Biosimilars And Follow-On Biologics 2014 Americas

SL51

Background Info

Paradigm Global Events are proud to present The Biosimilars and Follow – On Biologics 2014 Americas

Biosimilars also known as Follow-on Biologics or subsequent entry biologics are official subsequent version of innovator pharmaceutical products on which reference to the innovator product is crucial component for approval.

This conference examines a number of challenges including commercial, regulatory, and technical, all of them in turn and discusses for example: the current commercial trends of biosimilars; what the commercial impact of them is; and what is happening in the BRIC countries.

The conference also looks at the latest global regulatory guidelines and issues surrounding biosimilars and what this means for the data exclusivity, is there a need for a balance between innovation and competition?

Technical issues with biosimilars however are the major concern. Biological drugs unlike the more common small-molecule drugs maybe more sensitive to changes in manufacturing process due to its high molecular complexity, so biosimilar producers have to prove that the overall effects are the same.

Following the success of the first generation Monoclonal antibodies blockbusters, here we analyze many challenges to be faced to bring more efficient and affordable anti-body based drugs to the market.

Finally, biobetters are a new category of drug: why just copy a drug when you can improve it? This workshop examines the potential of biobetters for companies and how to maximize opportunities.

Why you should attend this conference

  • Gain a better understanding of the global regulations and guidelines for Biosimilars including variations and new developments
  • Explore clinical and preclinical challenges in the development of biosimilars
  • Identify challenges encountered with specific product manufacturing
  • Examine the issues of conducting trials, assessing immunogenicity and pharmacovigilance
  • In-depth characterization of Biosimilars by Mass Spectrometry
  • Explore CMC requirements in order to produce high quality similar biologic product
  • Focus on issues in developing biosimilars mAbs
  • Learn how the BRIC market is dealing with Biosimilars
  • Network with experts and leaders of the induustry

 

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
  • Clinical professionals / Development / Supplies
  • 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

I look forward to meeting you at the conference.

Kind Regards,

Jocelyn Raguindin Conference Director

Workshop

Monday 10th February 2014

2 Part – Pre-Conference Workshops:

Morning 1st Part Pre- Conference Workshop:

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

(Morning – networking refreshment break10:30 – 11:00)

09:00-12:30 – What Key Support Is Required for Next Generation Biosuperior Programs from Development to Validation?

Next generation biosuperiors, are complex protein structures that are difficult to characterize. Therefore, a development program consisting of analytical and bioanalytical assays, pharmacology and/or toxicology studies in animals and clinical trials are often needed. This workshop will focus on the key assays required to support development programs with an emphasis on the timing for development, regulatory requirements and information that can be derived from well thought out programs using case studies.

Workshop Leaders:

  • Dr. Christina Satterwhite, Director of Laboratory Sciences, Charles River Laboratories
  • Kelly S. Colletti, PhD, MBA, Research Scientist II, Program Director, Bioanalytical Sciences, Charles River

 

12:30 – 13:30 – Networking Lunch Break

Afternoon 2nd Part Pre-Conference Workshop:

13:30 – 17:00 – Biosimilars Mabs – From Development to Market

  • Biosimilars mAb global regulatory guidelines drive development of biosimilars MAbs
  • Development programs and comparability exercises for biosimilar MAbs
  • Designing global clinical trials for biosimilar MAb
  • Assessing immunogenicity of biosimilar MAbs; Regulatory and Bioanalytical considerations
  • Selecting the right marketing partners for biosimilar MAbs
  • Executing the optimal marketing plan for biosimilar MAbs for the right territory
  • Risks and rewards of being late with biosimilar MAbs

Workshop Leaders:

  • Richard DiCicco, Co-Founder, Harvest Moon
  • Isabel Zwart, Senior Consultant, Paraxel International

 

(Afternoon – networking refreshment break – 15:00 – 15:30)

Key Speakers


Richard Dolinar

Richard Dolinar, MD, Alliance Chairman, Alliance for Safe Biologic Medicines, USA

Richard Dolinar, MD, Chairman
A private practice Clinical Endocrinologist in Phoenix, Arizona, Dr. Dolinar received his undergraduate degree from Siena College in Albany, New York; his medical degree from The State University of New York at Buffalo and did his Endocrinology Fellowship at Duke University.
Dr. Dolinar is Chairman of the Alliance for Safe Biologic Medicines. He has testified before the U.S. Senate Subcommittee on Consumer Affairs and has also given Congressional briefings on Capitol Hill. He is a Senior Fellow in Healthcare Policy at the Heartland Institute.
A published author, in both professional and consumer publications, his articles and opinion pieces have appeared in The Wall Street Journal, USA Today, The New York Times, The Washington Times, The New England Journal of Medicine, JAMA (Journal of the American Medical Association), Diabetes Research and the Indiana Health Law Review Journal. He is co-author of the book, Diabetes 101.
Dr. Dolinar is a past member of the board of directors of the American Association of Clinical Endocrinologists and currently serves on its National Legislative and Regulatory Committee. Dr. Dolinar has also held leadership positions in other professional organizations as well, including the Juvenile Diabetes Research Foundation and the American Diabetes Association. He is on the Editorial Advisory Board for Endocrine Today.
Dr. Dolinar served as a Flight Surgeon in the Vietnam War and is a retired U.S. Air Force Colonel.


Dr. Michel Mikhail

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.


Hideaki Nomura

Hideaki Nomura, President & CEO, Fujifilm Kyowa Kirin Biologics, Japan

Hideaki Nomura is currently President & CEO for FUJIFILM KYOWA KIRIN BIOLOGICS (FKB). FKB is a joint venture company of FUJIFILM, a global film company, and KYOWA HAKKO KIRIN, a Japanese pharmaceutical company. FKB focuses on biosimilar manufacturing and development. Prior this position, Hideaki was a head of strategic planning in Nephrology field of KYOWA HAKKO KIRIN. He has over ten years of experiences in portfolio management and product management. During his scientific career, Hideaki held several key roles in pharmaceutical division of KIRIN BREWERY for formulation development, drug delivery system research, good manufacturing practice and operations.


Dr. Thekla Kurz

Dr. Thekla Kurz, Head of Biotech Project Management & GMS Business Partner Biosimilars, Merck KGaA

Dr. Thekla Kurz is a pharmacist by education and holds a PhD in Pharmaceutical Technology. After internships in a pharmacy in Stuttgart and at Bayer Leverkusen she worked as scientist and assistant lecturer at the University of Braunschweig. She joined MerckKGaA in 1992 and had several positions as lab head and group leader in the development of cosmetics and pharmaceuticals. Several years she headed the department of Analytical Development for small molecules and proteins. Thekla has set up a development sterile plant and a GMP manufacture of protein Drug Substances. In her current position she leads the project managers that coordinate all CMC related development activities of protein drugs at the different sites worldwide.


Andrea Laslop

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.


John Pakulski

John Pakulski is Head of US Biopharmaceutical Regulatory Affairs at Sandoz Inc., a Novartis company

John Pakulski is Head of US Biopharmaceutical Regulatory Affairs at Sandoz Inc., a Novartis company. He is the current chair of the GPhA Biologics Task Force, served as the Novartis and GPhA representative to the Biosimilar User Fee negotiations with FDA, and has spoken on the challenges of the US biosimilar pathway in many public forums. Mr. Pakulski joined Sandoz Inc. in November 2009 to build and lead the US regulatory affairs function responsible for biosimilars. Before Sandoz, he worked at Duramed Research, a division of Barr Pharmaceuticals, where he built a biologics regulatory affairs group that focused on the development of follow-on biologics. Prior to his involvement with biosimilars and follow-on biologics, he served for over 20 years on the originator side of the pharmaceutical industry in roles of increasing responsibility within global and US regulatory affairs at Pfizer, Aventis and Sanofi. He has broad experience on the regulatory aspects of the technical and clinical development for biologics, drugs and devices in a variety of therapeutic areas. Mr. Pakulski is a pharmacist and graduate of Rutgers College of Pharmacy.


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.


Nigel Rulewski

Dr. Nigel Rulewski, Vice President, Global Strategic Drug Development, Quintiles

Dr. Nigel Rulewski earned his medical degree from St. Bartholomew’s Medical School, University of London. After completing his training in pediatrics and obstetrics and gynecology, he practiced in the UK, in both London and Guildford. He was recruited into the pharmaceutical industry, initially working in Germany and Holland before being transferred to the US. He has held senior management positions, including serving as vice president of drug development for Astra for ten years. In this role, he managed a department that expanded to over 200 employees and achieved approval of multiple NDA’s in the areas of pain control, respiratory, cardiovascular and AIDS indications. In the mid to late ‘80s, Dr Rulewski initiated industry collaborations with AIDS activists groups, served as company spokesperson on AIDS- related drug development issues. He interacted extensively with the media and was interviewed on national television regarding highly sensitive issues confronting the pharmaceutical industry during the early period of the AIDS epidemic. Dr Rulewski has also worked in venture capital in New York, establishing funding for multiple early stage startup companies predominantly focused on oncology. He has also served as chief medical officer of two biotech companies, Procept and Arqule, both with a focus in oncology.
Presently Dr Rulewski is vice president for the Center for Integrated Drug Development at Quintiles. In this capacity, he works with companies around the world advising on drug development strategies. Most recently, he has been active in the area of Biosimilar biologic development. He initiated the Biosimilar Intelligence Group within Quintiles to monitor the emerging field of biosimilars. He has presented at international conferences on the topic and assisted companies in the US, the EU and Asia on the development of strategies to achieve global approval.


Dr. Joseph P. Fuhr

Dr. Joseph P. Fuhr, Jr, Professor, Economics, Widener University

Dr. Joseph P. Fuhr Jr. is a professor of economics at Widener University and currently serves as a senior fellow with The American Consumer Institute. Dr. Fuhr received his M.A. and Ph.D. from Temple University and his B.A. from LaSalle University. His primary research areas are antitrust, health economics, Pharmacoeconomics, telecommunications, and sports economics. He has published over 50 articles and presents regularly on these areas of expertise. In Pharmacoeconomics, he has written on cost benefit analysis, predictive modeling and biosimilars. He has published 6 artticles on biosimilars and has given various presentation. Professor Fuhr has been an expert witness on antitrust matters related to health economics and has worked on various consulting projects.


Richard DiCicco, Co-Founded 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.


Bluemel

Joerg Bluemel, PhD ERT, Director Biologics Safety Assessment, Translational Sciences, MedImmune

Joerg Bluemel currently holds a position as Director Biologics Safety Assessment within Translational Sciences at MedImmune, Gaithersburg MD. MedImmune is the worldwide biologics research and development arm of AstraZeneca. In his current position he is responsible for the nonclinical safety assessment and development strategy of bio-therapeutics in various indications. Prior to joining MedImmune, he was the head of Nonclinical Safety / Drug Metabolism at Merz Pharmaceuticals GmbH, Germany. Joerg is a board certified toxicologist and has more than 15 years of experience in nonclinical safety / nonclinical drug development for small molecules and bio-therapeutics. He has an academic background in immunotoxicology and received his PhD from the University of Düsseldorf, Germany.


Dr. Chris Beaver

Dr. Chris Beaver, PhD, Director, Ligand Binding and Exploratory Bioanalysis, inVentiv Health Clinical

Prior to joining inVentiv Health Clinical as Director of Ligand Binding Services and Exploratory Bioanalysis in 2010, Chris served as Scientific Director of the Ligand Binding/Cell Based Assays at MDS Pharma Services’ North American macromolecule bioanalytical operations. He has been responsible supervising the development and validation of all bioanalytical methods for the measurement of pharmaceuticals and biomarkers, immunogenicity testing and Cell Based neutralizing antibody assays. He previously held the position of Associate Director of Ligand Binding Services/Cell Based Assays overseeing the Montreal, Quebec operations. Before joining MDS Pharma Services in 2004 as a Team Leader in the Ligand Binding Department, Dr. Beaver served as an investigator at Cogent Neuroscience, a startup biotech company in North Carolina’s RTP. Dr Beaver obtained his PhD in Neuroscience at Dalhousie University in Canada in 1995. From 1996 to 2001, he performed his post-doctoral studies at Yale University, focusing on the role of cyclic nucleotides in neuronal development, publishing papers in several journals including Nature Neuroscience.


Michael Swit

Michael A. Swit, Special Councel, FDA Law Practice, Duane Morris LLP

Michael Swit has been addressing critical FDA legal and regulatory issues since 1984. Before joining Duane Morris LLP as a Special Counsel in its San Diego office in March 2012, Mr. Swit served for seven years as a Vice President for The Weinberg Group, a premier FDA regulatory consulting firm headquartered in Washington, D.C., where he developed and ensured execution of a broad array of regulatory and other strategies, compliance and enforcement initiatives for drug, biologic, device, IVD, and other life sciences companies, as well as those in the food, cosmetic, and dietary supplement industries. Mr. Swit’s multi-faceted experience includes serving as general counsel of Par Pharmaceutical, a major publicly-traded generic drug manufacturer, where he spearheaded Par’s successful response to multiple federal and state criminal and civil investigations arising out of the actions of prior management. Mr. Swit then served for over four years as CEO of FDAnews.com, a premier publisher of FDA regulatory newsletters and other specialty information. His prior law firm service included being a vital part of the FDA practices at two major international law firms and a national firm with a prominent food & drug practice.Mr. Swit has taught and written on an array of subjects relating to FDA law, regulation and related commercial activities. A former member of the Food & Drug Law Journal Editorial Board, Mr. Swit also has been a prominent speaker at conferences sponsored by such organizations as RAPS, FDLI, ACRP, and DIA.A magna cum laude graduate of Bowdoin College, with high honors in history, Mr. Swit earned his law degree from Emory University School of Law.


Saul Mashaal

Saul Mashaal, Chairman of Acertus Pharma LLC, USA and Co-Chair of Vanir Bio Pte Ltd, Singapore

Founder & Chairman of Acertus Pharma LLC, USA, Founder, Co-Chair and Head of Corporate Business Development of Vanir Bio Pte Ltd, a Singapore based Biotechnology Company with R & D in Israel, Valin Technologies Ltd, focusing on the research and development of Biosimlars and Biobetter. Saul Mashaal has over 40 years experience in the Biopharmaceutical industry. He started his career with Syntex Laboratories Ltd (now Roche) with the business development of systemic steroids and NSAID products. In 1973, he joined the 3M Company to head the Clinical Research Group, subsequently the management of 3M Health & Sciences subsidiary companies in Latin America & the Caribbean’s and International Business Development in the Health & Science Sector. In 1988 he founded SciTech Genetics for the development, thru networking with emerging Biopharmaceutical companies and Research Institutions, of Biotechnology derived products and diagnostics for human healthcare and Acertus Pharma for the distribution and marketing of Biopharmaceutical products. In 2002 SciTech Genetics listed in the Australian Stock Exchange (ASX) and in 2006 was acquired by Bioton S.A. Saul Mashaal remained as its Chairman & CEO until 2009. He then founded Valin and Vanir under UDM Corporate umbrella.
During the course of his career, he built several Biotech manufacturing facilities in several countries with a total Capex value of US$550 Million dollars. This included a successful transfer of technologies of E Coli and CHO Cell derived products.


Michael Cohen

Michael Cohen, 
Managing Director, Myoderm

Michael has been with Myoderm since 2001. Through his passion, leadership, and commitment to meeting each client’s unique needs, he has enabled the company to grow into a global leader in comparator and commercial drug sourcing for clinical trials. Prior to working for Myoderm, Michael held positions in the publishing, advertising, financial, and utility industries. He holds a B.S. degree in statistics from the University of Pittsburgh, and an M.B.A. degree from the university’s Katz Graduate School of Business.


Lauren Ingram

Lauren Ingram, Senior Manager, Worldwide Regulatory, Pfizer Inc.

Lauren started her career in the pharmaceutical industry in the areas target identification and validation. Since joining Pfizer, she has held positions of increasing responsibility within worldwide regulatory strategy and is currently a global regulatory lead for rare disease products and biosimilars at Pfizer. Ingram holds an MS in regulatory affairs from Temple University.


Dr. Isabel Zwart, Senior Consultant, PARAXEL International

Dr. Isabel Zwart is a regulatory affairs professional specializing in the field of biologics at PAREXEL Consulting, UK. Isabel has experience in providing regulatory support and advice to Companies developing biologics and biosimilars. She has worked on products at all stages of development, providing input on manufacturing process issues, as well as clinical strategy for recombinant protein products. Isabel has been involved heavily in the field of biosimilar monoclonal antibodies, as well as biosimilars and biobetters of filgrastim. Prior to joining PAREXEL Dr. Zwart worked in regulatory affairs within a leading UK-based biopharmaceutical consultancy, specialising in biologics. She has also worked in conjunction with the National Health Service Blood and Transplant UK as part of the London Cord Blood Bank scheme, as well as spent time in industry in the manufacture of recombinant protein vaccines. Dr. Zwart holds a PhD in Clinical Medicine Research from Imperial College London working on stem cell therapies.


Martin Bluggel

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.


Stephanie Finnegan

Stephanie Finnegan, President, Biopharmaceuticals Division, bioRASI

Stephanie Finnegan is the President of bioRASI’s Biotherapeutics Division. bioRASI is a Miami-based, global CRO with special expertise and focus on generics and biosimilar clinical development. The company is currently running the first clinical trial to be presented to FDA under the “new??? 2012 Draft Guidance. Ms. Finnegan has been prominent in the South Florida biotechnology industry since founding Goodwin Biotechnology in 1993. Goodwin was the industry’s first biologics contract manufacturer and specialized in the manufacture of diagnostic and therapeutic monoclonal antibodies and recombinant proteins for use in Phase I-III human clinical trials. She led Goodwin until it was acquired in 2004 by an Indian pharmaceutical company. After remaining as CEO for several years after that acquisition, she joined bioRASI to assist in ramping up the CRO’s activities in biotherapeutics translational medicine, including cell therapies, innovative and biosimilar molecules. bioRASI has staked a prominent position in the biosimilars arena, leveraging both its expertise in CMC biologics as well as its long history of managing pivotal clinical trials of multi-specialty (generic) pharmaceuticals and 505(b)(2) drug approvals.


Christina Satterwhite

Christina Satterwhite, PhD, Director, Laboratory Sciences, Charles River Laboratories

Christina Satterwhite has been with Charles River since September 2002. Christina Satterwhite joined Charles River Laboratories as a Study Director in 2002 as an Associate Research Scientist and conducted studies in the special pathology laboratory which included tissue cross reactivity and immunohistochemistry evaluations. Christina’s scientific expertise over the years has been in the area of Immunotoxicology with emphasis on the nonhuman primate model. As the program manager of immunology, she developed a laboratory that could support the assays and models that are required to investigate potential immunotoxicities or immunomodulation. Dr. Satterwhite developed models such as delayed type hypersensitivity, developmental immunological endpoints, and T-cell dependent antibody responses. Immunoassay expertise was developed so that the immunology program could support large molecule bioanalysis, immunogenicity, neutralizing antibody cell-based assays, innate immune assays and flow based assay and immunopharmacological evaluations. Dr. Satterwhite now oversees the Laboratory Sciences department which includes formulations, analytical chemistry and immunobiology.
Christina received her PhD in Cellular and Molecular Pharmacology and Physiology at the University of Nevada, Reno, School of Medicine in 2002. Christina’s area of scientific expertise was in the study of ion channels and their role in cardiovascular disease


Kelly S. Colletti

Kelly S. Colletti, PhD, MBA, Research Scientist II, Program Director, Bioanalytical Sciences, Charles River

Kelly Colletti obtained her PhD in Cellular and Molecular Biology at the University of Nevada, Reno in 2005. She is a trained herpes virologist that studied the molecular mechanisms of Cytomegalovirus and Karposi’s Sarcoma Associated Herpes Virus DNA replication. While pursuing her doctoral degree, she learned a diverse set of skills including protein expression and purification, antibody generation, enzymatic assay development, cell culture, molecular biology and protein chemistry. She also obtained an MBA during this time and has a keen business sense. Her postdoctoral fellowship was also in virology developing a reverse genetics model for the Sin Nobre Hantavirus.
Kelly joined Charles River in early 2009 and has since become the Program Director of Bioanalytical Sciences for preclinical and clinical services. She is also cross trained in immunotoxicology a nd has experience running studies in Non-Human Primates with
immunophenotyping, TDAR, NK cell activity, and cytokine analysis endpoints. Since joining CRL, Kelly has participated in over 15 biosimilar programs validating bioanalytical and immunogenicity assays to support preclinical and clinical studies. As an industry leader in this field, she has also authored several publications on the subject of biosimilars.


Shanaya Deboo

Shanaya Deboo, Director, Commercial Development/Market Development, Pfizer Inc.

Shanaya is a Director of Commercial Development in Pfizer’s Biosimilars business unit. Shanaya is currently responsible for global market development for Pfizer’s Biosimilars assets. In this role, she works closely with colleagues across the organization and external partners, including Patient and Professional Advocacy groups, on policy development and market preparation. Prior to joining the Biosimilars team, Shanaya was Regional Marketing Director, based in Brussels, responsible for driving strategy and tactics for Pfizer’s pain products across emerging Europe, Russia, India, and Turkey. Prior to that role, she spent five years in US Marketing and two years in Corporate Affairs. Before joining Pfizer, Shanaya was a consultant at the Boston Consulting Group. She graduated from Princeton University with a Bachelor’s in Public and International Affairs and has an MBA from Harvard Business School.

Day 1

Day 1 – Tuesday 11th February 2014

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

08:50-09:00 – Chairman’s welcome & Opening Remarks – Richard DiCicco, Co-Founder, Harvest Moon Pharmaceuticals, USA

09:00-09:30Understanding the Global Regulatory Landscape for Biosimilars

  • Understanding the nuinsance and implications of the FDA Guidelines on Biosimilars
  • EU vs the US: what are the key differences?
  • What other countries do you need to be aware of?

Lauren Ingram, Senior Manager, Worldwide Regulatory Strategy, Pfizer Inc.

09:30-10:10US Regulatory Update on Biosimilars Law-challenges and opportunities

  • Current regulatory guidelines
  • Open issues for FDA
  • FDA guidelines
  • An update on the Biologics Price Competition and Innovation Act (BPCIA)
  • What does the BPCIA mean for Healthcare reform?

John M. Pakulski, Head of US Biopharmaceutical Regulatory Affairs, Sandoz Inc. a Novartis Company

10:10-10:40Panel Discussion: Global Regulatory and Current Development

  • Are we near to International harmonized development?
  • Moving towards global Biosimilars guidelines
  • Update focus on the emerging market countries
  • Introducing Japan’s Situation on Biosimilars

Dr. Fiona M. Greer, BSc (Hons) MSc PhD, Global Director, BioPharma Services Development, SGS M – Scan, UK
Hideaki Nomura, President and CEO, Fujifilm Kyowa Kirin Biologics, Japan
Dr. Chris Beaver, PhD, Director, Ligand Binding and Exploratory Bioanalysis, inVentiv Health Clinical
Moderator – Dr. Michel Mikhail, Executive Vice President Global Regulatory Government Relations, Fresenius Kabi, Germany – European Generic Medicines Association (EGA) Belgium

10:40-11:10 – Networking – Morning Refreshments (Exhibitors Hall)

11:10-11:50Physician’s Perspective on Biosimilars

  • Challenges of Physicians education: Understanding the differences between biosimilars and generics.
  • Who decides when to use biosimilars?
  • Importance of pysicians / pharmacist collaboration
  • Harmonizing global standards to ensure patient safety

Dr. Richard Dolinar, MD, Alliance Chairman, Safety Biologics, Alliance for Safe Biologic Medicines

11:50-12:30Challenges with Sourcing Innovator Products for Research and Trials

  • What are the challenges for sourcing innovators for Biosimilars trials?
  • changes over the past 12 months
  • Issues with certain products
  • Looking outside of the US and EU
  • Case Studies
  • What does the future hold?

Michael Cohen, Managing Director, MYODERM

12:30-13:10 – How does the Technical Development of Biosimilars and Novel Drugs Differ?

  • Activities and timelines until FIM (First In Man)
  • Evaluation and timeline development strategies and their suitability for Biosimilars and Novel drugs
  • Applicability of QbD (Quality by Design)

Dr. Thekla Kurz, Head of Biotech Project Management & GMS Business Partner Biosimilars, Merck KGaA

13:10-14:10 – Networking – Lunch Break

14:10-14:50 – Non – Clinical Development of Biosimilars and Innovator Products: Status and Perspective

  • Current regulatory guidance and nonclinical development strategies for biosimilars and innovator biologics;
  • Differences, challenges and issues in nonclinical development strategies of biosimilars compared to innovator products;
  • Case studies highlighting challenges and issues;

Joerg Bluemel, Pht ERT, Director Biologics Safety Assessment, Translational Sciences, MedImmune

14:50-15:30 – Global Strategic Collaboration – How to succeed Global Biosimilars Business

  • Necessary factors for global biosimilars business
  • Aim of the collaboration
  • Key success factors of the partnering

Hideaki Nomura, President and CEO, Fujifilm Kyowa Kirin Biologics, Japan

15:30-16:00 – Networking – Afternoon break (Exhibitors hall)

16:00-16:30 – Biosimilars: Driving on Global Commercial Potential through the Emerging Markets

  • Understanding how developing healthcare policy in the emerging markets plays to the biosimilars opportunity
  • Identify key emerging markets particularly conductive to the biosimilars opportunity
  • Determine non – pricing options for achieving competitive advantage relative to other biosimilars

Richard DiCicco, Co-Founder, Harvest Moon Pharmaceuticals USA

16:30-17:00 – Initiative and Commercialization of Biosimilars and Biobetter and Access to Emerging Markets

  • Market Access, Initiative and Commercializing – Biosimilars and Biobetter
  • Manufacturing and finished product manufacturing site
  • Clinical Development Strategy
  • Key to success in securing approvals in major markets
  • Essentials in Partnering
  • Product roll-out

Dr. Saul Mashaal, PhMB, MBA, Chairman, Acertus Pharma, LLC USA – Chair Vanir Bio Pte Ltd, Singapore

17:00-17:30 – Biosimilars: Less than a Decade and New Paradigm already?

  • This discussion will focus upon some key strategic initiatives to be undertaken by companies developing Biosimilar molecules, to pro-actively win this battle by avoiding the reactive behavior of the wait and see approach.
  • The discussion will conclude with some likely scenarios that will play out as biosimilar product development, regulatory strategy, marketing and distribution globalize and mature.

Stephanie Finnegan, President, Biopharmaceuticals Division, bioRASI

17:30 – 17:40 – Chairman’s closing remarks – Richard DiCicco, Co – Founder, Harvest Moon Pharmaceuticals

17:40 – 19:00 – Networking Exhibitors Hall

19:00 – 21:00 – Networking Gala Dinner Reception

 

 

Day 2


Day 2 – Wednesday 12th February 2014

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

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

09:00 – 09:40 – Regulation of Biosimilars: From Europe to USA to Global Harmonization

  • Update on Europe guidelines
  • The Concept of biosimilars versus biobetters
  • Activities towards harmonization

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

09:40-10:20 – Preclinical and clinical Bioanalytical Strategies for Biosimilars and Follow – on Biologics Development

inVentiv Health Clinical

10:20 – 10:50 – Update on FDA Development for Biosimilars

  • Interchangeability – Guidance (if issued by then; if not, what is might say)
  • Naming issues – Where is the WHO going and will FDA follow on the INN – the GPhA Petition
  • State legislative activities to restrict substitution of interchangeable biosimilar
  • REMS and their impact on restricting access to branded products needed for biosimilar comparability studies

Michael A. Swit, Special Counsel, FDA Law Practice, Duane Morris LLP

10:50-11:20 – Networking morning refreshment (Exhibitors Area)

11:20 – 12:00 – Biosimilars: Hurdles to Patient’s Access

  • Regulatory Requirements
  • Comparability Exercise: Logistical issues: Case Study
  • INN
  • Switching of Patients: Interchangeability and Substitution

Dr. Michel Mikhail, Executive Vice President Global Regulatory Government Relations, Fresenius Kabi – European Generic Medicines Association (EGA) Belgium

12:00 – 12:40 – Mass Spectrometry Analysis for Biosimilars

Why mass spectrometry (MS) is growing in importance as comparator

  • Biosimilar development requires comprehensive physicochemical structural – Characterization of the (glyco) 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 the 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 Services Development, SGS M-Scan

12:40 – 13:10 – Establishing and demonstrating Biosimilarity – The CMC part

  • Reference product monitoring
  • Monitoring Biosimilarity from Cell line to GMP process
  • State of the art protein analytics and regulatory demands to demonstrate Biosimilarity
  • Case studies for Analytical testing to establish and demonstrate Biosimilarity

Martin Bluggel, Chief Executive Officer, Protagen Protein Services GmbH

13:10-14:10 – Networking Lunch Break

14:10 – 14:40 – Challenges and obstacles in conducting clinical trials for Biosimilars

  • Key considerations in planning clinical trials for biosimilars
  • Patients recruitment and education
  • Operational procedure to minimize cost and optimize delivery

Dr. Nigel Rulewski, Vice President, Global Strategic Drug Development, Quintiles

14:40-15:10 – Biosimilars containing monoclonal antibodies

  • Clinical and non-clinical issues
  • Risk assessment and management
  • mAbs update affecting Biosimilars

Isabel Zwart, Senior Consultant, PAREXEL International

15:10-15:40 – Networking afternoon refreshment (Exhibitors Area)

15:40 – 16:10 – Lots of Noise – Is Anyone Listening? The public discourse on Biosimilars and what people believe

  • How Biosimilars are being described in popular media, and by whom
  • What patients, physicians, and other key stakeholders believe
  • Approaches to clear message and better understanding

Shanaya Deboo, Director, Commercial Development / Market Development, Pfizer Inc.

16:10-16:40 – Economics of Biosimilars – Challenges in bringing the next generation of biosimilars to the market

  • Balance between innovation and competition
  • The potential entry in the US market
  • The European Experience of biosimilars
  • Barriers to Entry
  • Market Opportunities
  • Competitive response
  • Future of the Biologics Market

Dr. Joseph P. Fuhr Jr. Professor Economics, Widener University

16:40-17:30 – Panel Discussion: Obstacles and hurdles for entering the biosimilars marketAn interactive discussion on the barriers of entry for developing biosimilars; discussing topics such as:

  • Cost of development
  • Legal requirements
  • Technology demands

Dr. Joseph P. Fuhr Jr. Professor Economics, Widener University

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

Dr. Thekla Kurz, Head of Biotech Project Management & GMS Business Partner Biosimilars, Merck KGaA

Dr. Saul Mashaal, PhMB, MBA, Chairman, Acertus Pharma LLC USA, Chair Vanir Bio Pte Ltd, Singapore

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

17: 30 – 17:40 – Chairperson’s closing remarks – Ricard DiCicco, Co – Founder, Harvest Moon Pharmaceuticals

 

 

Sponsors & Exhibitors

Gold Sponsor

inVentive

InVentiv Health Clinical

inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 70 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing.

www.inVentivHealthclinical.com


Silver Sponsor

sgs

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


Silver Sponsor

Myoderm

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


Associate Sponsor

quintiles

Quintiles is the world’s leading biopharmaceutical service provider

With a network of more than 27,000 professionals working in more than 80 countries, we have helped develop or commercialize all of the top 50 best selling drugs on the market. With extensive therapeutic, scientific and analytics expertise, we help biopharmaceutical and health sciences customers navigate the increasingly complex landscape with more predictability to enable better outcomes. We address the needs of the biopharmaceutical industry and broader healthcare industries, including payers and providers. We use our expertise and insights to help customers optimize the value of their drug development, commercialization and health care delivery. We can support our customers from initial human testing through patent expiration, from strategy through planning and execution. Through our extensive range of services, we solve our customers’ biggest challenges: decreasing costs, improving productivity, and saving time. The broad scope of our services helps our customers rapidly assess the viability of a growing number of potential new therapies, cost-effectively accelerate development of the most promising ones, successfully launch new products to market and evaluate their impact and appropriate use in patients.
All along, we work with an unwavering dedication to patients, safety and ethics. www.quintiles.com


Associate Sponsor

protagen

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


Associate Exhibitor

bio-rasiAbout bioRASI- bioRASI is an award-winning Clinical Research Optimized™ CRO. From study design to execution success, optimization is engrained in our bioRASI Process Infrastructure (BPI), the most robust and innovative operating platform in the industry. Equipped with BPI, our full service project teams have developed numerous drugs, biologics and medical devices that received FDA and multi-venue approvals. bioRASI is headquartered in Miami, FL and has regional offices and operations across North America and around the world. www.biorasi.com


Exhibitor

ezose Ezose Sciences Inc. is a leading Glycomics company focused on glycan characterization for bioprocess development. Ezose’s analytical services leverage their proprietary automated GlycanMap® technology to provide glycan identification and quantitation across large batches of samples. Ezose offers both full service glycan analysis and a simpler, more cost effective version, GlycanMap® Xpress™, which enables more comprehensive characterization of the glycans on biosimilars and innovator molecules during cell line development, media optimization, and upstream process development. Ezose, a US company based in New Jersey, provides glycan analytical services for biosimilars and biologics clients in the US, Europe and Asia.
www.ezose.com

Partners


Media Partners

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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