Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 13th International Conference on Biologics and Biosimilars Boston, USA.

Day 2 :

Conference Series Biosimilars 2018 International Conference Keynote Speaker Himabindu Gaddipati photo

 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.



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.


Conference Series Biosimilars 2018 International Conference Keynote Speaker Ha Kung Wong photo

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.



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
Conference Series Biosimilars 2018 International Conference Keynote Speaker Stanton Mehr photo

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.




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.