DAY ONE:
Wednesday 25th Feb 2004Chairman: Steve Ellul, Associate Director, Licensing, Europe, Elan
Identifying a drug delivery portfolio that is applicable to your product portfolio
* What factors need to be overcome to create the optimum delivery system for
the appropriate drug?
* Overcoming today’s dosing problems with existing drug delivery technology
* Keeping up to date with technology in order not to miss opportunities
to improve your product portfolio
* Encouraging innovation and new ideas
* Understanding the need for current drug delivery information to be
available within your organisation
* Developing an accurate internal database of drug delivery
* Today’s market and possible future developments Dr Martin Wikberg (invited)
Head of Oral Controlled Release
AstraZeneca
Balancing drug delivery development time with your product patent life * Successfully structuring your drug development programme
* Avoiding high risk investments at an early stage in development
* Accurate testing of drug delivery devices
* Issues of integration and implementation
* Preparing the market for launch Speaker to be confirmed
Developing drug delivery partnerships for competitive advantage
* What specific challenges face medium-sized companies
* Accessing new capabilities through new partnerships
* The advantages of drug development partnerships
* Can drug delivery partnerships deliver a competitive advantage?
* Drug delivery companies: partners in development Bob Ingram (invited)
Vice Chairman Pharmaceutical Group
GSK
What are the Challenges behind a Shift from Drug Delivery to Speciality Pharmaceuticals ?
Some drug delivery companies are aspiring to move into the speciality pharmaceutical arena. Such a change also alters the business model of the company from one based solely on technology to one that partners a proprietary drug with the development and marketing expertise of a larger biopharmaceutical company: * Effects of changing models on financing activity, cash flow and productivity
* Expansion of pipeline development
* Preparing a product for the market place
* Life cycle development
* Partnering challenges
* Establishing fair royalties Alejandro Donoso (invited)
Director Technology Licensing and Alliances
Aventis Pharma
L-Oros Technology, an Approach to increasing the Bioavailability of Water Insoluble Drugs
40 percent of potential drug products suffer from poor solubility, therefore solubility enhancing technologies are key in drug delivery * L-Oros Technology- an overview
* Poor water solubility a problem or opportunity for new drugs?
* How L-Oros technology can be used in discovery to increase the number of product opportunities
* The future of L-Oros Drug Delivery Patrick Wong (confirmed)
Vice President, Advanced Drug Delivery
Alza Corporation
Future of Metered Dose Inhalers - CFC Free Market
A future ban on the use of CFC-propellants for medical use exist. With inhaler technology, developing non-CFC propellants is the future of the market. Hydrofluoroalkanes (HFA) compounds have emerged as the only propellants suitable for pharmaceutical use. To help facilitate the transition from CFC-containing products, 3M has introduced the world’s first CFC-free MDI * Studies showing stability of protein and peptide formulation
in HFA propellant systems
* delivery performance
* compatibility with container-closure systems
* potential for the delivery of proteins via metered dose inhaler technology Dr. Robert Clayborough (confirmed)
3M Drug Delivery Systems
Injectable drug delivery of proteins and peptides- Nektar Advanced PEGylation and PEG-based delivery systems
* How Pegylation optimises the performance of licensee’s products (Get a case study of a time when using PEGylation technology decreased the
time it took to market a certain drug) or Nektar is providing pegylation
technology for Pharmacia’s investigational new therapy CDP870,
which has completed Phase II clinical testing for the treatment of rheumatoid arthritis. Dr. Michael Roberts (confirmed)
Director, Business Development
Nektar Therapeutics
Close of DAY ONE
DAY TWO
Thursday 26th Feb 2004
The Potential of Monoclonal Antibodies: Zenapax by Roche
The market for using monoclonal antibodies in the delivery of drugs will increase by 322% during 2002-2007. Various monoclonal antibody therapies are either in development or have been introduced to the market as a treatment for cancer. * Zenapax and monoclonal antibody involvement and results Dr. Malick (invited)
Head of Formulations
Roche
Case Study: Zevalin, Targeting Cancer Treatment
* Explaining the Breakthrough of Zevalin
* The difficulties and benefits of combining a monoclonal antibody with a radioisotope
* Scientific preparation and therapeutic results
* Analysis of the efficacy of Zevalin and the degree
to which it is able to target cancer cells more effectively Joachim Kalmus (confirmed)
Clinical Development Oncology
Schering AG
Delivery of Macromolecules - Oral Heparin for Niche Indications
Research efforts in the field of genomics are expected to accelerate the discovery of new therapeutic biomolecules, placing an increased demand on the delivery systems for these drugs. Microparticulate systems have provided an interesting approach for delivery of macromolecules. * Difficulties of delivering macromolecules via oral route
* Approaches to circumvent the barriers to oral delivery: bioadhesive delivery systems, penetration enhancers, site-specific delivery to sites within the gastrointestinal tract that have less proteolytic activity, protease inhibitors and hydrogels
* Emisphere's eligen™ oral drug delivery technology
* Results of Phase III PROTECT study Robert Baughman (confirmed)
Managing Director, Corporate Strategy
Emisphere Technologies
Case Study: Oral Insulin in collaboration with GSK
* Results and conclusions from Phase I and II studies
* Medical benefits
* Problems which require to be overcome
* Lessons for the future Dr. Christopher Price (confirmed)
President and CEO
Nobex
Alternative Insulin Delivery System: Altea’s PassPort™ system
The PassPort System uses a novel technology designed for
non-invasive or short or long-term delivery of peptides/proteins
or small molecule drugs via the skin. The system combines a wafer thin
array of filaments with a patch containing the drug. One-step activation
rapidly and painlessly flashes minute amounts of energy into the surface
layer of the skin. The process creates tiny aqueous channels, or micropores,
in the skin surface, enabling entry of therapeutic substances such as insulin,
previously unable to move efficiently across the skin with
conventional transdermal technologies. * Innovative, non-invasive system for insulin
* Clinical and Preclinical Results
* Potential opportunities of treatment with the PassPort System Stefan Arver (confirmed)
Vice President, Europe
Altea Therapeutics
Improvements in Potency and Efficacy after combining GSK’s Hycamtin with INEX’s Transmembrane Carrier System
INEX entered into an agreement with GlaxoSmithKline (GSK) to develop Topotecan TCS which combines GSK's proprietary camptothecin compound topotecan hydrochloride (marketed as Hycamtin®), with INEX's drug delivery technology. * Introducing the technology behind the oral version of Hycamtin
encapsulated inside INEX’s second generation liposomal delivery technology
* Practical uses of the targeted chemotherapy platform, combining already approved conventional cancer chemotherapeutics with Transmembrane Carrier System shown in pre-clinical studies to increase the effectiveness of the drug while reducing toxicity in healthy non-targeted tissues
* Demonstrating the INEX Targeted immunotherapy platform, based on novel oligonucleotides
* Presenting data to support the extent of improvement in potency and efficacy when TCS technologies are combined with campothecin drugs Tom Madden (confirmed)
Senior Director, Technology, Development & Licensing
INEX Pharmaceuticals
Biodegradable Implants- the ATRIGEL® drug delivery system
* Advantages to using the ATRIGEL® system
* Products
* Strategic alliances with the use of ATRIGEL®
* Biodegradable Implants and their future Richard Dunn (invited)
Senior VP, Drug Delivery Research
Atrix Laboratories
Paediatric and Geriatric Drug Delivery
* Paediatric and Geriatric Formulation Methods and Issues
* Desirable Characteristics of an Oral Suspension
* Complicated treatment Paradigms
* Industry Challenges for Paediatric and Geriatric drug delivery
* Promising compounds utilising novel methods of delivery Hing Kin Chan (confirmed)
European Director of Business Development
Eurand
Anti-Cancer Agents and Alternative Delivery Methods
Progress in cancer therapies needs not only better and more efficacious
active drug substances but also powerful delivery systems able to circumvent
physiological barriers and to allow the targeted delivery of potent drugs
specifically at the tumour sites. This improves the quality of therapy and
limits side effects that are frequently severe for chemotherapeutic agents * Which products and delivery technologies are currently in development for oncology
* Targeting to tumours by means of drug delivery systems
* Focus on oral and subcutaneous methods of delivery
* Unique opportunities and new research areas for oncological delivery systems Alessandro Martini (confirmed)
Director, New Drug Delivery Systems
Pharmacia
Live, Genetically Modified Bacterial Drug Delivery ?
Inflammatory bowel disease is a chronic condition of the intestine
requiring lifelong treatment. In mice and pigs, the anti-inflammatory
cytokine interleukin-10 (IL-10) has been shown to be effective in treating entercolitis,
which mimics human IBD. Successful delivery of IL-10 to the intestine using
in situ expression from genetically modified Lactococcus lactis has been achieved,
since the compound cannot be delivered orally. This method of bacterial drug delivery has recently been approved as an experimental therapy for use in clinical trials on
humans with IBD- the first clinical trial to use live genetically modified bacteria Dr. Lothar Steidler (confirmed)
Scientist
Ghent University, Belgium
Bioinformatics: The Next Step in Formulation and Design of Novel Drug Delivery Systems
In the future, not only will we have software that could accurately predict
the optimum formulation for a specific compound, but simulate its behaviour
in man before the chemist even touches the bench. Ultimately, custom formulations
for drugs using a pharmacogenomics approach will result in software-driven “designer formulations”. These pre-optimised formulations that best suit patients given
their specific genetic makeup can be based on a specific aberration relative
to a specific gene, gene pool and history. New informatics drug delivery
approaches will result in the elimination of costly and embarrassing mistakes,
duplicate work, even while most promising formulation leads are identified stored
and managed in a library format to be called upon at any time. * Current efforts in utilizing bioinformatics in novel drug delivery
* The growing importance of simulation software
* Practical realities that will help the industry proceed to the next level Hugh Donovan (invited)
Global Head, Data Management
Roche
Polymers for drug delivery - Biodegradable colloidal drug delivery systems Biodegradable drug delivery systems which can be metabolised upon the completion
of drug delivery have reached the market in increasing numbers in recent years.
Colloidal system formulated using the solvent evaporation method is assessed. Paul Burke (confirmed)
Associate Director, Pharmaceutics and Drug Delivery
Amgen Inc
ALZA: Drug Delivery and Drug Targeting Challenges
* The broader approaches
* Vision
* Delivery
* Targeting concepts to develop new medicines Dr. Michael Silber (confirmed)
Vice President of Research and Technology Development
Alza Corporation
The Regulatory Challenges Surrounding New Drug Delivery Approaches
The industry must develop its regulatory strategy when seeking approval
for products that employ an innovative or unique delivery technology.
Under the current regulatory regime, companies with a combination product
can seek a Request for Designation (RFD) for a product based upon its primary mode of action. This often entails not only a regulatory assessment but also a competitive assessment.
How can companies play to their strengths and erect lawful and appropriate barriers to market entry for others? * When the FDA’s RFD system is worthwhile to pursue
* Making a product designation beneficial to your company
* Defining testing and approval standards to the advantage of your company
* Making establishing bioequivalence more difficult for branded and generic products
* Knowing and characterising the limitations of a drug delivery technology so FDA is aware
of them in subsequent product approvals
* Using a new drug delivery technology to get as close as possible to products currently marketed
can benefit from market share, yet still have some significant points of differentiation Dr. Claude Nicaise (confirmed)
Vice President of Regulatory Science
Bristol-Myers Squibb
Close of Conference
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