Venue: BSG Conference Centre, London, UK
Background Info
Key Speakers
Laurent Pinchard, Director EU Operations (API), Glenmark Generics
Rebecca Vangenechten, Consultant - Business and Project Development Life Sciences USA, Siemens
Paul Smith, Validation Program Manager (Europe), PerkinElmer
Sanjit Lamba, President, Eisai India
Nick Hutchinson, Technology Transfer Lead, Lonza Biologics
Maarten van Geffen, Senior Director CM&C, Movetis
Tarek Abdel-Gawad, Production Manager, Avecia Biologics
The recent surge in contract manufacturing landscape is influencing huge challenges and opportunities in the global pharmaceutical market. The highly competitive nature of the industry has been driving pharma and biotech companies to set up off-shoring alliances with emerging markets to minimise costs and maximise profits. The revenue for world contract manufacturing business in 2007 was approximately $30bn, with a growth rate of 6% from 2006. The revenues are expected to reach $48bn by 2015.
3rd Annual Contract Manufacturing conference will examine the current and emerging trends that are mobilising contract manufacturing companies, and shifting the focus from the west to east. This conference will address various quality, regulatory and development challenges to establish cost-effective and successful outsourcing alliances. As the global outsourcing landscape is changing, this conference will unleash opportunities to sustain a robust growth in the current economy.
Why Attend?
By attending this conference you will gain knowledge on:
How the globalisation of the contract manufacturing market is shifting focus from the west to east
Outsourced laboratory compliance and qualification services
Using PAT to accomplish real time release/continuous manufacturing
New shifts: from API to FDF, from generic drugs to R&D based companies
How to think globally and outsource locally
CMO's and SME's: the route to success of a virtual specialty pharmaceutical company
Designing major pharmaceutical drug dosage forms
Biostorage A critical and strategic component of the worldwide drug development process
Screening process to identify a suitable outsourcing partner
Embracing Quality by Design (QbD)
How to administer packaging engineering and design
Target Audience:
Pharmaceutical and Biotechnological Companies
Contract Manufacturing Organisations (CMOs)
Drug Regulators, Intellectual Property/Law Firms
Academia, Government Bodies, Regulatory Affairs
Who should attend?
VP, Directors, Managers, Team Leaders, Senior Scientists in:
CMC
Contract Management
R & D
Contracts & Outsourcing
Biologics
Operations
API and Technical Development
Strategic Alliances
Formulations Development
Planning & Logistics
Drug dosage form
Procurement & Purchasing
QbD/PAT
Business Process Excellence
Pharmaceutical Science & Process Development
Sales & Marketing
Bioprocess Research
Regulatory Affairs / Compliance
Manufacturing Science and Technology
Quality Assurance
Workshop
Pre-Conference Interactive Workshop, Monday 16th November 2009
Outsourcing early stage development activities
Led by: Dr. Rod Baker
Managing Director
Bioedge Pharma Consultancy
Timings: 09:30 - 10:00 Coffee & Registration
10:00 - 17:00 Workshop
Timing includes lunch and refreshment breaks
About the workshop:
Many companies, especially start ups, have no choice for outsourcing early stage development activities as they have no internal manufacturing capabilities. In addition, such companies are unlikely to have staff experienced in selecting and managing outsourced activities. As manufacturing and other early stage development activities are key to success for any project and time to first in man studies it is essential to select the right contractor and avoid the many pitfalls with outsourcing.
Furthermore, larger companies are tending to outsource more early stage development activities and this may be an activity that is not familiar to the internal staff involved.
The course will highlight the many factors that should be taken into account prior to selection of a contractor and how best to manage them once the work has commenced.
Workshop agenda:
Overview
Industry trends in outsourcing
Growth of service offerings by contractors
What can be outsourced and when
How to select a contractor
Defining your needs
Writing a request for proposal
Identifying suitable contractors
The one-stop shop integrated approach vs horses for courses
Short listing possible contractors
Final selection
Contract negotiation and other documentation
Main contract
Technical agreement
Quality agreement
Documentation generated during the contracted work
Final reports
Management of contractors
Internal systems for outsourcing
Who should manage the contractor
How to manage
Completion and review
Building a database of contractors
Case studies
Some real examples of outsourced work and arising problems
Please bring along your own examples
About your workshop leader:
Dr Rod Baker
Dr Rod Baker is a highly experienced drug development manager with specialist knowledge in CMC. In 2008, he founded Bioedge Pharma Consultancy Limited, a company offering drug development services to the biotech, pharmaceutical and drug delivery industries. Bioedge works with a wide range of companies at all stages of development and one key aspect of the services offered is reviewing, selecting and managing contractors for clients. Rod is a physical chemist by training and has over thirty years industrial experience working for a wide range of companies across different industries including agrochemicals, animal health and human healthcare. In the latter field, he worked for Stiefel Laboratories as Pharmaceutical Formulation Manager, British Biotech as Head of Pharmaceutical Technology, Avidex Limited as Head of Development & Director of Operations. Prior to forming Bioedge, he was the Vice President of Development & Operations for MediGene Limited with responsibilities including outsourcing as well as in-house work in the CMC area.
For further information, please visit: www.bioedge.co.uk
Who should attend?
The workshop is designed for the professionals involved in or responsible for the outsourcing of development activities, in particular, manufacturing although the review and decision making process for contactor selection applies to many different areas of development. Whether you are new to outsourcing, have limited experience or are already well versed with the outsourcing process, the workshop will have something to offer you.
This one-day workshop is aimed at providing valuable insights to outsourcing across disciplines for individuals from pharmaceutical, biotech, drug delivery and venture capitalist companies having responsibilities in manufacturing, API characterisation, salt screening, pre-formulation and formulation, analytical, toxicology, clinical development, quality assurance, regulatory affairs, operations and project management.
Day 1
Day One, Tuesday 17th November, 2009
09:30 Registration and refreshments
10:00 Opening address from the chair
Tim Cummins
President
International Association for Contract and Commercial Management (IACCM)
10:10 Globalisation of the contract manufacturing market - a shift from the west to east
Analysing key trends in the global PCM industry
Which regions and segments offer the greatest growth opportunities?
The competitive edge of emerging markets over USA and EU
Sanjit Lamba
President
Eisai (India)
10:50 Outsourcing APIs (advanced pharmaceutical ingredients = active substance) to India: a cheaper way?
Producing in India: cost, IP, manufacturing experience. Forever green?
Some consequences on the current market evolution: consolidations, new patent laws in India, decreasing number of NCEs
New shifts: from API to FDF, from generic drugs to R&D based companies
Laurent Pinchard
Director EU Operations (API)
Glenmark Generics
11:30 Morning refreshments
11:50 To outsource or not - Is it a solution for you?
Making the decision to outsource pros and cons
Screening process to identify a suitable outsourcing partner
Set of selection criteria is required to evaluate potential suppliers
Steps to ensure provision of the deliverables
Debra Nevin
Global CMC and QA Director
Plethora Solutions
12:30 EU Requirements for outsourced services (a QPs perspective)
Legal and regulatory considerations for outsourced manufacture
Importance of EU GMP
API vs. medicinal product
Issues specific to biologics and ATMPs
Bruce Vernon
Director
VYVO BioSolutions
13:10 Networking lunch
14:30 CMOs and SMEs: the route to success of a virtual specialty pharmaceutical company
What is the concept of a virtual pharmaceutical company
How to outsource all CM&C activities: dos and donts
Success drivers of a small company vs. established big pharma
How to relate with your CMO partners and how not?
Maarten van Geffen
Senior Director CM&C
Movetis
15:10 Managing the risk of contamination - A proactive approach
Rapid Hydrogen Peroxide vapour decontamination: science, efficacy and process validation
A proactive approach to Biodecontamination00
Case study: Emergency remedial decontamination of a site: impact on process, methodology and outcomes
Dr Richard Lucas
Biopharmaceutical Process Specialist
Bioquell UK
15:30 Afternoon refreshments
15:50 Integration of disposable technologies into process development and clinical trial production
Use of disposables in the CMO environment
The journey from development to clinical manufacture
Novel solutions to novel problems
Regulatory perspective for disposables
Future directions for disposables
Daniel Smith
Commercial Scientific Development Manager
Cobra Biomanufacturing
16:40 Manufacturing the impossible: From fundamental research to the patient
Research: containment, animal Models, biosafety, emerging infectious diseases
PAT: Eukaryote & prokaryote
cGMP Production: Therapeutic products of prokaryote fermentation
Mitch Rogers
Business Development Manager, Centre for Emergency Preparedness and Response
Health Protection Agency
17:20 Closing remarks from the chair
17:30 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting
Day 2
Day Two, Wednesday 18th November, 2009
09:30 Registration and refreshments
10:00 Opening address from the chair
Tim Cummins
President
International Association for Contract and Commercial Management (IACCM)
10:10 CMOs: A robust growth trend
What are the key indicators for the growth of CMO business
Understanding the current market trends and leveraging benefits from it
What are the commercial implications of increasing globalisation of the API contract manufacturing market
Shiva Khalafpour
Vice President, Europe - Business Development
CMC Biologics
10:50 Challenges of outsourcing biopharmaceutical manufacturing
Unique features of biopharmaceuticals
Manufacturing Strategy in-house or outsource?
Biopharmaceutical manufacturing capacity constraints
Emerging opportunities
Regulatory considerations
Steve Musgrave
Executive Director and co-founder
Unicorn Biologics
11:30 Morning refreshments
11:50 Embracing Quality by Design (QbD)
Learn on how the FDA is promoting QbD
Implementing to strengthen the contractor/client relationship
How to implement Quality by Design to differentiate contractors from competitors
Using PAT to accomplish real time release/continuous manufacturing
Rebecca Vangenechten
Consultant - Business & Project Development Life Sciences, USA
Siemens Industry & Automation
12:30 Outsourced laboratory compliance and qualification services
Benefits and advantages of harmonised services
Meeting regulatory requirements
Balancing risk and costs through flexibility
Supporting technology transfer and audits
A catalyst for change and continuous improvements
Provisions
Paul Smith
Validation Program Manager (Europe)
PerkinElmer Life and Analytical Sciences
13:10 Networking lunch
14:10 How to optimise the integration of process development and manufacturing into the biopharmaceuticals development value chain
Integration of the value chains for drug development and biopharmaceuticals production
Value of early data acquisition
Development of scalable and affordable manufacturing processes
Case studies
Dr. Philipp Gφpel
Business Development Manager
Richter-Helm BioTec
14:30 Technology transfer is simple in theory, but difficult in practice
Understanding different types of transfers
Formalising the technology transfer procedure
Allowing scope for future continuous improvements
Nick Hutchinson
Technology Transfer Lead
Lonza Biologics
15:10 Contract packaging is not just boxes
Choosing the right CMO
Considerations of pack design/process & reproducibility
Regulatory considerations current and future
Ease of use in the market/patient compliance
David Downey
VP, Commercial Operations
Almac Pharma Services
15:50 Afternoon refreshments
16:10 Leveraging profits through outsourcing in the current economic times
How to achieve sustained communication and address demand and supply issues to your overseas CMO?
Understanding the influence of global regulatory culture on establishing outsourcing projects
Indentifying lucrative opportunities and establishing strategic alliances in emerging markets to minimise costs
Panel members will be drawn from the speakers who take part on day one or day two. If you would like to submit a question to the panel, please email it to: info@bharatbook.com
Panelist: Michelle Scott, Executive Director and co-founder, Unicorn Biologics
16:50 Fitting processes to plant: Balancing flexibility and experience
Understanding the key manufacturing factors for process design
Leveraging plant knowledge for efficient manufacture
Converting learning into continuous improvement
Tarek Abdel-Gawad
Production Manager
Avecia Biologics
17:30 Chairs closing remarks
17:40 End of conference
