<br><font size=2 face="Arial"><b>SUBJECT: 2006 Natural Health
Product & Ingredients EVENTS [WASHINGTON DC METRO AREA]</b></font>
<br><font size=2 face="Arial"> </font>
<br><font size=2 face="Arial">On behalf of the respective Program Planning
Committees, the following Events <b><i>may be of interest to you and/or
your Colleagues: </i></b></font>
<br><font size=2 face="Arial"> </font>
<ul>
<li><font size=2 color=blue face="Arial"><b>August 5, 2006: </b></font><font size=3 color=#ff6600 face="Times New Roman"><b><i>SPONSOR
OPPORTUNITY</i></b> </font></ul><font size=2 color=blue face="Arial"><b>American
Society of Pharmacognosy – FDA</b></font><font size=2 color=#ff6600 face="Arial"><b>
</b></font><font size=3 color=#333399 face="Arial"><b><i>Workshop on Botanicals
as “New” Drugs </i></b></font>
<br><font size=2 color=blue face="Arial"><b>Crystal-Gateway Marriott (Arlington,
Virginia) -</b></font><font size=2 color=#ff6600 face="Arial"><b> </b></font>
<br><font size=2 color=blue face="Arial"><b> </b></font>
<ul>
<li><font size=2 color=blue face="Arial"><b>October 16-17, 2006:
</b></font><font size=3 color=#ff6600 face="Times New Roman"><b> <i>EXHIBITOR
OPPORTUNITY</i></b></font><font size=3 color=#333399 face="Times New Roman">
</font></ul><font size=2 color=blue face="Arial"><b>First International
DIA-ISAPP Conference on </b></font><font size=3 color=#333399 face="Arial"><b><i>Probiotics
as Foods and Drugs – Scientific and Regulatory Challenges</i></b></font><font size=3 color=#333399 face="Times New Roman">
</font>
<br><font size=2 color=blue face="Arial"><b>University of Maryland Conference
Center (College Park Campus – Adelphi, Maryland) </b></font>
<br><font size=2 face="Arial"><b> </b></font>
<br><font size=2 face="Arial"><b>See information below. </b></font>
<br><font size=2 face="Arial"> </font>
<br><font size=2 face="Arial">We hope you will POST and DISSEMINATE this
information. <b><i> TO REGISTER,</i></b> please <b>Contact the Sponsoring
Organizations</b>. </font>
<br><font size=2 face="Arial">For questions, feel free to contact me at
the numbers below. </font>
<br><font size=2 face="Arial"> </font>
<br><font size=2 face="Arial">Regards, </font>
<br><font size=2 face="Arial"> </font>
<br><font size=2 face="Arial">Dr. Freddie Ann Hoffman</font>
<br><font size=2 face="Arial">--- Conference Chair </font>
<br><font size=2 face="Arial"> </font>
<br><font size=2 face="Times New Roman">Freddie Ann Hoffman, MD</font><font size=3 face="Times New Roman">
</font><font size=4 color=blue><b><br>
H</b></font><font size=3 color=blue><b>eteroGeneity, LLC</b></font><font size=3 color=blue face="Times New Roman">
</font><font size=2 face="Times New Roman"><br>
5611 16th Street, NW</font><font size=3 face="Times New Roman"> </font><font size=2 face="Times New Roman"><br>
Washington, DC 20011-6809</font><font size=3 face="Times New Roman">
</font><font size=2 face="Times New Roman"><br>
Tel.: 202-545-6843 </font>
<br><font size=2 face="Times New Roman">Mobile: 202-294-5819</font><font size=3 face="Times New Roman">
</font><font size=2 face="Times New Roman"><br>
Fax: 202-545-6844</font><font size=3 face="Times New Roman"> </font><font size=2 color=blue face="Times New Roman"><u><br>
</u></font><a href="mailto:fhoffman@heterogeneity-LLC.com"><font size=2 face="Times New Roman"><u>fhoffman@heterogeneity-LLC.com</u></font></a>
<br><a href="http://www.heterogeneity-llc.com/"><font size=2 face="Times New Roman"><u>www.heterogeneity-LLC.com</u></font></a>
<div align=center>
<br><font size=3 face="Times New Roman"><b> </b></font>
<br><font size=4 color=#ff6600><b>** SPONSOR OPPORTUNITY ** </b></font>
<br><font size=4 face="Times New Roman"><b> </b></font>
<br><font size=4 face="Times New Roman"><b>The American Society of Pharmacognosy
</b></font>
<br><font size=3 face="Times New Roman"><b><i>Is proud to present:</i></b></font>
<br><font size=5 face="Times New Roman"><b>A Workshop: Botanicals
as “New” Drugs </b></font>
<br><font size=3 face="Times New Roman">Co-Sponsored by the</font>
<br><font size=4 face="Times New Roman"><b><i>Center for Drug Evaluation
and Research,</i></b></font>
<br><font size=4 face="Times New Roman"><b><i>Food and Drug Administration</i></b></font>
<br><img src=cid:_2_04536E6C04536C1800739F9285257180 alt="FDA logo">
<br><font size=4 face="Times New Roman"><b>Saturday, August 5, 2006</b></font>
<br><font size=4 face="Times New Roman"><b> </b></font><font size=3 face="Times New Roman"><b>(11
AM – 4PM)</b></font>
<br><font size=3 face="Times New Roman"> </font>
<br><font size=4 face="Times New Roman"><b>Crystal Gateway Marriott - Arlington,
Virginia </b></font>
<br><font size=2 face="Times New Roman"> (just
across the Potomac River from Washington, D.C.)</font>
<br><font size=4 face="Times New Roman"><b> </b></font>
<br><font size=3 face="Times New Roman">In conjunction with </font>
<br><font size=4 face="Times New Roman"><b>The 47th Annual Meeting of the
American Society of Pharmacognosy</b></font>
<br><font size=2 face="Times New Roman"><b>Aug 6 - 9, 2006</b></font>
<br><font size=2 face="Courier New"> </font>
<br><font size=2 face="Courier New"> </font></div>
<br><font size=3 face="Times New Roman"><u>COURSE DESCRIPTION</u>: This
Workshop is an introduction to the drug development process for <b>naturally
complex or heterogeneous products</b>, such as botanicals. Experts
in the field will address the current status of USA drug development for
botanical drugs. Learn how to select a product for development as
a “drug.” Learn what FDA is looking for in the Chemistry, Manufacturing,
and Controls (CMC) and Pharmacology-Toxicology sections of an Investigational
New Drug (IND) application for a Botanical Drug. </font>
<br><font size=3 face="Times New Roman"> </font>
<br><font size=2 face="Symbol">·</font><font size=1 face="Times New Roman">
</font><font size=3 face="Times New Roman"><i>How
does FDA define “botanical?” </i></font>
<br><font size=2 face="Symbol">·</font><font size=1 face="Times New Roman">
</font><font size=3 face="Times New Roman"><i>When
should a botanical be developed as a “drug”? </i></font>
<br><font size=2 face="Symbol">·</font><font size=1 face="Times New Roman">
</font><font size=3 face="Times New Roman"><i>What
are the differences between botanical “foods” and botanical “drugs”?
</i></font>
<br><font size=2 face="Symbol">·</font><font size=1 face="Times New Roman">
</font><font size=3 face="Times New Roman"><i>What
kinds of marketing claims can be made for botanical drugs? </i></font>
<br><font size=2 face="Symbol">·</font><font size=1 face="Times New Roman">
</font><font size=3 face="Times New Roman"><i>When
should an Investigational New Drug (IND) application be filed with FDA?</i></font>
<br><font size=2 face="Symbol">·</font><font size=1 face="Times New Roman">
</font><font size=3 face="Times New Roman"><i>How
does the FDA process and review Botanical INDs and New Drug Applications
(NDAs)?</i></font>
<br><font size=2 face="Symbol">·</font><font size=1 face="Times New Roman">
</font><font size=3 face="Times New Roman"><i>What
are the pertinent FDA regulations, policies and individuals you should
know about for botanical drug development? </i></font>
<br><font size=3 face="Times New Roman"><u><br>
WHO SHOULD ATTEND:</u> Ingredient Manufacturers, Suppliers,
Directors of Research and Development, Researchers, Academicians, Potential
Drug Sponsors, Medicinal & Natural Products Chemists, Pharmacologists,
Toxicologists, Botanists, GMP Specialists, Clinical Investigators, Clinical
Trials Specialists, Policy-makers. </font>
<div align=center>
<br><font size=3 color=#800080 face="Times New Roman"><b>WORKSHOP REGISTRATION:</b></font>
<br><font size=3 color=#800080 face="Times New Roman"><b>$295 – Workshop
Only [Sat. Aug. 5] $25 - ASP Attendees</b></font>
<br><font size=3 face="Times New Roman"><i>TO REGISTER—OR For more information
please see:</i></font>
<br><font size=3 face="Times New Roman"><i> </i><b>The American Society
for Pharmacognosy</b></font>
<br><font size=4 face="Times New Roman"><u> </u></font><a href=http://www.phcog.org/AnnualMtg/Washington.html><font size=4 color=#000080 face="Times New Roman"><b><u>www.phcog.org/AnnualMtg/Washington.html</u></b></font></a>
<br><font size=3 face="Times New Roman"><i> </i></font>
<br><font size=3 face="Times New Roman"><b>Contact: Dr. Tawnya McKee,
ASP Chair, Conference Program Committee</b></font>
<br><font size=3 face="Times New Roman"><b>e-mail: </b></font><font size=3 color=#800080 face="Times New Roman"><b> </b></font><a href=mailto:mckee@ncifcrf.gov><font size=3 color=#800080 face="Times New Roman"><b>mckee@ncifcrf.gov</b></font></a>
<br><font size=3 face="Times New Roman"><b>Dr. Freddie Ann Hoffman, Workshop
Organizer</b></font>
<br><font size=3 face="Times New Roman"><b>e-mail: </b></font><a href="mailto:Fhoffman@heterogeneity-LLC.com"><font size=3 color=#800080 face="Times New Roman"><b>Fhoffman@heterogeneity-LLC.com</b></font></a>
<br><font size=3 face="Times New Roman"><b>Tel: 202-545-6843</b></font>
<br><font size=3 color=blue>_____________________________________________________</font><font size=3>_</font>
<br><font size=3 color=#3300cc><b> </b></font>
<br><font size=3 color=#3300cc><b> </b></font>
<br><font size=4 color=#ff6600><b>** EXHIBITOR OPPORTUNITY ** </b></font>
<br><font size=3 face="Times New Roman"> </font>
<br><font size=3><b>Natural Health Products Special Interest Area Community</b></font>
<br><font size=4><b>Drug Information Association (DIA) </b></font>
<br><font size=3><b> </b></font>
<br><font size=3><b><i>in conjunction with the</i></b></font><font size=4 color=#800080><b><br>
International Scientific Association for Probiotics & Prebiotics </b></font>
<br><font size=3><b><i>present: </i></b></font>
<br><font size=3><b> </b></font>
<br><font size=3 color=#3300cc><b>The First DIA International Conference
on </b></font>
<br><font size=4 color=#3300cc><b>PROBIOTICS AS FOODS & AS DRUGS -<br>
SCIENTIFIC & REGULATORY CHALLENGES</b></font>
<br><font size=4 color=blue><b>16 -17 October 2006</b></font>
<br><font size=3><b>University of Maryland Conference Center <br>
College Park, Maryland</b></font>
<br><font size=3><b>Chairs: </b></font>
<br><font size=3><b>Patricia Hibberd, MD, PhD - <i>Tufts New England Medical
Center</i><br>
James Heimbach, PhD - <i>JHeimbach, LLC</i><br>
Freddie Ann Hoffman, MD - <i>HeteroGeneity, LLC</i></b></font>
<br><font size=3><b>[Continuing Education Credits]</b></font>
<br><font size=3 color=#3300cc><b>Contact: Drug Information Association
(215-442-6100)</b></font><font size=3 color=blue><b><u><br>
</u></b></font><a href=http://www.diahome.org/><font size=3 color=blue><b><u>www.diahome.org</u></b></font></a>
<br><font size=3 color=#3300cc><b> </b></font></div>
<br><font size=3 face="Times New Roman"> </font>