5th Product and Pipeline Enhancement for Generics


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5th Product and Pipeline Enhancement for Generics

  1. 1. 5th Product and PipelineEnhancement for GenericsAdopt Innovative Approaches to Strengthen the ProductPipeline and Prepare for Regulatory Changes to Emergeas a Global PlayerJuly 17-19, 2012Georgetown University Hoteland Conference Center | Washington, DC Impending patent cliffs are forcing both branded and generic pharmaceutical More Registration Details, Click Here! companies to re-evaluate their pipelines and take more creative approaches to ensure success. Featuring Case Studies from Leading Generics Experts Including: Richard DiCicco Steve Maddox Indranil Nandi, Ph.D.Conference Chairperson: Chairman Partner Director, Program ManagementRichard DiCicco Harvest Moon Knobbe Martens Olson Sandoz Inc.Chairman Pharmaceuticals USA, Inc. & Bear LLPHarvest Moon Pharmaceuticals USA, Inc. Sherri Leonard Dr. Vijay Soni David Saber VP, Business Development Executive Vice President – Senior Director, Business and Portfolio ManagementPre-Conference Workshop: July 17, 2012 IP, BD and Product Portfolio Development & Licensing OrchidPharma, Inc.Workshop: Overcoming the Challenges of Global Portfolio Glenmark Pharmaceuticals Par PharmaceuticalManagement to Improve Decision-Making with Hospira Candis Edwards Ram L.R. Gadi Raju Senior Vice President Gopalakrishnan Venkatesan Director of Regulatory Regulatory Affairs & Compliance Associate Vice President, Affairs & ComplianceAttending this Premier marcus evans Business Development VersaPharm Inc. Amneal PharmaceuticalsConference will Enable You to: Wockhardt USA LLC• Assess the most recent FDA proposals regarding biosimilars development Jeffrey Wasserstein Bill Zimmerman and user fees for generic companies SVP, Business Development Steven E. Feldman Partner• Develop key strategies to balance and diversify the companys & Strategy Partner Knobbe Martens Olson global portfolio Fougera Pharmaceuticals Inc. Husch Blackwell LLC & Bear LLP• Instill more innovative approaches for the drug pipeline to heighten a subsidiary of Nycomed US a competitive edge Vishal K. Gupta, PhD, MBA Patrick Nadeau, B.Pharm.• Implement techniques to sustain product portfolios and increase Karan Arora Chief Scientific Officer; M.Sc. MBA the company’s bottom line Senior Director of Global Vice President, Research Senior Director, Strategic• Understand regulatory nuances of global markets and how to frame Corporate Strategy & Development & Development Portfolio Management and prepare for potential expansion and Proprietary Pharmaceuticals CorePharma Pharmascience Canada Hospira Gregory Fernengel, JD, R.Ph. Carla Vozone, MSc, MBA Kevin NelsonWho Should Attend: Senior Intellectual Property Counsel Director, Business Development Partnermarcus evans invites Vice Presidents, Directors and Managers within Ben Venue Laboratories, Inc. Hovione Representing Locke Lordthe generic pharmaceutical, branded pharmaceutical and API industries A Boehringer European Fine Chemicalwith responsibilities in: Ingelheim Company Group (EFCG)• Portfolio / Project Management• Regulatory Affairs Markus H. Meier Huong Nguyen• Business Development Assistant Director Senior Director• Intellectual Property of the Health Care Division, Intellectual Property• General Counsel Bureau of Compensation Impax Laboratories, Inc.• API sourcing Federal Trade CommissionPlatinum Sponsor: Silver Sponsor: Panel Partner: Official Conference Blogger: EARN CLE CREDITS:Media Partners: www.gabionline.net • www.gabi-journal.net GaBI GENERICS AND BIOSIMILARS INITIATIVE Building trust in cost-effective treatments
  2. 2. PRE-CONFERENCE WORKSHOPS | Tuesday, July 17, 20121:30 Registration2:00 Pre-Conference WorkshopOvercoming the Challenges of Global Portfolio Management to Improve Decision-MakingUnderstanding techniques to create and sustain a robust portfolio is more important than ever as blockbuster drugs come off patents and generic companies reapthe benefits. Key to grabbing a share of the market is the adoption of strategies to build portfolio value and ensure a higher return of investment. Attending thisworkshop will enable you to:• Leverage the portfolio management function to take advantage of opportunities for expansion and drive revenue• Identify approaches to maintain a robust worldwide portfolio with unique products• Analyze the impact of regulatory changes in global project and portfolio management• Recognize and nurturing the crucial role of the portfolio management team to help increase the company’s profit margin• Gain buy-in from senior management to help support the progress of key projectsKaran Arora, Senior Director of Global Corporate Strategy & Development and Proprietary PharmaceuticalsHospira4:00 End of WorkshopsDay One | Wednesday, July 18, 20128:00 Registration & Morning Coffee8:20 Chairperson’s Opening Address Richard DiCicco, Chairman Harvest Moon Pharmaceuticals USA, Inc. REVIEWING CURRENT AND UPCOMING REGULATORY CHANGES TO ENSURE COMPLIANCE8:30 Case StudyImplementing Strategies to Meet Current and Heightened Abbreviated New Drug Application (ANDA) Standards to Gain Product Approval• Reviewing key changes in the regulatory filing checklist approved at the end of 2011 to help enhance the ANDA review process• Overcoming the challenges of lengthy FDA inspections and approvals to prevent an impact on the company’s ability to conduct business• Strengthening the preparation work and investment in the product to increase the likelihood that the drug will be approved and no additional submission materials will be requiredCandis Edwards, Senior Vice President, Regulatory Affairs & ComplianceAmneal Pharmaceuticals9:15 Case StudyUnderstanding Key Techniques to Ensure Regulatory Compliance• ANDA Compliance• General Systems Compliance• Generic Facility Compliance• Key Factors for Non compliance• Impact of non-compliance• Key elements to ensure complianceRam L.R. Gadi Raju, Director of Regulatory Affairs & ComplianceVersaPharm Inc.10:00 Networking Break10:30 Case StudyAmerica Invents Act: Assessing the Impact on Generics• First-to-file and grace periods• Opposition proceedings• Litigation impact for generics• Effective datesGregory Fernengel, JD, R.Ph., Senior Intellectual Property CounselBen Venue Laboratories, Inc., A Boehringer Ingelheim Company11:15 Case StudyUnderstanding Antitrust Concerns When Settling Paragraph IV Litigation and the Analysis of Pay-for-Delay Settlements• Dissecting the antitrust analysis of "pay-for-delay" patent settlements, the Federal Trade Commissions (FTC) theories of anticompetitive harm, and appellate court decisions• Reviewing filing requirements for Paragraph IV litigation settlements under the Medicare Modernization Act and understanding which documents need to be filed and the timeline for the review process• Discussing current practices in settling Paragraph IV patent litigation, including the FTCs reports regarding settlements and "side deals," and current industry practice for settling litigation• Status of federal court litigation regarding "pay-for-delay" patent settlementsMarkus H. Meier, Assistant Director of the Health Care Division, Bureau of CompensationFederal Trade Commission12:00 Luncheon
  3. 3. Day One | Continued PORTFOLIO MANAGEMENT/BUSINESS DEVELOPMENT TRACK INTELLECTUAL PROPERTY/PATENT TRACK1:00 Case Study 1:00 Case StudyAdopting Key Techniques to Select, Prioritize and Manage a Generics Analyzing Recent Updates to the Hatch-Waxman Act to Grasp FuturePortfolio Impacts and Challenges• Gaining a clear understanding of the upcoming market challenges regarding • Studying recent changes that could impact the industry, including 180-day patent cliffs and competition from other generic companies exclusivity and complications regarding patent listings• Understanding challenges for companies with branded and generic arms • Drawing lessons from the close relationship between the patenting of generic and the relationship between the two products and FDA regulatory approval to pinpoint areas of improvement• Developing robust review systems to continuously monitor the portfolio • Considering the impact biosimilar products could have on market entry and adjust funding based on product success and patent strategies• Prioritizing top-performing projects to increase the possibility of a high return • Reviewing both real-life rulings and hypotheticals regarding Hatch-Waxman on investment litigation to identify future strategiesSherri Leonard, VP, Business Development and Portfolio Management, Steve Maddox, PartnerOrchidPharma, Inc. Knobbe Martens Olson & Bear LLP1:45 Case Study 1:45 Interactive Roundtable DiscussionExamining Trends in Market Opportunities and Partnerships to Diversify Developing Key Patent Strategies to Protect Intellectual Propertythe Companys Portfolio and Ensure Market Sustainability• Adopting a flexible company strategy that considers future mergers, • Leveraging techniques to maximize patent lifecycles and contribute acquisitions and peer partnerships to product advancement and longevity• Identifying a balance in the portfolio between small molecule and biosimilar • Discussing recent cases and rulings involving intellectual property (IP) to help products based on long-term goals influence future litigation strategies• Accounting for changes in global regulations that could impact the portfolio • Identifying methods to incorporate competitive patent filing strategiesJeffrey Wasserstein, SVP, Business Development & Strategy to beat out the competitionFougera Pharmaceuticals Inc., a subsidiary of Nycomed US • Understanding key differences regarding intellectual property for medical devices vs. pharmaceutical products to strengthen approaches and strategies2:30 Networking Break 2:30 Networking Break3:00 Case StudyImplementing Successful Resource Management Techniques 3:00 Interactive Panel Discussionwith Limited Resources Identifying Strategies to Strengthen Paragraph IV Patent Filings• Understanding how resources are allocated for the development portfolio and Litigation to Maintain Exclusivity• Generating criteria to know when and why to halt a project • Strengthening and prioritizing the emphasis placed on Paragraph IV Disputes• Detailing the most effective resource allocation decision-making process to combat the effect of the patent cliff• Understanding the role of project management in resource allocation • Adopting key strategies and challenges from generics companies who have• Discussing strategies to ensure organizational alignment around been the first to file portfolio decisions • Dissecting the process for drafting, negotiating and assembling claimsIndranil Nandi, Ph.D., Director, Program Management and ways to make improvementsSandoz Inc. • Understanding and preparing for the impact of the America Invents Act (AIA) in relation to Hatch-Waxman litigation3:45 Case Study Steven E. Feldman, PartnerUnderstanding How At-Risk Product Launches Factor into Portfolio Husch Blackwell LLCDevelopment: A Canadian Perspective• Understanding the Canadian legislation in terms of patents 3:45 Case Study• Scrutinizing the benefits and drawbacks of going ahead with a product Exploring U.S. Healthcare Changes and the Effect on Patent Litigation launch with unresolved patent lawsuit for Generic Companies• Reviewing possible legal strategy in terms of portfolio development • Reviewing how healthcare legislation passed in the US will impact generic• Deciphering recent examples of at-risk launches companies and the effect on patent and intellectual property issuesPatrick Nadeau, B.Pharm. M.Sc. MBA, Senior Director • Developing strategies to prepare for current and future legislative developmentsStrategic Portfolio Management regarding patentsPharmascience Canada • Assessing the best way to approach and tackle patent lawsuits to help protect the company’s bottom line Huong Nguyen, Senior Director, Intellectual Property Impax Laboratories, Inc.4:30 Closing Remarks of the Chair Followed by a Cocktail Reception Sponsored by: More Registration Details, Click Here MARKETING INFO A limited amount of exhibition space is available at the conference. Sponsorship opportunities covering luncheon, evening functions and documentation also exist. For further details, please inquire to Michele Westergaard at michelew@marcusevansch.com 312 540 3000 ext 6625.
  4. 4. Day Two | Thursday, July 19, 20128:00 Registration & Morning Coffee GAINING A CLEAR UNDERSTANDING OF MARKET CHANGES AND FUTURE INDUSTRY DEVELOPMENTS8:25 Chairperson’s Opening Address Richard DiCicco, Chairman Harvest Moon Pharmaceuticals USA, Inc. 1:00 Case Study Leveraging Novel Drug Delivery Technologies to Drive Innovation and Differentiation DISSECTING APPROACHES TO IMPROVE THE BUSINESS MODEL • Controlled Release (CR) History, Market, and Economics • Health of Pharmaceutical Industry and Economic Indicators8:30 Case Study • Product Innovation through Design and Mechanistic Changes • Fundamentals and Design of Oral CR ProductsIdentifying Tactics to Improve Strategic API (Active Pharmaceutical • Life-Cycle ManagementIngredient) Sourcing • Mini Case Study• Assessing creative options to approach API sourcing • Looming Patent Losses and Life Cycle Management• Considering benefits and drawbacks of API custom development • Generic Pharma Perspective and Opportunities and manufacturing vs. alternative sourcing agreements Vishal K. Gupta, PhD, MBA, Chief Scientific Officer; Vice President, Research• Applying funding strategies to achieve vertical integration & Development• Analyzing API sourcing strategies the past decade to help identify future CorePharma expectations and changesDr. Vijay Soni, Executive Vice President—IP, BD and Product Portfolio 1:45 Case StudyGlenmark Pharmaceuticals Understanding the Role and Challenges of a Small Startup9:15 Case Study Generics Company • Incorporating strategies for small generic and biotech companies to breakHow the Generic Drug User Fees Act (GDUFA) is likely to impact in the field and find success with specialized productsthe API industry • Identifying the role that small companies play in the overall generics space• The European Fine Chemical Group (EFCG) perspective on GDUFA and the potential impact on mid-sized and large generics businesses• What is the generic API industry paying for? • Discussing whether the best business strategy is to compete with• GDUFA efficiency metrics affecting the API industry larger companies vs. creating partnerships with them• Practical aspects of GDUFA implementation from a manufacturer standpoint David Saber, Senior Director, Business Development & Licensing• A view about what generic API buyers are expected to face Par Pharmaceutical and recommendations on getting preparedCarla Vozone, MSc, MBA, Director, Business Development 2:30 Networking BreakHovione Representing European Fine Chemical Group (EFCG) 3:00 Interactive Panel Discussion10:00 Networking Break Generics in Emerging Markets: Analyzing the Benefits and Risks of Expanding to New Markets EXPANDING THE COMMERCIAL REACH THROUGH BIOSIMILARS • Understanding the global opportunity for generics and how to jumpstart an expansion to another market • Identifying which markets to break into and how to ensure you meet their10:30 Case Study regulatory and manufacturing requirementsStudying the Impact of the FDA’s Guidance on Biosimilars • Preparing for potential legal challenges that accompany global expansionfor the Generics Industry to Ensure Regulatory Compliance to prevent delaying the business plan• Understanding key elements of the FDAs draft guidance • Weighing the potential benefits of engaging in emerging markets and how it will affect companies looking to expand into biosimilars vs. the potential complexity of manufacturing or distributing products• Implementing strategies to overcome specific patent challenges tied in another country to producing the generic version of biologics • Incorporating strategies to launch biosimilars in markets with robust• Addressing the data that will be required for generic companies biosimilars regulations and approval processes submissions to the FDA Panelists:• Identifying potential improvements to the guidance that have been Richard DiCicco, Chairman submitted by the industry and how the guidance could change before Harvest Moon Pharmaceuticals USA, Inc. becoming finalized• Reviewing the timeline for when the guidance will be finalized 3:45 Case Study and identifying the next steps for generics companies Assessing Global Manufacturing Possibilities to Increase EfficiencyKevin Nelson, Partner and Explore Business OpportunitiesLocke Lord • Understanding the global manufacturing landscape and which companies are successfully and safely manufacturing generics11:15 Interactive Panel Discussion • Identifying top markets for drug manufacturing, such as India, to increaseGlobal Biosimilars: Differentiating Between the Draft U.S. Biosimilars the company’s profit marginGuidance and Existing EMA and Japanese Biosimilars Regulations • Discussing a shift in manufacturing to other countries and the impact• Comparing similarities in Japan, Europe and the U.S.s proposed regulations, on portfolio management strategies especially when considering the same product • Accounting for regulatory requirements in both the US and abroad when• Preparing for patent challenges when expanding globally outsourcing manufacturing functions• Building strategies to release the same drug into multiple markets while • Comprehending international regulations for manufacturing controlled considering the differences in regulations substances in one country and shipping to another• Identifying synergies between regulatory bodies to streamline submissions Gopalakrishnan Venkatesan, Associate Vice President, Business Development and potentially eliminate multiple clinical trials Wockhardt USA LLC• Reviewing lessons learned from development of biosimilars and experiences with the EMA in the European Union 4:30 Closing Remarks of the Chair & End of Conference12:00 Luncheon PRODUCER INFO I would like to thank everyone who has assisted with the research and organization of the event, particularly the speakers for their support and commitment. Sarah Michalos, Conference Producer, SarahM@marcusevansch.com.
  5. 5. PLATINUM SPONSOR: Consistently ranked among the top intellectual property law firms worldwide, Knobbe Martens Olson & Bear LLP has been servicing clients in the generic pharmaceutical industry for over ten years. The firm has litigated more than forty cases under the Hatch Waxman Act and has the experience and technical resources necessary to service all facets of the generic drug process.SILVER SPONSOR: Locke Lord LLP consistently ranks among American Lawyer’s top 100 U.S. law firms. From offices in 11 U.S. cities as well as London and Hong Kong, Locke Lords excellent reputation is earned from building collaborative relationships and crafting creative solutions – all designed and executed to meet clients long-term strategic goals.PANEL PARTNER: Husch Blackwell LLP is a full-service litigation and business law firm with 600 attorneys in locations across the United Statesand in London, serving clients with domestic and international operations. We focus on providing sophisticated legal services at a compelling value that helps manage risk,overcome hurdles and create meaningful advantages for our clients. We represent national and global leaders in major industries that include agribusiness, energy, financialservices, healthcare, manufacturing, chemicals and telecommunications. Our attorneys are recognized by leading professional and industry organizations for theirknowledge and expertise across a broad range of legal services.MEDIA PARTNERS: BioPortfolio.com - the life science and healthcare portal BioPortfolio provides continuously updated biotechnology, pharmaceutical and healthcare news from several hundred selected sources, including syndicated news, blogs and press releases writtenby our editors and contributors. Our archive contains: over 600,000 news articles; corporate details on 40,000 organizations; 300,000 published medical and life science abstracts; 33,000 profileson approved drugs; and 65,000 clinical trials. GenericsWeb provides patent intelligence to the worlds leading pharmaceutical companies, allowing their customers to significantly reduce the risk of developing patent-infringing pharmaceuticals for global markets, and identify when and where they can launch products.GenericsWeb boasts 50% of the worlds top 10 generics companies as key customers. Medical News Today is the largest independent medical and health news site on the web - with over 2,000,000 unique monthly users it is ranked number one for medical news on Google and Yahoo!. Medical News Today is used by Blue Chip pharmaceutical and health organizations, advertising agencies, PR companies and vertical ad networks to deliver targeted disease/condition and general health campaigns. For more information contact peter@medicalnewstoday.com or visit www.medicalnewstoday.com. www.pharmaphorum.com is the exciting new online discussion and networking site for the pharma, medical devices and diagnostics industry. The site features topical articles with user comments, a live forum and directories for upcoming conferences and relevant companies. With a growing audience of industry executives engaging in debate, www.pharmaphorum.com is the place for people in healthcare to shareideas, discuss leading issues and network. The Regulatory Affairs Professionals Society (RAPS) is a global membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. As regulatory professionals, RAPS members perform vital work in all areas of the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. FDAnews is the premier provider of domestic and international regulatory, legislative and business news and information for executives in industriesregulated by the U.S. Food and Drug Administration. Pharmaceutical and medical device professionals rely on FDAnews newsletters, books, special reports and conferencesto stay in compliance with international standards and FDAs complex and ever-changing regulations. The National Law Review (NLR) is a unique Web site featuring a legal magazine paired with a user-friendly database dedicated to providing legal consumers with authoritative legal analysis written by lawyers from many of the nation’s premier firms. We compile timely, well-researched articles submitted to us nationwide from law reviews, law journals, law firm newsletters, and bar association and other professional publications and make them accessible to all in an easy-to-use, searchable database. The NLR also publishes an online magazine that features articles with broad-based appeal to the legal communityand to legal consumers. PharmaVOICE magazine provides commentary about the challenges and trends impacting the life-sciences industry, covering a range of issues from molecule through market. PharmaVOICEs more than 27,000 BPA-qualified subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers. www.PharmCast.com is the world leading website designed specifically for pharmaceutical, clinical and biotechnology professionals. www.PharmCast.com brings up-to-date information on pharmaceutical patents, FDA, news, jobs and Buyers Guide to our visitors. It was created and is maintained by pharmaceutical and biotechnology professionals. Visit www.PharmCast.com and discover for yourself why it is so popular among professionals Orange Book Blog (www.orangebookblog.com) covers issues at the intersection of patent and FDA law – for example, ANDA litigation, FDA regulatory exclusivity, and patent term extensions. Visit www.InsideHealthPolicy.com to set up your one-month, no-obligation, free trial today. InsideHealthPolicy.com will bring you a daily online news service plus the Inside CMS and FDA Week newsletters, our Inside Health Reform news service, daily blogs, an enormous document archive and special news sections on Rx Drugs, Drug Policy, Medical Devices, Congress, Medicare, ACO, Supreme Court & Health Reform and Food Safety. And youll receive an early Morning Headlines e-mail to keep you on top of all the critical news as you begin your day. Sign Up today! Intellectual Property Watch, based in Geneva, Switzerland, provides independent news and information on international intellectual property policymaking. Our global network of professional journalists closely follows the issues and events that shape IP policy and law. IP-Watch publishes articles, expert opinions, and other features continuously on our website, www.ip-watch.org, with notification via e-mail alert, RSS, Twitter and Facebook.www.gabionline.net • www.gabi-journal.net Generics and Biosimilars Initiative (GaBI) was founded in 2008. GaBI aims to foster the worldwide efficient use of high quality and safe medicinesGaBI GENERICS AND BIOSIMILARS INITIATIVEBuilding trust in cost-effective treatments at an affordable price, thus advancing and supporting the idea of accessible, affordable and sustainable health care Subscribe at www.gabionline.net/Subscription-form to gain easy access of information on the latest scientific research and developments in generic and biosimilar medicines via GaBI Online.OFFICIAL CONFERENCE BLOGGER: Generics and Biosimilars Initiative (GaBI) was founded in 2008. GaBI aims to foster the worldwide efficient use of high quality and safe medicines at an affordable price, thus advancing and supporting the idea of accessible, affordable and sustainable health care. Subscribe at www.gabionline.net/Subscription-form to gain easy access of information on the latest scientific research and developments in generic and biosimilarmedicines via GaBI Online.