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Biomed/Biotech Special Interest Group  

Kelly's Deli Conference Center
Next to the entrance to 7519 Standish Drive
FDA/CVM Center
Rockville, Maryland  20855

Dec 4, 2014    6:00 pm - 8:45 pm (GMT -5:00) EST

�Overview of Parkinson�s Disease 
and CNS Drug Development�

To be presented by

G. David Podskalny, DO, MPHS 
Team Leader
Division of Neurology Drugs, Office of New Drug I
Center for Drug Evaluation and Research (CDER), US FDA

Thursday, December 4, 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, past speakers, teachers, students, interns, residents, postdocs, FDA Commissioner�s Fellows, MJ-DC members, NTUAADC members, CAPA members, CKUAADC members, CCACC volunteers/employees, FAPAC members, CBA members, AAGEN members, Commissioned Corp officers, and current job-seekers. 

Location: Kelly�s Deli Conference Center, 7529 Standish Place, Rockville (Derwood, for GPS users), MD 20855

Registration Deadline: Please register by Thursday noon, December 4, 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 of 7529 Building with its external entrance opposite to the left side of 7519 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.


This presentation will provide a brief overview of Parkinson�s disease (PD) including a description of the cardinal features of the disease, clinical staging, and clinical disease progression.  The classical histopathological features of PD will be discussed including recent theories of protein misfolding and its potential role in the pathogenesis of the disease.  The talk will also include a summary of approved drugs for the treatment of PD.  It will also discuss recent interest in treating the motor complication of advanced PD and the non-motor features of the disease.
The second part of the talk will provide general overview of drug development process with an emphasis on Investigational New Drug Applications (INDs).  The talk will highlight FDA resources (websites) that provide guidance and information to help individual investigators, researchers, and regulatory affairs professionals navigate IND application process.

Speaker�s Bio: 

Dr. Podskalny received a Bachelor�s of Science degree, in Biology from Rutgers University.  He went on to receive a second undergraduate degree in Physical Therapy at the State University of New York at Buffalo, followed by a Doctor of Osteopathy (DO) degree from the New York College of Osteopathic Medicine.  Dr. Podskalny completed Neurology Residency and Fellowship in Movement Disorders at Albany Medical College.  

He was a fulltime faculty member at Albany Medical College, The University of Medicine and Dentistry of New Jersey and the Penn State-Hershey College of Medicine.  Dr. Podskalny earned a Master Degree in Public Health Sciences (MPHS) from Penn State University.  He joined the FDA in the Division of Neurology Products in March, 2007, where he is currently a Cross Disciplinary Team Leader.

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).