Long-Acting Injectable (LAI) Generics: Navigating Technical Hurdles in Product Development and Regulatory Assessment

Date and Time: December 1 , 8:30 am  –  5:30 pm ,
December 2 , 8:30 am  –  5:30 pm

Co-hosts: FDA and the Center for Research on Complex Generics (CRCG)

In person (at The Universities at Shady Grove; Rockville, MD) and virtual workshop.

Registration Coming Soon

The purpose of this 2-day workshop is to facilitate an in-depth look at current challenges relating to LAI product characterization, drug release mechanisms, in vivo BE study conduct, and factors that impact product development and regulatory assessment. The workshop will discuss current thinking on LAI drug release mechanisms, in vitro methodologies, and predictive modeling approaches to support LAI generic drug development and regulatory assessment. Sessions will discuss common deficiencies observed during ANDA assessment, alternative BE study designs, and model-integrated evidence approaches that enable a more efficient and feasible BE assessment. The workshop will also facilitate a discussion about permissible formulation differences and their impact on product performance, reverse engineering approaches, and novel excipient evaluation strategies.

The workshop will be held at the Universities at Shady Grove (USG).

Address: Building II, Ballroom (please follow signs), 9630 Gudelsky Drive, Rockville, MD 20850

  • Travel from local airports to Rockville, MD. (The Universities at Shady Grove (USG)) will require an Uber or Lyft, which is by far the best way to obtain car service.
  • As there is road traffic in the region, the fastest way to the Shady Grove campus is the DCA airport, then taking the Metro subway from the airport to Shady Grove, then taking Uber or Lyft. Alternatively, fly into any WAS airport and take Uber or Lyft. If flying into BWI airport, we suggest taking Uber or Lyft to USG.
  • The Metro subway serves DCA and IAD airports, which connects with the Shady Grove stop on the red line. If flying into IAD, taking the Metro will save some cost, but will probably take extra time, even if traffic is heavy.

More links and information:

 

  • The Traville-Gateway Garage is the closest parking garage to the venue (parking map). Attendees may also park in Lot 2 and Shady Grove Garage but will need to allow more walking time to reach the event.
  • Visitor Parking: Levels 2-6 of Traville Gateway Garage. PLEASE NOTE: The ground floor of Traville Gateway Garage requires a USG employee permit at all times.
  • Guests are responsible for the cost of parking; parking will not be validated. Parking is $16 for all day.

Click for parking information from the USG website.

Please click on the following “all transportation options” links to find transportation from the airport via subway, bus, taxi, car, and town car.

  • Train tickets (Omio)
  • Washington, DC to Baltimore: Approximately 35 minutes
  • Penn Station Marc SB (Baltimore): Approximately 41 miles from campus

Empire Sedan & Limo Services (empiresedan12@gmail.com):  240-988-1796

Washington Flyer Taxi:  703-572-TAXI or 706-853-6094

Regency Taxi:  301-984-1900

Bob’s Limo Service (Email): 301-525-2525

B&B Executive Sedan (Email): 240-533-6262

East Coast Limousine (Email): 301-527-0413 or 240-793-8196

Uber: Baltimore, BWI Airport, Washington, DC, Dulles (IAD) Airport

Guests should mention they are attending a conference at Universities of Shady Grove; most hotels offer discounts.

There are many hotels within a short driving distance to the USG campus including:

1775 Rockville Pike, Rockville, MD 20852 (5.5 miles from USG)
855-879-3836