1. Register by June 5, 2009 and
save up to $1,596 off the standard price
Product Enhancement Technologies in TM
Pharmaceutical Life-Cycle Management
Maximize & Sustain Product Value through Innovative Product
Enhancement Technologies and Exclusivity Strategies
Sept. 14 – 16, 2009 • Philadelphia, PA
Evaluate Practical Life-Cycle Management Technologies and Techniques
through Hard-Hitting Case Studies and:
• Leverage Holistic Science to Strengthen • Manage Product Life-Cycle in the Changing Patent
Pharmaceutical Life-Cycle Management Environment
• Improve Bioavailability and Superiority through • Examine API Crystal Forms and their
Advanced Drug Delivery Systems Bioavailabilities to Achieve Product Exclusivity
• Apply Life-Cycle Management Techniques • Experiment with Dosing, Range and Routes of
throughout the Drug Development Process Administration
Meet Expert Speaker Faculty from:
Wyeth Research IMPAX Pharmaceuticals Rutgers, The State University of
New Jersey
Merck & Co. Pfizer Global Biologics
PTC Therapeutics
Eli Lilly and Company Covidien
Extend Consulting Group
Bristol-Myers Squibb RiconPharma
Center for Pharmaceutical Physics
Novartis Pharmaceuticals University of South Florida
Corporation Abbott Laboratories
Register Now! Call Dhaval Thakur @ +1-416-597-4754 or Email : dhaval.thakur@iqpc.com

2. Who will you meet at the
Product Enhancement Technologies conference:
Vice Presidents, Directors, Associate
Directors, Managers, Principals,
in Pharmaceutical Life-Cycle Management TM
•
Consultants, Business Leaders within:
Life-Cycle Management
• Portfolio Management
• Research & Development
Dear Colleagues,
• Strategic Planning
Products worth more than $100 billio • Partnering, Licensing & Alliance
n in sales are going off-patent and
subject to generic incursion by 201 becoming •
Regulatory Affairs
2. Generic companies are becomin
more advanced and aggressive to g technologically •
Process Chemists
develop the non-patent infringing
products, shortening the market life reformulation •
Pre-Formulation
of branded reformulations. Furtherm
expectations of absolute safety have ore, •
Formulation
led to greater attrition and a mea
the number of approved medicine surable decline in
s each year. Faced with unpreceden •
Clinical Scientists
these, effective lifecycle managem ted challenges like • Clinical Investigators
ent is becoming ever more importa
pharmaceutical companies to sust nt for
ain the product value and maximiz • Legal Counsel
each research dollar invested. e the return on
• Intellectual Property
• Patent
Pharmaceutical companies are imp
lementing new strategies and met • Pharmaceutical Consultants
improve candidate selection, minimiz hodologies that will
e candidate failure, and position new From Biopharmaceuticals,
greater success upon launch. At the products for
same time, effective practice of prod Pharmaceuticals, Biotech Companies &
enhancement through demonstrate uct Generics
d therapeutic superiority and a new
and exemplification of scientific opp understanding
ortunities for differentiation are beco
strategies for pharmaceutical com ming critical
panies. It’s mission critical for the Sponsorship and Exhibition
these strategies and increase the valu industry to leverage
e of pharmaceutical pipelines, max
on research investment, and conv imize the return Opportunities
ert the contemporary challenges into
pharmaceutical opportunities. modern Sponsorships and exhibits are excellent
opportunities for your company to showcase
Join us in Philadelphia and learn from its products and services to high-level,
the experts on these vital strategies targeted decision-makers attending Product
and technologies!
Enhancement Technologies in Pharmaceutical
Life-Cycle Management. IQPC helps
companies like yours achieve important sales,
marketing and branding objectives by setting
aside a limited number of event sponsorships
to check and exhibit spaces – all of which are custom-
Cathy Gu Don forget
’t tailored to assist your organization in
tive
Conference Director out our interac creating a platform to maximize its exposure
Pharmaceutical IQ, IQPC pr e-confer ence at the event.
e
Cathy.gu@iqpc.com workshops! Se ls. For more information on sponsoring or
page 3 for detai exhibiting at this or upcoming events, please
contact Dhaval Thakur at +1-416-597-4754
or dhaval.thakur@iqpc.com.
Registration Information Please note that multiple discounts cannot Reference: Please include the name of the
be combined. attendee(s) and the event number:
Qualified Pharmaceutical and Biotech Organizations Pricing 18028.001
A $99 processing charge will be assessed to
Register by Register by Register by Register by Register by Standard all registrations not accompanied by credit Payment Policy: Payment is due in full at
06/5/09 06/19/09 07/03/09 07/17/09 08/14/09 Price card payment at the time of registration. the time of registration and includes lunches,
refreshment and detailed conference
MAKE CHECKS PAYABLE IN U.S. DOLLARS
Conference (save $500) (save $400) (save $300) (save $200) (save $100) materials. Your registration will not be
TO: IQPC * CT residents or people
Only $1,099 $1,199 $1,299 $1,399 $1,499 $1,599 employed in the state of CT must add 6%
confirmed until payment is received and may
be subject to cancellation.
Each sales tax.
Workshop $549 Venue:
Team Discounts: For information on team
Please call Dhaval Thakur at +1-416-597-4754
All Access (save $1,596) (save $1,496) (save $1,396) (save $1,296) (save $1,196) (save $1,096) discounts, please contact Dhaval Thakur
for venue and corporate discounts.
Pass $2,199 $2,299 $2,399 $2,499 $2,599 $2,699 at +1-416-597-4754 Only one
discount may be applied per registrant. For IQPC’s Cancellation, Postponement
and Substitution Policy, please visit
Special Discounts Available: A limited
www.iqpc.com/cancellation
All Others Pricing number of discounts are available for the
non-profit sector, government organizations Special Dietary Needs: If you have a dietary
Register by Register by Standard and academia. For more information, please restriction, please contact Customer Service
07/17/09 08/14/09 Price contact customer service at 1-800-882- at 1-800-882-8684 to discuss your specific
8684. needs.
Conference Only (save $600) (save $300)
$1,999 $2,299 $2,599 Details for making payment via EFT or ©2009 IQPC. All Rights Reserved. The
wire transfer: JPMorgan Chase format, design, content and arrangement of
Each Workshop $549 Penton Learning Systems LLC dba IQPC: this brochure constitute a trademark of IQPC.
All Access Pass (save $1,296) (save $1,196) (save $1,096) 957-097239 Unauthorized reproduction will be actionable
$3,499 $3,599 $3,699 ABA/Routing #: 021000021 under the Lanham Act and common law
principles.
2 Register Now! Call Dhaval Thakur @ +1-416-597-4754 or Email : dhaval.thakur@iqpc.com

3. Pre-Conference Workshops Monday
September 14th, 2009
A 8:00 am – 10:30 am
Improving Efficacy, Bioavailability, and Toxicity through Effective Pharmaceutical Life-Cycle
Management Technologies
Efficacy, bioavailability and toxicity are the key indicators and measures for the How will you benefit:
drug development process. Applying advanced technologies during the product •
Having an overall understanding of life-cycle management technologies
life-cycle management to ensure absolute safety for the patients is essential for •
Developing effective life-cycle management strategies for different
the process. product portfolio
What will be covered: •
Learning from various case studies to improve your strategy
•
Overview of various technologies for pharmaceutical life-cycle management
•
Selecting specific tools that maximize efficacy, enhance bioavailability and Workshop Leader: Laman Alani, VP Pharmaceutical Product Development,
minimize toxicity IMPAX Pharmaceuticals
• Presenting case study examples for how companies have improved
drug performance
B 11:00 am – 1:30pm (Lunch Served)
FEATURING
EXTENSIVE CASE
Product Enhancement and Product Life Cycle Management through Strategic STUDIES
Pharmaceutical Development Journey Using Science, Technology, and Innovation
Building science, technology, and innovation into the products using advanced c. Reduce dosage strength
manufacturing technologies has been one of the key concepts of RiconPharma. d. Reduce dosage frequency
With a proven record of over 150 products approved and commercialized out e. Creative pre-formulation and formulation approaches
of 200 ANDA, Raj Devalapalli and his team are bringing clinical benefits to the f. Creating a regulatory pathway
patient population with advanced life-cycle management technologies. g. Implementation plan
What will be covered: • Discuss other examples
I. Strategic overview on product enhancement strategies How will you benefit:
• Paradigm shift • Obtaining an in-depth understanding of the business needs for product
• Understanding business needs and drivers enhancement strategies
• Examining opportunities and challenges • Understanding the opportunities and challenges
• Building an innovation model • Building up development and regulatory pathway from step to step
• Implementing strategic product development and • Learning how to implement the product ideas through a creative and strategic
technology approaches journey
• Developing appropriate strategies through both a development pathway • Going through the comprehensive life-cycle management journey to ensure
and a regulatory pathway maximum takeaway
II. Learning from Extensive Case Studies
• Case Study “A journey through Strategic Product Enhancement and Workshop Leaders: Raj Devalapalli, President & CEO, Riconpharma; Mukti
Implementation Plan” Gande, Chief Scientific Officer, Riconpharma; Satya Valiveti, VP, Preformulation
a. Opportunity evaluation and product selection and Analytical R & D, Riconpharma
b. Molecular modification to enhance the bio-availability and reduce
side effects
C 2:00 pm – 4:30 pm
Bridging up the Missing Link – Effective Partnering & Licensing Strategies to Identify Innovative
Technologies for Life-Cycle Extension
The most critical part of life-cycle management strategies is to identify and • Presenting a few key technologies for improving bioavailability and innovative
leverage advanced technologies. This workshop will guide you through the drug delivery
process of searching for and working with the scientific society more How will you benefit:
effectively. • Establishing a collaborative foundation for partnering and licensing strategies
What will be covered: • Building licensing resources for key technology areas
• Identifying key areas for life-cycle management and pipeline extension • Learning effective strategies for technology transfer
• Understanding how licensing is playing a key role in life-cycle management
strategies Workshop Leader: Ryan Nichols, Managing Consultant, Excend Consulting Group
D 5:00 pm – 7:30 pm (Dinner Served)
Co-Crystallization Technology Improving Solubility and Bioavailability
Technology and commercialization landscape for co-crystallization has changed How will you benefit:
dramatically in the past few years. More and more companies are utilizing or • Learning when and how co-crystallization works
researching on the technology to improve their drug delivery process and • Having access to real-life data on co-crystallization technology latest development
enhance the product bioavailability. • Understanding the challenges of co-crystallization implementation
What will be covered: • Leveraging the co-crystallization technology in drug development process
• Understanding Basics of co-crystallization
• Demonstrating research on the physic properties and how co-crystallization Workshop Leader: Mike Zawortoko, Professor and Chairperson,
enhances the bioavailability Department of Chemistry, University of South Florida
• Experimenting co-crystallization for orally delivered drugs
3 Register Now! Call Dhaval Thakur @ +1-416-597-4754 or Email : dhaval.thakur@iqpc.com

4. Main Conference Day One Tuesday
September 15th, 2009
8:00 Registration and Coffee 12:30 Networking Luncheon
8:45 Chairperson’s Opening Remarks 1:30 Applying Life-Cycle Management Techniques
throughout the Drug Development Process
9:00 Keynote Case Study: Leveraging Holistic Science to • An overview of the drug development process
Strengthen the Pharmaceutical Life-Cycle Management • Analyzing various stages of drug development and understand
Strategic Life-Cycle Management goes far beyond patent protection. where and how to apply life-cycle management techniques
Utilizing holistic science to examine the product from pre-clinical to • Developing effective life-cycle management strategies with cross-
product launch with patients’ safety in mind is crucial to absolute safety functional support
and efficacy. In this keynote session, Dr. Fawzi will be sharing real-life
examples from his extensive experience on life-cycle management Laman Alani
•
Providing the big picture of how holistic science enhances life- VP Pharmaceutical Product Development
cycle management IMPAX Pharmaceuticals
•
Going beyond the tools – life-cycle management is a strategy
rather than a project 2:15 Panel Discussion: Identifying and Examining
•
Presenting life-cycle management case studies on reformulation, Different Approaches for Life-Cycle Management
dosage, routes and indications •
Developing various approaches during different stages of drug
•
Learning from other industries such as the consumer goods industry development
Mahdi B. Fawzi, Ph.D. • Identifying key focus areas including: fixed dose combinations,
Executive Vice President, Preclinical Development bioavailability enhancement, dosage strength reduction,
Wyeth reduction of side effects etc.
• Researching on indications
• Discussing perspectives from clinical and medical areas
9:45 Improving Bioavailability and Superiority through
Advanced Drug Delivery Systems Saran Kumar, Ph.D
Alterations in drug delivery produce substantial changes in the Principal Fellow, Pharmaceutical & Analytical Development
bioavailability which may lead to significant improvement on Novartis Pharmaceuticals Corporation
efficacy and tolerability. Leveraging advanced drug delivery systems
to consistently enhance patient compliance and overall drug effect Raj Devalapalli
is crucial for product enhancement strategies. President & CEO
• Examining the recent advancement of drug delivery systems Riconpharma
• Analyzing the impact of drug delivery systems on bioavailability
• Sustaining product value and combating generics by launching the
3:00 Afternoon Break
improved or next-generation
Saran Kumar, Ph.D 3:30 Best Practices on Pharmaceutical Licensing
Principal Fellow, Pharmaceutical & Analytical Development Strategies to Enhance Life-Cycle Management
Novartis Pharmaceuticals Corporation • Understanding the key drivers and inhibitors for deal-making
• Examining the licensing process to identify opportunities
10:30 Morning Break • Developing effective valuating strategies
• Managing costs effectively
11:00 Understanding the FDA Requirements to Streamline Please refer to DHAVAL THAKUR for speaker updates:
the Process and Obtain Fast Track Approvals
Innovative pharmaceutical companies are faced with unprecedented
challenges to get approvals from the FDA as the regulations are
significantly tightened. As a veteran from both the agency and a 4:15 Managing Product Life-Cycle in a Changing Patent
leading innovation company, Vijay Tammara will be sharing practical Environmentt
suggestions for working with the FDA.
• US Patent Law and Pharmaceutical Life-Cycle Management
– Impact of USPTO Changes to Patent Law Rules
• Thinking through the FDA perspective to achieve more with less
– Impact of Recent Court Decisions
• Understanding the 505 (b) (2) filing process
• Streamlining the filing processes with proven drug superiority
• Update on Hatch-Waxman and Other Related Patent Regulations
– Safe Harbor Scope in Flux
• Creating internal synergy to accelerate the process
– Labeling and Patent Claims
Vijay Tammara – US and Ex-US Exclusivities
Senior Director, Regulatory Affairs • Identifying and Overcoming Small Entity Challenges
– Absolute Novelty: Funding v. Disclosure
Merck & Co.
– On the Road to Approval: Addressing Research Use
11:45 Examining Product Enhancement Opportunities Manufacturing
Based on Biopharmaceutical Performance • Effective Life-Cycle Management Strategies for a Changing
• Evaluating novel drug delivery systems with respect to their Patent Environment
– The “Relative” and Perceived Values of the Patent Portfolio v.
biopharmaceutical implications
• Improving efficiency of formulation development with novel Actual Value
– The Road Less Traveled and When to Let Go
technologies
• Conducting biopharmaceutical evaluations of enhanced product Paul Martin
candidates
Associate Director, Intellectual Property and Assistant General Counsel
Henry (Yunhui) Wu, Ph. D. PTC Therapeutics
Director of Biopharmaceutics & Parenteral Delivery, Pharm R&D, MRL
Merck & Co. 5:00 End of Day One
4 Register Now! Call Dhaval Thakur @ +1-416-597-4754 or Email : dhaval.thakur@iqpc.com

5. Main Conference Day Two Wednesday
September 16th, 2009
8:15 Registration and Coffee 12:30 Networking Luncheon
8:45 Chairperson’s Opening Remarks 1:30 Targeting Strategies: Delivering Product Value
through High Selectivity
9:00 Examining API Crystal Forms and their Drug targeting strategies have emerged as powerful tools that
Bioavailabilities to Achieve Product Exclusivity impact product toxicity and efficacy through greater therapeutic
One of the key processes in developing oral dosage form of drugs is selectivity or broader therapeutic performance.
selecting an appropriate active pharmaceutical ingredient (API) crystal • Discussing the considerable benefits of modern drug targeting
form for the final dosage product. Controlling and Managing the API and current technical capabilities
crystal forms are critical stages for product life-cycle management. • Examining how drug delivery can alter a single biological
• Understanding the API crystal forms and their bioavailability pathway or trigger a single receptor
• Selecting and controlling API crystal form for product development • Enabling greater medicinal efficacy with concomitant reduced
• Discussing the potential API crystal form transformations in the toxicity
API crystallization, post-crystallization and formulation stages • Discussing how targeting multiple diseases or indications using
• Examining how API crystal forms can extend the product life-cycle co-administration offers value through product combination
• Presenting case study examples for API crystal transformation
Tamara Minko, Ph.D
Shawn Yin, Ph.D Professor and Chair, Department of Pharmaceutics
Principal Scientist, Group Leader of Form, Chemistry and Rutgers, The State University of New Jersey
Characterization Group
Bristol-Myers Squibb 2:15 Leveraging Novel Drug Delivery Formulations to
Extend the Product Pipelines
9:45 Developing an Appropriate Salt Form for an Active • Exploring how novel drug delivery methods extend the product’s
Pharmaceutical Ingredient patent life
It is a fairly typical situation in pharmaceutical development that a • Maximizing ROI through reformulation of drug delivery systems
drug candidate will exhibit physical characteristics that are less than • Coordinating drug delivery technologies and drug development
satisfactory. One appropriate response to this situation is to Snehlata Mascarenhas
generate a salt form (if possible) that exhibits desirable properties. Project Management Consultant – Drug Delivery
This session will outline the salt selection process, concentrating on Eli Lilly and Company
the maximal use of computational methodologies to choose a
developmental pathway, and will address the following main topics:
• Pertinent ionic equilibria of acids, bases, and salts
3:00 Afternoon Break
• Strategies and procedures for the selection of an appropriate
3:30 Developing Differentiation, Innovation, and Long
salt form Term Growth Strategies with Life-Cycle
• General procedures for the isolation of salt forms
• Evaluation of the solid-state properties of salt forms
Technologies
• Providing a brief introduction on fundamentals of oral controlled
Harry G. Brittain, PhD, FRSC release
Director • Leveraging novel drug delivery technologies
Center for Pharmaceutical Physics • Providing big pharma and generic company perspective
• Looming patent losses for big pharma
10:30 Morning Break • Examining how emerging markets drive growth
• Understanding consolidation in specialty/generic sector
11:00 Achieving Greater Product Differentiation through • Analyzing different segments include demographics, biotech,
Pre-Formulation Technologies with an Emphasis on and personalized medicine
Co-Crystal Technology Vishal K. Gupta, PhD
• Learning properties of characterizations of various APIs Director, Pharmaceutical R&D
• Exploring the business development potential of co-crystals Covidien
• Examining the impact of co-crystals on improving solubility
Mike Zawortoko 4:15 Life-Cycle Management through Fixed Dosed
Professor and Chairperson, Department of Chemistry Combination (FDC) Products: Opportunities and
University of South Florida Challenges
• Providing an overview of marketed FDC products
11:45 Case Study: Life-Cycle Management Techniques for • Examining LCM opportunities through FDC product development
Biotherapeutic Products • Developing and execution of a FDC strategy
• Analyzing technologies and approaches taken on biotherapeutic • Exploring FDC product life-cycle management through latest case
life-cycle management studies
• Examining the similarities and differences between large Bill Huang, Ph.D
molecule and small molecule Section Manager, Global Pharmaceutical and Analytical Sciences
• Case study: Formulation challenges of a NBE candidate for
Abbott Laboratories
product enhancement
Tapan Das, PhD 5:00 End of Conference
Senior Principal Scientist
Pfizer Global Biologics, St. Louis Laboratories
5 Register Now! Call Dhaval Thakur @ +1-416-597-4754 or Email : dhaval.thakur@iqpc.com

6. REGISTRATION CARD International Quality & Productivity Center
60 St. Clair Ave. Suite 304
YES! Please register me for Toronto, ON M4T 1N5
Product Enhancement Technologies TM
in Pharmaceutical Life-Cycle Management
❑ Pre-Conference Workshops Please Choose Your Workshops:
❑ Main Conference ❑A ❑B ❑C ❑D
See Page 2 for pricing details.
Your customer registration code is:
TLS/DPT
When registering, please provide the code above.
Name__________________________________ Job Title ________________________
Organization____________________________________________________________
Approving Manager______________________________________________________
Address_______________________________________________________________
City__________________________________State______________Zip___________
Phone________________________________Fax_______________________________
E-mail__________________________________________________________________ 4 EASY WAYS TO REGISTER:
❑ Please keep me informed via email about this and other related events.
❑ Check enclosed for $_________ (Payable to IQPC) 1 Call: 1-416-597-4754
❑ Charge my __Amex __Visa __Mastercard __Diners Club
2 Email: dhaval..thakur@iqpc.com
Card #__________________________________Exp. Date___/___ CVM Code:____ 3 Fax: 1-146-598-4734
Details for making payment via EFT or wire transfer can be found on 4 Mail: IQPC
preceding page. 60 St. Clair Ave. Suite 304
❑ I cannot attend, but please keep me informed of all future events. 18028.001/KA Toronto, ON M4T 1N5
Register by June 5, 2009 and
save up to $1,596 off the standard price
Product Enhancement Technologies in TM
Pharmaceutical Life-Cycle Management
Maximize & Sustain Product Value through Innovative Product
Enhancement Technologies and Exclusivity Strategies
Sept. 14 – 16, 2009 • Philadelphia, PA