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Biosimilars North America
November 15 - November 16, 2017
Biosimilars North America

Building on the success of previous events, SAE Media Group proudly announces the return of its 4th annual Biosimilars North America Conference, taking place on November 15 and 16, 2017 in Iselin, New Jersey.

The first biosimilar product launched in the US in 2015. Currently there are only 4 biosimilar products approved but the North Americas market continues to grow and has become highly lucrative. As such, pharmaceutical companies continue to find ways to differentiate their products in such a saturated market. Thus, Biosimilars North America 2017 will provide an intelligent meeting to explore novel and innovative strategies to advance biosimilar development, and ensure optimal market access and commercialization opportunities whilst complying with evolving regulatory requirements.

This year, the conference will also explore significant developmental topics within the sector including the impact of FDA’s newly implemented biosimilar interchangeability guidelines, the US market access landscape, and biosimilars of orphan drugs.
 

FEATURED SPEAKERS

Bruce Leicher

Bruce Leicher

Sr. Vice President and General Counsel, Momenta Pharmaceuticals
Chrys Kokino

Chrys Kokino

Global Commercial Head, Mylan Inc
Cindy Cao

Cindy Cao

Executive Director & Head of US Regulatory Affairs for Biopharmaceuticals, Sandoz Inc
Richard Dicicco

Richard Dicicco

Chairman, Harvest Moon Pharmaceuticals USA, Inc.
Sarfaraz Niazi

Sarfaraz Niazi

Adjunct Professor, Department of Biopharmaceutical Sciences, UIC College of Pharmacy

Bruce Leicher

Sr. Vice President and General Counsel, Momenta Pharmaceuticals
Bruce Leicher

Carlos Angulo

Partner, Zuckerman Spaeder LLP
Carlos Angulo

Chrys Kokino

Global Commercial Head, Mylan Inc
Chrys Kokino

Cindy Cao

Executive Director & Head of US Regulatory Affairs for Biopharmaceuticals, Sandoz Inc
Cindy Cao

Don Stewart

CEO, PlantForm Corp
Don  Stewart

Gary C Cupit

President & CEO, Sapphire Therapeutics
Gary C Cupit

Hiten Gutka

Principal Scientist Formulation Development Biosimilar Development, Oncobiologics
Hiten Gutka

John Carlsen

Vice President, Covance Inc
John Carlsen

Mkaya Mwamburi

Founder, President and CEO, profecyINTEL, LLC
Mkaya Mwamburi

Rajani Srikakulam

Principal Scientist, Oncobiologics
Rajani Srikakulam

Richard Dicicco

Chairman, Harvest Moon Pharmaceuticals USA, Inc.
Richard Dicicco

Ronen Tchelet

VP Research & Business Development, Dyadic Nederland B V
Ronen  Tchelet

Ruchi Gupta

Senior Scientist, MedImmune
Ruchi Gupta

Sarfaraz Niazi

Adjunct Professor, Department of Biopharmaceutical Sciences, UIC College of Pharmacy
Sarfaraz Niazi

Steinar Madsen

Medical Director, Norwegian Medicines Agency
Steinar Madsen

Dr. Steinar Madsen is medical director at the Norwegian Medicines Agency. He has been working with generic substitution since it was introduced in Norway in 2001 and with biosimilars since 2006. He is member and previously chairman of the committee for generic substitution at the Agency. Dr. Madsen is engaged in the drug information service, with a special interest in the safe and cost-effective use of drugs. He is a specialist in internal medicine and cardiology and works part time as a consultant in cardiology.

Conference agenda

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8:30

Registration & Coffee

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9:00

Regulatory strategy and requirements in biosimilar development

David Lin

David Lin, Senior Consultant, Biologics Consulting

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9:30

High level overview of formulation development for biosimilars

Hiten Gutka

Hiten Gutka, Principal Scientist Formulation Development Biosimilar Development, Oncobiologics

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10:00

Morning Coffee

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10:30

Analytical development and the establishment of the release profi le

Amber Fradkin

Amber Fradkin, Director Particle Characterization Core Facility, KBI Biopharma

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11:30

Selection and limitations of extended characterization techniques for the establishment of biosimilarity

Brent  Kendrick

Brent Kendrick, CSO, Elion Labs LLC

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12:00

Statistics and the formal comparability exercise

Jose Ramirez

Jose Ramirez, Consultant, Amgen

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12:30

Close of Workshop

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13:30

Registration & Coffee

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14:00

Opening Remarks and Introductions

Candida Fratazzi

Candida Fratazzi, President, BBCR Consulting

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14:10

Critical considerations on confi rmatory study

Candida Fratazzi

Candida Fratazzi, President, BBCR Consulting

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14:50

Case study: Real life hands on experience

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15:30

Afternoon Tea

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16:00

Immunogenicity

Candida Fratazzi

Candida Fratazzi, President, BBCR Consulting

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16:40

Extrapolation

Candida Fratazzi

Candida Fratazzi, President, BBCR Consulting

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17:30

End of workshop

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Richard Dicicco

Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc.

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9:10

The Road to biosimilars: Reaching our destination with the patient in mind

Chrys Kokino

Chrys Kokino, Global Commercial Head, Mylan Inc

  • Road Today: Lessons learned from EU and RoW as we look towards US launches
  • Detours: New guidelines, naming, reimbursement, interchangeability
  • Road Ahead: Keeping the patient and other stakeholders in mind
  • clock

    9:50

    From biosimilar approval to biogenerics in clinical practice

    Steinar Madsen, Medical Director, Norwegian Medicines Agency

  • Attitudes and acceptance
  • Uptake in clinical practice – the European experience
  • Nor-Switch study and other clinical trials
  • Switching is already there – do we need interchangeability?
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    10:30

    Morning Coffee

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    11:00

    How to ensure optimal market access for biosimilars

    Gary C Cupit

    Gary C Cupit, President & CEO, Sapphire Therapeutics

  • The economics of biosimilars
  • How should we price biosimilars?
  • What can be done by payers to ensure long term savings?
  • clock

    11:40

    Building a biologics empire: Being both the originator and biosimilar Innovator

    Mkaya Mwamburi

    Mkaya Mwamburi, Founder, President and CEO, profecyINTEL, LLC

  • It’s not a conflicting scene - complimenting your portfolio with both original biologics and biosimilars
  • The story behind - from technical capabilities to branding
  • What’s the best approach and how to hedge?
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    12:20

    Networking Lunch

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    13:30

    Biosimilars of orphan drugs: The case study of biosimilar Eculizumab

    Richard Dicicco

    Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc.

  • Eculizumab global market data
  • Cost and development risk requires a change in extrapolation strategy
  • Defining the target quality profile and critical quality attributes
  • The right patient assistance program is necessary for biosimilar orphans
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    14:10

    Drug product and formulation development considerations for biosimilars

    Hiten Gutka

    Hiten Gutka, Principal Scientist Formulation Development Biosimilar Development, Oncobiologics

  • Considerations in development of formulation and Drug Product for Biosimilars
  • Excipient quality and influence on biosimilar drug product quality and stability, Container closure effect on stability of biosimilar drug product
  • Similarity assessment and the role of formulation and drug product.
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    14:50

    Afternoon Tea

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    15:20

    Functional similarity assessment

    Rajani Srikakulam

    Rajani Srikakulam, Principal Scientist, Oncobiologics

  • What is the importance of functional assays/ bioassays in biosimilar development? Why does one need functional assays in addition to an in-depth structural characterization?
  • What bioassays are appropriate for a given biosimilar? How does one determine what assays are necessary and when are they needed?
  • Diversity of bioassay methodologies – how to select the appropriate methodology for the purpose
  • Tiering of functional attributes based on mechanism of action and known clinical relevance
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    16:00

    Dyadic’s C1 Expression System, a potential CHO Stopper

    Ronen  Tchelet

    Ronen Tchelet, VP Research & Business Development, Dyadic Nederland B V

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    16:40

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Richard Dicicco

    Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc.

    clock

    9:10

    Bioinnovations: speed to market biosimilars.

    Sarfaraz Niazi

    Sarfaraz Niazi, Adjunct Professor, Department of Biopharmaceutical Sciences, UIC College of Pharmacy

  • Minimising bioprocessing steps, environment controls and cleaning validation.
  • Continuous manufacturing, scale-free lots, ready tech transfer
  • Addressing unique challenges in biosimilars development
  •  

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    9:50

    Understanding the U.S. market access landscape for biosimilars

    John Carlsen

    John Carlsen, Vice President, Covance Inc

  • Review key CMS policy developments for biosimilars (e.g., Medicare guidance, coding decisions, payment policies) and understand the potential impact on commercial payers' policies
  • Highlight coding and Medicare payment for currently available biosimilar products, understand the link between coding/payment and pricing, and discuss what this means for biosimilars approved in the future
  • Gain insight into how commercial payers are covering and managing biosimilars, as well as the resulting impact on patient access to competing innovator products (based on original research conducted by Covance)
  • Assess the implications for reimbursement hubs, patient assistance programs, and other customer support resources

     

  • clock

    10:30

    Morning Coffee

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    11:00

    Targeted Biobetters: Tissue Specific Delivery Using Caveolae Technology Improves Drug Efficacy

    Ruchi Gupta

    Ruchi Gupta, Senior Scientist, MedImmune

  • Current bio-therapeutics focus on the molecular targets expressed on cells/tumors. Inspite of increased antigen expression on the targeted organ, less than 10% of the IV administrated biologics can reach the diseased tissues.
  • Tissue targeting using caveolae proteins can allow for specific delivery to organs of interest within minutes to hours.
  • This talk will focus on caveolae technology to specifically deliver to lungs and kidneys and improve drug efficacy.
  • This technology can achieve markedly improved efficacy of drugs in several diseases including fibrosis, COPD, infections as well as tumors.
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    11:40

    Opportunities for biosimilar and biobetter drugs in Brazil

    Don  Stewart

    Don Stewart , CEO, PlantForm Corp

  • Establishing Partnerships
  • Funding Scenarios
  • Technology Transfer and Manufacturing

     

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    12:20

    Networking Lunch

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    13:30

    Legal, Policy and Commercial Obstacles to the development and launch of Biosimilars

    Bruce Leicher

    Bruce Leicher, Sr. Vice President and General Counsel, Momenta Pharmaceuticals

  • The use of Public Policy and Guidance to Promote Evergreening of Reference Products
  • Restricted access to reference products and REMS Abuse
  • clock

    14:10

    Amgen v. Sandoz: the U.S. Supreme Court’s First Foray into the BPCIA

    Carlos Angulo

    Carlos Angulo, Partner, Zuckerman Spaeder LLP

  • The Court’s BPCIA “patent dance” decision
  • The Court’s decision on the BPCIA’s “notice of commercial marketing” provision
  • How will the Court’s holdings affect biosimilars development going forward?
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    14:50

    Afternoon Tea

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    15:20

    FDA issues long awaited biosimilar interchangeability guidance

    Cindy Cao

    Cindy Cao, Executive Director & Head of US Regulatory Affairs for Biopharmaceuticals, Sandoz Inc

  • The impact of the new guidelines
  • Interchangeability: Considerations for a single switch vs. multiple switches
  • Engaging with your stakeholders - how will switching work?
  • clock

    16:00

    Chairman’s Closing Remarks and Close of Day Two


    Sr. Vice President and General Counsel
    Momenta Pharmaceuticals
    Partner
    Zuckerman Spaeder LLP
    Global Commercial Head
    Mylan Inc
    Executive Director & Head of US Regulatory Affairs for Biopharmaceuticals
    Sandoz Inc
    CEO
    PlantForm Corp
    President & CEO
    Sapphire Therapeutics
    Principal Scientist Formulation Development Biosimilar Development
    Oncobiologics
    Vice President
    Covance Inc
    Founder, President and CEO
    profecyINTEL, LLC
    Principal Scientist
    Oncobiologics
    Chairman
    Harvest Moon Pharmaceuticals USA, Inc.
    VP Research & Business Development
    Dyadic Nederland B V
    Senior Scientist
    MedImmune
    Adjunct Professor, Department of Biopharmaceutical Sciences
    UIC College of Pharmacy
    Medical Director
    Norwegian Medicines Agency

    Official Media Partner

    Official Publication

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    Preliminary Attendee List - Biosimilars North America

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    Interview with PlantForm - Don Stewart

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    Attendee List - SMi Pharma USA Week 2017

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    Interview with Pfenex - Patrick Lucy

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    Past Attendees - Biosimilars North America 2016

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    Biosimilar Development

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    Biosimilar Development is dedicated to presenting technical information, thought leadership, and commentary for the biosimilar development and manufacturing community. On this site, users will find exclusive and actionable content on the industry trends and challenges affecting the emerging biosimilars market. Browse our articles, case studies, and white papers on topics related to biosimilar development, manufacturing, quality, distribution, FDA guidance, BPCIA, global markets, government regulations, and intellectual property. Biosimilar Development is part of the Life Science Connect media group, which strives to facilitate connections and foster collaborations in pharmaceutical development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.


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    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




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