4th International Conference and Exhibition on Biologics and Biosimilars October 26-28, 2015 Baltimore, USA

Biography:

Patrick Lucy is the Chief Business Officer of Pfenex Inc. (NYSE: PFNX). He was a member of the team that founded Pfenex within The Dow Chemical Company. He has been in the biotechnology industry for over 22 years holding technical, operational and commercial roles throughout his career. He previously worked at The Dow Chemical Company, Collaborative BioAlliance, Lonza Biologics, Celltech Biologics and Repligen Corporation.

Abstract:

The United States biosimilars market was established based upon The Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act was formally passed under the Patient Protection and Affordable Care Act (ACA), and signed into law by President Barack Obama on March 23, 2010. The BPCI Act was an amendment to the Public Health Service Act (PHS Act) which created an abbreviated approval pathway known as the 351(k) pathway for biological products that are demonstrated to be highly similar (biosimilar) to a FDA approved biological product. Since March of 2010 there has been a flurry of activity in the US biosimilars market covering all aspects of the path to approval including a set of FDA guidances, 351(k) filings, and varying approaches to the “patent dance”. There has also been an emergence of biosimilar players from pure play biosimilar companies to large multinational pharmaceutical companies establishing divisions devoted to biosimilar development. This presentation will recap the evolution of the US Biosimilar market since the passage of the ACA and will explore the present and future global biosimilars opportunity.

Biography:

Dr. Kamali Chance is a Vice President and Head, Global Biosimilars Regulatory Strategy. She has over 25 years of work experience in the healthcare industry, including the last 17 years in regulatory affairs/regulatory strategy.Dr. Chance has extensive experience working with the FDA and EMA. She advises pharmaceutical and biotechnology companies in the development of region specific and/or global regulatory strategy for the development of biosimilar products. Dr. Chance has authored/co-authored number of articles on the development of biosimilars. She has a PhD in Nutrition/Nutritional Biochemistry, Masters of Public Health and Regulatory Affairs Certification.

Abstract:

The regulatory landscape for the development of biosimilars in the US and EU is dynamic as many of the guidances issued by European Medicines Agency (EMA) have undergone revisions and in 2015, the FDA issued number of revised guidelines for Quality and Scientific Considerations as well as updated Questions and Answers documents that lend much clarity as to FDA expectations.The thinking of the regulators both in the EU and US has evolved over the years and there is a great deal of convergence. This session is designed to provide current status of biosimilar guidelines in the US and EU. The focus will be to identify major updates in order to help sponsors navigate through the complex requirements for the regulatory approval of biosimilars in the US and EU.

Biography:

Alex Brill is the CEO of Matrix Global Advisors, LLC, an economic and public policy consulting firm in Washington, DC. Prior to founding MGA, he served as policy director and chief economist to the United States House of Representatives Committee on Ways and Means, where he worked from 2002-2007 and directed policy development and led staff-level negotiations on a variety of matters. Previously, he served at the White House Council of Economic Advisers. In addition, he is a Research Fellow at the American Enterprise Institute. He holds a BA in Economics from Tufts University and a MA in Mathematical Finance from Boston University.

Abstract:

Drug manufacturers have recently begun submitting biosimilar applications to the Food and Drug Administration (FDA), leading many to believe that a robust U.S. biosimilar industry and substantial health savings are right around the corner. In this paper, I present an empirical assessment of the viability of biosimilars in the U.S. market and caution against such optimism given biosimilars’ considerable development costs, moderate expected market share, and diminished profit margins relative to a typical biologic. Federal regulatory burdens (biosimilar naming and clinical testing requirements), statutory burdens (State laws intended to restrict biosimilar substitution could have the effect of hindering market uptake of biosimilars) and natural market risks (payment and coverage decisions by payors) all serve as potential impediments to biosimilar market uptake in the U.S. In this paper, I present the results of a break-even analysis in which I test the economic viability of biosimilars in the United States. This analysis shows that a biosimilar manufacturer would not find it worthwhile to enter the U.S. market for most average (by sales) biologics even under favorable market conditions. Under potential regulatory and market constraints that limit biosimilar market share, only the largest biologics (average annual sales greater than $1.3 billion) are expected to attract biosimilar competition. The paper concludes that adverse decisions by policy makers and effective dissuasion by biologics manufacturers not only may impede biosimilar market share, but may stifle market entry altogether for many products.

Biography:

Dr Mohan Dewan is the principal of R K Dewan &Co, with over 40 years of experience in the field of Intellectual Property Rights.Dr Dewan is a practicing advocate and jurist. He is a registered Patent & Trademark attorney. Dr Dewan has the unique distinction of being an exceptional litigator along with being an expert in patent & trademark prosecution. Having drafted and successfully prosecuted several thousand patent specifications, he has come to be acknowledged as a specialist in patent specification drafting. Dr Dewan has obtained over 5000 patents for various Indian and foreign clients in almost every sphere of technology. His firm represents over 4000 clients worldwide.

Abstract:

The talk will cover the patenting of inventions in the field of biologics in three important jurisdictions i.e. US, Europe and India and also the distinction between inventions in biologics and inventions relating to small molecule pharmaceutical compositions. Having said this several biologics patents are said to expire in the near future and after the next few years there is potential for Biosimilars to enter the market, particularly in the field of peptides, proteins, monoclonal antibodies and vaccines. Because biologic inventions deal with living cells, the conventional notions of biosimilarity cannot be applied to inventions of this type. The importance of the cell line and the process involving the use of these cell lines in new inventions relating to biologics needs to be fully understood. The next decade is likely to see patent works in the field of biologics. The patents acts throughout the world must keep pace with this development and specialist courts will be needed to understand the intricacies of this niche science.

Biography:

Jill Myers leads CMC efforts in regulatory communications in biosimilars and novel biologics at Momenta Pharmaceuticals. Previously she built an independent consulting firm with multiple operational and strategic projects. Before that she started a process development and manufacturing department at Applied Molecular Evolution and prior to that she was a program executive at and ran the Process Biochemistry group at Biogen. Dr. Myers earned her Ph.D. in Biochemistry from UCLA and was a post-doctoral fellow at Harvard Medical School and has served on multiple industry committees including past Chair of the Board of the Recovery of Biological Products Conference Series.

Abstract:

The Biologics Price Competition and Innovation Act of 2009 created an abbreviated pathway for biological products to be biosimilar or interchangeable with an FDA-licensed product in the US. The BPCI Act and subsequent guidance from both the FDA and EU regulatory authorities has catalyzed a surge in the development of biosimilars, as well as the first biosimilar approval by the FDA in 2015. A key component to any submission is the extent to which physicochemical and biological characterization data are applied to analytical similarity. This presentation will describe the challenges in obtaining data to assure characterization of both the brand product and the biosimilar being developed and how these data can be applied during process development. Lessons learned from approved complex generics will be discussed. The choice of a broad set of analytics, both physicochemical and biological, as well as the complementary and orthogonal nature of those analytics will be described. Key characteristics that define both the brand product and the biosimilar will be discussed and will include different approaches to establish equivalence criteria as well as statistical methods which may be used to evaluate the data. The challenges such as the diversity of the brand product as well as lot age will also be addressed.

Biography:

Jenny Chen is an Associate in the biotechnology and pharmaceutical groups at the intellectual property law firm Wolf Greenfield in Boston. She focuses her practice on US and foreign patent prosecution, opinion work, due diligence and counseling clients in the areas of biological, medical, and pharmaceutical sciences. She has worked on projects related to diagnosis and treatment for various diseases and disorders, vaccine technologies, drug discovery, antibiotic biosynthesis, medical implants, gene- and cell-based therapies, pharmaceutical formulations, and herb extracts. She received her PhD from Baylor College of Medicine, specializing in molecular biology and pharmacology, and her JD from Northeastern University School of Law.

Abstract:

When it comes to clearing the path for market entry of biosimilars, there are several options available before the U.S. Patent and Trademark Office (USPTO), including post-grant reviews, inter partes reviews (IPR), and ex parte reexamination. Introduced by the America Invents Act (AIA), post-grant reviews are available within nine months after issuance of a patent filed after March 16, 2013 to any party other than the patent owner. It allows patents to be challenged on essentially any patentability basis, including patentable subject matter, prior art, and enablement/written description requirements. IPRs were also introduced by the AIA as a counterpart to post-grant reviews. IPRs can be initiated immediately after issuance of a patent filed prior to March 16, 2013 or after the nine month window for filing a post-grant review in patents filed after March 16, 2013. It allows patents to be challenged only on the basis of anticipation or obviousness, and only based on printed publications. Finally, ex parte reexamination has been available since 1981 and remains available under the AIA. Through ex parte reexamination, the patent owner or a third party may lodge a request for USPTO reexamination of an already-granted patent based on patents and printed publications that they bring to the USPTO’s attention. The requester must establish that the submitted prior art establishes a substantial and new question of patentability. For some time, patent attorneys have known the advantages of challenging patents before the USPTO through the above-noted procedures, instead of or in addition to litigation. Such advantages include (i) there is no presumption of validity in the USPTO; (ii) post-grant procedures are quicker and relatively cheaper than litigation; and (iii) discovery is much more limited. As a result, these options should be carefully considered in the lead-up to market entry.

Biography:

Milind Antani is Partner in-charge of Pharma and Life Sciences Practice at the multi-skilled, research-based international law firm, Nishith Desai Associates. He represents clients in corporate, IP and regulatory matters including corporate mergers and acquisitions, investments, regulatory and transactional matters, intellectual property prosecution and litigation, joint ventures and formation of new companies. He practiced as an ENT surgeon for 14 years prior to joining Nishith Desai Associates. He has authored and co-authored many articles, publications including two books. He has been speaking regularly at various national and international forums. He has been a visiting faculty at various institutions. He has been nominated as one of the world's leading practitioners in ‘Who's Who Legal’ for Life Sciences 2013 and 2014 in the ‘Regulatory’ section as only lawyer from India. He is also the member of the Committee of Telemedicine Society of India.

Abstract:

Biologics sector in India has seen significant growth in last few years with many players entering this sector aggressively to meet the global demands. The similar biologics are regulated in India through various acts and guidelines. The Department of Biotechnology (DBT) that comes under the Ministry of Science and Technology is the main regulatory body that is responsible for approval of ‘similar biologics’ in India. DBT operates through its Review Committee on Genetic Manipulation (RCGM) and the Central Drugs Standard Control Organization that comes under the Ministry of Health and Family Welfare). Though there are regulations that govern similar biologics, there is a need to have more robust legislation that is conducive for the industry players. The talk will explain existing legal and regulatory landscape for similar biologics in India and way to navigate through the same.

Biography:

BILL SARRAILLE is a senior member of the Healthcare Practice group and a nationally-recognized lawyer in healthcare law. Mr. Sarraille concentrates on a variety of healthcare matters, including Medicare and Medicaid reimbursement, coverage and coding, pharmaceutical price reporting, issues related to the marketing and promotion of pharmaceuticals and medical devices, internal investigations, clinical research issues, Stark and Anti-Kickback Law analyses, Medicare and Medicaid audits, healthcare acquisitions and due diligence, compliance program audits, managed care matters, healthcare contracts, administrative litigation, legislative matters, coverage for new devices and services, the representation of witnesses and companies before Congressional Committees, and the defense of healthcare criminal and False Claims Act matters.

Abstract:

The Biologics Price Competition and Innovation Act (BPCIA) was signed into law on March 23, 2010 as part of the Patient Protection and Affordable Care Act (PPACA). BPCIA’s announcement of a new Food and Drug Administration (FDA) regulatory pathway for the approval of biosimilar products has created several government pricing and reimbursement policy challenges. The proposed presentation will discuss the coverage, reimbursement, and related strategy questions from the perspective of both an experienced reimbursement counsel and a reference product manufacturer. Reimbursement issues discussed during this joint presentation will include the impact of Average Sales Price (ASP) and non-ASP reimbursement systems and the crucial distinction between the biosimilar and interchangeability standards. The potential for National Coverage Determinations, Local Coverage Determinations, and innovation reimbursement reforms will also be discussed, as will value-based contracting approaches.

Biography:

Ron Lanton is President of True North Political Solutions, LLC. Mr. Lanton has over 20 combined years of government affairs and legal experience. This includes activities on the municipal, state, and federal levels of government. Most recently he worked for a pharmaceutical wholesaler, where he created and oversaw the company’s Government Affairs Department, served as their exclusive lobbyist and also advocated for the company’s various healthcare customers. Prior to that Ron worked at a government affairs consulting firm in Arlington, VA where he worked on healthcare, energy, commerce and transportation issues. He has also clerked for a federal magistrate, was appointed as a municipal commissioner on environmental issues and has consulted Wall Street firms on financial issues. He has been a featured industry speaker on issues such as pharmaceutical safety and healthcare cost containment. Mr. Lanton has a Juris Doctor from The Ohio State University Moritz College of Law and a Bachelor of Arts from Miami University of Ohio. He is also a 40 under 40 award recipient. He has been admitted to practice law in New York, Illinois and the District of Columbia.

Abstract:

Biography:

Timothy J Shea is Director of the Biotechnology/Chemical Practice Group at Sterne, Kessler, Goldstein & Fox P.L.L.C., where he has practiced for 20 years. He specializes in advising biopharmaceutical companies and research institutions on complex legal issues relating to the protection, enforcement and transfer of their intellectual property. He practices primarily in the fields of immunology, molecular biology, genetic and medical diagnostics, biotherapeutics, and drug delivery. He has extensive experience advising clients on the creation and management of strategic patent portfolios, freedom-to-operate and patentability issues, complex prosecution strategies, validity and infringement issues, and due diligence investigations in connection with acquisitions and investments. He has published and spoken extensively on IP issues related to therapeutic antibodies and biosimilars. In addition, a significant portion of his practice involves counseling emerging companies on strategies for creating, protecting and leveraging their IP assets to grow their businesses. He received his BS in Biology from Washington and Lee University in 1988 and his JD from Chicago-Kent College of Law (with High Honors, Order of the Coif) in 1995. He served as a judicial extern to the Honorable Rebecca Pallmeyer of the U.S. District Court for the Northern District of Illinois. Prior to attending law school, he worked for several years in the biotech industry in the areas of genetic diagnostics.

Abstract:

The Biosimilar Era has arrived in the US! The past few months have seen the first ever FDA approval of a biologic deemed biosimilar to a previously approved biologic, the first cases of the Federal Circuit addressing the scope and interpretation of the US biosimilars statute, and the first patent battles between biosimilar challengers and brand companies. Against this backdrop the broad contours of the US biosimilar landscape is taking shape, and the early strategies of both brand companies and biosimilar developers are being put to the test. This session will highlight the key legal developments in the US biosimilar industry over the past year with particular focus on the patent issues. The session will also outline the strategies being implemented by biosimilar developers to gain an advantages in the critical patent disputes that are central to any biosimilar launch, as well as the strategies of brand companies in attempting hold off biosimilar competition for as long as possible. We will also discuss which of these strategies are working, and whether they are applicable only to this "first wave" of biosimilar development, or whether they will have long term applicability.

Biography:

Marcel Bassil has done major in Biochemistry at the Université de Montreal, Canada, He continued his studies (MSc and PhD) in physiology at the Université de Montreal as well as he conducted a clinical research associate program. His academic background and his professional journey in Biotechnology industries in Montreal allowed him to acquire useful and tremendous experience in cell culture and in many types of protein expression platforms with their respective bioprocesses. In 2010, he moved to Lebanon to join the academic team of the Faculty of Health Sciences at the University of Balamand as an Assistant-Professor. Later on, he joined Benta Pharma Industries as the Associate Director Biotech in charge of developing the Biotech facility and the production/characterization of several Biotech products.

Abstract:

Biosimilars are those biologics which are developed after patent expiration of innovator biopharmaceuticals. They are known as similar biologics, follow-on biologics, subsequent-entry biologics, and second-entry or off-patent biotechnology in different countries. Furthermore, they require separate marketing approval since they are not generic versions of biologics which is new in the MENA region. They establish a group of new molecules owing to a number of heterogeneities as compared to the reference innovator biologics. Moreover, this presentation will also discusses the major challenges involved in the manufacturing of Biosimilars and the required documentation on quality, safety and efficacy including comparability exercises as well as the single most important factors affecting the Biomanufacturing capacity in the region. Moreover, Biologics are one of the most important growth drivers for global pharmaceutical market but several challenges impede the way of growth of Biosimilars in the emerging markets. However, we will also take into consideration some trends that promise the bright future of Biosimilars in the MENA region. Finally, we will throw light on the regulatory guidelines of different countries especially in the MENA region and their impacts on the development of Biosimilars.

Biography:

Gary Cupit, PharmD is currently the CEO of MRC Associates, a strategy and consulting firm for private biopharmaceutical startups. Previously, he was CEO of a sleep medicine company, Somnus Therapeutics. He held similar positions at Enzo Therapeutics, publicly traded, and Sapphire Therapeutics, a private biopharmaceutical company. Prior to Sapphire, Gary was a Vice President, Global Business Development and Licensing, Novartis. Before Novartis, Gary held senior positions at Knoll Pharmaceutical as well as The Medicines Company of Cambridge, MA. He entered the industry with SmithKline Beecham Pharmaceuticals in a number of capacities in field sales, product management, and new product development where he led the launch of four products. He has more than 28 years of pharmaceutical and healthcare industry experience in addition to 14 years in university-based academics.

Abstract:

• Understand the type of FDA approval (abbreviated versus full stop BLA) impacting reimbursement • Understand how labeling will mandate the promotion of biosimilars • Understanding the differing perspectives on physician and patient perceptions of interchangeability • Understanding the challenges of pharmacovigilance and the use of Big Data to monitor safety • Understand how stakeholders at the states level can determine switching or uptake based on interpreting best practices for prescriber and patient communication • Understand lessons from the EU and their impact on the US utilization of biosimilars

Biography:

Denise M Kettelberger received her PhD from the University of Maryland School of Medicine, completed Postdoctoral studies at Baylor College of Medicine with Bert O’Malley, and moved into patent law as DNA products advanced, and joined Pravel, Gambrell as a patent agent. A former Merchant & Gould partner, she recently joined Sunstein Kann Murphy & Timbers LLP, a premier patent firm in Boston. Active in the American Intellectual Property Law Association, she is a frequent speaker on biotechnology patent issues.

Abstract:

SANDOZ filed an aBLA seeking the first approval of a U.S. biosimilar, a filgrastim product. AMGEN’s Neupogen® was the reference product. U.S. biosimilar companies closely followed progress of the first product to use the U.S. Biosimilar law (Biologics Price Control and Innovation Act. Surprisingly, SANDOZ did not proceed through the multi-step aBLA pathway of the BPCIA’s patent dispute resolution system, choosing instead to notify AMGEN of the aBLA filing, expected approval date, and intended launch. Instead of the BCPIA’s elaborate process for confidential information exchange and resolution of patent disputes, SANDOZ opted out of the process and did not provide AMGEN with its aBLA application. Because SANDOZ failed to provide its application and manufacturing process, AMGEN was entitled to sue SANDOZ for patent infringement under non-compliance sanctions provided in BCPIA steps. AMGEN sued SANDOZ for unfair competition; conversion; and infringement of AMGEN’s patents. The, District Court dismissed unfair competition and conversion clams due to its interpretation of BPCIA, finding SANDOZ did not act unlawfully. On appeal to the Federal Circuit, the BCPIA was again interpreted in Amgen v. Sandoz, decided July 21, 2015. The Court reviewed SANDOZ’s failure to comply with the first step: applicant “shall provide” its application and manufacturing process; 180 day notice of intent to market; and whether BCPIA steps are optional or mandatory. The Court found the BCPIA steps to be required when the aBLA path is chosen, but not when the applicant chooses not to use the BCPIA. Federal Circuit en banc review was requested.

Biography:

Peter Pitts is President and co-founder of the Center for Medicine in the Public Interest. Prior to founding CMPI, Pitts was a Senior Fellow for healthcare studies at the Pacific Research Institute. He has served as an adjunct professor at Indiana University’s School of Public and Environmental Affairs and Butler University.

Abstract:

Biologic drugs are extremely complex medicines. As such, unlike traditional chemical drugs, it is all but impossible for biosimilar drugs to be identical to the approved biologic they are meant to resemble. The naming of these drugs is an important patient safety issue because the INN is used in the surveillance of drugs on the market to quickly identify which drug may be responsible for an adverse event. If biosimilars use the same INN as their reference biologics, it would be more difficult for regulators to recognize exactly which product is causing a problem. As the Food and Drug Administration (FDA) finalizes its naming policy, the agency must learn from real-world global biosimilar experiences to understand how different a biosimilar can be from the original biologic. These differences will make it resoundingly clear that FDA must finalize its policy in favor of unique names. Case in point: A poster presentation at the European Crohn’s and Colitis Organization titled “Biosimilar but not the same” offered timely and real-world data on the differences between originator biologics and their biosimilars. The study examined the clinical impact of both the innovator product (Remicade) and its European Medicines Agency-approved biosimilar (Inflectra). The findings show the rates of surgery in Remicade and Inflectra groups were significantly different. Specifically, 80 percent of the Inflectra group required hospital readmission versus 5 percent of the Remicade group. The conclusion of the study is not ambiguous: “Our results suggest that biosimilars may not be as efficacious as the reference medicine.” Biosimilar approvals are based on similarity — but in the real world, success will be measured by patient outcomes. Biosimilars are here to stay and it is not surprising that physicians will have more confidence in them if they know exactly what drug they are prescribing. Distinguishable names provide that transparency and a necessary safeguard to maximize safety and credibility. It’s really that simple.

Biography:

Dr. Robert E. Zoubek is an expert in biosimilar development, manufacturing, and analytics as well as regulatory affairs. Until he joined European′s leading Consultancy Company GRC&S, he worked in several positions at Formycon (Germany) and GlycoForm (UK). As Director Scientific Affairs Robert led Formycon′s drug product development and analytical services. A focus of Formycon was its Biosimilar portfolio. In other roles he was responsible on the CMC activities of the Novel Biologics programs and led the GMP-certified Quality Control laboratories. Robert earned a PhD from the University of Erlangen-Nuremberg for his research on wound-healing peptides and he was awarded MBA from the University of Manchester. He also holds a MSc from the University of Munich. Today Robert is involved in a number of projects throughout different development stages, from early development up to marketing authorization and post-approval activities. His profound CMC knowledge and development experience make him a valuable partner for the success of projects.

Abstract:

- Rational for the analytical toolbox - Sources of information to justify your analytical strategy - The way forward: The right strategy to prove biosimilarity - Minor differences:How similar is similar enough? With increasing experience with Biosimilars also the regulator′s perspective has further evolved andn is based on a fresh scientific principle. Robert will provide the latest insights from interactions with regulators worldwide. He will present the current thinking regarding the analytical requirements of both, EMA and FDA. He will highlight the key requirements of today′s Biosimilars development and exemplify different strategies to obtain marketing approval.

Biography:

Dr. Robert E. Zoubek is an expert in biosimilar development, manufacturing, and analytics as well as regulatory affairs. Until he joined European′s leading Consultancy Company GRC&S, he worked in several positions at Formycon (Germany) and GlycoForm (UK). As Director Scientific Affairs Robert led Formycon′s drug product development and analytical services. A focus of Formycon was its Biosimilar portfolio. In other roles he was responsible on the CMC activities of the Novel Biologics programs and led the GMP-certified Quality Control laboratories. Robert earned a PhD from the University of Erlangen-Nuremberg for his research on wound-healing peptides and he was awarded MBA from the University of Manchester. He also holds a MSc from the University of Munich. Today Robert is involved in a number of projects throughout different development stages, from early development up to marketing authorization and post-approval activities. His profound CMC knowledge and development experience make him a valuable partner for the success of projects

Abstract:

The Five requirements to be fulfilled - Different strategies exemplified - How you get your strategy validated - Why companies fail European regulators have been the first to develop Biosimilar Guidance and approve in an abbreviated route products which are highly similar compared to their originator. However, with increasing experience with Biosimilars also the regulator′s perspective has further evolved enabling sponsors more flexibility in their development. Robert will provide insights into the interaction with regulators and how you should seek for validation of your development strategy. He will highlight the key requirements of today′s Biosimilars development and exemplify different strategies to obtain marketing approval in Europe.

Biography:

George Yu is the owner of the Law Offices of George C. Yu. Mr. Yu focuses his practice on intellectual property, with an emphasis on patent infringement litigation and counseling. Mr. Yu has extensive experience advising clients on matters relating to the development of biosimilars and biologics. Prior to opening his own practice, Mr. Yu was Vice President of Litigation and IP at Ariosa Diagnostics and Assistant General Counsel, Litigation at Affymetrix. Mr. Yu received his bachelor’s degree from M.I.T., his masters in biochemistry from Stanford, and his law degree from U.C.L.A.

Abstract:

The biosimilars market is expected to range from $2-20 billion or more by 2020. Yet, six years since the enactment of the Biologics Price Competition and Innovation Act (BPCIA), we are only on the cusp of the launch of the first biosimilar in the U.S., Sandoz’s Zarxio™ (filgrastim). However, the development of Zarxio™ has come with significant litigation already, particularly the fractured decision of the Court of Appeals for the Federal Circuit in Amgen v. Sandoz. Even Judge Lourie, author of the majority opinion, borrowed Winston Churchill’s phrase to describe the BPCIA: “a riddle wrapped in a mystery inside an enigma.” The CAFC’s decision in Amgen that the biosimilar developer does not have to disclose its application to the reference biologic sponsor may render the BPCIA a nullity and lead to further litigation regarding how the participates should (must?) engage in the patent dance. We will address the implication of the Amgen decision, as well as the earlier Sandoz v. Amgen litigation relating to Enbrel® (etarnercept), we will examine the patent exchange process—the so called, “patent dance”—and look to some other legal avenues where stakeholders have tried to promote or delay the entry of biosimilars to the market.

Biography:

Gregory J Glover is a registered patent attorney and non-practicing physician with the Pharmaceutical Law Group. He has experience in food and drug law, intellectual property law, and technology licensing. He has particular expertise in the patent and non-patent market exclusivity provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (“the Hatch-Waxman Act”). He received an AB, magna cum laude, in Biochemical Sciences from Harvard College in 1981 and a JD, cum laude, from Harvard Law School in 1986. Following law school, he completed medical school at Duke University in 1987, and served as an intern in Internal Medicine at New England Deaconess Hospital in Boston.

Abstract:

This presentation will describe the market exclusivity provisions that apply to biosimilars in the United States and the associated commercial implications of those provisions. The presentation will include a brief review of the market exclusivity provisions for small molecules (the Hatch-Waxman Act) and a comparison between the legal and regulatory structure for generic drugs and biosimilars.

Biography:

Patrick Lucy is the Chief Business Officer of Pfenex Inc. (NYSE: PFNX). He was a member of the team that founded Pfenex within The Dow Chemical Company. He has been in the biotechnology industry for over 22 years holding technical, operational and commercial roles throughout his career. He previously worked at The Dow Chemical Company, Collaborative BioAlliance, Lonza Biologics, Celltech Biologics and Repligen Corporation.

Abstract:

The United States biosimilars market was established based upon The Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act was formally passed under the Patient Protection and Affordable Care Act (ACA), and signed into law by President Barack Obama on March 23, 2010. The BPCI Act was an amendment to the Public Health Service Act (PHS Act) which created an abbreviated approval pathway known as the 351(k) pathway for biological products that are demonstrated to be highly similar (biosimilar) to a FDA approved biological product. Since March of 2010 there has been a flurry of activity in the US biosimilars market covering all aspects of the path to approval including a set of FDA guidances, 351(k) filings, and varying approaches to the “patent dance”. There has also been an emergence of biosimilar players from pure play biosimilar companies to large multinational pharmaceutical companies establishing divisions devoted to biosimilar development. This presentation will recap the evolution of the US Biosimilar market since the passage of the ACA and will explore the present and future global biosimilars opportunity.

Biography:

Patrick Lucy is the Chief Business Officer of Pfenex Inc. (NYSE: PFNX). He was a member of the team that founded Pfenex within The Dow Chemical Company. He has been in the biotechnology industry for over 22 years holding technical, operational and commercial roles throughout his career. He previously worked at The Dow Chemical Company, Collaborative BioAlliance, Lonza Biologics, Celltech Biologics and Repligen Corporation.

Abstract:

The United States biosimilars market was established based upon The Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act was formally passed under the Patient Protection and Affordable Care Act (ACA), and signed into law by President Barack Obama on March 23, 2010. The BPCI Act was an amendment to the Public Health Service Act (PHS Act) which created an abbreviated approval pathway known as the 351(k) pathway for biological products that are demonstrated to be highly similar (biosimilar) to a FDA approved biological product. Since March of 2010 there has been a flurry of activity in the US biosimilars market covering all aspects of the path to approval including a set of FDA guidances, 351(k) filings, and varying approaches to the “patent dance”. There has also been an emergence of biosimilar players from pure play biosimilar companies to large multinational pharmaceutical companies establishing divisions devoted to biosimilar development. This presentation will recap the evolution of the US Biosimilar market since the passage of the ACA and will explore the present and future global biosimilars opportunity.

Biography:

Christopher J Leintz, DBe, MPH, currently is the Director and Emerging Markets Strategy Lead for biosimilars at Pfizer. He received his Doctorate in Bioethics from Loyola University Chicago and his MPH from the University of Illinois at Chicago. He developed a keen interest in human rights and healthcare access from his time serving in the United States Peace Corps. He continues to pursue these interests in his current role. He has worked in the pharmaceutical industry since 2001, focusing primarily on regulatory drug development and clinical research.

Abstract:

Emerging Markets are taking on a greater level of prominence in the pharmaceutical industry. They offer true growth areas in a world where developed markets face constant pricing pressures. As a result, the level of activities in emerging markets is growing exponentially. Nowhere is this more visible than in the arena of biosimilars. Emerging markets offer the alluring promise of willing clinical trial participants and cheaper operational costs for running studies. They also tempt industry with market expansion to fuel the growth the biotech industry so keenly desires. While the benefits of bringing research and eventual MAA filings to emerging markets does have a clearly visible upside, caution must also be exercised. Whether its localization, indemnification, or cultural considerations, emerging markets must be approached in an appropriate way; a way in which industry and patients can maximize the potential of this new pharmaceutical frontier.

Biography:

Dipti Gulati completed her PhD at the age of 25 years from Allahabad University and Postdoctoral studies from Indian Institute of Sciences, India and Albert Einstein College of Medicine on Protein-Carbohydrate Interactions, USA. Currently, she is the President of PJI Biotech, a Consulting Services Organization. Previously, she held various Management Positions at Amgen, BioMerieux, Emergent Bio Solutions, Diosynth and SmithKline Beecham Pharmaceuticals. She has published more than 25 papers in reputed journals and is serving as a committee member for several interest groups of PDA.

Abstract:

A biosimilar product is a biological product that is approved based on showing that it is highly similar to an already approved biological product, known as the reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety, efficacy and quality from the reference product. A biosimilar product can only be approved by the FDA if it has the same mechanism of action, route of administration, dosage form and strength as the reference product. Omnitrope, (Somatropin) was the first product approved in the EU as a biosimilar in 2006. To date, the EMA has approved 21 biosimilar within the product classes of human growth hormone, granulocyte colony-stimulating factor, erythropoiesis stimulating agent, insulin and tumor necrosis factor (TNF)-inhibitor, for use in Europe. Two biosimilar approvals have been withdrawn; one for Filgrastim in April 2011 and one for Somatropin in May 2012, leaving a total of 19 biosimilar products approved for use in Europe. On March 6, 2015, US FDA approved Zarxio, the first biosimilar product approved in United States. Sandoz Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (Filgrastim), which was originally licensed in 1991. Biosimilar’s are arelatively new emerging market. Two major growth drivers for the Biosimilar Market are Healthcare cost savings and Biologic patent expiration. The biologic products tend to have a very high price (about 20 times more than small molecule drug) and biosimilar are about a third less costly than the Originator drug and can potentially provide increased access to biologic therapies that treat life threatening cancers, anemia and immunological disease. Additionally, through 2015, about 45 Biologic drugsworth more than $60 billion in Global sales will lose Patent protection, presenting a major opportunity for the growth of the Biosimilar Market.

Biography:

Subir roy is currently leading teams to handle both marketing and medical affairs for Immunology division at Zydus Cadilla, Ahmedabad. He had worked as Senior Medical Advisor or Immunology at Bristol Myers Squibb since past 2.5 years. He was previously working as Manager, Medical Services at Glenmark Pharmaceuticals for global operations in countries like South Africa, Mauritius, Egypt, Kenya, Tanzania, Yemen, Sudan, Dubai etc., directly reporting to the Vice President.Started with MSD as HSA (Vaccines) for west zone. Specialties: Immunology, KOL management, marketing, project management, teaching, speaking in CMEs, data mining, clinical trials etc.

Abstract:

Recent data tend to suggest that immune system in Rheumatoid Arthritis (RA) might be in a state of decline and this weakened state results in demise of the tolerance mechanisms. Expansion of CD28-ve T cells is characteristically seen in RA; infact it precedes development of RA. Rising count of CD28-ve T Cells is a hallmark of immunosenecence. With successful management of RA, CD28-ve T cells count falls. Not many years ago achieving remission in rheumatoid arthritis was difficult due to lack of effective treatment. With the advent of biologics, remission is very much within reach. But biologics are expensive. And not all patients respond adequately to biologics. Hence it will be useful if we have a marker which predicts response to any disease modifying anti- rheumatic drug (DMARD), whether conventional or biologic. Newer biomarkers are constantly being looked at and CD28-ve T cells is one of them.

Biography:

Sunit Maity is highly-motivated, energetic and pro-active individual with around 6 years of Managerial experience in both upstream and downstream Development for biosimilars including recombinant protein and monoclonal antibodies, Vector development, Cell line Characterization and authentication, Assay development in well established Biotechnology industry in India. Have knowledge about Pre-clinical assay also. Has a profound knowledge and managerial experience regarding use of different model systems in drug development in Europe. He participated in a large-scale reverse genetic screen in a biotechnology industry in Germany using morpholino antisense technology in zebrafish to identify therapeutically relevant drug targets specific to tumor biology.

Abstract:

The hallmark of diabetes mellitus is hyperglycaemia resulting from impaired carbohydrate metabolism. Type 2 diabetes has a complex pathophysiology characterised by deficient insulin activity arising from decreased insulin secretion secondary to beta-cell failure, compromised insulin action in peripheral target tissues (insulin resistance), or a combination of the two abnormalities. Type 2 diabetes accounts for approximately 85% to 95% of diabetes cases in developed regions like the European Union. Age and weight are established risk factors for type 2 diabetes. The majority of patients with type 2 diabetes are overweight or obese. Byetta (Exenatide, Exendin-4) contains exenatide which is an incretin mimetic. Endogenous incretins, such as glucagon like peptide 1 (GLP-1), facilitate insulin secretion following their release from the gut into the circulation in response to food intake. Exenatide is licensed for the treatment of type 2 diabetes mellitus in combination with metformin and/or a sulfonylurea, or pioglitazone in patients who have not achieved adequate glycaemic control with these drugs alone or in combination. The increasing expenditures and cost of treatment of Byetta® highlight the absence of lower-cost generic substitutes for this drug usually referred to as biosimilars or follow-on-biologics. Biosimilars or follow-on biologics are protein-based therapeutic products that are near-identical (similar), comparable and equivalent to the branded therapeutic product. As, there is no single biosimilar developed or approved for Byetta®, we have developed the biosimilar of it using microbial route thus lowering the COGS significantly. The cell line development, process and analytical similarity data will be presented.

Biography:

Known as a pioneer of the stone-washed blue jean industry, a member of the Iowa Hawkeye NCAA Championship wrestling teams, Mark Emalfarb, CEO of Dyadic (OTCQX:DYAI) founded Dyadic in 1979. Since then, Mr. Emalfarb has successfully led and managed the evolution of Dyadic from its origins in the stone-washing business to the discovery, development, manufacturing and commercialization of specialty enzymes and other proteins, including human vaccines derived from DNA which are used in various applications to help feed, fuel and heal humankind. Mr. Emalfarb is an inventor of over 25 U.S. and foreign biotechnology patents, and is the architect behind the creation and development of Dyadic’s revolutionary patented C1 Protein Expression System,based on a recombinant Myceliopthora thermophile fungus. Mr. Emalfarb is also responsible for the formation of several strategic research, development, manufacturing and marketing relationships with U.S. and European global partners such as Sanofi Pasteur (human vaccines), BASF (food, feed and other enzymes),Abengoa (renewable non-food biofuels), and others.

Abstract:

Expression systems encompass the technologies — biological materials and associated know-how — needed to genetically modify organisms for the manufacture of recombinant proteins and other products. For Biosimilars - the future of affordable healthcare – there are many novel expression systems that offer significant improvements over the most common production hosts today (mammalian, bacterial and yeast). The new technologies are aiming to reduce theinvestments and the production and development costs in order to enable the rapid delivery of protein products into clinical development and commercialization. Biosimilar manufacturers need to develop these new technologies in order to increase expression-system yields to enable use of smaller bioreactors, reduce downstream freezer (storage) capacity and lower cost. In addition, those new technologies will also be ready to challenge the new development of personalized medicinespace. Dyadic’s Patented C1 Expression System is based on its recombinant host production organism Myceliopthorathermophila, a filamentous fungus that has been nicknamed C1. The recombinant C1 organism has demonstrated expression of much higherlevels of secreted proteins when compared to the best commercial yeast host production organisms. The C1 expression system is capable of expressing extremely high levels of secreted protein, upwards of 100 g/l, with 80% purity (or ~ 80 g/l) of a targeted heterologous protein of interest. By comparison the highest levels reported for yeast expression systems such as Pichia pastoris and Saccharomyces cerevisiae are reaching about 25% of the C1 expression levels. Dyadic is currently developing the C1 expression system to meet the Biologics and Biosimilar requirements, since this technologyhas several unique advantages over the current production host systems as:  No royalty stacking as our versatile genetic tools that enable efficient genetic manipulation and rapid selection procedure are solely owned by Dyadic.  C1’s very high productivity is expected to lead to dramatic reductions in bothfermentation and downstreamCapex, as well asOpex.  Efficient protein expression of high value proteins that include heterologous genetic sources.  The expressed protein can be secreted from the cells to the media at very high concentrations and purity, which significantly reduces the purification efficiency and cost, as well as the associated downstream freezer capacity.  C1 is proven in commercial-scale production that offers flexibility in manufacturing capacity from <1m3 up to 500 m3 fermenters.  C1 proteins are not over-glycosylated, as found in yeast, and have a structure that make the humanization of the glycosylation pattern of mammalian protein feasible.  Acquired Generally Regarded As Safe (“GRAS”) certificate recognized by the FDA. Our approach in further developing the commercially proven C1 technology for the production of therapeutic proteins in general and for Biosimilars in particular will be presented.

Biography:

Vivek K Morya has completed his PhD at the age of 29 years from DDU Gorakhpur University, Gorakhpur, India and postdoctoral studies from Inha University, Department of Biological engineering. He is an Assistant Professor in the Department of Bioengineering, at Inha University, Incheon, South Korea. He has, published more than 25 papers in reputed journals, 05 Patents, 28 Microbial Accession, and four book chapters, and has been serving as editorial board member of several journal of repute.

Abstract:

The expiring patents related to drug/pharmaceuticals and advancements in Recombinant DNA Technology (RDT) empower the mid/small-scale industries to produce pharmaceutical proteins at a large scale. These recombinant proteins are mainly expressed in E.coli, as the inclusion body. This inclusion bodies is hydrophobic and denatured lump of protein, and to recover an active protein, theoretically two steps are required, first solubilization and second refolding to achieve active protein configuration. However, most of the protein fails to achieve the 100% refolding, a common problem with heterologous protein expressed in a bacterial system. Generally, industrially purified proteins from inclusion bodies are poorly folded in respect to total protein content of purified sample. Several researchers have been carried to enhance the refolding efficacy but still striving. Among those attempted methods an Ionic Liquid (ILs) supplemented refolding process has been gained a huge attention in last decade. The ILs is molten salt (below 100oC) and regarded as green solvent for various processes. The application of ILs in protein refolding is relatively new and still in developmental phase. This present lecture is focused on application, mechanism, and experimental results with ILs based refolding buffer. In this study, Transforming growth factor beta 3 (TGF-β3) derived from E. coli host was used as refolding model protein. Refolded TGF-β3 was qualitatively analyzed via SDS-PAGE, HPLC and Fluorescence in order to calculate the refolding efficiency. The results in the present study, showed an elevated recovery of refolded protein by ILs augmented buffer, in comparison to the conventional method.

Biography:

Ines Fradi, pharmacist graduated from Faculty of Pharmacy, Monastir University. She fulfilled a specialization in hospital pharmacy in René Descartes University, Paris, France. She completed her PhD in pharmaceutical and biomedical sciences Liege University (Belgium) and Monastir University (Tunisia). She started her carrieer as hospital pharmacist in Charles Nicolle Hospital and as assistant Pofessor in analytical chemistry in the Faculty of Pharmacy of Pharmacy. She worked as assessor of Marketing Authorisation Applications in the tunisian National Laboratory of Drug Control. Actually, she is Associate Professor, Director of the Unit of the Pharmacy and Medicines, Ministry of Health, Tunisia.

Abstract:

This work deals with the tunisian experience in the redaction of guidelines on biosimilars registration and the main encountered problems. Our project started in April 2015 and we aim to accomplish the first draft before 2016. For this purpose, we established a working group composed of representatives of the competent authorities (responsibles of drug registration, quality assessment, clinical trials and pharmacovigilance) and experts in pharmacology, in analytical chemistry and in biotechnology. Delegates of the syndicate of local manufacturers (CNIP) and the tunisian syndicate of research and developement laboratories, clinical investigators and representatives of CRO biosimilar development were also involved in order to taketheir perspectives into account. Guidelines from other countries were also benchmarked. The working group was then splitted into 3 taskforces working on the quality, preclinical and clinical guidelines . In some sections, most of the guidelines are in a complete concordance. In others, many disparities were highlighted ; especially regarding interchangeability and clinical trials for some biosimilar classes. Even though the decision was made to refer to the existing guidelines in each part, many questions remained unanswered like the specific case of biosimilars manufactured in Tunisia after a technology transfer. Many other issues we were confronted to, such as the choice of the reference product when it is not registered in Tunisia and there is no access to its pharmaceutical data to assess its quality comparability.

Biography:

Abdel Halim Harrath has completed his PhD in 2005 from the University of Tunis El-Manar, Tunis, Tunisia. He is actually an Associate Professor at King Saud University, Riyadh. He has published more than 30 papers in reputed journals and is serving as an Editor-In-Chief of the Journal “Advances in reproductive Sciences”.

Abstract:

Gastric ulcers are part of a chronic relapsing disease that is well known to be a polyaetiologic chronic disease (Suleyman et al., 2001). Although many classic drugs are available to treat gastric ulcer, herbal medicines have triumphed as a diverse popular therapy and are emerging as an alternative to the available synthetic drugs (Ubaka et al., 2010). The aim of this study was to evaluate the ulceroprotective of essential oil extracted from the leaves of Juniperus. phoenicea (EOJp) against HCl/ethanol-induced ulcers in rats. The in vivo pre-treatment with EOJp at oral doses of 50, 75 and 100 mg/kg body weight has potent anti-ulcer activity, which justifies the ethnomedical claims about its significant gastroprotective effect. In fact, the pre-treatment with EOJp significantly decreased the malondialdehyde (MDA) content and increased the activities of superoxide dismutase (SOD), catalase (CAT) and glutathione peroxidase (GPx). This effect may be related to an increase in the gastric mucosal defence mechanisms and the results of our study revealed histopathological maintaining of the integrity of the mucosa. As a result, the protective effect of the essential oil and its low toxicity requires further study to elucidate the mechanism of action and isolate the active principles. References Ubaka MC, Ukwe VC, Okoye CT, Adibe OM. Investigation into the antiulcer activity of aqueous extract of Aspilla africana. Asian. J. Medic. Sci., 2, 40–43 (2010). Suleyman H, Demirezer LO, Buyukokuroglu ME. Antiulcerogenic effect of Hippophae rhamnoides L. Phytother. Res., 625–627 (2001).

Biography:

Mr. Ronald A. Rader has been President of his own publishing/consulting company, the Biotechnology Information Institute, since late 1990. Mr. Rader has a B.S. in Microbiology, Master sin Library Science, and over 30 years experience as a pharmaceutical and biotechnology information specialist, author, publisher and consultant. He is a world-class expert in biotechnology and pharmaceutical information, competitive intelligence, technology and market assessments, and information resources development; and concerning biopharmaceutical products and bioprocessing. Mr. Rader is best known as the author and publisher of BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets (biopharma.com), the only information resource specializing in biopharmaceuticals. He has also author and publisher of the Biosimilars/Biobetters Pipeline Database (biosimilarspipeline.com). For 15 years, from 1988-200, Mr. Rader was the author and publisher of the Antiviral Agents Bulletin, the only periodical specializing in antiviral and HIV drug and vaccine development. Prior his own company he served as a chemical and biomedical information specialist with companies including the Gillette, MITRE Corp. and Computer Sciences Corp.

Abstract:

The major factors that will most affect the evolution of the biosimilar markets, particularly, in the U.S. are the development pipeline and product nomenclature. There are more products, players and will be more competitionthan commonlypresumed. As reported in the BIOPHARMA : Biosimilars/Biobetters Pipeline Database, there are now nearly 700 biosimilars and 500 biobetters in development worldwide. The market will be more like generic drugs, with many, often 10 or more, biosimilars competing with reference products and each other (along with biobetters and other new me-too products). The U.S. market will be chaotic, with many players having different goals and approaches to competing in the marketplace. The nomenclature/names to be applied to biosimilars will be the primary driver shaping their market, particularly marketing, in the U.S. The names used will control underlying perceptions of these products – whether biosimilars are each unique high-tech biopharmaceuticals or are rather generic, all much the same. The official FDA-designated non-proprietary product name to be used in marketing and labeling will determine U.S. biosimilars marketing. Generic-type names indicate products are the same and reduce or even eliminate the need for marketing, as with most generic drugs. More unique names indicate products are each different, not comparable, and require biosimilars be proactively marketed, much like innovator products. The impact of ongoing nomenclature activities by the FDA and WHO/UN, with its INN nomenclature and proposed worldwide Biological Qualifier (BQ) manufacturing site identifiers, will be discussed.

Biography:

Schauer earned a Bachelor of Science in Biochemistry and Biology and his PhD in Anaerobic Microbiology from the Virginia Polytechnic Institute, Blacksburg. Neil Schauer, PhD joins Hospira as Senior Director, Biologics Process Development. Schauer is a versatile leader and scientist with a solid background in managing large teams in the identification and development of disruptive new technologies” noted Tom Callaway, MD, Founder and President of Life Science Partner. “With his global knowledge and reach, he will serve Hospira well in its mission to become a global leader in providing biosimilar versions of the world’s most critical biological drugs.”

Abstract:

Avaxia Biologics is a clinical-stage biopharmaceutical company developing gut-targeted biobetter therapeutics. TNF is a clinically validated target in gut inflammation. Discussion will center on Avaxia’s orally-delivered, minimally absorbed anti-TNF biologic drug that acts locally in the GI tract. In contrast to first generation systemically delivered anti-TNFs, AVX-470 has low systemic exposure for greater safety, higher local concentration to drive efficacy, and the convenience of oral administration.

Biography:

Sarfaraz K. Niazi, Ph.D., a leading authority on today’s biologic drug industry. Founder and Chairman of TheraProteins (TPI), a pure play biosimilar company located in Chicago, he is leveraging his diverse background and experiences to revolutionize the way biologics are made with the goal of enablinggreater access to high quality, life-changing biosimilars. Niazi began his career in pharma at the University of Illinois, College of Pharmacy where he was a tenured professor before entering industry at Abbott Laboratories as Director of Technical Affairs in its international Division. Throughout his experiences, he witnessed a global disparity that fueled his passion for making high quality biologics affordable and accessible to people in need. He departed Abbott as a Volwiler Fellow to pursue that goal, first through consulting and soon thereafter through the founding of TPI.

Abstract:

Competition in the small molecule market is clearly divided into two categories, brand and generic companies. Of course, some brand companies have generic businesses and some traditional generic companies such as Teva have launched their own brand products. But for the most part, the small molecule market is comprised of brand and generic players. With the biosimilars market, we’re seeing a competitive landscape that goes beyond the traditional brand/generic paradigm. Traditional brand companies such as Pfizer, Amgen and Merck are developing biosimilars, as are major generic companies such as Sandoz, Hospira and Apotex. But all these companies have business in areas outside their biosimilars unit as well, be it in novel drug development or in generic manufacturing. Pure Play biosimilar companies have a sole focus: developing biosimilars. Since these companies did not exist prior to the creation of the biosimilars market, they face many challenges and opportunities that other established competitors are without, ranging from financing to commercilization. This presentation will explore both the risk and benefit associated with competiting in the biosimilars market as a pure play company, and provide insight into how these risks and benefits differ from those of an established generic or brand company.

Biography:

Abstract:

The need to characterize glycosylated biologics in terms of the compositions and specific potencies of their underlying molecular species was recognized nearly 30 years ago when the first biologics entered clinics. However, little progress in improving the characterization of glycosylated biologics has been made. It continues to be widely presumed that manufactured heterogeneous biologics can be adequately characterized by qualitative descriptions of product quality and sample average measurements of biological activity. When quantitative activity-composition studies are performed, empirical or black box methods are used, often leading to more questions than answers. Recently Zhan and Chung reported on a molecular mechanistic mathematical framework that was based on classical ligand-receptor biochemistry and was developed specifically to analyze the effects that different afucosylated IgG1 forms have on Fc-Fc gamma RIIIa binding activity. Using data published in the public domain by the Roche organization, they were able to extract valuable biochemical property information embedded in the data, thus dissecting the contributions of concentration and biochemical property differences between the different IgG1 forms to sample average activity. Such information and methods had hitherto evaded the drug development community. Their study demonstrates that computational methods provide access to important product characterization information embedded in readily generated data and thus expands the totality of evidence associated with heterogeneous IgG1s. Since the methods of Zhan and Chung are directly applicable to characterizing a variety of currently-marketed, follow-on and newly-approved IgG1s, the use of mathematical methods based on established mechanisms in ligand-receptor biochemistry should be of interest to all parties engaged in biologics research.