MAY 2021
Dr Parisa Asvadi Joins NeuClone as Chief Development Officer
Dr. Asvadi has over fifteen years’ experience in the development of biotherapeutics.
Recently working at Intas Biopharmaceuticals and Aurobindo Biologics, Dr. Asvadi has over five years of experience working with biosimilars, leading large size analytical development laboratories and managing global regulatory teams focusing on early-stage product development and late-stage clinical/commercialization of biosimilar products in the EU and US. Previously working at Immune System Therapeutics in Australia, Parisa gained experience in all aspects of mAb therapeutic development; non-clinical, cGMP manufacturing, clinical, IP and regulatory.
Parisa earned her PhD focusing on engineering of anti-RhD antibodies and antibody fragments. Her postdoctoral work was dedicated to development of anti-platelet antibody fragments. Dr. Asvadi has been the author of a number of publications and the inventor in several patents.
OCT 2020
MAR 2020
Dr Noelle Sunstrom to Present at the 2020 Festival of Biologics USA
NeuClone CEO, Dr Noelle Sunstrom, is presenting in San Diego at the Festival of Biologics USA 2020 from 2-4 March as part of the Biosimilars conference.
Further details found here: www.terrapinn.com/FestivalofBio/NC/Home
DEC 2019
NOV 2019
NeuClone Features in Biosimilar Development: ‘Biosimilars: Not Just Big Pharma’s Playground’
Full article: https://www.biosimilardevelopment.com/doc/biosimilars-not-just-big-pharma-s-playground-0001
MARCH 2019
NeuClone has completed dosing of subjects in a Phase I clinical trial with its Herceptin® (trastuzumab) biosimilar, NeuCeptin
Over 100 healthy volunteers were dosed in the three-arm Phase I trial to compare the safety and pharmacokinetic (PK) properties of NeuClone’s trastuzumab biosimilar (NeuCeptin) to EU- and US-sourced Herceptin reference products. The trial is being conducted under the Australian Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) scheme. NeuClone’s trial is being prosecuted in Australia by a Top 5 global Clinical Research Organization (CRO) with data output expected to be submitted to global regulatory agencies such as the EMA and U.S. FDA.
NeuClone is the first Australian company to enter such a biosimilar trial of its own product.
JAN 2019
NeuClone representatives attend the 37th Annual J.P. Morgan Healthcare Conference
Dr Noelle Sunstrom (CEO) and Dr Russell Howard (Executive Chairman) attended the 37th Annual J.P. Morgan Healthcare Conference in San Francisco and engaged in business development and investment activities. Dr Sunstrom also delivered a presentation of NeuClone as part of the Biotech Showcase.
NeuClone features in BioWorld: Interview with Dr Noelle Sunstrom
An interview with Dr Noelle Sunstrom was featured in Volume 30, No. 18 of BioWorld titled ‘Australia’s NeuClone poised to disrupt pharma market with broad pipeline of biosimilars’.
“Neuclone is extremely well-placed for sustainable growth in a price disruption biosimilars market. We know pricing is extremely competitive, particularly in a tendering environment like Europe where prices have dropped as much as 80 percent. We know we can compete at that level and make a profit.”
Full article: http://www.bioworld.com/content/australias-neuclone-poised-disrupt-pharma-market-broad-pipeline-biosimilars-0
NOV 2017
NeuClone attends the 23rd International Partnering Conference BIO-Europe
MAY 2017
NeuClone presents at the 25th ESACT Meeting
NeuClone presents new data on its NeuMAX platform enabling the cost effective manufacture of biosimilars
JAN 2017
NeuClone attends the 35th Annual J.P. Morgan Healthcare Conference
NeuClone was invited to attend the J.P. Morgan conference and engaged in business development activities
NOV 2016
NeuClone presents at the 22nd Annual BIO-Europe Conference
Dr. Noelle Sunstrom, CEO of NeuClone, presented a company profile at BIO-Europe 2016.
AUG 2016
US patent granted for NeuCHO®
NeuClone has been granted a US patent for its proprietary host cell line NeuCHO®. NeuCHO® is derived from the Chinese Hamster Ovary (CHO) cell line having enhanced growth and viability due to the expression of an autocrine growth factor.
The patent was first granted from IP Australia in February 2016 after its publication in January 2016.
JUNE 2016
Dr. Angelo Perani presents at the 12th annual Cell Line Development and Engineering conference.
His presentation explores the selection of high productivity and high target bioactivity cell lines for the production of biosimilars.
Dr. Russell Howard, John Oksinski and Dr. Noelle Sunstrom attend the BIO International Convention.
Participating in over 30 “BIO One-on-One Partnering™” meetings in 3 days.
MAY 2016
Dr. Noelle Sunstrom attends Cell Culture Engineering XV
OCT 2015
NeuClone’s new biomanufacturing facilities
The new facility includes three new laboratories two of which have been used for GMP manufacture in the past. The 315 square meters of new space is located opposite NeuClone’s current facilities and will house a new high throughput sterile liquid handling system, an ambr 15 microbioreactor, Solentim cell imagers as well as a state-of-the-art FACS facility.
FEB 2015
Dr Angelo Perani joins NeuClone’s scientific team as Head of Upstream Development.
Dr Angelo Perani has over 15 years experience in Mammalian Cell Culture working for the Ludwig Institute for Cancer Research and Lonza Biologics. He holds a European PhD from the INPL-France on Apoptosis in Mammalian Cell Culture and its applications to the production of monoclonal antibodies from a joint project between the INSERM U284 in France, the European Cell Bank (ECACC) in the UK and the University of Barcelona in Spain. This was followed by a post-doc fellowship at the Animal Cell Technology Group (University of Birmingham UK) investigating the impact of over-expressing bcl-2 in industrial cell lines. He was also responsible of an EU-funded project “Suppression of Apoptosis in Large Scale Biological Production Systems” in collaboration with Hamburg-Harburg University in Germany.
JAN 2015
Dr. Russell J. Howard attends JP Morgan Healthcare Conference.
JUN 2014
NeuClone, a Sydney biotechnology company, announces a worldwide partnership with Serum Institute of India Ltd to produce a portfolio of biosimilar drugs.
NeuClone Pty Ltd (NeuClone) in Sydney, Australia and The Serum Institute of India Ltd (Serum Institute) based in Pune, India have today announced a licensing agreement and joint development partnership to manufacture and supply 10 biosimilar monoclonal antibody drugs globally for treatment of diseases such as cancer and autoimmune disorders. Each of these antibody drugs address markets between $100’s of millions and $10B.
The partnership leverages NeuClone’s patented technology to generate protein drugs at much reduced cost from proprietary manufacturing cell lines and the immense biologics manufacturing capability of Serum Institute, the world’s largest vaccine producer. “After several years of technology development and building our team expertise, NeuClone is very pleased to launch this multi-product co-development program with Serum Institute. Our products will exemplify the competitive advantages of our NeuMAXTM technology platform for cell line development”, said Noelle Sunstrom, NeuClone’s Founder and CEO.
NeuClone retains licence to the jointly developed biosimilars for the developed markets of USA, Europe, Canada, Australia, Taiwan, Japan and South Korea. For these markets NeuClone is seeking partnerships with large Pharmaceutical and Generics companies who can best deliver these products via their existing market channels.
For the rest of the world, including India, China, South East Asia, The Middle East, South America and Africa, Serum Institute has exclusive license for marketing and sales. In these markets, until now unable to afford these drugs, Serum Institute is well positioned to leverage its growing business as the world’s largest vaccine manufacturer by number of doses and as a global supplier of affordable vaccines. The company is ranked India’s No. 1 biotechnology company, manufacturing highly specialized life-saving biologic therapeutics since 1967. Serum Institute has a proven track record over four decades for supply of vaccines at an extremely affordable cost. We plan to extend the vision set by Dr. C.S. Poonawalla to develop biosimilar monoclonal antibodies at an extremely affordable cost through this collaboration” said Mr. A.C. Poonawalla, CEO & Executive Director, Serum Institute of India. Umesh Shaligram, Serum Institute’s Director of R&D added, “For this new strategic initiative in the biosimilar monoclonal antibodies market we are combining our extensive biologics manufacturing and distribution expertise and cost advantages with NeuClone’s technology for high quality and low cost of goods”.
The partnership will have multiple products in development simultaneously such that all 10 products will transition through clinical trials and enter the market.
MAY 2014
Dr. Noelle Sunstrom addresses IBC conference Cell Line Development & Engineering Asia 2014.
MAR 2014
John Macphillamy joins NeuClone as Chief Financial Office, Legal Counsel and Executive Director.
JAN 2014
David Anstice joins NeuClone Board of Directors as Non-executive Director.
Dr Russel J.Howard attends J.P. Morgan 32nd Annual Healthcare Conference.
MAY 2013
Dr Noelle Sunstrom, CEO, co-chairs Biomanufacturing Monoclonal Antibodies Session at the 4th Annual Biosimilars Asia 2013 conference.
MAR 2013
Russel J Howard Takes out Overall Winner of Advance Global Australia Awards 2013.
Russell Howard was the overall Advance Global Australian Award winner, selected from the category winners and announced at the event. The Advance Global Australian Awards celebrate the achievements of Australians living overseas who exhibit remarkable talent, ambition and exceptional vision. They are the only awards to recognize the important contributions of the more than one million Australians living abroad esayscaptain writing. The Awards Forum and Ceremony took on 21 March 2013, at the Museum of Contemporary Art, Sydney, Australia.
JAN 2013
Dr Russell J Howard joins NeuClone as Executive Chairman.
MAY 2018
NeuClone Announces Preclinical Results for Stelara (ustekinumab) Biosimilar Candidate
JAN 2018
NeuClone discloses details of its fifth product: a biosimilar candidate for Prolia®/XGEVA®
NOV 2017
NeuClone attends the 23rd International Partnering Conference BIO-Europe
MAY 2017
NeuClone presents at the 25th ESACT Meeting
NeuClone presents new data on its NeuMAX platform enabling the cost effective manufacture of biosimilars
JAN 2017
NeuClone attends the 35th Annual J.P. Morgan Healthcare Conference
NeuClone was invited to attend the J.P. Morgan conference and engaged in business development activities
NOV 2016
NeuClone presents at the 22nd Annual BIO-Europe Conference
Dr. Noelle Sunstrom, CEO of NeuClone, presented a company profile at BIO-Europe 2016.
AUG 2016
US patent granted for NeuCHO®
NeuClone has been granted a US patent for its proprietary host cell line NeuCHO®. NeuCHO® is derived from the Chinese Hamster Ovary (CHO) cell line having enhanced growth and viability due to the expression of an autocrine growth factor.
The patent was first granted from IP Australia in February 2016 after its publication in January 2016.
JUN 2016
Dr. Angelo Perani presents at the 12th annual Cell Line Development and Engineering conference.
His presentation explores the selection of high productivity and high target bioactivity cell lines for the production of biosimilars.
Dr. Russell Howard, John Oksinski and Dr. Noelle Sunstrom attend the BIO International Convention.
Participating in over 30 “BIO One-on-One Partnering™” meetings in 3 days.
MAY 2016
Dr. Noelle Sunstrom attends Cell Culture Engineering XV
OCT 2015
The Hon Sussan Ley MP, Minister of Health, officially opens NeuClone’s new biomanufacturing facilities
The new facility includes three new laboratories two of which have been used for GMP manufacture in the past. The 315 square meters of new space is located opposite NeuClone’s current facilities and will house a new high throughput sterile liquid handling system, an ambr 15 microbioreactor, Solentim cell imagers as well as a state-of-the-art FACS facility.
FEB 2015
Dr Angelo Perani joins NeuClone’s scientific team as Head of Upstream Development.
Dr Angelo Perani has over 15 years experience in Mammalian Cell Culture working for the Ludwig Institute for Cancer Research and Lonza Biologics. He holds a European PhD from the INPL-France on Apoptosis in Mammalian Cell Culture and its applications to the production of monoclonal antibodies from a joint project between the INSERM U284 in France, the European Cell Bank (ECACC) in the UK and the University of Barcelona in Spain. This was followed by a post-doc fellowship at the Animal Cell Technology Group (University of Birmingham UK) investigating the impact of over-expressing bcl-2 in industrial cell lines. He was also responsible of an EU-funded project “Suppression of Apoptosis in Large Scale Biological Production Systems” in collaboration with Hamburg-Harburg University in Germany.
JAN 2015
DR. Russell J. Howard attends JP Morgan Healthcare Conference.
JUN 2014
NeuClone, a Sydney biotechnology company, announces a worldwide partnership with Serum Institute of India Ltd to produce a portfolio of biosimilar drugs.
Read more
NeuClone Pty Ltd (NeuClone) in Sydney, Australia and The Serum Institute of India Ltd (Serum Institute) based in Pune, India have today announced a licensing agreement and joint development partnership to manufacture and supply 10 biosimilar monoclonal antibody drugs globally for treatment of diseases such as cancer and autoimmune disorders. Each of these antibody drugs address markets between $100’s of millions and $10B.
The partnership leverages NeuClone’s patented technology to generate protein drugs at much reduced cost from proprietary manufacturing cell lines and the immense biologics manufacturing capability of Serum Institute, the world’s largest vaccine producer. “After several years of technology development and building our team expertise, NeuClone is very pleased to launch this multi-product co-development program with Serum Institute. Our products will exemplify the competitive advantages of our NeuMAXTM technology platform for cell line development”, said Noelle Sunstrom, NeuClone’s Founder and CEO.
NeuClone retains licence to the jointly developed biosimilars for the developed markets of USA, Europe, Canada, Australia, Taiwan, Japan and South Korea. For these markets NeuClone is seeking partnerships with large Pharmaceutical and Generics companies who can best deliver these products via their existing market channels.
For the rest of the world, including India, China, South East Asia, The Middle East, South America and Africa, Serum Institute has exclusive license for marketing and sales. In these markets, until now unable to afford these drugs, Serum Institute is well positioned to leverage its growing business as the world’s largest vaccine manufacturer by number of doses and as a global supplier of affordable vaccines. The company is ranked India’s No. 1 biotechnology company, manufacturing highly specialized life-saving biologic therapeutics since 1967. Serum Institute has a proven track record over four decades for supply of vaccines at an extremely affordable cost. We plan to extend the vision set by Dr. C.S. Poonawalla to develop biosimilar monoclonal antibodies at an extremely affordable cost through this collaboration” said Mr. A.C. Poonawalla, CEO & Executive Director, Serum Institute of India. Umesh Shaligram, Serum Institute’s Director of R&D added, “For this new strategic initiative in the biosimilar monoclonal antibodies market we are combining our extensive biologics manufacturing and distribution expertise and cost advantages with NeuClone’s technology for high quality and low cost of goods”.
The partnership will have multiple products in development simultaneously such that all 10 products will transition through clinical trials and enter the market.
MAY 2014
Dr. Noelle Sunstrom addresses IBC conference Cell Line Development & Engineering Asia 2014.
MAR 2014
John Macphillamy joins NeuClone as Chief Financial Office, Legal Counsel and Executive Director.
JANUARY 2014
David Anstice joins NeuClone Board of Directors as Non-executive Director.
Dr Russel J.Howard attends J.P. Morgan 32nd Annual Healthcare Conference.
MAY 2013
Dr Noelle Sunstrom, CEO, co-chairs Biomanufacturing Monoclonal Antibodies Session at the 4th Annual Biosimilars Asia 2013 conference.
MAR 2013
Russel J Howard Takes out Overall Winner of Advance Global Australia Awards 2013.
Russell Howard was the overall Advance Global Australian Award winner, selected from the category winners and announced at the event. The Advance Global Australian Awards celebrate the achievements of Australians living overseas who exhibit remarkable talent, ambition and exceptional vision. They are the only awards to recognize the important contributions of the more than one million Australians living abroad esayscaptain writing. The Awards Forum and Ceremony took on 21 March 2013, at the Museum of Contemporary Art, Sydney, Australia.
JAN 2013
Dr Russell J Howard joins NeuClone as Executive Chairman.
