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</o:shapelayout></xml><![endif]--></head><body lang=EN-US link=blue vlink=purple><div class=WordSection1><p class=MsoNormal><span style='font-size:11.0pt;color:#1F497D'><o:p> </o:p></span></p><div><div style='border:none;border-top:solid #B5C4DF 1.0pt;padding:3.0pt 0in 0in 0in'><p class=MsoNormal><b><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'>From:</span></b><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'> Printing & Publishing 3Ds [mailto:PPSS3DS@LISTSERV.ARIZONA.EDU] <b>On Behalf Of </b>3D Memo<br><b>Sent:</b> Friday, September 16, 2011 3:37 PM<br><b>To:</b> PPSS3DS@LISTSERV.ARIZONA.EDU<br><b>Subject:</b> "How to Navigate the Biotech Regulatory Process" A Works hop and Networking Reception<o:p></o:p></span></p></div></div><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal style='text-autospace:none'><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'>TO: The UA Research Community<o:p></o:p></span></p><p class=MsoNormal style='text-autospace:none'><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'><o:p> </o:p></span></p><p class=MsoNormal style='text-autospace:none'><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'>FROM: Bruce Wright, Associate Vice President for University Research Parks<o:p></o:p></span></p><p class=MsoNormal style='text-autospace:none'><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'><o:p> </o:p></span></p><p class=MsoNormal style='text-autospace:none'><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'>SUBJECT: “How to Navigate the Biotech Regulatory Process” A Workshop and Networking Reception<o:p></o:p></span></p><p class=MsoNormal style='text-autospace:none'><b><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'><o:p> </o:p></span></b></p><p class=MsoNormal style='text-autospace:none'><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'>Presented by the Office of University Research Parks and The Arizona Center for Innovation <o:p></o:p></span></p><p class=MsoNormal style='text-autospace:none'><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'><o:p> </o:p></span></p><p class=MsoNormal style='text-autospace:none'><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'>When: Tuesday, September 20, 2011<o:p></o:p></span></p><p class=MsoNormal style='text-autospace:none'><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'> Workshop: 8:00 am – 4:15 pm<o:p></o:p></span></p><p class=MsoNormal style='text-autospace:none'><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'> BIO-SA Reception: 4:30 – 6:00 pm<o:p></o:p></span></p><p class=MsoNormal style='text-autospace:none'><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'><o:p> </o:p></span></p><p class=MsoNormal style='text-autospace:none'><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'>Where: Doubletree Reid Park<o:p></o:p></span></p><p class=MsoNormal style='text-autospace:none'><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'>445 S. Alvernon Way, Tucson, AZ 85711</span><span style='font-size:11.0pt'> <o:p></o:p></span></p><p class=MsoNormal style='text-autospace:none'><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'><o:p> </o:p></span></p><p class=MsoNormal style='text-autospace:none'><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'>Cost: $25 (includes materials, lunch and reception)<o:p></o:p></span></p><p class=MsoNormal style='text-autospace:none'><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'>Workshops Include:<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'><o:p> </o:p></span></p><p class=MsoListParagraphCxSpFirst style='text-indent:-.25in;mso-list:l0 level1 lfo2'><![if !supportLists]><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'><span style='mso-list:Ignore'>-<span style='font:7.0pt "Times New Roman"'> </span></span></span><![endif]><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'>General overview of the FDA regulatory process<o:p></o:p></span></p><p class=MsoListParagraphCxSpMiddle style='text-indent:-.25in;mso-list:l0 level1 lfo2'><![if !supportLists]><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'><span style='mso-list:Ignore'>-<span style='font:7.0pt "Times New Roman"'> </span></span></span><![endif]><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'>Importance of your patient demographic market<o:p></o:p></span></p><p class=MsoListParagraphCxSpMiddle style='text-indent:-.25in;mso-list:l0 level1 lfo2'><![if !supportLists]><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'><span style='mso-list:Ignore'>-<span style='font:7.0pt "Times New Roman"'> </span></span></span><![endif]><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'>Learn how to best develop and implement an international strategy for selling your device or drug outside the US<o:p></o:p></span></p><p class=MsoListParagraphCxSpLast style='text-indent:-.25in;mso-list:l0 level1 lfo2'><![if !supportLists]><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'><span style='mso-list:Ignore'>-<span style='font:7.0pt "Times New Roman"'> </span></span></span><![endif]><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'>Explore future trends in the development of new drugs and devices as well as the regulatory process<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'>Presenters: <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'><o:p> </o:p></span></p><p class=MsoNormal><b><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'>Marlene Haffner, MD, MPH</span></b><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'> is the CEO of Haffner Associates, LLC., a firm dedicated to the strategy, development and policy of drug development with a special emphasis on rare diseases and the products that treat them. She also spent more than 25 years working for the FDA as the Director of the Office of Health Affairs in the CDRH, and Director of the Office of Orphan Products Development<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'><o:p> </o:p></span></p><p class=MsoNormal><b><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'>David Feigal, MD, MPH</span></b><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'> is a Partner NDA Partners. He held senior positions in FDA medical product centers including the Center Director of CDRH, the Deputy Center Director of CBER and Director of the Office of Drug Evaluation IV (Anti-infective-Antiviral Drug Products), CDER.<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'><o:p> </o:p></span></p><p class=MsoNormal><b><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'>Barbara Wuebbels, RN, MS</span></b><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'> –is the Manager of Medical Affairs Investigator Relations for BioMarin Pharmaceutical located in Novato, CA. She has worked in the orphan drug arena for the past 12 years. Prior to joining BioMarin, she was Director at Ucycld Pharma a subsidiary of Medicis Pharmaceutical Corp. She is actively involved with national and international rare disease organizations and patient advocacy groups.<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'>For more information:<o:p></o:p></span></p><p class=MsoNormal><a href="http://azinnovation.com/sites/default/files/FDA%20Workshop%20Flyer%20Final.pdf"><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'>http://azinnovation.com/sites/default/files/FDA%20Workshop%20Flyer%20Final.pdf</span></a><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'><o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Arial","sans-serif"'>To register please</span> <span style='font-size:11.0pt;font-family:"Arial","sans-serif"'>contact Lori Kavanaugh at 520.382.3260 or <a href="mailto:lkavanaugh@azinnovation.com">lkavanaugh@azinnovation.com</a><o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'><o:p> </o:p></span></p></div></body></html>