Biosimilars and Follow-on Biologics 2016 Americas


Dear Colleagues

The global biosimilars market is anticipated to reach $6.22 Billion by 2020 from $2.29 Billion in 2015, growing at a CAGR of 22.1% from 2015 to 2020. The increasing pressure to decrease healthcare expenditures, growing demand due to its cost-effectiveness, expanding occurrence of different diseases, increasing numbers of biologics losing their market exclusivity, positive outcomes in ongoing clinical trials and rising demand in various therapeutic applications are all contributing factors for growth of the biosimilars market.

Between 2015 and the end of 2019, 39 biologics with combined US sales of $41 billion, representing 30% of the total market will lose their marketing exclusivity. This resulted in huge interest by big pharma and biotech company venturing into the Biosimilar sector in order to gain a slice of multibillion worth of biologics market.

The FDA’s approval of the first Biosimilar product in the US is a significant event. A full blown Biosimilars market offers a huge potential in bettering patient outcomes and contributing compelling cost, opening the doors for easy access and optimal care. It was reported that Biosimilars could save the US economy up to $250 billion within the next seven years.

However, circumstance such as high manufacturing complexities and costs, rigorous regulatory requirements in countries, and innovative strategies by biologic drug manufacturers to restrict the entry of new players are restraining the growth of this market.

In this congress, we will cover a diverse range of topic and address the challenges and obstacles encountered by the industry from development to successful market of biosimilars. This will also offer and provide a unique platform for knowledge sharing and convergence from Pharmaceuticals, Biotechnology, Regulatory and many more.

I look forward to meeting you at the conference.

Best regards,

Jocelyn Raguindin Conference Director Paradigm Global Events


  • 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
  • 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
  • Theimportanceofestablishingpartnershipsand 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 industy


Presidents, Vice Presidents, Heads, Directors, Decision Makers from following departments:

  • Commercialisation
  • Regulatory Affairs
  • Market Access
  • Sales & Marketing
  • Research & Development
  • Corporate & Business Development


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.


Rakesh Dixit, Vice President, R&D, Global Head, Biologics Safety Assessment, MEDIMMUNE

Dr. Dixit conducted extensive graduate and post-graduate training in Toxicology–Biochemistry with both Indian and US Institutions (Case Western Reserve University, Medical College of Ohio, University of Nebraska) and is board certified in Toxicology from the American Board of Toxicology, Inc. since 1992. Rakesh served as a Senior Toxicologist with Midwest Research Institute between 1987 and 1992.
In December 1992, Rakesh joined the Department of Safety Assessment, Merck and Co., Inc, West Point, PA where he served in various management positions. During his about 14 years with Merck, Rakesh contributed to the successful filings of many blockbuster drugs. For about a year, Rakesh was associated with Johnson and Johnson PRD, La Jolla/Alza as Senior Director of Toxicology.
In Aug 2006, Rakesh joined MedImmune, Inc. (an AstraZeneca Biologics company) as Senior Director (R &D) & Global Head of Biologics Safety Assessment, Experimental Pathology, and Laboratory Animal Medicine. In his current position as a Vice President of R &D since 2010, Rakesh is responsible for providing guidance on research and development of biological products; including nonclinical toxicology/safety support for all AstraZeneca-MedImmune biologics products, including monoclonal antibodies and vaccines. Rakesh has published more than 60 papers in renowned international journals and has given over 100 invited lectures/presentations/workshops in national and international
meetings. Rakesh is one of the most invited speakers in the biotechnology industry.
Rakesh’s areas of expertise are mainly in the area of pharmaceuticals and biologics drug development, safety assessment of small molecule drugs, biologics, vaccines and in exploring mechanisms of toxicity and biologics pharmacological activity. Rakesh has helped to bring several blockbuster pharmaceuticals to the market while working at Merck. Rakesh a recognized expert in safety and pharmacology biomarkers and their applications.. Rakesh is the Editor-in-chief of Toxicology Mechanisms and Methods and Associate Editor for Toxicology Applied Pharmacology, and Journal of Toxicology and Environmental Health. Rakesh was selected by his pharmaceutical peers as the 100 Most Inspiring People in Pharmaceutical Industry by PharmaVOICE in 2015. Rakesh also serves as an expert reviewer and in appointed committee for many programs managed by the prestigious U.S. National Academy of Sciences and US National Institutes of Health, including National Cancer Institute.


Bruce A. Leicher, Senior Vice President and General Counsel, MOMENTA PHARMACEUTICALS INC.

Mr. Leicher is Senior Vice President and General Counsel at Momenta Pharmaceuticals Inc., an innovator biotechnology company engaged in development of complex generic products, biosimilars, interchangeable biologics and novel products. Mr. Leicher has advised biotechnology companies for over 20 of his more than 30 years of legal experience. Mr. Leicher is a frequent lecturer on biotechnology law. Before joining Momenta, he served in senior legal positions at Altus Pharmaceuticals Inc., Antigenics Inc., Millennium Pharmaceuticals, Inc., Curis, Inc., Genetics Institute, Inc. and Wyeth. In private practice, he served as the Co-Chair of the Life Sciences Practice Group at Hill and Barlow, was an attorney at Hale and Dorr and Butler & Binion, and served as a law clerk to the Honorable Thomas F. Hogan in the U.S. District Court for the District of Columbia after receiving his J.D. from Georgetown University Law Center and his B.A. from the University of Rochester.


Dr. Harry Gewanter, Chairman, ALLIANCE FOR SAFE BIOLOGICS

Awaiting for photo and bio


Cornelia Ulm, VP Regulatory Affairs Biosimilars, MERCK SERONO

Cornelia joined Merck as Head Regulatory Affairs Biosimilars in November 2012. She has more than 20 years experience in the pharmaceutical industry. Prior to Merck, she served as Senior Director Regulatory Affairs – Biologics at Mylan, where she was responsible for all regulatory activities related to the development of Biosimilar products. Her pathway in Biosimilar development included also positions at Apotex and Biopartners, where she build up the Regulatory Departments, supported drug development and led registration procedures for Biosimilar products. During her tenure earlier at Serono, Cornelia gained widespread regulatory knowledge in the areas of CMC, non-clinical and clinical development. Cornelia has a degree in pharmacy from J.W. Goethe University of Frankfurt, Germany


Dr. Steinar Madsen, Medical Director, Norwegian Medicines Agency Norway

Dr. Steinar Madsen, is medical director at the Norwegian Medicines Agency.
He is a specialist in internal medicine and cardiology and works part time as a consultant in cardiology. He has been working with generic substitution since it was introduced in Norway in 2001. He is member of a working group at the Agency that is looking into several aspects on the regulation of generic substitution in Norway, including biosimilar drugs, with the aim of a better legal framework. Dr. Madsen is also engaged in the Agencys drug information service, with a special interest in the safe use of drugs.


Brian Harvey, EVP Scientific & Regulatory Affairs, GLOBAL LIVER INSTITUTE

Over 30 years of experience in biomedical research, clinical medicine, drug, biologic product, medical device and combination product development and pre-market regulatory evaluation. Special interests in Regulatory Science, FDA policy development, Biosimilars science & policy, Orphan products / Rare Disease Treatment development, healthcare delivery policy and medical/scientific communication. Firsthand knowledge of FDA regulations, guidance & procedures, effective verbal communication skills, competent technical writing skills and extensive management experience. Maintains active medical license in the state of Maryland.


Dr. Fiona M. Greer, 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.


Robyne J. Kelemen is Director, Regulatory Affairs – Biologics, at Dr. Reddy’s Laboratories (DRL). She has responsibility for strategy

development, regulatory agency interface, and registration of biosimilars and novel biologics for highly regulated markets. She is based in
Princeton, NJ. Prior to joining DRL, Dr. Kelemen held positions of increasing responsibility at Janssen Pharmaceuticals,
Endo.Pharmaceuticals, Cephalon,(Teva), and Merck and Co. in development, technical operations, and regulatory affairs for infectious disease,
oncology, therapeutic vaccines, novel biopharmaceuticals and other products. She began her industry career as a product development
engineer with Procter & Gamble Co. Dr. Kelemen holds M.S. and Ph.D. in bioengineering from University of Pennsylvania, Philadelphia PA,
and undergraduate degrees in chemical engineering and biology from University of Delaware, Newark DE. She has also served as adjunct
professor at Columbia University and Penn State University.


Michael Hunter, Pharmacist, Chicago Office, MILLIMAN

Michael Hunter is a pharmacist with the Chicago office of Milliman. Michael has more than 13 years of experience in the pharmacy industry,
including expertise in specialty pharmacy, drug pipeline analysis, pharmacy operations, drug purchasing, all pharmacy insurance markets,
and formulary management. He supports clients with expert knowledge in the pharmacy space and provides creative solutions with overall
efficiency and cost reductions as a focus.

As a consultant, Michael works with numerous clients including Medicare Part D carriers, wholesalers, manufacturers, pharmacy benefit
managers, pharmacies, and other entities within the pharmacy channel, and is a member of the Academy of Managed Care Pharmacy.


Katherine M. Holcomb, Consulting Actuary, MILLIMAN

Katie is an consulting actuary with the Milwaukee office of Milliman. Her career as a healthcare actuary began in 2008.
Katie’s areas of expertise are pharmacy, Medicare Advantage, employer health plans, and long-term care insurance.
In the pharmacy space, Katie has worked with pharmacy benefit managers, pharmaceutical companies, and industry organizations, with
particular emphasis on the Medicare Part D benefit. She also conducts firm-wide research and development of related tools for prescription
drug benefits in Milliman’s Health Cost Guidelines. Specific to the Medicare market, Katie has assisted several large Medicare Part D plans with bid preparation and strategic analyses. She is a key contributor to Milliman’s Part D research efforts.

In addition to Medicare Part D and other pharmacy work, Katie has assisted several employers with rate setting and reserving for their
employee health plans. She has also worked on claim reserves and rate filings for long-term care insurers, and has conducted research
studies on active vs. disabled long-term care mortality.
 Fellow, Society of Actuaries


Paul W. Price, Senior Consultant, Biological Pro duct Development, THE BIOLOGICS CONSULTING GROUP

Paul W. Price, Ph.D. comes to BioCG with over 25 years’ experience in the Biotechnology Industry. With Biologics Consulting Group, Paul is part
of the CMC-Analytics and Formulations Team, and also serves with the Early Development and Biosimilars Task Forces. He assists clients with
design and implementation of biologics development and manufacturing projects; design, development, qualification and validation of process
and release analytics; developing Project Management strategies for product development including Risk Management, Quality Oversight, and
Technology Transfer; and Identification, management, preparation, and submission of Government Contract and Grant Proposals.
Paul’s career has included work at Biocraft Laboratories and Barr Laboratories, Beckman Coulter, Inc., Abeome Corp., and Paragon Bioservices,
as well as working as an independent consultant. As Principle Scientist at Paragon, he lead the planning and implementation of biologics
development projects, including vaccines, viral-vectored products, monoclonal antibodies, protein therapeutics, and diagnostics. In addition,
Paul held the position of Director of Government Grants and Contracts, where he oversaw the development, management, and submission of
Government contract proposals and Grant applications. He is a SME in immunology, infectious diseases, microbiology, virology, and cancer, as
well as biological assay development, Risk Management, and Quality oversight.
Dr. Price holds a B.S. in Marine Biology and a M.S. In Microbiology from Fairleigh Dickinson University, he earned his Ph.D. in Biology
(Immunology) from Georgetown University, and completed post-doctoral studies at the University of Maryland, School of Medicine.


Kenneth Walsh, Senior Principal, Payer Strategy, EVIDERA (Previously from GSK)

Ken Walsh has been working in the life sciences industry for over 15 years. Ken currently leads Pricing for GlaxoSmithKline’s Emerging Markets Australasia division. Prior to joining GSK, Ken was Global Pricing & Market Access Lead at Sandoz Biosimilars based in Munich. Prior to moving into industry Ken also has a decade of consulting experience based in the USA and Singapore with firms such as Cambridge Pharma, GfK, Kantar Health and Bridgehead.


Dr. Yanan Xu, Director, Business Development, INNOVENT BIOLOGICS INC.

Dr. Yanan Xu is currently serving as director of business development in Innovent bringing his over ten years’ biopharmaceutical experience in the areas of business development, marketing and project management. Dr. Xu started his pharmaceutical career from Newsummitbio as BD manager in 2001 and served as BD director of Wisonbio group for over four years responsible for scouting and in-licensing multiple biological products in various stages.

He was also leading the department of marketing and sales Daicel (China) pharmaceutical chiral technology company, the China branch of a Japanese listed company. Before joining Innovent, Dr. Xu spent over three years in GE Healthcare Group as a business leader to explore and initiate novel business model to expand GE business in biopharmaceutical area.

Dr. Xu received his Ph.D degree in University of Maryland, School of Pharmacy with over 15 peer-reviewed publications and also earned a certificate of financial risk manager (FRM) by GARP.


Louk Pechtold, 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.
Amsterdam Center for Drug Research. Louk has closed more 20 collaborations and has extensive alliance management experience. He holds University and an MBA from the Rotterdam School of Management. Besides, Louk worked at Shire, Cygnus Inc., Bayer, the Boots Company, Hermal, Vifor, Merz Pharmaceuticals and the Leiden Amst ds a Ph.D. in Pharmacology from Leiden.


Kevin Cancelliere, Director, Marketing, WEST PHARMACEUTICALS SERVICES, INC.

Kevin Cancelliere joined West Pharmaceutical Services in January 2013 as Director of Marketing, Pharmaceutical Delivery Systems. Kevin brings almost thirty years of broad operational and strategic marketing and sales experience to this position. He comes to us from Vicept Therapeutics where he was Senior Director, Project Management for an investigational drug for the treatment of Rosacea. Prior to Vicept, Kevin was the Senior Director, US Marketing at Wyeth Laboratories. Kevin holds a B.S. in Biology from De Sales University and a Masters in Biochemistry from Thomas Jefferson University.


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.


Dr. John Snyder, Research Fellow/Group Leader, EUROFINS LANCASTER LABORATORIES,INC

Dr. Snyder is a Research Fellow and Group Leader in the BioChemistry Department at Eurofins Lancaster Laboratories where he has been employed for the past 33 years. In the early half of his career, he witnessed the rapid growth of Lancaster Laboratories as an environmental laboratory specializing in the analysis of PCBs and priority pollutants. During this early part of his career, he earned a Ph.D. in Analytical
Chemistry from Villanova University while working full time and discovered his passion for gas chromatography and especially mass spectrometry. During this tenure, he oversaw a number of special projects and developed methods for environmental contaminants using gas chromatography and mass spectrometry.

One of his most notable projects was establishing the present Air Laboratory for the analysis of volatile organic compounds at Lancaster Laboratories. In 1999, he transferred to the new and rapidly growing Pharmaceutical Division. During this time, he specialized in liquid chromatography and tandem mass spectrometry and was responsible for developing quantitative methods for pharmaceutical small molecules. Approximately nine years ago, Dr. Snyder made the transition from small molecules to large biomolecules and joined the Biochemistry Method Development and Validation Department. Presently he heads a group of scientists that specialize in characterizing biotherapeutic proteins using various forms of liquid chromatography and mass spectrometry.

Dr. Snyder resides in Lititz, Pa, near the heart of Amish country in beautiful Lancaster County. He has been married over 35 years, is the father of four grown children, and is grandfather to three. He has been a member of ACS (over 25 years), ASMS and is active in the Delaware Valley Chromatography Forum and Mass Spec Discussion Groups. Over his career he has produced approximately 30 publications and presentations at scientific meetings.


Bruce Babbitt, V.P. Early Stage, PAREXEL Consulting

Babbitt joined PAREXEL International in June 2000 where he is primarily responsible for integration of key CMC, nonclinical, clinical development, regulatory issues across PAREXEL/client project teams. Dr. Babbitt’s primary expertise is in development of new biological entities and biosimilars. His biologics experience spans recombinant proteins (primarily monoclonal antibodies), blood products, vaccines (cancer, infectious diseases), and cellular therapies (mesenchymal stem cells, T-lymphocytes). His biosimilars experience includes filgrastim, infliximab, adalimumab, bevacizumab, trastuzumab, rituximab and ranibizumab.

He has presented PAREXEL’s key positions on biosimilar development at November 2010 and May 2012 FDA public meetings Prior to joining PAREXEL, Dr. Babbitt spent 12 years as VP/Director R&D in biotech industry (LipoGen, Inc., Cellcor, Inc.). He has a Ph.D. in Biochemistry (Univ. of Tennessee); post-doctoral research in cellular immunology (Harvard Med. School, Washington Univ. Med. School).


Dr. Ming Wang, Vice President and Disease Area Leader of Diabetes/Metabolism, JANSSEN PHARMACEUTICALS OF J & J)

Dr. Ming Wang is currently Vice President and Disease Area Leader of Diabetes/Metabolism at Janssen Pharmaceuticals of Johnson & Johnson. In this role, he is responsible for setting disease area strategies, making investment decisions and building a portfolio of assets for disease treatment and prevention. Previously, he was President and Chief Operating Officer and a member of the Board of Directors at Gan & Lee Pharmaceuticals, a biotech pioneer in China focused on insulin-based therapies with annual combined sales of ~$100 million in
China, Latin America and Southeast Asia. Prior to that, Ming was Executive Director and Head of Diabetes Research at Amgen where he headed a group of ~50 scientists located on two research sites working on developing novel therapies for metabolic diseases. Before joining Amgen, Ming championed drug discovery programs in cardiovascular and metabolic diseases and managed corporate partnerships in Parke-Davis, Pfizer and Pharmacia.

Ming served on multiple advisory boards, including the Scientific Advisory Board (SAB) of Amgen Ventures ($100 million in management). Ming is a frequent speaker at scientific and drug discovery conferences and has 59 publications and a book entitled “Metabolic Syndrome: underlying mechanisms and drug therapies” (publisher: John Wiley & Sons, Inc.). Ming is also an adjunct faculty in the Department of Bioengineering and Therapeutic Sciences at the University of California, San Francisco Schools of Pharmacy and Medicine. Ming holds a PhD.



Mr. Shea is a director in the Biotechnology/Chemical Group where he advises biotech and chemical companies and research institutions on complex legal issues relating to the protection, enforcement and transfer of their intellectual property. He practices primarily in the fields of immunology, molecular biology, genomics, proteomics, medical diagnostics, biotherapeutics, and drug delivery. He has extensive experience advising clients on the creation and management of strategic patent portfolios, freedom-to-operate and patentability issues, complex prosecution strategies, validity and infringement issues, and due diligence investigations in connection with acquisitions and investments.

A significant portion of Mr. Shea’s practice involves counseling emerging companies on strategies for creating, protecting and leveraging their IP assets to grow their businesses. He frequently advises clients on all aspects of technology transfer, including the drafting and negotiation of patent and technology license agreements, material transfer agreements, sponsored research agreements, confidentiality and
nondisclosure agreements, joint developments agreements, etc. Mr. Shea is currently Vice-Chair of the Life Sciences Committee for Licensing Executives Society International, an international network of IP licensing professionals. He also serves as the Executive Editor of the Chicago-Kent Law Review.

Prior to attending law school, Mr. Shea worked for several years in the biotech industry in the areas of medical diagnostics and genetic profiling.
J.D., Chicago-Kent College of Law with high honors, Order of the Coif
B.S., Biology, Washington & Lee University


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

Rodeina, has 25 years of experience in healthcare, cancer research, and the pharmaceutical industry across a wide range of roles including clinical development strategies for biosimilars and serving as head of clinical operations globally. Experienced in all aspects of biosimilar development including global strategies, study design and regulatory agency discussions (Europe, US, Japan, Australia, Singapore, and South Korea) and has worked on 10 biosimilar molecules across a range of products and indications, including ESAs, Filgrastims, LMWH, growth hormones, FSH, Insulins, monoclonal antibodies and more recently biosimilar orphan drugs. For over 10 years directed the conduct of Phase I-IV clinical trials, including large pivotal biosimilar multi-national, multi-center trials and several post-authorization safety studies for biosimilars. In her role in PRA, she is currently working on several Biosimilar programs in various capacity including consulting, regulatory and clinical strategies, feasibility and supporting study delivery across all phase of development (phase I to IV).

She has also represented PRA as a speaker in several International Biosimilar conferences across the Globe. While in the Pharmaceutical industry she was the company’s representative in several EMA consultations with regard to the development of the EMA Biosimilar Guidelines and was a member of the European Biopharmaceutical Group, which is a sector of the European Generic Association.


Dr. Harry Gewanter, Chairman, ALLIANCE FOR SAFE BIOLOGICS)

Harry L Gewanter, MD, FAAP, FACR is a Richmond, VA pediatric rheumatologist and the current chair of the Alliance for Safe Biologic Medicines. A graduate of Duke University and the Wayne State University School of Medicine, he completed his pediatric residency and Robert Wood Johnson General Pediatric Academic/Rheumatology fellowship training at the University of Rochester/Strong Memorial Hospital where he remained until moving to Richmond. Beyond his pediatric rheumatology practice, Dr. Gewanter has also served as a general pediatrician and chronic illness/disability consultant. He has practiced in a variety of settings including private pediatric practices, public clinics as well as community, university and pediatric specialty hospitals.

Throughout his career Dr. Gewanter has always advocated for children, families and people with disabilities. He has been a member and held leadership positions in a variety of national, state and local committees and organizations, including the American Academy of Pediatrics, American College of Rheumatology, CARRA, Arthritis Foundation, Virginia Board for People with Disabilities and Richmond Pediatric Society. Some of his honors include serving as the initial Walter E. Bundy, Jr Clinical Professor of Pediatrics and Chair of the Division of Community Pediatrics at the Virginia Commonwealth University School of Medicine, receiving the Earl Brewer Award for Physician Leadership from the Arthritis Foundation and being the first pediatrician to receive the Paulding Phelps Award from the ACR. With two colleagues he founded Medical Home Plus, Inc, a nonprofit organization dedicated to connecting families of children with any chronic or disabling condition with appropriate information, services and support.

He and his wife, Cynthia, have four adult children, some of whom have chronic issues. His personal and professional experiences fuel his passion for improving the lives of all individuals with varying abilities.


Ubavka DeNoble, Corp. V.P. Phase II/III,Portfolio Leadership, PAREXEL)

In her role as Corporate Vice President, Phase II/III, Key Accounts, Dr. DeNoble is responsible for the global management of the PAREXEL phase II/III business as well as overseeing the quality, delivery and client satisfaction on key accounts. Dr. DeNoble works with her team to identify client needs and develop solutions for projects, leveraging expertise, operational capabilities and technologies. She also identifies new business opportunities and help tailor appropriate strategy.

Prior to joining PAREXEL, Dr. DeNoble was the Senior Vice President, Global Project Management at I3, a therapeutically specialized CRO. Previously, she
held several senior executive positions at Kendle, Charles River Laboratories and Inveresk Research Group. Dr. DeNoble earned her M.D. at University of Sarajevo Medical School and completed an internship in internal medicine at Naval Hospital Split, Military Academy, Belgrade, Yugoslavia. She is boardcertified in internal medicine.


Martin Tochacek, Senior Project Leader, PAREXEL)

Martin Tochacek is an experienced, team-oriented project leader with more than 15 years of leadership and clinical research experience in Phase I-IV drug/biologic trials. Dr. Tochacek has a research background in molecular biology translated to site level clinical research, where he has co-authored protocols and managed clinical trials in rheumatology. At the CRO level, he has led investigator selection and patient recruitment initiatives across several therapeutic areas including inflammation, oncology and infectious disease.

Most recently, he has managed clinical programs in the autoimmune/inflammatory therapeutic area with a focus on biosimilar research to successfully enroll patients globally.


Pauline Baur, Dir. Project Management, Clinical Operations, PFIZER)

Pauline Baur is a clinical research professional with more than 14 years of experience in product lifecycle development from phase II-IV and has led global clinical trials in multiple therapeutic areas including vaccines, inflammation/infection (Rheumatoid Arthritis/Osteoarthritis, Lupus, Psoriasis), neuroscience (Alzheimer’s), pain management (Migraines), oncology/hematology (Oral Mucositis/Sickle Cell Disease), endocrine disorders (Diabetes) and Biosimilars. She has held various roles within Pfizer Development Operations, Alliance Partnerships, CROs and Pharmaceutical organizations.

08:30 – 09:00 – Registration

09:00 – 12:30 – MORNING WORKSHOP
The value CRO`s can bring in biosimilar development

 Creating a win/win alliance (45 minutes) — Speaker TBD
 Working with a CRO to understand and navigate the regulatory challenges (60 minutes)
 Gaining regulatory acceptance of doable study designs
 Designing a program to meet the requirements of multiple regions
 Understanding the global regulatory requirements for conducting biosimilar clinical studies
Bruce Babbitt, V.P. Early Stage – PAREXEL Consulting
Break (30 mins)
 How to leverage CRO experience & expertise in biosimilar development
 Working with a CRO to speed up clinical development
 Ensuring global reach and successful management of global biosimilar trials to enhance recruitment
 Dealing with clinical studies in emerging countries vs established countries
Ubavka DeNoble, Corp. V.P. Phase II/III,Portfolio Leadership, PAREXEL
 Case Study
Pauline Baur, Dir. Project Management, Clinical Operations, Pfizer
Martin Tochacek, Senior Project Leader, PAREXEL

12:30 – 13:30 – Lunch break

13:30 – 17:00 – AFTERNOON WORKSHOP

15:00 – 15:30 – Refreshment Break
Regulatory, Scientific and Clinical challenges of interchangeability

 Regulators decisions regarding biosimilar interchangeability and indications.
 How to demonstrate biosimilarity to the reference product
 How similarity informs interchangeability and extrapolation
 Current requirements in clinical considerations: switching and immunogenicity
Led By : Rodeina Challand B.Sc., Executive Director, Biosimilars Development, Scientific Affairs, PRA HEALTH

08:00 – Registration

09:00 – Chairperson’s Opening Remarks
Brian Harvey, EVP Scientific & Regulatory Affairs, GLOBAL LIVER INSTITUTE


09:10 – Where does FDA stands on Biosimilars
 Overview of current regulatory guidelines
 Approval pathway in place for biosimilars
 Key development approaches
 Clinical and Non-clinical studies
Brian Harvey, EVP Scientific & Regulatory Affairs, GLOBAL LIVER INSTITUTE

09:50 – Key Global Regulatory Considerations for Biosimilars
 Things to consider before developing Biosimilars
 What are the challenges and opportunities
 The current status of biosimilars products in the US, Europe and rest of the World
Cornelia Ulm, VP Regulatory Affairs Biosimilars, MERCK SERONO

10:30 – Networking Morning Break


11:10 – Implications of the US “Patent Dance” for Biosimilar Developers
 What are the risk faced by the Biosimilar developers
 How to effectively prepare a patent list ready before filing a submission
 What are the challenges and consequence
Tim Shea, Director, STERNE, KESSLER, GOLDSTEIN & FOX Attorney at Law

11:50 – Effect of the FDA draft guideline on Non-Propriety Naming of biological and biosimilar products
 Is the draft guidance the best approach to address accidental substitution or pharmacovigilance associated with
 Is the proposed use of suffixes potentially confusing or even misleading about the biosimilarity of noninterchangeable
biosimilars? Or substitutability of interchangeable biologics?
 What other alternatives might be considered?
Bruce A. Leicher, Senior Vice President and General Counsel, MOMENTA PHARMACEUTICALS INC

12:30 – Understanding biosimilars and projecting the cost savings to employers: Update
 Understanding the current cost of biologic drugs to employers for active and retired employees and dependents
 Projecting the cost of biologics to employers through 2019
 Modeling the potential employer savings due to the introduction of biosimilars
 Consideration for the drivers of biosimilar savings
 Predicting the employer response to biosimilars
Michael Hunter, Pharmacist, Chicago Office, MILLIMAN
Katherine M. Holcomb, Consulting Actuary, MILLIMAN

13:10 – Networking Lunch Break

14:10 – 14:50 – Challenges and Opportunities in Development Biosimilars vs. Biobetters/Biosuperiors
 Challenges of developing biosimilars versus biosuperiors
 Examining current biosimilar portfolio and opportunities to make best in class biosuperior molecules
 Clinically validated biologics targets
 Application of innovative technologies in creating better best-in-class biologics
 Identifying the biologics that are best suited for making biosuperior biologics
 Improving efficacy, safety and immunogenicity with the biosuperior molecules
Rakesh Dixit, Vice President, R&D, Global Head, Biologics Safety Assessment, MEDIMMUNE

14:50 – Establishing “Finger-print” Like Biosimilarity Prior to the Clinic- Critical Steps for Biosimilar Assessment.
 Critical first step involves extensive interrogation of multiple originator batches to define the target.
 Subsequent side-by-side comparison of the biosimilar with the originator to determine biosimilarity
 Strategies for protein primary and higher order structure determination including measurement of posttranslational
modifications such as glycosylation and other Critical Quality Attributes.
 Orthogonal analytical techniques for “fingerprint-like” assessment.
Dr. Fiona M. Greer,Global Director, BioPharma Services Development, SGS M-SCAN

15:30 – Networking Afternoon Break


16:10 – Best strategies in bringing biosimilars to the US Market
 Things to consider before biosimilar development for global and US market
 Examples and future strategies for bringing biosimilars to the US market
 Some challenges and opportunities
Dr. Robyne Kelemen, Director, Regulatory Affairs – Biologics, DR.REDDY’S LABORATORIES

16:50 – Physicians and Patients Perspective on Biosimilars
 Challenges of Physicians education: Understanding the differences between biosimilars and generics
 Importance of Physician and Patients input in shaping international standards for biosimilars
 Policies in place to encourage physicians / pharmacist collaboration
 Harmonizing global standards to ensure safety and efficacy of biosimilars
Dr. Harry Gewanter, Chairman, ALLIANCE FOR SAFE BIOLOGICS

17:30 – How the Emerging market countries is dealing with the Biosimilars Market
 Anticipate the growing demand for low-cost countries in developing Biosimilars
 Recognize how the BRIC market have a competitive presence in Biosimilars
 Understanding how the BRIC and Asian government are assisting local companies to develop biosimilars
Dr. Yanan Xu, Director, Business Development, INNOVENT BIOLOGICS INC.

18:10 – Chairperson’s Closing Remarks
Brian Harvey, EVP Scientific & Regulatory Affairs, GLOBAL LIVER INSTITUTE

18:30 – 21:30 – Networking Drink Reception and Gala Dinner

08:00 – Registration

09:00 – Chairperson’s Opening Remarks
Rodeina Challand, Executive Director, Biosimilars Development, Scientific Affairs, PRA HEALTH SCIENCES


09:10 – Advancing biosimilar development: shift of focus from clinical to quality data
 Risk-based approaches to biosimilar development
 Strategies in maintaining high quality standard
 Recent development shaping the guidelines for advancing product development and its implications
Prof. Andrea Laslop, Head of Scientific Office, AGES MEA

09:50 – Importance of Device Selection for Your Biosimilar Combination Product
 Review of devices used with branded biologics
 Case studies of currently marketed biosimilar device combination products
 Lifecycle strategies for devices to enhance your brand
 Key risk factors and how to mitigate them in your selection process
 Successful planning for device implementation
Kevin Cancelliere, Director, Marketing, WEST PHARMACEUTICALS SERVICES, INC.

10:30 – Morning Networking Break

11:10 – CMC Pre-clinical and clinical considerations for Biosimilar Drug
Development and Manufacturing
 How to successfully design a comparability studies
 Quality strategy in developing Biosimilars
 What are the benefit of earlier guidance on comparability as a result of manufacturing changes
 State of the Art Analytics in Biosimilar Development
Martin Bluggel, Chief Executive Officer and Co-Founder, PROTAGEN PROTEIN SERVICES GMBH

11:50 – Practical approach for determining Interchangeability
 Assessing biosimilarity with the reference product
 Clinical switching studies
 Different approaches for interchangeability based on individual product characterization
 Extensive pharmacovigilance strategies for long term safety and efficacy
Rodeina Challand, Executive Director, Biosimilars Development, Scientific Affairs, PRA HEALTH SCIENCES

12:30 – Early-Stage Biosimilar Development – Creating a Cost-Effective Strategy
 Product characterization and Analytics development
 Product Development Plan, and the Importance of establishing design space and Target Product Profile during
 Planning for quality and regulatory compliance
Paul W. Price, Senior Consultant, Biological Product Development, THE BIOLOGICS CONSULTING GROUP13:10 – Networking Lunch Break

14:10 – A Review of Current Analytical Methods and Recent Advancements in the Characterization of Biotherapeutic monoclonal antibodies
 Mass analysis of the Intact mAb and subunits using novel enzymes
 Advances in peptide mapping for sequence confirmation, post translational modifications, and disulfide mapping
 Trends in glycoprofiling using accelerated sample preparation techniques, ultra-performance chromatography,
and highly responsive labelling for detection by florescence, and mass spectrometry
Dr. John Snyder, Research Fellow/Group Leader, EUROFINS LANCASTER LABORATORIES,INC

14:50 – Biosimilars in Nordic countries – what strategies work to increase uptake in clinical practice?
Dr. Steinar Madsen, Medical Director, Department of Drug Information, NORWEGIAN MEDICINES AGENCY

15:30 – Networking Afternoon Break


16:10 – Merck partnerships with Bionovis Brazil
Louk Pechtold, Director – Alliance Management Biosimilars, MERCK SERONO

16:50 – Current trends in Market Access: Challenges and Potentials
 Special trends impacting market access in the US and globally
 Evolving methods for managing specialty product utilization and reimbursement toward ensuring appropriate
 Ways of balancing rewards of access and inherent risk between manufacturers and insurers
 Challenges in ensuring market access and reimbursement
Kenneth Walsh, Senior Principal, Payer Strategy, EVIDERA (Previously from GSK)

17:30 – Chairperson’s Closing Remarks
Rodeina Challand, Executive Director, Biosimilars Development, Scientific Affairs, PRA HEALTH SCIENCES


fins Lancaster Laboratories, Inc.

With a proven track record of providing quality testing services for the largest pharmaceutical and biopharmaceutical companies in the world, Eurofins Lancaster Laboratories is a global leader in bio/pharmaceutical laboratory services providing comprehensive, innovative and timely solutions to streamline all of your CMC testing requirements. As a member of Eurofins Scientific’s BioPharma Product Testing Group—the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide— Eurofins Lancaster Laboratories provides comprehensive laboratory services to support all functional areas of bio/pharmaceutical production.
With a global capacity of more than 500,000 square feet, our network of GMP laboratories operates under the same strict quality procedures, LIMS, and centralized billing system across 14 locations worldwide to make working with any of our global operations seamless.

In addition to these laboratory locations, we also have teams of scientists placed at more than 40 client facilities throughout the U.S. and Europe through our Professional Scientific Services (PSS) insourcing program. We also provide secure 24-hour data access from all of our laboratories via LabAccess.comSM.


West Pharmaceutical Services, Inc.

West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world’s pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West’s 2014 sales of $1.42 billion reflect the daily use of approximately 110 million of its components and devices, which are designed to improve the delivery of healthcare to patients around the world.



For more than 60 years, Milliman has pioneered strategies, tools, and solutions around the globe. One of the world’s largest independent actuarial and consulting firms, we are recognized leaders who have helped shape significant changes in the markets we serve. Set apart by our independent ownership, we deliver -unbiased advice based solely on what’s best for our clients.

Milliman insight reaches across global boundaries and multiple industries, offering specialized consulting services in healthcare, employee benefits, investment, life insurance and financial services, and property and casualty insurance. Our consultants serve a wide range of clients, with highly personalized service and a unique combination of actuarial and business expertise. With offices in principal cities worldwide, Milliman combines global experience with local knowledge. We can help you be prepared to operate in new markets, expand beyond your boundaries, and understand how your industry is affected by developments around the world.



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.



Sterne, Kessler, Goldstein & Fox is an intellectual property law firm of 180+ professionals devoted solely to providing outstanding patent, trademark, Patent Office litigation, district court, and International Trade Commission legal services.
For more than 37 years, we have helped companies build and enforce worldwide IP portfolios. Sterne Kessler has a proven track record at U.S. district courts, federal appeals courts, and the ITC, with worldwide oppositions, 300+ inter partes reviews, 50+ interferences, 400+ reexaminations, and 30+ covered business method patent reviews. We are the leader in PTAB litigation in the biotech and pharmaceutical industry. We have represented both patent owners and petitioners in more than 40 inter partes reviews involving biotech and pharmaceutical patent, including patents covering Ado-trastuzumab emtansine (Kadcyla®), Moxifloxacin (igamox®/Moxeza®), Doxycycline (Oracea®) and Azelastine hydrochloride (Astepro®).

We understand the business of branded, generic, and biosimilar pharmaceuticals. Our Digital Healthcare Industry Group brings together expertise in digital technology – such as software/analytics, wireless communication, networking, electronics, and mobile technologies – with medical and other biological fields.

Sterne Kessler’s service model is built on the unrivaled technical depth of its professionals. Most have an advanced technical degree and/or significant industry or academic experience; more than 50 hold a Ph.D., including backgrounds in Immunology, Molecular Biology, Biochemistry, Genetics, Pharmacology, Medicinal Chemistry, Organic Chemistry, Antibodies, Proteomics, Cell Biology, Therapeutic and Industrial Biotechnology, DNA Diagnostics, and Protein Biochemistry.
We have one agenda: IP law on behalf of companies whose future depends on developing and protecting the ideas that make them a success.



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.



Caprion provides proteomics and immune monitoring services to pharmaceutical and biotechnology companies with GCP/GLP/GCLP capabilities. Its immune monitoring
division, ImmuneCarta®, offers multi-parametric flow cytometry, cytokine testing and ELISpot for comprehensive analyses of innate and adaptive immune responses.

The division has expertise in clinical trial monitoring as well as assay development and validation of complex assays used during clinical trials. Caprion’s proteomics
division, ProteoCarta™ leverages expertise in sample preparation, mass spectrometry and bioinformatics to provide comprehensive protein analysis services in support of biomarker development and biotherapeutic development. ProteoCarta offers gel-free, label-free mass spectrometry for discovery and validation of novel protein biomarkers.

ProteoCarta also develops, qualifies and validates quantitative assays for protein biomarkers and biologics/biosimilars drug products (including ADC) in support of preclinical and clinical phases of drug development.



biocompareBiocompare 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 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



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:



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



Select Science 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. is a unique video news channel for laboratory application and product information. For further information please visit:

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


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.


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.


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:



FiercePharma is the pharma industry’s daily monitor, with a special focus on pharmaceutical company news and the market development of FDA approved


Pharma Phorum is the premier digital publication for thought leadership relating to the pharmaceutical industry. The news, opinions and insights published every day help industry executives better understand the broader healthcare landscape within which they operate, including regular contributions from their peers, innovative service providers, physicians, payers / policy makers, patient organisations and patients.


Pharmafile is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, and pharma service company listings. Site content is produced by our editorial team for and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant


My Event Guru

My Event Guru is an interactive portal that allows individuals and businesses to set up, market and promote events, sell tickets and collect RSVP’s, instantly process payments for events online, obtain feedback via sophisticated surveys and generate additional revenue by selling event content.
Our mission is to be your comprehensive local business event resource. We strive to be the one-stop solution for anyone looking to promote their events, take advantage of our event tools, and generate additional revenue from event content. We are committed to helping you make and maintain local connections and relationships that will make a difference your business and your career.



Bio-equip is a professional website which provides the information of equipments, consumables, chemical reagents and experimental animals in life science. Our website which takes full advantage of the most up-to-date computer technologies and networks offers the most all-round and considerate service in the information of biology equipments for not only institutes, universities, labs in hospitals but also scientists in bio-engineering and bio-medicine industries and suppliers of lab equipments who would be exposed to comprehensive and well-timed market information to compare the different products in function and price and promote the development of scientific research and industry.

pharma-tech is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field. Our international scope allows us to examine all pharmaceutical markets closely, from biotechnology to therapeutics, vaccines and



Conference Alerts is an online conference calendar for academics and professionals. Organizers post conference information on and subscribers receive alerts about conferences in their areas of interest via



Conferize is the world’s biggest social platform for events. You’re invited.We connect the world of events with speakers, people and media from any industry. We help event organizers build communities, websites and mobile experiences to increase the quality and attendance of their events.


Originally, was created solely as a directory of conferences, but due to popular demand we are now offering other services. Currently these include:
• Featured Listings
• Advertising Opportunities
• Online Registration Services
In the future we plan to offer even more services. If you have any requests or suggestions,
we would love to hear from you. Just drop us an email