Day 2 :
Keynote Forum
Ha Kung Wong
Fitzpatrick Cella Harper & Scinto, US
Keynote: Why so serious: The increasing impact of post grant challenges to biologics and biosimilars in the US
Biography:
Ha Kung Wong practices general intellectual property law with an emphasis on complex patent and trade secret litigation in pharmaceuticals, biologics, and chemistry. Cases he has litigated include those related to proton pump inhibitors, anti-epileptic drugs, and other pharmaceuticals. He has also extensive experience with inter partes review (IPR), intellectual property counseling, pre-suit investigations, licensing and due diligence. He is the recipient of the 2017 ILO Client Choice Individual Award For Intellectual Property in New York. He is currently the chair of the recruiting committee, serves as faculty for NITA (the National Institute of Trial Advocacy) and Lawline, and has been named a "Furthered 40" by Lawline for his contributions. He is also an advisory board member for the center for biosimilars. He was named to The National Law Journal's 2017 inaugural list of Elite Boutique Trailblazers. He holds a B.S. in chemistry and biochemistry of the University of Illinois Urbana-Champaign and J.D. for the University of Notre Dame Law School.
Abstract:
Biologics and biosimilar products are the fastest growing pharmaceutical products in the US, being 3 of the top 5 best selling pharmaceutical products in the US in 2018. As such, it has become even more important to companies in both the biologics and biosimilars space to acquire and protect related intellectual property, as well as conduct a thorough analysis concerning potential infringement and validity issues of competitor intellectual property. The supreme court has now upheld the constitutionality of inter partes review and post grant review as viable avenues for challenging patentability, and recent developments with the federal circuit have potentially increased the likelihood of challenges, particularly with respect to the very important area of biologics. We will take a look at the IPR and PGR processes, discuss strategies for filing and responding to these petitions, consider recent case law and it impacts on these processes and provides insight as to what steps to take to prepare for a potential future challenge.
Keynote Forum
Stanton Mehr
Biosimilars Review & Reports, USA
Keynote: Where the us biosimilars market is going and when it might get there
Biography:
Stan Mehr has more than 30 years of experience in healthcare publishing and project management, specializing in the payer markets, clinical issues, health policy, and health delivery. He is Principal and Content Director of BR&R, a web resource, informational site, and consulting service in the biosimilar arena since 2014. Since the founding of SM Health Communications in January 2007, he has been writing, editing, and presenting on a variety of clinical, business, and policy topics of interest to the healthcare industry, including health plans, insurers, and PBMs. He consults with several sectors including health care agencies, healthcare publishers, and other firms, helping them to better understand the payer market and achieve their organizational goals. He spent 20 years as Executive Vice President and Editorial Director of Medicom International Inc, where he was the Founding Editor of Managed Care Interface, the first monthly, peer-reviewed journal for the managed care industry, and its sister publication Long-Term Care Interface. He received his Bachelors of Science degree in Biology from the State University of New York, Stony Brook.
Abstract:
Nine years after the passage of the biologics and biosimilars price competition and innovation act, 14 biosimilar agents have been approved by the US Food and Drug Administration but only 4 biosimilars have reached the US market. None have been designated as being interchangeable with the reference biologic. Of these 4 available biosimilars, only one (filgrastim-sndz) has attained competitive market share in its drug category. Lingering patent litigation, aggressive rebating by reference manufacturers, and insufficiently aggressive pricing by biosimilar makers have contributed to the current situation. The federal government has taken recent action to alleviate specific challenges to biosimilar market entry. The biosimilar action plan announced in July by US FDA Commissioner Scott Gottlieb may be successful in clearing the path for biosimilar marketing, but the other action will need to be taken on a legislative level (e.g., drug rebates as a safe harbor). Biosimilars may also benefit from a move from Medicare part B to part D, where payers can employ more pharmacy benefit tools to restrict access to nonpreferred products. Payers can also employ preferred and nonpreferred specialty drug tiers to make biosimilars more attractive to patients. There are significant market opportunities in several drug classes, but biosimilar manufacturers will have to carefully balance the potential revenues with delayed launches, and the viability of their business model.
Keynote Forum
Himabindu Gaddipati
Elixsys, Inc., USA
Keynote: Enabling a global collaborative ecosystem in the realm of biopharma
Biography:
Himabindu Gaddipati is a medical oncologist based in San Diego, CA. Her varied background has provided her with a comprehensive understanding of the biopharma lifecycle encompassing basic research, product development, regulatory and Intellectual property and practical translational into the clinical realm. Following medical school, she pursued Internal Medicine residency followed by fellowships in Genetics and Molecular Biology from the University of Pennsylvania and Hematology/Oncology from University Hospitals/Case Western Reserve. She served as a visiting scientist at the Wistar Research Institute. She gained valuable insight about the regulatory requirements for marketing approval of drugs as a reviewer in the division of oncology at the US FDA. At the National Cancer Institute, she served as an analyst for the Federal Small Business Innovation Research (SBIR Program) and also completed a certificate program in Technology Transfer. She completed her Master’s degree in Business and Technology Management from the Wharton School of Business. She is currently the co-chair for the Biocom oncology group, a network of more than 120 organizations including hospitals, research institutions, companies and foundations engaged in cancer-related activities in Southern California. Her company Elixsys is committed to facilitating engagement between diverse stakeholders who are engaged in oncology product discovery, development, and commercialization.
Abstract:
The current era of rapidly evolving technology, market trends and policy is creating an increasingly fragmented biopharma value chain. End-to-end research or comprehensive development of a life science product which was once accomplished within an institution or organization is now being facilitated by multiple parallel interactions. Integrating diverse technology and expertise between an array of varied stakeholders across organizational and geographical boundaries is now becoming the norm. However, the logistics required to support a streamlined mechanism to facilitate more effective and efficient interaction and breakdown inter-organizational silos is largely deficient. This is especially relevant in the dynamic arena of cancer research and product development which is being accelerated by the utilization of cutting-edge technology. The solution likely lies in creating a niche environment with the required resources that will bring together diverse stakeholders along the biopharma value chain such as Institutions, pharma and biotech companies, foundations and hospitals in a streamlined manner. The participants can leverage complementary skills and knowledge to amalgamate their capabilities towards unified objectives. Towards this vision, our organization has developed a novel online platform, designed to bring together diverse stakeholders across the cancer care continuum. This is an integrative “Virtual Ecosystem” that will connect groups of organizations worldwide to create “interlinked clusters” of concentrated knowledge, expertise and resources. The cloud-based platform enables users to review domain-specific expertise of others and initiate communication with the potential partner(s). The platform is specifically designed to integrate and streamline all activity amongst group members throughout the process of preliminary exploration, sourcing/raising funds, strategic planning and execution of a project. Ultimately this will empower stakeholders along the lifecycle to conduct synchronized initiatives on a global scale. Immense value can be generated by creating such cohesive mechanisms to enhance cost and time efficiency while reducing redundancy.
- Regulatory Approach for Biosimilars | Globalization of Biosimilars | Biosimilars Research Pipeline| Analytical Characterization of Biotherapeutics |Biopharmaceutical Regulatory Affairs
Location: Parker Boardroom
Session Introduction
Nitin Naik
Frost and Sullivan, USA
Title: Transformations in global pharmaceutical indutsry
Biography:
Nitin Naik leads the global life sciences practice at Frost and Sullivan and is responsible for aligning cross-functional initiatives to achieve focused business results. He plays a pivotal role in helping life science companies realize their audacious goal of unhinging the most transformative pivots in the precision medicine landscape. He has more than 20years of healthcare industry expertise, including 15 plus years of consulting expertise focusing on the pharmaceutical and biotechnology sector. He works closely with Frost and Sullivan’s leadership and sales teams to expand research services and brand and demand solution footprint. Prior to his current role, he worked with GE Healthcare (national distributor), Frost and Sullivan Asia and A*STAR Singapore in various roles from strategy, marketing to in-licensing, portfolio management, and market planning. His experience and expertise have made him a go-to expert for commentary about emerging industry trends. He studied Biomedical Engineering (Gold Medalist) at Bombay University. He has an MBA (International Business) from S.P. Jain Institute of Management and Research (SPJIMR), India and pursued Advanced Management Program (Corporate Strategy and Finance) from Stanford-NUS.
Abstract:
The global life sciences industry is witnessing a surge in Chief Executive Officer (CEO) confidence from US tax reforms, turbulent equity markets, and the strengthening global economy. The growth of the life sciences industry is boosted by healthcare digitization and democratization creating an explosion in patient data, the emergence of value based reimbursement models, and healthcare consumerism shifting the risk from payers to providers. The convergence of biopharmaceuticals, drug delivery devices, and companion diagnostics enabled by digital connectivity is driving regulatory and commercial changes in many exciting ways for the industry. In this session hear about Frost and Sullivan’s perspective of how business models are changing to maximize growth in life science companies as they embrace the new trends and technology. Key takeaways include top 3 growth opportunities in the biopharmaceutical industry, perspectives from game changing companies on collaborative projects, impact on disruptive technology platforms and best practices for implementing new business models
Gregory Gierer
America’s Health Insurance Plans, USA
Title: Health plan perspective: Assuring a vibrant and competitive marketplace for biosimilars
Biography:
Gregory Gierer has over 15 years of experience with health care policy and analysis. Prior to joining America's Health Insurance Plans (AHIP), he served as a senior director for policy at the pharmaceutical research and manufacturers of america (PhRMA) where he worked on developing and managing public policy issues related to comprehensive health care reform, health-system and delivery reforms, and public programs such as Medicaid and the Children’s Health Insurance Program (CHIP). He previously served as a senior policy consultant at the Blue Cross and Blue Shield Association (BCBSA) and a Policy Analyst at America’s Health Insurance Plans (AHIP). He also worked on the legislative staff for U.S. Senator Christopher J. Dodd (D-CT) from 1997-1999 and 2001-2002. He received his Bachelor of Arts (B.A.) from Providence College (1995) and a master’s in public policy (M.P.P.) from Georgetown University (2001). AHIP is the national trade association representing the health insurance industry. AHIP’s members provide health and supplemental benefits to more than 200 million Americans through employer-sponsored coverage, the individual insurance market, and public programs such as Medicare and Medicaid. AHIP advocates for public policies that expand access to affordable health care coverage for all Americans through a competitive marketplace that fosters choice, quality, and innovation.Senior Vice President for Policy at America’s Health Insurance Plans (AHIP) where he leads policy development work on legislative and regulatory policy issues—with a primary focus on health reform.
Abstract:
Prescription drug spending increases fueled by high launch prices for new therapies and price increases for existing brand name drugs are contributing to unsustainable health care costs growth across the US. In addition to straining the health care system overall, high drug prices also place financial burdens on patients who rely on prescription medicines. Recent advances in medicine which have resulted in new treatment options for patients with serious and chronic conditions have been mostly concentrated in the area of biologics and specialty drugs. While many of these treatments have led to improved health outcomes and quality of life for patients with debilitating conditions, they also lack meaningful competition and as a result are a key driver of increased medical and prescription drug costs. Spending on biologics and other specialty drugs reached $105.5 billion in 2016 and biologics are the fastest growing component of prescription drug spending increasing between 11.3% and 17.7% last year alone. Some treatments for biologics and specialty drugs have annual costs that exceed $250,000. Despite the passage of the biologics price competition and innovation act of 2010 which established a dedicated pathway for FDA approval of biosimilar drugs overall availability and utilization of biosimilar drugs have largely fallen short of market expectations. The FDA has approved 12 biosimilar products but only 4 are currently available to patients including approved biosimilar alternatives to neupogen and remicade. A number of barriers legal, regulatory and others have prevented and limited the availability and widespread adoption of biosimilars in the marketplace. Legal strategies such as aggressive patent litigation by brand name biologic manufacturers have prevented or delayed FDA approved biosimilars from coming to market and being made available to patients. Moreover, legislative and regulatory barriers have also contributed to a biosimilars marketplace that has failed to meet expectations in terms of product availability, uptake and cost savings.
Jose Carlos Ferreyra Lopez
The Pharmaceutical Institute, Mexico
Title: Market access barriers and market value in Mexican public sector for biosimilars
Biography:
Jose Carlos Ferreyra Lopez, MBA, is currently President of the Pharmaceutical Institute in Mexico (Institute of Research and Pharmaceutical Innovation), a think-tank and research center for access barriers specialized in the Mexican market. Worked for Eli Lilly as a Demand Realization Project Manager (2000 to 2005), and has been a consultant for more than 200 pharmaceutical companies established in Mexico. He has been either chairman or keynote speaker in several international congresses in Mexico, Bucharest, USA, and Italy. Speaks 3 languages, and his background includes being the congressman for the Nuevo Leon administration in 2007.
Abstract:
In this presentation, I will explain the composition of one of the biggest and complex public health systems in the world. Over 150 public buyers in Mexico provide health services to over 125 million beneficiaries. Mexico public health system is managed by 33 independent (yet organized) health ministers, managing over 9,500 medical units and hospitals. The total pharma market value is worth over 4,500 MUSD per year, and 1,750 million units. Also, will explain the access roadmap to get to the 150 government public buyers, including timings and procedures.
Biography:
Joel I Osorio is an innovative businessman with a distinct entrepreneurial mindset concentrated adding value on areas of Biotechnology (mRNA), reprogramming & regenerative medicine for translational use in humans and a variety of clinical applications aimed for both the private and the public health sectors. He is the founder, president, and CEO of RegenerAge Clinic and RegenerAge Beauty initiatives for transnational implementations. Vice President and International Clinical Developer for Bioquark, Inc. Executive Vice President: Chairman of the WAMS Americas Division, member of the WAMS Executive Council (WAMS Executive Board), a member of the WAMS Education & Training Board (ETB), a member of the WAMS Editorial Board, an Honorary Member of the Academy Faculty FWAMS, an Honorary Fellow of the Academy & is also a Senior Partner at WAMS, The World Academy of Medical Sciences.
Abstract:
Bioquantine a mRNA extract from Xenopus laevis frog oocytes (purified from intra- and extra-oocyte liquid phases of electroporated oocytes), showed potential as a treatment for a wide range of conditions in animal models, including Spinal Cord Injury (SCI) and Traumatic Brain Injuries (TBI) among others. The current study observed beneficial changes with Bioquantine administration in a patient with a severe SCI. Pluripotent stem cells have therapeutic and regenerative potential in clinical situations CNS disorders. One method of reprogramming somatic cells into pluripotent stem cells is to expose them to extracts prepared from Xenopus laevis oocytes. Due to ethical reasons and legal restrictions we selected a no option patient, deciding to include in our protocol the RestoreSensor SureScan to complete it. Based on the electrical stimulation for rehabilitation and regeneration after spinal cord injury published by Hamid and MacEwan, we designed an improved delivery method for the in-situ application of MSCs and Bioquantine in combination with the RestoreSensor SureScan. To the present day the patient who suffered a complete section of spinal cord at T12-L1 shows an improvement in sensitivity, strength in striated muscle and smooth muscle connection, 14 months after the first Bioquantine and MSCs treatment and 9 months after the placement of RestoreSensor at the level of the lesion, showing an evident improvement on his therapy of physical rehabilitation (legs movement) on crawling forward and backwards and standing on his feet for the first time and showing a progressively important functionality on both limbs