Event No. 1
Lunchtime discussion probing some of the regulatory quandaries of the 21st century
Dr Sylvain Mandeville: Director of Bioanalytical Services CPR Pharma Services Pte Ltd.
â€œRaising the bar of regulatory compliance: Current best practice in bioanalysisâ€
Dr Mandeville will discuss new trends and future directions such as CFR 21 Part 11 compliance, FDA trends, paperless laboratories, recent White papers that will shape the FDA guidance documents of the future.
Dr Mandeville has worked in the fields of general management, business development, bioanalytical method development and the implementation of quality and laboratory information management systems. Dr Mandeville was Director of Bioanalytical Services at Ricerca Biosciences LLC between 2008 and 2010, Senior Director Bioanalytical Services and Business Development at LAB Research Ltd between 2006 and 2008, a consultant responsible for establishment of a new GLP bioanalytical facility for LAB Research in Hungary between 2004 and 2006, Senior Director at Warnex Analytical/Bioanalytical Services Inc between 2001 and 2004, Head of Bioanalytical Services at Phoenix International Life Sciences between 1999 and 2001, and occupied positions of increasing responsibility at LAB Pharmacological Research International between 1993 and 1999. He holds a PhD in Analytical Chemistry and a BSc in Food Sciences and Agricultural Chemistry from McGill University.
Dr Jean-Marie Houle: Director of Clinical Science Sales and Business Development CPR Pharma Services Pty Ltd.
â€œEfficient First-In-Human study designs; the standard more than the exceptionâ€
Dr Houle will discuss the progression in adaptive clinical trial design, and the associated advantages.
Dr Houle is a pharmacokineticist by training and is an expert in drug development. He has worked in the fields of operations, management, business development, pharmacokinetics, clinical pharmacology and as a consultancy to the pharmaceutical industry. Dr Houle was VP of Clinical Operations at Anapharm between 2007-2010; VP of Research and Development at Chronogen between 2006 and 2007 where he headed up R and D, a consultant to the pharmaceutical industry where he assessed clients PK strategy and evaluated PK/Clinical Pharmacology packages, between 2005 and 2006, Director of PK and Clinical Pharmacology at QLT Inc where his role was key in supporting the regulatory submissions for approval of Visudyne globally between 1998 and 2005 and Director of Scientific Affairs at LAB Pharmacology Research from 1987-1997. He holds a PhD in Pharmaceutical Science and a BSc in Pharmacy from The University of Montreal.
Date: 29 February 2012.
Time: 12pm â€“ 2pm
Location: Aspiration, Matrix at Biopolis
Cost: $30 to Members and $50 for non-members. Individual membership of $50 can be paid at the door or directly online. If you take an individual membership, your money will be returned if your company enrolls as a Corporate Member for $1000 during the same financial year.
Event No. 2
BioSingapore Networking Event.
Wednesday 29 February 2012 from 18:30 â€“ late.
As always, this networking event will provide a good opportunity for you to mingle and get to know the other members better for potential future linkups and to enhance your professional and personal contact database. Itâ€™s a lucky date that wonâ€™t come around again until the next leap year.
Contract research organizationsâ€™ are set to be the next area of growth in the Biotech industry. This month Mr. Jason Valentine Chief Executive Officer and founder of CPR Australia will give a 20 minute talk on Why Singapore? Jason will briefly discuss why CPR, a contract research company, chose to set up operations in Singapore.
Please join us at:
8 Rochester Park
The event is $30 to Members and $40 for non-members. Individual membership of $50 can be paid at the door or directly online. If you take an individual membership, your money will be returned if your company enrolls as a Corporate Member for $1000 during the same financial year.
Hope to you'll be able to join us; do bring your friends and colleagues.
Please RSVP before 22 February 2012 to Yvette Flanigan -