Biosimilars Global Congress 2015 Europe

SL51

Background Info


Over the last decade, there has been a swift increase in the quantity of biological medicines that have received regulatory approval globally.

To obtain approval for consumption, a biosimilar medicine which is medicine that is develop to be similar to an existing biological medicine, have to establish that they are as safe and effective as the original reference medicine and have the same quality.

A number of top-selling biological medicines have lost or will be losing their patent over the next few years, particularly, monoclonal antibodies. Hence, Bio- similar Medicines are develop in expectation of imminent patent expiry of innovator biologics drugs.

Although biosimilars are already in use to some extent, it is likely that their availability and use will become more comprehensive over the next few years as it has the potential to present a more cost effective tool for pharmaceutical expenditures.

The Congress will provide a unique platform for knowledge sharing and convergence from Pharmaceuticals, Biotechnology, Regulatory and many more. The congress will also cover a diverse range of topics and offer an interesting insight as to latest strategies and obstacles faced by the industry, from the develop- ment to market of Biosimilars.

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

GAIN LATEST INSIGHTS ON:

  • Learn the current global regulatory guidelines and considerations for developing and bringing the next generation of Biosimilars to the market
  • Know the strategies in place in developing and manufacturing biosimilars in emerging markets
  • Establishing and integration of biosimilarity and comparability into developing Biosimilars
  • Identify challenges encountered with Extrapolations and interchangeability, assessing immunogenicity and Pharmacovigilance
  • Fine Tuning Product Quality to Meet Demands of Process Transfer and Biosimilar Products
  • Explore CMC regulatory challenges and considerations for Biosimilars drug development and manufacturing
  • Study the pre-clinical and clinical challenges associated with the development of biosimilars
  • The importance of establishing partnerships and successful collaboration for Biosimilars business
  • Learn the latest updates, trends and current Biosimilars market situations in different regions
  • What does the future hold for Biosimilars and Biologics
  • Network with experts and leading drug developers, regulators and investors in the industry

Key Speakers

Alpna Seth

Alpna Seth, Vice President and Head of Biosimilars, Biogen Idec

Alpna brings more than two decades of biotech industry experience spanning R&D to commercialization, and strategy to operations. She joined Biogen nearly 18 years ago in the commercial organization. Most recently she was vice president and global head of TECFIDERA® as program executive, where she successfully led the pivotal Phase III read???outs, regulatory filings, marketing approvals, and commercial launches worldwide. Before that, she was managing director in India where she set up an affiliate from the ground up. In her first eight years at Biogen, she served in various leadership roles across marketing, strategy and portfolio planning, and R&D, including leading the company’s first gene therapy program. Prior to joining the company, she was a management consultant in the health care industry. She conducted her postdoctoral research at Harvard University in Immunology and Structural Biology. Her PhD is in Biochemistry and Molecular Biology from the University of Massachusetts Medical School. Alpna is also a graduate of Harvard Business School’s Advanced Management Program (AMP) and routinely serves as a guest lecturer at Harvard and Tufts Universities. She recently relocated with her family from Boston to Zürich to set up and run Biogen’s biosimilars business.


Robert Zoubek

Dr. Robert Zoubek, Senior Consultant, Granzer Regulatory Consulting & Services

Robert has more than 15 years of experience in development of biologics and biosimilars. His expertise comprises the Characterisation of the Originator molecule, the cell line development incl. candidate selection phase, API and drug product development, production processes, and fill & finish. Robert is Senior Consultant at Granzer Regulatory Services and advises clients on the regulatory requirements from early development up to marketing authorization for Europe and USA.
Until he joined Granzer Regulatory Services, Robert worked in several positions at the Formycon/Germany, a leading developer of Biosimilars for regulated markets. As Director Scientific Affairs he led Formycon´s drug product development and analytical services. In this role he was responsible for the development strategies and accompanied projects through the different development stages. Before that, Robert was Head of Protein Characterisation & Preformulation and Manager Quality Operations. In those positions he supervised Formycon´s GMP-Quality Control and analytical labs, the core of Quality-Biosimilar development.
Robert earned the PhD from the University of Erlangen-Nuremberg for his research on the wound-healing peptide Thymosin beta 4, he was awarded Master of Business Administration from the University of Manchester and he also holds a MSc from the University of Munich.


Duncan Emerton

Duncan Emerton, Senior Director, Syndicated Insights & Analysis, FirstWord

Duncan has been working in the pharma industry for over 15 years and has gained experience across a broad range of disciplines including pre-clinical and clinical R&D, sales, marketing, medical affairs, competitive intelligence, management consulting and business analysis. Duncan currently heads up FirstWord’s syndicated reports business where he’s responsible for delivering future-focused research and analysis across a wide range of issues. Duncan’s current passion is biosimilars, a subject which he has been following since 2006 when the first biosimilar was approved in Europe. He is a regular presenter and Chair at biosimilar-focused conferences, and has contributed several articles and book chapters on key issues in the biosimilars industry including LCM, profitability, commercialisation and strategy development. Before joining FirstWord in October 2013, Duncan worked at Datamonitor Healthcare where he was Director and Biosimilars Practice Lead for Datamonitor Healthcare’s Consulting business. In his spare time Duncan plays golf, likes to cook and spend as much time as he can with his three beautiful daughters. He also runs a blog focused on biosimilars called The Biosimilarz Blog (www.biosimilarz.com). Duncan holds a BSc(Hons) in Medical Biochemistry from the University of Surrey and a PhD in Microbiology from the University of Kent.


Laurence Darmency

Laurence Darmency, Head of Biosimilars Clinical Operations, Biosimilars Unit, Merck

Mrs. Laurence Darmency is Head of Clinical Operations at Merck Serono – Biosimilars (Aubonne, Switzerland). She has more than fourteen years of international clinical operations experience in various senior positions, in various therapeutic indications such as oncology, neurology and nephrology, with global Pharma.

Also at Merck Serono (Geneva, Switzerland and Billerica, USA), Laurence led complex multiple clinical trial programs within an alliance partnership and led a global task-force on filing NDA/MAA`s for Multiple Sclerosis. For these accomplishments, Laurence was awarded several times.
Prior to Merck Serono, Laurence worked at Hoffmann-La Roche (Basel, Switzerland), where she led a large clinical trial on Renal Anemia, and at Kosan Biosciences (Hayward, USA) as Project Manager.
Laurence holds a Master’s Degree in Health Engineering, specialized in Clinical Research, obtained at the Pharmacy University (IUP Ingénierie de la Sante) (Montpellier, France).


Mourad Farouk Rezk

Dr. Mourad Farouk Rezk, MD, Senior Director, Global Head Medical Affairs Biosimilars, Biogen

Dr. Rezk is a diabetologist who has spent more than 20 years in the pharmaceutical industry. Prior to joining Biogen as the Senior Director, Global Head of Medical Affairs for their biosimilars business unit, he was with Amgen as an international medical lead for the company’s nephrology innovator biologics and their EU biosimilars taskforce. While there, he established an internal biosimilars medical platform and led the development and execution of a significant number of multinational studies, key publications and poster presentations. Prior to Amgen, he was with Novo Nordisk Africa & Gulf as the region’s medical affairs director, establishing diabetes and hematology clinical and medical educational infrastructures supporting the launch of the company’s second-generation insulin analogues and hemophilia treatments. He also spent nearly 11 years with Johnson & Johnson Middle East where he was marketing and sales lead for the company’s biotechnology business unit, after which he moved to head the medical affairs team.


Mohamed Oubihi

Dr. Mohamed Oubihi, Japanese Pharma Regulatory and Drug Development Consultant, YAKUMED

Dr. Mohamed Oubihi is an Expert in Japanese Pharmaceutical and Drug Development. He has 15 years global experience covering EU, MENA, Japan and Asia Pacific Regions.
Mohamed has worked in the last 15 years for several global pharmaceutical and biotech companies in various capacities in R&D, Regulatory Affairs, Business Intelligence and Drug Development areas.
In his position with NovoNordisk (Novozymes), he was Vice Chairman of Japanese Association of Enzyme Additives. In 2007 Mohamed joined Biogen Idec in the UK to lead the company’s expansion into Japanese market.
From 2010 Mohamed was appointed as EU regulatory drug development lead for Biogen whilst still advising the organization on Japan and Asia Pacific Strategy. Mohamed has led advocacy efforts of Biogen Idec in Europe and Japan on several global industry initiatives.
From 2012 until Sep 2013 Mohamed was directing several projects at Abbott/Abbvie Regulatory Strategy group covering Japan and Asia Pacific. He has led regulatory strategy and submissions across various therapeutic areas for both development and commercial products.
From October 2013, Mohamed established YAKUMED Ltd, a niche consultancy focused on the Japanese and Middle East and African markets. Since its inception YAKUMED has provided professional strategic and operational support to a dozen of European, US and Japanese pharmaceutical and Biotech companies on the Japanese pharmaceutical market.


Kumar Dhanasekharan

Kumar Dhanasekharan, Ph.D., Director of Process Development, Cook Pharmica LLC

Dr. Dhanasekharan is Director of Process Development at Cook Pharmica in Bloomington, Indiana and is responsible for cell culture, purification, analytical, and formulation development including lab operations and scale-up to meet client drug substance and drug product needs. Cook Pharmica is an integrated contract development and manufacturing organization providing the pharmaceutical and biopharmaceutical industries with biologics drug substance and parenteral manufacturing in vials and prefilled syringes. Prior to his current role, Kumar worked for 5.5 years at Genzyme in various roles including process development, process engineering and most recently served as the Associate Director of Process Sciences and Technology at Genzyme in Framingham, Massachusetts. He was responsible for manufacturing process development for both cell culture and protein purification for enzyme replacement therapies in driving a science and risk-based strategy for continuous process improvements including improved control strategies, cell culture productivity and downstream recovery improvements. In a previous role, he led the implementation of Quality by Design (QbD) principles in development and successfully led a QbD based Lyophilization scale-up and tech. transfer project for approval. He also led efforts in viral risk mitigation which resulted in an invention and patent on a UV-C based viral inactivation device. He also provided technical leadership for several projects related to Consent Decree remediation. Prior to joining Genzyme, Kumar led small-molecule process development focused on API crystallization at Bend Research Inc., Bend, OR. Prior to that he was group leader for consulting services at Fluent Inc. (Now ANSYS) with focus on both small-molecule and biologics development and manufacturing challenges across upstream, downstream, and Fill/ Finish operations. Kumar has a Ph.D. in Food Science from Rutgers University and a Bachelor’s in Chemical Engineering from Indian Institute of Technology, Chennai, India. He has over 50 conference presentations and over 10 peer-reviewed publications.


Pedro Morfin

Pedro Morfin, Consultant, Pharmaceutical, Biotech and Medical Device, Sanape LLC

Pedro is a consultant with more than 25 year of experience in the Pharmaceutical and Health Industries in US, Europe, Asia and Latin America.
Strong focus in Biotechnology over the past 7 years, participating representing strong companies and an individual in shaping current legislation in Latin America for Biosimilars, and its influence over the world.
For more than 5 years Pedro has been and independent consultant in US, Europe, China, India, Asia and Latin America covering pharmaceutical companies, innovative technologies, medical devices and M&A.
His career in the pharmaceutical area started in Mexico where he was a Marketing Director for the largest pharmaceutical company for a period of 10 years, experiencing 3-fold organic revenue increase. Later he moved to US where he worked in areas of Business Development, M&A in Ivax-Teva for 10 years, experiencing 20-fold revenue increase in the first 6 years.
He also worked for 4 years at Wharton Econometrics a consulting company in Philadelphia.
Pedro studied engineering and has MBA in finance and information systems.
He is also member of the Board of Advisors of the International Institute of the Medical School in the University of Miami.


Shivanthy Visvalingam

Shivanthy Visvalingam, EU Regulatory Lead, Biosimilar Mabs, Pfizer

Shivanthy Visvalingam is an EU regulatory lead for biosimilar mabs at Pfizer. Shivanthy studied Molecular Genetics and obtained a DPhil from Oxford University in 2009. Shivanthy advises on EU regulatory strategy for biosimilar mabs including leading numerous EMA scientific advice procedures and clinical trial regulatory oversight. Shivanthy has also been involved in biosimilar policy and commenting on the draft EMA guidances for biosimilars via trade organisations.


Dr Fiona M Greer

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.


Martin Bluggel

Martin Bluggel, Chief Executive Officer and Co-Founder, 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.


Richard Di Cicco

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.


Jennifer Campbell

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.


DR Mikhail Miche

Dr. Mikhail Michel, Biosimilars Expert, Germany

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 Generic 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 is an Expert in Biosimilars. He 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 Board, Executive Committee and the Biosimilars & Regulatory and Scientific Affairs Group of the European Generic medicines Association (EGA), as well as on different associations and organisations. He is member of The Organisation for Professionals in Regulatory Affairs (TOPRA). Dr Mikhail is and member of the Expert Committee of the Federal Institute for Risk Assessment, Berlin, and member of the Expert Committee for Toxicology of the United States Pharmacopea (USP), Washington DC.


Andrea Laslop

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.


Andrew J. G. Simpson

Andrew J. G. Simpson, Scientific Director, Orygen Biotecnologica

Andrew Simpson earned his Ph.D. in 1980 at the National Institute for Medical Research, Mill Hill, London in the Division of Parasitology and subsequently spent two years at the National Institutes of Health, Bethesda Maryland before returning to Mill Hill where he was a member of the scientific staff until 1990. In 1990, Dr. Simpson moved to Brazil where he continued his research into schistosomiasis and other parasitic diseases while working at the Centro de Pesquisas René Rachou of the Fundação Oswaldo Cruz in Belo Horizonte until joining the Ludwig Institute for Cancer Research in São Paulo in 1995. At LICR he extended his research interests into genomics and led the FAPESP and national genome projects between 1997 and 2002 that sequenced the genomes of bacteria of local interest as well as contributing significantly to the identification of human genes expressed in cancer. In 2002, Dr Simpson transferred to the Ludwig Institute’s office in New York and eventually became LICR Scientific Director in 2007 leading the internationally renowned not for profit research and biotechnology institute for five years. In 2012, Dr. Simpson left LICR and moved back to Brazil to take up the position of Scientific Director of the Brazilian startup biotechnology company Orygen. Orygen, jointly owned by the major Brazilian pharmaceutical companies Biolab and Eurofarm, is currently being structured to produce and commercialize biosimilar and biobetter monoclonal antibodies primarily for the treatment of cancer and inflammatory diseases.


Mr. Huiguo(Forrest)

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

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 (Hong Kong platform of CPGJ).
CPGJ is a bio-pharmaceutical company which focuses on the R&D, pilot production, and commercialization of monoclonal antibody medicines. CPGJ established the largest mAb production capacity in China and 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. Mr. Hu is handling the partner relationship 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).


Cecil Nick

Cecil Nick, Vice President (Technical), Biotechnology, PAREXEL International

Gained BSc (Hons) in Biochemistry from University of Cape Town and has been working in regulatory affairs and clinical development for over 30 years; for the last 25 years focused on biological medicines. Particular expertise in monoclonals and biosimilars, having worked on over ten such programs and participated extensively in Industry and International meetings on the subject.

Joined PAREXEL in February 2001 and has been involved with issues relating to clinical development, regulatory submissions, biosimilars, orphan drugs and training. In the last five years alone has worked on scores of clinical development plans connecting the input from pharmacologists, statisticians, therapeutic experts, and feasibility analyses to craft development plans which are effective, highly efficient and achievable with extensive experience in the field of inflammatory disease.

From 1987 – 2000 served as Regulatory Manager at Novo Nordisk Ltd. working on the development and registration of biotechnological products and NCE’s. Previous experience includes Farmitalia Carlo Erba, May and Baker, London International Group and Lundbeck. In addition has knowledge of health economic assessments, quality assurance, pharmaceutical distribution and clinical research.

Has been a guest lecture at Cardiff University MSc in Clinical Research and Greenwich University MSc in Pharmaceutical Sciences courses and Biotech Module leader for the TOPRA MSc course. He is on the editorial panel of SCRIP Clinical Research and has authored many articles on regulatory and clinical development issues.

Cecil has particular expertise in regulatory, biotechnology and clinical development and is a well-known expert on biosimilarity and comparability. Most recently Cecil has been extensively involved in the development of monoclonal biosimilars and has supported a number of global marketing applications. He has been a frequent international speaker and author on the topic of biosimilars and comparability.


Paul K. Audhya

Paul K. Audhya MD, MBA, Vice President, Medical Affairs Europe, Middle East and Africa (EMEA), Hospira UK Ltd.

Dr. Paul Audhya serves as Vice President, Medical Affairs EMEA and brings over 18 years of diverse pharmaceutical industry experience to develop winning medical affairs strategies and drive tactical execution for Hospira’s portfolio of biosimilars, specialty injectable products, and proprietary medicines across EMEA. Prior to joining Hospira in June 2013, Dr. Audhya served as Chief Medical Officer at Reata Pharmaceuticals from 2011 to 2013 where he was responsible for leading all medical activities including clinical development, safety, medical affairs and health economics to advance a first in class, new chemical entity product for the treatment of chronic kidney disease and other chronic inflammatory conditions from Phase 1 development through global product submission, approval and launch. Dr. Audhya started his career at Janssen, and has held positions of increasing responsibility in clinical development and medical affairs at Bristol-Myers Squibb, Amgen and Abbott in multiple therapeutic areas including gastroenterology, infectious disease, intensive care, heart disease, and kidney disease. Dr. Audhya received his MD from the New York University School of Medicine, completed his Internal Medicine residency at UMDNJ, and received his MBA from Pepperdine University. Paul has authored numerous abstracts, posters, oral presentations and manuscripts.


Paul W. Tebbey

Paul W. Tebbey Ph.D, M.B.A., Therapeutic Area Head, Biotherapeutics, Global Medical Affairs, Abbvie

Paul W. Tebbey, PhD, MBA is Therapeutic Area Head of Biotherapeutics, Global Medical Affairs, Abbvie, Chicago, IL, USA. Dr Tebbey has over 20 years of healthcare experience across the biotechnology and pharmaceutical sectors. He received a PhD in Microbiology and Immunology from East Carolina University School of Medicine (Greenville, NC) where his research focused on T lymphocyte cell signaling and immunosuppression. Subsequent to his postdoctoral studies at Vanderbilt University (Nashville, TN), which were focused on the regulation of gene expression, he then studied for a MBA at Rochester Institute of Technology (Rochester, NY). Dr Tebbey’s research, development and launch experiences include complex biotechnological therapies, including the monoclonal antibodies adalimumab, infliximab and ustekinumab, as well as complex vaccines, in particular, a conjugated pneumococcal vaccine. Dr Tebbey’s publications include 40 peer-reviewed articles that span across immunology, immune-mediated and infectious diseases, as well as pharmaceutical brand success.


ALAN SHEPPARD

ALAN SHEPPARD, Principal, Global Generics, Thought Leadership, IMS Health

Alan has over 40 years extensive experience within the healthcare industry, including innovator R&D pharmaceuticals, OTC and generic companies and working with Government departments, law firms, venture capital companies and industry associations.
Heading up the global generics arm of IMS Health’s Thought Leadership Alan is responsible for developing the services provided to the industry and its associations on generic medicines and biosimilars through a combination of consulting, information and market analyses.
Previous positions held include Executive Vice-President, Europe Generics, for Dr Reddy’s Laboratories Ltd. In this role he was responsible for devising and implementing Dr Reddy’s generic strategy to enter the major markets of Europe through start-ups and acquisition of companies and products. He was responsible for the development pipeline for Europe as well as establishing partnerships to form alliances.
Prior to this he was Vice-President of Global Corporate Strategy for PLIVA, responsible for the strategic approach to the businesses of NCE development, generics, specialities, OTC and diagnostics.
Earlier positions held included European Marketing Director for Medeva; General Manager, Rhône-Poulenc Rorer UK; General Manager, Institute Mérieux UK; and management roles with Servier Laboratories, SmithKline & French and Upjohn.
Alan is also Chairman of the Technical Advisory Group for the Access to Medicines Foundation; an expert witness on patent litigation issues and their commercial impact, working with leading international law firms; a guest lecturer at the University of Wales working in the medicines faculty specialising in pharmaceutical marketing and the role of clinical trials within the marketing mix.
Alan was a long serving member of the Prescription Medicines Code of Practice Authority Appeals Board, a Fellow of the Chartered Institute of Management, and Fellow of the International Doctors’ Association and a Member of the Chartered Institute of Marketing.


Louk Pechtold

Louk Pechtold, Ph.D. MBA, Director – Alliance Management Biosimilars, Merck Serono SA

Dr. Louk Pechtold is a Dutch national with more than 20 years’ of international commercial and scientific experience in various parts of the life science industry (Rx, OTC, biologicals, devices) in various functional areas (licensing, M&A, marketing, research, clin ops, teaching), in various types of companies (big pharma, silicon valley biotech, midsize) and in various therapeutic indications (CNS, analgesia, oncology, rare-diseases, GI, dermatology)

Currently he is Director Biosimilars at Merck Serono Biosimilars. Previously, at Roche, he had been leading all global alliances Roche/Genentech have with CROs. Prior to this position also at Roche, Louk was Director Business Development & Licensing, closing and managing global strategic alliances on drug discovery, human stem cell therapeutics and (biological) drug formulation. The antibody delivery technology, he in-licensed in 2007 and managed the alliance of, enabled Roche in 2014 to launch sub-cutaneous formulations of Herceptin and MabThera.
Besides, Louk worked at Shire, Cygnus Inc., Bayer, the Boots Company, Hermal, Vifor, Merz Pharmaceuticals and the Leiden Amsterdam Center for Drug Research.
Louk has closed more 20 collaborations and has extensive alliance management experience. He holds a Ph.D. in Pharmacology from Leiden University and an MBA from the Rotterdam School of Management.


Dr Frederik Rudolph

Dr. Frederik Rudolph, Associate Director Purification & Formulation Development, BioPharmaceuticals, Process Science, Boehringer Ingelheim Pharma GmbH & Co. KG

Studies: 2000 – 2007
RWTH Aachen University, Germany
Course: Biology
• Degree: Dipl.-Biol. (diploma in biology)
• Diploma thesis at the Institute of Molecular Pharmacology, RWTH University Hospital
Ph.D. Ship: 2007 – 2011

  • RWTH Aachen University, Germany
  • Institute of Molecular Pharmacology, RWTH University Hospital

Work Experience:
2012 – 2013 – Boehringer Ingelheim Pharma GmbH & Co. KG

  • PostDoc
  • Innovative Technology Projects
  • Since 2013 – Boehringer Ingelheim Pharma GmbH & Co. KG
  • Associate Director Purification Development
  • Downstream Development of NBE & Biosimilar projects
  • Scale up and global process transfer to clinical supply facility
  • Technology Projects

Day 1


08:00-08:50 – Registration and Coffee


08:50-09:00 – Chairman’s Welcome Remarks

Richard DiCicco, Co – Founder, Harvest Moon Pharmaceuticals


09:00-09:40 – EMA’s Adaptive Licensing Programme

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


09:40-10:20 – Brazil’s take on Biosimilars Regulations and Development

  • ANVISA’s regulatory stance
  • Speed of regulatory review
  • Biosimilar’s approved in Brazil
  • Advantages of PDP system during regulatory review
  • The government’s goal of promoting Brazilian biotech

Andrew J. G. Simpson, Scientific Director, Orygen Biotechnologica


10:20-11:00 – Morning Refreshment and Networking


11:00-11:40 – Awaiting Abstract

Alpna Seth, Vice President and Head of Biosimilars, Biogen Idec


11:40-12:20 – Fine Tuning Product Quality to Meet Demands of Process Transfer and Biosimilar Products

  • New Biologic vs. Biosimilars Timeline
  • Levers to Adjust Product Quality Attributes
  • Process Development with Narrow Target Ranges
  • Product Quality Optimization

Dr. Frederik Rudolph, Process Science, Boehringer Ingelheim Pharma GmbH & Co. KG


12:20-13:00 – 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 and Co – Founder, Protagen Protein Services GmbH


13:00-14:00 – Networking Lunch


14:00-14:40 – Establishing “fingerprint” biosimilarity prior to the Clinic

  • What are regulatory guidelines associated with structural characterization and comparability / biosimilarity testing of Biosimilars?
  • What are the challenges in characterizing complex (glycol protein products?
  • What strategies for primary and higher order structure are required? – case examples

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


14:40-15:20 – A case study approach to interchangeability and extrapolation for biosimilar products

  • Evaluating the degree of similarity with the reference product
  • How similarity informs interchangeability and extrapolation
  • Clinical considerations: switching and immunogenicity

Paul W. Tebbey, Ph.D, M.B.A. Therapeutic Area Head, Biotherapeutics Global Medical Affairs, Abbvie


15:20-16:00 – Join Session

Session A: Integrating Biosimilarity and Comparability into Early Development: Case Study with Trastuzumab as a model molecule

  • Biosimilar Development
  • Biosimilarity and Comparability
  • Glycosylation
  • Analytical strategy

Kumar Dhanasekharan, PhD, Director of Process Development, Cook Pharmica LLC

Session B: Downstream Technologies for Biosimilar Manufacturing

  • Eshmuno® chromatography media features
  • Productivity and process economics data
  • Pre-packed Chromabolt® columns

Jennifer Campbell, WorldWide Director Biosimilars Market, Milipore S.A.S., France, a subsidiary of Merck, KGaA, Darmstadt, Germany


16:00-16:40 – Afternoon Refreshments and Networking


16:40-17:20 – Biosimilarity versus Comparability

  • Exploring key differences between comparability and biosimilarity
  • Importance of understanding the regulatory contexts of biosimilarity versus comparability
  • Implications of incorrectly merging the two concepts

Shivanthy Visvalingam, EU Regulatory Lead, Biosimilar Mabs, Pfizer


17:20-18:00 – CMC Regulatory Challenges for Biologics are Different

  • Understanding the terminology: biologic, specified biologic, biopharmaceutical, biosimilar
  • Comparison on the regulatory landscape (IND /IMPD, NDA/BLA, MAA centralized procedure) for biologics
  • The six CMC regulatory compliance
  • Biologics are not chemical drugs – four unique CMC regulatory compliance challenges presented by biologics

Dr. Robert E. Zoubek, Senior Consultant, Granzer Regulatory Consulting & Services


18:00-18:40 – 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

Panelist:

  • Jennifer Campbell, Worldwide Director Biosimilars Market, Merck Millipore
  • Dr Fiona M. Greer, BSc (Hons) MSc PhD, Global Director, BioPharma Services Development, SGS M- Scan
  • Martin Bluggel, Chief Executive Officer, Protagen Protein Services GmbH

18:40-19:00 – Chairman’s Closing Remarks

Richard DiCicco, Co-Founder, Harvest Moon Pharmaceuticals


19:00-22:00 – Networking Drink Reception and Gala Dinner

Day 2


08:00-08:50 – Coffee and Registration


08:50-09:00 – Chairman’s Opening Remarks

Richard DiCicco, Co – Found, Harvest Moon Pharmaceuticals


09:00-09:40 – Proposed New Biosimilars Guideline in China

  • Reference drug to use
  • Non-Clinical Comparability Studies: in-vitro
  • Non-Clinical pK/PD Studies: in-vivo
  • Immunogenicity and toxicity testing: animals
  • pK/PD clinical studies: patients, equivalence design
  • Immunogenicity testing: patients
  • Extrapolation and Pharmacovigilance

Dr. Michel Mikhail, Expert in Biosimilars


09:40-10:20 – The Importance of Establishing Symbiotic Partnerships for Biosimilars Business in Emerging Market

  • The current situation and latest regulation guideline issued;
  • Making a suitable and feasible business development strategy in different territories;
  • The main hurdles for Biosimilars Business in Emerging Market

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


10:20-11:00 – Morning Refreshments and Networking


11:00-11:40 – Biologics: The Bigger Picture

  • Biologics driving pharmaceutical spend
  • Biologics meeting unmet clinical needs
  • Biosimilars increasing access and reducing costs
  • Future prospects

Alan Sheppard, Principal, Global Generics, Thought Leadership, IMS Health


11:40-12:20 – Can Biosimilars compete with small molecule generics in the same indication?

  • Can a biosimilar be priced less than a branded generic for oncology indications?

– Breast Cancer
– Lung Cancer
– CML
– CLL

  • How high can biosimilars be discounted in regulated
  • markets and still make a profit?
  • Is a 90% discount realistic?

Richard DiCicco, Co – Founder, Harvest Moon Pharmaceuticals USA


12:20 – 13:00 – Analytical development of monoclonal Antibody

  • Regulatory requirements in developing Biosimilar Mabs
  • Impact of the new draft guidelines on non-clinical and clinical studies of Mabs
  • Comparability Studies

Cecil Nick, Vice President (Technical), PAREXEL International


13:30 – 14:00 – Networking Lunch Break


14:00 – 14:40 – Translating from approval to uptake – the experiences of the first biosimilar mAb in Europe

  • The approval of the first biosimilar mAb is a lighthouse event, paving the way for future approvals
  • Significant education is required to overcome biosimilar myths and misconceptions
  • Early experience with biosimilar infliximab

Paul K. Audhya, MD, MBA, Vice President, Medical Affairs Europe, Middle East and Africa (EMEA), Hospira UK Ltd.


14:40-15:20 – How to structure and negotiate a successful collaboration between east and west

  • Selecting the right deal structure
  • Preparing for the deal (do`s & don’ts)
  • Merck Serono – Dr Reddy`s labs strategic alliance

Louk Pechtold Ph.D. MBA, Director – Alliance Management Biosimilars, Merck Serono SA


15:20-16:00 –Afternoon Refreshments and Networking


16:00-16:40 – Biosimilars Latam and Emerging Markets

  • Global Considerations Influencing Emerging Markets
  • Challenges
  • Success Factors to Launch Biosimilars
  • Biosimilars Latam Regulation
  • BIO comments: LATAM Biosimilars Related Regulations

Pedro Morfin, Consultant, Pharmaceutical, Biotech and Medical Devices, Sanape LLC


16:40-17:20 – Biosimilar Market Situation in Japan Market and MENA region, Latest updates, Trends and future

  • Overview of Japanese Biosimilar Market

– Market Potential
– Regulatory hurdles
– Entry Strategies

  • Overview of African and Middle east Regions

– Market Potential
– Regulatory landscape
– Entry Strategies

Dr. Mohamed Oubihi, Japanese Pharma Regulatory and Drug Development Consultant, YAKUMED


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

Panelists:

  • Pedro Morfin, Consultant, Pharmaceutical, Biotech and Medical Device, Sanape LLC
  • Dr. Mohamed Oubihi, Japanese Pharma Regulatory and Drug Development Consultant, YAKUMED
  • Dr. Michel Mikhail, Expert in Biosimilars

 

18:00 – Chairman’s Closing Remarks and Summary

Richard DiCicco, Co – Founder, Harvest Moon Pharmaceuticals


 

Post Conference Workshop

09:00 – 12:30 – Morning Workshop

Biosimilars Investment in Emerging Markets and Europe

The purpose of the workshop is to provide delegates with detailed information to make a choice: to target emerging markets, or to invest in the European biosimilar market. Delegates will find very useful the global regulatory landscape covering biosimilar guidelines and laws related to non-clinical analytical and in -vivo tests, phase I & III trials, immunogenicity and pharmacovigilance for 93 countries.

Biosimilar development in the emerging market

  • Non original biologics manufactured and launched in emerging markets
  • Non original biologics pipeline and expected launch dates
  • Why being late is an advantage in emerging markets

Biosimilar regulatory requirements in 93 countries

Overcoming key commercial challenges in specific emerging markets

Best partners for successfully developing biosimilars in the emerging market

  • Cost of goods for biosimilars manufactured in the emerging market

Investment in biosimilars

  • What to expect for an return on investment (ROI)
  • Developing a biosimilar sales forecast from a manufacturing view
  • Costs to build a biosimilar mAb factory
  • CMO costs for mAb Production
  • Net present value of a biosimilar mAb
  • Profit margins in biosimilar production and how to use them in EU tenders
  • Evaluating biosimilar unti floor prices in a hyper – competitive market

Workshops Leaders:

Richard DiCicco, – Co – Founder, Harvestmoon Pharmaceuticals


12:30 – 13:30 – Networking Lunch Break


13:30 – 17:00 – Afternoon Workshop

Biosimilar Asset Selection, Prioritization and Strategy Development

Is it too late to invest in the biosimilars market? Some say yes, others say no. It’s now time for you to decide. During this workshop you,along with other workshop delegates, will be playing the role of a business development and licensing team tasked with assessing the potential opportunities and challenges for your company, AweSome Biotech Inc., in the biosimilars market. Key activities will include:

  1. Developing a long list of potential biosimilar opportunities, including their clinical feasibility and commercial attractiveness by region (e.g. US, EU5, Japan or BRIC)
  2. Prioritising your long list down to a short-list of potential opportunities, creating a SWOT analysis for each product by region and providing reasons why the others didn’t make this short-list
  3. Providing a fi nal recommendation on which product (or products) to invest in fi rst, along with the clinical and commercial strategy for the product (or products) in each region

Duncan Emrton, your workshop facilitator, will be playing the role of AweSome Biotech’s CEO who you have to convince of your choices (and rejections).

Support will be provided throughout all of the exercises and key bits of information will be provided. A prize will be made available to the winning team!


Sponsors

ASSOCIATE SPONSORS

Merck Millipore
Merck Millipore

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.

http://www.merckmillipore.co.uk


protagenProtagen 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

http://www.protagenproteinservices.com


sgsSGS 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

EXHIBITORS

durbin

Durbin – your complete medical resource

Durbin is one of the world’s leading specialist medical suppliers. Established more than 50 years ago in 1963, we source and distribute pharmaceuticals, medical equipment and consumable supplies to healthcare professionals in over 180 countries.

Our main divisions encompass everything from international sales, sales to NGO’s and charities, clinical trials supply, early access programmes and imported unlicensed medicines to sexual health supplies, and the storage and distribution of medical products and devices for third parties. From both our offices and warehouse facilities located in London and USA, we are able to supply everything from a single cold chain item to large scale humanitarian projects. In short, we are your complete medical resource.

Durbin has grown rapidly over the last five decades and our multi-lingual workforce includes pharmacists, medical engineers and nurses, as well as commercial, warehouse and logistics staff. Our philosophy has always remained the same however – to put our customers first and to supply what they want, when they want it, at a competitive price.

Durbin. Saving lives by saving time.​ ​
www.durbin.co.uk


biomedica

Biomedica

With 13 offices in Central and Eastern Europe (CEE) and a team of 250 professionals, Biomedica is a leading distributor of medical devices, in-vitro diagnostics, products for life sciences, Biomedica Immunoassays and Clinical IT.
Additionally, Biomedica which is ISO 9001:2008 certificated provides innovation in the following areas:
1. Glycomics – Simplified Glycoanalysis using Lectin Microarrays – High sensitivity, complementary to mass spectrometry and HPLC

System Features: fluorescence image scan, easy labeling, direct application of glycoproteins-crude samples, high throughput
Benefits: both N-and O-glycans, isomer differentiation, epitope profiling, no glycan cleaving from protein
Application: testing of biosimilars, monitoring of biologicals, supporting QC activities (batch to batch variation), IPC testing

2. Biomedica Immunoassays provides internationally recognized, high quality ELISAs for clinical research in the field of cardiovascular and renal diseases as well as bone and mineral disorders.

For more information: www.bmgrp.com

Partners


Media Partners
GaBI logo 3.eps


biocompare

Biocompare

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


pharma-voice

PharmaVOICE

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


evenbrite

Eventbrite

Bringing the world together through live experiences . We’re creating the world’s first marketplace for live experiences by developing the technology that lets anyone create, share and find new things to do. For further information please visit: www.eventbrite.co.uk

 


select-science

Select Science

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


pharmiweb

PharmiWeb.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, PharmiWeb.com


bio-process

BioProcess International

BioProcess International™ is a monthly, controlled-circulation magazine devoted to the development, scale-up, and manufacture of biotherapeutics and biodiagnostics. Each issue provides the global industrial biotherapeutic community with up-to-date, peer-reviewed information detailing the business, politics, ethics, applications, products, and services required to successfully drive biopharmaceuticals, vaccines, and biodiagnostics through the development and manufacturing process. www.bioprocessintl.com


global-event-list

Global Events List

Global Events List is an online directory of scientific and medical events from around the world, brought to you by Elsevier. Attending these types of events facilitates the proliferation of scientific discoveries and the building of productive relationships. We hope to play our part by providing the most comprehensive, user-friendly, reliable, and high quality listing of events available. www.globaleventslist.elsevier.com


mc

Manufacturing Chemist Pharma

Manufacturing Chemist is among the longest established and most respected information sources in the global pharmaceutical manufacturing industry. Manufacturing Chemist reports on current and future trends in the global marketplace, including the latest developments in drug discovery, biotechnology, drug delivery, ingredients, processing technologies and equipment, packaging, business strategies and regulatory updates. – See more at: www.manufacturingchemist.com


fierce-pharma

FiercePharma

FiercePharma is the pharma industry’s daily monitor, with a special