D Y 2 V EM Y
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“A thoroughly interesting ...
Biosimilars & Biobetters USA


Day One I Monday 7th April 2014

Biosimilars & Biobetters USA


Day Two I Tuesday 8th April 2014

Registration & Coffee

• Identify...
Wednesday 9th April 2014 I 8.30am – 12.30pm
Renaissance Woodbridge Hotel,
Iselin, New ...
Wednesday 9th April 2014 I 1.30pm – 5.30pm
Renaissance Woodbridge Hotel,
Iselin, New J...



Conference: Monday 7th April & Tue...
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SMi Group's Biosimilars & Biobetters conference USA


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SMi Group's very successful Biosimilars & Biobetters conference is ocming to the US next year

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SMi Group's Biosimilars & Biobetters conference USA

  1. 1. BO AN 20T BO O D H O A K B SA DEC K B N D Y 2 V EM Y SA 8T E BE VE H FE $3 R 0 $1 BRU 0 00 ARY “A thoroughly interesting and very informative conference with excellent chairs and presenters. More of the same please.” Biosimilars & Biobetters Europe 2013 Attendee 7th - 8th Biosimilars & Biobetters USA APRIL SMi present their inaugural conference on… Creating an Innovate Plan for the USA Biosimilars Market Renaissance Woodbridge Hotel, Iselin, New Jersey, USA 2014 Chairperson Dr Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals Key Speakers Include: • Dr John Pakulski, Senior Director, and Head US Biopharmaceutical Regulatory Affairs, Sandoz • Rodeina Challand, Executive Director, Biosimilars Development, Scientific Affairs, PRA International • Dr Stanley (SeungSuh) Hong, President, Research and Development, Celltrion, Inc. • Paul Ashton, President & CEO, pSivida • Peter Pitts, President, Center for Medicine in the Public Interest (Former FDA Associate Commissioner) • Douglas M. Long, Vice President, Industry Relations, IMS Health • and many more! Benefits of attending: • Gain up to date insight into the regulatory landscape and how it is effecting the industry • Evaluate commercialization and development strategies to gain a competitive advantage • Calculate possible revenue streams from biosimilar production • Discover what lessons have been learned so far and what the future holds • Boost your industry knowledge and relationships by networking and learning from key industry and academic leaders PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS Wednesday 9th April 2014, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA A: Differentiation Strategies for the Generics Industry Workshop Leader: Asa Cox, Founder & CEO, Generic Pharma 2.0 8.30am - 12.30pm B: Launching a Biosimilar in an Innovator v. Generic World Workshop Leader: Kristie Kuhl, JD, Executive Vice President, Health Practice, Makovsky 1.30pm - 5.30pm Sponsored by Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 ACADEMIC & GROUPS DISCOUNTS AVAILABLE
  2. 2. Biosimilars & Biobetters USA www.biosimil Day One I Monday 7th April 2014 8.30 9.00 COMMERCIALIZATION & PRODUCT DEVELOPMENT STRATEGIES (PART 1) Registration & Coffee Chairman's Opening Remarks Dr Richard Dicicco, Chairman, Harvest Moon 1.30 Pharmaceuticals • Reviewing the European experience of biosimilar production - barriers to entry OPENING ADDRESS - market opportunities Biosimilars and specialty products: current status and future - competitive response • Understanding how the global pharmaceutical market is becoming - differences in the biosimilars versus biobetter route more specialized and precise • Identifying what the experience on follow on biologics, generics and biosimilars has been so far Professor Joseph Fuhr, Professor of Economics, Widener University 2.10 • Assessing what role follow on biologics, generic biologics and biosimilars play in the future Insights into the structure function relationship of monoclonal antibodies (mAbs) with respect to their evaluation of biosimilarity • Ensuring quality CMC is in place before embarking on mAb Douglas M. Long, Vice President, Industry Relations, IMS Health 9.50 • Examining the balance between innovation and competition • Analysing potential entry into the USA market REGULATORY AND MARKET REVIEW (PART 1) 9.10 Considering the impact of biosimilars on competition production to achieve successful biosimilarity • Considerations for building a pipeline of mab biosimilars Ensuring that interchangeability does not thwart US innovation – legislation at both federal and state level and FDA’s expectations • Understanding why US mAbs will be an important target for the • Understanding the basis for interchangeability at state and federal Dr Magdalena Leszczyniecka, President and CEO, STC Biologics development of biosimilar therapeutic products • Assessing the risk of interchangeability to biologic innovation level • Analyzing the variations in state-level legislation governing biosimilar substitution 2.50 Physician's perspective on biosimilars: the importance of pharmacovigilance • Understanding why patient safety is paramount • Reaching a consensus on interchangeability - how and when should this be permitted • Realizing that information is power: the more doctor's have, the • Determining whether physicians should be notified when better it is for patients pharmacies substitute biosimilar for brands • Examining why manufacturers must be transparent for physician's to considerations for interchangeable products Dr Richard Dolinar, Chairman, Alliance for Safe Biologic Medicines • Preparing for future FDA guidance regarding safety and quality have confidence in the product Dr John Pakulski, Senior Director and Head US Biopharmaceutical Regulatory Affairs, Sandoz 10.30 10.50 3.30 PRICING & COST RETURNS Morning Coffee Biosimilars - the state of the union 3.50 • Reviewing current regulatory concerns • An update on biobetters and biosimilars • Profit margins in biosimilar production Peter Pitts, President, Center for Medicine in the Public Interest (Former • Evaluating biosimilar unit floor prices in a hyper-competitive market FDA Associate Commissioner) Ready, set, go! …… but watch out for IP hurdles along the way in an • Reviewing the impact of patent laws on biosimilar production • Identifying and overcoming the potential patent pitfalls biosimilar applicants may encounter pertaining to: - development - marketing - approval production • Presenting a biosimilar sales forecast from a manufacturing view • Analysing cost versus quality age of post-patent medicine! Evaluating the potential revenue streams achievable from biosimilar • Biosimilar investing: what to expect for a return on investment (ROI) • Discussing the EU experience 11.30 Afternoon Tea Dr Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals 4.30 THE TE D EB A What is the state of play! Highlighting what lessons have been learned to date and where the industry is heading • Discussing industry insights and what work you should be planning to do • What opportunities are awaiting the market • Deciding which models to use for successful biosimilar launch • What benchmarks can be learned from biosimilar development in Europe • Evaluating how to challenge patents and potential patent Rodeina Challand, Executive Director, Biosimilars Development, Dominic Adair, Senior Associate, Patent Litigation, Bristows Dr Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals Scientific Affairs, PRA International extensions from innovator companies 12.10 Networking Lunch Sponsored by 5.10 Chairman's Closing Remarks and Close of Day One *Subject to final confirmation As a leading CRO, PRA is transforming clinical trials through our people, innovation and transparency. We combine therapeutic and operational expertise with local knowledge to serve clients across all phases of drug development. PRA’s dynamic services and forward-thinking approach are making a difference to healthcare patients worldwide. pSivida (PSDV, NASDAQ) is a leading provider of innovative sustained-release drug delivery products. Our proven proprietary technologies enable us to achieve highly focused, long-term delivery of therapeutics. We have developed three of the only four products approved by either the US or EU for the long-term, sustained-released delivery of drug to treat chronic eye disease. We are now working a long term sustained delivery system (Tethadur®) for large molecules (including anti-bodies) for the eye. This fully bioerodible delivery system can be readily applied to virtually any site in the body and can be used for systemically administered products. pSivida has a long history of successfully working with partners and with licensing agreements with companies of various sizes such as Pfizer, Bausch and Lomb, Alimera Sciences. pSivida's intellectual property portfolio consists of over 150 issued patents in countries including the U.S., Europe, Japan, China and Australia. Register online at: • Alternatively fax yo
  3. 3. Biosimilars & Biobetters USA 8.30 9.00 Day Two I Tuesday 8th April 2014 Registration & Coffee • Identifying which products have significant potential for ‘biosuperior’ development • Developing biosuperior protein therapeutics that address sub-optimal, in-market characteristics of currently licensed biologics • Examining current active projects in research and development of biosimilar and novel biobetter/biosuperior therapeutic proteins Dr Rakesh Dixit, Vice President, R & D Head, Global Biologics Safety Assessment, MedImmune (AstraZeneca Biologics) Chairman's Opening Remarks Dr Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals REGULATORY REVIEW - PART 2 9.10 9.50 10.30 10.50 11.30 12.10 1.30 OPENING ADDRESS What is in a name! Reviewing the ongoing debate in the biosimilars naming process to ensure appropriate pharmacovigilance! • Presenting an update on the FDA’s naming preference - determining their stand on distinctive International Nonproprietary Names (INNs) for biosimilars • Assesing the options for long-term biosimilar naming: - Common non-proprietary name - Shared root or prefix - Distinct non-proprietary name • Recognizing the need for clear naming principles to avoid patients receiving the incorrect product and reduce confusion among healthcare providers Rodeina Challand, Executive Director, Biosimilars Development, Scientific Affairs, PRA International Exploring the European (EU) biosimilars landscape to determine what lessons and ‘take homes’ the US market can employ • Analyzing current regulatory requirements for biosimilar approval in Europe and the future path of this legislation • Reviewing the variations between the EU and US law and regulations • Implementing strategies for harmonizing US and EU developments to avoid program duplications Liz Fuller, Partner, Bird & Bird 2.10 2.50 Morning Coffee Essential infrastructure for successful mAb biosimilar development • Introduction of biosimilars and how to secure the comparability to reference products • Highlighting key global opportunities of mAb biosimilars • Understanding the key infrastructure for successful biosimilar development • Approval of world’s first mAb biosimilar from both developed and emerging countries • Utilizing bridging studies to enable the application of already generated data Dr Stanley (SeungSuh) Hong Ph.D. President, Research and Development, Celltrion, Inc. 3.30 3.50 MARKET ACCESS FOR BIOBETTERS Biosimilars vs. biobetters! Determining the implications for product developers in the pharmaceutical industry • Biobetters claim that they are a better product, but what evidence is there to prove this? • Discussing the regulatory status pertaining to production of biobetters • Analyzing which features can be improved by utilizing biobetters • Evaluating whether biobetters are better than biosimilars based on efficacy, safety and delivery Paul Ashton, President and CEO, pSivida Networking Lunch Can biobetters or biosuperiors meet the challenges of best in class molecules and cheaper biosimilars • Reviewing the challenges and opportunities in developing relatively cost effective biosimilars • Innovations in improving the existing biologics therapies in diseases with unmet medical needs • Making biobetters or biosuperiors successful and cost effective through advances in protein engineering and pioneering technologies - case studies of biosuperior vs. biosimilars 4.30 EL PAN ION USS DISC 5.10 COMMERCIALIZATION AND PRODUCT DEVELOPMENT STRATEGIES (PART 2) Identifying how to create a truly marketable product! Assessing commercialization considerations for biosimilars • Understanding the role of partnerships in the development and delivery of commercially successful biosimilars to secure specific capabilities • What are the various partnership models to consider in cocommercializing • Providing relevant preclinical and clinical data for marketing authorization • Honing marketing tactics to achieve accelerated biosimilars sales • Ensuring sufficient manufacturing capability and human capital to produce and commercialize biosimilars Dr Branimir Cvetkovic, Global Strategy Lead – Biosimilars, Novartis Designing effective strategies to achieve excellence in clinical trials • Identifying the key operational considerations for delivering high quality trials on time and budget : - What size should the trial be - How many patients should be exposed to the drug • What trial design should be used • Developing strategies to optimize patient recruitment and retention in clinical trials • Examining the benefits of investigator/ patient education • Implementing non clinical and clinical data to guarantee pharmacovigilance for biosimilars Session reserved for Pfizer further to final speaker confirmation * Afternoon Tea Creating effective strategies to control the manufacturing process and address the unique challenges facing biosimilar producers • Overcome challenges in developing biosimilars through formulated testing strategies: - analytical and bioanalytical method development capabilities - defined characterization programs • Implementing procedures to prepare your manufacturing lifecycle for each step of product development • Applying the fundamentals of process analytical technology (PAT) • Discovering how a small difference in the manufacturing process may create a different product • Understanding the importance of supply-chain expertise procurement and quality assurance to speed up development Dr Steve Flatman, Head Biosimilars Research and Development, Lonza Biologics plc The optimal manufacturing strategy! - Exploring what is shaping the strategic biosimilar manufacturing plan of today's leading companies • Discovering how to build or procure this manufacturing base in a cost effective way • Evaluating where should this manufacturing base be located and why • Analysing how competition from new players is changing the landscape Kristopher Howard, Managing Director, Operational Excellence Leader, NRL Enterprise Solutions Chairman’s Closing Remarks and Close of Day Two Supported by our registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 *Subject to final confirmation
  4. 4. HALF DAY POST CONFERENCE WORKSHOP A Wednesday 9th April 2014 I 8.30am – 12.30pm Renaissance Woodbridge Hotel, Iselin, New Jersey, USA Differentiation Strategies for the Generics Industry Workshop Leader: Asa Cox, Founder & CEO, Generic Pharma 2.0 Overview of workshop: This workshop will help to develop an expert understanding of the differentiation strategies used in worldwide markets, to explore new ideas and opportunities for differentiation, plus possible requirements demanded by industry evolution. Why you should attend: Gain insights into the future of the generic industry and how differentiation might be the only option for success. Programme: 8.30 Registration & Coffee 9.10 Session 1: Current differentiation tactics 9.50 Session 2: The challenges that 10.30 Coffee Break 9.00 Introductions and opening remarks in global markets differentiation brings 11.00 11.40 Session 3: Ideas for differentiation Session 4: The future of the industry and why differentiation is needed 12.20 12.30 Closing remarks Workshop ends About the workshop host: Asa has been involved in the generic pharma sector for over 16 years; covering all aspects of the industry, both commercial and technical. Asa launched in 2008. The platform now manages more than 9000 products and is used by generic companies the world over. Asa created Generic Pharma 2.0 in 2010 as a vehicle to convert substantial market intelligence into a dedicated consulting company. The firm now consults with clients on portfolio strategy, international market entry and pharmagination models. About Generic Pharma 2.0 Generic Pharma 2.0 are ‘masters of business development & marketing’. Established in 2008, Generic Pharma 2.0 has built a global network of 30,000 companies; achieved by combining ferocious business development and the latest web technologies. It offers clients both access to a network and the intelligence gained from a unique perspective. We work with companies of all sizes, locations and product categories. We partner with clients. We create together. We have a lot of fun. SPONSORSHIP AND EXHIBITION OPPORTUNITIES SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick, Director on+44 (0) 20 7827 6168 or email: Want to know how you can get involved? Interested in promoting your services to this market? Contact Julia Rotar, SMi Marketing on +44 (0) 207 827 6088, or email:
  5. 5. HALF DAY POST CONFERENCE WORKSHOP B Wednesday 9th April 2014 I 1.30pm – 5.30pm Renaissance Woodbridge Hotel, Iselin, New Jersey, USA Launching a Biosimilar in an Innovator v. Generic World Workshop Leader: Kristie Kuhl, JD, Executive Vice President, Health Practice, Makovsky Overview of workshop: This interactive workshop will discuss the unique aspects of successfully launching a biosimilar in the United States. Topics to be discussed include: • Filing a BLA or sBLA – when to determine the path to approval • Government affairs – likely allies and foes of biosimilars, what regulations to expect • Marketing – what level of support will biosimilars need • Revenue discussion – what will reimbursement look like. How will the major biologics be impacted and when Why you should attend: Attendees of this interactive workshop will have the opportunity to learn the pluses and minuses of various approaches about new products that fall between an innovator and a generic. Programme: 1.30 Registration and coffee 2.10 Session 1: BLA v sBLA 2.00 2.50 3.30 4.00 4.40 5.20 5.30 Introductions and opening remarks Session 2: USA regulation & substitution update – friends and foes Coffee Break Session 3: Marketing Session 4: Revenue and reimbursement Closing remarks Workshop ends About the workshop hosts: Kristie Kuhl, JD is Executive Vice President and Deputy Practice Head at Makovsky Integrated Communications. Her experience as a regulatory communications attorney and counselor on biosimilar challenges started in 2005. She is a sought-after expert on biosimilars, and has served as a panelist and/or session leader at more than 10 biosimilars conferences since 2006. She was instrumental in creating and executing the Pfizer Genotropin communications strategy when the company feared biosimilar entry in Europe would collapse the growth hormone market. Kristie has been hailed for her knowledge of legal communications, media strategy and account-team management. She bridges the divide between public relations and public affairs. Utilizing her legal and public relations background, Kristie is a counselor on communications strategy. About Makovsky Makovsky is a leading healthcare communications company in its ongoing mission to improve the lives of patients served by biotech, pharmaceutical and device manufacturing companies. Through giving voice to patients in advocacy programs, brand communications and disease education, Makovsky connects audiences via social media, news coverage and engagement at thought leader events such as TEDMED, Prix Galien and medical congresses such as ACOG, ASCO and AHA. The Makovsky team lives with intent; fostering deep knowledge of the underlying science, a profound understanding of the regulatory space, and a sensitivity to the complex interactions between patients, physicians, researchers and regulatory agencies. In 2013 alone, Makovsky received 11 healthcare communications industry awards, including “Best in Healthcare,” “Best Education/Public Service Campaign,” and “Best of the Best” across other industry sectors.
  6. 6. BIOSIMILARS & BIOBETTERS USA Fee $2997.00 $2398.00 $1799.00 $1198.00 $599.00 $999.00 Conference: Monday 7th April & Tuesday 8th April, 2014, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA I Workshops: Wednesday 9th April 2014, New Jersey 4 WAYS TO REGISTER ONLINE FAX your booking form to +44 (0) 870 9090 712 PHONE on +44 (0) 870 9090 711 South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK EARLY BIRD □ DISCOUNT □ Unique Reference Number Our Reference DELEGATE DETAILS Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Title: Surname: Forename: Department/Division: Email: Company VAT Number: Direct Fax: Switchboard: Signature: I agree to be bound by SMi's Terms and Conditions of Booking. ACCOUNTS DEPT Title: Surname: DOCUMENTATION Country: Mobile: I cannot attend but would like to purchase the following document portal/paper copy documentation. Date: Forename: Direct Tel: □ Access to the conference documentation £499.00 on the Document Portal □ The Conference Presentations – paper copy £499.00 Total + VAT £598.80 - £499.00 PAYMENT Address (if different from above): Post/Zip Code: Price (or only £300 if ordered with the Document Portal) Email: Town/City: I would like to attend: (Please tick as appropriate) □ Conference & 2 Workshops □ Conference & 1 Workshop □ Conference only □ 2 Workshops only □ 1 Workshop only Workshop A □ Workshop B □ The Conference fee includes refreshments, lunch, conference papers and CD ROM containing all of the presentations. Address: Direct Tel: GROUP DISCOUNTS AVAILABLE PROMOTIONAL LITERATURE DISTRIBUTION □ Distribution of your company’s promotional literature to all conference attendees £999.00 Company/Organisation: Post/Zip Code: Book by 28th February to receive $100 off the conference price Pharmaceutical Companies Rates: □ Conference only LIMITED AVAILABILITY Job Title: Town/City: Book by 20th December to receive $300 off the conference price CONFERENCE PRICES P-102 + VAT £1198.80 POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor Country: Direct Fax: VENUE Renaissance Woodbridge Hotel, 515 U.S. Route 1, Iselin, NJ 08830 □ Please contact me to book my hotel Alternatively call us on +44 (0) 870 9090 711, email: or fax +44 (0) 870 9090 712 Payment must be made to SMi Group Ltd, and received before the event, by one of the following methods quoting reference P-102 and the delegate’s name. Bookings made within 7 days of the event require payment on booking, methods of payment are below. Please indicate method of payment: BANK DETAILS □ Wire Transfer □ Cheque □ Credit Card Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU Sort Code: 300009 Account: 11775391 Swift (BIC): LOYDGB21013 IBAN GB75 LOYD 3000 0911 7753 91 We only accept cheques in US dollars □ Visa □ MasterCard □ American Express All credit card payments will be subject to standard credit card charges. Terms and Conditions of Booking Card No: Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another delegate to take your place at any time prior to the start of the event. Two or more delegates may not ‘share’ a place at an event. Please make separate bookings for each delegate. Cardholder’s Name: Payment: If payment is not made at the time of booking, then an invoice will be issued and must be paid immediately and prior to the start of the event. If payment has not been received then credit card details will be requested and payment taken before entry to the event. Bookings within 7 days of event require payment on booking. Access to the Document Portal will not be given until payment has been received. Cancellation: If you wish to cancel your attendance at an event and you are unable to send a substitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providing that cancellation is made in writing and received at least 28 days prior to the start of the event. Regretfully cancellation after this time cannot be accepted. We will however provide the conferences documentation via the Document Portal to any delegate who has paid but is unable to attend for any reason. Due to the interactive nature of the Briefings we are not normally able to provide documentation in these circumstances. We cannot accept cancellations of orders placed for Documentation or the Document Portal as these are reproduced specifically to order. If we have to cancel the event for any reason, then we will make a full refund immediately, but disclaim any further liability. Alterations: It may become necessary for us to make alterations to the content, speakers, timing, venue or date of the event compared to the advertised programme. Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection Act 1998 and we may use this to contact you by telephone, fax, post or email to tell you about other products and services. Unless you tick here □ we may also share your data with third parties offering complementary products or services. If you have any queries or want to update any of the data that we hold then please contact our Database Manager or visit our website quoting the URN as detailed above your address on the attached letter. □□□□ □□□□ □□□□ □□□□ Valid From □□/□□ Expiry Date □□/□□ CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card Signature: I agree to be bound by SMi's Terms and Conditions of Booking. Card Billing Address (If different from above): Date: VAT VAT at 20% is charged on Document Portal and literature distribution for all UK customers and for those EU Customers not supplying a registration number for their own country here If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at