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Day 1

Speaker’s
Biographies
Join Plenary Session

MICHAEL ENTZEROTH

Chairman, BioSingapore

Dr. Michael Entzeroth is the Senior Vice President, Drug Discovery at


the Experimental Therapeutic Centre, Biopolis, Singapore. He has
extensive experience in the pharmaceutical industry, with many
success records in drug discovery and development, as well as in
generating entrepreneurial drug discovery cultures in an internationally
competitive environment. He is presently Chairman of BioSingapore, an
industry association for life sciences businesses in Singapore.

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

President, Asia Pacific, Hospira, Australia

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.

He recently returned to Australia as Hospira's President, Asia Pacific,


and is looking to bring the company's global expertise in biogenerics to
the region. Tim holds PhD (Chemistry) and LLB degrees, and has
worked with McKinsey & Company, Mayne Pharma and Hospira in
Europe, India and Asia.
SAMANATHA DU

Chief Scientific Officer and Executive Vice President, Hutchison China


MediTech Ltd, China and Managing Director, Hutchison
MediPharma Ltd

Dr. Du is the Managing Director of Hutchison Medipharma Limited;


Chief Scientific Officer and Executive Vice President of Hutchison Chi-
Med, a publicly traded company in London.

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.

Dr. Du received her Ph.D. in biochemistry from University of Cincinnati.


Prior to Hutchison, she was at Pfizer’s global strategic operation
division in US in charge of global Licensing and related MPA activities
for metabolic diseases. She started her research career at Pfizer’s
Global R&D in Connecticut and led teams that delivered multiple INDs
and NDAs in several therapeutic areas. Dr. Du served on FDA sponsored
working committees while working at Pfizer and is currently an active
adviser on healthcare issues for various government agencies in China.

STEVEN FANG

Group CEO, Cordlife Ltd, Singapore

Steven founded CordLife in Singapore, in 2001 and negotiated the


merger with Cytomatrix leading to the establishment of CyGenics in
2004. He led the team towards a successful listing of CyGenics on the
Australian Stock Exchange in June that year.
He has a great depth of knowledge of the healthcare provider business,
with over 15 years of sales and business development experience in
the USA and the Asia Pacific region.

He previously worked for Sterling Withthrop, Baxter and Becton


Dickinson, having undertaken business development assignments in
Malaysia, Korea, Taiwan, and the Philippines, including the
establishment of private dialysis centres. At Becton Dickinson he was
the General Manager for Singapore, Malaysia and Vietnam.

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

Partner, Bird and Bird, UK

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.

Lorna is a regular speaker at seminars and conferences around the


world. She was a member of the European Union’s expert missions to
China in 1995 and to the ASEAN countries in 1996, advising on
intellectual property protection and enforcement issues. She has
published many articles on intellectual property, regulatory and trade
issues over the years. She contributed chapters to Database Law
(Jordans, 1998), The Pharmaceutical Pricing Compendium (Urch, 2002)
and was co-author with Trevor Cook of The Copyright Directive: UK
implementation (Jordans, April 2004). Her book Electronic Signatures
Law and Regulation (Sweet & Maxwell, London) was published in
December 2003. She is an author and the Editor of the Intellectual
Property Handbook being published by Law Society Publishing in 2007.

KENT CHENG
Partner, Cohen, Pontani, Lieberman & Pavane, USA

Dr. Kent H. Cheng is a partner in the intellectual property law firm of


Cohen, Pontani, Lieberman & Pavane in New York City. His practice of
more than twenty years includes client counseling, patent prosecution,
opinion work, licensing and litigation in various areas including
pharmaceuticals, biotechnology, medical devices, chemical processing
and semiconductor fabrication.

Dr. Cheng has extensive experience in pharmaceutical and


biotechnology litigation and related Food and Drug Administration
matters including The Drug Price Competition and Patent Term
Restoration Act of 1984 (the Hatch-Waxman Act).

L. CHRISTIAN CLAUSS

Director of New Product Development, RA Global Biologics, Baxter


Bioscience Global NPD, France

Global Director Regulatory Affairs New Product development Global,


BioScience, Baxter World Trade

Graduate both and Sciences with a Master in Bio-Pharmacy and a Ph. D


in Pharmacy and in Business administration (IAE).
Resident Biologist in Public Hospitals before moving in the Multinational
Health Care Industry both in the Medical Devices field and in the
Pharmaceutical one (Merieux, Dow corning, Boston Scientific, Clintec,
B.D Baxter), with more than 20 years experience in International
Marketing, Product development and Regulatory Affairs.

Lead the development of numerous products drugs, devices and


Biologics such as BioSimilar.

Member of numerous Professional Societies e.g DIA, RAPS (past


General secretary, RACS,), EUCOMED (past chairman of the FRG),
APIMCA (past President elected), etc....

Published More than 40 papers and conferences (Scientific, Regulatory


and Reimbursement subjects)

THOMAS BOLS
Director of Government Affairs, Amgen

Thomas is Amgen’s Director Government Affairs Europe and a member


of the Amgen International Leadership Team. He joined Amgen in
January 2003 from Fleishman-Hillard/GPC International, a worldwide
government and public relations consulting firm, where he was
Executive Director Health Care & Pharmaceuticals. Previously, he has
been working for management consultancies, industry federations and
the EU Institutions.

Thomas is a member of EuropaBio’s Healthcare Council and is Vice-


Chairman of the EBE’s public affairs committee. Furthermore he is the
Chairman of both the EuropaBio’s and EBE’s Task Forces on Biosimilar
Medicinal Products.

Thomas studied Political Sciences at the University of Amsterdam and


holds a postgraduate degree in European Law. A Dutch citizen, born in
1964, he is married and has 2 children.

ANDREW C. CHANG

Senior Director, PharmaNet Consulting, USA

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.

Consulting Expertise: Regulatory considerations for natural,


recombinant, and combination products, product comparability, follow-
on/biosimilar biologics, viral safety, immunogenicity, cGMP audit, and
interpretation of FDA regulations, policies, and guidances

MARTIN WISHER

Scientific Director, BioReliance, UK

Martin Wisher is Scientific Director at BioReliance, a leading contract


testing company that performs cell line characterisation, viral
clearance, analytical chemistry and manufacturing services to the
biological/biopharmaceutical industry worldwide. Martin has worked for
BioReliance for over 17 years and has a total of over 21 years
experience in the contract services industry. In this time he has been
responsible for running routine laboratory services, developing new
assays and services and Head of Quality Systems and Regulatory
Affairs. As Scientific Director he spends considerable time working with
clients to devise testing strategies that will meet the requirements of
regulatory agencies worldwide. Martin gained his Ph.D. in membrane
biochemistry from the National institute for Medical Research, London
and has been involved in the development of monoclonal antibodies
and recombinant vaccines.

SIMON ROGER

Renal Unit, Gosford Hospital, Australia

Simon Roger underwent advanced training in nephrology at Westmead


Hospital, Sydney, followed by two years of clinical and laboratory
research in London, leading to a thesis on Mechanisms of
Erythropoietin-Induced Hypertension, which was awarded a Doctorate
of Medicine. On completion, he returned to Gosford Hospital, Australia,
as Director of Renal Medicine and was appointed Clinical Associate
Professor at the University of Newcastle.

Clinical practice includes management of in-centre and home


haemodialysis and peritoneal dialysis patients in addition to both
chronic kidney disease and renal transplant patients, both in the
hospital setting and private practice.

The 2007 clinical research profile includes pharmaceutical industry


sponsored trials and investigator initiated trials targeting diabetes,
lipids, iron and anaemia in the chronic kidney disease (currently 16
active trials). Both the research and busy clinical practice has resulted
in Dr Roger being requested to contribute to both national and
international advisory boards.

BIOMANUFACTURING
Strategies for Achieving Manufacturing Excellence and
Entering Key Regulated Markets

UWE GOTTSCHALK

Group Vice President, Purification Technologies, Sartorius

Dr. Gottschalk is Group Vice President, Purification Technologies, with a


global responsibility for bioseparation products at Sartorius Stedim
Biotech. He worked in different capacities for Bayer Health Care from
1991-2004 and become head of the GMP protein purification facility in
Wuppertal (Germany). He was responsible for the production of
monoclonal antibodies and other recombinant proteins using various
expression systems. Dr. Gottschalk holds a PH.D. in Chemistry from the
University of Munster. He is member of BioPharm International’s
editorial advisory board and has written one book, five book chapters
and many other publications in the areas of biotechnology and somatic
gene therapy. In academia Dr. Gottschalk is Head Lecturer at the
University of Duisburg-Essen (Germany) and also lectures at the Ecole
Polytechnique Federale de Lausanne EPFL (Lausanne, Switzerland).

DAVID HUGHES

General Manager, BioPharmaceuticals Australia

David Hughes is CEO of BioPharmaceuticals Australia Pty Ltd, a


Queensland Government-owned company charged with
implementation of a major project to build and operate a world-class,
fee-for-service biologic drug manufacturing facility for use by Australian
biotech and interantional companies. David Hughes is an experienced
manager in the food and pharmaceutical sectors. David has
considerable technical and commercial experience in the scale-up and
commercialisation of biotech products. Significantly, David was
responsible for the design, construction and commercial operation of
Australia’s largest-ever recombinant protein facility. This project,
spanning more than 15 years, encompassed the classical
developmental path from “idea to invoice”. David’s role included direct
responsibility for process development, pilot plant design and
operation, as well as the design, construction, validation, and
commercial operation of a world-scale microbial recombinant protein
plant. The plant comprised fermentation capacity of two 20,000 litre
fermenters and during 2002 it produced over 300 kg of pharmaceutical
grade protein to GMP standards.

RICK NG

Director QA/QC, A-Bio Pharma, Sinagpore


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.

Rick has authored a number of scientific articles. He is the author of


one of the best selling medicine/pharmacology books – Drugs: From
Discovery to Approval (Wiley 2004).

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.

Rick has authored a number of scientific articles. He is the author of


one of the best selling medicine/pharmacology books – Drugs: From
Discovery to Approval (Wiley 2004).

ABDULQADER ALKHAYAT

Executive Chairman, DuBiotech, UAE

Executive Director of Dubai Biotechnology and Research Park


DuBiotech)

Dr. Abdulqader Al Khayat was appointed as an Executive Director of


Dubai Biotechnology and Research Park (DuBiotech), a zone dedicated
to the development of the biotechnology industry, in September 2004.
Under his leadership, DuBiotech is creating a comprehensive
infrastructure and environment to catalyze biotechnology development
in the region.

Dr. Al Khayat was the Director General of Dubai Police’s General


Department of Forensic Administration. He brings over 20 years of
experience in genetics and forensics. He obtained his PhD in Forensic
Science from the University of Strathclyde in Glasgow, (2003), a Master
of Science in Criminalistics from John Jay College of criminal justice,
City University of New York in New York, (1989) and a Bachelor of
Science in Biology from the UAE University in AlAin, (1983).

Dr. Al Khayat is a member of several premier international


organizations and is a renowned expert in DNA, trace evidence and
crime scenes. He also led the organization of several major
international conferences in Dubai including the Forensic Science
Expert Conferences, Intersect and also with Naif University, Saudi
Arabia.

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.

DATO’DR MOHD NAZLEE KAMAL

CEO, Inno Biologics

MIN-CHI WU

President, Development Centre for Biotechnology, Taiwan

Dr.Ming-Chi Wu is current the President of Development Center for


Biotechnology in Taiwan. He is also Professor Emeritus of Molecular
Biology and Immunology , University of North Texas Health Science
Center at Fort Worth , Texas, Where he has taught the past 25 years.
His research interests are in the area of regulation of hematopoiesis
and bone marrow stem cell biology.

JAMES P. MILLER

Vice President SSF Biochemical Manufacturing, Genentech


James Miller, 49, joined Genentech in December 2005 as vice
president, South San Francisco Biochemical Manufacturing responsible
for the production of clinical and commercial proteins using
recombinant and bacterial cell technology. He has recently accepted a
new assignment as vice president and general manager, Singapore
Product Operations. He and his family will be relocating to Singapore in
2008.

Miller joined Genentech from Centocor Biologics, a division of Johnson


& Johnson, where he served as General Manager. Miller has held
executive and senior positions as Managing Director at Wyeth and
Chiron Corporation, as well as a variety of manufacturing leadership
positions at invitron Corporation, Lever Brothers Company and
Schering-Plough Corporation.

Jim brings 26 years of leadership skills in manufacturing to Genentech.


His experience in all aspects of biotech manufacturing will benefit the
company’s clinical and commercial protein production operations. He is
well versed in Design Excellence, Six Sigma and Lean Manufacturing.

Miller is past Chairman of the Board of Directors of the Center for


Emerging Technologies in ST. Louis Missouri and was Board Member of
the Missouri Biotechnology Association.

Miller hold a Bachelor of Science degree in Business Administration


from the Unversity of Missouri.

BART MOORS

Business Development Manager South East Asia, Competence Center


Pharmaceuticals, Siemens AG

Bart is Business Development Manager South East Asia of the


Competence Center Pharmaceutical industries. The Competence
Center is past of the Siemens Headquarters.

He started his profession by Philips. He was Product specialist and in a


second stage Project Manager for a division responsible as world wide
supplier for fuel pumps in the automotive industry. Bart started in 1997
his profession by Siemens as International Project manager for the
pharmaceutical industry. He realized projects by customers as Janssen
Pharmaceutica, UCB, Genzyme, Schering & Plough,... In 2005 Bart
started in the competence Center Pharma and is now responsible for
the region South East Asia for the pharmaceutical industry.
Bart has a Master in Engineering degree in Electrical-Mechanical
Engineering (University of Hasselt, Belgium), a specialism in Polymer
Chemics and a Master degree in Applied Economics.

STEVE OH

Associate Director & Principal Scientist, Stem Cell & Fermentation


Groups, Bioprocessing Technology Institute, Singapore

Dr. Steve Oh received his B.Sc. Eng. (Hons) in Biochemical and


Chemical Engineering at University College London and completed his
Ph.D. at Birmingham University, England in 1991. At the Bioprocessing
Technology Institute (BTI) at the Agency for Science Technology &
Research (ASTAR) since 2001, he is currently the Principal Scientist of
the Stem Cell and Fermentation Groups as well as the Associate
Director of Intellectual Property and Academic Affairs. His roles include
developing bioprocess research, serum free media development in
human embryonic stem cells and human mesenchymal stem cells,
managing the Bioprocess Internship Programme, and BTI’s intellectual
property and collaborations. Most recently he has been appointed as
Project Manager for the building of the first GMP Cell Therapy
Processing Facility (CTPF) in Singapore. He is also a member of the
International Stem Cell Initiative (ISCI) which has characterized the
properties of 59 human embryonic stem cell lines.

DAVID BRAMHILL

Director, Research Corporation Technologies, USA

JANET MCNICHOLAS

Partner, Bell, Boyd & Lloyd, LLP, USA


Day 2

Speaker’s
Biographies
Join Plenary Session

JOHN BIRCH

Chief Scientific Officer, Lonza Biologics, UK

John Birch graduated in microbiology from London University where he


also completed a Ph.D. After a period lecturing at the University he
moved into industry, holding senior technical positions at Tate and Lyle,
G.D. Searle, Celltech and Lonza. He is currently Chief Scientific Officer,
Lonza Biopharmaceuticals. His scientific interests have focused on the
production of therapeutic proteins, particularly from mammalian cells
and he has published extensively in this field. He is a visiting Professor
at the University of Reading , in the Department of Biochemical
Engineering at University College London and in the Department of
Chemical Engineering at Oxford University.

UWE GOTTSCHALK

Group Vice President, Purification Technologies, Sartorius

Dr. Gottschalk is Group Vice President, Purification Technologies, with a


global responsibility for bioseparation products at Sartorius Stedim
Biotech. He worked in different capacities for Bayer Health Care from
1991-2004 and become head of the GMP protein purification facility in
Wuppertal (Germany). He was responsible for the production of
monoclonal antibodies and other recombinant proteins using various
expression systems. Dr. Gottschalk holds a PH.D. in Chemistry from the
University of Munster. He is member of BioPharm International’s
editorial advisory board and has written one book, five book chapters
and many other publications in the areas of biotechnology and somatic
gene therapy. In academia Dr. Gottschalk is Head Lecturer at the
University of Duisburg-Essen (Germany) and also lectures at the Ecole
Polytechnique Federale de Lausanne EPFL (Lausanne, Switzerland).

SANJAY JAIN

Chief Scientific Officer (Vaccines and Biologicals), Panacea Biotec,


India

Dr. Sanjay Jain has over 20 years of experience working at several


biopharmaceutical companies, including Apex Bioscience, Cephalon,
Astra-Zeneca, and BioChem Pharma/ Shire Biologics, Inc. At these
companies, Dr. Jain held a series of increasingly responsible positions in
the area of process development and scale-up for GMP production of
recombinant proteins and vaccines for human clinical studies. Dr. Jain
has been involved with the production of a range of recombinant
vaccines and protein therapeutics using a variety of expression
systems such as Filamentous fungi, Saccharomyces cerevisiae, Pichia
pastoris, E. coli, Baculovirus, and Mammalian cell culture. He was also
Project Manager for cell-culture based Influenza vaccine project at Shire
Biologics, and Principal Investigator on a US $9.5 million grant from
U.S. National Institutes of Health (NIH) for the development of
Pandemic influenza vaccine technology. He has experience from IND to
NDA submission, project management and prospecting new business
development opportunities. Dr. Jain received his Ph.D. in Microbiology
from the Paul Sabatier University, Toulouse, France.

Currently, as a consultant, Dr. Jain supports product development,


project management and business development activities, and also
designs and sets up multi-product GMP production facilities.
BIOSIMILARS
Seizing Opportunities for Competition and Commercialisation
in Domestic and Global Markets

ANDREW C. CHANG

Senior Director, PharmaNet Consulting, USA

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.

Consulting Expertise: Regulatory considerations for natural,


recombinant, and combination products, product comparability, follow-
on/biosimilar biologics, viral safety, immunogenicity, cGMP audit, and
interpretation of FDA regulations, policies, and guidances

BRUCE MURDOCH

Chief Business Officer, Avesthagen, India

Bruce has over 30 years of experience in the fields of General


Management, Marketing and Corporate M&A within the global
pharmaceutical industry.

Since 1975 he has held a number of Senior Management positions with


Rhone-Poulenc, AstraZeneca, Pharmacia and Schering-Plough
within UK and Asian markets including Japan. He was also involved in
the early entry of the pharmaceutical industry into China with a
number of joint-ventures.

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.

From 2004 he was Senior Vice-President of Bioaccelerate Inc in London


and CEO of a small biotechnology start-up company called GENADERM
Ltd.

In 2006 Bruce joined Avesthagen Pvt Ltd , a Systems Biotechnology


company based in Bangalore, India as Chief Business Officer. They are
currently developing a number of “Biosimilars” for the world markets.
( see www.avesthagen.com)

He graduated from Nottingham University in 1971 with an Honours


Degree in Biological Sciences with Statistics. He has been Chairman of
various Pharmaceutical branches of IFPMA and PhRMA. He is currently a
member of the Institute of Directors in UK.

CARTIKEYA REDDY

Senior Director, Biologics Development Centre, Dr. Reddys


Laboratories, India

Dr. Cartikeya Reddy, Vice President, Dr. Reddy’s Laboratories Limited,


heads the Biologics Division of the company which focuses on
biosimilars for India as well as global markets. Dr.Reddy’s has
launched two biosimilar molecules (filgrastim and rituximab) in India
and a few other Countries and is working on several other products for
development.

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.

Cartik holds a MS and Ph.D. in Chemical Engineering from the


University of Illinois, Urbana, USA, and was a visiting scholar at the
Massachusetts Institute of Technology, Cambridge, USA. He had earlier
graduated with a B.Tech in Chemical Engineering from the Indian
Institute of Technology, Chennai, India.

Cartik can be reached at creddy@drreddys.com

HALEH HAMEDIFER

President and CEO, CinnaGen, Iran

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

Chief Technology Officer, Shengyang Sunshine Pharmaceuticals,


China

Dongmei Su, Chief Technology Officer of 3SBio. She has been


employed by 3SBio since 1992. In Charge of the 3SBio’s
manufacturing, processing engineering. Co-inventor of several of
3SBio’s patents. She received her BS in Biochemistry from Jinlin
University and MS in Microbiology and Pharmacology from Shenyang
Pharmaceutical University.

JON ZIFFERBLATT

Director, General Biologics, China

DAVID SONG

CEO, PNS BIO, Korea

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

Chief Scientific Officer (Vaccines and Biologicals), Panacea Biotec,


India
Dr. Sanjay Jain has over 20 years of experience working at several
biopharmaceutical companies, including Apex Bioscience, Cephalon,
Astra-Zeneca, and BioChem Pharma/ Shire Biologics, Inc. At these
companies, Dr. Jain held a series of increasingly responsible positions in
the area of process development and scale-up for GMP production of
recombinant proteins and vaccines for human clinical studies. Dr. Jain
has been involved with the production of a range of recombinant
vaccines and protein therapeutics using a variety of expression
systems such as Filamentous fungi, Saccharomyces cerevisiae, Pichia
pastoris, E. coli, Baculovirus, and Mammalian cell culture. He was also
Project Manager for cell-culture based Influenza vaccine project at Shire
Biologics, and Principal Investigator on a US $9.5 million grant from
U.S. National Institutes of Health (NIH) for the development of
Pandemic influenza vaccine technology. He has experience from IND to
NDA submission, project management and prospecting new business
development opportunities. Dr. Jain received his Ph.D. in Microbiology
from the Paul Sabatier University, Toulouse, France.

Currently, as a consultant, Dr. Jain supports product development,


project management and business development activities, and also
designs and sets up multi-product GMP production facilities.

EDWARD LEE

Research Advisor, Pfizer, USA

RAMANI AIYER

Chief Scientific Officer, Actis Biologicss Pvt. Ltd, India

Dr Ramani A Aiyer is Chief Scientific Officer, Actis Biologics Private


Limited, Mumbai (INDIA), a start-up biotechnology company focused on
discovery and development of innovative and novel bio-therapeutic
products. Prior to that he was Senior Vice President, Strategic Planning,
R&D at Nicholas Piramal India Limited, Mumbai, where his
responsibilities included Business Development & Licensing and Project
Management of new drug discovery and development programs. Prior
to this he was Chief Operating Officer at Avesthagen, a start-up
biotechnology company in Bangalore.

Before moving to India, Dr Aiyer had over 17 years of experience in the


biotechnology industry in the USA. He held senior positions in R&D and
Business Development at biopharmaceutical companies including
Genentech, LifeScan (subsidiary of Johnson & Johnson) and Sugen
(subsidiary of Pharmacia/Pfizer). He received an MBA from University of
California, Berkeley, has a PhD in Biochemistry from Harvard
University, and did post-doctoral research at Stanford University.

FREDRICH NACHTMANN

Head Biotech Cooperations, Sandoz GmbH, Austria

► Born 06.04.1950 in Bruck/Austria

► Study of Chemistry and Biochemistry at Technical University in


Graz/Austria

► Ph. D. in Technical Chemistry 1977

► Associate Professor at University Linz/Austria since 1984

► Various functions in QA, Licensing, Business Development, R&D


at Biochemie/Austria from 1977 – 2003

► Since 2003 Head of Biotech Cooperations at Sandoz GmbH,


Austria

MARK CARVER

Chief Scientific Officer, Avecia Biologics

Dr Mark Carver is Chief Scientific Officer of Avecia Biologics Ltd.


He is responsible for the Technology Strategy of the business, and for
the Research and Development and process validation programmes for
biopharmaceuticals and recombinant vaccines being developed for its
Biotechnology and major Pharma clients . He is a member of the Avecia
Biologics Ltd. board and plays a key role in developing and delivering
business strategy.

Avecia Biologics is a specialist in the invention, development and


validation of recombinant microbial processes for biopharmaceuticals
and the manufacture of these under cGMP. Mark has 24 years
experience with ICI, Zeneca and Avecia, in designing research and
development programmes to develop scaleable and validatable
manufacturing processes for recombinant protein products based on
microbial expression in bacterial, yeast and filamentous fungal
systems. In the last ten years his teams have been responsible for the
development and scale up to clinical manufacture of more than 40
products that have gone forward into clinical trials under FDA, MHRA
and EMEA jurisdictions. He therefore has developed a keen
understanding of the technical, regulatory and commercial issues
businesses face at each stage of the development and manufacturing
process for biopharmaceuticals.

Mark is based at Avecia Biologics HQ on Teesside in the UK .


HANNS-CHRISTIAN MAHLER

Head of Formulation Developments Biologics, F. Hoffmann- La


Roche, Switzerland

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.

From 2000-2005, he was working as Principal Scientist and Lab


Manager at Merck KGaA (Darmstadt, Germany) in Formulation
Development Sterile Dosage Forms and as CMC team leader Erbitux.

He has technical experience in formulation development of sterile


dosage forms including biologics, production of clinical trial and non-
clinical study material, technical registration, upscaling and validation.

Since 2003, he additionally holds a university teaching position for


"Pharmaceutical Biotechnology" at the University of Frankfurt/Main,
Germany.

Dr. Mahler holds a degree in Pharmacy and a Ph.D. in Pharmacology &


Toxicology obtained at the Johannes Gutenberg-University of Mainz,

BJORN HAMMARBERG

Managing Director & Partner, ABD LifeSciences Ltd, Hong Kong

Ph.D. in Biochemistry from KTH in Stockholm, Sweden and Post Doc in


Biochemical Engineering at RIKEN, Tokyo, Japan, 1990, as well as
Business Administration from Stockholm School of Economics in 97.
Worked across R&D, Marketing & Sales and Business Development
functions at Siemens, Pharmacia Biotech, Amersham Biosciences,
Pharmadule, and the last three years as a Business development
consultant in Asia based in Hong Kong for both small and large
companies such as Astra Zeneca and PALL Life Sciences. Involved in
lecturing at university based programs, e.g. University College London
(UCL) and Peking University (PKU).

NADINE RITTER
Senior CMC Consultant, Biologics Consulting Group Inc, USA

Nadine Ritter has 15 yrs of in-depth biotechnology industry experience


in the technical, quality and regulatory elements of product
development for a wide variety of protein and peptide therapeutics.
She is a protein analytical biochemist with hands-on expertise in the
design and execution of a wide array of biopharmaceutical CMC
analytical studies. Her technical specialties include test method
procedures and study protocols for biotechnology product
characterization, release and stability testing; analytical test method
development and validation; pre- and post- approval product
comparability; and assay technology transfers.

Additionally, Nadine has considerable experience in the management


of laboratories conducting R&D, GLP and cGMP studies for
biotechnology product physiochemical and functional testing.
Currently, she routinely performs third-party quality and compliance
audits ranging from small start-ups to multinational pharmaceutical
corporations. She has delivered numerous invited presentations on
numerous technical and quality topics, and has published articles and
book chapters on biotechnology CMC analytical studies and analytical
laboratory practices.

For many years, Nadine has been an active member of several


professional scientific organizations dedicated to improving technical,
quality and regulatory elements of biotechnology product
development. She is a highly-regarded member of various scientific
review boards as well as program organizing committees in the
biopharmaceutical industry. She has recently been elected as US chair
of the PDA Biotechnology Analytical Method Development and
Validation Task Force.

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