Others have taken note of Dr. Niazi’s extensive work, and through published articles and awarded accolades, celebrated his accomplishments. Find below examples of the kind words that have been shared on Dr. Niazi’s feats and endeavors. And also, the talks Dr. Niazi has given.
. Invited presentation at the Regulatory and Development Strategies Biosimilars Markets Access and Commercialization Strategies Summit, Boston September 18-19, The Westin Boston Waterfront. Biosimilar Market Access and Commercialization Strategies Summit provides detailed presentations, intensive case studies and collaborative panel discussions relevant to many fields including biosimilars. Dr. Niazi will be speaking on the topic of why do biosimilar filings fail and how we can manage them to assure fast to market approval, based on his 20+ years of developing biosimilars, writing the largest numbers of books on the subject and holding the largest number of bioprocessing patent in the world that help reduce the development and approval cycle.
The American Statistical Association Biopharmaceutical Section Regulatory-Industry Statistics Workshop was originally a meeting for the FDA statisticians that later expanded to include all statisticians interested in statistical practices for all areas regulated by the FDA. This year over 800 people are expected to attend this workshop on Sep. 25-27, 2017 in Marriott Wardman Park, Washington D.C.
Dr. Niazi is providing a unique thermodynamic equivalence insight into Statistical Evaluation of Generic Transdermal Delivery Systems and Tropical Patches, as one of his areas of expertise and plans to participate in several sessions relating to biosimilars. The FDA provides the following comment on the Niazi's session: “With the passage of Generic Drug User Fee Act (GDUFA), there is an increased emphasis on research for generic drugs, especially in the field of statistical evaluation of generic transdermal delivery systems and topical patches (hereafter referred as TDS products). Office of Generic Drugs (OGD) in FDA CDER recommends two types of studies for TDS products Abbreviated New Drug Applications (ANDAs): one is bioequivalence (BE) with pharmacokinetic (PK) endpoints study, and the other one is the skin irritation, sensitization and adhesion study. For skin irritation, sensitization, and adhesion study, the applicant usually conducts two studies, an adhesion study and an irritation/sensitization study. To support regulatory approval, in addition to the bioequivalence of PK endpoints, the test product must adhere at least as well as the reference product, be no more irritating than the reference and be no more sensitizing than the reference. This session will discuss statistical issues, challenges and approaches in the adhesion study and irritation/sensitization study for generic TDS products.”
Given below is a listing of all session; of great significance if you are involved in biosimilars development
Tuesday Sept 26, Parallel Session 1 ( 1:15 to 2:30 p.m.)
200359 Panel Session: Better characterization of disease burden by using recurrent event endpoints
200296 Parallel Session: Sample Size Re-Estimation in Regulatory Applications, Experiences and Lessons Learned
200377 Parallel Session: Statistical Opportunities in Disease Interception – Screening, Intervention, and Evaluation of Benefit-Risk Trade-Offs
200311 Parallel Session: Advances in handling non-proportional hazard issues under different clinical settings
200392 CMC2 Session: Statistical Considerations when assessing product stability and/or Shelf-Life
200315 Parallel Session: Statistical Evaluation of Generic Transdermal Delivery Systems and Topical Patches
Tuesday Sept 26, Parallel Session 2 (2:45 to 4:00 p.m.)
200361 Town Hall Session: Enhanced regulatory and sponsor interactions for modern drug development
200301 Parallel Session: Adaptive randomization: a balance between innovation, bias reduction, regulatory and ethical considerations
200385 Panel Session: Bayesian Methods in Assessing Benefit-Risk Preference in a Structured Framework
200317 Parallel Session: Recent Advancements in Statistical Methods and Tools for Go/No-Go Decision Making
200393 CMC1 Session: Product quality tests and clinical evaluation for transdermal patches
200360 Parallel Session: Adaptive design for biosimilar product development
Tuesday Sept 26, Parallel Session 3 (4:15 to 5:30 p.m.)
200375 Parallel Session: Statistical Issues and Challenges in Regulatory Animal Drug Studies
200338 Parallel Session: Different Approaches to the Increase of a Sample Size When the Unblinded Interim Estimate of the Treatment Effect Looks Promising.
200355 Parallel Session: Recent Bayesian Applications/Examples in Clinical Trials
200369 Parallel Session: Win ratio: Recent methodological developments and applications in clinical trial design and analysis
200394 CMC3 Session: Statistical advances in demonstration of analytical similarity
200363 Parallel Session: Drug combination dose finding studies in oncology
5:30 p.m. to 6:30 p.m.
Mixer to immediately follow
Wednesday Sep 27, Parallel Session 4 (8:30 to 9:45)
200352 Parallel Session: Pragmatic Trials – Past, Current and Future?
200340 Parallel Session: What Industry and FDA see: How Adaptive Our Clinical Trials Are
200342 Parallel Session: Recommendations from the Clinical Trials Transformation Initiative Data Monitoring Committee Project
200326 Parallel Session: Choosing Estimands and Sensitivity Analyses in Clinical Trials – The Impact of the ICH E9(R1) Addendum
200314 Parallel Session: Best Practices in Concentration-QTc Modeling - Recommendations from the ICH E14 Scientific White Paper
200328 Parallel Session: Patient-reported outcomes (PROs) in oncology and hematology trials-past, present and future
Wednesday Sep 27 9:45 a.m. to 10:30 a.m.
Poster Session - Atrium
Wednesday Sep 27, Parallel Session 5 (10:45 to 12:00pm)
200310 Parallel Session: Statistical Challenges for Medical Tests with Reference Databases
200345 Parallel Session: Unlocking the power of exploratory analysis in clinical research
200302 Parallel Session: Simulation Practices for Adaptive Trial Designs
200335 Parallel Session: Estimand, Causal Inference, and Missing Data
200386 Parallel Session: Statistical Challenges and Potential Solutions for Small Clinical Trials
200336 Parallel Session: Listening to Patients: Developing, Validating, and Analyzing Patient Reported Outcomes for Clinical trials
Wednesday Sep 27, Parallel Session 6 (1:15 to 2:30pm)
200351 Parallel Session: Statistical Issues in Agreement studies
200306 Parallel Session: Challenges in using meta-analysis for regulatory decision making
200322 Parallel Session: ICH E17 on Multi-Regional Clinical Trials (MRCTs)
200387 Parallel Session: New Applications of Missing Data Methodologies in Clinical Trials
200368 Parallel Session: How we determine and communicate who benefits from which treatment and by how much
200332 Parallel Session: Challenges and Utility of Analyses of Actigraphy Data
Wednesday Sep 27, Parallel Session 7 (2:45 to 4:00pm)
200388 Parallel Session: Developing and Validating Classifiers in the Context of Diagnostic Devices
200305 Parallel Session: Evaluation of treatment-switching in oncology and hematology registration clinical trials - What and how should it be done?
200318 Parallel Session: Seeing is believing: effective use of statistical graphics across drug development
200358 Parallel Session: Real World Evidence in Clinical Trial: New Era of Informed Decision Making Session
200346 Parallel Session: Subgroup Analysis in Clinical Trial: Where are We Now?
200391 Parallel Session: Multiplicity Issues in Clinical Drug Development
Pharmaceutical Scientist, Inc.: FDA Calls For Public Comments On Bioequivalence Testing
In a significant move, the US Food and Drug Administration (FDA) is asking for public comments on bioequivalence testing of generic drugs, specifically novel dissolution methods, to allow biowaivers for all types of drugs. The call comes in response to a Citizens Petition filed by Dr. Sarfaraz K. Niazi, Executive Chairman, Pharmaceutical Scientist, Inc., and Adjunct Professor of Biopharmaceutical Sciences at the University of Illinois at Chicago College of Pharmacy and author of dozens of books and research papers on the subject (www.niazi.com).
Dr. Niazi would like to speed the approval process for generic drugs to get medicine to patients as quickly and cost-effectively as possible by using a faster process called thermodynamic equivalence. The FDA has agreed to the validity of Niazi’s argument, in theory at least. In a response letter to Dr. Niazi’s petition, Dr. Janet Woodcock, Director of the Center for Drug Evaluation Research at the FDA, wrote that her department “is largely responsive to your request that we "open comment" on novel dissolution tests that can be used to establish bioequivalence…Therefore, your Petition is granted….” “It has taken years of communication with FDA to reach this stage,” said Niazi.
The focus of expanding biowaivers in the petition calls for establishing a new parameter—thermodynamic equivalence, to obviate the need for blood level studies that significant biologic variability that confounds true differences between products. The suggested change fits well within the purview of the Fair Access for Safe and Timely Generics Act of 2017 or the FAST Generics Act of 2017 and other measures taken by the FDA to allow faster approval of generic chemical and biosimilar drugs. Thermodynamic equivalence demonstration requires identifying dissolution conditions that can discriminate differences in chemical potential, a process created by Dr. Niazi. Thermodynamic equivalence can be used to assure life-cycle clinical equivalence of a generic product and provide a critical measure of GMP compliance.
Now Dr. Niazi is calling on the scientific community to send their feedback to the FDA. “I am encouraging scientists to respond to this challenge and help reduce the cost and time to approval for both chemical and biologic drugs,” said Dr. Niazi. To participate in the public comments, go to https://www.regulations.gov/comment?D=FDA-2007-P-0055-0004 and the correspondence between FDA and Pharmaceutical Scientist, Inc., a global science-driven idea company (www.pharmsci.com).
At the 4th Annual Biomanufacturibg Summit, Dr. Niazi analyzes the major hurdles, never fully recognized, that have caused delays in approvals and escalated cost of development of biosimilars in USA and offers clear solutions. Read the presentation here.
Title: Bioinnovation of Future for Cost Optimization. Dr. Niazi discloses a complete plan, from facility design to upstream and downstream manufacturing in ISO9 environment, continuous processing and a cost-optimized manufacturing platform that is a subject of dozens of US and worldwide patents owned by Dr. Niazi.
Safaraz K. Niazi, Founding Executive Chairman, Therapeutic Proteins International
As the conference chair for the 2015 Bioproduction Summit in San Francisco, California, Dr Niazi lead discussion around the manufacturing and development of biosimilars.
For three decades, the Chicago Area Entrepreneurship Hall of Fame has been honoring local entrepreneurs that have left their mark on the business community and the city of Chicago
IBM Research and the Accelerated Discovery Forum invited Dr. Niazi as Distinguished Speaker at the IBM Research Distinguished Seminar Series on 9th April 2015. Dr. Niazi spoke of the changes in biological processing hat are coming to accommodate the new types of biological drugs and the need to develop these drugs on a faster path. A copy of his presentation is provided here.
Dr. Niazi speaks at the Bisimilar 2015 Conference. Click here to see the presentation titled A Pure play Perspective
Each year, the UIC College of Pharmacy recognizes alumni who have distinguished themselves through their research and service and who embody the highest values...
CEO da Therapeutic Proteins International, o indiano Sarfaraz Khan Niazi é um defensor da popularização dos biossimilares como alternativa aos custos crescentes na saúde
The Epress, Pakistan.
He wrote his first world-renowned book at the age of 26. On weekends he recites love poems (ghazals) on Voice of America. He casually – and humbly – references his more than 70 patents that range from aging wine to chewing gum to bioreactors...
CEO of Therapeutic Proteins International, the Indian Sarfaraz Khan Niazi is a defender of the popularization of biosimilars as an alternative to rising health costs...
The 2010 Affordable Care Act created a shorter licensing path for lower-cost versions of cell-derived drugs called biologics. Sarfaraz Niazi is working to get among the first of these substitute drugs called biosimilars approved...
Sarfaraz Niazi grew up in India and, as a pharmaceutical consultant later, visited impoverished countries where families sometimes had to choose between buying medicine for one child or food for them all...
Illinois Governor Pat Quinn congratulated Dr. Sarfaraz K. Niazi, a long-time Illinois resident, for being awarded the Pakistani civil award Sitara-i-Imtiaz (Star of Excellence) announced on Pakistan's Independence Day...
26 June, 2013