The life sciences industry has undergone dramatic changes and effective global collaboration has become a key success factor in this new age. BIOVIA is providing a hosted and comprehensive solution stack for externalized, collaborative research for pharma/biotech and CROs to address these new challenges. Recently we added the support for biologics data management and IP capture. In this talk we will present collaborative and comprehensive capabilities in antibody characterization and development: capabilities to analyze, annotate and predict developability as part of a framework that facilitates secure data sharing and collaboration.
3. Industry Trends
• Number of new drugs
approved per billion US
dollars spent on R&D has
halved roughly every 9 years
since 1950
• Average cost of bringing a
new drug to market: $2.6B*
Nature Reviews Drug Discovery 11, 191-200 (March 2012)
* ‘Cost to Develop and Win Marketing Approval for a New Drug’
Joseph A. DiMasi, director of economic analysis at Tufts CSDD, 2014
5. External Collaboration Challenges
• Internal IT infrastructure not suitable for external projects
• Work is manual and error prone
• Starting up / closing down projects can take months
• Every collaboration is different / not clear where to go
6. ScienceCloud
• A suite of cloud-based integrated apps able to interface with on-prem systems to
support networked scientific workflows for all shapes of external collaborations
A
AA
Transfer,
Translate,
Transform
A
Data
Documents
Context
Integrated Apps
API
Social Mobile Security IntegrationAdmin
Business rules Tech transfer Automation
8. Challenges in Biologics Discovery
Innovation Barriers
• Lack of dedicated tools to:
• process and understand high volume
antibody sequence data, assay data
and cell line data together
• assess developability early in the
process
• rapidly customize workflows
• Integrate, process and report on
data through all phases of the
discovery process
• Lack of real time project tracking and
collaboration with internal and external
partners
• Lack of biologically aware and
integrated:
• registration system
• sample and assay management systems
• ELN and corporate databases
• bioprocess systems
• process optimization systems
• regulatory quality and compliance systems
Process Efficiency Barriers
9. BIOVIA Suite for Antibody R&D
Antibody
R&D
Analysis
Biotherapeutics
Workbench (BTx) Predictive
Analytics
Discovery
Studio
Custom
Workflows
Pipeline Pilot
Entity
Mgmt
Registration
and Sample
Laboratory
Management
ELN & EKB
Process
Knowledge
Discoverant
Innovation
Barriers
Process
Efficiency
Barriers
10. External Collaboration with Biologics
Notebook
Registration
1. Receive biologic (antigen) from
supplier
2. Register biologic
3. Share with external partner
4. Request synthesis of hybridoma
clones
4. Synthesize biologic
5. Document experiment in
ScienceCloud Notebook
6. Send notification to pharma
7. Pick up synthesized clones
8. Merge with assay data
9. Analyze in BTX workbench (annotate cluster)
10. Share and report
BTX
Workbench
22. Wrap Up
• Effective external collaboration is key
success factor
• Biologics functionality has matured and
now available both on-prem and in the
cloud
• ton.vandaelen@3ds.com
23. Contact Info
• Visit us on the web at www.sciencecloud.com
• Find us on LinkedIn:
• Join the ScienceCloud LinkedIn Group: ScienceCloud: Transforming Externalized
Drug Discovery
• Follow the BIOVIA page
• To get in touch with a ScienceCloud team member, please click here
Editor's Notes
I want to start out by stating a fact that I am sure you are well too aware of. the number of new drugs approved per billion dollars spent on R&D has halved roughly every 9 years since 1950. The cost of getting a drug to market is growing the curve here is adjusted for inflation and appears to be the opposite of the graphs we are used to seeing representing Moores law depicting the dramatic increase in the computer processing power,.
Here’s just a quick overview of the Product Life Cycle for Discovery, Dev and manufacturing of biologics,
Informatics needs are highlighted by t the arrows below. Today we are only going to talk about value we add in the biologics discovery space but keep in mind that the whole is much greater than the sum of its parts. and
There are innovation barriers that include a lack of dedicated tools to:
process and understand high volume antibody sequence data
manage high volumes of sequence data, cell line data,
analyse sequence annotation and activity data together
assess developability early in the process
rapidly customize workflows
These barriers slow speed to market and cost organizations 100’S OF Millions of dollars for each year a drug is not on the market $30Mdollars a day (humira)
There are also process efficiency barriers that include:
a lack of real time project tracking and collaboration with various groups involved in the process
a lack of biologically aware and integrated:
Registration, sample management and bioprocess management systems
Lab management ELN’s and corporate dB’s
if you could:
improve scientific insight and decision-making on promotion of biologic candidates
reduce experiments performed, attributable to easy access to modeling and previous experimental data
reduce time spent recording information for bioprocess experiments
save time assembling relevant information for biologics portfolio review
reduce effort required for technology transfer from research to development
optimize bioprocess and manufacturing
and easily maintain and process compliance documents for regulatory agencies.
(This is the elevator pitch)
If you are developing biologics and are faced with barriers to innovation and barriers to process efficiency we have a solution suite that can save you time and reduce cost associated with errors or lack of accessible information early in the process.
The BIOVIA suite for biologics will allow you to:
capture and render all relationships and structural information for novel biologics
manage and mine all experimental, sample, and results data from bioprocess and cell line management processesintegrate predictive modeling, characterization, and assay information for tracking the progress of your biologics portfolio
And facilitate team decision making and collaboration with:
project-level sharing of data, analysis results and reporting
project-tracking dashboards
And cloud and SaaS-based deployment options
Business Issues in externalization:
How can each participant in the project share the data they have generated with the sponsoring company and where appropriate between the partners in real time?
How can each partners IP be tracked and ownership maintained?
How can dynamic collaborations be spun up and down as needed to support a fast changing project landscape?
What do I do when my internal IT systems can’t address these issues?
Accelrys ScienceCloud addresses these issues, will cover in the next few slides. At a high level, ScienceCloud provides a platform for Information exchange, technology transfer, collaborative workspace, and hosted scientific data
Initial vision is a suite of integrated applications which network of RD partners can use for collaborations, to facilitate better sharing and exchange of data and information
This sharing takes place between “Applications” and partners.
Many apps will still reside on prem, so we have capability to link on prem to cloud…internal and external sources are connected
ScienceCloud Project Data is central collaboration core, applications surround it.
This slide is a complete vision- through releases of a variety of applications, Accelrys ScienceCloud helps customers achieve this vision all at once, or a bit at a time.