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Speaker’s
Biographies
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MICHAEL ENTZEROTH
Chairman, BioSingapore
Dr. Michael Entzeroth is the founder of Pharma Resources Asia Pte Ltd,
Singapore. Previously, he was Chief Scientific Officer of S*BIO Pte Ltd in
Singapore and Vice President of CEREP SA in France where he was a
member of the Executive Management Committee and responsible for
the company’s pharmacology service and discovery activities. From
1985 to 1999, he was with Boehringer Ingelheim Germany, responsible
for a variety of drug discovery programs and finally Head of High
Throughput Screening.
TIM OLDHAM
Tim Oldham has been involved in the biogenerics industry for over five
years, first as a leader of Mayne Pharma's biogenerics program, then as
a member and Chair of the joint development committee for Mayne
Pharma's biogeneric collaboration with Pliva, and as a Chair of the
Biosimilars and Biotechnology Committee of the European Generic
Medicines Association.
Samantha joined Hutchison in 2001 and has since led all aspects of
R&D and related investment activities in Hutchison. In 2003, she
founded Hutchison Medipharma Limited, a R&D based company
focusing on oncology and autoimmune diseases, in Shanghai, China.
The company has since grew to over 140 employees with cutting edge
technology platforms and a rich portfolio of drug candidates at various
stages of development including one in US phase II trial for IBD
diseases and one in US phase I/II trials for radiosensitizer. Under Dr.
Du’s leadership, Hutchison Medipharma has signed groundbreaking
and landmark deals with global pharmaceutical companies in discovery
research collaboration with Eli Lilly in Indianapolis, US, Merck KGaA in
Darmstadt, Germany, and P&G in Cincinnati, US. In 2006, the company
has been rated as “the Pioneer in China, R&D” by Forbes China. Dr. Du
played a key role in the successful IPO of Hutchison Chi-Med in London
on May 19, 2006.
STEVEN FANG
Steven has a first degree in Computer Engineering and completed his MBA with the
University of Hull (U.K.) in business strategy.
BIOSIMILARS
Seizing Opportunities for Competition and Commercialisation
in Domestic and Global Markets
LORNA BRAZELL
Lorna Brazell graduated with first class honours in geophysics from the
University of Edinburgh in 1986 and spent several years in research at
the University of Cambridge before switching to a career in law. She
obtained her masters degree in law with Merit from Kings College
London in 1993. She joined Bird & Bird upon qualifying as a solicitor,
becoming a partner in the Intellectual Property Department in May
2001 and a solicitor-advocate in 2005. She advises on intellectual
property protection and enforcement and regulatory issues in the
pharmaceuticals and biotechnology industries, and conducts litigation
in the English High Court and County courts.
KENT CHENG
Partner, Cohen, Pontani, Lieberman & Pavane, USA
L. CHRISTIAN CLAUSS
THOMAS BOLS
Director of Government Affairs, Amgen
ANDREW C. CHANG
Dr. Chang has more than 17 years of experience with biologics and
pharmaceuticals. Prior to joining PharmaNet, he served more than 11
years at the FDA, most recently as an Associate Director for Policy and
Regulation and Senior Regulatory Scientist in the Division of
Hematology, Office of Blood Research and Review, Center for Biologics
Evaluation and Research (CBER). During his tenure at the FDA, Dr.
Chang helped develop many of CBER’s science and public health
policies for the regulation and approval of biologic therapies. He is
considered one of the foremost regulatory experts in recombinant and
naturally derived protein products. Dr. Chang was a member of CBER’s
Chemistry, Manufacturing and Control (CMC) Coordinating Committee
and CBER representative to FDA committee on Follow-On Protein
Products. He was FDA deputy topic leader for ICH Q5E, Comparability
of Biotechnological/Biological Products Subject to Changes in Their
Manufacturing Process. Dr. Chang also worked closely with CBER’s
Office of Compliance and Biologics Quality and FDA Manufacturing
Science Working Group in developing both FDA and ICH CMC related
guidances, and FDA inspection program including Team Bio and CBER
pre-license/approval inspections.
His formal scientific training includes a Doctor of Philosophy degree in
Biochemistry from the State University of New York, 1991, and a
Bachelor of Sciences degree in Pharmaceutical Chemistry from the
China Pharmaceutical University, 1982. Supplementing his academic
degrees, Dr. Chang also studied at the National Institute of Allergic and
Infectious Diseases, National Institutes of Health as a postdoctoral
fellow from 1991 until he joined CBER in 1995. In addition to his very
extensive regulatory responsibilities, Dr. Chang was the lead in CBER
for the preparation of national and international potency standards for
blood coagulation factors. His publications cover regulatory science as
well as blood coagulation and thymocyte biochemistry.
MARTIN WISHER
SIMON ROGER
BIOMANUFACTURING
Strategies for Achieving Manufacturing Excellence and
Entering Key Regulated Markets
UWE GOTTSCHALK
DAVID HUGHES
RICK NG
He has held several senior positions in R&D, QA, QC, regulatory affairs
and business development in the healthcare and biopharmaceutical
industry in Australia for more than 20 years. He was the Project
Director at the Australian Institute of Mucosal Immunology with
responsibility in the R&D, preclinical and clinical trials of mucosal
vaccines as well as the development of rapid diagnostics kits. Dr Ng
joined A-Bio Pharma Pte Ltd in 2000. Currently he holds the position of
Director, QA/QC at A-Bio Pharma.
Dr Rick Ng received his BSc (Hons) and PhD degrees in Chemistry from
the University of Canterbury, Christchurch, New Zealand. His PhD
thesis was on X-ray crystal structure determinations of metal
complexes to biological model systems. In addition Rick has an MBA
degree majoring in international business.
He has held several senior positions in R&D, QA, QC, regulatory affairs
and business development in the healthcare and biopharmaceutical
industry in Australia for more than 20 years. He was the Project
Director at the Australian Institute of Mucosal Immunology with
responsibility in the R&D, preclinical and clinical trials of mucosal
vaccines as well as the development of rapid diagnostics kits. Dr Ng
joined A-Bio Pharma Pte Ltd in 2000. Currently he holds the position of
Director, QA/QC at A-Bio Pharma.
ABDULQADER ALKHAYAT
Since 1991, Dr. Al Khayat has been a faculty member of Dubai Police
College for Forensic Sciences. He has numerous academic
achievements to his credit and has published and presented over 32
papers in international journals and at conferences.
MIN-CHI WU
JAMES P. MILLER
BART MOORS
STEVE OH
DAVID BRAMHILL
JANET MCNICHOLAS
Speaker’s
Biographies
Join Plenary Session
JOHN BIRCH
UWE GOTTSCHALK
SANJAY JAIN
ANDREW C. CHANG
Dr. Chang has more than 17 years of experience with biologics and
pharmaceuticals. Prior to joining PharmaNet, he served more than 11
years at the FDA, most recently as an Associate Director for Policy and
Regulation and Senior Regulatory Scientist in the Division of
Hematology, Office of Blood Research and Review, Center for Biologics
Evaluation and Research (CBER). During his tenure at the FDA, Dr.
Chang helped develop many of CBER’s science and public health
policies for the regulation and approval of biologic therapies. He is
considered one of the foremost regulatory experts in recombinant and
naturally derived protein products. Dr. Chang was a member of CBER’s
Chemistry, Manufacturing and Control (CMC) Coordinating Committee
and CBER representative to FDA committee on Follow-On Protein
Products. He was FDA deputy topic leader for ICH Q5E, Comparability
of Biotechnological/Biological Products Subject to Changes in Their
Manufacturing Process. Dr. Chang also worked closely with CBER’s
Office of Compliance and Biologics Quality and FDA Manufacturing
Science Working Group in developing both FDA and ICH CMC related
guidances, and FDA inspection program including Team Bio and CBER
pre-license/approval inspections.
BRUCE MURDOCH
Since 2002 he has been based in UK and has set up his own
pharmaceutical/healthcare consulting business called NMR Ltd,
assisting companies and small enterprises enter the UK market. He has
been involved as a Non-executive Director of Thermascan Medical
Services Ltd, which is now merged into The Chiron Clinic. He also
part of the original founding group who set up BiOracle, which is a
“Point of Care” diagnostic company founded in 2003.
CARTIKEYA REDDY
Prior to his current assignment, Cartik had worked with Genentech Inc,
South San Francisco, USA, where he was a Group Leader in the Cell
Culture and Fermentation R & D Department. From 1996-2001, he was
with the Biotechnology Division of Bayer Corporation, Berkeley, USA,
where as a Staff Scientist, he had successfully led teams in the areas of
Bioprocess Development & Pilot Scale manufacturing.
HALEH HAMEDIFER
Haleh Hamedifer was born in Apr. 1972 in Tehran, and educated as top
student from Faculty of Pharmacy of Tehran University of Medical
Sciences in 1995 as a Pharm. D.
He have spent several long ang short term training couses reagrding
QA and GMP in France, Cuba and Switzerland.
He was working for Pasteur Institute of Iran as Head of QA Dept and
CinnaGen Co. as QA advisor scince 1997. He was a member of
WHO GMP asessment teams as temporal advisor during these
years. He is an organizer and main teacher of national GMP training
courses for pharmaceutical industry and GMP advisor of Ministry of
Health of Iran.
From 2001 he is working in CinnaGen Co. as managing director. His
great aim was changing CinnaGen from a diagnostic manufacturer to a
Biopharma one and making an infrastructure for this industry in my
country. After 5 years they are proud that they have 3 biopharma
product in the market which are CinnoVex (IFN beta-1a), Erytrex (EPO
beta) and Buserelin. they have 5 other products in our pipeline which
will be in the market in 2008.
DONGMEI SU
JON ZIFFERBLATT
DAVID SONG
Experience:
- Head of Product Development, Green Cross Corp. (1985-1997):
rHBV vaccine, Rotavirus, rPTH, EPO, G-CSF, hGH
- Head of Biopharmaceutical Product Development, LG Life
Sciences (1998-2003): hGH, EPO, IFN-a, G-CSF, sr-hGH, FSH
- Member for drafting of KFDA Guidance for Biopharmaceutical
products since 1993
Education:
- B.S. Degree in Veterinary Medine, Seoul National Unversity
- Master in Epidemiology, Seoul National University
BIOMANUFACTURING
Strategies for Achieving Manufacturing Excellence and
Entering Key Regulated Markets
SANJAY JAIN
EDWARD LEE
RAMANI AIYER
FREDRICH NACHTMANN
MARK CARVER
Since 2005, Dr. Mahler holds the position as Head of Formulation R&D
Biologics at F. Hoffmann-La Roche Ltd (Basel, Switzerland) as Center of
Excellence for biotech formulation R&D for Roche biotech projects
globally.
BJORN HAMMARBERG
NADINE RITTER
Senior CMC Consultant, Biologics Consulting Group Inc, USA