Hyper Innovations in Pharma 2015
Reporter : Gérard Henri Loiseau, ESQ
Bio Pharma 2015: Soaring to New Heights
Pharmaceutical Manufacturing, Steven E. Kuehn, Nov 10 2015
Growth Statistics
Bio Pharma is an “evolving accelerating science” (John J. Castellani, PhRMA).
R&D spending which was
$2 billion in 1980 is estimated
$51,6 billion in 2013,
it represents 1 in every 5 dollars spent on domestic R&D in the US.
90% is spent on Clinical Trials,
6199 Clinical Trials in 2013.
>$2.6 billion is the cost estimated to develop and bring a new drug on the market
In 2014 FDA approved 44 drugs, so a good year both for NCEs and NBEs, Forbes Magazine, Bernard Munos
Hyper Innovation
According to Mr. Munos the main players are
- Novartis
- J&J
- GSK
- AstraZeneca
Deloitte’s report “Advanced Biopharmaceutical Manufacturing: An Evolution, Underway” identifies several targets:
- Continuous manufacturing
- New process analytical tools
- Single-use systems
- Alternative downstream processing technique
Amgen vice president Jim Thomas points out:
- A more competitive business environment
- A more challenging reimbursement environment
- A more conservative regulatory environment
There is a necessity for the highest quality manufacturing environments.
“Design the molecule. Design the Process. Design the plant,” is his credo, which generates its “transforming Biotechnology Manufacturing” initiative
- Trends in analytical tools will support operational excellence
- Bio therapeutics manufacturing will be centered on cell-based systems
- A greater productivity within a smaller footprint will be allowed
- Flexibility is the goal thanks to standardized processes across all stages
These are the keys to operational excellence.
Process Analytical Technology (PAT)
FDA’s perspective is that ”quality cannot be tested into products; it should be built-in or should be by design”
Deloitte estimates that PAT can promote fewer recalls and less scrap inventory.
Towards a continuous future?
A recognized potential for small molecule drugs, and some companies have developed this continuous technology.
Deloitte’s study says that FDA views continuous manufacturing as consistent with the FDA’s quality by design efforts.
How to define a batch in case of product recall is a true challenge, which means that new measurements methods are needed.
Continuous manufacturing opposed to efficient, well-planned and engineered facilities, which is the vision developed by Amgen and others innovative players.
SOURCE
http://www.pharmamanufacturing.com/articles/2015/bio-pharma-2015/
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This is very insightful. There is no doubt that there is the bias you refer to. 42 years ago, when I was postdocing in biochemistry/enzymology before completing my residency in pathology, I knew that there were very influential mambers of the faculty, who also had large programs, and attracted exceptional students. My mentor, it was said (although he was a great writer), could draft a project on toilet paper and call the NIH. It can’t be true, but it was a time in our history preceding a great explosion. It is bizarre for me to read now about eNOS and iNOS, and about CaMKII-á, â, ã, ä – isoenzymes. They were overlooked during the search for the genome, so intermediary metabolism took a back seat. But the work on protein conformation, and on the mechanism of action of enzymes and ligand and coenzyme was just out there, and became more important with the research on signaling pathways. The work on the mechanism of pyridine nucleotide isoenzymes preceded the work by Burton Sobel on the MB isoenzyme in heart. The Vietnam War cut into the funding, and it has actually declined linearly since.
A few years later, I was an Associate Professor at a new Medical School and I submitted a proposal that was reviewed by the Chairman of Pharmacology, who was a former Director of NSF. He thought it was good enough. I was a pathologist and it went to a Biochemistry Review Committee. It was approved, but not funded. The verdict was that I would not be able to carry out the studies needed, and they would have approached it differently. A thousand young investigators are out there now with similar letters. I was told that the Department Chairmen have to build up their faculty. It’s harder now than then. So I filed for and received 3 patents based on my work at the suggestion of my brother-in-law. When I took it to Boehringer-Mannheim, they were actually clueless.
This is very insightful. There is no doubt that there is the bias you refer to. 42 years ago, when I was postdocing in biochemistry/enzymology before completing my residency in pathology, I knew that there were very influential mambers of the faculty, who also had large programs, and attracted exceptional students. My mentor, it was said (although he was a great writer), could draft a project on toilet paper and call the NIH. It can’t be true, but it was a time in our history preceding a great explosion. It is bizarre for me to read now about eNOS and iNOS, and about CaMKII-á, â, ã, ä – isoenzymes. They were overlooked during the search for the genome, so intermediary metabolism took a back seat. But the work on protein conformation, and on the mechanism of action of enzymes and ligand and coenzyme was just out there, and became more important with the research on signaling pathways. The work on the mechanism of pyridine nucleotide isoenzymes preceded the work by Burton Sobel on the MB isoenzyme in heart. The Vietnam War cut into the funding, and it has actually declined linearly since.
A few years later, I was an Associate Professor at a new Medical School and I submitted a proposal that was reviewed by the Chairman of Pharmacology, who was a former Director of NSF. He thought it was good enough. I was a pathologist and it went to a Biochemistry Review Committee. It was approved, but not funded. The verdict was that I would not be able to carry out the studies needed, and they would have approached it differently. A thousand young investigators are out there now with similar letters. I was told that the Department Chairmen have to build up their faculty. It’s harder now than then. So I filed for and received 3 patents based on my work at the suggestion of my brother-in-law. When I took it to Boehringer-Mannheim, they were actually clueless.