Replies to post #332221 on Avid Bioservices Inc (CDMO)

[biopharm]

PS Targeting and all IP related data including the Bavituximab treated patients are being HIDDEN from public and all because some Merckly Big Pharmas want it for themselves it seems....and will the SEC FBI DOJ FDA etc etc do their jobs without being lobbied to not disrupt the Big Pharma Cartel ??

Face the facts ...the late Dr Thorpe likely murdered in his lab to have PS Targeting IP controlled going forward and has it been controlled ?

No...just look at prior posts and FBI involvement with monitoring work and personal emails from TOP medical institutions like MD Anderson to Memorial Sloan Kettering and dozens more which includes Indiana

Maybe instead of hiding advances in medicine...all related to PS Targeting IP and risk others jumping on the same IP yet they MAY call it that they are Targeting something else!

Did Min Yue work for US based Green Valley and learn things related to PS Targeting (which is why Omeros went public with the facts that there are two brakes and PS Targeting is required ....then Min Yue on the record to being with parent company China based Green Valley and now they filed for Alzheimer's approval first.

Let's face it ... PS Targeting ALWAYS had been the story ...yet John Springs Stafford tried to tell investors otherwise

A bonus this morning for those paying attention....remember the "Lockheed Martin" patent that would REQUIRE PS Targeting patents ...well PAV#1 on Min Yue Linkedin profile is Lockheed Martin. I said the same for PAV#1 being Brigitte Phan of Allergan immediately after the death of Dr Phil Thorpe and we all know Brigitte Phan was involver with a medical device patent with Peregrine Ramone Valencia and others

China approves Alzheimer's drug, inviting fresh debate in field with few successes

Nov 4, 2019

...
...

Reducing neuroinflammation is one of the proposed mechanisms of action for oligomannate, which Green Valley says reconditions dysbiosis of gut microbiota as well as reduces amyloid protein deposition.

Links between bacteria in the gut and Alzheimer's have been proposed before, and researchers from Green Valley made the case for oligomannate's beneficial role via this pathway in a September 2019 paper published in Cell Research.

"There is no question that this data further supports the emerging idea that modulation of the gut microbiome via treatments such as GV-971 or other strategies should be further explored as novel strategies to slow the progression of AD," wrote researchers from Washington University School of Medicine in St. Louis, in an accompanying piece. GV-971 is another name used by Green Valley for oligomannate.
..
..


https://www.biopharmadive.com/news/china-alzheimers-drug-oligomannate-approval-green-valley/566540/

Min Yue, DVM, MS, RAC

Director of Regulatory Affairs
- US Green Valley Pharmaceuticals, a Shanghai Green Valley Pharmaceuticals Company
Shanghai Green Valley Pharmaceutical CO.,LTD
University of Wisconsin-Madison
Indianapolis, Ind


About
Globally focused regulatory expert and leader with over 25 years of direct working experience and management positions at top pharmaceutical, medical device & diagnostics, CRO companies, and research institutes; Seasoned in project and people management with multi-cultural, multi-geographic and different level of communication skills; Frequently invited speaker for CIMDR, Q1 Productions, RAPS, FDA News, DIA, Indiana Life Sciences, and other industry associations since 2005. Direct China Q&RA team establishment and supervision experiences with full service of commercial quality, clinical and regulatory activities. Trained in Veterinary Medicine, Immunology and US Regulator Affairs Certified (RAC). I am now working with the great team at US Green Valley Pharmaceuticals to lead the regulatory strategies and planning for new drug development and commercialization globally.

Connections

See Min Yue,’s 2,395 connections
Discover who you know in common

See Min Yue,’s 2395 connections


An Alzheimer Disease (AD) new drug just...
An Alzheimer Disease (AD) new drug just...
Shared by Min Yue, DVM, MS, RAC
...
...


Experience

Shanghai Green Valley Pharmaceutical CO.,LTD
Director of Regulatory Affairs
Shanghai Green Valley Pharmaceutical CO.,LTD
Aug 2019 – Present
4 months

US
US Green Valley Pharmaceuticals, a Shanghai Green Valley Pharmaceutical Co. - Developing drugs that patients are yearning for, has led us to pave our way to innovation.
US Green Valley Pharmaceuticals, a Shanghai Green Valley Pharmaceutical Co. - Developing drugs that patients are yearning for, has led us to pave our way to innovation.
MinYue-Pharos Consulting - Focusing on US-China pharmaceutical, medical device and IVD businesses



Founder & President
MinYue-Pharos Consulting
- Focusing on US-China pharmaceutical, medical device and IVD businesses
Jan 2019 – Aug 2019
8 months

Indianapolis, Indiana Area

With my over 25 years working in pharmaceutical and medical device companies in the US, combining my background in veterinary medicine, immunology and biologic drug R&D, 15 years hand-on registration experiences in over 100 countries with focused 2-years management roles for China commercial quality and regulatory affairs, plus my vast professional network and committed partners located in the US, China and other countries, I am passionate in helping any aspects of medical product registrations and related processes. I can be reached by phone or email at 317-908-3013, [e-mail].
With my over 25 years working in pharmaceutical and medical device companies in the US, combining my background in veterinary medicine, immunology and biologic drug R&D, 15 years hand-on registration experiences in over 100 countries with focused 2-years management roles for China commercial quality and regulatory affairs, plus my vast professional network and committed partners located in the US, China and other countries, I am passionate in helping any aspects of medical product...
Show more


Beckman Coulter
Sr. Manager of Global and China Regulatory Affairs & China Commercial Quality Management
Beckman Coulter
Oct 2013 – Dec 20185 years 3 months

Indianapolis, Indiana Area

Key Responsibilities:
• Global regulatory affairs for product registrations in rest of world countries including China clinical trials and submissions
• China commercial quality, and regulatory affairs (Q&RA) team establishment, staff hiring and development, and day to day operation management (Jan 2017 - Dec 2018)
• Medical device and IVD filing in the US, Canada
• Liaison between Beckman's manufacturing sites (located in the US, France, China, and India) and in-country affiliates/agents for product development strategies, planning, registrations and corporate communications.
Key Responsibilities:
• Global regulatory affairs for product registrations in rest of world countries including China clinical trials and submissions
• China commercial quality, and regulatory affairs (Q&RA) team establishment, staff hiring and development, and day to day operation management (Jan 2017 - Dec 2018)
• Medical device and IVD filing in the US, Canada
• Liaison between Beckman's manufacturing sites (located in the US, France, China, and India) and in-country...
..

PAREXEL
Sr. Regulatory Consultant - International
PAREXEL
Jan 2010 – May 20133 years 5 months

Bethesda, MD

Key Responsibilities:
• Project proposals, contracts writing and defending
• Project lead for client's project management
• Global regulatory strategies, planning and submissions
• Project budget, timeline and milestone management and problem solving
Key Responsibilities:
• Project proposals, contracts writing and defending
• Project lead for client's project management
• Global regulatory strategies, planning and submissions
• Project budget, timeline and milestone management and problem solving




Eli Lilly

Regulatory Manager/Consultant; Sr. Biochemist
Eli Lilly
Apr 1998 – Jan 201011 years 10 months

Indianapolis, IN

Key Responsibilities:
• International Regulatory Affairs (formerly IcRA) for Lilly's product registrations in rest of world (ROW) countries; agency correspondence and advisory meetings; cross-functional communications and regulatory guidance
• Affiliate staff training program management and short-term assignment staff supervision
• Sr. Biochemist in ADME drug disposition for large molecule drug development and GLP pre-clinical studies - writing protocols and study reports, develop drug development methods and conduct immunoassays
Key Responsibilities:
• International Regulatory Affairs (formerly IcRA) for Lilly's product registrations in rest of world (ROW) countries; agency correspondence and advisory meetings; cross-functional communications and regulatory guidance
• Affiliate staff training program management and short-term assignment staff supervision
• Sr. Biochemist in ADME drug disposition for large molecule drug development and GLP pre-clinical studies - writing protocols and study reports, develop...
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Bayer
Research Scientist
Bayer
Aug 1996 – Apr 19981 year 9 months

Preclinical studies and GLP lab work.
Preclinical studies and GLP lab work.
University of Wisconsin-Madison

Research Associate
University of Wisconsin-Madison
Mar 1991 – Jul 19965 years 5 months

Monoclonal antibodies and allergy studies.
Monoclonal antibodies and allergy studies.
????????????

Chief Inspector
????????????
Mar 1986 – Mar 19915 years 1 month

Associate director in animal food product inspections and GMP audit.
Associate director in animal food product inspections and GMP audit.
Hunan Agricultural University

Assistant Professor
Hunan Agricultural University
Jan 1983 – Mar 19863 years 3 months

Teaching in Vet School - Veterinary Immunology.
Teaching in Vet School - Veterinary Immunology.



Education

University of Wisconsin-MadisonUniversity of Wisconsin-Madison
University of Wisconsin-Madison
M.S.Immunology
1993 – 1995

Hunan Agricultural UniversityHunan Agricultural University
Hunan Agricultural University
DVMVeterinary Medicine
1978 – 1982


Volunteer Experience

Indianapolis Chinese Performing Arts, Inc. (ICPAI)
Founder/President
Indianapolis Chinese Performing Arts, Inc. (ICPAI)
Jun 2004 – Present
15 years 6 months

Arts and Culture

A nonprofit organization to cultivate volunteers and leaders to promote culture, arts and diversity in central Indiana. The organization has 6 functional performing arts groups with over 200 active members ranged 3-65 years old. The major activities are routine practices and performances in dances, music, instruments, lions, drums, and Taiji with over 40 performing events each year. For more information, please visit www.icpai.org.
A nonprofit organization to cultivate volunteers and leaders to promote culture, arts and diversity in central Indiana. The organization has 6 functional performing arts groups with over 200 active members ranged 3-65 years old. The major activities are routine practices and performances in dances, music, instruments, lions, drums, and Taiji with over 40 performing events each year. For more information, please visit www.icpai.org.
Indianapolis Sister City Committee

Chair, Arts and Culture
Indianapolis Sister City Committee
Jan 2011 – Present
8 years 11 months


Arts and Culture

Licenses & Certifications
RAC
Regulatory Affairs Professionals Society (RAPS)
Issued Aug 2006
(See credentialExternal link)



Honors & Awards

Jefferson Award
Eli Lilly - United Way
Jan 2010

President Award
Eli Lilly
Mar 2000



Languages

English
Chinese
Japanese-Limited working proficiency



Organizations

Indianapolis Chinese Performing Arts, Inc. (ICPAI)
Founder/President
May 2004 – Present
Indianapolis Chinese Performing Arts (ICPAI) - ???????, is a not-for-profit organization established in 2004 with the following missions:
Organize and prepare Chinese traditional and cultural related shows, dances and performances. Perform and show at local cultural, celebration, and recreational related events. Promote Chinese traditional Tai Chi and other martial arts. Introduce cross culture performing arts and dances to Chinese community. Promote performing arts by organizing classes and activities for all age groups. Promote and support culture related activities such as exhibitions, shows and exchange programs. ICPAI has Functional Groups: ICPAI Show and Performance Group ???????; ICPAI Tai Chi Group ???????; ICPAI Little Flower Group ????????; ICPAI NewGen Group. Website: http://www.icpai.org. Contact: [e-mail]
Indianapolis Chinese Performing Arts (ICPAI) - ???????, is a not-for-profit organization established in 2004 with the following missions:
Organize and prepare Chinese traditional and cultural related shows, dances and performances. Perform and show at local cultural, celebration, and recreational related events. Promote Chinese traditional Tai Chi and other martial arts. Introduce cross culture performing arts and dances to Chinese community. Promote performing arts by organizing classes and activities for all age groups. Promote and support culture related activities such as exhibitions, shows and exchange programs. ICPAI has Functional Groups: ICPAI Show and Performance Group ???????; ICPAI Tai Chi Group ???????; ICPAI Little Flower Group ????????; ICPAI NewGen Group. Website: http://www.icpai.org.
Contact: [e-mail]

Websites

My company
http://www.beckmancoulter.comExternal link

My Hobby
http://www.indychineseperformingarts.orgExternal link

nutraMetrix consultant
http://www.nutrametrix.com/cynetExternal


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[biopharm]

Mark Bamforth seems to not want Avid Bioservices BOD not listed on MassBio site, yet there is evidence of past "other" companies making their way through MassBio with PS Targeting patents / EXOSOMES etc

I wonder why Lana Gladstein was hired over to Arranta and a little conflict of interest with her and others ....knowing the IP assets at Avid Bioservices / future royalties and manufacturing rights are directly related ....maybe Jeffrey Gladstein tells her to just accept the monies and go along it ...as Merrill Lynch and others ...like Ronin Capital to Millennium Management etc etc....have much monies tied up on other plans

Very interesting links surfacing and more to be disclosed if Ampersand Capital can play it correctly

Maybe we can get some depositions from Josh Harrell ( ex Nutter McClennan Fish now works for Merck ) to clear things up or just bring in Israel Englander to give their side of the story

...What IP asset Biomarkers did Min Ting have knowledge of between Dana Farber and Peregrine Pharmaceuticals employment...must be worth Billions with that Biomarker knowledge ...as is Erez Eitan knowledge of PS Targeting that MassBio legal Nutter .. etc are well aware

______

Jeffrey Nathan Gladstein

AGE: 69

LOCATIONS

Narberth, PABala Cynwyd, PAPhiladelphia, PACharlotte, NCChambersburg, PANew York, NYArdmore, PA- less

RELATIVES

Lana Gladstein ( Mark Bamforth hired for Arranta )
Svetlana Gladstein


WORKED AT

Bank of America CorporationMerrill Lynch & Co. IncMerrill Lynch, Pierce, Fenner & Smith IncorporatedMerrill Lynch Capital Partners, Inc.Waterstone Capital Advisors, LLC- less

____________

In the meantime....still there are those Targeting flipped PS for CART / CTCs etc etc as Lockheed Martin posts recently along with Oded Biran

FILTRATION OF CIRCULATING TUMOR CELLS FOR THERAPUTIC PURPOSES
Publication number: 20170080142
Abstract: The present invention provides a method for filtration of CTCs directly out of patient blood and returning the blood after filtration to the patient. CTCs are an important factor for diagnosis and prognosis of cancer patients and can cause cancer metastasis. By eliminating CTCs from the bloodstream the chances for metastasis reduction decrease.

Type: Application
Filed: September 23, 2015
Publication date: March 23, 2017
Inventor: Oded Biran

https://patents.justia.com/patent/20170080142

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MassBio bio for Mark Bamforth

Mark R. Bamforth
President & CEO, Arranta Bio

About Mark

Mark Bamforth founded a new CDMO, Arranta Bio, in May 2019.

Previously, Mark founded Brammer Bio in 2015, a best-in-class viral vector contract development and manufacturing organization (CDMO) supporting cell and gene therapies. Brammerâ??s team grew from 110 in 2016 with the addition of 100 from the acquisition of two Biogen commercial facilities, to over 600 at the time of its acquisition by Thermo Fisher Scientific in April 2019.

In 2010, Mark founded a biologics CDMO, Gallus BioPharmaceuticals, and acquired a world-class facility and team of 160 from J&J with a commercial supply agreement. Gallus tripled through organic growth and merging with Laureate Biopharma. Gallus was sold to DPx Holdings B.V. in Sept. 2014.

Mark previously spent 22 years in the UK and USA running a global manufacturing operation and a pharmaceutical CMO business for Genzyme and served as a corporate officer for 9 years.

He began his career as a petroleum engineer exploring for North Sea oil with Britoil, then as a chemical engineer in the whisky industry with Whitbread.

Mark serves on the boards of Avid Bioservices, MassBio, Wentworth Institute of Technology, and Entrepreneurial Scotland. He has a BS in Chemical Engineering from Strathclyde University and an MBA from Henley Management College.


https://www.kget.com/news/politics/us-failing-to-stop-china-from-stealing-research-report-says/amp/

__________________


MassBio Welcomes Four Life Sciences Startups to Participate in MassCONNECT® Fall Mentorship Cycle

10/17/2018 Announcements

Entrepreneurs developing innovative solutions for:
Improving lead selection and clinical trial design
Enabling gene therapy and advancing treatment of autoimmune disease
Treating serious inflammatory and neurological disorders
Developing blood-based diagnostic tests for various neurological conditions

October 17, 2018 (CAMBRIDGE, MA) MassBios MassCONNECT®, the only mentoring program in Massachusetts that is solely dedicated to serving the needs of early-stage entrepreneurs in the life sciences, yesterday kicked off its third and final cycle of 2018 with a technology showcase. During the event, the four chosen life sciences startups presented their ideas to a room of industry executives and potential mentors for early feedback. Their research represents the incredible innovation spinning out of academia in Massachusetts, with this cycles cohort focused on improving lead selection and clinical trial design, enabling gene therapy and advancing treatment of autoimmune disease, treating serious inflammatory and neurological disorders, and developing blood-based diagnostic tests for various neurological conditions

This MassCONNECT cycle is being sponsored by Boehringer Ingelheim, Evaluate and Nutter.

"Boehringer Ingelheim is proud to be a continuing partner with the MassCONNECT program and mentor and support life science entrepreneurs in the thriving Massachusetts community," said Ioannis Sapountzis, Ph.D., Global Head of Business Development & Licensing for the USA & Specialty Care at Boehringer Ingelheim Pharmaceuticals, Inc. "As participants in the innovation ecosystem, we see this as a leading initiative to foster the best and brightest ideas and speed advancements to patients in need."

"The MassCONNECT mentoring program reflects both the entrepreneurial spirit and established expertise of the Massachusetts life science hub. Weâ??re delighted support this next generation of leaders with commercial insights that can help them bring new innovations to the industry," said Alex Karle, CEO, Evaluate Ltd.

"Nutter is excited to partner with MassCONNECT for the third time, as the participants demonstrate the cutting-edge technical expertise and incredible talent in Bostons life sciences and innovation communities," said Kathy Williams, Ph.D., a partner in Nutters Intellectual Property Department and co-chair of the firms Life Sciences practice group. "We look forward to mentoring and working with these pioneers in the health care industry."

Following this weeks showcase, entrepreneurs will be paired with a team of mentors, based on their individual objectives and needs, for eight weeks of hands-on coaching as they seek to develop business plans, launch companies and raise capital. The startups will then present in front of potential investors and partners.

The applicants chosen for the latest round of mentorship are:

-------

Javelin Biotech
Co-founders:

Murat Cirit, PhD;
Kevin O'Handley, MBA;
Emily Geishecker, MS

Javelin Biotech provides an integrative preclinical drug testing platform for the pharmaceutical and biotech industries by merging organ-on-chip (OoC) technologies and computational biology/AI to optimize lead selection and clinical trial design. Human OoC technologies culture human tissues in microphysiological environments enabling the most human relevant in vitro drug tests. The preclinical safety, efficacy, and pharmacokinetics data are translated to predictions of how drugs perform in humans without the gaps and shortcomings of animal models and other current approaches. Javelin Bio is interacting with FDA towards reducing animal studies for drug development and safety regulatory filings, helping to define the path towards using OoC tech and computations in place of animal tests.

--------

JURA Bio
Co-founders:

Julie Norville, PhD;
Elizabeth Wood, PhD;
George Church, PhD

Delivering on the promise of synthetic biology, JURA Bio is combining the newest advances in gene editing and therapeutic cell delivery to enable gene therapy and advance the treatment of autoimmune disease. Supported by world-leading clinical teams, the JURA Bio platform promises to meet the challenge of known and emerging autoimmune disorders with transformational therapies that promise to be both curative and definitive. JURA Bio, Inc. is actively developing its leading drug candidate, a novel class of CAR-T therapies against primary progressive multiple sclerosis (PPMS) and systemic lupus erythematosus (SLE). These leading therapies are the product of cell engineering, synthetic biology and clinical insight necessary to create a platform that may enable curative CAR-Ts in the fight against autoimmunity.

-------

NeuroCycle Therapeutics
Co-founders:

Jed Hubbs, PhD;
Matthew Toczko, PhD

NeuroCycle Therapeutics (NCT) discovers and develops therapeutics that act within the central nervous system to treat serious inflammatory and neurological disorders. Our science is based on cutting-edge research on the GABAA receptor and the latest disease-relevant in vivo pharmacology models. NCT will initially develop their lead candidate NCT10004 for moderate to severe atopic dermatitis. In addition, NCT is developing novel mechanisms for treating fibromyalgia, a chronic condition causing widespread muscle pain and fatigue; and Dravet syndrome, a rare and potentially fatal lifelong form of epilepsy that begins in infancy.

----

NeuroDex
Co-founders:

Erez Eitan PhD, MBA,
Oded Biran L.L.B, and
Raphael Nir PhD

NeuroDex Inc. is a diagnostics development company focusing on developing blood-based diagnostic tests for various neurological conditions. NeuroDexâ??s technology is based on the isolation of brain derived exosomes, nanoparticles which are regularly released into the bloodstream by brain cells. These exosomes can provide a window into the biology of the human brain. Their lead blood test can potentially diagnose Alzheimerâ??s Disease before the appearance of symptoms.

"We welcome this remarkable group of entrepreneurs into Cycle III and look forward to helping them shape and catalyze their inspiring ideas," said John Hallinan, Chief Business Officer at MassBio. "We want to recognize the MassCONNECT mentors for offering the immeasurable value of their experience and insights, and our ardent appreciation to Boehringer Ingelheim, Evaluate, and Nutter for their generous sponsorship."

About MassCONNECT

MassBios MassCONNECT program is the only entrepreneur mentorship program in Massachusetts that dives deep into the life sciences. MassCONNECT matches entrepreneurs and founders with seasoned life sciences professionals to catalyze and commercialize innovation. The MassCONNECT process involves a two-month mentorship where industry experts guide entrepreneurs as they seek to develop business plans, launch companies, and raise capital. MassCONNECT mentors evaluate and provide feedback on commercial feasibility; identify strengths, weaknesses, opportunities and threats; and team up to furnish industry-specific business advice for innovative ideas in therapeutics, diagnostics, medical devices and health IT. Entrepreneurs gain invaluable advice and coaching on defining value proposition, developing pitches and building professional networks. For more information, or to apply to be a mentor, mentee or MBA project manager, visit https://www.massbio.org/discover/massconnect.

https://www.massbio.org/news/recent-news/massbio-welcomes-four-life-sciences-startups-to-participate-in-massconnect-fall-mentorship-cycle-146533

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