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BEYOND THE BOOKS

Dr. Niazi's Bold Leap Forward

Dr. Sarfaraz K. Niazi’s groundbreaking petition, acknowledged by the FDA, marks a significant leap forward in the realm of generic and biosimilar drug development. By championing the concept of thermodynamic equivalence, Dr. Niazi proposes a revolutionary approach that promises to streamline the approval process and ensure safer, more timely access to essential medications.

Imagine a world where the need for costly and unpredictable biological tests is replaced by a simple, yet powerful concept: thermodynamic equivalence. This innovative idea, spearheaded by Dr. Niazi, aims to transform how we assess drug equivalence, making it more efficient and accessible than ever before.

The FDA’s recognition of Dr. Niazi’s petition underscores their commitment to advancing regulatory science and embracing cutting-edge methodologies. This presents a unique opportunity for collaboration and innovation, where stakeholders can come together to shape the future of drug development.

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DEVELOPMENT FOR ACCESSIBILITY

Fast to Market Biosomilar

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:

01.

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.

02.

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.

03.

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.

04.

Bioprocessing Innovations

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. 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.

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.

05.

351k and 505(b)(2) Submissions

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. 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

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.

Single Use Manufacturing

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.

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.

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.

Continuous Manufacturing

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

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