PROVENTA INTERNATIONAL INNOVATION. Strategies for Transforming Safety, Regulatory, and Benefit-Risk Management of Established Products

Transcription

1 INNOVATION SPOTLIGHT SESSION Strategies for Transforming Safety, Regulatory, and Benefit-Risk Management of Established Products WEDNESDAY 4TH NOVEMBER 2015 Hyatt Regency, Princeton, NJ PROVENTA INTERNATIONAL

2 INNOVATION INNOVATION SPOTLIGHT The bar has been raised the traditional barriers between regulatory and safety must be eliminated to ensure optimal portfolio line of sight, and ultimately the success of your established products. In one day of interactive sessions, industry senior executives such as Veronique F. Kugener of Takeda will join forces with industry thought leaders such as Steve Gens to discuss breakthrough strategies for maximizing the value vigilance of your established product. Delegates will participate in lively discussions intended to address the challenges and lessons learned of maintaining the health of your mature, or established products, amidst ever-changing regulations and global compliance mandates. In addition to hearing from companies like Takeda, who have been faced with the harrowing decision to hold or fold new product portfolios, our line-up of best-in-class thought leaders will share strategies for how to: Identify, manage and mitigate product risks Maintain profitability later in your product s lifecycle Generate greater insights into your established product portfolio Contain technology and maintenance costs Manage and staff a complex global network KEY OPINION LEADERS Veronique F. Kugener Senior Vice President, Global Pharmacovigilance Takeda Pharmaceuticals Geoff Garabedian Senior Vice President and Managing Director, Advisory Services Steve Gens Managing Partner Gens & Associates John Jones Vice President, Technology Solutions Ajay Singh Team Lead, Safety & Pharmacovigilance GSK Simon Ashworth Executive Medical Director, Established Products, Global Pharmacovigilance Takeda Pharmaceuticals Peter Lassoff Pharm.D. Vice President and Head, Global Regulatory Affairs FOLLOW US ON SOCIAL MEDIA

3 IN PARTNERSHIP WITH SPOTLIGHT SESSION 2015 Marketed Product Maintenance to maximize established product value Go Beyond Regulatory Compliance Ensuring the success of established products goes beyond just meeting requirements. Amidst increasing regulatory complexity and growing stakeholder pressures to reduce costs, while driving revenue, there exists an opportunity to better align regulatory, safety and medical affairs to maximize product value. Enhance Value & Maximize Investments delivers an integrated turnkey solution, managing all aspects of regulatory, safety, and benefit risk management to lower maintenance costs and to bring visibility to your marketed products portfolio. This service addresses your challenges with: Navigating an evolving regulatory environment and increasingly complex global compliance Identifying, managing & mitigating product risks Maintaining profitability later in the life cycle Containing technology and maintenance costs Managing and staffing a complex global network of local operating countries By aligning all aspects of marketed product maintenance, can help you maximize value and manage safety. It s what we call value vigilance. ONLINE COMMUNITY DISCUSS I COLLABORATE I ACCELERATE Proventa International is proud to announce that we are now expanding our portfolio of services by breaking into the digital landscape with the launch of our new online community, Syensya.com. We have tailored Syensya.com with the core objective to provide you with a pre-competitive digital platform that enables direct communication with other Life Sciences Executives. Syensya.com acts as an important extension to our Innovation Spotlight Sessions whereby you may now prolong key discussions attended during the day including the ability to add and build connections with industry peers, read and discuss current whitepapers, participate in webinars, and ask industry experts key questions relevant to your specific area of expertise. Join us online now at

4 TIME AGENDA ROOM 9:00-9:30 REGISTRATION HALL 9:30-9:45 Welcome Address: Steve Gens, Managing Partner, Gens & Associates Opening Presentation: Industry trends and challenges of maintaining established product portfolios 9:45-10:15 Abstract: This presentation will discuss new regulations and the complexity of emerging market regulations, the increased emphasis on ongoing benefit-risk assessments and the complexity, compliance risk and cost pressures associated with silo d regulatory, safety and benefit-risk functions. Speaker: Simon Ashworth, Executive Medical Director, Established Products, Global Pharmacovigilance, Takeda Pharmaceuticals 10:15-11:00 Case Study: The challenges of acquiring new company/product portfolio Abstract: Listen as senior leadership at Takeda Pharmaceuticals discuss some of the challenges the company faced when acquiring a new established product portfolio, as well as the key drivers behind their strategic decision to outsource the routine regulatory and safety maintenance to a trusted partner. Moderator: Simon Ashworth, Executive Medical Director, Established Products, Global Pharmacovigilance, Takeda Pharmaceuticals 11:00-11:10 Morning Break HALL Presentation: The competitive advantage: integrated technology for transparency into the benefit-risk profile of your global, established products 11:10-11:40 Abstract: Using our ground-breaking relationship with Takeda as a prime example, Technology Solutions will discuss the benefits of a seamless technology as the underlying factor to product maintenance. More specifically, our experts will highlight the importance of creating an intuitive dashboard that combines KPI reporting with a layer of analytics that integrates with product portfolio insights, allowing for faster decision-making and greater cost-savings. Speaker: John Jones, Vice President, Technology Solutions 11:40-12:40 Roundtable Discussion: Trends and challenges being faced by marketing authorization holders today Abstract: The pharmacovigilance and regulatory landscapes which continue to evolve on a global basis with lack of harmonization, pose significant challenges. Inspections are becoming more common for both innovative and mature products. In parallel, companies are increasingly looking to better integrate their safety, regulatory, and benefit-risk activities, particularly those related to the recent EU Good Pharmacovigilance Practices (GVP) requirements for marketed products. During this round table, there will be ample opportunity to discuss challenges as well as best practices and strategies to keep on top of the changing regulations in a cost-effective manner, while continuing to focus on patient safety as a priority. Moderator: Ajay Singh, Safety & Pharmacovigilance Team Lead, GSK 12:40-13:40 Networking Lunch WATER S EDGE

5 TIME AGENDA ROOM Presentation: Burning platform the case for change in maintaining marketed products 13:40-14:10 Abstract: Learn about the financial imperatives for transforming safety, regulatory and benefit-risk maintenance by shifting organizational, technological and management thinking. Renowned regulatory thought leader Steve Gens will focus on industry-wide trends and challenges as seen from our market leaders. Speaker: Steve Gens, Managing Partner, Gens & Associates 14:10-15:10 Roundtable Discussion: Integration of regulatory and safety functions: efficient and cost-effective strategies for the maintenance of marketed products Abstract: Discussion pertaining to how integrating regulatory and safety/pv functions for the maintenance of established products works in practice, pros and cons, and how the breakdown of functional silos can facilitate effective established product maintenance. Organizational structures pertaining to maintenance activities (HQ versus local affiliates) will also be discussed. Moderator: Peter Lassoff, Pharm.D. Vice President and Head Global Regulatory Affairs, 15:10-15:20 Afternoon Break HALL Roundtable Discussion: Common challenges in program oversight of established products from a safety perspective: problems and solutions 15:20-16:20 Abstract: Discussion will allow guests to share known challenges and lessons learned with the unique features of pharmacovigilance activities related to established product portfolios. Breakout session will focus on brainstorming potential solutions to some of the key issues. Moderator: Veronique F. Kugener, Senior Vice President, Global Pharmacovigilance, Takeda Pharmaceuticals 16:20-17:20 Roundtable Discussion: Focusing on Value Abstract: Companies often struggle with how to translate a more virtual model for maintaining a mature product portfolio into tangible value and how to articulate that value to senior management to enact change. In some cases, the value is very apparent and concrete in terms of financial savings, especially when current costs of operations are known. In other cases, however, the value derived could be from addressing compliance issues or the ability to focus limited internal resources on growth products. The ability to think holistically about all functions and capabilities involved in maintaining mature brands is key and can be a limiting factor in maximizing value. During this session, we will discuss the various value levers that companies could consider and what is seen as most important in different environments, as well as other, broader solutions that could create additional value for key stakeholders. Moderator: Geoff Garabedian, Senior Vice President and Managing Director, Advisory Services, 17:20-18:00 Panel Discussion: Adopting an integrated PV/regulatory model: next steps for maximizing the value of your established product portfolios Panellists: Steve Gens, Managing Partner, Gens & Associates Peter Lassoff, Pharm.D. Vice President and Head Global Regulatory Affairs, Veronique F. Kugener, Senior Vice President, Global Pharmacovigilance, Takeda Pharmaceuticals Matthew McKeever, MD, FAAP, VP, Safety Knowledge and Reporting, Chair: Geoff Garabedian, Senior Vice President and Managing Director, Advisory Services, 18:00-21:00 Gala Dinner TBA

6 INNOVATION KEY OPINION LEADERS Veronique F. Kugener, Senior Vice President, Global Pharmacovigilance, Takeda Pharmaceuticals Veronique Kugener, MD, MSc, MBA joined Takeda in 2007 and has around 20 years of experience in clinical safety and pharmacovigilance in the pharmaceutical industry both in Europe and in the USA. Veronique started her career in global pharmacovigilance in 1991 at Rhone-Poulenc Rorer and has also held positions in clinical drug safety and pharmacovigilance with Aventis, Biogen Idec and Bristol-Myers Squibb. Veronique received her medical training and earned her medical degree in France. She earned her masters degree in advanced studies (DEA) in Epidemiolgy from the University of Medicine, Victor Segalen in Bordeaux, France and her masters degree in pharmacology from the University of Medicine, Paris VII, France. She is a graduate of the Masters in Business Administration (MBA) from the Institut of Administration des Entreprises (IAE) at the University of Bordeaux, France. Veronique and her family reside in Boston, MA, USA. John Jones, Vice President, Technology Solutions John Jones joined in May 2010 to lead IT Consulting Division. In October 2014, John joined the newly formed Technology Solutions group, heading up customer engagement and technology advisory services. John has more than 18 years experience in developing and delivering IT Solutions for various companies, and has extensive experience in clinical and commercial areas. His technical specialties include: enterprise architecture planning and definition, long-term technology strategy development, knowledge and content management, information architecture and metadata definition, structured content authoring and data integration/business intelligence platform implementation. John earned his BS and MBA from Rutgers University in New Jersey. Ajay Singh, Team Lead, Safety & Pharmacovigilance, GSK Ajay received his medical training from Jefferson Medical College and received his post medical graduate training at Robert Wood Johnson Medical College in internal medicine. He completed a clinical nephrology fellowship at Case Western University and a research fellowship at Robert Wood Johnson Medical School. From 1989 to 1998 Ajay served on faculty at Robert Wood Johnson Medical School/Princeton Medical Center, the last 3 years serving as associate program director at Princeton. Ajay joined Wyeth Pharmaceuticals in Clinical Research in 1998 and transferred to the safety department in He joined GSK in 2011 and currently serves as a Team Leader. Peter Lassoff, Vice President and Head, Global Regulatory Affairs, As Vice President and Head, Global Regulatory Affairs at, Peter Lassoff works with global clients in the pharmaceutical, medical device, cosmetic, nutrition and other industries on regulatory strategy and implementation to ensure their products are placed on the market using the most efficient and cost-effective strategies. Peter has considerable expertise in the development and worldwide registration of medicinal and borderline products, medical devices, cosmetics and cosmeceuticals, nutritional supplements and other regulated health-care products. He has also run extensive large-scale license transfer projects. Prior to joining, Peter was Vice President Europe for Parexel Consulting and has also worked for Bristol-Myers Squibb, ConvaTec and Stiefel over a career spanning 30 years in the pharmaceutical industry. Peter holds a Doctor of Pharmacy (Pharm.D.) from the University of Southern California School of Pharmacy, Telephone:

7 SPOTLIGHT SESSION 2015 Steve Gens, Managing Partner, Gens & Associates Gens is the Managing Partner of Gens and Associates Inc., a global Life Sciences consulting firm specializing in strategic planning, organizational performance, regulatory information management, and industry benchmarking. His early career was spent at Johnson and Johnson in a variety of management positions and then moved into consulting to grow and lead several global healthcare consulting practices for First Consulting Group and Booz Allen Hamilton. Steve and his colleagues consult for many of the large multi-nationals along with smaller high growth Life Science organizations. His organization is well known for their respected and insightful industry benchmarks that focus on several regulatory aspects including Regulatory Information Management (RIM), operations, and the status / trends for the local affiliate office and regional hubs. The studies include strategy, trends, regulatory activity efficiency, investment, and software and dossier outsourcing vendor market-share / satisfaction. 85% of the top 70 biopharmaceuticals have participated in Gens and Associates studies. Steve has 30 years of experience and a Masters of Science in Organization Development and undergraduate degree in Business Computer Science. Simon Ashworth, Executive Medical Director, Established Products, Global Pharmacovigilance, Takeda Pharmaceuticals Simon Ashworth, MD, BSc oversees the safety of a large portfolio of established products globally. He undertook his medical training in a number of London teaching hospitals, and received his medical degree from the University of London. He then specialized in haematology and oncology. After 9 years of clinical practice he moved into the pharmaceutical industry, where he has worked for a number of companies including Eisai, Roche/Genentech and GSK prior to joining Takeda in He has 12 years experience in clinical safety and pharmacovigilance, including experience in early development, product registrations and both early and late post-marketing safety surveillance. Geoff Garabedian, Senior Vice President and Managing Director, As a leader in Advisory Services, Geoff Garabedian works with pharma, biotech and device companies to advise them on innovative growth strategies, as well as the capabilities needed to enable those strategies and scale globally. Geoff focuses primarily in the R&D space, with an emphasis on regulatory, quality and safety solutions. Over the past 24 years, Geoff has been delivering management consulting solutions to Life Sciences clients, through a mix of strategy development, process design, technology implementation and change management. During his career, Geoff has primarily focused on helping companies develop new business models, increase operational performance and improve quality and compliance through global process and organizational transformations. Prior to joining, Geoff was a partner at BusinessEdge Solutions, which was acquired by EMC. During his 7 years at BusinessEdge/EMC, he led the R&D practice, which focused on innovative process and technology solutions for clinical development, regulatory affairs, medical affairs and pharmacovigilance organizations. Prior to joining BusinessEdge, Geoff focused on implementing process and technology solutions within Accenture s Life Sciences R&D practice for 11 years.

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