Speakers

Speakers Line-Up

Abrar Mir
Managing Partner
Quadria Capital Investment Management

Dr Abhay Kumar Sinha
Regional Director
Pharmexcil (the Ministry of Commerce & Industry, Govt of India)

Dr Anurag Tiwari
Biologic Development and Scientific Manager
Zumutor Biologics, India

Belinda Wood
Chief Executive Officer
Generic and Biosimilar Medicines Association, Australia 
Cheni Kwok
Head of Business Development
Shanghai Henlius Biotech Co. Ltd
Chua Hui Ming
Senior Principal Assistant Director, Biologics Section, Center for Product Registration, National Pharmaceutical Regulatory Division (NPRA)
Ministry of Health Malaysia
Dinesh Kundu
General Manager, Biologics Business Strategy, Business Development & Program Management
Intas Pharmaceuticals, India
Daniel Furtner
Area Therapeutic Lead Rheumatology & Biotherapeutics, Japan-Asia-Pacific (JAPAC), Global Medical Affairs
Abbvie Pty Ltd, Australia

Associate Professor Dieter TRAU
Associate Head Research, Department of Biomedical Engineering and Department of Chemical & Biomolecular Engineering, Faculty of Engineering, National University of Singapore (NUS)

Evelyn Pang
Head of Operations, Singapore
Sanofi Aventis

George Hutchinson
Head of Asia Pacific Business
Solentim Ltd., 
United Kingdom

Joo Sik Choi
Head of Business, Pharmerging Market
Celltrion Healthcare, South Korea
Karthik Ramani
Senior Director, Process and Product Development
Biocon, India

Dr Ken Wong
Deputy Director, Process Technology
Sanofi Pasteur, United States

Kerry Roche Lentine
Director of Technology Management, Process Solutions, Life Science Business of Merck KGaA

Lee Kyoung Hoon
Assistant Senior Manager, Physico-chemical assay team Analytical Science Dept. R&D
Celltrion, South Korea

Jamaludin Elis
Country Managing Director
Culia Life Sciences, Malaysia 

Mary Ramos
Regional Regulatory Manager - APAC
Accord Healthcare
Mitul Agarwal
General Manager - Business Development & Licensing
Intas Pharmaceuticals, 
India
Michelle Peake
Senior General Manager
PT Kalbio Global Medika, Indonesia
Nathan Ihle
Vice President, CMC Strategy & Management
Seattle Genetics, United States
Pearl Fong
Associate Vice President, Division of Project Development
Mycenax Biotech Inc., Taiwan
Dr Sugumar Parthasarathy
 Head – Bio Risk Management and Quality Assurance Manager
 Indian Immunologicals Limited, India
Stefan Kappeler
Senior Project Manager
Compliance & Validation M+W Group, Switzerland

Steven Blakely
Director, Drug Discovery & Development Business
Bio-Rad Laboratories

Dr Wen Zaiqing
Vice President of CMC
Generon Corpoation (Shanghai) Limited, China

Dr Yang Yuan Sheng
Senior Staff Scientist
Bioprocessing Technology Institute, Singapore

Speakers Profile

Abrar Mir
Managing Partner
Quadria Capital Investment Management

Abrar Mir is the co-founder and Managing Partner of Quadria Capital, the largest healthcare focused private equity firm in Asia with over US$1.5b in managed capital.

Abrar is actively involved in managing the firm and serves on the fund’s Investment Committee. Abrar has led private equity and capital markets transactions with an aggregate value of over US$40 billion across Asia, US and Europe. Abrar currently serves on the boards of Quadria Capital, Healthquad Advisors, FV Hospital, Singapore Medical Specialists Centre, Healthcare at Home, Soho Global Health and Medica Synergie.

Prior to founding Quadria Capital, Abrar was Global Head of Healthcare at Religare Capital Markets. Before that he was a Managing Director at Bank of America Merrill Lynch in London where he was part of the senior leadership team that led the bank’s healthcare investment banking strategy in Europe and Emerging Markets.

Abrar received a M.Phil in International Law from the University of Cambridge and is fluent in five languages.


Dr Abhay Kumar Sinha
Regional Director
Pharmexcil (the Ministry of Commerce & Industry, Govt of India)

Working as Regional Director in Pharmaceuticals Export Promotion Council, an organization set up by Ministry of Commerce & Industry, Govt of India. Leading numerous initiatives on pharma and related sector.

19 years of experience in promotion of international trade, market research and international trade information services. Had been associated with various projects of Export Promotion Councils, UNCTAD, Coffee Board, APEDA and Coir Board while working with National Centre for Trade Information-a joint venture of ITPO and NIC under Ministry of Commerce, Government of India.

Headed Western U.P. Zone of CII based at Noida during the period 2005-2008, besides taking Charge as State Head-UP in the year 2007. Also Headed the Manufacturing Competitiveness Sub-committee of CII-Northern Region. Initiated a number of activities related to industry-institute partnership, innovation and CSR.

Obtained specialized training on international trade related sources of information and databases by UNCTAD and also received training in Market Information System by CBI, Netherlands.

Academic qualifications include PhD, MBA with specialization in Marketing and Masters in International Trade and a Diploma in Pharma Regulatory Affairs.


Dr Anurag Tiwari
Biologic Development and Scientific Manager
Zumutor Biologics, India

Dr. Anurag Tiwari is scientific manager at Zumutor Biologics, India. At Zumutor Biologics Pvt. Ltd, his major research focuses on antibody engineering through Yeast surface Display.

Dr. Anurag Tiwari served as Principal Investigator in DuPont Knowledge Center (DKC), Hyderabad. DuPont Knowledge Center (DKC) located in Hyderabad is the first integrated R&D and knowledge science center of E.I. DuPont, USA providing R&D application development capability in India and the surrounding Asia Pacific region. At DKC, his major research focus was on metabolic engineering to establish a platform for the production of neutraceuticals in microbes.

Dr. Anurag Tiwari has earned PhD degree from Indian Institute of Technology, Mumbai, India and post-doctoral research at Tulane University, New Orleans, USA. During his stay at Tulane University, he explored aging biology in baker’s yeast.


Belinda Wood
Chief Executive Officer
Generic and Biosimilar Medicines Association, Australia 

Belinda Wood is the CEO of the Generic and Biosimilar Medicines Association (GBMA), the Australian association representing companies that manufacture, supply and export generic and biosimilar medicines. Belinda has over 22 years’ experience in the pharmaceutical industry and was appointed CEO in December 2014, having been the organisation’s Policy Director from 2012. Belinda was pivotal in negotiations leading to the signing of a Strategic Agreement with the Australian Government in May 2015 that recognises the important role of generic medicines and biosimilars in PBS affordability. In 2017 her leadership and advocacy resulted in an extension to that Agreement that includes uptake drivers for generic and biosimilar medicines, as well as grant to conduct biosimilar awareness activities. Belinda holds a BMedSc in Pharmacology and is a graduate of the Australian Institute of Company Directors. She proudly contributes to the work of the International Generic and Biosimilar Medicines Association (IGBA) Trade Committee, and is the deputy-chair of the IGBA Biosimilars Committee.


Dr Cheni Kwok
Head of Business Development
Shanghai Henlius Biotech Co. Ltd

Dr. Kwok is a senior biopharmaceutical executive who has executed over 100 business transaction. She is Managing Partner, Linear Dreams LLC and serves as Head, Business Development at Shanghai Henlius Biotech, a leading biopharmaceutical company specialized on biosimilar and novel antibody therapeutics.

Previously, Dr. Kwok was Senior Vice President, Corporate Development at Poniard Pharmaceuticals; Director, Business Development at Celera Genomics; Associate Director, Business Development at Exelixis and investigator at SmithKline Beecham (GSK). 

Dr. Kwok received a bachelor's degree in biotechnology from Imperial College London, a Ph.D. in human molecular genetics from University of Cambridge and is a Certified Licensing Professional (CLP).  She is President of the Chinese-American Biopharmaceutical Society (CABS), and serves on the Standards, Admissions & Recertification Committee of CLP.


Chua Hui Ming
Senior Principal Assistant Director, Biologics Section, Center for Product Registration, National Pharmaceutical Regulatory Division (NPRA)
Ministry of Health Malaysia

Madam Chua Hui Ming is a pharmacist in practice registered with Malaysia Pharmacy Board. She obtained her Bachelor of Pharmacy degree at University of Malaya, Malaysia and served for the Ministry Of Health ever since graduated in June 2005. She acted as a regulatory pharmacist handling pharmaceutical product registration at the National Pharmaceutical Regulatory Division (NPRA, which acts as the secretariat for Drug Control Authority, DCA) under the MOH Malaysia.

In year 2013, she further pursued her master degree in Pharmaceutical Technology at King's College London, United Kingdom and graduated in year 2014. Upon returned to the country, she resumed back her service with the MOH Malaysia and positioned at Biologics Section, Centre of Product Registration in NPRA. Recently she has been promoted as the ‘Head of Biotechnology & Blood Product Unit’ under the Biologics Section. Currently she handles mainly the review and approval of Biotechnology and Biosimilar products, as well as other biotherapeutics which include vaccines, blood or cell-derived products.


Daniel Furtner
Area Therapeutic Lead Rheumatology & Biotherapeutics, Japan-Asia-Pacific (JAPAC), Global Medical Affairs
Abbvie Pty Ltd, Australia

Daniel Furtner is AbbVie’s Therapeutic Area Lead Rheumatology & Biotherapeutics for the Japan-Asia-Pacific region. 

MD with clinical background and over 9 year of pharmaceutical industry experience in Europe and Asia-Pacific with R&D focused innovator companies.


Dinesh Kundu
General Manager, Biologics Business Strategy, Business Development & Program Management
Intas Pharmaceuticals, India

A medical doctor by training and an alumnus of London Business School & Indian School of Business. Worked as a clinician in the Indian Army for 7 years before joining the Biosimilar Industry. Started the corporate career with Wockhardt Ltd, India and joined Intas 2 years back. In the current position, handling Business Strategy, program management and BD for the Intas portfolio.


Associate Professor Dieter TRAU
Associate Head Research, Department of Biomedical Engineering and Department of Chemical & Biomolecular Engineering, Faculty of Engineering, National University of Singapore (NUS)

Dieter Trau holds an engineering degree (Dipl. Ing. FH) from the Aachen University of Applied Science, 1994 in Chemical and Bioengineering and a PhD degree from the Hong Kong University of Science & Technology (HKUST) 2001 in Chemistry. He worked as a Research Engineer in Germany from 1994 to 1998 and started his entrepreneurial activities with the foundation of the biotechnology companies Xantec in Muenster (1995) and 8sens biognostic in Berlin, Germany (2000). After completion of his PhD he was a Research Fellow (2001), then Assistant Lecturer (2002) and later Assistant Professor (2003) at the Hong Kong University of Science & Technology. In 2004 he joined the Division of Bioengineering and the Department of Chemical & Biomolecular Engineering at the National University of Singapore (NUS) as an Assistant Professor. He was promoted to Associate Professor with tenure in 2013. At NUS, he founded the life-science companies AYOXXA Pte Ltd in 2010 and Tip Biosystems Pte Ltd in 2014. 

Prof. Trau is a serial inventor entrepreneur with research interests in encapsulation technologies, bioanalytics and microdevices. In his interdisciplinary work he combines microfabrication, encapsulation, surface/colloidal chemistry and molecular biology to develop novel analytical techniques and translated them into several technology startup companies. He is author of >50 international peer reviewed research papers and inventor of 17 patent families resulting in more than 80 patent applications of which 20 are granted and commercialized by different companies.


Evelyn Pang
Head of Operations, Singapore
Sanofi Aventis

Evelyn is a pharmacist by training who has over 10 years of experience in the pharmaceutical industry.  Taken on sales, marketing, medical and commercial operations roles for Singapore and JAPAC, she has successfully launched key brands across various therapeutic areas and developed strengths in building cross-functional capabilities and collaboration. Passionate in the biopharma arena, she enjoys working in the field of biologics eg: immunology and vaccines to improve the lives of patients.  


George Hutchinson
Head of Asia Pacific Business
Solentim Ltd., 
United Kingdom

George Hutchinson has more than 30 years’ experience working in the life science instrumentation industry. He has diverse experience in the development, application and global commercialisation of leading edge, intelligent imaging based technologies.

His experience includes the commercial development of bacterial colony pickers for use in high throughput sequencing applications into post genomic applications such as Phage Display, Directed Evolution and automated cloning.

In 2005 he was responsible for the global commercial launch of the ClonePixFL and CloneSelect Imager technologies and remained involved in the technologies for a number of years with a particular interest in commercialisation of these technologies in the Asia-Pacific region.
With the acquisition of Genetix he transferred to Leica and focussed on commercialisation and promotion of imaging systems for chromosomal and digital pathology applications into the Asia-Pacific region.

In 2013 he became director of Life Science at FFEI Ltd., where amongst other assignments, he was head of a research project developing calibration tools for the imaging performance, colour, dynamic range and resolution of digital pathology imaging systems.

In 2014 he joined Solentim where he has taken on responsibility for the commercialisation of the Cell Metric Imaging and documentation system into the Asia-Pacific market.


Karthik Ramani
Senior Director, Process and Product Development
Biocon, India

Karthik graduated with a dual major in Pharmacy and Biological Sciences from BITS, Pilani, India in 1999. Subsequently, he graduated with a Ph.D. in Pharmaceutical Sciences from University at Buffalo, State University of New York, USA in 2005. After his doctoral training, Karthik relocated to India and established the Biologics formulation group at Biocon, Bangalore. He was also one of the founding members of the Devices team at Biocon. Currently, he is a Senior Director and Group Leader in the R&D division of Biocon. Karthik’s group is responsible for the formulation and associated process development of all novel biologics and biosimilars (insulins, monoclonal antibodies, fusion proteins, peptides), scale-up and technology transfers to Biocon’s DP manufacturing facilities, as well as support the manufacturing of clinical and commercial supplies.

Karthik has several scientific publications to his credit in peer reviewed international journals and has also co-authored a book chapter. He also has two patents to his credit. Karthik has also been an invited speaker in national and international forums and is a member of the Parenteral Drug Association (PDA).


Dr Ken Wong
Deputy Director, Process Technology
Sanofi Pasteur, United States

Ken Wong is a Deputy Director of Process Technology at Sanofi Pasteur at Swiftwater Pennsylvania site, USA. His 18-year biopharma professional career has ranged from R&D to development and commercialization to cGMP manufacturing support. For the last 16 years, he has specialized in extractables and leachables packaging systems. For the last 9 years, he has been heavily involved with SUT and currently representing Sanofi on the BioPhorum Operations Group (BPOG) Disposable Governance Team as well as the USP <665> Expert Panel and the ELSIE material working group.


Kerry Roche Lentine
Director of Technology Management, Process Solutions, Life Science Business of Merck KGaA

Kerry Roche Lentine has over 25 years of experience in research and development, product management, and technology management with a background in virus and mycoplasma clearance, aseptic processing and sterilization.

She is currently Director of Technology Management Process Solutions in the Life Science Group of Merck KGaA. Previously she was Head of Virology and Microbiological Sciences R&D, Bioprocess Division of Millipore Corporation where she led a group focused on research, method development, and validation in the areas of viral and mycoplasma clearance, sterilizing filtration, preservation, sanitization, and moist heat and radiation sterilization.

She is a speaker on subjects related to mycoplasma clearance, sterile filtration, moist heat sterilization, and microbiological testing. She has presented at the US-FDA Basic Drug School, PDA Training and Research Institute, Parenteral Drug Association, ISPE, University of Tennessee, and JAACT and has published articles on mycoplasma
clearance and sterilization.

She was a member of the Parenteral Drug Association Mycoplasma Task Force Filtration subcommittee that recently published PDA Technical Report 75 Consensus Method for the Rating of 0.1 μm Mycoplasma Reduction Filters, and a member of the American Society of Testing Materials subcommittee WK43140 – that published the revision of F838-15 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration. She is the holder of patents related to sterile filtration and mycoplasma clearance.


Lee Kyoung Hoon
Assistant Senior Manager, Physico-chemical assay team Analytical Science Dept. R&D
Celltrion, South Korea

Lee is leading a physico-chemical assay team at Department of Analytical Science in R&D, Celltrion. He has been working for 10 years in Celltrion. He involved on the development of Remsima™ which is the world’s first biosimilar monoclonal antibody medication to be approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). His team mainly works with method development, tech transfer, forced degradation study, product characterization, and comparability and similarity study for monoclonal antibodies, ADC and small proteins etc. Also, He is responsible for analytical CMC of filing for regulatory agencies including FDA and EMA. Recently, He managed characterization and similarity study for TruximaTM, Rituximab biosimilar, approved by EU and Korea. Currently, He is still working on the development of various biosimilar and new drug.


Mary Ramos
Regional Regulatory Manager - APAC
Accord Healthcare

License Pharmacist, with years of experience in the Regulatory field in Pharmaceutical, Biosimilar, Medical Device, Food (Nutritional & Supplement) and Cosmetics Industry in the Regional Regulatory position for Asia Pacific Countries. Current responsibility under Accord Healthcare, Overall in command for regulator activities for Asia Pacific Region: Singapore, Malaysia, Vietnam, Indonesia, Philippines, Myanmar, Thailand, Hong Kong, Taiwan, S. Korea, China. Ensure continuous support in maintenance of existing Product Portfolio in compliance with the Company and Local Health Authority Regulations. Deliver a reliable CMC strategy for all Regulatory submissions and activities to warrant continues commercial activities, such as product launch. Assess and provide robust regulatory plan whenever there’s new proposed guidelines/ regulation from local Health Authority and ensure important information are cascaded to Key Stake holder and cross functional department. Responsible for coordinating Pharmacovigilance activity/ report across the region. Provides PV training to new Employee/ Partner in-charge for PV report and drafts and provide final approval of SDEA (Safety Data Exchange Agreement).Identify and implement a regional strategy for Pharmacovigilance in close cooperation with the Global Pharmacovigilance team in UK.


Michelle Peake
Senior General Manager
PT Kalbio Global Medika, Indonesia

Michelle Peake has been working in the field of biotechnology for over 20 years, for companies in Australia, England, Malaysia and Indonesia. She has worked in all areas from research, to process development, with her main experience in cGMP manufacturing for biopharmaceuticals. She has extensive experience in protein purification, analytical assays and fill/finish. In December 2003 Michelle was appointed as the Director of Manufacturing for Alpha Biologics, a biopharmaceutical CMO in Penang, Malaysia, where she was responsible for the design and construction of the Alpha cGMP facility and equipment and establishment of the company. Currently she is Senior General Manager at Kalbio Global Medika in Cikarang, Indonesia.


Mitul Agarwal
General Manager - Business Development & Licensing
Intas Pharmaceuticals, 
India

17-year experience across sales, BD and in-licensing activities in India, APAC, LATAM and MENA. Started his career in Fresenius Kabi in sales and set up Baxter’s biosciences & biosurgery division across India and SE Asia. Joined Intas 6 years back and headed the BD and in & out-licensing division. In the current techno-commercial profile, he has overseen filing of 12 Biosimilars in 30 markets including Regulated and SRMs.


Nathan Ihle
Vice President, CMC Strategy & Management
Seattle Genetics, United States

Nathan Ihle joined Seattle Genetics in 2002 and has held various leadership positions in the company. In his current role, Nathan has responsibility for CMC Project & Alliance Management as well as overseeing the CMC Strategy for the company’s product portfolio. He led the CMC team responsible for the development and commercialization of ADCETRIS® (brentuximab vedotin).  Prior to joining Seattle Genetics, Nathan served as Director of Chemistry at Celltech and at PathoGenesis. Earlier in his career, he conducted drug discovery research at Merck. Dr. Ihle is trained as a synthetic organic chemistry, having earned a BA from Whitman College and a Ph.D. from Stanford University. He conducted postdoctoral research at the University of California, Berkeley.


Dr Sugumar Parthasarathy
 Head – Bio Risk Management and Quality Assurance Manager
Indian Immunologicals Limited, India

Dr. Sugumar Parthasarathy is Head- Bio risk management systems at Indian Immunologicals Limited, Hyderabad, India. His qualifications include M.Sc (biochemistry) from University of Madras and received his Doctoral degree in Biotechnology from Jawaharlal Nehru Technological University, Hyderabad. He worked as Scientist at R&D Centre, IIL for more than a decade. His experience includes in developing various recombinant vaccines for animal and human health and biotherapeutics at R&D Centre. He has published many international journals and filed 4 patents to his credit. His current activities are majorly focused in establishing the bio risk management system in order to frame the strategies for biocontainment and biosafety for the personnel, environment and product quality.


Stefan Kappeler
Senior Project Manager
Compliance & Validation M+W Group, Switzerland

Dr. Stefan has an MSc from the Swiss Federal Institute of Technology in Zurich, Switzerland and a PhD in molecular biotechnology. He has 16 years of experience in the pharmaceutical industry with a focus on biotechnology and has completed a variety of projects in the areas of R&D, tech transfer, USP and DSP production, QA, plant design and engineering and Q&V.


Steven Blakely
Director, Drug Discovery & Development Business
Bio-Rad Laboratories

Steven is the Director of the Drug Discovery and Development business at Bio-Rad and is leading strategic efforts to deepen Bio-Rad’s global relationships across BioPharma, CROs and CMOs, supported by an extensive portfolio of Life Science and Clinical Diagnostic solutions. Steven has more than 15 years of experience leading teams in life science and diagnostics product development and marketing.


Dr Wen Zaiqing
Vice President of CMC
Generon Corpoation (Shanghai) Limited, China

Dr. Zaiqing Wen is the VP of CMC department at Generon Corporation (Shanghai) Limited, China. He is responsible for the processes, analytical, formulation and drug delivery development. Prior to this role, he was a group head and principal scientist at the Process Development of Amgen Inc., USA.  He had extensive experience at Amgen on process development analytical, manufacturing non-conformance investigation, prefilled syringe development and trouble shooting. He was involved in a number of biological products commercialization of glycoproteins, monoclonal antibody as well as combination products at Amgen. He was awarded three times by PDA society for the Frederick D. Simon award in 2010, 2011 and 2014. He had over 60 journal publications. He obtained his Ph. D. in physical chemistry at the Glasgow University, UK and BS in Chemical Physics, in The University of Science and Technology of China (USTC).


Dr Yang Yuan Sheng
Senior Staff Scientist
Bioprocessing Technology Institute, Singapore

Dr. Yuansheng Yang received his doctorate degree from Vanderbilt University’s Department of Chemical Engineering in 2005. Upon graduation, he joined the Animal Cell Technology group, Bioprocessing Technology Institute (BTI) in Singapore as a research scientist. He has been an adjunct assistant professor of Nanyang Technological University from 2012 to 2015. He is currently leading a group working on vector design, cell line development, cell engineering, and bioprocess optimization to enhance the yield and quality of biopharmaceutical drugs produced using CHO cells. He has published over 30 peer reviewed papers and filed several patents related to developing cell lines for high level expression of monoclonal antibodies and other recombinant proteins. His vector technologies have been licensed to a few companies.