Product Enhancement Technologies in PLM Dpt


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Product Enhancement Technologies in PLM Dpt

  1. 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 :
  2. 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 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 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 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 :
  3. 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 :
  4. 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 :
  5. 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 :
  6. 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: 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