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

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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 Londonand 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.