
biologics

Ensuring Bioequivalence in Generic Drug Development to support INDs, NDAs and ANDAs

 

  • Designing the appropriate bioequivalence study/model
  • Achieving data validation for regulatory approval and compliance
  • Understanding the needs of bioequivalence study for specific delivery systems

Mike Hrystsak
Head of Formulation
Regeneron
US

stream 3
technology

Applying nanotechnology to enhance IV drug delivery

  • Understanding the technology and its implications on oncological product formulation and delivery
  • The Facts and figures - presenting data to prove the beneficial physical properties & behaviours of therapies in vivo
  • Making unfavourable drugs amorphous to enhance bioavailability & solubility profiles
  • What are the advantages of this technology to existing drug products? Is there a clear ROI?

Mostafa Nakach
Head of Pharm Eng
Sanofi
France

stream 4
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?


10:15-10:50
10:50-11:10
11:10-12:00
12:00-12:35
stream 1
small molecules

Successfully delivering poorly soluble compounds by taking advantage of the thermodynamic properties of NCE 

  • Using the optimal precipitation inhibitor and solubablisers for commercial products
  • Drastically improving  solubility of systematics, dispersals oral forms to reduce the challenges  amorphous states
  • Investing in solid dispersal hydrogens HME interactions to increase stability


stream 3
technology

Best practices in formulating SIRNA therapeutics

  • Selecting the appropriate target: Technological challenges and how to overcome them
  • Applying siRNA technology to targets
  • Effectively choosing the most appropriate API
  • Reducing antagonistic mechanisms to the repair process
  • Formulating siRNA therapies with nanoparticles to enhance delivery
  • In vitro and in vivo data collection and findings

Matthias Wacker
Professor
Institute of Pharmaceutical Technology
Germany

stream 4
partnerships

Utilising collaborative relations to ensure long-term agreements and developmental Success

  • Promoting cultural relations in evolving external partnerships
  • Limiting barriers to collaboration by communicating with one voice
  • Prioritising an open and transparent framework in cementing relations and building trust
  • Analysing the three tiers of an appropriate partner - Technologies, quality and finances

Holger Memmesheimer
Director
Boehringer Ingelheim Pharma
Germany

12:35-13:10
stream 1

Using the power of automation to improve repeatability, data quality and knowledge retention

                                           

 

 

An introduction to automation followed by case studies in:

  • Hot melt extrusion
  • Lipotropic nanoparticle dispersions
  • Polymorph and salt screening.
  • SMEDDs


stream 2
biologics


stream 3

stream 4

13:10-14:10
14:10-14:35
stream 1
small molecules

Investing in the appropriate tools, resources and technologies to develop novel treatments for oncology

  • Using nanotechnology as an implantable drug delivery device to release chemotherapy in both a controlled and a timely manner
  • Understanding how dime-sized polymer wafers can be used to treat malignant brain tumours
  • Understanding how to deliver the API to the target site of tumours to minimise systemic toxicity 

Dr Andrea Hanfeld
Head of Delivery
Merck

stream 2
biologics

Sourcing new biological principles and targets for continued development

  • Evaluating disease areas and targets that are yet to be addressed
  • Characterising the biochemical & biophysical properties of the target
  • Addressing stability challenges with buffers and/or bulking agents

Jesper Lau
VP Protein & Peptide Chemistry
Novo Nordisk
Denmark

stream 3
technology

Utilising Statistics, IT Systems and novel models to determine PK profiles early in development

  • Enhancing statistical testing to determine whether a compound has the desired features for market and to gather data for regulatory approval
  • Implementing software IT systems to help streamline the development process and reduce wasted time and cost
  • Traditional models vs novel simulations - benefits and challenges


stream 4
partnerships

Understanding the latest risk management advances

  • Keeping up to date with risk management concepts about product quality
  • Overcoming the most significant outsourcing risk hurdles
  • Creating a risk management programme to encourage innovation


14:35-17:10

We will invite 6 leading companies who will bring an innovative technology


15:10-15:45
stream 1
small molecules

Maximising compound success by using tools to predict solubility, in-vitro correlation and analytical methods

  • Enhancing current formulation projects by exploring novel technologies coming to market and the implications it has on poorly soluble drugs
  • Overcoming the challenges that forecasting technologies and emerging approaches can present
  • Efficiently overcoming the barriers of bioavailability and solubility by exploring past case studies and looking into amorphous, in-vitro and analytical methodologies

 

Pol Adriaansen
Head of Formulation
Crucell
Netherlands

stream 2
biologics

Attempting to Standardise a Highly Variable Process

  • What are the current practices in launching development of a novel biologic?
  • Establishing more in-depth characterisation tools
  • Identifying the appropriate cell line to maximise molecule yield
  • Overcoming the additional challenges of working with a vaccine


stream 3
technology

Successfully developing and commercialising combination products

  • Patient requirements from combination products - ease-of-use and aesthetic requirements
  • Formulation challenges for parenteral combination products - concentration and stability issues in liquid formulations
  • Sourcing devices for combination product development

Claus Selch Larsen
Professor
University of Copenhagen
Denmark

stream 4
partnerships

Sourcing a partner based on the needs of your company, your existing CDMO  

  • Negotiating a win-win arrangement and drafting appropriate legal & IP contracts
  • Ensuring efficient data and technology transfers to third parties
  • Collaborating to ensure maintained quality, productivity and efficiency


15:45-16:00
16:00-17:00
17:00-17:30
keynote

Identifying the major cost drivers from clinical trials to commercialisation

  • Adapting to a volatile and changing market by implementing a flexible strategy to adhere to a changing market
  • Working with the right CDMOS and meeting the demands of patients
  • Successfully reducing cost of cycles by using forecasting models


17:30-18:00
showcase

We will invite 5 leading companies who have recently developed new delivery technologies.

Theme: New technologies improving development processes 

This session brings you five of the newest and best innovations addressing your technical needs, as voted by our advisory board (pharm / biopharm representatives). At the end of session you have the opportunity to cast your vote and choose who you think is ahead of the pack. 


18:00-18:10

Chair's closing remarks


DAY 2, 11 February 2015

08:20-08:30
09:35-10:10
keynote

Regulators point of view on the current challenges and opportunities that pharma companies are facing

  • Keeping abreast of paediatric and geriatric drug delivery requirements and incorporating it to investigation plans
  • Breaking down EUs regulations on the different stages, early, late and clinical development and understanding the impact it has on the market
  • Implementing a water tight investigation plan by carefully analysing quality, safety and efficacy


10:10-10:45
stream 1

stream 2

stream 3

stream 4

10:45-11:00
11:00-11:50
11:50-12:25
stream 1
small molecules

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


stream 2
biologics

Moving away from the model of design space development for specific formulations

  • Presenting analytical method validation data covering formulation extremes, and thus any formulation structure, to the regulator
  • Applying Qb8 principles to method validation to reduce cost and time wastage
  • Ensuring all applications are well-defined to reduce late-stage hurdles

Dr Joël Richard
VP, Peptides
Ipsen
France

stream 4
partnerships

Protecting a company's reputation by managing responsible partnerships

  • Meeting the demands of patients at an appropriate time and protecting a company's reputation
  • Successfully meeting important campaign dates with CDMO providers
  • Having the right forecast model in order to meet demands


12:25-13:35
13:35-14:00
stream 1
small molecules

stream 2
biologics

stream 3
technology

stream 4
partnerships

14:00-14:35
keynote

Parenteral delivery of poorly soluble drugs

  • Characterising the parenteral solubilisation challenge
  • Finding the right platform for highly concentrated formulations
  • Relating drug substance properties and technology platform
  • Nanomedicine as an advanced technology option

 

Dr. Stefan Proniuk
VP, Product Development
Arno Therapeutics
USA

14:35-15:10
keynote

Supporting all levels of the organisation during a lean transformation

  • Best practices in implementing and sustaining vital cultural change
  • Incorporating existing core principles and systems with lean values and culture
  • Determining key challenges areas and resolving them efficiently

Dr. Petra Wicklandt
Vice President Global Chemical & Pharmaceutical Development
Merck Serono
Germany

15:10-15:20