Sino-American Pharmaceutical Professionals Association
Greater
2008
Member Conference
Quality by Design & Biostatistics
May 10th (Saturday), Holiday
Online registration: http://www.sapa-gp.org/mconf/reg8.htm
The pharmaceutical Quality by
Design (QbD) is a systematic approach to product and process design and
development. To facilitate the implementation of QbD, a pilot program launched
by FDA for new drug application (NDA). Nine original NDAs and two supplemental
NDAs were accepted. As of Sept 19, 2007, seven of these NDAs had been submitted,
of which six were approved and one was under review.
To better understand what are
QbD and the relationship to PAT and statistics, what are Lean Six Sigma and the
best practice in process and control for improved quality and efficiency from
development to manufacturing, leading experts from FDA and major pharmaceutical
companies were invited to address the challenges and implementation of the
"Quality by Design & Biostatistics.
Through the presentation and
interactive discussions, you will have an unrivalled opportunity to hear from
and network with industry practitioners, academic experts and technology
providers.
You can not afford to miss
this pharmaceutical industry event if you work in the areas:
♦
QA/QC ♦
Consultancy
♦
Analytical development ♦
PAT Team
♦
Technology ♦
Process Development & Control
♦
R & D ♦
Chemistry/Chemical Engineering
♦
Operations ♦
General Management
♦
Pharmaceutical Development ♦validation
♦
Sales/Marketing
Quality by Design & Biostatistics
8:30 a.m. Registration / Breakfast
9:00 a.m. Welcome and Opening Remarks, Conference
Chair
Laura Hong, MD., PhD Sr.
Research Biochemist, Merck& Co
9:05 a.m. SAPA-GP President Remarks
Zhongda
Zhang, Ph D. Principal
Scientist, Biomol International
9:10 a.m. Keynote
speech:
Quality by Design: Bridging the Gap between Drug
Development and Manufacture
Timothy Schofifld, MS. Senior Director, Merck &
Co.
Timothy Schofield is a Senior Director in the Nonclinical
Statistics department of Merck Research Laboratories,
Abstract A new age of drug development and
manufacture is upon us. Industry and
regulators are working toward the vision of a desired state expressed by Janet
Woodcock, Deputy Commissioner of the
9:50
a.m. Keynote speech: Pharmaceutical Quality by Design: Product and Process,
Development, Understanding,
and Control
Dr. Lawrence X. Yu is currently the Director for Science in the Office of Generic Drugs, FDA. He is also an adjunct Professor of
Pharmaceutical Engineering at the
Abstract The pharmaceutical Quality by Design (QbD) is a
systematic approach to development that begins with predefined objectives and
emphasizes product and process understanding and process control, based on
sound science and quality risk management. It means designing and developing
formulation and manufacturing processes to ensure a predefined quality. Some of
the QbD elements include:
–
Defining target product quality profile
–
Designing product and manufacturing processes
–
Identifying critical quality attributes, process parameters, and sources of
variability
–
Controlling manufacturing processes to produce consistent quality over time
Using QbD, pharmaceutical quality is
assured by understanding and controlling formulation and manufacturing
variables. Product testing confirms the product quality. Implementation of QbD
will enable transformation of the chemistry, manufacturing, and controls (CMC)
review into a science-based pharmaceutical quality assessment. The presentation
will discuss the pharmaceutical Quality by Design (QbD) and describe how it can
be used to ensure pharmaceutical quality.
10:30 a.m. Networking
Coffee Break
10:45
a.m. From concept to practice: Implementation
of QbD in late-phase pharmaceutical R&D and commercial manufacturing
Weiyong
Li, Ph D. Research
Fellow, J&J
Dr. Weiyong Li graduated from the East
China Institute of Chemical Technologies,
Abstract Today’s pharmaceutical industry is in an
increasingly tougher business environment. The difficulties are caused by many
factors including patent expirations, pricing pressure from the societies, and
more stringent securitizations from the regulatory bodies. To tackle these
problems, some companies are off-shoring development programs to reduce cost
while others are seeking more innovative ways in R&D to remain competitive.
In the past years, FDA and ICH have been advocating a Quality by Design
approach to the pharmaceutical industry. The new paradigm covers the entire
pharmaceutical R&D processes, from formulation design to commercial manufacturing.
One of the important aspects in QbD is to adopt relevant and cost effective
technologies in pharmaceutical R&D and manufacturing. This presentation
will give a brief overview on the status of QbD implementation in the industry
and a review on the most widely used QbD tools such as near infrared
spectroscopy and chemometric data analysis. A few case studies will also be
presented with regard to the most widely used pharmaceutical manufacturing unit
operations.
11:20
a.m. Pharmacovigilance: Principle, Practice and
Perspective
Jie
Chen, MD., PhD. Associate Director, Merck
& Co
Jie is an
Associate Director with the Investigational Research Department of Merck
Research Laboratories (MRL), Upper
Jie has been
with Merck for more than 12 years. His first 9 years with Merck were devoted to
non-clinical statistics including biologic quality operation, stability study,
bioassay development and validation, etc. Jie joined the Investigational
Research department about 3 years ago, focusing on methodology research in
biopharmaceutical product development. He is a co-organizer for the 4th
international conference on MCP, a co-guest editor of a special issue of Biometrical Journal, a co-founder of the
International Society for Biopharmaceutical Statistics and a co-chair of the
Executive Committee for the First International Symposium on Biopharmaceutical
Statistics to be held from June 30 – July 2, 2008, in
Abstract With increasing public awareness over
biopharmaceutical product safety, post-licensure product safety monitoring has
been an integrate part of biopharmaceutical research and development. Product
withdrawal due to safety reason will have not only a profound impact on the
financial situation of a company, but also on the public trustfulness over the
business conduct of the industry. Nevertheless, the relatively short-term
clinical development exhibits some constraints that prevent from discovery of
potential risk of biopharmaceutical products for long-term human use.
Therefore, the post-approval product risk management and safety surveillance
becomes a crucial ingredient in establishing the overall safety profile of a
product. With the availability of some spontaneous reporting and observational
databases, statistics plays an increasing role in determining whether an
adverse event is associated with the use of a product. In addition to the
rationale, functional structure and process of pharmacovigilance as well as
regulatory requirements and guidance, this talk will introduce some statistical
methods that are widely used in safety signal detection. Investigation and
interpretation of a potential safety signal are also discussed. Some
perspectives in pharmacovigilance and safety surveillance are presented.
11:50
a.m. Some Theoretical and
Practical Aspects of QbD/PAT Implementation in Pharmaceutical Development
Jun
Hung, Ph D. Principal Scientist II, Wyeth
Jun Huang, Ph.D, is currently a Principal
Scientist II – PAT at the
Abstract Some theoretical and practical
aspects of QbD/PAT implementation
in pharmaceutical development will be discussed. Current
definitions and terminologies of QbD/PAT will be reviewed, as well as
application examples. Topics for the discussion include:
- QbD/PAT principles and tools
- Design space
- Real time release
- Chemometrics and PAT
- Batch/Multivariate statistical
process control
12:20 p.m. Networking
Lunch
01:20
p.m. Keynote Speech Randomized Clinical Trials: Advances and
Challenges
James Hung, Ph D.
Director, CDER, FDA
Dr. H.M. James Hung
is presently Director of Division of Biometrics I, Office of Biostatistics,
Office of Translational Sciences, Center for Drug Evaluation and
Abstract Randomized clinical trial (RCT) has set a
paradigm for the development of medical products and served public health well
for many decades. It continues to be a gold standard to provide the best and
reliable information about the medical products marketed or to be marketed. As
considerations from other dimensions such as costs of clinical trial, patient
welfare, are increasingly demanded, the traditional paradigm and methodology
for RCT are faced with a great many of challenges. Nowadays clinical programs
must consider globalization. Multi-regional involvements in clinical trials
compete in resources. Design modifications that were once unthinkable are now
becoming thinkable and many argue that they are necessary or preferable.
Conventional approaches to clinical trials are under intensive scrutiny. New
approaches generate lots of controversies. Initiatives coming from many
regulatory agencies put many of the challenges in perspective. The journey is
on; let us revisit the past, the present and fertilize this paradigm for the
future.
* The views expressed here are not
necessarily those of the U.S. Food and Drug Administration.
02:00 p.m. Application of Lean Six-Sigma
Methodologies to Pharmaceutical Basic Research: an Example of Improving Turnaround
Time for Bioanalysis
James Yergey. Ph D. Senior Director, Merck
& Co.
James Yergey is currently a Senior
Director who leads the Preclinical DMPK Bioanalysis group at the Merck &
Co. West Point, PA site. The group is responsible for in-life and bioanalytical
measurements in support of Basic Research projects at the site, including both
small and large molecule therapeutics. Jim’s background and training are
as an analytical chemist with a specialization in mass spectrometry.
Since joining Merck Research Labs at the Merck Frosst site in
02:40
p.m. Quality by Design in
Process Development and Analytical Science
Sarah
Chen, PhD. Investigator, GSK
Sarah obtained her Ph.D. in analytical chemistry from
Abstract This
presentation will introduce the concept and practice of Quality by Design in
Process Development, from both regulatory agency's perspective and industry's
perspective: what is QbD, why is this practice useful, when should it be
applied to project, who will be impacted and how should it be implemented. From analytical science's perspective, QbD
means both to support the QbD activities and to apply the concept into the
analytical world. Case studies of how
QbD concept is impacting the change in analytical science will be discussed.
03:15 p.m. Networking
Coffee Break
03:30
p.m. Statistics: Use it and
Love it
Jason
Liao, Ph D. Associate
Director, Merck & Co
Jason
Liao, Ph.D. is currently an associate director at Merck Research Laboratories.
He obtained his Ph.D. in statistics from The University of Michigan in 1997.
Since then, he has been working in the biopharmaceutical industry covering a
broad range functional areas with both clinical and non-clinical experience for
designing experiments, conducting statistical analyses, addressing
questions/issues from regulatory agencies, and providing statistical educations
and consultations to non-statisticians. He is also very active in promoting the
right statistics and/or more powerful statistics to improve and/or solve
statistical issues in drug development. He has published about 30 peer-reviewed
articles and served as a reviewer for many journals.
Abstract In
a new era of biopharmaceutical industry with increasing competition for high
quality and pricing pressure for low cost products, new challenges and unique
opportunities are presented to the industry. To meet the new challenges and
capture the opportunities, there are industry-wise efforts to reduce product
developmental times and to lower the cost in producing a quality
drug/protein/vaccine products. Thus, new philosophy such as the six-sigma is
widely used with emphasis on quantitatively speaking after the data. Toward
this end, statistical techniques in design of experiment (DOE), calibration, and
statistical process control (SPC), which are mostly used by scientists and are
essential for scientists, are presented along with motivating examples.
04:05
p.m. Clinical Trial Paradigm
in Drug and Vaccine Development
Ivan
Chan, Ph D. Senior
Director, Merck & Co.
Dr. Ivan S. F. Chan is Senior Director of
Late Development Statistics, Merck Research Laboratories. He received M.S. in
Statistics from The Chinese University of Hong Kong (1991) and Ph.D. in
Biostatistics from
Abstract
Clinical
trial activities are an integral part of pharmaceutical development in
evaluating whether new drugs or vaccines are safe and efficacious in humans.
These human trials start after new compounds have been tested successfully in
preclinical studies, including analytical and animal experiments. Before a new
compound is submitted for regulatory review and approval, clinical trials are
conducted generally in three phases to assess the safety in health volunteers,
determine a safe and efficacious dose in the target patient population, and
confirm both safety and efficacy of the optimal dose in large-scale
studies. After a compound is approved,
clinical trial activities continue to collect additional safety data and to
evaluate efficacy in expanded populations. In this presentation we will
highlight some of the issues and challenges in designing clinical trials in
different phases. We will also briefly discuss a new paradigm of using adaptive
designs to accelerate clinical development of new compounds.
04:50 p.m. Closing Remark of Conference Co-Chair
Lee Kang, PhD, MBA. Sr. Director, Perrigo
05:00 p.m. Close of Member Conference