Biomed/Biotech Special Interest Group  

�Herbal Medicines and Plant-Derived Drugs 

� A Pharmacognosist�s Perspective�

To be presented by

Jinhui Dou, PhD

Expert Pharmacologist

Botanical Review Team, Office of Pharmaceutical Sciences (OPS)

Center for Drug Evaluation and Research (CDER), US FDA

Thursday, May 22, 2014

6:00 � 6:20 PM � Networking; Pizza/drink 

6:20 � 8:45 PM � Program 

8:45 � 9:00 PM � Door-prizes drawing; Networking

Online Registration site: https://asq509.org/ht/d/DoSurvey/i/35817

Open to Public � 

$5: non-ASQ members to cover pizza/drink cost; 

Free: ASQ members, veterans, senior citizens, teachers, students, interns, residents, postdocs, FDA Commissioner�s Fellows, MJ-DC members, NTUAADC members, CAPA members, CCACC volunteers/employees, FAPAC members, CBA members, AAGEN members, Commissioned Corp officers, and current job-seekers. 

Location: Kelly�s Deli Conference Center, 7519 Standish Place, Rockville (Derwood, for GPS users), MD 20855

Registration Deadline: Please register by Thursday noon, May 22, 2014.  

Question: Please contact Dr. C.J. George Chang, Chair of Biomed/Biotech SIG, ASQ509; [email protected] or 240-793-8425 (cell).

Driving Directions: By Cars: From I-270 (N or S bound): Take Exit 9A and exit from the FIRST right exit; turn left (east) onto Shady Grove Dr.; turn right (south) onto Rockville Pike (Route 355); turn left (east) onto East Gude Dr.; turn left (north) immediately onto Crabb�s Branch Dr.; turn left (west) immediately onto Standish Place. The first building on your right side is 7519 Standish Place; open parking). The venue is on the first floor with its entrance opposite to the left side of building main entrance. By Metro trains: Off from Red Line Shady Grove Station, and take RideOn Route 59 TOWARD ROCKVILLE and get off from �Calhoun Place� stop. Standish Place is next to the Bus stop. Our venue is within 2 min of walking distance from the stop.

Summary:  

Outline of presentation 

� What is pharmacognosy? 

� Introduction to Chinese herbal medicines 

� Purified drugs from medicinal plants

� �Plants that Heal�

� Artemisinin

� Paclitaxel 

� Botanical drug guidance and new drug approvals

� Examples of plant-derived, over-the-counter (OTC) drugs

� Examples of approved prescription botanical new drugs

� Veregen (Sinecatechins) for genital warts

� Fulyzaq (Crofelemer) for HIV-related diarrhea 

� Discussions and closing remarks

� The value of further development of traditional /herbal medicines as new botanical drugs

Presenter�s Bio: 

Dr. Jinhui Dou received his PhD degree in Pharmacognosy from the Pharmacy School, University of Mississippi (1996) and completed post-doctoral research at the University of Kansas on immuno-modulating medicinal plants.  His BS (Pharmacy) and MS (Pharmacognosy) degrees were from Beijing University of Chinese Medicine.  

Dr. Dou joined the Botanical Review Team in FDA/CDER in 2002, and is currently an expert pharmacologist reviewer on botanical drugs.  He has conducted primary reviews on the majority of the botanical Investigational New Drug (IND) applications and the first two botanical New Drug Applications (NDAs).  He has also conducted pharmacology and toxicology reviews on non-botanical, small-molecule INDs and NDAs.  

Prior to FDA, Dr. Dou had worked as a lead natural products scientist for a biopharmaceutical company on anticancer drug discovery and development from medicinal plants.  He had taught pharmacognosy classes at Beijing University of Chinese Medicine for 4 years (1987-1991) before coming to the US for graduate studies.   Dr. Dou enjoys running, playing basketball, and photography of plants.  

This Biomed/Biotech SIG event is cosponsored by the Monte Jade Science and Technology Association of Greater Washington (www.MonteJadeDC.org) and NTU Alumni Association at DC (www.ntuaadc.org).