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Activity Outline
Advancing Generic Drug Development: Translating Science to Approval
September 20 - 21, 2022
Virtual (Adobe Connect and You Tube Live Stream)
Advancing Generic Drug Development: Translating Science to Approval
September 20 - 21, 2022
Virtual (Adobe Connect and You Tube Live Stream)
Activity Coordinators:
Forest Ford (Forest.Ford@fda.hhs.gov), Brenda Stodart (Brenda.Stodart@fda.hhs.gov)
Description
The purpose of this public workshop is to communicate how FDA's Generic Drug User Fee Amendments (GDUFA) Science and Research Program outcomes guide and facilitate generic drug development, regulatory assessment, and approval. This workshop will focus on common issues seen in abbreviated new drug applications (ANDAs), link GDUFA science and research on complex products and scientific issues to product-specific guidance development, and pre-ANDA meeting discussions, and examine various areas of innovative science and cutting-edge methodologies behind generic drug development. This workshop will also provide some insight into upcoming GDUFA III enhancements.
References
- Pre-ANDA Program https://www.fda.gov/drugs/generic-drugs/pre-anda-program
- GDUFA Science and Research https://www.fda.gov/drugs/generic-drugs/science-research
- Product-Specific Guidances for Generic Drug Development https://www.fda.gov/drugs/guidances-drugs/product-specific-guidances-generic-drug-development
- Guidances Related to Generic Drugs (under topics, choose “generic drugs”) https://www.fda.gov/regulatory-information/search-fda-guidance-documents#guidancesearch
- Federal Register Notices Related to Generic Drugs https://www.federalregister.gov/documents/search?conditions%5Bterm%5D=generic+drugs
- GDUFA III https://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-iii
Learning Objectives
- Explain new developments in science, guidance, and regulatory assessment experience for generic drug products
- Describe FDA’s perspectives, research, and regulatory assessment relating to generic drug development
- Apply various mechanisms and methodologies that drug developers can use to facilitate generic drug development
Target Audience
This activity is intended for physicians, pharmacists, and nurses.
This activity is intended for physicians, pharmacists, and nurses.
Agenda
Day 1 September 20, 2022
Day 2 September 21, 2022
Day 1 September 20, 2022
| Time | Topic | Speaker |
|---|---|---|
| 8:00 - 8:15 AM EDT | Opening Remarks | Brenda Stodart, PharmD, MS, BCGP, RAC |
| 8:15 - 8:30 AM EDT | Keynote by Commissioner of Food and Drugs | Robert M. Califf, MD |
| 8:30 - 8:50 AM EDT | Guidance for Peptide Products and Assessing Immunogenicity Risk | Eric Pang, PhD |
| 8:50 - 9:10 AM EDT | Common Deficiencies Associated with Comparative Peptide Impurity Profile Studies and Qualification of Impurity Levels and Proposed Limits | Yili Li, PhD |
| 9:10 - 9:30 AM EDT | Assessing Impurities to Inform Peptide Immunogenicity Risk: Developing Informative Studies | Daniela Verthelyi, MD, PhD |
| 9:30 - 10:00 AM EDT | Session 1A: Q&A Panel |
Eric Pang, PhD Yili Li, PhD Daniela Verthelyi, MD, PhD Cameron Smith, PhD |
| 10:00 - 10:10 AM EDT | BREAK | |
| 10:10 - 10:30 AM EDT | Oligonucleotides: Current Thinking and Analytical Challenges Identified in the Nusinersen PSG Development | DEYI ZHANG, PhD |
| 10:30 - 10:50 AM EDT | In-Depth Impurity Assessment of Synthetic Oligonucleotides Enabled by High Resolution Mass Spectrometry | Kui Yang, PhD |
| 10:50 - 11:10 AM EDT | Session 1B: Q&A Panel |
Daniela Verthelyi, MD, PhD DEYI ZHANG, PhD Kui Yang, PhD Likan Liang, PhD |
| 11:10 - 11:30 AM EDT | Comparing Device User Interfaces and Seeking Advice in the Pre-ANDA Period | Kathryn Hartka, PhD, PharmD |
| 11:30 - 11:50 AM EDT | Conducting a Comparative Analysis When the RLD is Not Available | Stephanie Soukup, MD |
| 11:50 - 12:10 PM EDT | Future Challenges: Electronic Devices, PDURS, Impacts on Generic Development and Substitution | Betsy Ballard, MD |
| 12:10 - 12:40 PM EDT | Session 2: Q&A Panel |
Kathryn Hartka, PhD, PharmD Stephanie Soukup, MD Betsy Ballard, MD LISA BERCU, JD Markham Luke, MD, PhD Katharine Feibus, MD Andrew Fine, PharmD |
| 12:40 - 1:15 PM EDT | LUNCH BREAK | Not offered for CE |
| 1:15 - 1:35 PM EDT | Q1/Q2 Assessment and Requirements for Biowaiver of Injectables | XINRAN LI, PhD |
| 1:35 - 1:55 PM EDT | Current Thinking and Research On In Vitro Only Approaches for Injectable Suspensions of Drug Substances– A Scientific Discussion | Bin Qin, PhD |
| 1:55 - 2:10 PM EDT | Challenges and Considerations in Developing In Vitro Release Testing Methods for Parenteral Suspensions | William Smith, PhD |
| 2:10 - 2:35 PM EDT | MAPP 5019.1 - Allowable Excess Volume/Content in Injectable Drug and Biological Products | HONGNA WANG, PhD |
| 2:35 - 3:05 PM EDT | Session 3: Q&A Panel |
XINRAN LI, PhD Bin Qin, PhD William Smith, PhD HONGNA WANG, PhD Utpal Munshi, PhD David Anderson, PhD Janice Brown, MS |
| 3:05 - 3:15 PM EDT | BREAK | |
| 3:15 - 3:35 PM EDT | Q1/Q2 Challenges from a BE Assessment Perspective | Dapeng Cui, PhD |
| 3:35 - 3:55 PM EDT | Application Of Quantitative Modeling and Simulations to BE Determination for Long-Acting Injectables – Sharing Research Progress and Regulatory Experience | Kairui Feng, PhD |
| 3:55 - 4:15 PM EDT | Mechanistic Modeling of Complex Injectables: Recommendations to Navigate Regulatory Challenges | Khondoker Alam, PhD |
| 4:15 - 4:35 PM EDT | Recommendation of Partial Area Under the Curve Metrics in Product- Specific Guidances for Long-Acting Injectable Drug Products | Sherin Thomas, PhD |
| 4:35 - 5:05 PM EDT | Session 4: Q&A Panel |
Dapeng Cui, PhD Kairui Feng, PhD Khondoker Alam, PhD Sherin Thomas, PhD Hao Zhu, PhD Lanyan Fang, PhD Bing Li, PhD |
| 5:05 - 5:10 PM EDT | Day 1 Closing Remarks | Lei Zhang, PhD |
| Time | Topic | Speaker |
|---|---|---|
| 8:00 - 8:15 AM EDT | Day Two - SBIA Overview | Forest Ford, PharmD, R. Ph |
| 8:15 - 8:35 AM EDT | In-Vitro Binding Studies for Bioequivalence Demonstration | Wei-Jhe Sun, PhD |
| 8:35 - 8:55 AM EDT | Assessing API “Sameness” | Hongmei Li, PhD |
| 8:55 - 9:15 AM EDT | In Vitro Assessments that Support In Vitro Binding Studies in Demonstrating Bioequivalence of Locally Acting Gastrointestinal Drugs | Manar Al-Ghabeish, PhD |
| 9:15 - 9:35 AM EDT | Common Deficiencies and Case Studies of In-Vitro Binding Bioequivalence Studies | Hongfei Zhou, PhD |
| 9:35 - 10:05 AM EDT | Session 5: Q&A Panel |
Wei-Jhe Sun, PhD Hongmei Li, PhD Manar Al-Ghabeish, PhD Hongfei Zhou, PhD Hongling Zhang, PhD |
| 10:05 - 10:15 AM EDT | BREAK | |
| 10:15 - 10:35 AM EDT | Nasal Products: Current Landscape and Recent Advancements | Bryan Newman, PhD |
| 10:35 - 10:55 AM EDT | Alternative BE Approaches and Considerations for Nasal Products | Susan Boc, PhD |
| 10:55 - 11:15 AM EDT | Mechanistic Modeling and Realistic In Vitro Models to Facilitate Development of Generic Nasal Drug Products | Ross Walenga, PhD |
| 11:15 - 11:35 AM EDT | In Vitro Characterization of Nasal Powder Drug Products | Nicholas Holtgrewe, PhD |
| 11:35 - 12:05 PM EDT | Session 6: Q&A Panel |
Bryan Newman, PhD Ross Walenga, PhD Nicholas Holtgrewe, PhD Ke Ren, PhD |
| 12:05 - 1:00 PM EDT | LUNCH BREAK | Not offered for CE |
| 1:00 - 1:20 PM EDT | Alternative Model-Based Data Analysis Approach to Demonstrate BE | Yuqing Gong, PhD |
| 1:20 - 1:40 PM EDT | Evaluation and Application of New/Novel Data Imputation Approaches to Support BE Assessment | Jing Wang, PhD |
| 1:40 - 2:00 PM EDT | Challenges And Opportunities on Using Oral PBPK To Support Risk Assessment and Biowaiver in Regulatory Submissions | Fang Wu, PhD |
| 2:00 - 2:20 PM EDT | Dermal PBPK Modeling for a Transdermal Delivery System to Assess the Impact of the Application Site on In Vivo Performance | Eleftheria Tsakalozou, PhD |
| 2:20 - 2:50 PM EDT | Session 7: Q&A Panel |
Yuqing Gong, PhD Jing Wang, PhD Fang Wu, PhD Eleftheria Tsakalozou, PhD Zhen Zhang, PhD Stella Grosser, PhD |
| 2:50 - 3:00 PM EDT | BREAK | Not offered for CE |
| 3:00 - 3:20 PM EDT | Suitability Petitions Enable Generics | Robert Lionberger, PhD |
| 3:20 - 3:35 PM EDT | Suitability Petitions: A Policy Perspective | Susan Levine, JD |
| 3:35 - 3:55 PM EDT | Best Practices for Submitting a Suitability Petition | Rosanne Pagaduan, PharmD |
| 3:55 - 4:20 PM EDT | Bridging the Difference: Bioequivalence Assessments for Suitability Petitions |
Pamela Dorsey, PhD Heather Boyce, PhD |
| 4:20 - 4:50 PM EDT | Session 8: Q&A Panel |
Robert Lionberger, PhD Susan Levine, JD Rosanne Pagaduan, PharmD Pamela Dorsey, PhD Heather Boyce, PhD Andrew Fine, PharmD Arlene Figueroa, JD |
| 4:50 - 5:00 PM EDT | Closing Remarks | Robert Lionberger, PhD |
Continuing Education Accreditation
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
This activity was planned by and for the healthcare team, and learners will receive 16 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 16.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-22-079-L04-P for 16.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 16.00 contact hour(s).
Requirements for Receiving CE Credit
Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.
Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.
Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Disclosure
Faculty
Planning Committee
CE Consultation and Accreditation Team
Faculty
- Al-Ghabeish, Manar, PhD, Staff Fellow, FDA/CDER/OGD/ORS/DTPII - nothing to disclose
- Alam, Khondoker, PhD, Senior Staff Fellow, U.S. Food and Drug Administration - nothing to disclose
- Anderson, David, PhD, Branch Chief, FDA - I have the following relationship(s): Eli Lilly & Co. - Former employee with vested pension
- BERCU, LISA, JD, Regulatory Counsel, Office of Generic Drug Policy - nothing to disclose
- Ballard, Betsy, MD, Medical officer, CDER/OGD/ORS - nothing to disclose
- Boc, Susan, PhD, Pharmacokineticist, FDA - I have the following relationship(s): The Honest Company Inc - individual stocks; Johnson & Johnson - individual stocks; Target Corporation - individual stocks
- Boyce, Heather, PhD, Pharmacokineticist Team Leader, CDER-OGD - nothing to disclose
- Brown, Janice, MS, Supervisory Biologist, CDER/OPQ/OPPQ - nothing to disclose
- Califf, Robert M., MD, Commissioner, Food and Drug Administration - I have the following relationship(s): Various - My financial disclosure report and ethics agreement are publicly available documents (https://www.oge.gov/web/oge.nsf/home).
- Cui, Dapeng, PhD, Pharmacologist, FDA - nothing to disclose
- Dorsey, Pamela, PhD, Senior Pharmacologist, FDA - nothing to disclose
- Fang, Lanyan, PhD, Deputy Director, FDA - nothing to disclose
- Feibus, Katharine, MD, Team Leader, Device Evaluation Team, FDA/CDER/OGD/ORS/DTP-1 - nothing to disclose
- Feng, Kairui, PhD, Staff Fellow, FDA - nothing to disclose
- Figueroa, Arlene, JD, Regulatory Counsel, Food and Drug Administration - nothing to disclose
- Fine, Andrew, PharmD, Senior Advisor, FDA - nothing to disclose
- Ford, Forest, PharmD, R. Ph, CSO, FDA - nothing to disclose
- Gong, Yuqing, PhD, Staff Fellow, FDA - nothing to disclose
- Grosser, Stella, PhD, Division Director, DBVIII/OB/OTS/CDER - nothing to disclose
- Hartka, Kathryn, PhD, PharmD, Pharmacologist, FDA - nothing to disclose
- Holtgrewe, Nicholas, PhD, Chemist, OPQ/OTR/DCDA - nothing to disclose
- LI, XINRAN, PhD, Staff Fellow, FDA - nothing to disclose
- Levine, Susan, JD, Deputy Director, Division of Policy Development, Office of Generic Drug Policy - nothing to disclose
- Li, Bing, PhD, Pharmacologist, FDA - nothing to disclose
- Li, Hongmei, PhD, SPQA, FDA/CDER/OPQ - nothing to disclose
- Li, Yili, PhD, Chemist, OLDP/OPQ/CDER - nothing to disclose
- Liang, Likan, PhD, Supervisory Chemist, CDER/OPQ/OPQAII/DPQAX - nothing to disclose
- Lionberger, Robert, PhD, Director, Office of Research and Standards - nothing to disclose
- Luke, Markham, MD, PhD, Director, DTP, U.S. Food and Drug Administration - nothing to disclose
- Munshi, Utpal, PhD, Division Director, CDER/OGD/OB/DBI - nothing to disclose
- Newman, Bryan, PhD, Lead Pharmacologist, OGD/ORS/DTP - nothing to disclose
- Pagaduan, Rosanne, PharmD, Supervisory Pharmacist, US F.D.A. - nothing to disclose
- Pang, Eric, PhD, Senior Chemist, CDER/FDA - nothing to disclose
- Qin, Bin, PhD, Staff fellow, FDA - nothing to disclose
- Ren, Ke, PhD, Supervisory Pharmacologist, CDER/OGD/OB/DBIII - nothing to disclose
- Smith, Cameron, PhD, Supervisory Chemist, CDER/OPQ/OLDP/DLBPI/LBB2 - nothing to disclose
- Smith, William, PhD, ORISE Fellow, U.S. FDA - nothing to disclose
- Soukup, Stephanie, MD, Physician, FDA - nothing to disclose
- Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose
- Sun, Wei-Jhe, PhD, Staff fellow, OGD/ORS/DTP II - nothing to disclose
- Thomas, Sherin, PhD, Pharmacologist, FDA - nothing to disclose
- Tsakalozou, Eleftheria, PhD, Staff fellow, US FDA - nothing to disclose
- Verthelyi, Daniela, MD, PhD, Supervisory Biologist, CDER/OPQ/OBP/DBRR-III - nothing to disclose
- WANG, HONGNA, PhD, Chemist, CDER/OPQ/OPPQ - nothing to disclose
- Walenga, Ross, PhD, Senior Chemical Engineer, CDER/OGD/ORS/DQMM - nothing to disclose
- Wang, Jing, PhD, ORISE Fellow, FDA CDER OGD ORS - nothing to disclose
- Wu, Fang, PhD, Senior Pharmacologist, FDA - nothing to disclose
- Yang, Kui, PhD, Senior Research Scientist, US FDA - nothing to disclose
- ZHANG, DEYI, PhD, Senior Chemist, CDER - nothing to disclose
- Zhang, Hongling, PhD, Division Director, FDA - nothing to disclose
- Zhang, Lei, PhD, Deputy Director, Office of Research and Standards, Office of Generic Drugs, CDER, FDA - nothing to disclose
- Zhang, Zhen, PhD, Master Pharmacologist, FDA/CDER/OGD/OB/DBI - nothing to disclose
- Zhou, Hongfei, PhD, Senior Pharmacologist, CDER/OGD/OB/DB III - nothing to disclose
- Zhu, Hao, PhD, Deputy Director, CDER/OTS/OCP/DPM - nothing to disclose
Planning Committee
- Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose
- Soukup, Stephanie, MD, Physician, FDA - nothing to disclose
- Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose
CE Consultation and Accreditation Team
- Harrison, Catherine, CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
- Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.
All relevant financial relationships have been mitigated.
Registration Information
Registration is complimentary; therefore refunds are not applicable.
Registration is complimentary; therefore refunds are not applicable.
Requirements for Certificate of Completion (Non CE)
There are no imposed requirements.
There are no imposed requirements.
U.S. Food and Drug Administration