Day 2 :
- Keynote Session
Session Introduction
Andreu Soldevila
LeanBiopro, Spain
Title: Leanbioproduction of biosimilars for small to mid-size pharma companies
Time : 09:00-09:45
Biography:
Andreu Soldevila has done PhD in Biology, MsC in Biotechnology, MsC in Microbiology and Genètics, MsC in Environmental sciences, BS in Biology and BS in Biotechnology with 16 years of experience in the biotechnology and bio-pharmaceutical industry. He developed as a professional in the area of small molecules, peptides, biotherapeutics and in the last years specially in New Biological entities and Biosimilars. Professionally, he is interested in functions related to science and business (research and development, business development, technology transfer, project management) in the biotech and biopharma sectors.
Abstract:
Andreu Soldevila will present approach for Biosimilar development at Leanbiopro, providing straightforward solutions for the Lean Bioproduction of Biologics, especially Biosimilars in a Quality driven and risk based approach to minimize cost and time to market for our clients. Leanbio will provide solutions for mid-size companies, offering expression systems with freedom to operate, will emphasize in life cycle of analytical methods to support innovator drug characterization, specifications and IPC as proper control strategy and will present leanbiopro approach for life cycle in process development to support early stages of development to process characterization which will provide knowledge to support CMC for nonclinical and clinical trials in compliance with regulatory guidelines.
Fiona M Greer
SGS Life Sciences, Switzerland.
Title: Establishing “Finger-print like†biosimilarity - critical characterization steps for biosimilar assessment
Time : 09:45-10:30
Biography:
Dr Fiona Greer was a founding Director of M-Scan, contract analytical laboratories specializing in biopharmaceutical characterization. Following acquisition in 2010, she is now Global Director, Biopharma Services Development, SGS Life Sciences. Following a Ph.D. in Protein Biochemistry from Aberdeen University (1984) she joined M-Scan to establish and direct biologics characterization services. Here, she pioneered new developments in Mass Spectrometry for structural analysis and sequencing of proteins and carbohydrates resulting in numerous publications and patents. She was instrumental in expansion of the group, establishing a US facility where she was appointed VP. With over 35 years experience in glycoprotein analysis using mass spectrometry and other instrumental techniques, she has been involved with a diverse range of biotechnology products, both novel and biosimilar and consults to companies throughout the world. She is regularly invited to give presentations and workshops at international meetings and has designed and presented various technical training courses.
Abstract:
The development pathway of a biosimilar is unlike that of a novel biotherapeutic. Many regulatory authorities reference a “step-by-step” approach to establishing biosimilarity. In the early stages there is an increased requirement for ana¬lytics. This enhanced analytical effort entails physical, chemical, and biological characterization of the biosimilar in comparison to the originator reference product. Strategies at this stage must include assessment of primary and higher-order structure as well as batch-to-batch variation for both products. If found to be “similar” during this extensive characterisation, subsequent non clinical and clinical data are then required to demonstrate the same safety and efficacy profiles as the reference. The premise is that the amount of clinical data required will be less than for a novel stand-alone application. This presentation will highlight the benefit of using modern instrumental approaches to provide analytical data to support regulatory submissions. • Biosimilar development requires comprehensive physicochemical structural characterization of the (glyco)protein to demonstrate “Biosimilarity” with the originator. • Initially, batches of the target molecule are studied to determine the exact structure, post-translational modifications such as glycosylation and variability of quality attributes to establish the Quality Target Product Profile (QTTP). • Subsequently, comparative data for the biosimilar side-by-side with the originator is required. This includes both structural and functional activities. • Strategies for primary and higher order structure determination will be discussed particularly for antibodies where their size and complexity requires LC/MS/MS approaches. Appropriate orthogonal analytical techniques for “finger-print like” assessment will be reviewed.
Noelle Sunstrom
NeuClone PTY, Ltd, Australia
Title: Cell line development for the production of biosimilar monoclonal antibodies with high target bioactivity and high productivity
Biography:
Dr Sunstrom has been the CEO of NeuClone since it was established in 2007. Dr Sunstrom has over 20 years experience in the biopharmaceutical industry including more than 10 years of executive experience in biopharmaceutical companies. Dr Sunstrom has led teams in product development from bench to the market and founded and led two biotechnology companies based on CHO cell line development. Dr Sunstrom has held previous positions as CSO and Co-Founder of Acyte Biotech Pty Ltd as well as Deputy Director of both the CRC for Biopharmaceutical Research and the Bioengineering Centre at the University of New South Wales.
Abstract:
The cell line development group at NeuClone generates high quality cell lines for the production of biosimilar monoclonal antibodies (mAbs). Two characteristics are required to ensure the successful generation of a biosimilar production cell line – (1) the recombinant molecule must be expressed in sufficient quantityto ensure the project is economically viable, and (2) the molecule expressedmust behighly similar in structure and activity to the originator molecule. Traditionally the selection of cell lines expressing antibodies has been based on the selection of high producing mini-pools of cells that are subsequently further enriched for production by either limiting dilution cloning, clone-picking in semi-solid medium or by single-cell fluorescence-activated cell sorting. Clones are then expanded and evaluated in laboratory scale bioreactors to determine the best process development parameters prior to production scale up that will generate purified material for further product characterisation. The biological activity of a biosimilar mAb should mimic the originator in all aspects in order to achieve biosimilarity, including target binding and various effector functions such as signalling, cell death, proliferation, etc. We have designed a strategy that concurrently screens mini-pools and clones at an early stage for productivity as well as biosimilarity. This novel quality by design approach aims to minimise the riskof isolating high producing clones with insufficient biosimilarity early on– thus reducing the time in identifying clones with high productivity and with the right biosimilar attributes.
Reem Hamdy A Mohammed
Cairo University, Egypt
Title: Biosimilars in rheumatology practice: Where we stand?
Biography:
Reem Hamdy A Mohammed is Professor of Rheumatology and Clinical Immunology, Department of Rheumatology and Rehabilitation, Kasr Alainy School of Medicine, Cairo University. She graduated in year 1995- with excellent grades with honors, received a Master degree in Rheumatology and Rehabilitation in May 2000, PhD in Rheumatology/Clinical Immunology and MD Rheumatology and Rehabilitation in 2004. She is Fellow of the RCP, International Fellow of the American College of Rheumatology. She shared in three international book publications, has over 20 research publications in the field and is a member of the editorial board and a reviewer in a number of reputable rheumatology journals. She is devoted to serving the field of rheumatology at different levels including academic, clinical as well as research.
Abstract:
Biopharmaceuticals are biological medical products derived from cell culture or fermentation to produce therapeutic proteins that target pathogenic protein molecules by either neutralization or inhibition of their biologic hazards. Biosimilars on the other hand represent a form of biopharmaceuticals intended to be clinically equivalent end product yet unidentical to another existing biopharmaceutical. Reasons behind their being unidentical to an existing biologic are rather complex, however, many of such products are being increasingly investigated in the field of autoimmune diseases. The use of biosimilars has been linked to a 20-25% cutdown in therapeutic costs. With the increasing need for such product clinical development programs are being progressively updated to provide sufficient evidence for equivalent efficacy and comparability of safety and immunogenicity between candidate biosimilar and the reference biologic. Considering the latest therapeutic advent with the establishment of the treat to target strategy, the use of biosimilars in rheumatology practice seems tempting and deserves potential consideration with intense efforts.
- Track 3 Biosimilar Analytical Strategies
Track 10 Bioequivalence Assessment
Track 13 Biosimilar Pharmacovigilance
Session Introduction
Dipti Gulati
PJI Biotech, USA
Title: Biosimilar Development Cost: Role of Analytics
Time : 10:55-11:25
Biography:
Dipti Gulati completed her Ph.D 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 groups of PDA.
Abstract:
A biosimilar product is a biological product that is approved based on showing that it is highly similar to the reference product, with no clinically meaningful differences in terms of safety, efficacy and quality from the reference product. Biosimilar development is more time consuming and costlier that the generic development due to complex manufacturing process and product. While generics takes only couple years to develop with a cost of about 5-10 millions, biosimilar takes 8-10 years to develop with the cost of 100-300 millions. Typical steps in Biosimilar development are to characterize US licensed reference product, define target product profile, reverse engineer the biosimilar, define critical quality attributes, perform analytical comparability between proposed biosimilar and reference product, optimize the process until high analytical similarity between reference and biosimilar is achieved and address the residual uncertainties with analytical, non-clinical and clinical studies. A deep knowledge of critical quality attribute of reference and biosimilar product is the critical step for the development of biosimilar. It is important to understand how CQA links to the manufacturing process (critical process parameter and critical material attributes) and clinical performance of product (safety, efficacy and immunogenicity). A biosimilar product is not exact copy of reference product but similar to reference product. However, if biosimilar critical quality attributes are highly similar to reference product CQA, there is a great possibility that clinical performance of biosimilar will be similar to innovator product. Thorough understanding of product quality attributes can be achieved by analytical characterization and testing. The comparison between critical quality attributes can also be performed by analytical comparability studies. Analytics also allows the detection of changes in quality attributes due to change in molecule or process. There are great number of tools which can even detect minor differences in carbohydrate structures. Additionally, there are a whole array of biological assays available, which can detect if change is clinically meaningful or not. Higher analytical capability (Product Knowledge and analytical tools) is the key to reducing the development time and cost of Biosimilar.
Luis H. Camacho
Center for Oncology and Blood Disorders, USA
Title: Pharmacovigilance in Cancer Medicine
Time : 11:25-11:55
Biography:
Luis H. Camacho, MD, MPH received his MD degree from The Universidad Militar Nueva Granada in Bogota Colombia and Internal Medicine at The George Washington University in Washington DC. He subsequently trained in Medical Oncology and Hematology at Memorial Sloan-Kettering in New York. Dr Camacho has dedicated his career to clinical investigation and drug development. He has over 150 peer reviewed publications including scientific abstracts, original articles, and book chapters. Dr Camacho serves the board of several regional and National societies and committees. This year, Dr. Camacho has joined our organizing committee at Euro Biosimilars 2016.
Abstract:
Biologicals are critical in cancer medicine. Four of the top ten biological blockbusters worldwide are oncology drugs used for therapeutic or supportive care. The global market for biologic cancer therapies approximately totalled US$ 51.2 billion in 2014 and is expected to reach US$ 66.4 billion in 2019. Since the patents for most of these top-selling agents will expire by the year 2020, industry will turn to develop. In fact, manufacturing biosimilars is more cost and time effective than developing their reference products. However, the postmarketing safety monitoring is among many concerns surrounding the field of biosimilars in oncology. A PUBMED search for safety reports of the top three top cancer biologicals with upcoming patient expiration demonstrated only between two and eighteen publications since their FDA approval over one decade ago. Interestingly, while the toxicities observed during the development of bevacizumab were similar to the pre-marketing experience, a greater incidence of neutropenia was described with rituximab and a higher incidence of heart failure when in combination with adriamycin was described with the use of trastuzumab in their postmarketing vigilance. Greater efforts to educate patients and healthcare providers to report AEs as well as requesting periodical dissemination and publication of reports by sponsors will be determinant to ensure the post-marketing safety of these agents and gaining the trust of health care providers. Ultimately, the responsibility for identifying safety signals in postmarketing should be shared by healthcare providers, sponsors, and regulatory agencies in Europe and the US.
Alexander Pitters
Kaiser Optical Systems, SARL, France
Title: Process Raman Spectroscopy for In-Line Monitoring of Mammalian Cell Cultures in Real Time
Time : 11:55-12:25
Biography:
Alexander Pitters is a Life-Science Engineer (M.Sc. - University of Technology and Economics Berlin), worked at Max Planck Institute for Molecular Genetics in Berlin as a Biologic-Technical Assistant, at Procter&Gamble Brussels Innovation Centre as a Process Development Engineer, and at Bayer Technology Services in Berkeley as a PAT-Biologics Engineer. He joined Kaiser as an Applications Scientist to analyze data, create chemometric models and develop business within the pharmaceutical industry.
Abstract:
Mammalian cell cultures are complex processes where cells are cultivated under highly controlled conditions using media with a very high number of components. Current effort is focused on obtaining a better understanding of mammalian cell cultures by cultivating predominantly CHO cells for therapeutic protein production. To ensure a healthy progression of the cell culture, it is important to understand and monitor the stages of the biologic manufacturing. In order to build quality into a process a primary step is to analyze the process, understand what the critical quality attributes are, and monitor or rather control those factors. Consequently, there is a significant interest and value in techniques that provide instantaneous response for monitoring and analyzing biopharmaceutical processes. Molecular techniques - such as Raman spectroscopy - are widely used for PAT applications, because they provide in-situ information in real-time. Kaiser Raman spectroscopy is a method by which multiple bioprocess assays can be measured in situ within the bioreactor or fermenter environment. Raman is a fundamental vibrational spectroscopic technique that provides chemical and physical information that can be used to generate multi-component qualitative and quantitative predictive models. The presence of water does not interfere with the spectrum as it does with other spectroscopic methods such as NIR and mid-IR. Thus, Raman is well-suited for a host of upstream and downstream bioprocess applications. Real-time measurements within Biopharma are achieved for Glucose, Glutamine, Glutamate, Lactate, Ammonium, Viable Cell Density, Total Cell Density, Osmolality, Monoclonal Antibodies and Viability. The analyzer software enables a fully integrated bioprocess management and the instruments allow to control 4 bioreactors from a working distance of 1 to 1000 m. In recent years, Kaiser Raman has opened up new avenues to bioprocess analytics by demonstrating a technology that is robust, scaleable, provides in situ knowledge, and is transferable between cell lines, media feedstocks, and process conditions. During process development, Raman is now crucial for adopting QbD principles to define manufacturing design spaces and demonstrate holistic process and quality understanding. During production, a single Raman sensor can be used to monitor and enable control of several critical parameters in real time. Compared to traditional off-line analytical methods, in situ Raman reduces cost, consumables, sterility risk, equipment maintenance, and operator overburden. The wealth of bioprocess information enabled by in situ, real-time Raman is being realized by many companies to deploy leaner, continuous, and hybrid biopharmaceutical manufacturing. Analyzers can be used to study solids, liquids or gas without sampling accessories or preparation. Kaiser Optical Systems is the leader in Raman instrumentation and advanced holographic components for spectroscopy. Products and services are positioned in pharmaceutical and chemical manufacturing around the world.
Biography:
Dipti Gulati completed her PhD 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 groups of PDA.
Abstract:
A biosimilar product is a biological product that is approved based on showing that it is highly similar to the reference product, with no clinically meaningful differences in terms of safety, efficacy and quality from the reference product. Biosimilar development is more time consuming and costlier that the generic development due to complex manufacturing process and product. While generics takes only couple years to develop with a cost of about 5-10 millions, biosimilar takes 8-10 years to develop with the cost of 100-300 millions. Typical steps in Biosimilar development are to characterize US licensed reference product, define target product profile, reverse engineer the biosimilar, define critical quality attributes, perform analytical comparability between proposed biosimilar and reference product, optimize the process until high analytical similarity between reference and biosimilar is achieved and address the residual uncertainties with analytical, non-clinical and clinical studies. A deep knowledge of critical quality attribute of reference and biosimilar product is the critical step for the development of biosimilar. It is important to understand how CQA links to the manufacturing process (critical process parameter and critical material attributes) and clinical performance of product (safety, efficacy and immunogenicity). A biosimilar product is not exact copy of reference product but similar to reference product. However, if biosimilar critical quality attributes are highly similar to reference product CQA, there is a great possibility that clinical performance of biosimilar will be similar to innovator product. Thorough understanding of product quality attributes can be achieved by analytical characterization and testing. The comparison between critical quality attributes can also be performed by analytical comparability studies. Analytics also allows the detection of changes in quality attributes due to change in molecule or process. There are a great number of tools which can even detect minor differences in carbohydrate structures. Additionally, there is a whole array of biological assays available, which can detect if change is clinically meaningful or not. Higher analytical capability (Product Knowledge and analytical tools) is the key to reducing the development time and cost of Biosimilar.
Christina Vessely
Biologics Consulting, USA
Title: Analytical Assessment of Biosimilarity – Considerations in Study Design
Time : 12:25-12:55
Biography:
Christina Vessely, earned her Ph.D at the University of Colorado Health Sciences Center. has about 20 years experience in analytical and formulation development within the biotechnology industry. Her experience ranges from early stage research through late stage development and commercialization for small and large pharmaceutical companies. Areas of expertise include analytical method development and validation, development of reference standards, stability strategy and evaluation, and establishment of comparability and/or biosimilarity. Product experience includes vaccines, insulin analogs, cytokines, monoclonal antibodies, and other therapeutic proteins. She has been involved in the development and execution of CMC/Regulatory strategy for both novel and biosimilar products.
Abstract:
The demonstration of biosimilarity is critical to the approval of biosimilar products. While confirmatory studies may be required to confirm safety in animals and in the clinical setting, these studies are limited in their ability to assess differences between the biosimilar and the reference product. Analytical characterization has therefore become the key to the assessmet of biosimilarity. One of the most difficult aspects of the demonstration of biosimilarity is the design of the biosimilarity study. This includes the determination of how many lots of reference material must be analyzed as well as which analytical methods are required for the comparison. A strong analytical package should include release assays as well as extended characterization methods. The specific methods are dependent on the individual product. Procurement strategies for reference product must also be considered. Asessment of the reference product should be a survey of the product quality over time, as opposed to a snapshot of product quality for a single lot. Cost of the reference products can become a critical factor in procurement strategy and study design. This goal of this presentation is to provide some guidance on the design of biosimilarity studies for the analytical characterization of the biosimilar product, looking both at release characteristics as well as degradation pathway assessments.
Aparna Kasinath
Syngene International Limited
Title: Recommendations from the AAPS LBABFG Biosimilars Action Program Committee for the Validation Of Pharmacokinetic and Immunogenicity Assays in Support of Biosimilar Drug Development
Time : 14:45-15:15
Biography:
Aparna Kasinath is currently Head & Test Facility Management, Regulated Bioanalytical Laboratory, Syngene International Limited, Bangalore, India. Aparna has more than 14 years of assay experience which includes close to a decade of Immunoassay Development/Transfer, Validation and Sample analysis in support of PK and Immunogenicity studies for novel biologics and biosimilars. Aparna has a PhD from Sardar Patel University, Gujarat, India and was selected as a UNESCO fellow to the Czech Academy Of Sciences, Prague as a part of her PhD program. Aparna is an active member of various Bioanalytical Groups and works to not only to synchronize bioanalytical Practices with Global Regulatory Requirements, but also strives to bring out the Indian Bioanalytical Perspective on to a Global Platform for effective Harmonization of best practices.
Abstract:
While, the development of Biologics is complicated and a strategy driven approach, mainly owing to the complexity and nature of the molecule, development and commercialisation of a Biosimilar is two fold challenging. The Biosimilar is not only required to meet safety and efficacy end points as with all biologics, but also must demonstrate comparability with its Innovator. Demonstration of comparability requires robust developed and validated assays that are able to pick out bioanalytical differences between the Biosimilar and Innovator. Pharmacokinetic and Immunogenicity assays are the major measurement platforms for safety and efficacy data arising from non clinical and clinical studies. Currently there are no regulatory guidelines that clearly define the process/ path to be taken for designing comparability assays. This talk is aimed at discussing the recommendations made by the AAPS Ligand Binding Assay team for a harmonized strategy for Biosimilar assay development and a One or Two assay bioanalytical strategy. This discussion is tailored to all biosmilar manufacturers and biosimilar bioanalytical scientists in particular.
Rafiq Islam
Celerion Inc., USA
Title: A case study: Scientific challenges for bioanalytical method development of biosimilars
Biography:
Rafiqul Islam is the Senior Director of Bioanalytical Services at Celerion Inc. In his current role he is responsible for the scientific and operational leadership of both small and large molecule bioanalysis which includes the development, validation and execution of sample analysis to support pharmacokinetic, immunogenicity, bioequivalence and biosimilar studies. Previously, he held similar positions at EMD Millipore, Covance and Huntingdon Life Sciences. He also held several positions of increasing responsibility with Curagen Corporation. His experience and expertise includes biosimilar product research and development; bioanalytical analysis in FDA regulated environment, and streamlining workflows for laboratories with diverse operations in multiple sites. He has successfully led bioanalytical businesses over last 15 years utilizing a blend of scientific knowledge and managerial expertise in major CROs
Abstract:
According to recent FDA guidance, a Biosimilar is a biological product which is shown to be highly similar to the reference product not withstanding minor differences in clinically inactive components. It is essential to demonstrate that there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency. Accurate and reliable bioanalytical and immunogenicity data are critical to demonstrating safety and efficacy of biosimilar and to show comparability between innovator and Biosimilar. Demonstration of comparability between biosimilar and innovator compound could be challenging due to different methods used to establish the strength of the drugs. This may lead to significantly different concentrations between biosimilar and innovator drug. Cell-based potency assays may not be able to detect differences between biosimilar and innovator due to wide acceptance ranges (70% to 130%) used in these assays. If the concentration differences cannot be resolved, it may require two assays to measure pharmacokinetic samples for innovator and biosimilar drugs. Use of two separate assays may indicate that the two products are significantly different and necessitate analysis of both compounds using both assays. Proving similarity of the immunogenicity of the biosimilar and innovator can also be quite challenging due to the fact that these types of assays are generally qualitative. The rate of immunogenicity can be particularly difficult when the incidence of positive response is low. In addition, a small process changes during the manufacturing of therapeutic proteins may lead to significant changes in the rate of immunogenicity. Due to these reasons, it is necessary to develop two robust immunogenicity assays, one for biosimilar and one for innovator, with comparable sensitivity, precision, specificity and drug tolerance. Our labs recently developed bioanalytical assays to support biosimilars of Forsteo® (also known as Forteo®). This presentation will explore above challenges and present solutions using Forsteo® assays as a case study.
- Keynote Session 2
Session Introduction
Ruediger Jankowsky
Cinfa Biotech, Germany
Title: Overcoming the challenges of biosimilar development as a mid-size player
Time : 14:00-14:45
Biography:
Ruediger Jankowsky was appointed to the Managing Director of Cinfa Biotech in 2014. He is responsible for the set-up and leadership of Cinfa Biotech’s international organization. He has over 15 years of experience in the pharmaceutical industry, where he held various international executive positions in global and mid-size pharmaceutical companies. During this time he developed an expertise in medicinal product development and business development. Before joining Cinfa Biotech, he was responsible for the global management of biosimilar development projects at a leading biopharmaceutical manufacturer. He holds a PhD in protein biochemistry.
Abstract:
The market for biosimilars is evolving, rapidly. Based on the growing confidence in biosimilars, many players are entering this market, including mid-size companies. Such players with a more local focus have many opportunities in the future biosimilar market because of their strong local presence, flexibility and nimbleness. However, there are challenges regarding development costs, timelines and risk. To address these challenges, mid-size players require a clear strategy for product design, development and market launch right at the project start. In the first place, the product design has to reflect the requirements from all stakeholders. Pharmacists can provide valuable input to product design as they have a holistic view in terms of quality, usability, economics of treatment, supply chain and other aspects. Secondly, for product development, there are essential prerequisites such as robust funding, an expert team and a strong partner network. However, the development costs for biosimilars are significant and the development time up to approval exceeds five years in most cases. Hence, efficient development programs are needed without compromising quality. The biosimilar concept provides tools to make the development efficient. Accordingly, biosimilarity is established at the analytical and functional levels and confirmed by clinical studies. Thus, a thorough analytical and functional data set using state-of-the-art methods is required as well as highly specific and sensitive clinical study designs to detect clinically relevant differences. The biosimilar concept approach allows for high-quality data, and helps making development efficient, thereby supporting mid-size players to overcome the challenges of biosimilar development.
- Track 6 Biosimilar Innovator Pharmaceutical Products
Track 7 Globalization of Biosimilars
Track 11 BCS & IVIVC Based Biowaivers
Track 12 Biosimilar Market Analysis
Session Introduction
Christelle Dagoneau
Catalent Biologics, USA
Title: Impact on technology integration on better and faster biosimilars pipeline
Biography:
Christelle Dagoneau, PhD, is Director, Business Development for Catalent Pharma Solutions where she has been heavily involved in the design of biosimilar development programs for the past 5 years. Prior to joining Catalent, she served as Head of Marketing and Sales at PX'Therapeutics (France) for 6 years and has held additional commercial, marketing and research funding roles in France and in the United Kingdom between 2001 and 2005. She holds a PhD in Organic Chemistry as well as a Master in Technology & Busines Management obtained from Grenoble Business School.
Abstract:
By 2020, patents will have expired for originator biologics accounting for about $100bn and Biosimilars are expected to take over on about 25% of this market. Today, 250 companies are focusing on follow-on biologics therapies and, looking at the key players, strategic alliances are now in place and recent acquisitions have further structured this new and expanding market. Still, a swarm of new biosimilar developers plan to enter the game and will rely on stategic partnership with Biosimilar expert solution provider like Catalent to support their with innovative and virtual business models. In this talk, the author will give an overview of the standard development strategies applied to the development of biosimilar products from innovator’s characterizationn through to Phase I manufacturing stage including general timelines and budget estimates. She will also describe how the end-to-end integration of development, analytical and manufacturing activities combined with customized and high-throughput design of experiments (DOE) for cell line/process development stages can accelerate development timelines and help select better biosimilar molecules.
Candida Fratazzi
BBCR Consulting, USA
Title: Biosimilar globalization- A silver lining in untested waters
Biography:
Candida Fratazzi devised the concept of SCIO, cost-effective trial design, and streamlining solutions. She has been involved in the development of several biosimilars. As President of BBCR, she acts as a consultant to biotech, pharmaceutical, medical device companies and investors. She is a renowned Immunologist and has over 15 years of experience in Orphan Drug development. She is the recipient of 2013, 2014 and 2015 Best Pharmaceutical Consultant, Cambridge Award and 2014 top ranked US Executives. She helps international companies to enter the US and EU markets. She has had her training at the Johns Hopkins University, Harvard University and at Imperial College in London, UK.
Abstract:
Twenty-four countries have already approved biosimilars. Some of them, like China and Russia, are not WHO compliant or have developed a biosimilar specific development pathway. Biosimilar authorisation poses a number of substantial scientific and regulatory challenges for local regulatory authorities. Overall, the WHO perspective drives the similar biotherapeutic products globally. The WHO promotes a stepwise comparability exercise indicating that more work is done in pre-clinical comparability, less work is needed in clinical studies. The clinical requirements vary accordingly to existing knowledge of the reference product and the claimed therapeutic indication(s). This presentation focuses on two challenges that, in our opinion, are common across the globe. Clinical studies are necessary to demonstrate comparative efficacy. Special attention should be devoted to immunogenicity which must be always investigated for all products with due consideration to risks in different indications. Clinical Safety is to be monitored closely via risk specification and pharmacovigilance plan (PV). From a regulatory perspective, a risk management plan (RMP) or PV plan requirements do not differ in biosimilars from other biologic therapeutics. Extrapolation of safety and efficacy data is justified from one indication to another with a comprehensive comparability program with the innovator and when the target receptor and the mechanism of action are identical. We reckon it critical to discuss extrapolation of data in the context of major changes in the manufacturing process of the originator biologicals. In such situations, the clinical data and the overall information of the exercise from one indication could be allowed to other indication extrapolation.
Luis Ulloa
Rutgers – New Jersey Medical School, USA
Title: From neuronal networks to neuromodulation with biosimilars
Biography:
Dr. Ulloa completed his postdoctoral studies from Memorial Sloan Kettering Cancer Center. He is currently Associate Professor at Rutgers – New Jersey Medical School. He has published more than 75 papers in reputed journals and serves as an editorial board member of pretigious scientific journals.
Abstract:
Sepsis remains a leading cause of death in hospitalized patients, despite the efficacy of the new antibiotics and the major advances in modern hospitals. These mortality rates remain high because new antibiotics are efficient controlling the infection, but they do not control inflammation. Sepsis is one of the most lethal examples of inflammation as the overzealous systemic inflammation becomes more dangerous than the infection itself. Currently, most of the therapies are largely supportive, and there is no effective treatment for severe sepsis. We reported that electrical vagal stimulation controls inflammation and improves survival in experimental models of sepsis1,2 . But, the clinical implications of this mechanism were limited by the surgical procedure required for electrical nerve stimulation. We recently reported that neuronal stimulation with transdermal neurostimulation prevented systemic inflammation and improved survival in experimental sepsis. Neurostimulation inhibited the production of inflammatory factors by inducing the production of dopamine from the adrenal medulla. From a pharmacological perspective, dopamine inhibited macrophage’s activation via D1-like dopaminergic receptor3. Clinically, neural stimulation through neurostimulation is a promising strategy to control inflammation, but its efficacy is questioned due to the placebo effect. We also studied the effects of electroacupuncture in anesthetized patients during surgery, analyzing blood samples collected under general anesthesia to avoid any placebo effect. Electroacupuncture during surgery reduced the postoperative use of analgesics, physiological stress, hyperglycemia and inflammatory responses to trauma. These studies were funded by the NIH-GM084125.
Michael G Tovey
Ecole Normale Supérieure, France
Title: High throughput assays for the determination of the potency and comparability of biosimilars and innovator products
Biography:
Michael G Tovey, PhD, is INSERM Director of Research, Laboratory of Biotechnology, Ecole Normale Supérieure, Cachan, France. He is author of >250 articles on cytokines, biotechnology, and immunogenicity, a member of numerous scientific boards, Chair of the International Cytokines Standards Committee, a Member of the ICIS International Council, the European Adjuvant Advisory Committee, Editor-in-Chief of Detection and Quantification of Antibodies to Biopharmaceuticals, Associate Editor Cytokine, Associate Editor Journal of Interferon and Cytokine Research, Associate Editor The Scientific World Journal, a member of the Editorial Board of the Journal of Immunoassay & Immunochemistry and chair of Coral Gables Symposia.org
Abstract:
Successful development of biosimilars is dependent upon the establishment of validated and standardized assays that allow direct comparisons of the relative potency and comparability of innovator molecules and biosimilars. A validated standardized high throughput assay platform will be described in this presentation that is applicable to most biopharmaceuticals and that allows direct comparison of drug potency and comparability of innovator molecules and biosimilars in the same assay. Case studies will be presented for biopharmaceuticals ranging from novel forms of human insulin and FGF-21 to bevacizumab, trastuzumab, and structurally diverse TNF-α antagonist.
Md Abu Zafor Sadek
Renata Limited, Bangladesh
Title: Growth potential of biosimilar products in Bangladesh
Biography:
Md Abu Zafor Sadek is a Pharmacy & Business Graduate who has been successful in his 10 years career in pharmaceutical brand management & training with a high degree of creative mindset and who loves to enjoy the stretching goals. In addition to his regular job, he is pursuing for Doctor of Business Administration Degree from the Institute of Business Administration (IBA), University of Dhaka, the leading business school of the country. He has two publications in two different journals.
Abstract:
In view of the global changes in disease pattern, reduced health budget, patent expiry of some high valued products and side effects of chemical drugs, global pharmaceutical giants are concentrating on biotech products among which anticancer, cardiovascular, antidiabetic, antiasthmatic, antiarthritic products are specially important. However, developing a biotech product involved huge cost which is possible only by research based top companies. Realizing the fact, many pharmaceutical companies tried to imitate the original biotech products after patent expiry and became successful which bring a breakthrough in terms of health cost. These imitated products are termed as biosimilar products. Considering present stumpy growth in pharmaceuticals, geographical location, economic growth, drug policies, expertise etc Bangladesh may be an impressive hub for rapid growth of biosimilar products. Therefore, this study will concentrate to determine the growth potential of biosimilar products in Bangladesh.