With broad experience across multiple disciplines, Dr Niazi’s expertise includes developing business, conducting research and generating innovation. Here are a few areas of expertise that is of current significance and partnership. To learn more about Dr. Niazi's expertise, visit the Contact page.
Bioequivalence Waivers Using Thermodynamic Equivalence Testing
A Citizens Petition filed by Dr. Sarfaraz K. Niazi, Adjunct Professor of Biopharmaceutical Sciences at the College of Pharmacy, University of Illinois, Chicago, a well-recognized authority on bioequivalence testing, having written dozens of books on the subject, and having hands on experience in conductive bioequivalence and biosimilarity testing, was granted by FDA. In a response letter to Dr. Niazi, Dr. Janet Woodcock, Director, CDER, wrote: “We believe that the current system of publishing product-specific recommendations for generic drug development, in conjunction with our other efforts to obtain public input on and disseminate our current thinking on bioequivalence testing methodologies, is largely responsive to your request that we "open comment" on novel dissolution tests that can be used to establish bioequivalence. These initiatives and efforts inform how we exercise our discretion to recommend a particular method for demonstration of bioequivalence or specific study design fora proposed generic product, and enable us to advance our regulatory science more generally with regard to bioequivalence testing. Therefore, your Petition is granted in part to the extent that it asks us to open comment on novel dissolution tests that can be used to establish bioequivalence”. The focus of expanding biowaivers in the petition is based on establishing a new parameter—thermodynamic equivalence, to obviate the need to examine differences in products by adding large biologic variability, an approach that 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 and biosimilar drugs.
Blood level testing (PK studies) are not required by statute that defines bioequivalence as a measure of concentration at the "site of action." that is in most cases not known, and rarely accessible; as a result, the FDA suggested blood level studies as a "surrogate test." This assertion followed the system of biowaivers where the risk of equivalence is minimal, such as highly soluble and easily penetrable drugs. While biowaivers have reduced some burden, a scientific basis of measuring the chemical potential of a dosage form remains the best surrogate test for therapeutic equivalent, as proposed by Dr. Niazi. The variability of biological factors confounds the difference between products and inevitably requires expensive large studies to establish equivalence if thermodynamic equivalence is demonstrated--from this point forward, the interaction of drug molecules will be similar. Dissolution rate is one measure of thermodynamic potential of a dosage form but creating a model, such as through novel dissolution conditions, not necessarily emulating any physiologic process, allows a side-by-side demonstration of equivalence.
The FDA is always responsive to scientific arguments and now we have an opportunity to change the course of development of chemical generic and biosimilar drugs by responding to there challenge given by the FDA.
Please write to me, if you wish to receive details on how to design thermodynamic equivalence studies that will be acceptable to the FDA for awarding biowaivers.
Fast to Market Biosimilars
After spending over two decades in developing biosimilars, from cell line to market, that included cytokines, hormones, antibodies and many more, and after writing several pivotal books on the subjects, I have come to realize that "a biosimilar delayed is a biosimilar denied," and there is a dire need to rethink the development model for biosimilars that does not cost hundreds of millions dollars and many years. I am now developing several biosimilars using this model and invite inquiry if you are interested in acquiring technology, or supply of finished product and any level of regulatory involvement--this model, now opens the opportunity for companies not associated with manufacturing to become the largest supplier of biosimilars. Following are the service ads associated with this exprtise:
Selecting the Right Product
Biosimilars are classified into three categories, from the fastest to longest to market based on FTO, technical complexity, clinical design and cost. I have developed a proprietary model to short list products, even if you do not have any financial constraints. There is always a way to do things smartly.
Complete 351k filing map
The FDA guidance provides a mapping opportunity, that will always be molecule-specific. Getting the most of the meetings reduces the development timeline. With years of experience, I can help develop a mapping that could provide a timeline and cost-line earlier in the development stages.
Review of BLA
While the CMC/GMP remains the key component, a 351k approval requires an entirely different perspective on demonstrating biosimilarity--how to decide what to present, and how to present makes big difference that one understands through a scientific approach and experience of applying these metrics.
Managing FDA meetings
Writing meeting requests takes good understanding of science and a better understanding of the art of communication. After writing dozens of books on this subject, I can show you how to make these meetings conclusive, not just informative.
Freedom to Operate Opinions
As a patent law practitioners and as someone who has written most on bioprocessing, I have created a team of patent law experts to provide a FTO that is specific and conclusive.
High Concentration Formulations
As biologics come off patent, one strategy used by the reference product owners is to create alternate delivery systems, higher concentration being one of the most important. Can you justify to FDA a 351k with a different formulation; yes, you can, if you can dig into scientific justification.
Novel Methods for Establishing Analytical Similarity
The 351k approval is mostly dependent on demonstrating at least a high similarity, if not a finger-print similarity. Creating a tier-based statistical model requiring CQAs is critical and so are novel analytical methods; know that FDA is always responsive to creativity.
505(b)(2) filing of biologics
Till 2019 end we have a window of opportunity for several biological drugs to be filled under 505(b)(2); how does this filing differ from 351k and how you can make the mandatory fee submission with first meeting is important to understand.
Managing COGS of biological drugs
The current average off $500 Million to a Billion dollars needed to establish biologic manufacturing impacts the COGS, which may not be as important for new drugs, but certainly matter in a competitive markets. I am the largest solo inventor of bioprocessing technology, and related proprietary methods to get you started fast and at most optimal capital cost. The technology includes:
Low Cost Manufacturing Facility
The risk-based GMP establishes measures to assure safety of the product; decades ago, the industry adopted a facility design that was hard-walled model but now we have better technology to justify alternate designs of much lower cost, in both capital and maintenance. I have patented several designs that allow manufacturing in ISO9 environment.
The future of biological manufacturing is undoubtedly in single-use elements; having written a book on the subject, I can assist in creating a compliant facility where the challenges of leachable are minimized and COGS reduced substantially.
Single Container Manufacturing
The classical upstream/downstream model can be redefined by focussing on the expressed molecule; dozens of patents that I own allow expressing and purifying the biological molecule in a single container allowing faster development of clinical supplies.
Minimizing Variability Due to PTMs
Nothing produces more variability than the stress on the cells and expressed proteins. Several proprietary and patented methods now allow achieving high consistency of structure, besides increasing the total yield, to allow faster development of biosimilars.
A long-sight dream is now possible using a train of single-use containers feeding down to recover expressed protein continuously reducing contamination risk and COGS, as well as constraints on the facility size.
Clinical Supplies from Smaller Facilities
New drugs, biosimilars and any alternations thereof need to be manufactured in facilities that cost hundreds of millions to offer a clinical supply; what if we have a system that does not require a GMP-certified facility to produce a safe product? We now do have this opportunity opening the door to R&D organizations and smaller companies to seek out the fast expanding market of biologics.
GMP Manufacturing Facility
The FDA and EMA have adopted a risk-based GMP stance that requires a fresh look at how the GMP facilities are designed including the HVAC systems, area separation, and point of use compliance to reduce the cost of constructing and maintaining facilities. The design technology includes:
Patented HVAC Design to Reduce Cost by 70-80%
Single-Use Systems to Reduce Utilities
Continuous Automated Compliance
Other Areas of Expertise
LinkedIn Endorsements: Over 3,000 for skills: Biotechnology, Pharmaceutical Industry, Technology Transfer, Protein Chemistry, Life Sciences, Formulation, Biopharmaceuticals, GMP, FDA, Research, Vaccines, SOP, Regulatory Affairs, GLP, Analytical Chemistry, Validation, Cell Culture, Pharmacokinetics, Biochemistry, Medical Devices, Drug Delivery, R&D, Sop, Microbiology, Immunology, Chromatography, Molecular Biology, Cell, Drug Discovery.