Advancing Generic Drug Development: Translating Science to Approval
September 21 - 22, 2021
Webcast
This conference will advance the same concepts to help the generic industry pave a clear scientific pathway for generic drug development. We will focus on common scientific issues seen in Abbreviated New Drug Applications (ANDAs), commonly known as generic drug applications. We will link GDUFA science and research on complex products and complex scientific issues to product-specific guidance development, discuss pre-ANDA meetings and assessment, and examine various areas of the science behind generic drug development.
- Product-Specific Guidances for Generic Drug Development https://www.fda.gov/drugs/guidances-drugs/product-specific-guidances-generic-drug-development
- Generic Drug Development https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/generic-drug-development
- Apply various mechanisms and processes that industry can use to obtain advice from FDA to facilitate generic drug development.
- Comprehend new developments in science, guidance, and review experience for specific types of generic drug products.
This activity is intended for physicians, pharmacists, and nurses.
Day 1 September 21, 2021
Time | Topic | Speaker |
---|---|---|
8:30 - 8:45 AM EDT | Day One Introduction |
Brenda Stodart, PharmD, MS, BCGP, RAC
Not offered for CE |
8:45 - 9:00 AM EDT | Keynote | Janet Woodcock, MD |
9:00 - 9:20 AM EDT | Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency | Mitchell Frost, MD |
9:20 - 9:40 AM EDT | Alternative Bioequivalence (BE) Approaches for Data Analysis Due to COVID-19 Related Study Interruptions | Yuqing Gong, PhD |
9:40 - 10:00 AM EDT | Quality Consideration in the Development of FDA Guidance “Temporary Policy on Repackaging or Combing Propofol Drug Products During the COVID-19 Public Health Emergency” | Gloria Huang, PhD |
10:00 - 10:20 AM EDT | Practice and Lessons Learned for Conducting Adaptive Designs in Generic Drug Development | Kairui Feng, PhD |
10:20 - 10:50 AM EDT | Panel Discussion and Questions |
Mitchell Frost, MD Yuqing Gong, PhD Gloria Huang, PhD Kairui Feng, PhD Kimberly Witzmann, MD Stella Grosser, PhD |
10:50 - 11:05 AM EDT | Break | |
11:05 - 11:25 AM EDT | Nasal Insufflation Studies for Abuse-Deterrent Formulations (ADF) of Opioids | SAEID RAOFI, MS |
11:25 - 11:45 AM EDT | Advancement in Evaluation of Abuse-Deterrent Formulations (ADF) for Opioid Analgesics: Research and Review Perspectives | Manar Al-Ghabeish, PhD |
11:45 - 12:05 PM EDT | PBPK Absorption Modeling and Virtual Bioequivalence to Support Generic Drug Development and Regulatory Decision Making for Oral Products | Fang Wu, PhD |
12:05 - 12:25 PM EDT | Safety Assessment of Flavors in Generic Drug Products | Melanie Mueller, PhD, PharmD |
12:25 - 12:55 PM EDT | Panel Discussion and Questions |
Fang Wu, PhD SAEID RAOFI, MS Manar Al-Ghabeish, PhD Melanie Mueller, PhD, PharmD Xiaoming Xu, PhD Huzeyfe Yilmaz, PhD Heather Boyce, PhD |
12:55 - 1:30 PM EDT | Lunch | |
1:30 - 1:50 PM EDT | Advances in Iron Colloid Products: Product-Specific Guidance (PSG) Discussion | Wenlei Jiang, PhD |
1:50 - 2:10 PM EDT | Advances in Iron Colloid Products: Comparability Study Considerations from a Quality Perspective | YIWEI LI, PhD |
2:10 - 2:30 PM EDT | Injectable Suspensions: Tools and Methods Bridging the In Vivo and In Vitro Gap | Bin Qin, PhD |
2:30 - 3:00 PM EDT | Questions and Panel Discussion |
Bing Li, PhD Darby Kozak, PhD Wenlei Jiang, PhD YIWEI LI, PhD Bruce Lerman, PhD |
3:00 - 3:15 PM EDT | Break | |
3:15 - 3:35 PM EDT | Addressing Challenges in the Approval of Complex Ophthalmic and Otic Generic Products: Bioequivalence (BE) Perspectives | Chunsheng Zhao |
3:35 - 3:55 PM EDT | Addressing Challenges in the Approval of Complex Ophthalmic and Otic Generic Products: Quality Perspectives | Poonam Chopra, PhD |
3:55 - 4:15 PM EDT | Physiological Based Pharmacokinetic Modeling and Simulation (PBPK) Modeling to Support Generic Ophthalmic Drug Product Development and Regulatory Decision Making | MINGLIANG TAN, PhD |
4:15 - 4:45 PM EDT | Panel Discussion and Questions |
Chunsheng Zhao Poonam Chopra, PhD MINGLIANG TAN, PhD Yan Wang, PhD Asif Rasheed, PhD Yu Kai Kwok, PhD |
4:45 - 4:50 PM EDT | Closing Remarks | Lei Zhang, PhD |
Time | Topic | Speaker |
---|---|---|
8:30 - 8:40 AM EDT | Day Two Introduction |
Renu Lal, Pharm.D.
Not offered for CE |
8:40 - 9:00 AM EDT | Utility of Artificial Intelligence to Facilitate the Development and Regulatory Assessment of Complex Generic Drugs | MENG HU, PhD |
9:00 - 9:20 AM EDT | Model-Integrated Evidence for Bioequivalence (BE) Assessment of Complex Generic Drugs | Miyoung Yoon, PhD |
9:20 - 9:40 AM EDT | Scanning Electron Cryomicroscopy (Cryosem) for Characterization of Complex Drug Products | Huzeyfe Yilmaz, PhD |
9:40 - 10:00 AM EDT | Advanced Imaging and Data Analysis to Support Compositional Structure Similarity of Polymeric Matrix Formulations | Yan Wang, PhD |
10:00 - 10:30 AM EDT | Questions and Panel Discussion |
MENG HU, PhD Huzeyfe Yilmaz, PhD Yan Wang, PhD Daniel Willett, PhD Miyoung Yoon, PhD Robert Lionberger, PhD |
10:30 - 10:45 AM EDT | Break | |
10:45 - 11:05 AM EDT | Product-Specific Considerations for Alternative Bioequivalence (BE) Approaches to Comparative Clinical Endpoint BE Studies | Susan Boc, PhD |
11:05 - 11:25 AM EDT | Guidance on Studies Interrupted Due to COVID-19 for Nasal and Inhalation Products | Vipra Kundoor, PhD |
11:25 - 11:45 AM EDT | Demonstrating Bioequivalence with Inhalation Spray Drug Products | Sneha Dhapare, PhD |
11:45 - 12:05 PM EDT | Comparative Analyses for Inhalation Products | Michael Spagnola, MD |
12:05 - 12:35 PM EDT | Panel Discussion and Questions |
Changning Guo, PhD Michael Spagnola, MD Sneha Dhapare, PhD Susan Boc, PhD Vipra Kundoor, PhD Bryan Newman, PhD BING CAI, PhD |
12:35 - 1:10 PM EDT | Lunch | |
1:10 - 1:30 PM EDT | “No Difference” Standard vs. Q1|Q2 Sameness for Topical Drug Products | Megan Kelchen, PhD |
1:30 - 1:50 PM EDT | Use of Q3 Characterization Tests for Bioequivalence (BE) of Topical Semisolid Drug Products | Sameersingh (Sam) Raney, M.S., Ph.D. |
1:50 - 2:10 PM EDT | Recent Research Related to Q3 Characterization of Topical Products Containing Porous Microparticles | Ahmed Zidan, PhD |
2:10 - 2:40 PM EDT | Virtual Bioequivalence for Topical Drug Products |
Eleftheria Tsakalozou, PhD Khondoker Alam, PhD |
2:40 - 3:10 PM EDT | Panel Discussion and Q&A |
Megan Kelchen, PhD Sameersingh (Sam) Raney, M.S., Ph.D. Ahmed Zidan, PhD Eleftheria Tsakalozou, PhD Markham Luke, MD, PhD Khondoker Alam, PhD |
3:10 - 3:20 PM EDT | Break | |
3:20 - 3:40 PM EDT | Common Issues Identified in In Vitro Release Test (IVRT) And In Vitro Permeation Test (IVPT) Studies Submitted in an Abbreviated New Drug Application (ANDA) To Support Bioequivalence | Josephine Aimiuwu, PhD |
3:40 - 4:00 PM EDT | Theoretical Principles and Best Practices: In Vitro Release Test (IVRT) | Tannaz Ramezanli, PhD, PharmD |
4:00 - 4:20 PM EDT | Theoretical Principles and Best Practices: In Vitro Permeation Test (IVPT) | Priyanka Ghosh, PhD, Ph.D. |
4:20 - 4:50 PM EDT | Panel Discussion and Questions |
Tannaz Ramezanli, PhD, PharmD Sameersingh (Sam) Raney, M.S., Ph.D. Markham Luke, MD, PhD Josephine Aimiuwu, PhD Priyanka Ghosh, PhD, Ph.D. |
4:50 - 5:00 PM EDT | Closing Remarks | Robert Lionberger, PhD |
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.
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.
Faculty
- Aimiuwu, Josephine, PhD, Pharmacologist, FDA/CDER/OGD/OB/DBII - nothing to disclose
- 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
- Boc, Susan, PhD, Pharmacokineticist, FDA I received Stocks from Johnson & Johnson, Target for a role as Stockholder. My spouse received Stocks from Costco, Johnson & Johnson, 3M, Pfizer, Target, Walmart, Starbucks, Coca-Cola, Proctor & Gamble, Amgen, Altria Co., Philip Morris, Viatris Inc., Kraft Heinz Co., Beyond Meat, Kroger for a role as Stockholder.
- Boyce, Heather, PhD, Pharmacokineticist Team Leader, CDER-OGD - nothing to disclose
- CAI, BING, PhD, DIVISION DIRECTOR, CDER/OPQ/OLDP - nothing to disclose
- Chopra, Poonam, PhD, Chemist, OPQ - nothing to disclose
- Dhapare, Sneha, PhD, Visiting Associate-Pharmacologist, FDA - nothing to disclose
- Feng, Kairui, PhD, Staff Fellow, FDA - nothing to disclose
- Frost, Mitchell, MD, medical officer, FDA CDER - nothing to disclose
- Ghosh, Priyanka, PhD, Ph.D., Lead Pharmacologist, CDER/OGSD/ORS/DTP My spouse received Salary from Amazon.com Services LLC for a role as Employee. My spouse received Stocks from Amazon.com Services LLC for a role as Employee.
- Gong, Yuqing, PhD, Staff Fellow, FDA - nothing to disclose
- Grosser, Stella, PhD, Division Director, DBVIII/OB/OTS/CDER - nothing to disclose
- Guo, Changning, PhD, Research Chemist, FDA/CDER/OPQ/OTR/DCDA - nothing to disclose
- HU, MENG, PhD, Staff Fellow, CDER\OGD\ORS\DQMM - nothing to disclose
- Huang, Gloria, PhD, Lead Chemist, FDA/CDER/OPQ/OLDP/DLBPII - nothing to disclose
- Jiang, Wenlei, PhD, Senior Advisor for Innovation and Strategic Outreach, Office of Research and Standards/Office of Generic Drugs/CDER - nothing to disclose
- Kelchen, Megan, PhD, Senior Pharmacologist, FDA - nothing to disclose
- Kozak, Darby, PhD, Supervisory Chemist, FDA/CDER/OGD/ORS/DTP1 - nothing to disclose
- Kundoor, Vipra, PhD, Pharmacologist, Food and Drug Administration - nothing to disclose
- Kwok, Yu Kai, PhD, Senior Pharmaceutical Quality Assessor, FDA - nothing to disclose
- LI, YIWEI, PhD, Supervisory Chemist, CDER/OPQ/OPMA - nothing to disclose
- Lal, Renu, Pharm.D., Pharmacist, FDA - nothing to disclose
- Lerman, Bruce, PhD, Lead Pharmacologist, FDA - nothing to disclose
- Li, Bing, PhD, Pharmacologist, FDA - 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
- Mueller, Melanie, PhD, PharmD, Lead Toxicologist, FDA/CDER/OGD - nothing to disclose
- Newman, Bryan, PhD, Lead Pharmacologist, OGD/ORS/DTP My spouse received Salary from AstraZeneca for a role as Employee.
- Qin, Bin, PhD, Staff fellow, FDA - nothing to disclose
- RAOFI, SAEID, MS, Pharmacologist, FDA - nothing to disclose
- Ramezanli, Tannaz, PhD, PharmD, Pharmacologist, FDA - nothing to disclose
- Raney, Sameersingh (Sam), M.S., Ph.D., Associate Director for Science, United States Food and Drug Administration - nothing to disclose
- Rasheed, Asif, PhD, Pharmaceutical Quality Assessor, OPQA-II/OPQ/CDER/FDA - nothing to disclose
- Spagnola, Michael, MD, Lead Physician, US Food and Drug Administration - nothing to disclose
- Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose
- TAN, MINGLIANG, PhD, Staff Fellow, CDER/OGD/ORS - nothing to disclose
- Tsakalozou, Eleftheria, PhD, Staff fellow, US FDA - nothing to disclose
- Wang, Yan, PhD, Acting team lead, U.S. FDA - nothing to disclose
- Willett, Daniel, PhD, Chemist, US FDA - nothing to disclose
- Witzmann, Kimberly, MD, Deputy Office Director, FDA/CDER/OGD/OSCE - nothing to disclose
- Woodcock, Janet, MD, Acting Commissioner of Food and Drugs, FDA - nothing to disclose
- Wu, Fang, PhD, Senior Pharmacologist, FDA - nothing to disclose
- Xu, Xiaoming, PhD, Division Director, FDA/CDER/OPQ/OPQR/DPQRV - nothing to disclose
- Yilmaz, Huzeyfe, PhD, Research Scientist, FDA - nothing to disclose
- Yoon, Miyoung, PhD, Reviewer, DPM/OCP/OTS/CDER/FDA - nothing to disclose
- Zhang, Lei, PhD, Deputy Director, Office of Research and Standards, Office of Generic Drugs, CDER, FDA My spouse received Other - Consulting fees from Alavanda Regulatory and Drug Development Consulting, Inc. for a role as Consultant.
- Zhao, Chunsheng, Staff Fellow, Food and Drug Administration - nothing to disclose
- Zidan, Ahmed, PhD, Senior staff fellow (Pharmacologist), FDA - nothing to disclose
Planning Committee
- Kleppinger, Cynthia, MD, Medical Officer, FDA - nothing to disclose
- Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - 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
Registration is complimentary; therefore refunds are not applicable.
Must attend 85% of the activity.