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  • small moleculess
  • biologics
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DAY 1, 9 February 2015

12:30-13:20
13:20-13:30

Chair's welcome address


13:30-14:05
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

Anand Subramony
VP
Medimmune
US

14:05-14:10
14:10-14:45
stream 1
small molecules


stream 2
biologics

 

  • 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 utilization.
  • 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 (color, turbidity, and particles), viscosity and pH.

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

14:45-14:50
14:50-15:35
15:35-15:55
15:55-16:30
stream 1
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.

 

 

 


16:30-16:35
16:35-17:10
stream 1
small molecules


stream 2
biologics


stream 3
technology


17:10-17:15
17:15-17:50
17:50-17:55
17:55-18:30
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

18:30-18:40

Chair's closing remarks


DAY 2, 10 February 2015

08:00-08:50
08:50-08:55
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

Rustam Ixanov
VP
Akrikhin
Russia

09:40-09:45
09:45-10:20
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

Image result for Norwegian medicine agency logo

  • 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?

Ornela Ademi
Excutive Officer
Norwegian Medicines Agency
Norway

10:20-10:25
10:25-11:00
stream 1
small molecules


stream 2
biologics

Quotient Clinical Logo


11:00-11:05
11:05-11:50
11:50-12:10
12:10-12:45
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

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

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

12:45-12:50
12:50-13:25
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
technology


stream 4
partnerships


13:25-14:25
14:25-15:00
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

Patrick Berna
Chief Development Officer
Trophos
France

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

Andrew Lewis
Director
Ipsen

15:00-15:05
15:05-15:40

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

 


15:40-16:15
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

Uri Herzberg
Senior Director, Preclinical and Translational Development
Celgene

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

Robert Gury
Professor
University Geneva
Denamark

16:15-16:20
16:20-17:05
17:05-17:25
17:25-18:00
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


18:00-18:05
18:05-18:40
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. 


18:40-18:50

Chair's closing remarks


DAY 3, 11 February 2015

08:50-09:00
09:00-09:35
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


09:35-09:40
10:10-10:45
10:45-11:05
11:05-11:50
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

Philippe Rogueda
Monash University
Adjunct Senior Lecturer
UK

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

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

Jaya Abraham
Head Formulation Development
Torrent Pharma
India

12:25-13:35
13:35-14:00
stream 3
technology

Striking a balance between what is expected and what the industry/consumer is willing to support


stream 4
partnerships

Selecting financially stable partners by using sophisticated R&D models


14:00-14:05
14:05-14:40
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

14:40-15:15
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

15:15-15:25