Replies to post #152695 on Avid Bioservices Inc (CDMO)

[patientsdeservebest]

Steve King has neither a PhD nor an MD.
He does have a failed phase II and a product Cotara that is doing virtually nothing except losing patent life if it even has any left at this point.

[biopharm]

CEO Dr. Steve King has been correct in his revenue projections on Avid and the latest quarter, again it was projected that Avid will be in line for $18-22 Million this year (2014). Looks like Avid was able to recruit one that has had much success in his past at Allergan and Gilead. Hired to the Avid Bioservices side of the house and since June (7 months on the job)... very impressive I would say!

Ok, I got some attention there for that "Dr." King but hey, eventually some school will hand out an honorary MD degree for SK I'd say : )

So back to Michael Molony and how he was brought into Peregrine/Avid from Gilead and you tell me that after at least doubling in size the Avid facilities that Michael just departs, without a strategic plan with Peregrine/Avid? I don't buy it and now I look at where he lands:

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Director of Analytical Development, ADCs
Althea, CMO
July 2015 – Present (2 months)Greater San Diego Area

•Establish and direct an industry leading AD group that will support external clients and internal manufacturing teams for preparation of ADC processes for GMP manufacture that includes novel analytical method development, in process testing, raw material testing, analytical method validation, DS and DP release testing, DS and DP stability studies, reference standard characterization, etc.
•Collaborate with Process Development/Technical Transfer, Project Management, and Manufacturing Operations to devise practical analytical solutions to a variety of synthesis, conjugation, purification, and formulation problems.
•Generate technical reports, review regulatory documents and risk assessments.
•Provide scientific leadership in analytical development and the use of statistical methods for process optimization, characterization, and establishing the relationship between process parameters and product quality attributes.
•Support and meet departmental KPI’s
•Hire AD staff and create development and training plans and established performance goals. Provide periodic feedback and year end reviews.
•Travel visit client’s sites and work out ADC analytical strategies/proposals.
•Day to day oversight of ADC Quality Control staff.

https://www.linkedin.com/pub/michael-molony/5/7a8/bb5

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Althea is a leading expert in aseptic filling of drug product in vials and syringes, and our focused expertise and capabilities make us one of the industry’s top leaders for cGMP microbial fermentation of recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services including: upstream and downstream process development, complex formulations, lyophilization cycle, analytical development, product release and ICH-compliant stability testing.

Located in San Diego, CA, Althea is a fully owned subsidiary of Ajinomoto Co., a global manufacturer of high-quality seasonings, processed foods, beverages, amino acids, pharmaceuticals and specialty chemicals. Ajinomoto acquired Althea to expand the business for biopharmaceuticals manufacturing in the U.S. market by combining Ajinomoto’s experience in biotechnology with Althea’s sophisticated technology, experienced personnel, and expertise in cGMP manufacturing.

Our cGMP facilities have produced 250 cell banks, 180 bulk purified protein lots, 136 bulk purified plasmid DNA lots and over 2,100 fill & finish lots. Over the past 20 years, we have successfully completed more than 25 FDA drug approvals, 20 FDA audits, and 40 audits by international agencies.

Althea has an excellent track record with global regulatory agencies, including the FDA, EMA, PMDA (Japan), and RP (Germany). Our processes and procedures are in compliance with European cGMP standards and FDA guidelines. Our expertise in aseptic filling and extensive knowledge of international requirements help assure your product will meet the highest possible quality standards.

http://altheacmo.com/about/company-profile-history/

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Ajinomoto Co., Inc. (??????? Ajinomoto Kabushiki-gaisha?) is a Japanese food and chemical corporation which produces seasonings, cooking oils, TV dinners, sweeteners, amino acids, and pharmaceuticals. In particular it is the world's largest producer of aspartame, with a 40% global market share.[2]

The literal translation of Aji no Moto is “Essence of Taste,” used as a trademark for the company’s original monosodium glutamate (MSG) product.[3]

Its head office is located in Chuo, Tokyo.[4]

Ajinomoto operates in 26 countries, employing around 27,518 people as of 2013.[1] Its yearly revenue in the fiscal year of 2013 stands at around US$12 billion.[1]

Monosodium glutamate
This section does not cite any references or sources. Please help improve this section by adding citations to reliable sources. Unsourced material may be challenged and removed. (April 2013)

Ajinomoto’s main product, monosodium glutamate (MSG; ???????????) seasoning, was first marketed in Japan in 1909, having been discovered and patented by Kikunae Ikeda. He found that the most important compound within seaweed broth for common use was actually a glutamate salt, which he identified with the taste umami, a word meaning 'pleasant taste' or 'savoriness'. As the simplest such salt for human consumption, the popularity of MSG helped the company rapidly expand to other countries, with Ajinomoto U.S.A., Inc. established in 1956.[citation needed]

Before the eventual publicity, the conglomerate was founded on Ikeda's work: it was the first to suggest that industrially purified glutamic acid salts, residues or analogues, originally found in seaweed or dried fish-based broth, might have a characteristic taste of its own. That idea was rapidly connected to the much older Japanese, culinary term of umami. This led to early adoption of MSG as a culinary agent in Japan.
Aspartame

Ajinomoto is the world's largest manufacturer of aspartame, sold under the trade name Aminosweet. It acquired its aspartame business in 2000 from Monsanto for US$67 million.[5]
Glutamine

Ajinomoto supplies the amino acid L-Glutamine.

https://en.wikipedia.org/wiki/Ajinomoto

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When we speak of astronomical value, wouldn't you think it may be because as we enter these times of Immuno-Oncology, the Enlightenment Age of Disease I call it, we shall soon also be informed more of what is good and what certain ingredients are good and bad....and Billions upon Billions of dollars are at stake here! I've spoke of Bavi to the moon and Bavi crops (Bayer Crop Sciences..) and all in between but hey, its time to dig deeper into Ajinomoto, global nutrition and why PS Targeting may well go far beyond the value we all initially just thought it would be restricted to.

I'll come back for 100% sure on this topic... and very much Peregrine Pharmaceuticals related and just following some other linkedin profiles may give more clues... and biomarkers for oncology are important, but also biomarkers of nutrition for development are critical and worth Billions from the moment one is born.