CURRICULUM VITAE
NAME: Hak-Kim Chan, BPharm, PhD
Professor in Pharmaceutics (Advanced Drug Delivery)
ADDRESS: (Work) Faculty of Pharmacy
University of Sydney
NSW 2006, Australia.
Phone (02) 9351-3054 Fax (02) 9351-4391
Email: kimc@pharm.usyd.edu.au
EDUCATION and AWARDS:
2006 Fellow of the American Association of Pharmaceutical
Scientists
2005 Grand Prize of Innovation Challenge, University of Sydney
2004 Faculty of Pharmacy Excellence in Teaching Award for
Physical Pharmaceutics and Formulation, University of Sydney
1999 Awarded the John A Brodie Medal by the Institute of
Engineers Australia for achievement on processing of
pharmaceutical powders for aerosol applications.
1998 Graduate Certificate in Educational Studies (Higher Education)
University of Sydney
1989 Awarded the Sigma Drug Delivery Prize 1989 Australia for
research on cromoglycic acid powder for inhalation.
Jun 1988 PhD in Pharmaceutics, University of Sydney.
1984 - 1988 Research on "Crystal Growth and Aerodynamics of Drug
Particles" leading to a PhD degree in pharmaceutics in the
Faculty of Pharmacy, University of Sydney, NSW, Australia.
Mar 1984 Awarded U.R.G. special project grant overseas scholarship by
the University of Sydney for four years.
Aug 1983 Graduated BPharm. Ranked the first in a class of twenty-two.
1979 - 1983 Awarded 5 prizes and 1 medal for distinction in academic
record. School of Pharmacy, National Defense Medical Center,
Taipei.
2
EMPLOYMENT HISTORY
Jan 2007 – present Professor, Faculty of Pharmacy, University of Sydney.
Jan 2002 – Dec 2006 Associate Professor, Faculty of Pharmacy, University of
Sydney.
Jan 2002 – Dec 2002 Acting Head of Pharmaceutics, Faculty of Pharmacy,
University of Sydney.
Jan 1999 – Dec 2001 Senior Lecturer, Faculty of Pharmacy, University of Sydney.
Aug 1995 – Dec 1998 Lecturer, Department of Pharmacy, University of Sydney
May 1992 - Aug 1995 Scientist, Department Pharm R & D, Genentech, Inc., South
San Francisco.
Jul 1989 - Dec 1991 Postdoctoral fellow, Faculty of Pharmacy, University of
Sydney.
Jul 88 - Jun 89 Postdoctoral associate, College of Pharmacy, University of
Minnesota, Minneapolis, USA.
TEACHING EXPERIENCE:
Lecturing on formulation and physical pharmaceutics (1995-
present). Coordinator of third year Formulation course (2003-
2006). Coordinator of second year Physical Pharmaceutics
course (1995-2002). Coordinator of third year dispensing
course (1995). (Detailed in Attachments 1 to 4)
ADMINISTRATIVE
EXPERIENCE: Besides the regular teaching administration (Detailed in
Attachments 1 & 2) and Faculty administration (Attachment 9),
I have extensive administrative experience in interfacing with
the pharmaceutical industry (Attachment 6).
PROFESSIONAL
EXPERIENCE: My professional activities are detailed in Attachments 8 and 10
RESEARCH EXPERIENCE:
Therapeutic and diagnostic inhalation aerosols: in vitro
generation and characterization, including dry powder aerosols
and radioaerosols from medical jet nebulisers, and in vivo
studies of pulmonary deposition and mucociliary clearance
using single photon emission computed tomography (SPECT).
Development of stable formulations of therapeutic recombinant
human proteins. Solid and solution state characterization of
proteins.
3
Particle engineering of drugs, and their characterization,
including the mechanisms of crystal growth and shape
modifications of pharmaceutical particles. Effects of crystal
defects and impurities on the dissolution rate and other crystal
properties of drug and excipients.
RESEARCH INTERESTS:
Formulation and delivery of therapeutic and diagnostic aerosols
for inhalation. In vivo deposition and clearance studies by
gamma scintigraphy.
Biotechnology-derived protein pharmaceuticals development -
formulation and aerosol delivery.
Application of novel powder technology and particle
engineering of pharmaceuticals to drug delivery systems and
dosage form design, i.e. the modification of physical form,
dissolution rate, physical properties, mechanical behaviour and
formulation characteristics of pharmaceutical solids by
processing treatment e.g. supercritical fluid technology
PUBLICATIONS: A complete list is attached separately.
PATENTS Six patents on pharmaceutical formulations including
biotechnology proteins (Detailed in the Application)
INVITED TALKS: Invited keynote speaker in various scientific conferences,
academic institutes and industry (Detailed in Attachment 7)
JOURNAL EDITORIAL International Journal of Pharmaceutics
BOARD MEMBER Pharmaceutical Research
Current Clinical Pharmacology
Recent patents in Biotechnology
Recent patents in Drug Delivery and Formulations
Pharmaceutical technology Asia
Hong Kong Pharmaceutical Journal
PROFESSIONAL Royal Australian Chemical Society (2005-present)
MEMBERSHIP: International Society for Aerosols in Medicine (1993-2005)
American Association of Pharm Scientists (1995-present)
Australasian Pharmaceutical Science Association (1995-2000)
Sigma Xi (1992-1997)
New York Academy of Science (1992-1996)
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p66陳克儉
Professor Hak-Kim Chan
Professor Chan has made significant contributions to the fundamental science and commercialisation of dry powder inhalation products over a period of 20 years. The products resulting from his advances have revolutionised, and will continue to transform, the delivery of existing and novel compounds to treat life-threatening diseases.
During the early 1990s, he made a major breakthrough at Genentech Inc, San Fransisco, in demonstrating that the significant therapeutic protein recombinant human deoxyribonuclease (rhDNase) can be produced as a biochemically and physically stable fine powder by spray drying. He created the formulation and showed its superior performance in inhalation aerosol delivery. This advance is set to be a key factor in the market when the patent for the liquid form expires in 2010, and is likely to lead to the significantly more effective delivery and treatment of cystic fibrosis with protein compounds. This work came after his involvement in the company’s development of the liquid form, which itself had been the first major breakthrough in the aerosol delivery of protein drugs using rhDNase (Pulmozymeä), the first and only protein product marketed for aerosol delivery to the lungs for local effect. His success in this field was evidence of his thesis that the development of dry powder aerosol compounds involves the dual challenge of achieving both chemical and physical stability, a theoretical and methodological issue that has had an impact on the way in which research in this field is conducted.
Leadership ability to build world-class research capacity
World-class research team built from scratch. Since joining the University of Sydney in 1995, Professor Chan single-handedly established a world-renowned and interdisciplinary research group in the area of therapeutic aerosols for inhalation. To develop a product from bench to market requires a clear understanding of all the key components involved in the R&D chain. With this in mind, he created a research group comprising specialists in both in vitro and in vivo research. A decade later, his research group is considered to be the best in Australia, and among the top three in the world (based on the number of publications and the number of plenary presentations in the field’s two leading premier conferences, Respiratory Drug Delivery Symposium and International Society of for Aerosols in Medicine Conference between 2005 and 2007). His approach to team-building has come from his industry background and an understanding of the value of integrating fundamental and applied research for successful inhalation product development. The corporate perspective he has brought to the team stresses engagement with a wider domain of ‘problem space’ than is normally found in university laboratories. His research ranges from in vitro production methods and the characterisation of inhalation aerosols to the in vivo imaging study of deposition in the lungs and therapeutic outcomes after inhalation. The group is one of the few in the world that can conduct both the fundamental and applied aerosol research that is required to bring innovations to the stage where companies can commercialise them. Such breadth is rare. Over the past 10 years, his group has attracted competitive research grants of $4 million.
Leadership in the scientific field. He has 161 refereed journal articles and book chapters; 79 of them published as book chapters (6) or in high-impact journals (73) over the past 5 years. The total number of non-self citations for all his research articles is over 1200. Many of these citations are evidence that his work has had a considerable influence on the way his fellow researchers see the topic. As examples, his work on the spray drying of rhDNase has been non-self-cited over 50 times in the pharmaceutical literature by scientists who followed his method to produce proteins for delivery by aerosols. His study on asthma monitoring using mannitol powder has been non-self-cited 69 times in the field of respiratory science by researchers who used his powders for their studies.
Best-equiped laboratory for pharmaceutical aerosol research in Australia. Recognising that aerosol research is heavily instrumentation-oriented, he has acquired state-of-the-art equipment worth $2 million for his laboratory, ranging from the relevant types of laser-based particle sizers to atomic force microscopy and thermal analytical systems for the R&D of pharmaceutical powder aerosol. This enables his group to perform the advanced characterisation of materials at very high resolution in the laboratory. There is no better place in Australia for conducting their research.
Mentorship. Over the past five years, he has mentored five junior research colleagues, particularly with respect to their research directions and the framing and writing of their grant applications, which has led to five successful competitive government grants worth $1.4 million in the past two years. He communicates the importance of industry experience for PhD graduates, and ensure that during their candidature they become familiar with the rigours of corporate research culture. He has been mentoring graduates through placements in corporate R&D, including Pfizer (the world’s largest pharma company), Genentech (the world’s second-largest biotech company), ISIS (an advanced drug delivery company using ‘anti-sense’ strategies) and NanoMaterials Technology (one of the leading privately owned nanotechnology companies in Asia).
Extensive leadership experience in multidisciplinary research. Professor Chan has an outstanding track record of collaboration leading to successful research outcomes. His integrated approach to the science of pulmonary drug delivery is unique. Over the past decade, he has initiated seven strategic national and international multidisciplinary research collaborations, in particular with Princeton University and Beijing University of Chemical Technology, along with other major research institutes in Australia. This has underpinned his successes in creating advance aerosol drug delivery.
Honours
· Named as Fellow of the American Association of Pharmaceutical Scientists (AAPS) 2006, in recognition of his sustained level of outstanding professional achievements and distinguished contribution in inhalation drug delivery research.
· Vice President of the inaugural Asian Federation for Pharmaceutical Sciences (AFPS), 2007–2009. He represented Australia at the first meeting held in October 2007, Philippines. The mission of the AFPS, which includes members from all countries in the Asia–Pacific, is to advance pharmaceutical sciences in the region, through research, education and a contribution to public policy.
Appointments
· Invited member of Subcommittee on Pharmaceutical Aerosol Standards for the Australian Therapeutic Goods Administration (TGA) 1996–97. He made a significant contribution to setting the testing standards required for the pharmaceutical inhalation products in Australia.
· Invited academic member (since 2006) to serve on the in vitro – in vivo correlation subgroup of the International Pharmaceutical Aerosol Consortium on Regulation and Science in Washington DC.
· Chair of the Royal Australian Chemical Institute (RACI) New South Wales Pharmaceutical Science Group (2005–present).
· Honorary Hospital Scientist at the Royal Prince Alfred Hospital providing expert advice on pharmaceutical inhalation aerosol therapy (2000 – present).
· Member of six Editorial Advisory Boards on pharmaceutical research, formulation and drug delivery: International Journal of Pharmaceutics, Pharmaceutical Research, Current Clinical Pharmacology, Recent Patents in Drug Delivery and Formulations, The Open Drug Delivery Journal, and Recent Patents in Biotechnology.
Patents
· Professor Chan holds six patents and pending patents on powder and aerosol formulations. These achievements show strong evidence of his leadership and entrepreneurial skills in commercialisation of research: (i) WO 9523613; (ii) WO 9523854; (iii) WO 0245690; (iv) WO 0294342 European Patent EP 1 389 137 B; (v) WO 0696906 g; (vi) Australian provisional patent June 2007.
Professor Chan has made significant contributions to the fundamental science and commercialisation of dry powder inhalation products over a period of 20 years. The products resulting from his advances have revolutionised, and will continue to transform, the delivery of existing and novel compounds to treat life-threatening diseases.
During the early 1990s, he made a major breakthrough at Genentech Inc, San Fransisco, in demonstrating that the significant therapeutic protein recombinant human deoxyribonuclease (rhDNase) can be produced as a biochemically and physically stable fine powder by spray drying. He created the formulation and showed its superior performance in inhalation aerosol delivery. This advance is set to be a key factor in the market when the patent for the liquid form expires in 2010, and is likely to lead to the significantly more effective delivery and treatment of cystic fibrosis with protein compounds. This work came after his involvement in the company’s development of the liquid form, which itself had been the first major breakthrough in the aerosol delivery of protein drugs using rhDNase (Pulmozymeä), the first and only protein product marketed for aerosol delivery to the lungs for local effect. His success in this field was evidence of his thesis that the development of dry powder aerosol compounds involves the dual challenge of achieving both chemical and physical stability, a theoretical and methodological issue that has had an impact on the way in which research in this field is conducted.
Leadership ability to build world-class research capacity
World-class research team built from scratch. Since joining the University of Sydney in 1995, Professor Chan single-handedly established a world-renowned and interdisciplinary research group in the area of therapeutic aerosols for inhalation. To develop a product from bench to market requires a clear understanding of all the key components involved in the R&D chain. With this in mind, he created a research group comprising specialists in both in vitro and in vivo research. A decade later, his research group is considered to be the best in Australia, and among the top three in the world (based on the number of publications and the number of plenary presentations in the field’s two leading premier conferences, Respiratory Drug Delivery Symposium and International Society of for Aerosols in Medicine Conference between 2005 and 2007). His approach to team-building has come from his industry background and an understanding of the value of integrating fundamental and applied research for successful inhalation product development. The corporate perspective he has brought to the team stresses engagement with a wider domain of ‘problem space’ than is normally found in university laboratories. His research ranges from in vitro production methods and the characterisation of inhalation aerosols to the in vivo imaging study of deposition in the lungs and therapeutic outcomes after inhalation. The group is one of the few in the world that can conduct both the fundamental and applied aerosol research that is required to bring innovations to the stage where companies can commercialise them. Such breadth is rare. Over the past 10 years, his group has attracted competitive research grants of $4 million.
Leadership in the scientific field. He has 161 refereed journal articles and book chapters; 79 of them published as book chapters (6) or in high-impact journals (73) over the past 5 years. The total number of non-self citations for all his research articles is over 1200. Many of these citations are evidence that his work has had a considerable influence on the way his fellow researchers see the topic. As examples, his work on the spray drying of rhDNase has been non-self-cited over 50 times in the pharmaceutical literature by scientists who followed his method to produce proteins for delivery by aerosols. His study on asthma monitoring using mannitol powder has been non-self-cited 69 times in the field of respiratory science by researchers who used his powders for their studies.
Best-equiped laboratory for pharmaceutical aerosol research in Australia. Recognising that aerosol research is heavily instrumentation-oriented, he has acquired state-of-the-art equipment worth $2 million for his laboratory, ranging from the relevant types of laser-based particle sizers to atomic force microscopy and thermal analytical systems for the R&D of pharmaceutical powder aerosol. This enables his group to perform the advanced characterisation of materials at very high resolution in the laboratory. There is no better place in Australia for conducting their research.
Mentorship. Over the past five years, he has mentored five junior research colleagues, particularly with respect to their research directions and the framing and writing of their grant applications, which has led to five successful competitive government grants worth $1.4 million in the past two years. He communicates the importance of industry experience for PhD graduates, and ensure that during their candidature they become familiar with the rigours of corporate research culture. He has been mentoring graduates through placements in corporate R&D, including Pfizer (the world’s largest pharma company), Genentech (the world’s second-largest biotech company), ISIS (an advanced drug delivery company using ‘anti-sense’ strategies) and NanoMaterials Technology (one of the leading privately owned nanotechnology companies in Asia).
Extensive leadership experience in multidisciplinary research. Professor Chan has an outstanding track record of collaboration leading to successful research outcomes. His integrated approach to the science of pulmonary drug delivery is unique. Over the past decade, he has initiated seven strategic national and international multidisciplinary research collaborations, in particular with Princeton University and Beijing University of Chemical Technology, along with other major research institutes in Australia. This has underpinned his successes in creating advance aerosol drug delivery.
Honours
· Named as Fellow of the American Association of Pharmaceutical Scientists (AAPS) 2006, in recognition of his sustained level of outstanding professional achievements and distinguished contribution in inhalation drug delivery research.
· Vice President of the inaugural Asian Federation for Pharmaceutical Sciences (AFPS), 2007–2009. He represented Australia at the first meeting held in October 2007, Philippines. The mission of the AFPS, which includes members from all countries in the Asia–Pacific, is to advance pharmaceutical sciences in the region, through research, education and a contribution to public policy.
Appointments
· Invited member of Subcommittee on Pharmaceutical Aerosol Standards for the Australian Therapeutic Goods Administration (TGA) 1996–97. He made a significant contribution to setting the testing standards required for the pharmaceutical inhalation products in Australia.
· Invited academic member (since 2006) to serve on the in vitro – in vivo correlation subgroup of the International Pharmaceutical Aerosol Consortium on Regulation and Science in Washington DC.
· Chair of the Royal Australian Chemical Institute (RACI) New South Wales Pharmaceutical Science Group (2005–present).
· Honorary Hospital Scientist at the Royal Prince Alfred Hospital providing expert advice on pharmaceutical inhalation aerosol therapy (2000 – present).
· Member of six Editorial Advisory Boards on pharmaceutical research, formulation and drug delivery: International Journal of Pharmaceutics, Pharmaceutical Research, Current Clinical Pharmacology, Recent Patents in Drug Delivery and Formulations, The Open Drug Delivery Journal, and Recent Patents in Biotechnology.
Patents
· Professor Chan holds six patents and pending patents on powder and aerosol formulations. These achievements show strong evidence of his leadership and entrepreneurial skills in commercialisation of research: (i) WO 9523613; (ii) WO 9523854; (iii) WO 0245690; (iv) WO 0294342 European Patent EP 1 389 137 B; (v) WO 0696906 g; (vi) Australian provisional patent June 2007.
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