Best Practices in Modeling and Simulation for Oncology Products; Public Workshop, 4660-4661 [2018-01992]

Download as PDF 4660 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Notices 2. Question #7 has been revised to change wording to ‘‘Name of program offered.’’ Estimated Annualized Burden Hours The proposed Falls Prevention Data Collection Tools can be found at ACL’s Website at: https://www.acl.gov/aboutacl/public-input. The total estimated burden is 4,345 hours per year. ACL/AoA estimates the burden of this collection of information as 288 hours for project staff, 1,435 hours for local agency staff, and 2,622 hours for individuals. Average time per response (in hours) Total burden hours (annual) Type of respondent Form name Estimated number of respondents Number of responses per respondent Project staff ..................... Semi-annual Performance Report. Program Information Cover Sheet/Participant Information Form/ Attendance Log/Post Program Survey. 18 ................................... Twice a year ................... 700 leaders .................... Twice a year (one set per program). .50 700 36 data entry staff .......... .50 700 .05 35 Local agency leaders ...... 8 288 Host Organization Data Form. 700 staff ......................... Once per program × 1,400 programs. 1 ..................................... 16,390 ............................ 1 ..................................... .10 1,639 Program participants ....... Participant Information Form. Post Program Survey ..... 9,834 .............................. 1 ..................................... .10 983 Total Burden Hours .. ......................................... ......................................... ......................................... .......................... 4,345 Local data entry staff ...... Local organization staff and local database entry staff. Program participants ....... Dated: January 26, 2018. Mary Lazare, Principal Deputy Administrator. [FR Doc. 2018–02000 Filed 1–31–18; 8:45 am] BILLING CODE 4154–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0001] Best Practices in Modeling and Simulation for Oncology Products; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration’s (FDA, the Agency, or we) Center for Drug Evaluation and Research (CDER), in co-sponsorship with the International Society of Pharmacometrics (ISoP), is announcing a public workshop entitled ‘‘Best Practices in Modeling and Simulation for Oncology Products.’’ The purpose of the meeting is to discuss ‘‘best practices’’ in integrating pharmacokinetic, pharmacodynamic, efficacy, and safety data into models to best inform oncology drug development, evaluate disease- and mechanismspecific early endpoints to predict longterm efficacy, and discuss potential regulatory implications of modelinformed decisions in drug development. This workshop is also sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:34 Jan 31, 2018 Jkt 244001 being conducted to satisfy one of FDA’s performance goals included in the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA), to hold a series of workshops related to model-informed drug development (MIDD). DATES: The public workshop will be held on February 1, 2018, from 8 a.m. to 5 p.m., Eastern Time. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, B and C), Silver Spring, MD 20993–0002. Entrance for public workshop participants (non-FDA employees) is through Building 1 where routine security procedures will be performed. For parking and security information, please refer to: https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. FOR FURTHER INFORMATION CONTACT: Jeannette Dinin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2108, Silver Spring, MD 20993–0002, 240– 402–4978, email: Jeannette.Dinin@ fda.hhs.gov; or Yvonne Knight, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2142, Silver Spring, MD 20993–0002, 301– PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 796–2133, email: Yvonne.Knight@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Under FDARA, FDA agreed, in accordance with section I of the PDUFA VI Performance Goals, Ensuring the Effectiveness of the Human Drug Review, part J, Enhancing Regulatory Decision Tools to Support Drug Development and Review, to convene a series of workshops to identify best practices for MIDD (https:// www.fda.gov/downloads/ForIndustry/ UserFees/PrescriptionDrugUserFee/ UCM511438.pdf). FDA is conducting this workshop as part of the MIDD workshop series. Over the past few decades, there has been extensive investment in oncology drug discovery and development. Despite greater understanding of disease biology and drug mechanisms of action, further progress in model-informed strategies is needed to continue advancements in oncology drug development. Innovations in clinical trial design utilizing more informative endpoints could help bring more effective treatment options to cancer patients faster by accelerating development of effective new drugs and reducing failure rates in expensive latephase development. As more effective and complex combination strategies and novel targets for cancer treatment evolve, exploring more informative and predictive endpoints to assess treatment response E:\FR\FM\01FEN1.SGM 01FEN1 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Notices (e.g., response evaluation criteria in solid tumors-based endpoints (RECIST)) has become an active area of research. Alternative metrics that require shorter periods of observation or provide more precise assessment of treatment effects could lead to more rapid completion of clinical trials and require fewer patients. Promising among these alternative metrics are model-based metrics, such as those based on longitudinal continuous tumor size measurements. Additionally, model-informed approaches can help satisfy a need to optimize dosing regimens for patients. Investigations to refine dosing regimens often occur after new drug approval and/or are driven by pharmacometric modeling approaches. There is growing interest in using model-informed approaches to help balance the risks and benefits of oncology products by identifying optimal dosing regimens, and broad stakeholder engagement and discussion around this topic can be beneficial. sradovich on DSK3GMQ082PROD with NOTICES II. Objectives The objectives of the workshop are to: 1. Discuss ‘‘best practices’’ in integrating human pharmacokinetic, pharmacodynamic, efficacy, and safety data into models that best inform oncology drug development. 2. Describe novel imaging techniques and diagnostic and predictive biomarkers that may be utilized in oncology drug development. 3. Describe disease- and mechanismspecific early endpoints to predict longterm efficacy. 4. Evaluate the potential to shift from traditional RECIST-based endpoints such as Overall Response Rate (ORR) and Progression Free Survival (PFS) to modified RECIST approaches (e.g., imRECIST for immunotherapies) as well as to other (model-based) tumor kinetic metrics to support early decision making in Phase 1/2 as well as in confirmatory trials. 5. Discuss potential regulatory implications of model-informed decisions in drug development, including, model-based target identification, dose/exposure justification based on preclinical evidence, dose selection for first-inhuman trials, quality by design, early clinical study design, dose finding/ titration, confirmatory trials, product labeling, and post-marketing studies. A detailed agenda will be posted on the following website in advance of the workshop: https://www.fda.gov/ downloads/Drugs/NewsEvents/ UCM589458.pdf. VerDate Sep<11>2014 19:34 Jan 31, 2018 Jkt 244001 III. Registration and Accommodations Registration: Persons interested in attending this public workshop must register online by January 31, 2018, at https://fdaoce.formstack.com/forms/ isop. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. Registration is free and based on space availability, with priority given to early registrants. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 8 a.m. If you need special accommodations due to a disability, please contact Yvonne Knight (see FOR FURTHER INFORMATION CONTACT) no later than January 24, 2018. Streaming Webcast of the Public Workshop: The meeting will also be webcast. A live webcast of this workshop will be available at https:// collaboration.fda.gov/fdaisop/ on the day of the workshop. If you have never attended a Connect Pro event before, test your connection at https:// collaboration.fda.gov/common/help/en/ support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/ go/connectpro_overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https:// FDAOCE.formstack.com/forms/isop. It may be viewed at the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: January 29, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–01992 Filed 1–31–18; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 4661 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2016–E–1234 and FDA– 2016–E–1257] Determination of Regulatory Review Period for Purposes of Patent Extension; CORLANOR AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CORLANOR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. SUMMARY: Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 2, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by July 31, 2018. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 2, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. DATES: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your E:\FR\FM\01FEN1.SGM 01FEN1

Agencies

[Federal Register Volume 83, Number 22 (Thursday, February 1, 2018)]
[Notices]
[Pages 4660-4661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01992]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0001]


Best Practices in Modeling and Simulation for Oncology Products; 
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration's (FDA, the Agency, or we) 
Center for Drug Evaluation and Research (CDER), in co-sponsorship with 
the International Society of Pharmacometrics (ISoP), is announcing a 
public workshop entitled ``Best Practices in Modeling and Simulation 
for Oncology Products.'' The purpose of the meeting is to discuss 
``best practices'' in integrating pharmacokinetic, pharmacodynamic, 
efficacy, and safety data into models to best inform oncology drug 
development, evaluate disease- and mechanism-specific early endpoints 
to predict long-term efficacy, and discuss potential regulatory 
implications of model-informed decisions in drug development. This 
workshop is also being conducted to satisfy one of FDA's performance 
goals included in the sixth reauthorization of the Prescription Drug 
User Fee Act (PDUFA VI), part of the FDA Reauthorization Act of 2017 
(FDARA), to hold a series of workshops related to model-informed drug 
development (MIDD).

DATES: The public workshop will be held on February 1, 2018, from 8 
a.m. to 5 p.m., Eastern Time. See the SUPPLEMENTARY INFORMATION section 
for registration date and information.

ADDRESSES: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (Rm. 1503, B and C), Silver Spring, MD 20993-0002. Entrance for 
public workshop participants (non-FDA employees) is through Building 1 
where routine security procedures will be performed. For parking and 
security information, please refer to: https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Jeannette Dinin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 2108, Silver Spring, MD 20993-0002, 240-
402-4978, email: [email protected]; or Yvonne Knight, Center 
for Drug Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 51, Rm. 2142, Silver Spring, MD 20993-0002, 
301-796-2133, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Under FDARA, FDA agreed, in accordance with section I of the PDUFA 
VI Performance Goals, Ensuring the Effectiveness of the Human Drug 
Review, part J, Enhancing Regulatory Decision Tools to Support Drug 
Development and Review, to convene a series of workshops to identify 
best practices for MIDD (https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf). FDA is conducting this 
workshop as part of the MIDD workshop series.
    Over the past few decades, there has been extensive investment in 
oncology drug discovery and development. Despite greater understanding 
of disease biology and drug mechanisms of action, further progress in 
model-informed strategies is needed to continue advancements in 
oncology drug development. Innovations in clinical trial design 
utilizing more informative endpoints could help bring more effective 
treatment options to cancer patients faster by accelerating development 
of effective new drugs and reducing failure rates in expensive late-
phase development.
    As more effective and complex combination strategies and novel 
targets for cancer treatment evolve, exploring more informative and 
predictive endpoints to assess treatment response

[[Page 4661]]

(e.g., response evaluation criteria in solid tumors-based endpoints 
(RECIST)) has become an active area of research. Alternative metrics 
that require shorter periods of observation or provide more precise 
assessment of treatment effects could lead to more rapid completion of 
clinical trials and require fewer patients. Promising among these 
alternative metrics are model-based metrics, such as those based on 
longitudinal continuous tumor size measurements. Additionally, model-
informed approaches can help satisfy a need to optimize dosing regimens 
for patients. Investigations to refine dosing regimens often occur 
after new drug approval and/or are driven by pharmacometric modeling 
approaches. There is growing interest in using model-informed 
approaches to help balance the risks and benefits of oncology products 
by identifying optimal dosing regimens, and broad stakeholder 
engagement and discussion around this topic can be beneficial.

II. Objectives

    The objectives of the workshop are to:
    1. Discuss ``best practices'' in integrating human pharmacokinetic, 
pharmacodynamic, efficacy, and safety data into models that best inform 
oncology drug development.
    2. Describe novel imaging techniques and diagnostic and predictive 
biomarkers that may be utilized in oncology drug development.
    3. Describe disease- and mechanism-specific early endpoints to 
predict long-term efficacy.
    4. Evaluate the potential to shift from traditional RECIST-based 
endpoints such as Overall Response Rate (ORR) and Progression Free 
Survival (PFS) to modified RECIST approaches (e.g., imRECIST for 
immunotherapies) as well as to other (model-based) tumor kinetic 
metrics to support early decision making in Phase 1/2 as well as in 
confirmatory trials.
    5. Discuss potential regulatory implications of model-informed 
decisions in drug development, including, model-based target 
identification, dose/exposure justification based on preclinical 
evidence, dose selection for first-in-human trials, quality by design, 
early clinical study design, dose finding/titration, confirmatory 
trials, product labeling, and post-marketing studies.
    A detailed agenda will be posted on the following website in 
advance of the workshop: https://www.fda.gov/downloads/Drugs/NewsEvents/UCM589458.pdf.

III. Registration and Accommodations

    Registration: Persons interested in attending this public workshop 
must register online by January 31, 2018, at https://fdaoce.formstack.com/forms/isop. Please provide complete contact 
information for each attendee, including name, title, affiliation, 
address, email, and telephone number.
    Registration is free and based on space availability, with priority 
given to early registrants. Early registration is recommended because 
seating is limited; therefore, FDA may limit the number of participants 
from each organization. Registrants will receive confirmation when they 
have been accepted. If time and space permit, onsite registration on 
the day of the public workshop will be provided beginning at 8 a.m.
    If you need special accommodations due to a disability, please 
contact Yvonne Knight (see FOR FURTHER INFORMATION CONTACT) no later 
than January 24, 2018.
    Streaming Webcast of the Public Workshop: The meeting will also be 
webcast. A live webcast of this workshop will be available at https://collaboration.fda.gov/fdaisop/ on the day of the workshop. If you have 
never attended a Connect Pro event before, test your connection at 
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. 
To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website 
addresses in this document, as of the date this document publishes in 
the Federal Register, but websites are subject to change over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://
FDAOCE.formstack.com/forms/isop. It may be viewed at the Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

    Dated: January 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01992 Filed 1-31-18; 8:45 am]
 BILLING CODE 4164-01-P

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