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2008 Final Brochure
Enjoy an enriching sojourn with Process Management experts as they chart the route to success employing sage strategies and practical ‘nuts and bolts’ solutions to help you and your group reach new heights in your product development quest.
Thursday, January 10
7:00am - 3:00pm Registration Open
7:30am Morning Coffee
8:15 Chairperson’s Opening Remarks
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ENSURING
QUALITY IN YOUR PROCESS |
| Opening Keynote Presentation |
| 8:20 Balancing Quality, Speed and Value Across A Bioproduct Portfolio |
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William Heath, Ph.D., Executive Director, Bioproduct Research & Development, Eli Lilly & Co. |
| By their very nature, biotherapeutics present unique challenges to the industry. They often make the transition from lead to clinical candidate in very rapid order compared to traditional synthetic organic molecules, compressing the timeline and forcing tough strategic choices on investment. This speed theme and timeline compression continues to be felt as the molecules move through clinical development. In addition, their downstream complexity moving towards regulatory submission and commercialization provide for fewer opportunities to close technical gaps and requires that decisions around drug product presentation, global submission strategy and manufacturing options be made long before certain critical data are available. On the surface this would appear to be an inconsistent set of challenges yet the industry as a whole has managed over the years to deliver using a range of approaches that span the spectrum of ‘brilliance coupled with good luck’ to sheer brute force. As our bioproduct portfolio has grown, we have evolved a paradigm that seeks to balance investment choices with risk and speed with downstream commercial robustness – a ‘pay to play/play to win’ concept. |
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| Featured Presentation |
9:05
What
if You are Right! An Aggressive Facilities
and Quality Systems Approach for
Developing Biopharmaceutical Manufacturers
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R.
Barry Holtz, Ph.D., Principal, Holtz
BioPharma Consulting
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| Biotechnology
has developed extremely powerful
descriptive tools such as genomics,
proteomics and metabolomics, making the
promise of creating patient-specific
therapies for cancer and other diseases
closer to becoming a reality. As the flood
of information is turned into new
strategies for treating disease, the
opportunities may soon outstrip our
abilities to provide these treatments
commercially to larger patient
populations. Early-stage companies must
get products to the clinic so that proof
of principle in human trials will catalyze
the necessary funding to move forward
toward licensure. We also have to consider
that as biotechnology really starts this
maturation phase and moves from research
and development to product manufacture, we
will be "right" more often and
at a higher percentage of success. The
necessity to start human clinical trials
early in the development cycle of these
companies, has focused the development of
pilot facilities that can operate under
cGMP compliance. Many of these facilities
have been and are extensions of the
laboratory. However, new generations of
facilities are being constructed to
provide robust production of materials for
clinical trials. As
these therapies start to show success in
clinical trials, there is the potential
for rapid regulatory approval of
therapies, especially in cases of unmet
medical need. To maximize the benefit to
the patient population and the value of
the company going forward, a more robust
early stage manufacturing platform must be
developed that can lead to rapid
commercialization. This of course has to
be tempered with the continued lack of
ready capital for early-stage companies.
This talk outlines specific strategies for
accelerating the commercialization process
as far as possible with resources typical
of an early-stage biotherapeutics company.
Case studies highlight the specifics of
how an aggressive approach to quality
systems development, building high-level,
scalable facilities. and engineering
planning and modeling can deliver a
platform for rapid commercialization in a
capital conservative environment. |
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9:45
Designing Developabilty in Biopharmaceuticals
by Targeting Protein Aggregation and Stability
Jesús Zurdo, Ph.D., Head of Advanced Protein
Technologies, Lonza Biologics plc
Protein stability and aggregation are major
issues affecting the developability of
biopharmaceuticals, their cost of production and
even their safety profile (i.e. immunogenicity,
etc.). The industry spends a considerable
ammount of effort in tackling aggregation
through the modification of production and
purification proceses and the development of
formulations that would stabilise
biopharmaceuticals, but also regulators are
taking a hard stance on aggregation in an
increasing effort to tackle safety in
biopharmaceuticals. Lonza is applying pioneering
technologies in predicting aggregation in
proteins before it occurs, opening ways to
select optimal sequences for development or
designing processes before practical issues
appear, but also creating ways of modify
polypeptides to increase their stability in
solution or even design specific stabilisers
when protein engineering is not an option.
10:15 Coffee Break in the Exhibit Hall
11:15 Risk Management -- A Practical Approach
Courtland R. LaVallee, Director, Development Project Management, Genentech, Inc.
This talk will discuss managing risk in a biopharmaceutical environment, including:
- The case for risk management
- Risk management basics
- A practical approach to qualitative risk management methodology
- Tips for successful implementation
11:45 Change
Management -- A Regulatory Requirement
David
L. Chesney, Vice President, Strategic Compliance
Services, PAREXEL Consulting
Change Management, or Change Control, is a
significant element of regulatory compliance.
Control of changes, including proper evaluation
of change impact on drug products, is an
important Quality System GMP requirement.
Management of changes with regard to regulatory
submissions (for example, NDA or BLA) and
appropriate agency approvals is an important
element for regulatory compliance. This
presentation will discuss FDA requirements for
Change Management, some common Change Control
problems, and the elements for a compliant and
efficient Change Management Program.
12:15pm Close of Morning Session
12:30 Luncheon Workshop
(Sponsorship Available.
Please contact Suzanne Carroll at 781-972-5452 or
scarroll@healthtech.com
for information.) or Lunch on Your Own
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PROCESS ANALYTICAL TECHNOLOGY |
1:45 Chairperson’s Remarks
1:50 Process Analytical Technology
-- Implications for Bioprocessing
Beth Junker, Ph.D., Senior Director, Fermentation and Development Operations, Merck Research Laboratories
Process Analytical Technology has broad implications for bioprocessing efficiency based on several robust past and numerous potential future applications. Key to its successful application is identifying the correct analytical opportunity in terms of feasibility, cost, and impact. The extent of novel PAT methods currently incorporated in bioprocessing has been limited owing to technical, regulatory, and sensor development challenges. This presentation reviews drivers for PAT efforts focused on improving process understanding, reducing process variability, and overall continuous process improvement.
2:20 Advances that Will Impact PAT for Process Characterization
Melvin Koch, Ph.D., Director, Center for Process Analytical Chemistry, University of Washington
The need for improved process understanding in the pharmaceutical and biotechnology industries has been a driver for the advancement of measurement tools to support efforts for improved process monitoring and control. A key part of these advances has been in miniaturization technology, where the development and application of micro-analytical tools in high through put experimentation, process optimization, and process monitoring will have a large impact. These micro-analytical tools, combined with advances in process sampling and sensor platforms will be described as a valuable approach for implementing Process Analytical Technology (PAT).
2:50 The
Roles of Design Space and Process Knowledge in
Implementing Process Improvements
Michael Lennick, Ph.D., Associate
Director, Purification Technology, Global
Biologics Supply Chain, Centocor
3:20 Technology Spotlight
(Sponsorship Available. Please contact Suzanne Carroll at 781-972-5452 or
scarroll@healthtech.com
for information.)
3:35 Refreshment Break in the Exhibit Hall
4:30 Program Management for an Exploding Pipeline - The Wyeth BioPharma Model
Steven Max, Ph.D., Development Project Leader, Business Operations and Program Management, Wyeth BioPharma
A modified program management strategy has been developed utilizing Operational Excellence tools to improve the planning and oversight of activities and resources in response to the overwhelming number of Phase 0 projects entering the Development pipeline. Drivers for this initiative will be presented as well as an overview of the new program management model as it relates to cross-functional activities, governance structures and modes of communication underlying Wyeth’s platform development strategy.
5:00 Managing
the Outsourcing Process for Protein Production
Faming Zhang , Ph.D., President, Crown
Bioscience
Outsourcing protein process development provides
a cost-effective route to scale-up the internal
R&D capability. Since different vendors in
cell line generation, purification process
development, and analytical development maybe
used, a project and data management strategy
plays a key role for coordinating the project
flow. Cases of antibody, fusion protein, and
drug target protein process development will be
presented.
5:30 Manage Your Process or Your Process Will Manage You
Diana Bartlett, Director of Corporate Partnerships, Keck Graduate Institute of Applied Life Sciences
What can process management in an academic setting tell us about managing processes in the “real world”? Plenty. First and foremost, academic experiences in dealing with protein expression, development of peptide-based therapeutics, bioprocessing, etc. educates us about the need to manage the process before the process manages us.
Issues will include: Identify steps for successful management of key development and production processes; Capture and implement “best practices” in process management within biotech functions and organizations; Develop goals, milestones and metrics to assist in managing processes; Create and deliver effective communications; Identify, classify, and manage risk; Productively manage individuals and teams; Generate and use dynamic scheduling; Successfully develop and manage budgets and forecasts
6:00 Reception in the Exhibit Hall
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