Building the Scientific Bridge for Comparability of Combination Products

As combination products become an increasingly important component of the pharmaceutical product portfolio, building a strong scientific bridge for the drug and/or device constituent part is vital. Indeed, the recently passed 21st Century Cures Act contains new statutory provisions aimed at facilitating the use of already-approved components in novel combination products, and in PDUFA VI, the FDA has agreed to issue guidance on bridging studies. 

In this one-day workshop, participants will learn from regulators and industry representatives the key considerations for comparability bridging studies for the drug and device components for combination products.Through presentations, panel discussions, and group break-out sessions, participants will learn the importance of a risk-based bridging approach and the challenges/opportunities in executing robust product development plans that expeditiously deliver new therapeutic products to the patients who need them. The workshop will examine the multi-discipline testing approaches and opportunities for leveraging prior experience for an established drug or device constituent part in combination with a new drug/device. In an interactive break-out session, attendees will also analyze thought-provoking case studies based on real-life scenarios to stimulate discussion and identify the concerns, challenges and opportunities.

During this workshop, you will learn:

  • Why is comparability bridging a necessary aspect of combination product development
  • What are the current bridging study requirements and expectations
  • What challenges are currently being faced in bridging
  • The array of testing strategies and study tools available in the demonstration of comparability
  • Use of leveraging prior experience for an established drug/device constituent parts
  • Real-life case study examples that highlight and draw out the opportunities with bridging
  • Considerations informing implementation of 21st Century Cures and PDUFA VI requirements

Please join us for this interactive one-day, open dialog workshop that will stimulate comparability bridging opportunities and help in the planning and execution of development plans for your combination products.




  • At a Glance
  • Objectives & Audience
  • Agenda
  • Faculty
  • Registration Info
  • Cancellation

At a Glance

Date:

30 November 2017 (8:30 am-5:00 pm EST)

Meeting Location:

US Pharmacopeial Convention 
12601 Twinbrook Parkway
Rockville, MD 20852

Registration Closes:

28 November 2017

Refund Deadline:

25 October 2017

Substitution Deadline:16 November 2017 

RAC Credits:

7

Will this meeting be recorded?

No

Proof of Attendance:

An electronic letter of attendance will be sent upon request.

Registration Fees:

Registration to 31 October 2017
RAPS Members: $600
Nonmembers: $600

Registration 1 November to 28 November 2017
RAPS Member: $650
Nonmembers: $650

 

Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 50 people.

Objectives

After hearing the presentations and panel discussions, and participating in the case study activities, attendees will be able to:

  • Describe the dynamics in building the scientific bridge for combination products
  • Describe the multiple testing/study tools employed to demonstrate comparability
  • Leverage prior drug/device component experience in building the bridge

Who Should Attend

This workshop is for people who have a working knowledge of the comparability bridging testing tools both at bench top (analytical testing, Design Verification, Human Factors) and clinical trials (PK/PD, Safety & Efficacy). The workshop is intended to bring together the subject matter experts from across the multiple disciplines that are involved in building the scientific bridge in the demonstration of comparability.  This workshop is beneficial for professionals working in the drugs, biologics or combination products fields who are involved in development the study requirement strategies for building the scientific bridge and for those responsible for capturing rationale in regulatory submissions.

Agenda

  • Growing need of building the scientific bridge for combination products
  • Current guidance and baseline understanding of comparability bridging requirements
  • What has been resolved, areas can be built upon; opportunities to address remaining uncertainty and variability
  • Tools available for comparability bridge – Analytical, Design Verification, Human Factors, PK, Actual Home use, Efficacy CTs
  • Importance of assuring safety/efficacy of to-be-marketed product and allowable bridging scenarios (discussion of platforms, leveraging, ‘least burdensome’ concepts).
  • Use of previous experience and knowledge for established medications and/or device platforms. Determining the platforms and acceptance criteria based on prior experience within and even between companies
  • Importance of a risk-based approach and correct testing/study tool(s) to address specific issue.
  • Panel discussion of FDA/Academia/Industry panelists to provide interactive forum.
  • Break-Out session split into groups to discuss real-life case study scenarios; more deeply understand concerns and opportunities based on variety of detailed case studies.  What we’ve seen, what works, what doesn’t and why; perspectives on acceptable device and drug platforms, acceptable use scenarios and attributes of user groups.
  • Read-outs from case study groups to glean learning, agreements and remaining opportunities
  • Next steps for participants in the goal of truly ‘moving the bar’ on Bridging, especially in light of Cures and PDUFA VI.
  • Publication of workshop proceedings to capture the discussions and learnings of the workshop.

NOTE: Program content may vary

Faculty

Thinh Nguyen, director, FDA OCP
John Towns, PhD, senior research fellow, Eli Lilly and Company

Registration Info

IMPORTANT: Attendees must bring their own laptops. RAPS does not provide equipment for attendees. Apple computers are discouraged. 

Registration to 31 October 2017
RAPS Members: $600
Nonmembers: $600

Registration 1 November to 28 November 2017
RAPS Member: $650
Nonmembers: $650

Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 50 people. 

» Registration Online
» Registration Form (PDF) - for registration by mail or fax

If it is your preference, please use the registration form to register by mail, email , or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. 

Questions? Call RAPS Solutions Center at +1 301 770 2920, ext. 200.

Refund Deadline: 31 October 2017

Other Information
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

Program Contact

Nichelle Sankey
nsankey@raps.org
+301 770 2920, ext. 291

Parking 
Paid parking is available in the parking ramp directly behind 5635 Fishers Lane in Rockville (next door to US Pharmacopeial Convention). 

Area Airports
Ronald Reagan Washington National Airport (24 miles) 
Washington Dulles International Airport (36 miles)
Baltimore-Washington International Airport (37 miles)

Area Hotels
The following hotels are located near US Pharmacopeial Convention

Even Hotel Rockville (Walking Distance)
1775 Rockville Pike
Rockville, MD 20852
Reservations: +1 877 834 3613

Hilton Washington DC/Rockville Hotel (Walking Distance
1750 Rockville Pike
Rockville, MD 20852
Reservations: +1 301 468 1100

Bethesda North Marriott Hotel
701 Marinelli Road
Bethesda, MD 20852
Reservations: +1 301 822 9200

Bethesda Marriott Suites
6711 Democracy Boulevard
Bethesda, MD 20817
Reservations: +1 800 228 9290

Washington Metro Access
The Twinbrook Metro Station is a short walk to 12601 Twinbrook Parkway. Take the Red Line to the Twinbrook Metro Station.

 

Cancellation

All cancellation requests must be submitted to raps@raps.org by 31 October 2017. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. A 20% cancellation fee will be assessed. 

Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 16 November 2017. 

If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.

NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.