Tobacco Products

April 2016: Biomarkers of Potential Harm - A Public Workshop

April 4 and 5, 2016
8:30 a.m. to 4:30 p.m.

Food and Drug Administration (FDA)
Center for Tobacco Products (CTP)
FDA White Oak Conference Center
Building 31, Room 1503
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002

Archived Webcast:
  • Day 1 - April 4

Part 1: April 4 2016
Part 2: April 4 2016
Part 3: April 4 2016
Part 4: April 4 2016

  • Day 2 - April 5

Part 1: April 5 2016
Part 2: April 5 2016
Part 3: April 5 2016
Part 4: April 5 2016

Workshop Objective:

FDA/CTP is hosting the second biomarker workshop designed to open the discussion on how to identify and implement the use of biomarkers for the purposes of tobacco product regulation.  Biomarkers have broad application at FDA/CTP, including the potential to inform product reviews.  For example, studying the effects of tobacco product use on biomarkers may provide information on potential health risks of a new product within a relatively short timeframe.  Thus, biomarkers could play a critical role in the review of premarket applications of new tobacco products that may not have long-term epidemiological studies on health risks.  A large number of biomarkers exist, but their practical utility in the regulatory context needs to be carefully considered.  The objectives of the workshop (“Biomarkers of Potential Harm”) are to identify 1) approaches to assessing and selecting biomarkers of potential harm; 2) the processes of identifying biomarkers of potential harm that may be useful in tobacco product regulation; and 3) areas of research which may further strengthen knowledge about biomarkers of potential harm. 

Who Should Attend this Workshop?

Scientific and medical experts; other interested participants from academia, public health organizations, federal, state and local government agencies; the tobacco industry; and other interested stakeholders.

Registration to Attend or View Live Webcast of the Workshop:

If you wish to attend the workshop in person or by Webcast, you must register by submitting either an electronic or written request no later than March 14, 2016.

Please submit electronic requests at  Persons without Internet access may send written requests for registration to Dhanya John (see Contact for Questions, below).  Requests for registration must include the prospective attendee’s name, title, affiliation, address, email address if available, and telephone number.  Registration is free and you may register to either attend in-person or view the live Webcast.  Both seating and viewership are limited, so early registration is recommended.  FDA may limit the number of registrants from a single organization, as well as the total number of participants, if registration reaches full capacity. 
For registrants with Internet access, confirmation of registration will be emailed to you no later than March 21, 2016.  Onsite registration may be allowed if space is available. If registration reaches maximum capacity, FDA will post a notice closing registration in our News and Events section.

Presenters and Panelists: 

FDA/CTP is interested in gathering scientific information on biomarkers of potential harm from individuals with a broad range of backgrounds on the scientific topics to be discussed at the workshop. We are inviting presenters and panelists to address the pertinent information and provide insight into methods to better answer the questions listed below.  

In the context of tobacco regulation and with respect to tobacco-related mortality and morbidity, including cancer, nonmalignant pulmonary disease, and cardiovascular disease:

  1. Can biomarkers of potential harm offer a valid scientific prediction of longer-term clinical outcomes? 
  2. What criteria, such as biomarker characteristics and pathophysiology, should be considered when identifying, evaluating, and selecting biomarkers of potential harm? 
  3. What are the currently well-established biomarkers of potential harm?  What biomarkers have been identified as having the potential to be validated biomarkers of potential harm contingent upon future research and development?
  4. In clinical trials, surrogate endpoints are used when the clinical outcomes require a very long time to study or when the clinical benefit of improving the surrogate endpoint is well understood.  However, rigorous testing is needed to show that these surrogate endpoints can reliably predict, or correlate with, clinical benefit.  In other regulatory settings, what validated surrogate endpoints have been used to predict longer-term clinical outcomes?  What are the lessons learned from the use of surrogate endpoints?
  5. What shorter-term clinical endpoints such as lung function tests could also serve as biomarkers of potential harm for longer-term clinical outcomes?
  6. Of the currently identified biomarkers of potential harm, what are their strengths and limitations in terms of their measurement? 
  7. What factors (e.g., interindividual variation, potential confounders) should be considered in the data analysis and interpretation of biomarkers of potential harm?
  8. What considerations should be taken into account when selecting biomarkers of potential harm to compare potential health risks across different classes of tobacco products?
  9. What studies have been conducted using biomarkers of potential harm to compare potential health risks across different classes of tobacco products?
  10. What biomarkers of potential harm can be considered translational (i.e., might be useful to compare across clinical and nonclinical studies)?
  11. What are the strengths and weaknesses of using Mode of Action analysis of harmful and potentially harmful constituents (HPHCs) in identifying biomarkers of potential harm? 
  12. How can advancements and findings from newer areas of research such as genomics, metabolomics, and proteomics be applied to the evaluation of the potential health risks of tobacco products in clinical and nonclinical studies?  What are the challenges to interpreting and applying data from these newer technologies?

If you are interested in serving as a presenter or panelist, please submit the following information found in the paragraph directly below, along with the topic on which you would like to speak, to by February 5, 2016.

To be considered to serve as a presenter, please provide the following:

  • A brief abstract for each presentation. The abstract should identify the specific topic(s) to be addressed and the amount of time requested.
  • A one-page biosketch that describes and supports the speaker’s scientific expertise on the specific topic(s) being presented, nature of the individual’s experience and research in the scientific field, positions held, and any program development activities.

Panelists will discuss the scientific presentations and questions listed above. To be considered as a panelist, please provide the following: 

  • A one-page biosketch that describes and supports the speaker’s scientific expertise on the specific topic(s) being presented, nature of the individual’s experience and research in the scientific field, positions held, and any program development activities.
FDA Invites Public Comments on Biomarkers of Potential Harm

To present oral comments at the workshop:

For those attending the workshop in person, FDA will hold a public comment session on the above listed topics on April 5, 2016, during which comments from the public will be accepted. If you would like to present during the public comment session, please indicate this at the time of registration and provide the specific topic of your presentation. FDA will do its best to accommodate requests to speak.  Individuals and organizations with common interests are urged to consolidate or coordinate their remarks and request time for a joint presentation.  FDA will determine the amount of time allotted to each speaker and provide instructions to speakers ahead of the meeting.

Requesters with Internet access and who have submitted a working email address will receive an email regarding your request to speak during the public comment period by March 21, 2016.

Key Dates:
  • Deadline for Requests to Serve as a Presenter or Panelist:   February 5, 2016
  • Registration Deadline:  March 14, 2016
  • Deadline for Requests to Speak During Public Comment Session:  March 14, 2016
  • Date Successful Registrants will Receive Registration Confirmation: March 21, 2016
Special Accommodations:

If you need special accommodations because of disability, please contact Dhanya John (see Contact for Questions) at least seven days before the meeting. Contact for Questions:

Dhanya John, J.D.
Office of Science
Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue, Building 75
Silver Spring, Maryland 20993-0002
Telephone: 1-877-287-1373 (choose Option 5),
FAX: 301-595-1138

Page Last Updated: 04/27/2017
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