Biosimilars and Follow – On Biologics 2015 Americas
Biosimilars and Follow-on Biologics are copied version of reference biologics which are protected by intellectual rights. We are now reaching the long anticipated period of patent expiration which is the major driving factor of the Biosimilars market. With some $60 billion worth of the pharmaceutical industry’s biggest blockbuster biologics coming off patent in the US and Europe in the next four years, contributing a significant gap to be filled with a more cost-effective follow-on products. This would provide a competitive advantage to local pharmaceutical manufacturers over the global players, undoubtedly that the market for biosimilar and follow-on biologic products is due to burst.
Furthermore, regulations plays a crucial role in sustaining feasibility and equilibrium between the original and biosimilar products. Key markets such as US and Europe are now vigorously regulating the sector, with FDA and EMA now providing guidelines for regulatory approval, biosimilar companies from less established market can now see to differentiate current practices needed to gain approval in new markets.
Another contributing factor to take the biosimilars market to a new heights is the continued rise in chronic diseases among aging populations which continues to drive the need for more cost-effective healthcare in developed countries.
However, some scientific challenges, unanswered questions and uncertainties surrounding biosimilars and follow-on biologics are creating remarkable obstacles for companies to increase uptake in the global market. The only way to success is to organize a cross disciplinary team with expertise in biological products, clinical development, regulatory affairs, and medical practices to watchfully plan a proper development strategy.
A recently released report suggests that the global market will reach $36 billion by the year 2020, up from the estimated $1.3 billion in 2013. High profitability is the attractive aspect that is enticing companies to invest in the biosimilars industry.
Why you should attend?
- Learn the current global regulatory guidelines and considerations for developing and bringing the next generation of Biosimilars to circulation
- Explore the effect of FDA’s draft guidance, impending patent expiration, and role of exclusivity in patents
- Study the pre-clinical and clinical challenges associated with the development of biosimilars and follow-on biologics
- Examine the non-clinical strategies and safety assessment to facilitate clinical and market entry efficiently
- Explore CMC, mass spectrometry requirements to establish biosimilarity
- Identify challenges encountered with Extrapolations and interchangeability, assessing immunogenicity and Pharmacovigilance
- Focus on the issues and implication of INN’s
- Learn the regulatory requirements in analytical development and market entry of biosimilar Mabs
- Know the strategies in place in developing and manufacturing biosimilars in emerging markets
- Network with experts and leading drug developers, regulators and investors in the industry
Who should attend?
Chief Executives, Executive Directors, Vice Presidents, Heads and Team Leaders and Managers working within:
- Follow on Biologics/Follow on Proteins/Biosimilars
- Biologics/Biotechnology/ Biogenerics
- Biopharmaceuticals/ Biotherapeutics
- Legal Affairs
- Intellectual property
- Pricing and Reimbursement
- Clinical Immunology
- Regulatory Compliance
- R & D
- Preclinical and Clinical Development
- New Product Development
- Quality Affairs/ Quality Control
- Principal Scientist
- Chief Scientific Officer
- Drug Safety & Risk Management
- Health Economics
- Process Control and Analytical Technologies
- Business Development
- Commercial Affairs
- Marketing & sales
- Intellectual Property
- Legislation and Policy Advice
- Business Development
- Drug and Safety Assessment
- Market Strategy
- Regulatory Affairs
I look forward to meeting you at the conference.
Paradigm Global Events
Pre- Conference Workshop
Pre-Conference Workshops: Monday 23rd February 2015
09:00-13:00 – Best Approach and Latest Updates for Successfully Bringing Biosimilars to Market
- Commercial potential and best ways on how to gauge such an opportunity in biosimilar.
- What are the latest trends in biosimilar development
- Risk management approaches and innovative entry strategies
- Effective time and cost management to increase sales and profitability
- Leading strategies in launching new biosimilar product
Workshop Leader: Richard DiCicco, Co – Founder, Harvest Moon Pharmaceuticals
- Liz Fuller, Partner, Bird & Bird
13:00 – 14:00 – Networking Lunch
14:00-18:00 – Understanding the Global Regulatory Landscape for biosimilars and Follow-on Biologics
- Understanding the different regulatory approaches currently in place in different regions
- Key regulatory issues encountered by biosimilar manufacturers
- What are the regulatory guidance on proving comparability?
- Immunogenicity studies: how to assess risks and concerns effectively
- How can regulators advocate doing extrapolations of indication?
- Best approach for successful approval
Workshop Leader: Dr. Andrea Laslop, Head of Scientific Office, Austrian Agency for Health and Food Safety, AGES
- Brenda Huneycutt, PhD, JD MPH, Director Regulatory Strategy and FDA Policy Practice, Avalere Health
Dr. Thomas Felix – R&D Policy Director – Amgen’s Global Regulatory Affairs and Safety organization
He has worked at the company since 2006. As Amgen develops its biosimilars, Dr. Felix contributes to a cross-functional, multidisciplinary team committed to advancing science and policy for a successful, patient-focused implementation. Dr. Felix interacts with private/public payers, medical societies, and leaders from various therapeutic areas to help inform and shape biosimilar policy in the US. He serves as a subject matter expert, informing US State governments on necessary legislative provisions to allow for science-based substitution of biosimilars in the retail/specialty pharmacy settings. Dr. Felix also contributes to the advancement of pharmacovigilance (AKA. drug safety) systems to accurately identify adverse events in a timely manner. He partners with internal and external pharmacovigilance experts to better understand the ability to track and trace multisource therapeutics across treatment settings and regions.
Dr. Felix earned his medical degree at the PSG Institute of Medical Sciences and Research (India). Prior to Amgen, Dr. Felix was Vice-President of Medical Affairs at an NBC Universal health media company (Healthology, Inc., New York, NY), an organization dedicated to the development of physician-led educational programs on disease management across therapeutic areas. Prior to that, Dr. Felix worked at Aventis Pharmaceuticals (Bridgewater, NJ) as a member of the medical team dedicated to studying and sharing the appropriate use of anticoagulant therapy enoxaparin (Lovenox®).
Jennifer Campbell, Director WorldWide Biosimilars Market, Process Solutions, Merck Millipore
Jennifer Campbell is the Director WorldWide Biosimilars Market for Process Solutions at Merck Millipore. Jennifer has 20 years of industry experience, including research and development, assay development, process development, cGMP manufacturing, and technical consulting. Jennifer has 2 scientific Masters degrees and an MBA, and she is published in the fields of animal research, biopharmaceutical validation, viral clearance, and biosimilars development.
Jim Roach – M.D., FACP, FCCP, SVP, Development and Chief Medical Officer – Momenta Pharmaceuticals, Inc.
James M. Roach, M.D., FACP, FCCP has been Senior Vice President, Development and Chief Medical Officer at Momenta Pharmaceuticals, Inc. since February 2008, responsible for preclinical and clinical development and regulatory affairs. Prior to joining Momenta, Dr. Roach was the Senior Vice President, Medical Affairs at Sepracor, Inc, where he led the Medical Affairs group from 2002 to 2008. Dr. Roach has also held senior clinical research and/or medical affairs positions at Millennium Pharmaceuticals, Inc., LeukoSite, Inc., Medical and Technical Research Associates, Inc. (a contract research organization), and Astra USA.
Dr. Roach has held an academic appointment at Harvard Medical School and has been an Associate Physician at Brigham and Women’s Hospital (BWH) and member of the BWH Pulmonary and Critical Care Medicine Division since 1993. He received his B.A. in Biology and Philosophy from the College of the Holy Cross and his M.D. from Georgetown University School of Medicine. Dr. Roach completed his residency in Internal Medicine and fellowships in Pulmonary Disease and Critical Care Medicine at Walter Reed Army Medical Center in Washington, D.C., and served in the US Army Medical Corps for ten years. Dr. Roach is board certified in Internal Medicine and Pulmonary Disease, and is a Fellow of the American College of Physicians (ACP) and the American College of Chest Physicians (ACCP).
Rakesh Dixit – Ph.D., DABT, Vice President R & D – Global Head, Biologics Safety Assessment , Pathology & LAR, MedImmune Inc., USA (AstraZeneca Global Biologics)
Dr. Dixit conducted extensive graduate and post-graduate training in Toxicology–Biochemistry with both Indian and US Institutions (Case Western Reserve University, Medical College of Ohio, University of Nebraska) and is board certified in Toxicology from the American Board of Toxicology, Inc. since 1992. Rakesh served as a Senior Toxicologist with Midwest Research Institute between 1987 and 1992.
In December 1992, Rakesh joined the Department of Safety Assessment, Merck and Co., Inc, West Point, PA where he served in various management positions. During his about 14 years with Merck, Rakesh contributed to the successful filings of many blockbuster drugs. For about a year, Rakesh was associated with Johnson and Johnson PRD, La Jolla/Alza as Senior Director of Toxicology.
In Aug 2006, Rakesh joined MedImmune, Inc. (an AstraZeneca Biologics company) as Senior Director (R &D) & Global Head of Biologics Safety Assessment, Experimental Pathology, and Laboratory Animal Medicine. In his current position as a Vice President of R &D, Rakesh is responsible for providing guidance on research and development of biological products; including nonclinical toxicology/safety support for all AstraZeneca-MedImmune biologics products, including monoclonal antibodies and vaccines. Rakesh has published more than 60 papers in renowned international journals and has given over 100 invited lectures/presentations/workshops in national and international meetings.
Rakesh’s areas of expertise are mainly in the area of pharmaceuticals and biologics drug development, safety assessment of small molecule drugs, biologics, vaccines and in exploring mechanisms of toxicity and biologics pharmacological activity. Rakesh has helped to bring several blockbuster pharmaceuticals to the market while working at Merck. Rakesh a recognized expert in safety and pharmacology biomarkers and their applications.. Rakesh is the Editor-in-chief of Toxicology Mechanisms and Methods and Associate Editor for Toxicology Applied Pharmacology, and Journal of Toxicology and Environmental Health. Rakesh also serves as an expert reviewer and in appointed committee for many programs managed by the prestigious U.S. National Academy of Sciences and US National Institutes of Health, including National Cancer Institute.
Hideaki Nomura – President & CEO – Fujifilm Kyowa Kirin Biologics in Japan
Hideaki Nomura is currently President & CEO for FUJIFILM KYOWA KIRIN BIOLOGICS (FKB). FKB is a joint venture company of FUJIFILM, a global film company, and KYOWA HAKKO KIRIN, a Japanese pharmaceutical company. FKB focuses on biosimilar manufacturing and development. Prior this position, Hideaki was a head of strategic planning in Nephrology field of KYOWA HAKKO KIRIN. He has over ten years of experiences in portfolio management and product management. During his scientific career, Hideaki held several key roles in pharmaceutical division of KIRIN BREWERY for formulation development, drug delivery system research, good manufacturing practice and operations.
Yariv Hefez, Vice President, Business Development and Alliance Management, Biosimilars Merck Serono, Switzerland
Yariv Hefez is the Vice President of Business Development, Strategy, Portfolio Management and Partnering of Merck Serono’s Biosimilar Division. Yariv has more than 15 years experience in business development, strategy, alliance management, strategic partnering, negotiations, deal making and conflict resolution. Yariv is responsible for defining and leading the strategy of the biosimilar business division and for identifying, evaluating and partnering with potential partners and then growing and maintaining these strategic alliances to secure the growth of Merck Seron’s biosimilar business. Yariv’s professional experience include several years experience in professional services; Yariv was the managing partner in a law firm and successfully built a business as an entrepreneur. Yariv carried out his studies in different universities in the field of Commercial Law and Business Management. He holds both a Master (LL.M) in Commercial Law from the Tel Aviv University and a Master in Business Administration (MBA) from IMD business school in Switzerland. Yariv joined Merck Serono in 2008 and since then led and managed strategic alliances, successfully negotiated and executed deals and led key strategic initiatives in collaboration with Pharmaceutical companies, Biotechs, CROs, CMOs and Generic Companies. Yariv led, on behalf of Merck’s biosimilar Divisons, the discussions and negotiations with Dr Reddy’s that resulted in the strategic partnership between Merck Serono and Dr Reddy’s.
Kenneth Surowitz, VP, Regulatory Affairs (Biologics), Dr. Reddy’s Laboratories (Awaiting for Photo & Bio)
Kenneth G. Surowitz is Vice President, Regulatory Affairs – Biologics, at Dr. Reddy’s Laboratories (DRL). He has responsibility for strategy development, Agency interface and registration of biosimilars and novel biologics for both emerging markets and highly regulated markets. He is based in Princeton, NJ.
Prior to joining DRL, Dr. Surowitz held positions of increasing responsibility at GlaxoSmithKline, Merck & Co., Progenics Pharmaceuticals, and Wyeth-Lederle Vaccines in development, commercial manufacturing and Regulatory Affairs for infectious disease and therapeutic vaccines, novel biopharmaceuticals and biosimilar products. He began his industry career as a product development microbiologist with Procter & Gamble Co.
Dr. Surowitz holds an MS and Ph.D. in Microbiology from The Ohio State University, Columbus and an AB in Biology from Lafayette College, Easton PA. He has served on several key issue teams (KITs) and technical committees of PhRMA and IFPMA for vaccines, biologics and international affairs, and serves as an adjunct professor in the RA/QA graduate program at Temple University College of Pharmacy.
Prof. Andrea Laslop, MD Head of Scientific Office, AGES MEA
Dr. Andrea Laslop joined AGES, the Austrian Agency for Health and Food Safety, on January 1st, 2006. She is heading there the Scientific Office, which constitutes the link to the European Medicines Agency (EMA) with a focus on the different types of centralised European procedures during drug development, marketing authorisation applications and life-cycle management.
Prior to this Andrea Laslop worked as an associate professor of pharmacology and toxicology at the Medical University of Innsbruck, Austria. Already during her engagement at the university she was appointed as member to several working groups of the EMA, e.g. the Efficacy Working Party in 1998, the Paediatric Expert Group and the Scientific Advice Working Party in 2003, in the latter serving on an ongoing basis. In June 2007, she also became alternate member of the Committee for Human Medicinal Products of the EMA, where she is representing Austria now as the full member since January 2009. Andrea Laslop studied medicine at Innsbruck University where she earned her MD and later on specialized as a pharmacologist. Her professional career included several sojourns for joint research projects at the NIMH in Bethesda, the Albert Einstein College of Medicine in New York and the Clinical Research Institute of Montreal. Since November 2007 Andrea Laslop served as the president of the Austrian Pharmacological Society and from November 2011 as vice president.
Dr. Steinar Madsen, Medical Director, Norwegian Medicines Agency Norway
Dr. Steinar Madsen, is medical director at the Norwegian Medicines Agency.
He is a specialist in internal medicine and cardiology and works part time as a consultant in cardiology. He has been working with generic substitution since it was introduced in Norway in 2001. He is member of a working group at the Agency that is looking into several aspects on the regulation of generic substitution in Norway, including biosimilar drugs, with the aim of a better legal framework. Dr. Madsen is also engaged in the Agencys drug information service, with a special interest in the safe use of drugs.
Richard Di Cicco, Co-Founder, Harvest Moon Pharmaceuticals USA
Richard DiCicco co-founded Harvest Moon Pharmaceuticals USA, Inc. in 2007 with a proven pipeline of products developed since 1984. Harvest Moon Pharma develops, manufactures, markets and exports worldwide, complex generic drug products and biosimilars. Small molecule generics include a complete line of transplantation products; complex hospital injectables such as enoxaparin, octreotide LAR and generic depots; transdermal patches; complex oral solids such as dronedarone; and, oral controlled release products such as -methylphenidate and nifedipine. Biosimilar products include adalimumab, rituximab, trastuzumab, infliximab, bevacizumab and etanercept entering phase III clinical trials and comply with the WHO revised biosimilar guidelines, all to be launched no later than 2015. Mr. DiCicco is a member of the Editorial Board of the Journal of Generic Medicines, a member of the Licensing Executives Society, speaks often and is widely published in generics and biosimilars.
Dr. Partha Roy, Principal Consultant, at PAREXEL Consulting
Dr. Roy has over 15 years of pharmaceutical R&D experience both in industry and US FDA with proven expertise in Clinical Pharmacology and Regulatory Sciences across multiple therapeutic areas encompassing both small molecules and biologics. Dr. Roy provides strategic guidance on various clinical and regulatory aspects of drug development. His primary areas of expertise include Biosimilars and Biologics, Oral Inhalation and Nasal drug products, Over-The-Counter medications, Pediatric drug development and Formulation development and. As a FDA reviewer/team leader, Dr. Roy had extensive review experience dealing with issues around 505(b)(2) pathway, BA/BE, dose selection, PK and PK/PD, biomarkers, clinical trial design, drug-drug interactions, special populations, pediatric plan and physician labeling.
Dr. Roy utilizes his experience to negotiate drug development plans with review divisions at FDA and develop regulatory strategies with clients for a favorable outcome. He is currently helping multiple clients mapping out regulatory strategies for drug candidates ranging from pre-IND to NDA stages, each one facing significant development challenges. Dr. Roy also frequently leads and coordinates FDA submissions (PIND, IND, NDA, post-marketing) for clients. Dr. Roy holds a PhD in Biochemical Toxicology from the College of Public Health, University of South Florida, and has completed a postdoctoral training in Drug Metabolism and Pharmacokinetics at Boston University. Dr. Roy is a frequent speaker at national and international meetings and has authored several peer-reviewed articles.
Sang Hoon Lee, Head of Hanwha Bio Division and Senior Vice President, Hanwha Chemicals
Dr. Sang Hoon Lee has strong industry experiences in drug discovery and development with cross functional knowledge. His expertise includes areas such as biosimilar development, new drug discovery and development as well as early stage clinical trials. He also possesses strong experience in building and constructing business plan, fund raising as well as managing start – up Biotech Company. As the co – founder of PharmaAbcine, he has headed R&D activities in target discovery, preclinical and clinical development of therapeutic antibodies as well as successful fund raising.
Currently, he is the Head of Hanwha Bio Division at Hanwha Chemicals where he is the leader of executive leadership team including R&D, clinical development and cGMP facility. He also leads antibody – based biosimilar and new drug discovery and development.
Bruce A. Leicher, Senior Vice President and General Counsel, Momenta Pharmaceuticals, Inc.
Mr. Leicher is Senior Vice President and General Counsel at Momenta Pharmaceuticals Inc., an innovator biotechnology company engaged in development of complex generic products, biosimilars, interchangeable biologics and novel products. Mr. Leicher has advised biotechnology companies for over 20 of his more than 30 years of legal experience. Mr. Leicher is a frequent lecturer on biotechnology law. Before joining Momenta, he served in senior legal positions at Altus Pharmaceuticals Inc., Antigenics Inc., Millennium Pharmaceuticals, Inc., Curis, Inc., Genetics Institute, Inc. and Wyeth. In private practice, he served as the Co-Chair of the Life Sciences Practice Group at Hill and Barlow, was an attorney at Hale and Dorr and Butler & Binion, and served as a law clerk to the Honorable Thomas F. Hogan in the U.S. District Court for the District of Columbia after receiving his J.D. from Georgetown University Law Center and his B.A. from the University of Rochester.
Dr. Bernd Liedert, Sr. Clinical Program Leader Biosimilars, Boehringer Ingelheim
Dr. Liedert is familiar with both sides of the table, the developers´ objectives and the regulators´ perspective on biosimilars development: Today Sr. Clinical Program Leader Biosimilars and Strategic Advisor for Extrapolation at Boehringer Ingelheim. For more than 6 years Head of Immunopharmacology at Merck Serono. He was member of the strategy implementation group, which established Merck Serono´s Biosimilars Unit in 2012. In parallel, Dr. Liedert and his group was intimately involved in Merck´s innovator program, especially in clinical development of monoclonal antibodies for oncology and AIIDs. Before, Dr. Liedert got insight experience of the Health Authorities´ perspective, when he served as senior regulator at the Paul-Ehrlich-Institute (PEI), the German Federal Agency for biologics and at the EMA, where he represented Germany in the Safety Working Party. He was co-author of several guidelines, which focus on risk mitigation for early clinical trials, immunogenicity and comparability/biosimilarity exercises.
Hillel P. Cohen, PhD, Executive Director, Scientific Affairs, Sandoz Biopharmaceuticals (a Novartis company)
Hillel Cohen is Executive Director of Scientific Affairs at Sandoz Biopharmaceuticals. He provides science-based input to help articulate Novartis policy for development of biosimilars, an area in which he has been active since 2003. Recently, Dr. Cohen had responsibility for orchestrating the all preparation and execution activities related presentation of Zarxio (filgrastim) to the FDA’s Oncological Drug Advisory Committee in January 2015.
Prior to joining Sandoz Biopharmaceuticals, Dr. Cohen was Head of Global Strategic Labeling and Head of Regulatory Affairs for North America for Novartis Vaccines. He has also held positions of increasing responsibility at Novartis Pharmaceuticals, Merck Research Laboratories, and Hoffmann La-Roche in the areas of regulatory affairs, bioanalytical chemistry and biotechnology quality control. Dr. Cohen has been active in trade associations and has chaired several association committees. He received a BA from New York University and a PhD from Dartmouth College.-
Brenda Huneycutt, PhD, JD, MPH, Director Regulatory Strategy and FDA Policy Practice, Avalere Health
Brenda Huneycutt, PhD, JD, MPH, Director in Avalere’s Regulatory Strategy and FDA Policy practice, advises clients on regulatory strategy and policy spanning drugs, biologics, and diagnostics, and conducts due diligence assessments for clients looking to acquire or in-license products. Using her molecular biology research background, combined with her legal and public health policy training, Brenda helps clients translate technical information into clear descriptions for various audiences, and offers special expertise in regulatory strategy for FDA approval strategies involving accelerated and new pathways, including breakthrough therapy and orphan designations, and biosimilars and interchangeable biologics. Prior to joining Avalere, Brenda conducted research at the Genetics and Public Policy Center at Johns Hopkins University and was an Patent Attorney for Finnegan, LLP. Brenda has a BA in Biology from the University of Delaware; a PhD in Molecular, Cellular, and Developmental Biology from the University of Colorado at Boulder; a JD from the George Washington University School of Law; and a MPH from Johns Hopkins Bloomberg School of Public Health.
Kevin M. Nelson, Partner, Duane Morris LLP
Kevin M. Nelson practices in the area of intellectual property with a focus on complex pharmaceutical patent litigation. For the past 13 years, Mr. Nelson has represented generic drug companies in patent litigation brought under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. He has experience with a wide array of issues relating to the pharmaceutical field, including oral and ophthalmic dosage forms, extended- and modified-release dosage forms, polymorphic drug substances, formulation and process development, analytical testing of drug substances and drug products, organic and inorganic chemistry, process chemistry, bioequivalence studies, Abbreviated New Drug Application (ANDA) preparation, Food and Drug Administration (FDA) regulations, drug delivery systems, pharmacokinetics, and pharmacodynamics. Mr. Nelson has been involved in litigation over blockbuster drugs, and have assisted clients in bringing their FDA-approved drug products to market.
Mr. Nelson has served as lead attorney for trial and has been an author of several briefs submitted to the Court of Appeals for the Federal Circuit. He has also argued before the Federal Circuit. He has further represented clients before FDA in regulatory matters and in opposing citizen petitions. In addition, Mr. Nelson has counseled clients on the regulatory issues associated with filing an abbreviated biologics license application (aBLA) to approve a biosimilar under Section 351(k) or a biologics license application (BLA) under Section 351(a). Mr. Nelson has been a frequent invited speaker on regulatory aspects of the biosimilars legislation and guidances.
Liz Fuller, Partner, Bird & Bird
Liz Fuller is a regulatory specialist, with over fifteen years experience in this field.
Liz is a consultant for our Intellectual Property Group. Liz is a practising US lawyer with over twenty years experience, focusing on regulatory and corporate life sciences work.
Liz spent 16 years in Switzerland and during her time there worked for the World International Health Organisation as Technical Officer (global programme for vaccines/vaccine supply) and Product Development Officer (Polio eradication initiative) and at biotech/pharmaceutical consultancy firm Triskel Integrated Services S.A, as General Counsel and Director of Legal Affairs. She was a Director at Wragge & Co in the Intellectual Property Group based in London before joining Bird & Bird.
Liz’s practice is focused on the development and regulation of pharmaceutical and biotechnology products, working with clients in the EU and US throughout the pharmaceutical life cycle. Her thorough knowledge of the strategic concerns and legal issues affecting biotech and pharmaceutical development makes Liz highly sought-after across the industry. In addition to her regulatory expertise, Liz has extensive experience with technology licensing, contract drafting and negotiation, both in biotechnology and other pharmaceutical contexts.
Liz is a member of the New York State Bar, American Society of Law Medicine and Ethics and the Regulatory Affairs Professional Society.
Liz is fluent in spoken French and proficient in spoken Spanish. She is also proficient in written French and Spanish.
08:00-08:45 – Registration and Coffee
08:45-09:00 – Chairman’s Welcome Remarks – Richard Di Cicco, Co-Founder, Harvest Moon Pharmaceuticals USA
09:00-09:40 – The new era of Biologic regulations
- Reference Product Exclusivity for Biological Products (FDA Draft Guidance)
- Affordable Care Act and BPCIA
- Patent provisions in relations to BPCIA
- The role of market exclusivity in Patents
Ajaz S. Hussain, Ph.D, Executive Director, NIPTE & Founder CEO at Insight Advice & Solutions LLC
09:40-10:10 – European regulatory overview and latest guidelines on use of reference products
- Updates on the latest EU regulatory guidelines
- Close collaboration with HTA’s for patients benefit
- Current challenges to make sure the development pathways are ready for the latest scientific development
Dr. Andrea Laslop, Head of Scientific Office, Austrian Agency for Health and Food Safety, AGES
10:10-10:50 – Regulatory considerations in developing global biosimilars products
- Things to consider before global biosimilar development
- Current regulatory status of biosimilar products in highly regulated markets and emerging markets
- Some challenges and opportunities
Kenneth Surowitz, vice President, Regulatory Affairs – Biologics, Dr. Reddy’s Laboratories
10:50-11:30 – Morning Refreshment and Networking
11:30-12:10 – Utilization of Clinical Pharmacology Data to Support a Demonstration of Biosimilarity
- Regulatory Framework and Expectations
- Role and current scope of comparative PK, PD and PK/PD data
- Examples of programs that adopted Clinical Pharmacology data as pivotal to demonstration of Clinical Similarity
- Abbreviated clinical programs based on PK/PD in the future – a reality check
Partha Roy, Principal Consultant, PAREXEL International
12:10-12:50 – CMC considerations for Biosimilar drug development and manufacturing
- Characterization studies to enhance comparability
- Modern manufacturing techniques and analytics to demonstrate similarity between Biosimilars and reference product
- Selection of reference product and cell line development
Martin Bluggel, Chief Executive Officer, Protagen Protein Services GmbH
12:50-13:20 – Smart Extrapolation Strategies for Biosimilar TNFa Antagonists
- Analogies to an established regulatory principle: Comparability Exercise after change of the manufacturing process
- How to reflect different modes of action: Smart combinations of preclinical models and clinical studies
- Sensitivity is the key: How to identify the most sensitive population for PK, efficacy, safety and immunogenicity extrapolation
- Impact of comorbidity and concomitant medication
- Extrapolation failed: Lessons from Eprex
- Extrapolation successful: Lessons from Remsima/Inflectra
Dr. Bernd Liedert, Sr. Clinical Program Leader Biosimilars, Boehringer Ingelheim
13:20-14:20 – Networking Lunch
14:20-15:00 – Designing a Biosimilars to Obtain a Designation of Interchangeability
- FDA/EMA positions on Interchangeability
- Complex generics: precedence and relevance
- “Interchangeability” of innovator biologics to themselves following product drift/process changes
- Approach to establishing fingerprint-like similarity (= interchangeability?)
- Role/Utility of Non-Clinical Models and Clinical Trials/Switching studies
Jim Roach, SvP, Development and Chief Medical Officer, Momenta Pharmaceuticals
15:00-15:40 –Process development strategy for biosimilars
- The development of biosimilars faces many challenges, including abbreviated process development timelines, regulatory hurdles for biosimilarity and cost pressures to develop robust manufacturing processes. This presentation will show data generated to overcome challenges such as minimizing process development, reducing capital investment and creating cost effective and scalable manufacturing operations.
Jennifer Campbell, Director WorldWide Biosimilars Market, Process Solutions, Merck Millipore
15:40-16:20 – Afternoon Refreshments and Networking
16:20-17:00 – Pharmacovigilance: Considerations for Manufacturer Accountability in Age of Biosimilars
- The state of pharmacovigilance in the US and Europe with multisource biologics using case studies
- Both passive and active methods of pharmacovigilance will be covered
- Identification of gaps in our current electronic health systems in various settings
Dr. Thomas Felix, R & D Policy Director, Global Regulatory Affairs and Safety Organizations, Amgen
17:00-17:50 – Extended Panel Discussion: Biosimilars development strategies
- Difficulties associated with producing Biosimilars
- How to increase development success and minimise cost
- Techniques in bringing the next generation of Biosimilars to the market
Moderator: Dixit Rakesh, vP, R & D, Global Head, Biologics Safety Assessment, Medimmune
- Jim Roach, SvP, Development and Chief Medical Officer, Momenta Pharmaceuticals
- Jennifer Campbell, Director Worldwide Biosimilars Market, Process Solutions, Merck Millipore
17:50-18:00 – Chairman’s Summary – Richard Di Cicco, Co-Founder, Harvest Moon Pharmaceuticals USA
18:00-19:00 – Networking Drink Reception (Exhibitor’s Lounge)
19:00-21:00 – Networking Gala Dinner
08:00-08:50 – Registration and Coffee
08:45-09:00 – Chairman’s Opening Remarks – Richard Di Cicco, Co-Founder, Harvest Moon Pharmaceuticals USA
09:00-09:40 – Update on FDA Development for Biosimilars
- Interchangeability guidance
- Naming issues- where is the WHO going and will FDA follow on the INN-GPhA Petition
- State legislative activities to restrict substitution of interchangeable Biosimilar
- REMS and their impact on restricting access to branded products needed for Biosimilar Comparability Studies
Kevin M. Nelson, Partner, Duane Morris LLP
09:40-10:20 – Biosimilars naming debate continues
- Should Biosimilars be allowed to share the same name as the reference products or required to have a distinct non-propriety names
- With Focus on Pharmacovigilance
- Patient safety issues
Bruce Leicher, Senior vice President, General Counsel, Momenta Pharmaceuticals
10:20-11:00 – Morning Refreshments and Networking
11:00-11:40 – Totality of Evidence
- Evaluating of critically of quality attributes
- Importance to focus on clinically relevant differences
- Analytical studies as the basis of high similarity
- Non- – clinical studies toe evaluate potential toxicology
- Human PK/PD studies
- Clinical confirmation of high similarity
Hillel Cohen, Executive Director of Scientific Affairs, Sandoz Biopharmaceuticals
11:40-12:20 – Lessons from the introduction of biosimilar infliximab in Norway
- What are the attitudes of physicians?
- Monitoring prices and sales
- Switching study – what is the status?
Dr. Steinar Madsen, Medical Director, Norwegian Medicines Agency Norway
12:20-13:00 – Merck (EMD) Biosimilars Division innovation partnership under the Productive Development Partnership (PDP’s) in Brazil.
In this case study you’ll hear how this collaboration was formulated and gain insights into:
- What is a Productive Development Partnership (PDP’s)
- Challenges and opportunities in entry into PDP for biosimilar drug development
- Decision-making process behind the partner selection, technology transfer and contracting
- The partnership and its contribution to the future of biologic R&D in Brazil and Latin America
Yariv Hefez, vice President, Business Development and Alliance Management, Biosimilars, Merck Serono
13:00-14:00 – Networking Lunch Break
14:00-14:40 – Clinical Development of HD 203 (Davictrel), Enbrel Biosimilar: Lessons Learned and Future
- Overview of Hanwha Chemical & Biologics Division
- HD 203 Development: Pre-clinical & Clinical Development
- Hanwha Biologics pipelines: HD201 (Herceptin Biosimilar) & HD204 (Avastin Biosimilar)
Sang Hoon Lee, PhD, Head of Bio Division and Senior Vice President, Hanwha Chemicals
14:40-15:20 – What influence is Monoclonal Antibodies to unlocking the Biosimilars Market
- The future of Biosimilar Mabs
- What are the Biosimilar Mabs on the horizon
- Obstacles to overcome before Biosimilar mAbs can enter daily clinical practice
Hideaki Nomura, President and CEO, Fujifilm Kyowa Kirin Biologics
15:20-16:00 – Afternoon Refreshments and Networking
16:00-16:40 – Possibility of biosimilars wiping out research budgets for innovation (in the long term).
- What is long term: 2017 – 2020 or 2021-2030?
- Biosimilars global forecast 2017 – 2020 and third wave biosimilars 2021 – 2030
- How the market will change with multiple biosimilars of the same originator product
- Regulatory changes necessary to maximize biosimilars potential
Richard Di Cicco, Co – Founder, Harvest Moon Pharmaceuticals
16:40-17:20 – Global market outlook in Biosimilars
- Challenges and opportunities in global Biosimilars market
- Current trends in global industry of Biosimilars
- Priorities of investments and opportunity for market growth
17:20-18:00 – Panel discussion: Market strategies for Biosimilars
- Strategies and techniques to overcome the challenges
- Considerations for successful market of biosimilars
- What are the key for a successful Biosimilars
18:00-18:20 – Chairman’s Closing Remarks and Summary – Richard Di Cicco, Co-Founder, Harvest Moon Pharmaceuticals USA
Merck Millipore is the Life Science division of Merck KGaA of Germany and offers products used by pharmaceutical and biotechnology companies to develop and manufacture biopharmaceutical drugs safely and efficiently. We provide an extensive range of products to support you during all stages of the drug manufacturing process from research to industrial-scale production and quality control. Our products meet the highest purity standards with extensive documentation and services to assure regulatory compliance. Through dedicated collaboration on new scientific and engineering insights, EMD Millipore serves as a strategic partner to customers and helps advance the promise of life science.
Protagen Protein Services GmbH is an international leading specialist in the fields of Protein Characterization, Biopharmaceuticals and GMP-compliant protein analysis. 15 year’s experience in business and the comprehensive, GMP compliant spectrum of analytical methods ensure highest quality the customers in the pharmaceutical, biotech, and the entire life science industry. Besides a large number of new biological entities (NBE) currently in development, Protagen has supported a vast number of customer projects to develop biosimilars for Etanercept, Rituximab, Infliximab, Trastuzumab, Erythropoietin, Adalimumab, Bevacizumab, Filgrastim, Insulin, Interferons and several other products. PPS data sets are accepted by EMA, FDA, and Korean-FDA for scientific advices, phases 1 to 3 or release testing. www.protagen.com
BioFactura develops and commercializes high-value biosimilars using our patented StableFast™ Biomanufacturing Platform that rapidly generates NS0 cell lines for biopharmaceutical manufacturing. The Company is targeting a unique set of marketed biologic drugs that are currently manufactured in Lonza’s GS-NS0 system or in the closely related SP2/0 cell line. These targets worth over $18B such as Synagis, Erbitux, and Remicade are optimally suited for development employing the StableFast™ technology. StableFast™ cell lines are cholesterol-free providing the only NS0 platform for single-use technology. BioFactura is developing biosimilars both internally and with strategic partners, and currently has multiple programs in the pipeline at the late preclinical stages.
SGS Life Science Services is a leading contract service organization providing clinical research, pharmaceutical development, biologics characterization, biosafety, and quality control testing. With a strong focus on biologics / biosimilars and vaccines, operating 28 facilities in 15 countries across the Americas, Europe and Asia, SGS represents the broadest wholly owned global network of contract analytical laboratories.
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