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 enabling greater 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:

Angela Furlanetto is a Partner at Dimock Stratton LLP where she practices exclusively in the area of intellectual property litigation, particularly patent litigation with an emphasis on chemical, biochemical and pharmaceutical subject-matter. Angela has significant experience in all aspects of intellectual property litigation, ranging from pre-litigation opinions to conduct of matters through trial and appeal. She has worked with counsel in various jurisdictions to co-ordinate the Canadian part of multi-jurisdictional lawsuits.Angela is an active member of the profession, recently completing her term as Chair of the Canadian Bar Association National IP Section; she is also member of the Court Practices Committee, Federal Court Bench and Bar Committee, Fellow of the Intellectual Property Institute of Canada (IPIC), and Chair of the Harold G. Fox Intellectual Property Moot. Angela is described as "a top-drawer litigator" by IAM Patent 1000 and has been ranked for litigation since 2012. She has also been named to the International Who's Who of Life Sciences Lawyers,the International Who's Who of Patent Lawyers, Best Lawyers for intellectual property law and was ranked by Benchmark Canada as a Future Star – Ontario.

Abstract:

What’s new in Canada? New biologic approvals by Health Canada for subsequent entry biologics (SEBs) and a review of Canadian litigation involving biologics, including Canada’s first biologics decision in a patent infringement action AbbVie Corporation v. Janssen Inc., 2014 FC 55,involving the drug Stelara (ustekinumab), along with the Federal Court of Appeal decision (2014 FCA 242) to set aside the decision of the trial judge and remit the case back to the court for a new trial. The next steps and what is on the horizon for Canadian litigation.

Biography:

Ronald A Rader has been President of his own publishing/consulting company, the Biotechnology Information Institute, since late 1990. He has a BS in Microbiology, Master in 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. He is best known as the author and publisher of BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets, the only information resource specializing in biopharmaceuticals. He is also the author and publisher of the Biosimilars/Biobetters Pipeline Database. For 15 years, from 1988-2003, he was the author and publisher of the Antiviral Agents Bulletin, the only periodical specializing in antiviral and HIV drug and vaccine development. Prior to 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 competition than commonly presumed. 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:

Raymond A Huml, MS, DVM, RAC is Executive Director of Strategic Drug Development and Head of Global Biosimilars Strategic Planning for Quintiles’ Global Biosimilars Unit. He has over 25 years of experience in the clinical and biopharmaceutical industries. He has published over 50 articles and two books: One on due diligence and one on competitive intelligence. He holds an MS in Biology from East Stroudsburg University and a DVM from North Carolina State University’s College of Veterinary Medicine, and has earned the RAC (US) certification.

Abstract:

Driving the burgeoning biosimilars industry is the lucrative biologics market, worth billions, with multiple patents expiring or set to expire soon. Historically, European and Canadian regulatory authorities have taken global leadership roles in biosimilars drug development. For example, EMA published test procedures and acceptance criteria for biological products in 1999. Europe leads the pack with the most advanced and detailed biosimilar regulatory guidance - spearheading a “totality of evidence” approach - and has granted the most approvals. Other countries are moving ahead rapidly to provide cheaper copies of biologics to their citizens. The US has made significant advances towards issuing draft guidance, though it still appears that near-term, approvals will be made on a case-by-case basis. Commensurate with limited guidance and extensive innovator lobbying, the FDA has granted only one biosimilars approval – a less complex protein (filgrastim-sndz or “Zarxio” from Novartis) - in March, 2015 under the 351(k) registration pathway approved under the Biologics Price Competition and Innovation Act (BPCIA) of 2009. Further hampering progress towards US approval of a monoclonal antibody biosimilar, an FDA Advisory Committee meeting on a Remicade biosimilar from Celltrion was recently delayed. CDER recently announced that four additional biosimilar documents are set to be published in 2015. This presentation will describe the evolution of http://biosimilars-biologics.pharmaceuticalconferences.com/biosimilar development over the last 15 years, discussing key milestones leading to the first approvals in various markets. Outstanding issues will also be addressed relating to the race to identify and obtain the patients needed for global biosimilar registration trials.

Biography:

James Harris III has extensive experience within biotech, pharmaceuticals and medical devices with small start-ups, mid-sized and large firms. Mr. Harris is the founder of Healthcare Economics LLC, Co-founder of AS Biotech AG and participates on the board of directors as well as advisory boards for various firms. Prior to this he served as General Manager and Vice President at Dragon Pharmaceuticals, Inc. where he was instrumental in the launch and successful market penetration of rh-Erythropoietin (“EPO\\\\\\\") in non patented markets and is very well experienced in product licensing, business development, market access and reimbursement. Mr. Harris’s publications include “Biosimilars landscape and FDA regulatory expectations”, “Generic Drugs: World Market Outlook 2011-2021”, “Patient Empowerment and Compliance: The Role of Direct to Consumer (DTC) Advertising”, “Marketing and Globalizing Biosimilars”, “How to Establish Comparability for a faster route to Market, and “GCSF and Bioequivalence: The Emergence of Healthcare Economics”. Mr. Harris is Lead Faculty Area Chair – Financial Planning and Risk Control at the University of Phoenix West Florida Campus, has an MBA in Finance from Long Island University and participates extensively as a featured speaker at medical meetings globally.

Abstract:

The lecture will cover The presentation will cover assessing the promise and potential of biosimilars with respect to commercialization and marketing considerations to maximize market share. Recent commercial developments will also be discussed as well as provider and payer perspectives with regard to biosimilar acceptance. • Assessing the promise and potential of biosimilars • Latest progress in biosimilars development • Provider perspectives and acceptance of biosimilars • Payer perspectives and formulary acceptance

Biography:

Lisa Mueller is a partner in Michael Best’s Intellectual Property Practice Group and a Chair of the Life Sciences and Chemical Industry Group. Ms. Mueller has extensive experience in the biotechnology and pharmaceutical areas. She also has experience in evaluating, filing and securing trademarks, particularly in the pharmaceutical and life sciences area. Ms. Mueller has recently spoken at Informa’s Conference on Biosimilars and Biotech in Turkey and MENA (November 2014) as well as ACI’s Biosimilar Conference (June 2014). Ms. Mueller has written extensively about life science issues, including biosimilars

Abstract:

Biosimilars are highly-similar versions of biological drugs (biologics) approved for the treatment of a variety of disorders and diseases. Originator biologics are the most expensive drugs in the pharmaceutical industry and many cost nearly $100,000 per patient per year. As a result, biologics impose a heavy financial burden on patients and healthcare systems. While patent protection for several biologics has already expired, several other biologics are expected to lose patent protection between now and 2020. This impending patent cliff has given many biotechnology companies the opportunity to develop and market biosimilars with a cost benefit of about 20% to 30%. In order to gain a slice of the $190 billion worth of biologic’s market, many biotechnology companies have ventured into the biosimilar sector. This session will examine the key players that have ventured into this sector as well as the size and development of the market worldwide.

Biography:

Raj Davé is a partner in the Intellectual Property Group of Pillsbury Winthrop Shaw Pittman LLP – a 700 attorney law firm. He focuses on strategic intellectual property counseling, patent prosecution, dispute resolution, licensing, technology transactions, intellectual property mining and enforcement, reexamination and reissue practice, pre-litigation opinions and patent litigation. He is the author or co-author of more than 30 scientific publications and about 15 legal publications.

Abstract:

Biologics are products manufactured from living matter or manufactured in living cells using recombinant DNA biotechnologies. In Diamond v. Chakrabarty, the US Supreme Court held that a “nonnaturally occurring manufacture or composition of matter — a product of human ingenuity — having a distinctive name, character, [and] use” is patent eligible subject matter. Relying solely on the distinction between ‘product of nature’ and ‘nonnaturally occurring manufacture or composition of matter,’ currently all types of nonnaturally occurring biologics are patent eligible in the US. However, this expansive scope of patent eligibility in the US may be curtailed for patenting biologics under AIA, and the US Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc. AIA states, “No patent may issue on a claim directed to or encompassing a human organism.” Is it possible that the courts might decide that, under AIA, stem cells derived biologics fall within the scope of a human embryo? Subsequent to the passage of AIA, in Myriad, the US Supreme Court held that isolated DNA are not patent eligible, because isolated and purified human genes are indistinguishable from the products of nature, while cDNAs are patent eligible because they are synthetic DNA and are product of human ingenuity. In light of Myriad, biologics may be subject to contentions in aspect of patent eligibility, such as, are they synthetic products analogous to cDNA or mere isolation of naturally occurring products? It may be contended that isolated and purified biologics are essentially identical to naturally occurring biologics.

Biography:

Dr Fratazzi devised the concept of a Strategic Clinical Innovation Organization (SCIO) and founded the first SCIO –Boston Biotech Clinical Research (BBCR), LLC in 2009, with the objective of actively contributing to innovation in streamlining clinical research and developing strategic clinical regulatory pathways to product approval. Dr. Fratazzi has worked on several Biosimilars’ development with special attention to the major variables that impact costs. As the President of BBCR, LLC, Dr. Fratazzi acts as a consultant to biotech, pharmaceutical medical device companies, and investors on optimum clinical plan development and how to design clinical trials that reduce product development risk. She is a renowned Immunologist with over 15 years of experience in Orphan Petitions in US and EU and phase 1-4 clinical programs, contributed to the registration and approval of 4 successful products.Dr. Candida Fratazzi expertise includes Drug, Device as well as Combination Products. . Recipient of 2013, 2014 and 2015 Best Pharmaceutical Consultant, Cambridge Award, 2015 Cambridge Business Hall of Fame Award,and 2014 Top Ranked US Executives, National Council of American Executives. Act as Member of Advisory Board and Board of Directors in Life-science Technology companies. Invited speakers and chairman at international conferences. Authored over 50 scientific papers in peer review journals and several book chapters. Dr Fratazzi helps international companies to enter the US and EU markets.Dr Fratazzi received her early training in biomedical research at the Johns Hopkins University and Harvard University in the USA, and at Imperial College in London, UK.

Abstract:

Biotherapeutic products are the fastest growing medicines in the pharmaceutical market. Here we discussthe major variables that have an impact on cost and timelines of biosimilars’ development. Specifically, wereport the challenges of duplicating the innovator product results and how the dialogue on indication extrapolation has elicited new interest as the FDA compares extrapolation’s core issues. Accordingly to the WHO “it is expected that the elaboration of the data requirements and considerations for the licensing of Biosimilar products will facilitate development and worldwide access to biotherapeutics of assured quality, safety and efficacy at more affordable prices.” To address the WHO requirements, we have reviewed trial options that could assess interchangeability between the branded product and the biosimilar. Here, we discuss a case study with the objective ofassessing the immunogenicity rate between biosimilar and innovator productand evaluate the data in light of regulatory requirements. Our developed framework based on evidence-based strategies and design-centered trials highlights the factors impacting the potential cost savings in biosimilar development.

Biography:

Kerisha Bowen is a registered patent agent in Dentons’ Intellectual Property and Technology practice. She has a doctorate in organic chemistry and her practice focuses on patent prosecution in chemical and biological arts. Prior to joining Dentons, Kerisha held several assistant professorships and research positions at prestigious universities including the University of Pennsylvania and Penn State University. Kerisha was a patent analytic intern at the Union Station Technology Center where she assessed patent cost estimates of orphan drug research. She was also on the editorial staff of the Journal of Chemical and Engineering Data. As a postdoctoral fellow at the University of Pennsylvania School of Veterinary Medicine, her research focused on the P13K signaling pathway and the link between cancer and diabetes. Kerisha's doctoral research was concentrated on the synthesis of nitrogen-based pharmaceuticals from sulfinimines.

Abstract:

On March 6, 2013, Janssen Biotech, Inc. and New York University filed suit against Celltrion Healthcare Co., LTD, Celltrion, Inc,., and Hospira in the Federal District of Massachusetts. Janssen filed the suit as an attempt to assert its intellectual property rights for the drug Remicade® (Infliximab). The patents in dispute are U.S. Patent No. 6,284,471, which covers the infliximab cA2 monoclonal antibody; U.S. Patent No. 7,223, 396, which covers novel uses of infliximab to treat disease; and U.S. Patent No. 5,807,715, which covers methods of producing functional antibodies that are capable of specifically binding antigens. Celltrion submitted a Biologic License Application in August of 2014, which the FDA accepted for review in October of 2014. However, Celltrion indicated that they would begin commercial marketing of their proposed biosimilar product as early as August 5, 2015. The question at hand is was Celltrion's notice of commercial marketing premature, and how does a biosimilar company properly serve notice of commercial marketing?

Biography:

Ricardo Ibarra-Cabrera is a Biotechnology Engineer from Tecnologico de Monterrey, Mexico City. He is Industry Analyst & Editor at Mexico Health Review, an annual publication that provides a comprehensive overview of the latest developments, industry trends, business strategies, operational challenges, and legal and regulatory issues in the Mexican health industry. Ricardo is responsible for interviewing the 200 most relevant leaders of the health industry, which is the primary source of the editorial content of the 350 page publication. Ricardo is the first author of the article called “Review on the worldwide regulatoryframework for biosimilars focusing on the Mexican case as an emerging market in Latin America”, published on December 2013 in the Journal of Biotechnology Advances, which is the top 5 of all life sciences Journals today. Ricardo gave the conference “Business and Regulatory Environment of Biopharmaceuticals and Biosimilars in Latin America” in the 4th International Conference on Pharmaceutical Regulatory Affairs, Raleigh, NC, August 2014. His experience includes pharmaceutical clinical trials and consulting services to Total Quality Management for clinical studies units. He is interested in health innovation, business strategy, business intelligence, and industry analysis.

Abstract:

Biopharmaceuticals represent a very promising option for treating the most challenging diseases; nevertheless, there is no budget in the world that could effectively provide universal healthcare with a purely innovative drugs portfolio.Biosimilars represent a lower cost alternative for public healthcare systems. For instance, subsequent versions of recombinant erythropoietin with price reductions of up to 90% were launched in Mexico in 2006, and 82% cheaper rituximab versions entered the market later, among many others. Such products were originally registered as traditional generics in Mexico, but now that the regulatory framework for biosimilars is complete and well established by the Official Norm NOM-257-SSA1-2014issued in December 2014, local manufacturers face a great challenge. They need to perform some or most of the required studies for demonstrating their products’ safety, quality and biocomparability within eight months in order to renew their sanitary registration. Unfortunately, some of them cannot be fully done in Mexico due to lack of R&D infrastructure. Therefore, the biosimilars industry is at a crucial time in the country now that the Government is eager to have low-cost medicinesbut at the same time has developed more strict regulations for them. This all represents many business opportunities for laboratories, distributors and biotech companies who are willing to make quality their competitive advantage, as well as the possibility for patients to haveimproved access to safer and more efficacious treatments.

Biography:

Abe Hershkovitz founded Hershkovitz & Associates, PLLC, in Alexandria, Va. in 2003. He is a former Director of the Office of Petitions at the USPTO, where he worked for more than 27 years. Prior to working in the Office of Petitions, Mr. Hershkovitz worked as an Expert Primary Examiner. As Director of the Office of Petitions, he worked on setting policy-related USPTO guidelines. Mr. Hershkovitz specializes in petitionable matters and prosecution of Ex Parte, Inter Partes Reexamination Proceedings and CBMs. He assists clients with complex matters before the USPTO and serves as an expert witness in litigated cases. He has strong business ties with many intellectual property firms in Europe and Asia. He lectures frequently to Bar Associations and international IP organizations on various topics of patent laws and regulations and procedural tips on patent prosecution before the USPTO.

Abstract:

After enactment of the American Invents Act signed into law by President Obama effective September 16, 2012, there have been significant changes in how patentable inventions are protected and new ways of enforcing patent protection. Biomedical and computer software patents were particularly hard hit by the Supreme Court decision in Alice Corp. v. CLS Bank International and the finding that patents drawn to an abstract idea may not be enforceable. Patent invalidation through inter partes reviews and Covered Business Method challenges have become favorite vehicles over the more expensive court litigation used before. Inventors and owners of patent applications have to be far more careful when working with their patent attorneys and agents in formulating patent claims. Accused infringers and opponents of certain patents, on the other hand, need to educate themselves quickly in how to best challenge patents they believe to be unenforceable. Basic patent prosecution and very advanced reexamination practice have become more complex, and at the same time, more critical to master.

Biography:

Dr. Nigel Rulewski has 25+ years’ experience in Drug Development and Regulatory Affairs, in both large and small pharma, Venture Capital and Pharmaceutical Business Development. He is presently VP, Strategic Drug Development Group and Head, Biosimilar Center of Excellence, at Quintiles.He has planned the development of biosimilar versions of EPO, GCSF, peg-GCSF, Remicade, Humira, Enbrel, Rituximab, Avastin and Herceptin. Dr Rulewski earned his medical degree at St Bartholomew’s Medical School, University of London and also holds a Diploma in Child Health, Royal College of Physicians and a Diploma of Royal College of Obstetricians and Gynecologists

Abstract:

Biosimilars in the US are still in their infancy with only one product approved for the US market to date. However the first wave of Biosimilar products, EPO, Filgrastim, Anti TNFs and several oncology products are now well underway. The issues faced in the development of these products have evolved over time and now provide a firm basis for the next generation of biosimilar products. The issues surrounding the choice of indication in which to demonstrate biosimilarity, the basis of extrapolation and the need for transition data have all now been established. Interchangeability, a situation unique to the US approval systems still remains to be clarified, although the FDA’s likely requirements are becoming clearer. Levels of interest expressed by clinical investigators has increased significantly as the financial consequences of biosimilars become better understood. The issues encountered in the clinical development of this first wave of biosimilars and the implications of those lessons learnt for the next wave of products will be discussed.

Biography:

Currently holding the position of Chief Operating Officer & Chief Technical Officer at Bills Biotech Pvt Ltd, Vadodara,GJ (Ph. D – Molecular Microbiology - Maharaja Sayajirao University, Vadodara, M. Sc-Biotechnology- Maharaja Sayajirao University, Vadodara, Graduation B.Sc.- Zoology and Chemistry -Banaras Hindu University,Varanasi) Industrial Position Held: 1. Head of R&D & Sr. GM – Biologics and Biosimilar at Virchow Biotech Pvt Ltd, Hyderebad, 2. Head & Asst. General Manager - Biopharma operation at Microtherapeutics Research labs Pvt ltd, Chennai, 3. Sr .Manager & Head - Biosimilar and Biologics Development, Research & Training ,process consultancy at BiOZEEN, Bangalore, 4. Senior Group leader - Fermentation and Synthesis R & D at Concord Biotech Limited, 5. Senior Executive - Downstream at Intas Biopharmaceuticals Summary of Experience: More than 15 years industrial experience on process development and production of following molecules e.g. GCSF, Erythropoetin, IFN-2b, IL-2, rH-GCSF, PEG-GCSF, r-URATE OXIDASE, PEG-UOX, r-INSULIN,r-GLARGINE,r-PTH,r-EK, r-CBP, L-ASPARAGINASE,r-tPA,r-EPO,r-Protein Award Received : 1. Department of Biotechnology India fellowship Award during Post Graduation, 2. Meritorious Fellowship Award during Ph.D 3. FEMS Grant Award-2011, 4. Asian PGPR Best Research Work Award-2010, , 5. Key Note Speaker at Bioprocess India-2014,IIT-Mumbai.

Abstract:

The biologics market consists primarily of vaccines, monoclonal antibodies, recombinant proteins and diagnostics. Global pharmaceutical market projected of the growth rate 12%, Growth in biopharmaceutical market,to reach US$138 bn by 2014,dominated by products from mammalian cell cultures (>75%). Global biosimilars market ≈ $19.4 billion by 2014, growing at an expected CAGR of 89.1% from 2009 to 2014.By 2015, sales of biosimilars in US are expected US$1.9-2.6 billion, up from US$378 million in 2011.There is great opportunities in biopharmaceuticals, novel biologics & biosimilar r-proteins, Vaccines development and process parameter set up.Different scale-up criteria have been used depending on the type of fermentation and bioreactors. Growing mammalian cells in fermenters/bioreactors and to produce the protein of interest is a very cautious process and process parameters like pH or dissolved oxygen concentration need to be controlled very strictly to corroborate the consistency of a product. Minor deviations of the predefined process parameters can easily result in changes of product quality attributes like glycosylation, aggregation, c-terminal clipping or acidic variation, which can affect the pharmacokinetics of the protein e.g. case study for eryhtropoetin,Darbepoetin,Mabs etc..In reality scale-up of laboratory and pilot-plant data to commercial size industrial bioreactors is complicated.No actual data or correlation or exisiting formula is fixed for scale-up. Different people use different scale-up criteria to design commercial size bioreactor systems.In fermentation industry there are a lot of trade secrets on scale-up of bioreactors and fermentors , and very few published results.

Biography:

Tom specialises in biotech and pharmaceutical patent litigation and has been involved in some of the most significant patent cases in the UK in recent years. Conor v Angiotech and Eli Lilly v Human Genomes Sciences both went to the House of Lords/Supreme Court (the highest appeal court), while Dr Reddy v Eli Lilly only reached the Court of Appeal but is the definitive case in the law of selection patents in the UK. Tom has published many articles on patent law issues, including in the CIPA Journal (the official journal of the Chartered Institute of Patent Attorneys in the UK).

Abstract:

SPC squatting and SPCs for biologics are a hot topic in Europe following a recent slew of decisions from the courts. First, Supplementary Protection Certificates in Europe are similar to, but not quite the same as, Patent Term Extensions in the US. Tom will explore some of the differences between the two systems, and in particular Tom will examine who may apply for an SPC and on the basis of which patent. The SPC Regulation requires that the ‘product’ the subject of an SPC application must be protected by a ‘basic patent’. In the field of antibodies, is the ‘basic patent’ that patent which claims the antibody in question, or is the ‘basic patent’ that patent which claims the DNA sequence of the protein antigen, or both? Second, only one SPC is permitted per ‘product’. Tom will explore how this might apply to biologics and biosimilars – is a biosimilar the same ‘product’ as the original?

Biography:

Vivek Halan has a Postgraduate degree in biotechnology from Bharathidasan University in Trichy, Tamilnadu. He has around 10 years of research experience in downstream process development of biologics in oncology, diabetes, osteoporosis, metabolic disorder, inflammation, rheumatoid arthritis, and liver-associated diseases. He has worked for companies such as Magene Life sciences, Avesthagen Ltd., and Syngene International Ltd., where he was involved in downstream processing of various biologics, biosimilars, innovators, and a few other proteins like kinases, GPCRs, and phosphatases. Moreover, he was also involved in shake-flask protein expression in bacterial cells, mammalian cell lines, and insect cell lines. Currently, he is heading the Downstream Department at Theramyt Novobiologics.

Abstract:

Biosimilars are increasingly being developed by many companies and used as therapeutics for various diseases worldwide. There is a lot of scope to improve in biosimilar story. Biosimilar products are approved through stringent regulatory pathways in highly regulated markets such as the US, EU, Japan, Canada and Australia following loss of exclusivity of their originator reference product. The development of biosimilar product possesses various challenges such as comparable quality, safety and efficacy to a reference product in addition to other challenges in product development from laboratory to manufacturing scale. Biosimilar from process development, pre-clinical trials and clinical trials upto fill finish meets number of challenges. Quality attributes of monoclonal antibody or bio-therapeutic proteins are highly affected by both process and product related impurities. There should be an efficient upstream as well as downstream process to overcome all the bottlenecks and establishing appropriate standards for biosimilarity remains an important area for scientific, legislative and regulatory debate. I would like to give an overview on biosimilar development in various countries and current scenario. My discussion is intended for audience from biopharma industry as well as from active collaborators from various institutes and universities.

Biography:

Wolfgang Rehmann is partner of the international law firm Taylor Wessing. He counts among Germany's acknowledged experts in the field of pharmaceutical and medical law. His clients include medium-sized and international enterprises engaged in the manufacture and distribution of pharmaceutical, medicinal or medical-technological products, as well as companies acting as consultants in that area. Wolfgang Rehmann offers both advice and forensic services to leading companies of the Life Sciences industry. His forensic work is presented before German courts and also the EU courts in Luxembourg, concentrating on issues of pharmaceutical law, intellectual property, antitrust law and Community law. Wolfgang Rehmann regularly publishes specialist articles and is the author of a commentary of the German Pharmaceutical Act as well as co-author of a commentary of the German Medical Devices Act. Her regularly presents on international conferences on life sciences issues.

Abstract:

In Europe biosimilars are governed by the statutory provisions applicable for generic medicines. The legal requirements and the procedures for making an application for a marketing authorisation are set out in Directive 2001/83/EC and in Regulation (EC) No 726/2004. There are a number of possible approaches to getting approval for a biosimilar product in Europe, in particular to either submit a full dossier of pre-clinical and clinical data as would be required for any new medicinal product or to apply under the abridged procedure. An applicant for approval of a biosimilar product under the abridged procedure is required to demonstrate that its product is similar to a previously authorised product. The EMA is responsible for assessing applications from companies to market biological medicines for use in the European Union, including biosimilar medicines in case the centralised procedure is applicable. The EMA has published guidelines that govern how biosimilars are to be assessed. There are three guidelines that apply to all biosimilars: an overarching guideline which was first adopted in September 2005 and was amended in 2014, coming into effect on 30 April 2015; and two further guidelines which were both adopted by the EMA on 22 February 2006, one relating to non-clinical and clinical issues and one to quality issues. The guideline on quality issues was also amended in 2014. The presentation will give an overview to the audience about how the legal framework in the EU works and will give an update on most recent legal development within the EU in this regard.

Biography:

Marcus Mreyen is an expert for peptide and protein analysis with a focus on mass spectrometric techniques. He holds a PhD in chemistry and spent two years in Australia were he worked in the protein analytical field at Macquarie University and the Australian Proteome Facility (APAF). Starting at Protagen in 2000 he successfully worked as a Project Manager and supported customer projects in the various protein fields. He transferred and deepen his technical understanding during a time working for Shimadzu, one of the worldwide leading analytical instrument provider, as a Product Manager for the Mass Spectrometry and Life Science products. During this time he supported customer in pharma and biotech in Europe and Russia, before returning to Protagen´s Protein Services Unit as a Director Business Development, a company serving now over 180 international clients as CRO to support the development of new protein therapeutics and biosimilars from early phases of discovery, production to GMP release testing.

Abstract:

As more and more blockbuster biologics loose patent protection, hundreds of biosimilar/ follow-on biologics developments have been started by multiple companies internationally and more will follow next years. Matching Biosimilarity is the key for these projects giving a high priority on CMC consideration with new aspects compared to NBE developments like Originator Monitoring to define the QTPP for the upcoming biosimilar and for the subsequent pool and clone selection phase. The analytical characterization and monitoring is crucial to make a quality driven development and to select the most promising candidate on top of aspects productivity, stability and upscaling possibility. Depending on the molecule complex structural characterization, glycosylation and physicochemical analysis with orthogonal techniques is required to demonstrate the biosimilarity to the originator molecule. The presentation will focus on the CMC requirements needed in the different steps of Biosimilar development. In addition different examples will highlight the analytical modules used in each development stage and how they align in a multidisciplinary overall Biosimilar development project.

Biography:

Dr. Min Zhang has over 10 years of experience in mammalian cell culture, from cell line engineering, media development, bioprocess development and biomanufacturing, bioprocess characterization, Quality-by-Design (QbD), and therapeutic protein commercialization. He is currently a Principal Scientist and Group Leader at FUJIFILM Diosynth Biotechnologies U.S.A., Inc. (FDBU) where he leads a cell culture team to support upstream process development and cGMP manufacturing for cell culture programs at various development and clinical phases. Prior to joining FDBU, Min had tenures in Cell Culture Development Department at Eli Lilly and Company and SAFC (Sigma-Aldrich). Min was a Staff Scientist and did his postdoc research at University of California at Berkeley after he received his doctorate in Molecular Cell Biology from Institute of Genetics at Fudan University.

Abstract:

In thebiosimilar journey of drug development through regulatory approval, the product quality attributes of the biosimilar protein must compare within defined limits to those of the innovator product.Unlike small molecule drugs, whose structure can usually be completely defined and entirely reproduced, biologicals are typically more complex and are almost unlikely to be shown to be structurally identical to aninnovatorproduct. Therefore, biosimilarity is generally demonstrated as having matched product quality attributes, comparablein-vitro biological activity, and no clinically meaningful differences between the biosimilar drug and innovatorproduct. The complexity of recombinant protein manufacturing processes, including expression systems (i.e. host cell line, expression vector, cell line development process), cell culture process conditions and related nutrient systems,such as cell culture media and feeds, present significant challenges to achieve the required product qualityfor biosimilars. To address these challenges, Fujifilm Diosynth Biotechnologies (FDB) has developed a systematic approach of combining media toolbox methodology and bioprocess“know-how” to screen and optimize manufacturing conditions that promote the desired product quality profilesof recombinant proteins. Case studies will be presented to highlight the efficacy of this approach and successful implementation in manufacture of biosimilar recombinant monoclonal antibodies.

Biography:

Abstract:

Streptokinase, a 414 amino acid polypeptidewithmolecularweightof 47kDa, is a potent activator of the fibrinolytic system in humans.High level expression of recombinant proteinin E.coli frequently results in accumulation of protein as in soluble aggregates known as inclusion bodies and they do offer several advantages. Expression as inclusion bodies is useful to obtain large amount of the protein, provided refolding is not difficult and recovery of the active protein is high. This is particularly true with the proteins not having disulfide bonds. Since Streptokinase does not have disulfide bonds, the focus is to obtain higher quantity of stable protein as inclusion bodies. In the present study, an attempt was made to investigate the effect of temperature and post induction time on stable (non-degradable) expression of recombinant streptokinase of highercontentas inclusion body in Escherichiacoli.

Biography:

Volker Schellenberger is President and CEO of Amunix Operating Inc., which he co-founded together with Willem Pim Stemmer in 2006. He initially served as Amunix’ Chief Scientific Officer and is the lead inventor of the company’s XTEN technology. He has over 20 years of industry experience in protein engineering and drug discovery. Prior to co-founding Amunix he served as head of Genencor’s protein engineering department where he invented combinatorial consensus mutagenesis, selection by micro-compartmentalization as well as mutator technology. He focused on the discovery and engineering of antibody-enzyme fusion proteins. Prior to his work on biotherapeutics, he led projects optimizing enzymes for industrial applications as well as microbes for metabolic pathway engineering. He received his PhD from Leipzig University(Germany) in 1986 for studies on protease catalyzed peptide synthesis. After Postdoctoral work at the Institute for Protein Research in Pushchino (Russia) he moved to the University of Göttingen where he developed a novel method for the production of peptides from recombinant peptide-multimers. After a Postdoc with Bill Rutter at the University of California, San Francisco he joined Genencor in 1994. He is author of over 40 scientific papers and inventor of more than 70 issued or pending patent applications. He is a recipient of the Karl Lohmannprize of the German Society of Biochemists.

Abstract:

PEGylation is commonly used to generate long-acting biologics (Biobetters). However, there are increasing concerns about the safety of PEG resulting from its resistance to being metabolized resulting in the accumulation in various organs including the kidney and brain. PEG is further limited by its polydispersity as well as an increasing risk of pre-exposure caused by the use of PEG in many cosmetics. Amunix has developed XTEN, a protein-based polymer that mimics the biophysical properties of PEG. XTEN is easily metabolized, thereby eliminating the risk of tissue accumulation. Proteins and peptides can be genetically fused to XTEN in a precisely controlled locations to increase biological half-life. XTEN polymers can also be produced by large scale microbial fermentation enabling chemical conjugation similar to PEGylation. XTEN has been successfully applied to a wide range of biotherapeutics and the most advanced product, human growth hormone-XTEN, VRS-317, is currently in late stage clinical testing.

Biography:

Roman joined LFB USA in 2013 where he holds position of Senior Director of Regulatory Affairs. Before joining LFB USA he was a Team Leader at the Office of Blood Research and Review of CBER FDA. His research included molecular biology, cell biology, and expression of recombinant therapeutic proteins. Before joining the FDA, he worked at Holland Laboratory of American Red Cross (ARC). Roman received his Ph.D. in Experimental Endocrinology from Polish Academy of Sciences and subsequently held positions at University of Georgia in Athens and University of Montreal.

Abstract:

Expression of recombinant proteins in the milk of transgenic dairy goats has been established asa viable and cost- effective alternative to mammalian cell culture systems. The first transgenically produced therapeutic protein, recombinant human Antithrombin (ATryn), has been approved by the European authorities in 2006 and by the FDA in. 2009. Since then it has been successfully used to treat patients with hereditary deficiency of antithrombin. Due to the high capacity of the mammary gland for protein expression and milk output, the transgenic system is particularly suitable for production of complex proteins in large quantities. This production system and large capacity for recombinant protein expression has been put to use generating monoclonal antibodies to develop several biosimilar products that will be described herein. This presentation will specifically explorethe scientific and regulatory pathwayfor the development of therapeutic monoclonal antibodies (MAb)expressed in the milk of transgenic animals under the provisions of the Biologic Price Competition and Innovation Act of 2009 (BPCI Act)

Biography:

Dr. Epstein received his BA degree from Wesleyan University, Middletown, CT and his MD/PhD degrees from the Medical Scientist Training Program at Stanford University School of Medicine under the tutelage of the late Henry Kaplan. He is currently Professor of Pathology at the USC Keck School of Medicine since 1984 and has over 160 publications and 30 patents in the field of tumor cell biology and cancer immunotherapy. He is expert in the development of novel cancer cell lines, monoclonal antibodies, antibody fusion proteins, and immunodiagnostics useful for the treatment and diagnosis of lymphomas and solid tumors.

Abstract:

Supported by a NCI SBIR contract, a biosimilar Erbitux antibody, designated ch225, has been developed over the last three years for the immunotherapy of EGFR+, KRAS mutation negative tumors. In 2011, there were 141,210 new cases of colon and rectal cancers and 49,380 deaths in the USA accounting for the 12.2 billion dollars spent on colorectal cancer treatment alone. In addition,head and neck cancers account for 45,000 additional cases that are eligible for Erbitux treatment. These statistics show that Erbitux is an important treatment modality especially since its therapeutic effects against other tumors such as non-small cell lung cancer has been demonstrated.After extensive analyses of commercial Erbitux, a biosimilar antibodywas developed using genetic engineering methods. Our initial studies demonstratedthat ch225 has the same primary amino acid sequence, charge distribution, and glycosylation profile as Erbitux required for its biosimilarity. In addition, the potencyof ch225 against EGFR positive and negative cell linesand PK/PD studies closely matched commercial Erbitux batches both in vitro and in vivo. Based upon these results, extensive cloning methods were used to develop a high yielding subclonein serum free medium which produces over 1mg/ml of antibody stable out to 35 generations. A growth supplement was also identified which increased its productivity enabling the accumulation of 4 x 107 cells/ml with over 98% viability. In conclusion, despite numerous difficulties encountered during the course of this work, a biosimilar Erbitux has been produced and readied for cGMP and clinical trials.

Biography:

Dr. Upendra Nagaich received his Ph.D. from Jiwaji University, Gwalior, India. Presently, Dr. Nagaich is working as Co-ordinator [M.Pharm], Department of Pharmaceutics, Amity Institute of Pharmacy, Amity University, Noida, India. Dr. Nagaich has been conferred with several awards and honors: Award of Excellence in Pharmacy, Young Pharmacy Teacher Award, Young Performer Award, Distinguished Alumni Award. He is approved supervisor for doctoral research. Dr. Nagaich guided 23 thesis of M.Pharm. and presently guiding 03 thesis of Ph.D& 04 thesis of M.Pharm. He has filed 03 patents, published more than 50 high quality papers in international and national journals of repute, invited as speaker in various conferences.

Abstract:

Therapeutic recombinant proteins are the most significant and swiftly expanding sector of the biopharmaceutical market. The promising commerce of therapeutic proteins have remarked a standard change with enhanced efficacy, greater safety, and reduced immunogenicity approaches from the combination of clinical, scientific, technological and commercial drivers that have identified unmet needs. These proteins can be grouped into molecular types which fundamentally includes anticoagulants, blood factors, engineered protein scaffolds, enzymes, growth factors, hormones, interferons, interleukins, and thrombolytic. Recombinant proteins are manufactured in bacteria, yeast, filamentous fungi, insect cells, mammalian cells, transgenic animals, and transgenic plants. Major production of 39 percent recombinant proteins is achieved by E. coli, 35 per cent by CHO cells, 15 per cent by yeasts, 10 per cent by other mammalian systems. Recombinant Protein drugs have revolutionized the prospects for the treatment of many types of cancer and rheumatic conditions. The foremost approach which has been adopted for the production of second generation protein products comprises reformulation, pegylation and other forms of modification, or the creation of analogues with different amino acid structures. Now the long established pharmaceutical manufacturers will have to spotlight for these future biologic products. It will be a great challenge to bring about the innovation, instead of renovation, to achieve pure, safe, high efficacy, cost effective and high yielding recombinant human therapeutic proteins with excellence.