Drug Shortages from the FDA, Industry, and Consumer Perspectives
Orange County Regulatory Affairs Discussion Group (OCRA)
Friday, February 22, 2013
8:00 am to Noon
Free of Charge
OCRA Membership is Required
(Employees of Host Locations do not need to be Members)
Four Locations To Choose From:
Amgen
One Amgen Center Drive; Thousand Oaks, CA 91320
Beckman Coulter
250 South Kraemer Boulevard; Brea, CA 92821
Bausch + Lomb
50 Technology Drive; Irvine, CA 92618
Ardea
4939 Directors Place; San Diego, CA 92121
(see below for driving directions to each location)
Program Managers:
Damon Jones, Vice President, Director of Operations, McGuff Pharmaceuticals, Inc.
Tania Hoffman, MSRS, Sr. Regulatory Affairs Manager, Spectrum Pharmaceuticals, Inc.
Ruchika Raval, RAC, Principal, Global Biopharmaceutical Regulations, Inc.
Synopsis
Disruptions in the supply of potentially life-saving medications have become a critical public health issue. Many factors lead to prescription drug shortages. Manufacturers are often unable to provide timely and complete information on the causes and potential resolution of these shortages to the public, which often leads pharmacies and healthcare facilities to try to find ways of avoiding negative outcomes in the patients they treat. In 2011, President Barack Obama signed an Executive Order directing the Food and Drug Administration to take on a greater role in reducing and preventing drug shortages. In 2012, Title X of the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law, which lists the mandatory reporting requirements for manufacturers and provides FDA with important new authorities to help alleviate drug shortages. This program will look at drug shortages from the FDA, industry, and consumer perspectives and highlight efforts on all three fronts to manage this challenging issue.
Speakers:
FDA Perspective
Jeannie David, Program Management Officer, CDER Drug Shortage Program, FDA
(live from FDA Headquarters)
The speaker will discuss efforts underway at the FDA to address drug shortages, including interactions between the Agency and industry on manufacturing issues to maintain the safety and quality of medically necessary products while ensuring their continued availability.
Jeannie David, M.S. has been with the FDA since 2008. She is currently a Program Management Officer in the CDER Drug Shortage Program. She brings experience from her role as a Regulatory Health Project Manager in the CDER Office of New Drug Quality Assessment, the chemistry, manufacturing and controls (CMC) review division for new drug applications (NDAs), where she managed pre- and post-marketing applications, President’s Emergency Plan for AIDS Relief (PEPFAR) submissions, and presented a talk on Preparing for CMC Meetings with the FDA at the DIA 2012 Annual Meeting. Previously, Jeannie worked 7 years in the biopharmaceutical industry as a research scientist at Roche Palo Alto. She has a M.S. degree in neuroscience from the University of Wisconsin-Madison. Ms. David will speak to us from Washington D.C.
Industry Perspective
Scott McCarty, Risk Management Director, Amgen, Inc.
(Speaker will be at Amgen location)
Scott McCarty has been with Amgen for 15 years, serving in a variety of roles in Operations and Quality Assurance. He is currently Director of Operations Risk Management, with responsibility for identification, characterization, and evaluation of risks to Amgen’s product supply chain. His prior Amgen experience includes leadership of a commercial product launch team and implementation of Amgen’s global change control system.
Prior to joining Amgen, Scott was a 20-year Navy fighter pilot, logging many aircraft carrier-based flight hours in F-4 and F-14 aircraft. Scott holds a bachelor’s degree in Economics from Stanford University, a master’s degree in Aeronautical Engineering from the Naval Postgraduate School, and the degree of Engineer in Aerospace Engineering from the University of Southern California.
Consumer Perspective
Speaker TBD
The speaker will discuss the effects of drug shortages on hospitals and patients.
Schedule
8:00 – 8:45 am
Registration and Security Check In
Continental Breakfast
8:45 – Noon
Speaker Presentations
REGISTRATION INSTRUCTIONS
For Amgen, Beckman Coulter and Ardea employees, please email Rob Fleming (rob.fleming@yahoo.com) with your name(s) and email addresses for each attendee.
All others please follow the instructions below.
Be sure to log on and join or renew your OCRA Membership. If you have not used our online system, you will need to create a new user profile before registering
Once you are logged on, click on “Register for a Meeting” on the right-hand side of the page. Next click on the meeting for which you would like to register, then follow the online instructions. You will receive an immediate confirmation.
CLICK HERE TO DOWNLOAD EVENT FLYER
Orange County Regulatory Affairs Discussion Group
5319 University Dr., Suite 641, Irvine, CA 92612
Tel: 949-387-9046
Fax: 949-266-8461 or 949-387-9047
Email: ksyre@cox.net
OCRA’s non-profit Federal Tax ID# 33-0630455
DRIVING DIRECTIONS
Amgen
One Amgen Center Drive
Thousand Oaks, CA 91320
Note: Please arrive at 8:00 am sharp as you need to be escorted to another building using Amgen’s shuttle.
Please bring your photo ID for check in with Amgen security
Traveling Northbound on 405 and 101 Freeway
Take 405 Freeway North to 101 (Ventura) Freeway North.
Exit 47A Rancho Conejo Blvd.
Turn Right onto Ventu Park Road
Make a Left (before light at Pauling Dr.) into Building #37 parking lot.
Visitors to check in at Building #37 Lobby
Amgen Contact: Amy Gonzales
Traveling Southbound on 101 Freeway
Traveling 101 S (towards Los Angeles)
Exit 47A, Borchard Rd. / Rancho Conejo Blvd.
Turn Left on Borchard Rd / Rancho Conejo Blvd
Continue to follow Rancho Conejo Blvd.
Turn Right on Ventu Park Road
Make a Left (before light at Pauling Dr.) into Building # 37 Parking Lot
Visitors to check in at Building #37 Lobby
Amgen Contact: Amy Gonzales
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Building #A
Brea, CA 92822
Directions from LA:
Take 405 S to 22 East. Then take 57 N to Imperial Blvd. Turn right onto Imperial Blvd. Go to the 5th Light and turn left onto Kraemer Blvd. Beckman Coulter will be on the right hand side.
Directions from San Diego:
Take 405 N to 55. Then take 57 N to Imperial Blvd. Turn right at the end of the exit onto Imperial Blvd. Go to the 5th Light and turn left onto Kraemer Blvd. Beckman Coulter will be on the right hand side.
Bausch + Lomb
50 Technology Drive
Irvine, CA 92618
From San Diego
Take 5 Freeway North
Exit at Alton Parkway (Exit 94B)
Turn Right onto Alton Parkway.
Take 1st Left onto Technology Dr. W.
Bausch + Lomb will be on the Right.
From Long Beach
Take 405 Freeway South.
Exit at Irvine Center Drive (Exit 1C).
Turn Left onto Irvine Center Drive.
Turn Right onto Baranca Parkway.
Turn Left onto Technology Drive.
Bausch + Lomb will be on the Right.
Ardea
4939 Directors Place
San Diego, CA 92121
From San Diego Airport
Take 5 Freeway North.
Exit at Sorrento Valley Road (Exit 30).
Turn Left onto Roselle St.
Take the 1st Right onto Sorrento Valley Road.
Take the 2nd Right onto Vista Sorrento Pkwy.
Turn Left onto Directors Place.
Ardea will be on the Right.
From Oceanside
Take 5 Freeway South to 805 Freeway South.
Exit at Mira Mesa Blvd (Exit 27).
Turn Left onto Sorrento Valley Road.
Turn Left onto Vista Sorrento Pkwy.
Turn Right onto Directors Place.
Ardea will be on the Right.
