Article
Chemistry, Multidisciplinary
Brian E. Harvey
Summary: Nonalcoholic fatty liver disease is a growing public health crisis, with no approved drugs or biological treatments for NASH or related liver diseases. The regulatory pathway for product approval is unclear due to extra-hepatic factors and the organizational structure of FDA.
ACTA PHARMACOLOGICA SINICA
(2022)
Article
Engineering, Biomedical
Jiaxin Tian, Xu Song, Yongqing Wang, Maobo Cheng, Shuang Lu, Wei Xu, Guobiao Gao, Lei Sun, Zhonglan Tang, Minghui Wang, Xingdong Zhang
Summary: Combination products, composed of multiple medical devices or drugs/biological products, present unique challenges in research, translation, and regulatory evaluation. New tools and approaches have been developed to assess the safety, efficacy, quality, and performance of combination products, offering opportunities for advancements in regulatory review and science.
BIOACTIVE MATERIALS
(2022)
Editorial Material
Multidisciplinary Sciences
Kevin Klein, Gerrit Borchard, Vinod P. Shah, Beat Fluhmann, Scott E. McNeil, Jon S. B. de Vlieger
Summary: The development of regulatory guidelines for complex generic drug products faces challenges, but existing FDA pathways can be used to approve them. Decisions on which application to submit can be based on FDA classification and guidance document. The aim is to increase clarity on regulatory approaches for complex generics and promote sustainability.
ANNALS OF THE NEW YORK ACADEMY OF SCIENCES
(2021)
Review
Pharmacology & Pharmacy
Marina Lopez-Paniagua, Ana de la Mata, Sara Galindo, Francisco Blazquez, Margarita Calonge, Teresa Nieto-Miguel
Summary: ATMPs are innovative and complex biological products for human use, including cell therapy, tissue engineering, gene therapy, and combined products with medical devices. The development of ATMPs for treating eye diseases has rapidly expanded in recent years, offering novel therapeutic approaches for incurable conditions.
Article
Oncology
Erica C. Nakajima, Paz J. Vellanki, Erin Larkins, Somak Chatterjee, Pallavi S. Mishra-Kalyani, Youwei Bi, Hisham Qosa, Jiang Liu, Hong Zhao, Missiratch Biable, Lauren Tesh Hotaki, Yuan-Li Shen, Richard Pazdur, Julia A. Beaver, Harpreet Singh, Martha Donoghue
Summary: Nivolumab with ipilimumab has been approved by the FDA as first-line treatment for unresectable MPM. The combination therapy showed improved overall survival compared to chemotherapy. The approval was obtained through FDA's Orbis project and international collaboration.
CLINICAL CANCER RESEARCH
(2022)
Review
Microbiology
Tony Yang, Larry G. Kessler, Matthew J. Thompson, Barry R. Lutz
Summary: Home testing for infectious diseases, including COVID-19, has gained significant attention and commercial interest. However, the regulatory science and procedures for approval of home infectious disease tests have not yet been formalized by the FDA. This article discusses the state of home-based testing for influenza, regulatory pathways for market access, and provides recommendations for study designs and other important features.
JOURNAL OF CLINICAL MICROBIOLOGY
(2022)
Article
Hematology
Bindu Kanapuru, Laura L. Fernandes, Lola A. Fashoyin-Aje, Andrea C. Baines, Vishal Bhatnagar, Rachel Ershler, Thomas Gwise, Paul Kluetz, Richard Pazdur, Elizabeth Pulte, Yuan-Li Shen, Nicole Gormley
Summary: African Americans are underrepresented in multiple myeloma clinical trials and have more favorable outcomes compared to patients from other regions.
Editorial Material
Medicine, General & Internal
Joshua M. Sharfstein, Jesse L. Goodman, Luciana Borio
Summary: The FDA plays a crucial role in facilitating the rapid development of COVID-19 vaccines.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
(2021)
Article
Chemistry, Physical
Yunhui Si, Huanyao Liu, Mengsha Li, Xuzhou Jiang, Hongying Yu, Dongbai Sun
Summary: In this study, a metal-organic framework (MOF) based drug delivery platform was used to modify titanium implants, providing them with antibacterial activity, biocompatibility, and osteogenesis-promoting properties. The modified implants released Zn2+ and MV, which caused oxidative damage to E. coli and S. aureus, inhibiting bacterial proliferation. Furthermore, the MV@ZIF-8 coating promoted osteogenic differentiation of human bone mesenchymal stem cells by activating the canonical Wnt/b-catenin signaling pathway. This research demonstrates the potential application of MOF-based drug delivery platforms in bone tissue engineering.
JOURNAL OF COLLOID AND INTERFACE SCIENCE
(2023)
Article
Medicine, General & Internal
Mariana E. Reis, Ana Bettencourt, Helena M. Ribeiro
Summary: Combination products that combine drugs and medical devices have become increasingly complex, posing new regulatory challenges. The lack of a clearly defined principal mode of action (PMOA) for novel combination products makes their classification difficult. This article discusses case studies of innovative combination products and proposes a decision-tree scheme to assist with classification. Current regulations do not fully address the complexity of personalized 3D-printed scaffolds, suggesting a need for multidisciplinary collaborations and systematic processes to adapt to these innovative healthcare solutions and overcome classification challenges.
FRONTIERS IN MEDICINE
(2022)
Article
Surgery
Carter J. Boyd, Jonathan M. Bekisz, Mihye Choi, Nolan S. Karp
Summary: Acellular dermal matrices, derived from human tissue, have significantly advanced breast reconstruction in surgery. However, the U.S. Food and Drug Administration has stated that these matrices are not approved for use in breast reconstruction, leading to the classification of their use as off-label.
PLASTIC AND RECONSTRUCTIVE SURGERY
(2022)
Review
Pharmacology & Pharmacy
Chiara Ferraris, Clara Rimicci, Sara Garelli, Elena Ugazio, Luigi Battaglia
Summary: Nanosystems have various cosmetic functions and properties being widely used in the global market. However, safety concerns and regulatory landscape still need to be considered. The European context shows the most restrictive regulations and main safety concerns regarding nanomaterials.
Article
Engineering, Biomedical
Ellen T. Newsom, Ameneh Sadeghpoura, Ali Entezari, Joan Lace U. Vinzonsa, Ralph E. Stanfordc, Mohammad Mirkhalafb, Daniel Chone, Colin R. Dunstanb, Hala Zreiqat
Summary: We have developed a bioceramic material, Sr-HT-Gahnite, which has the potential to be a fusion device material that mimics the biological and mechanical performance of natural bone. In a study conducted on sheep, it has been shown that this material is safe for systemic use over a period of 26 weeks, indicating the systemic safety of the Sr-HT-Gahnite fusion device.
ACTA BIOMATERIALIA
(2023)
Review
Pharmacology & Pharmacy
William F. Salminen, Olu Aloba, Angela Drew, Agnieszka Marcinowicz, Madelyn Huang
Summary: The 505(b)(2) NDA pathway offers the opportunity to decrease drug development costs and expedite time to market by utilizing existing public data and employing clinical bridging and regulatory strategies. Eligibility for the 505(b)(2) pathway depends on various factors including the active ingredient, drug formulation, and clinical indication. Streamlining and accelerating clinical programs and gaining unique marketing benefits, such as exclusivity, are possible based on the chosen regulatory strategy and product. Considerations regarding chemistry, manufacturing, and controls (CMC) and the specific manufacturing challenges that might arise due to the accelerated development of 505(b)(2) drug products are also addressed.
DRUG DISCOVERY TODAY
(2023)
Article
Oncology
Luckson Mathieu, Sujay Shah, Lee Pai-Scherf, Erin Larkins, Jonathon Vallejo, Xiaoxue Li, Lisa Rodriguez, Pallavi Mishra-Kalyani, Kirsten B. Goldberg, Paul G. Kluetz, Marc R. Theoret, Julia A. Beaver, Richard Pazdur, Harpreet Singh
Summary: Atezolizumab and durvalumab, in combination with chemotherapy, have been approved by the FDA for first-line treatment of extensive stage small cell lung cancer, showing improved overall survival in clinical trials. These approvals mark a significant advancement in treatment options for small cell lung cancer patients.
Article
Pharmacology & Pharmacy
Dedeepya Uppalapati, Manisha Sharma, Zaid Aqrawe, Frazer Coutinho, Ilva D. Rupenthal, Ben J. Boyd, Jadranka Travas-Sejdic, Darren Svirskis
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2018)
Article
Chemistry, Medicinal
Darren Svirskis, Waldron Martis, Prabhat Bhusal, Manisha Sharma, Renus Stowers, Simon W. Young
JOURNAL OF PHARMACEUTICAL SCIENCES
(2018)
Review
Pharmacology & Pharmacy
Sanjukta Duarah, Manisha Sharma, Jingyuan Wen
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS
(2019)
Article
Chemistry, Analytical
V. R. Jayaneththi, K. Aw, M. Sharma, J. Wen, D. Svirskis, A. J. McDaid
SENSORS AND ACTUATORS B-CHEMICAL
(2019)
Review
Pharmacology & Pharmacy
Hani Abdeltawab, Darren Svirskis, Manisha Sharma
EXPERT OPINION ON DRUG DELIVERY
(2020)
Review
Pharmacology & Pharmacy
Mengyang Liu, Jingyuan Wen, Manisha Sharma
CURRENT PHARMACEUTICAL DESIGN
(2020)
Article
Chemistry, Medicinal
Mengyang Liu, Manisha Sharma, Guo-Liang Lu, Naibo Yin, Murad Al Gailani, Sree Sreebhavan, Jingyuan Wen
DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY
(2020)
Review
Pharmacology & Pharmacy
Sana Al-Jawadi, Sachin S. Thakur
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2020)
Article
Chemistry, Physical
Young Eun Park, Kaushik Chandramouli, Maureen Watson, Mark Zhu, Karen E. Callon, Donna Tuari, Hani Abdeltawab, Darren Svirskis, David Shaun Musson, Manisha Sharma, Jillian Cornish
Summary: The study investigated the potential of poloxamers for sustained delivery of LF to enhance local bone regeneration. The LF/poloxamer formulations supported cell viability and did not induce unfavorable immune responses, but did not demonstrate enhanced bone regeneration in the rat calvarial defect model.
Article
Pharmacology & Pharmacy
Hani Abdeltawab, Jagdish Kumar Jaiswal, Simon W. Young, Darren Svirskis, Andrew Hill, Manisha Sharma
Summary: This study demonstrates the chemical stability of BH/KT parenteral admixtures for a period of 4 weeks when stored at room temperature. The developed HPLC method allows for simultaneous determination of BH and KT concentrations in human plasma, facilitating pharmacokinetics studies.
EUROPEAN JOURNAL OF HOSPITAL PHARMACY
(2023)
Article
Pharmacology & Pharmacy
Hani Abdeltawab, Scott M. Bolam, Jagdish K. Jaiswal, Sue R. McGlashan, Simon W. Young, Andrew Hill, Darren Svirskis, Manisha Sharma
Summary: A thermoresponsive in situ gelling system based on poloxamer was developed for sustained delivery of bupivacaine hydrochloride and ketorolac tromethamine. The system demonstrated prolonged drug release and potential clinical benefits.
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS
(2022)
Review
Pharmacology & Pharmacy
Harpinder K. Brar, Jiney Jose, Zimei Wu, Manisha Sharma
Summary: This review explores the potential of targeted therapies, such as tyrosine kinase inhibitors (TKIs), in treating glioblastoma multiforme (GBM). It also analyzes the reasons why TKIs have been unsuccessful in clinical trials for GBM despite their success in treating other cancer types. The main focus is on promising drug delivery strategies, particularly the use of nanocarriers, to enhance the efficacy of TKIs in GBM by overcoming the limitations imposed by the blood-brain barrier.
Article
Polymer Science
Hani Abdeltawab, Darren Svirskis, Andrew G. Hill, Manisha Sharma
Summary: This study aims to investigate different formulation approaches to minimize the initial burst release and extend the release time of the small hydrophilic drug bupivacaine hydrochloride from poloxamer-based thermoresponsive gels.
Article
Polymer Science
Eileen Hulambukie, Hani Abdeltawab, Sanjukta Duarah, Darren Svirskis, Manisha Sharma
Summary: This study aims to develop an NRT formulation that offers sustained nicotine release. Thermoresponsive in situ gelling systems containing nicotine were successfully prepared using poloxamer. The optimized formulation demonstrated prolonged release of nicotine.