Biosimilars Global Congress 2014 Europe

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Background Info

Biosimilars Global Congress 2014 Europe

Paradigm Global Events is proud to present Biosimilars Global Congress 2014 Europe.
The two – day Congress will provide and interactive discussion and networking format led by key industry expert speakers with intimate knowledge in the industry. Gain practical strategies and best practices on challenges, innovations, technologies and concepts surrounding biosimilars.

Day one topics will focus on:
• Global Regulatory Perspective
• Current Regulations and future Challenges for the development of Biosimilars in Europe & US
• Regulatory Strategies in the Emerging Markets
• Harmonization
• Global Commercialization & Reimbursement
• Clinical & Non-Clinical
• Impact of Healthcare system on Biosimilars
• Patients perspective on Biosimilars
• Scientific and Clinical Considerations for Biologics and Biosimilars
• Harmonization to ensure patient safety
• Global Strategic Collaboration
• Including two interactive panel discussion on:

Day two topics will focus on:
• Update on FDA Development for Biosimilars
• Interchangeability – Guidelines
• Preparing for U.S. Market entry – strategy consideration in view of BPCIA
• Key Regulatory aspects for development and approval of Monoclonal Antibodies
• Manufacturing & development process considerations of Biosimilars
• Substitution and Interchangeability
• Challenges & Obstacles in Conducting Clinical Trials
• CMC requirement s for Biosimilars Product Development / Manufacturing
• Mass Spectrometry for Characterization & Comparability

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
• Pharmacovigilance
• 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
• Licensing
• Manufacturing
• APIs
• Bioequivalence
• Drug and Safety Assessment
• Market Strategy
• Regulatory Affairs

Workshop

Wednesday 17th September 2014 (Two Part: Pre – Conference Workshop)

Morning – 1st Part – Pre – Conference Workshop:

08:00 – 09:00 – Registration & Networking Coffee

09:00 – 13:00 – Biosimilar Monoclonal Antibodies: From theory in guidelines to reality after approval

• Update on regulatory guidelines and scientific advice
• Challenges during approval and post – marketing
• Update on global regulatory approaches

Dr. Andrea Laslop, Head of Scientific Office, Austrian Agency for Health and Food Safety, AGES, Austria
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.


13:00 – 14:00 – Networking – Lunch Break


Afternoon – 2nd Part – Pre – Conference Workshop:

14:00 – 17:30 – Clinical Development of Biosimilars

This Workshop will highlight and discuss the must know critical issues in the clinical development of biosimilars; how to navigate potential hurdles and how to build an efficient and effective program leading to ultimate success.

      • Deciding when ready to move to clinical trials
      • Challenges of Phase 1 programs (healthys vs. patients; combination with phase 3; study designs; pitfalls)
      • Therapeutic equivalence trials (overcoming challenges; choice of trial population; sample size; justifying margin; selecting endpoints; safety considerations)
      • Extrapolation across indications
      • Immunogenicity testing
      • Substitutability vs. interchangeability
      • Interacting with the regulators
      • Educating the market
Bridget Theresa Heelan, Vice President (Technical), PAREXEL International
Dr. Heelan has a background in medicine and immunology research. She has longstanding experience in the clinical management of patients with immune system dysfunction, including primary/secondary immunodeficiency, allergy and autoimmunity. She worked as a consultant immunologist in the NHS before moving to pharmaceutical medicine. At the MHRA she was a senior clinical assessor and was Chair of the Rheumatology Immunology working part of the EMA and the UK delegate for the Committee for Advanced Therapies. Areas of experience include immunogenicity assessment and biological products. As an MHRA assessor she assessed biological products in oncology and biosimilar products. Currently Dr Heelan is Vice President (technical) at Parexel.

Key Speakers

Key Speakers

Richard Di Cicco, Co-Founder, Harvest Moon Pharmaceuticals USA (Conference Chair)

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. Robert Friesen, VP and Head of Biologics Research, Biotechnology Center of Excellence, Janssen R & D Pharmaceutical companies of Johnson & Johnson

Dr. Robert Friesen, is Vice President and Head, of Biologics Research in the Biotechnology Center of Excellence within Janssen R&D. He was most recently VP and Head, Preclinical and Clinical Research at the Crucell Vaccine Institute (CVI), the Janssen Center of Excellence for Immunoprophylaxis, Johnson & Johnson. He also acts as deputy scientific director and is a member of the CVI management team. His work at CVI focused on the development and discovery of drugs that mimic the immune system and have the potential to be used for both prophylaxis and treatment of a variety of infectious and non-infectious diseases.
Dr. Friesen assumed his current position in 2011 when the Crucell Vaccine Institute was established, following the acquisition of Crucell by Johnson & Johnson. His expertise in antibody research made him a crucial member of the team when joining Crucell in 2008 as Vice President of Antibody Discovery. Prior to Crucell, Dr Friesen was Head of Preclinical and Early Clinical Development at MorphoSys in Munich, Germany, a company dedicated to the discovery and research of antibodies. He has also held positions at Dutch companies AM-Pharma and at the BioMaDe Technology Foundation, which he joined following a fellowship at the University of Groningen. Dr Friesen has a remarkable track-record in transitioning of preclinical programs and their entry into the clinic. He has over 10 years of experience in conducting research and development of peptides, enzymes, and antibodies in the field of biopharmaceuticals bringing innovation from bench to bedside. Dr Friesen holds a Master’s in Biology from the University of Utrecht and received his PhD in Biochemistry from the University of Texas.


Martin Bluggel, Chief Executive Officer, Protagen Protein Services GmbH

Martin Blüggel is an expert for peptide and protein analysis, mass spectrometry and bioinformatics for protein analysis and proteomics. He is author of more than 35 scientific publications and has presented state of the art analytical methods to the Biotechnology Working Party (BWP, EMA) and Paul Ehrlich Institute (PEI). He became member of the extended Board of the EAPB (European Association of Pharma Biotechnology) in 2009. He holds a diploma in Chemistry for his research in protein chemistry combined with mass spectrometric methods for protein structure analysis. As a co-founder of Protagen in 1997 Martin Blüggel set up the business in Protagen´s Protein Services Unit serving over 100 international clients as CRO to support the development of protein therapeutics from early phases of discovery, production to GMP release testing. He has supervised
biosimilar comparability studies and protein characterization for a range of 15 top originator molecules for leading Biosimilar developers worldwide and is an expert in CMC part of Biosimilars including latest regulatory aspects. Martin Blüggel holds the position of Chief Operating Officer of Protagen since 2002; Executive Vice President Protein Services since 2009 and CBO since 2012.

Dr. Marcus Mreyen, Director Business Development, Protagen Protein Services GmbH

Marcus Mreyen (PhD). He is a senior person and in pharmaceutical industry since 15 years and is working with PPS for about 5 years. He is dealing currently with ca. 10 Biosimilar Developments we are supporting. He will not only substitute myself but will provide another point of view on the topic with more practical aspects of Biosimilar development layouts.


Renita Rathinam, Partner, Litigation Practice, Sughrue Mion, PLLC, USA

She has served as litigation counsel in matters involving the pharmaceutical and mechanical arts, and has significant experience in all pre-trial, trial, and post-trial aspects of patent litigation. She also engages in pharmaceutical/biotechnology patent infringement and validity opinion practice, as well as freedom-to-operate, due diligence and product clearance work, and licensing and contract matters, including joint ventures. Central to Ms. Rathinam’s practice is Hatch-Waxman Act analysis and as such she has represented a number of pharmaceutical companies in ANDA/NDA related actions and in preparation of Paragraph IV Notifications under section 505(j). Her practice likewise includes analysis of the Biologics Price Competition and Innovation Act (BPCIA) and developments concerning implementation of the U.S. abbreviated approval pathway. Ms. Rathinam speaks on licensing, litigation, pre-litigation strategies, including U.S. post-grant proceedings and developments in U.S. patent law pertinent to both small molecule pharmaceuticals and biologics. Ms. Rathinam holds a B.S. in Biology from Emory University, a M.S. in Biochemistry and Molecular Biology from Georgetown University and received her law degree from the University of North Carolina – Chapel Hill.


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.


Jaap Venema, Therapeutic Area Lead Biotherapeutics, Global medical Affairs, Biologics Strategic Development, Abbvie

Jaap Venema is Senior Director Biotherapeutics, Global Medical Affairs at AbbVie, serving as the global head as well as the US lead. He holds a Master’s degree in Chemistry from the Free University (Amsterdam, the Netherlands); a Ph.D. in Biochemistry and Molecular Biology from Leiden University (the Netherlands); and he is a certified Project Management Professional (PMP). He has over 13 years of pharmaceutical industry experience ranging from early discovery, clinical development, project management, business development to medical affairs.
While at Solvay Pharmaceuticals in the Netherlands, he served as the Global Head of Exploratory Biology before he transferred to the Business Unit Vaccines, where he was Global Project Director for marketed as well as early phase vaccines, including the 2009 H1N1 pandemic influenza vaccine. After the acquisition by Abbott Laboratories, he spent several years as Project Director in different therapeutic areas, including Early Immunology and Pain, with accountability for the clinical and product development of several early phase compounds, including monoclonal antibodies. In his current role, he oversees the global medical and scientific biotherapeutics strategy, focusing on the Immunology therapeutic area.


Nancy Martin, V.P., Global Clinical Development, Hospira, Inc.

Nancy Martin, MD, PharmD, FCP serves as Vice President, Global Clinical Development at Hospira, Inc. In her current role, Dr. Martin brings over 15 years of pharmaceutical industry experience to clinical global product development strategy and tactical execution for Hospira’s portfolio of biosimilars, specialty injectable products, and proprietary products. Prior to joining Hospira in early 2013, Nancy served as Medical Director at Astellas in Clinical Development and Medical Affairs from 2008 to 2013 where she was responsible for leading a cross functional team as Global Medical Lead to advance a first in class, new chemical entity product from early Phase 2 development through global product submissions, approvals and launches. Nancy has also held positions of increasing responsibility in clinical development at Aventis and Hoffman-La Roche, contributing to successful clinical programs and product launches for small molecules as well as biologics in various therapeutic areas including infectious disease, transplant medicine and cardiology. Nancy received her Doctor of Medicine from the UMDNJ-Robert Wood Johnson Medical School and her Doctor of Pharmacy from the University of Illinois at Chicago-College of Pharmacy. She is a Fellow of the American College of Clinical Pharmacology and has authored numerous abstracts, scientific posters, book chapters and manuscripts. She and her family currently reside near Chicago.


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Rodeina Challand B.Sc., Executive Director, Biosimilars Development, Scientific Affairs, PRA HEALTH SCIENCES

Rodeina Challand B.Sc., Executive Director, Biosimilars Development, Scientific Affairs, has 25 years of experience in healthcare, cancer research, and the pharmaceutical industry across a wide range of roles including clinical development strategies for biosimilars and serving as head of clinical operations globally. For over 10 years, she directed the conduct of Phase I-IV clinical trials, including large pivotal biosimilar multi-national, multi-center trials and several post-authorization safety studies for biosimilars. Experienced in all aspects of biosimilar development including global strategies, study design and regulatory agency discussions (Europe, US, Japan, Australia, Singapore, and South Korea) and has worked on 10 biosimilar molecules across a range of products and indications, including ESAs, Filgrastims, Heparins, Insulins and monoclonal antibodies. In her role in PRA, she is currently working on several Biosimilar programs in various capacity including consulting, regulatory and clinical strategies, feasibility and supporting study delivery across all phase of development (phase I to IV). She has also represented PRA as a speaker in several International Biosimilar conferences across the Globe. While in the Pharmaceutical industry she was the company’s representative in several EMA consultations with regard to the development of the EMA Biosimilar Guidelines and was a member of the European Biopharmaceutical Group, which is a sector of the European Generic Association.


Dr Fiona M. Greer. BSc (Hons) MSc PhD, Global Director, BioPharma Services Development, SGS M- Scan

Following a Ph.D. in Protein Biochemistry from Aberdeen University, she joined M-Scan Ltd in 1984 to found the Biochemical Services Department. Here, she pioneered and applied developments in Mass Spectrometry for structural characterisation. She was appointed Director of Biochemical Services in 1988. At the same time, she was instrumental in establishing a facility in the United States where she was appointed Vice President. Dr Greer was responsible for establishing the Quality Management Systems and for directing Quality Assurance across the four M-Scan laboratories.

With over 30 years experience in the structural analysis of glycoproteins using instrumental techniques, she has published many articles on the use of mass spectrometry and other physicochemical techniques to fulfil regulatory characterisation requirements. She has been involved with global Biosimilar product development since the early 2000’s. She is regularly invited to give presentations at international meetings and has designed and presented various training courses. Since the acquisition of the M-Scan group in 2010 by SGS, she is now Global Director for Biopharma Services Development, SGS Life Sciences.


Mr Cyrus Karkaria | President, Biotech
Lupin Pharmaceuticals

Cyrus Karkaria is currently President of the Biotechnology division of Lupin Pharma is based in Pune. Prior to that he was Vice President at Celldex Therapeutics and CuraGen Corporation in New Haven, Connecticut, USA heading Operations and Biopharmaceutical Process Sciences. He has also held positions at Biogen Idec and Scios. He has been part of teams that have developed multi billion $ blockbusters in the field of neurology, immunology and oncology such as Avonex, Amevive and Tysabri (Biogen Idec) from the bench to manufacturing scale (2000L to 15,000L). As part of the commercialization process he has also faced Regulatory bodies from the US FDA, EMEA, Australian TGA etc., through pre-IND to BLA filings. He holds a Ph.D in Biochemistry from the University of Maryland and was a post doctoral researcher at the Harvard Medical School.


Edward Hume, EU Regulatory Lead for Biosimilar MAbs, Pfizer

Edward Hume is an EU regulatory lead for biosimilar mabs at Pfizer. He studied Biopharmacy and obtained a Masters from King’s University in 2000. Edward advises on EU regulatory strategy for biosimilar mabs including leading numerous EMA scientific advice procedures and clinical trial regulatory oversight. He has also been involved in biosimilar policy and commenting on the draft EMA guidances for biosimilars via trade organisations.


Dr. Mourad Farouk, International Medical Director, Amgen Europe, Switzerland

Dr. Mourad Farouk is the Nephrology and Biosimilars Medical lead for Amgen Europe and Middle East.
He was trained as a diabetologist in the national diabetes institute of Cairo/Egypt where he received his masters in internal medicine after which he developed his career in the pharmaceutical industry with different multinational pharmaceuticals (including Janssen Cilag, Novo-Nordisk and Amgen) where he had assumed a variety of regional and international leading roles in research and development and medical affairs along the course of the last 20 years
Dr Farouk is a member of the European society of nephrology, dialysis and transplant as well as selected diabetes societies worldwide and he has co-authored a range of publications in nephrology and biotechnology.


David Zylbergeld Neto, CEO, BIOCAD BRAZIL

Dr. David Zylbergeld Neto Graduated in Medicine. Title of doctor specializes in Internal Medicine awarded by the Brazilian Society of Internal Medicine. Master Business Administration (MBA) in Economics and Management Health (Federal University of São Paulo – UNIFESP). CEO BiocadBrazil Pharmaceuticals LTD (current). Former Medical Director for Brazil, Chemo Group (Spanish Pharmaceutical Company)
Former General Manager of Meizler Biopharma (Brazilian Pharmaceutical Company). Former Municipal Health Secretary. Former Professor of Clinical Medicine (UNISA)


Huiguo (Forrest) Hu, General Manager of International Business,
Shanghai CP Guojian Pharmaceutical Co., Ltd

Mr. Hu is working for Shanghai CP Guojian Pharmaceutical Co., Ltd (CPGJ) as the General Manager of International Business as well as the General Manager of CN-GEN Mab Co. Ltd (in-out China platform of CPGJ). CPGJ is a bio-pharmaceutical company which focuses on the R&D, pilot production, and commercialization of monoclonal antibody medicines. CPGJ launched the first biosimilar Etanercept in China, India, Mexico, Colombia, etc.
Mr. Hu is in charge of the International Business of CPGJ including Sales, Business Development, Regulatory Affairs, Strategy Cooperation, etc., during which the partnership was already established in more than 50 countries. Mr. Hu has many years’ experience in fields like quality, production, R&D, international business, as well as BD affairs (license in & out).


Robert A Salcedo,President of Therapeutic Proteins International

Robert A. Salcedo is an industry leader, bringing over 25 years of experience in biopharmaceutical products manufacturing. As President of Therapeutic Proteins International, he has a strategic leadership role in overall operations, manufacturing, management and growth of the company.

Salcedo previously served as Vice President, General Manager for Mylan Pharmaceuticals and held a series of leadership positions over 10 years at Amgen in both the U.S. and Puerto Rico, culminating in Executive Director, Plant Management. Prior to that, he held senior leadership roles at Genentech, Roche and Warner Lambert. He brings a deep cross-functional understanding of the many facets of the operational areas.
Salcedo holds a Bachelor of Applied Science (B.A.Sc.) in Chemistry from Cornell University, is a Certified Quality Engineer (ASQC) and holds Six Sigma process improvement credentials.


Stephen Murby, Board Director, Consumer Health Forum Australia

Born in Melbourne, Australia, Stephen has lived on the far north-west coast of Scotland since 2012. He is a Board director of Consumers Health Forum of Australia (CHF), a member of the International Advisory Board of the Alliance for Safe Biologic Medicines (USA) and a Life Fellow of the Royal Society of Arts (UK). In 2006 Stephen moved into in the community sector as CEO of Cystic Fibrosis Victoria (Australia). During his six year tenure at CFV he was also Chair of the Chronic Illness Alliance, Chair of CHF and a Board member of the Australian Council for Healthcare Standards.
Formerly, Stephen was Vice President of Swinburne University of Technology, where he worked for nine years. Before joining Swinburne he spent five years in Hong Kong and was the Foundation Head of Continuing and Community Education at the now Open University of Hong Kong. Stephen has spent over 30 years in “Greenfield??? public and community sector innovation around the world. He has travelled widely in Europe, Asia and North America. He has diverse community interests, working with a number of community organisations, groups and councils. He has been a board member of the Sir Edward Dunlop Medical Research


Prof. Andrea Laslop, MD Head of Scientific Office AGES MEA

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. Michel Mikhail, Executive Vice President Global Regulatory Government Relations, Fresenius Kabi

Dr. Dr. Michel Mikhail has more than 25 years Pharmaceutical Industry experience and track record of achievement in R & D and International Regulatory Affairs in large multinational Research-based pharmaceutical companies as well as in the Generics industry. Dr Mikhail is a Chartered Expert in Pharmacology -Toxicology, he is a chartered Clinical Expert as well as a chartered Analytical Expert. Dr Mikhail served on the Safety working group and Efficacy working Group of the European Federation of pharmaceutical Industry associations (EFPIA) also as a Topic leader. He served on the Regulatory Group of the European branch of the Pharmaceutical Research and Manufacturers of America (PhRMA Europe), on the Regulatory and Scientific Affairs Group of the European Generic medicines Association (EGA), as well as on different associations and organisations. Dr Mikhail is a Board Member of The European Generic Medicines Association (EGA) as well as member of the Executive Committee of the EGA. He is member of the British Institute of Regulatory Affairs (BIRA), the European Society of Regulatory Affairs (ESRA), both now known as The Organisation for Professionals in Regulatory Affairs (TOPRA). Dr Mikhail is member of the Expert Committee for Toxicology of the United States Pharmacopea (USP). Currently Dr. Mikhail is Executive Vice President Global Regulatory – Governmental Relations at Fresenius Kabi, a Multinational Pharmaceutical company.


Patricia Hurley, Ph.D.
Associate Director, Development Solutions, Regulatory Affairs

As associate director in regulatory affairs, Patricia Hurley advises on the preparation of regulatory submissions, and provides global strategic regulatory advice to external and internal clients, determining the most appropriate strategy for their projects.
Since joining PPD in 2010 as a manager in global regulatory development, Dr. Hurley has successfully supported a large number of clients with global clinical trial authorization applications and strategic consulting discussions in several disease areas. She is the therapeutic area lead for general medicine/immunology/rheumatology within in PPD’s regulatory affairs development solutions group, leads PPD’s advanced therapies forum and is a member of PPD’s biosimilar development group. In addition, Dr. Hurley belongs to The Organization for Professionals in Regulatory Affairs (TOPRA) and sits on the editorial board of Regulatory Rapporteur. Prior to joining PPD, Dr. Hurley was head of project management and biomarkers division at Consulting where she undertook the full range of global regulatory activities.
Dr. Hurley has a doctorate in molecular pharmacology and a bachelor’s in pharmacology and molecular genetics from University College in Dublin, Ireland.


Jakob Lange, PhD, Account Director Ypsomed AG

After obtaining an MSc degree in Chemical Engineering from the Royal Institute of Technology in Stockholm, Sweden, Jakob Lange completed a PhD in Polymer Science at the EPFL in Lausanne, followed by a post-doc at the Queensland Institute of Technology in Brisbane, Australia. In 2009 he completed a CAS in Pharma, Biotech and Medtech Management at EPFL.

Jakob started his professional career as a Research Scientist in packaging R&D with Nestlé at the Nestlé Research Centre in Lausanne, and then went on to take on roles as Project Manager, Group Leader and Portfolio Manager in R&D with GE Healthcare Biosciences in Uppsala, Sweden, before joining Ypsomed in Burgdorf in 2006.

With Ypsomed he has held the positions of Key Account Manager and Team and Account Manager within Marketing and Sales as well as Head of Project Management. Currently he has the role of Account Director, overseeing a team with responsibility for managing customer relationships in development projects as well as for marketed products.


Bridget Theresa Heelan, Vice President (Technical), PAREXEL International

Dr. Heelan has a background in medicine and immunology research. She has longstanding experience in the clinical management of patients with immune system dysfunction, including primary/secondary immunodeficiency, allergy and autoimmunity. She worked as a consultant immunologist in the NHS before moving to pharmaceutical medicine. At the MHRA she was a senior clinical assessor and was Chair of the Rheumatology Immunology working part of the EMA and the UK delegate for the Committee for Advanced Therapies. Areas of experience include immunogenicity assessment and biological products. As an MHRA assessor she assessed biological products in oncology and biosimilar products. Currently Dr Heelan is Vice President (technical) at Parexel.


David Uguen, Pharm.D. Executive Director, Drugs and Biologics, Voisin Consulting Life Sciences

David Uguen is responsible for the management of projects involving the design and implementation of regulatory strategies for the development of drugs and biologics. David gained a 15-year experience in European regulatory affairs applied to the development, registration and maintenance of both pharmaceutical and biotechnology medicinal products.
He is actively involved in the design, preparation and management of registration applications, orphan drug designation applications, protocol assistance and scientific advice procedures. In this context he frequently participates in meetings with Regulatory Agencies (both European Medicines Agency and National Agencies).
David also developed a particular interest in the regulatory issues related to the implementation of the Pediatric Regulation and the development and registration of “biosimilar??? and “biobetter??? medicinal products in Europe.
David has significant experience in the development of small molecules, recombinant proteins, and advanced therapies (cell and gene based medicinal products), specifically in the areas of Oncology (treatment of blood cancer, brain tumours), Nephrology (peritoneal dialysis, treatment of anaemia in CKD patients), Anesthesiology and Rheumatology.
Prior to joining Voisin Consulting, David served as Senior Consultant at MDS Pharma Services. Before, he worked in the European Regulatory Affairs department of Baxter (Renal division) in France for 5 years. David acquired international experience while working for Eli Lilly in the UK and by doing clinical pharmacy at Roger Williams General Hospital in Providence, USA. He started his career at Theraplix (the OTC division of Rhone-Poulenc Rorer, now included within Sanofi).
After completing his pharmacy studies at the University of Rennes, France, he earned a post- graduate diploma in International Drug Development and Registration at the University of Paris XI. David also holds a Master of Science in Cell Biology and Toxicology form the University of Rennes. He is a Registered Member of TOPRA.


Amanda Gibbons, PhD Director,Biologics CMC and Regulatory Science, Voisin Consulting Life Sciences

Amanda is responsible for the design and implementation of strategic development plans, particularly on Chemistry Manufacturing and Control (CMC) aspects of biological products, such as Recombinant, Gene-therapy, Vaccines and Biosimilar Medicinal Products.
Following her BSc in Biochemistry Amanda gained a PhD from Bath University, UK in mesenchymal stem cell (MSC) biology and a post-doc preparing and studying immortalized MSCs.
Early experience in a startup tissue regeneration company, Intercytex Ltd, gave her a solid background in Regulatory Science of Advanced Therapy Medicinal Products (ATMPs). Amanda planned and managed EU and US phase II clinical trials and provided technical support to R&D teams on manufacturing process, cGMP and QA issues.
Previously Amanda was a Global Project Leader for AstraZeneca PLC-Medimmune based in the UK. She was responsible for overseeing manufacturing process development of candidate monoclonal antibodies through to delivery of clinical material for early phase oncology studies. This was achieved by leading global (EU, US, Japan) development teams and Contract Manufacturing Organisation (CMO) project managers for regulatory and manufacturing tasks, and representing CMC on the Corporate Emerging Product team to define strategy and support clinical and marketing plans.
Amanda has prior experience as a Senior Biotechnology Consultant with MDS-Pharma Services where she supported development of a variety of vaccines and biotechnology projects. She supported scientific advice meeting and prepared IMPD and Module 3 and 2.3 sections leading to EU and US submissions. In this role, Amanda liaised with EU Regulatory Agencies and Notified Bodies, managed US to EU conversions and several orphan drug designation applications. During this time Amanda was an active member of the TOPRA Biotechnology Special Interest Group.
Currently Amanda is involved in supporting clients with EU focused projects on the development and registration of cell and gene based medicinal products and monoclonal antibodies.

Day 1


08:00 – 08:50 – Registration – Networking Coffee


08:50 – 09:00Chairperson’s Welcome and Opening Remarks
Richard DiCicco, Co-Founder, Harvest Moon Pharmaceuticals


09:00 – 09:40 – Global Regulatory Perspective on Biosimilars

  • Most recent regulatory requirement for Biosimilars
  • EU vs the US: what are the key differences?
  • What other countries do you need to be aware of?
  • Clinical and non – clinical studies for biosimilars
  • Demonstration of efficacy and safety

Dr. Andrea Laslop, Head of Scientific Office, Austrian Agency for Health and Food Safety, AGES, Austria


09:40 – 10:20 – An Evolving Global Regulatory Landscape; Opportunities for Biosimilars Development

  • A global perspective on the use of the evolving regulatory landscape to develop Biosimilars
  • Overcoming regulatory hurdles in EU/FDA/Emerging markets
  • Upcoming EU Clinical Trials regulation (2016); are you ready? Advantage or Disadvantage to Biosimilars development?

Patricia Hurley, Ph.D. Associate Director, Development Solutions, Regulatory Affairs, PPD


10:20 – 11:10 – Networking – Morning Refreshment (Exhibitors Lounge)


11:10 – 11:50 – Panel Discussion: Global regulations and current developments

  • Are we near to international harmonized development?
  • Moving towards global Biosimilars guidelines
  • Update focus on the emerging markets

Moderator – Dr. Andrea Laslop – Austrian Agency for Health and Food Safety, AGES

  • Renita RathinamSughrue Mion, PLLC
  • Patricia Hurley, PPD
  • Dr. Michel Mikhail – Fresenius Kabi

11:50 – 12:25 – Biosimilars vs Biobetters: A Regulatory Perspective

  • A regulatory based explanation of Biobetter Medicinal Products and how they compare to Biosimilars
  • Pros and Cons of developing Biobetters vs Biosimilars.
  • How Biobetters are currently regulated in the EU.
  • Considerations on how Biobetters could be regulated in the future.

David Uguen,Pharm.D. Executive Director, Drug and Biologics, Voisin Consulting Life Sciences


12:25 – 13:00 – Injection Drug Delivery Devices for Biosimilars

  • Overview of primary containers and device types
  • Factors to consider when selecting an injection device
  • Delivery devices for Biosimilars; me-too or differentiator?
  • Integrating the device into the overall development program

Jakob Lange, PhD, Account Director, Ypsomed AG


13:00 – 14:00 – Networking Lunch Break


14:00 – 14:40 – An Innovator Perspective on Developing a Global Biosimilars Strategy

  • For biologics – including biosimilars – design and manufacturing matters because product quality and supply are affected by how medicine is made
  • Science – based, tailored EU Regulatory pathway has successfully brought biosimilars to market; other regulatory bodies across the globe have followed suit
  • The development and availability of EMA approved biosimilars may increase competition in the market, leading to reduced prices and wider access to medicines
  • As highly complex medicines, biologics and biosimilars require robust and active identification and traceability to ensure any adverse effects are quickly detected, reported and attributed to the correct product and manufacturer
  • As biosimilar mAbs become available, greater focus will be given to the terms of use and building trust and understanding with healthcare practitioners and patients.
  • Amgen is uniquely equipped to leverage our leading position in biotechnology to produce and reliably supply biosimilars globally

Dr. Mourad Farouk, International Medical Director, Amgen Europe, Switzerland


14:40 – 15:20 – Biosimilar INNs – unique or same

  • INN & Traveability
  • Science or business?
  • WHO guideline
  • EU position
  • US position
  • ROW

Rodeina Challand B.Sc., Executive Director, Biosimilars Development, Scientific Affairs, PRA HEALTH SCIENCES


15:20 – 16:10 – Networking – Morning Refreshment (Exhibitors Lounge)


16:10 – 16:50 – Patients perspective on Biosimilars

  • Scientific and Clinical Considerations for Biologics and Biosimilars
  • Challenges on patient education
  • Harmonization to ensure patient safety

Stephen Murby, Board Director, Consumer Health Forum of Australia


16:50 – 17:30 – Preparing for U.S. Market entry–strategy considerations in view of BPCIA and AIA

  • Brief review of BPCIA patent information exchange and litigation framework – updates on applicable U.S. case law
  • Brief review of key modifications under the America Invents Act
  • Practical steps and immediate considerations for prosecution, collaboration/partnering and litigation strategies

Renita Rathinam, Partner, Litigation Practice, Sughrue Mion, PLLC, USA


17:30 – 18:10 – The challenges of Developing Biobetters, They has Better be Better!

  • Biobetters, which are designed in discovery, need to differentiate in the clinic, typically using the same or similar mechanism-of-action
  • Biobetter may be better based on efficacy, safety, delivery, dosing frequency, and other such factors
  • Biobetter development strategies need to include early indicators of differentiation from exeisting therapeutics

Dr. Robert Friesen, VP and Head of Biologics Research, Biotechnology Center of Excellence, Janssen R & D, Pharmaceutical companies of Johnson & Johnson


17:30 – 17:40Chairperson’s closing remarks

Day 2

08:00 – 08:50Registration – Networking Coffee


08:50 – 09:00Chairperson’s Welcome and Opening Remarks
Richard DiCicco, Co-Founder, Harvest Moon Pharmaceuticals


09:00 – 09:40 – Biosimilars: Hurdles to Patient’s access

  • Development of Biosimilars – Case Study
  • INN
  • Switching, Interchangeability and Substitution

Dr. Michel Mikhail, Chief Regulatory Officer, Executive VP, Global Regulatory Affairs, Fresenius Kabi, Germany, EGA Belgium


09:40 – 10:20 – CMC requirements for Biosimilar Product Development / Manufacturing

  • How to achieve comparability to the reference product?
  • Analytical testing to demonstrate similarity between biosimilars and reference product
  • Reference product selection and cell line development

Martin Bluggel, Chief Executive Officer, Protagen Protein Services GmbH


10:20 – 11:10 – Networking afternoon refreshment break (Exhibitors Area)


11:10 – 11:50 – Extrapolations of Biosimilars

  • The Importance of extrapolation to the global adoption of biosimilars
  • Biotechnology: the science behind biosimilarity and comparability
  • How extrapolation reduces the cost of development and results in cost-savings: patient and healthcare system benefits

Nancy Martin,M.D., Pharma.D., Vice President, Global Clinical Development,Hospira


11:50 – 12:30 – Complexity of Biologics Manufacturing: Manufacturing Changes in the Biosimilars Era

  • Good manufacturing process
  • Focus on patient safety
  • Achieving a quality and reliable supply

Jaap Venema, Therapeutic Area Lead Biotherapeutics, Global medical Affairs, Biologics Strategic Development, Abbvie


12:30 – 13:10 – Understanding Labelling and Extrapolation for Biosimilars

  • Overview of biosimilars and generics labelling landscape
  • EBE’s position on labelling
  • Options for labelling of biosimilars
  • Pfizer’s position on labelling of biosimilars
  • Explanation of extrapolation in biosimilars development
  • Current EU policy on labelling and extrapolation of biosimilars

Edward Hume,EU Regulatory Lead for Biosimilar MAbs,Pfizer


13:10 – 14:10 – Networking Lunch Break


14:10– 14:50Mass Spectrometry Analysis for Biosimilars
Why mass spectrometry (MS) is growing in importance as comparator

  • Biosimilar development requires comprehensive physicochemical
  • Structural – Characterisation of the (glycol) protein to demonstrate “Biosimilarity” with the originator
  • Initially, batches of the target molecule should be studied to determine the exact structure, post – translational modifications and variability of quality attributes. This is to establish the Quality Target Product profile (QTTP)
  • Subsequently, comparative data for biosimilar side-by-side with the originator is required by various regulatory guidelines
  • Strategies for primary and higher order structure determination will be discussed particularly for antibodies where their size and complexity requires LC/MS/ MS approaches.

Dr. Fiona M.Greer, BSc (Hons) MSc PhD, Global Director, BioPharma Service Development, SGS M-Scan


14:50 – 15:30 – Biosimilar Infliximab- Experiences and Expectations

  • Experiences with Biosimilar Infliximab in Norway
  • Physicians attitude and public debate
  • Switching study
  • Prices and reimbursement of Infliximab

Dr. Steinar Madsen, Medical Director, Department of Drug Information, Norwegian Medicines Agency


15:30 – 16:10 – Afternoon refreshment break – Networking – Exhibitors Lounge


16:10 – 16:50 – Regulatory strategies for biosimilars in emering markets

  • Regulatory framework of biosimilars
  • Interchangeability studies
  • Clinical and non-clinical comparability studies
  • Are we moving towards harmonisation?

David Zylbergeld Neto, CEO, BIOCAD BRAZIL


16:50 – 17:30 – Panel Discussion – How the Emerging market countries is dealing with the Biosimilars Market

  • Anticipate the growing demand for low-cost countries in developing Biosimilars
  • Recognise how the BRIC market will be a competitive presence in Biosimilars
  • Understanding how the BRIC and Asian government are assisting local companies to develop biosimilars
  • David Zylbergeld Neto, CEO, BIOCAD BRAZIL
  • Cyrus Karkaria, President, Biotech, Lupin Pharma, India
  • Huiguo (Forrest) Hu, General Manager of International Business, Shanghai CP Guojian Pharmaceutical Co., Ltd

17:30 – 18:10 – Biosimilars: Driving on Global Commercial Potential through the Emerging Markets

  • Understand how developing healthcare policy in the emerging markets plays to the biosimilars opportunity
  • Identify key emerging markets particularly conducive to the biosimilars opportunity
  • Determine non- pricing options for achieving competitive advantage relative to other biosimilars Market
  • Richard DiCicco, Co- Founder, Harvest Moon Pharmaceuticals, USA

18:10 – 18:20 – Chairs Closing Remark – End of Conference Richard DiCicco, Co- Founder, Harvest Moon Pharmaceuticals, USA

Sponsors & Exhibitors

Silver Sponsor

Therapeutic Proteins International

Therapeutic Proteins International, LLC (TPI) is a fully integrated manufacturer of biosimilar recombinant protein products. TPI’s vision is to produce high quality, life-altering biologics that are affordable and accessible to patients around the globe. This vision has resulted in a unified corporate culture and a high-energy commitment to product innovation with an underlying passionate belief in making a difference. The company’s application of its groundbreaking proprietary process and patented manufacturing platform makes it a leader in developing these important drugs that will serve to lower health care costs thus allowing expanded access to more patients.
Located in Chicago, Illinois, TPI is exclusively focused on developing and manufacturing biosimilar products with nine currently in its development pipeline. With a fully integrated facility, TPI’s aim is to fulfill the vision of providing low-cost versions of off-patent biologics, using disposable bioreactors and the deployment of a totally single-use system to manufacture biologics. These proprietary systems allow for quick scale up reducing the timeline and cost associated with bringing these products to market. Additionally, TPI performs analytics at each step to optimize performance and aim for high quality, fingerprint-like similarity.

TPI’s fully-integrated process, characterization expertise, analytical frameworks and end-to-end process allows TPI to quickly respond to the evolving regulatory requirements of the biosimilar environment while creating competitive advantages through practical and efficient solutions.

TPI’s senior leadership team is comprised of talented and seasoned industry leaders recognized for their unique depth and breadth of knowledge, exceptional analytical abilities and commitment to quality. They have served various segments of the healthcare industry from leading global pharmaceutical to healthcare organizations.
For more information about Therapeutic Proteins International, visit www.theraproteins.com or call 312.620.1500.


Associate Sponsors

PPD Global Ltd.

PPD is a leading global contract research organization providing drug discovery, development, lifecycle management and laboratory services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and approximately 13,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. PPD offers a full range of cGMP and bioanalytical laboratory and clinical development services, which support a seamless approach to biosimilar drug development, and is experienced in developing customized development programs for a range of biosimilars aimed at supporting marketing authorization application in emerging and developed markets. www.ppdi.com

Protagen Protein Services GmbH

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

Voisin Consulting Life Sciences

VCLS supports life science companies throughout product development, and engages in communication with regulators and payers. We partner with Biotech, Pharma and Medtech manufacturers to develop, register and launch innovative products in North American and European markets. Through a network of partners, we also assist clients in Southeast Asia, Latin America, and a number of additional markets. We provide people-powered solutions to complement our clients’ in-house resources, from product development strategy, communication with regulators and payers up to market authorization and reimbursement.www.voisinconsulting.com

Ypsomed

Ypsomed is the leading independent developer and manufacturer of user-friendly injection systems for the self-administration of injectables such as insulin, hGH and mAbs. With patented and innovative products including single and dual-chamber pens and disposable autoinjectors Ypsomed can meet virtually all pharma partner needs in the market for self-injection systems.
www.ypsomed.com


Exhibitors

Myoderm

Myoderm is a global leader in the sourcing, distribution, and management of pharmaceuticals for clinical trials. We offer two unique sourcing solutions: GlobalSource, which provides global sourcing and distribution of pharmaceuticals for clinical trials; and CentralSource, a turnkey service for sourcing, warehousing, and distributing rescue, concomitant, and standard-of-care therapies directly to clinical sites.
www.myoderm.com


BioVirtus Research

BioVirtus Research Site is a leading full-service Research Unit with 45-bed clinic located in Central Europe (Poland).
BioVirtus provides international pharmaceutical and biotech customers with comprehensive, cost effective, FDA/EMA compliant, early clinical studies (Phase I/II), including study design and execution, electronic data capture, data processing and reporting.
BioVirtus has experience in CTs for biologics, including monoclonal antibodies and biosimilars, and will be happy to discuss your needs.
BioVirtus expertise include:

  • First-in-Man
  • Phase I/II healthy & patients
  • Special populations
  • Proof-of-Concept
  • Bioequivalence
  • Bioavailability
  • Food effect
  • PK/PD studies
  • Biosimilars
  • Therapeutic equivalence
  • Tobacco risk evaluation & smoking-cessation studies.

For further information please contact: info@biovirtus.eu
www.biovirtus.eu


The Clinigen Group is a specialty pharmaceuticals and services business with offices in the UK, US and Japan, serving more than 50 markets globally with an extensive customer base of pharmaceutical companies, biotechnology companies and contract research organizations.

Clinigen is made up of two operating divisions:

Services:

  • Clinigen CTS – Clinical Trials Supply is dedicated to the global sourcing and supply of commercial medicines for clinical study use
  • Clinigen GAP – Global Access Programs provides consultancy, development and implementation of programs to manage access to unlicensed, licensed or end-of-lifecycle products

Specialty Pharmaceuticals:

  • Clinigen SP – Specialty Pharmaceuticals focuses on acquiring and in-licensing specialist, hospital-only medicines worldwide and commercializing them in niche markets

Promotional Sponsors

SGS LIFE SCIENCE SERVICES

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.
www.sgs.com

Applied Photophysics Ltd. (APL)

Applied Photophysics Ltd. (APL) has firmly established itself as a global developer and manufacturer of high quality, high performance, modern spectrometers for the study of structural, thermodynamic and kinetic properties of a wide range of samples with particular focus on proteins and other bio-macromolecules.
From research through development to production, our scientific expertise and world-class support help life science researchers to understand complex biological systems, allowing them to be at the forefront of discovery.
From our UK headquarters near London, we are dedicated to providing our customers with the latest advances in spectroscopy technology and applications support with over one third of our staff working directly in research and development to bring our customers the latest innovations. The development of close relationships with academic and industrial parties has enabled us to understand their applications and provide meaningful solutions to the challenges they face.
APL was established in 1971 by Lord Porter and the Royal Institution of Great Britain. During 2011, we celebrated our 40th birthday.
www.photophysics.com

Partners

Media Partners

PharmaVOICE magazine provides commentary about the challenges and trends impacting the life-sciences industry, covering a range of issues from molecule through market. PharmaVOICE’s more than 25,000 BPA-qualified subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers. For further information please visit: www.pharmavoice.com

Biocompare is the most comprehensive, in-depth, and objective website for life science product information. Thousands of scientists use Biocompare daily to quickly find the right product for their experiments rather than looking through multiple print catalogs. Visit www.biocompare.com to find the products you need, stay informed of new technologies, read product reviews, watch product videos, and keep up-to-date on life science news. For further information please visit: www.biocompare.com

European Life Science is the premier journal devoted to presenting outstanding research and researchers within the life science fields. For further information please visit: www.life-science.se

SelectScience.net is the leading online product and application publication for laboratory scientists featuring the latest news, application articles, videos, product directory and product reviews. Membership is fast, free and provides access to all of the SelectScience services. SelectScience.tv is a unique video news channel for laboratory application and product information. For further information please visit: www.selectscience.net

InPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is home to InPharmjobs.com, Pharmafile and Pharmafocus. For further information please visit: www.In-Pharm.com

PharmiWeb.com is the leading industry-sponsored portal for the pharmaceutical sector. Supported by most of the leading pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and international jobs to industry professionals across Europe and the US. For further information please email: corporate@pharmiweb.com

BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is based and located in Warsaw, Poland. Biotechnology World was founded in 2007 to provide the world’s biotech and pharma information and market to make it universally accessible and useful for scientific and business processes. Its first step to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to global biotechnology, pharmaceutical and life science activities. For further information please visit www.biotechnology-europe.com

Future Pharmaceuticals has forged powerful relationships with key industry leaders to provide a platform for successful brand recognition, and for senior decision- makers to have the means to procure and plan implementation strategies based on the topics covered. Positioned to be an authoritative resource within top pharma companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted and responsive audience, bridging the gap between the industries’ top issues and the solutions top-tier vendors can provide. For further information please visit: www.futurepharmaus.com