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A SERVICE
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Getting Your Drug through Phase I Early Development Effectively
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| Date: |
Thursday, June 21, 2012
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| Time: |
11:30 AM-6:00 PM |
| Location: |
Chilford Hall
Balsham Road, Linton, Cambridge CB21 4LE |
| RSVP: |
events@patheon.com |
| Cost: |
Free |
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Our team of expert pharmaceutical scientists is pleased to invite you to a complimentary seminar titled Getting Your Drug Through Phase I Early Development Effectively. The seminar will be held on Thursday, June 21st at Chilford Hall in Cambridge, UK.
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| About This Seminar |
In this half-day seminar, four scientific leaders will share their experiences and answer questions on strategies for effectively progressing a drug through early drug development. Through case studies and interactive presentations, they will discuss early stages of API development, challenges of low solubility and formulation, formulation strategies and regulatory considerations to improve the preparations for your clinical studies.
Our panelists will answer your drug development questions through interactive Q&A sessions after each presentation, as well as during a networking lunch and evening reception.
As the global leader in Pharmaceutical Development Services, Patheon is committed to providing effective science-based learning opportunities for local scientific professionals.
Seating is limited. Please RSVP as soon as possible.
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| Agenda |
| Time |
Schedule |
| 11:30 AM-12:15 PM |
Registration & Lunch |
| 12:15-12:30 PM |
Opening Remarks |
| 12:30-1:30 PM |
Anatomy of a Typical API Project, Dr. Paul Madeley, Synth-Isis Ltd. |
| 1:30-2:30 PM |
Formulation Strategies for Early Development,
Dr. Robin Platt, Patheon |
| 2:30-2:45 PM |
Break |
| 2:45-3:45 PM |
Solubility and Bioavailability Enhancement for Poorly Soluble Drugs,
Rick Bastin, M.Sc., MBA, Patheon |
| 3:45-4:45 PM |
Regulatory Considerations for Early Phase Drug Development, Dr. Sue Marlow, Regulatory Affairs and Quality Consultant |
| 4:45-5:00 PM |
Closing Remarks |
| 5:00-6:00 PM |
Networking Cocktail Reception |
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| Presentations |
Anatomy of a Typical API Project,
Dr. Paul Madeley, Synth-Isis Ltd.
- Synthetic route issues (impact on impurity profile)
- Genotoxic impurities
- Solubility and physical form
- Purity and specification
- Salt selection and polymorphism
- Target product profile
- Importance of communication between stakeholders
Solubility and Bioavailability Enhancement for Poorly Soluble Drugs, Rick Bastin, Patheon
- Biopharmaceutical Classification Systems
- Solubility and bioavailability enhancement for oral delivery
- Considerations for parenteral delivery.
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Formulation Strategies for Early Development, Dr. Robin Platt, Patheon
- Understanding the target product profile
- Importance of physico-chemical properties
- Formulation approaches for phase I studies
- Streamlining your development programme
Regulatory Considerations for Early Phase Drug Development, Dr. Sue Marlow, Regulatory Affairs and Quality Consultant
- Introduction to the regulatory landscape and processes
- Planning for regulatory success
- The development process
- Key components of the regulatory package
- Chemistry, Manufacturing and Control (CMC)
- Non-clinical expectations
- First in Man Studies
- Next steps
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| Biographies of Speakers |
Paul Madeley, Ph.D., is an organic chemist with over thirty years’ experience of chemical synthesis. He has worked for three large companies (Boots, Courtaulds and Abbott Laboratories) and two biotech companies (British Biotech and OSI Pharmaceuticals) before setting up his consultancy company, Synth-Isis Ltd. Read more… |
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Robin Platt, Ph.D., is Operations Director of Patheon’s Milton Park site in the UK. Robin has over 30 years experience in the pharmaceutical industry... Read more…
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Rick Bastin M.Sc., MBA, is the Associate Director Formulation Development Strategy at Patheon and has worked within the pharmaceutical industry for over 25 years and has held senior management and technical roles in a range of organisations including large pharma, generics, startup companies and CDMOs…Read more… |
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Sue Marlow, Ph.D., is a Regulatory Affairs and Quality Consultant with experience working in both the Biotech sector and contract manufacturing environment as a Qualified Person for Investigational Medicinal Products (IMP’s)… Read more… |
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