Agenda at a Glance

Take a look at this year's discussion topics, and keep an eye out for the full agenda coming soon!
 

San Diego, 23 - 24 May 2018

Schedule

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May 2309:00
Conference pass

Chairperson’s Opening Remarks

Keynotes
Nacer E. Hedroug, Former Director, QA Ops Injectable Vertical & Tech Transfer, Mylan Inc.
May 2309:10
Conference pass

Keynote interview: Balancing biosimilars, biobetters and new molecular entities – discussing Pfenex’s next move

Keynotes
  • How past experiences play a vital role in the current and future state of biosimilar products
  • How recent advances in regulatory science and guidance are influencing the development of biosimilars and complex generics: case study with teriparatide
  • How Pfenex looks to drive its current pipeline and evolve its resources to enter new avenues
  • How to maintain the right balance between adding more novel proteins and maintaining a presence in biosimilars/complex generics space
Interviewee: Hubert Chen, Chief Medical and Scientific Officer, Pfenex Inc
Interviewer: Anna Rose Welch, Executive Editor, Biosimilar Development
May 2309:40
Conference pass

Biosimilars 2018 – The current and future state

Keynotes
  • Analyzing major events in 2017 and how it impacts market size and trends for 2018 and beyond
  • Exploring potential trends in the next 12-18 months
  • Evaluating major action points and focuses for industry in the long-term
Jorge Santos da Silva, Partner, McKinsey & Company
May 2310:00
Conference pass

Panel: Evaluating the complexities of patient studies, FDA requirements and biosimilars price points

Keynotes
  • What are elements in the approval of biosmilars that can be changed to reduce the time and cost to market for biosimilars including safety and efficacy clinical studies and bridging studies.
  • Since there is no clinically meaningful differences, shouldn’t biosimilars be substituted for new patients? What are the views of prescribers and payors?
  • Price points – What are the complexities of pricing and how does this dictate savings at a patient level?
Moderator: Sarfaraz Niazi, Chairman, Professor, Karyo Biologics/UIC
Ambrose Carrejo, Pharmaceutical Contracting Leader, Kaiser Permanente
Peg Ford, President, Ovarian Cancer Alliance of San Diego
Jorge Santos da Silva, Partner, McKinsey & Company
May 2311:40
Conference pass

Pharmaceutical Quality Systems – Ensuring Compliance in the Emerging Biosimilar Sector

DEVELOPMENT AND MANUFACTURING
  • What is a Pharmaceutical Quality System – Incorporating the essential elements of quality through the development of biosimilars
  • Quality oversight in the Biosimilar development process
  • Phase-appropriate compliance – Maintaining an appropriate level of rigor as you move forward in the product development lifecycle
Michael Fairbanks, VP, Quality, Adello Biologics LLC
May 2311:40
Conference pass

Launching biosimilars in the retail space – understanding its complexities

COMMERCIALIZATION
  • Understanding how the BPCIA act impacts transition products and why they’re not called biosimilars yet in the US
  • Analyzing the payer landscape and payer perception of retail biosimilars and how they compare between the US and the EU
  • Examining HCP and patient perceptions of biosimilars - how do they differ between the US and the EU and why
  • Understanding the importance of pharmacy for biosimilars in the retail space
Christine Cannon, Global Lead, Sanofi
May 2312:10
Conference pass

Unlock the full potential of biosimilars -analyzing necessary action points and exploring real world examples in EU

COMMERCIALIZATION
  • Understanding key action points to unlock the full potential of biosimiliars
  • Implementing strategies such as benefit sharing to overcome disincentives of stakeholders
  • Educating the healthcare systems - exploring real world examples of successes and failures in EU
Florian Turk, Head of Global Payor Marketing, Sales and Relations, Sandoz
May 2312:40
Conference pass

ROUNDTABLES

Keynotes
Achieving desired protein quality profiles - Can media and supplements have an impact?
Stacy Holdread, Staff Scientist, BD
Chuck Velnoskey, Market Development Manager, BD Biosciences
Agency expectations – Coping with increased quality expectations
Dinesh Kundu, CEO & Co-Founder, QbD Biosciences
Biosimilars and retail – Understanding the importance of pharmacy for biosimilars in the retall space
Maria Nishi, Director, Merck & Co
EU markets – Exploring real world examples of successes and failures
Florian Turk, Head of Global Payor Marketing, Sales and Relations, Sandoz
May 2314:20
Conference pass

Critical attributes to consider when choosing an appropriate CDMO to manufacture your products

DEVELOPMENT AND MANUFACTURING
  • Understanding the developers’ perspective on finding the right CDMO
  • How do we evaluate the commercial capacity of a potential CDMO?
  • What role does CDMO culture and flexibility play when choosing the right partner?
Vimal Gandhi, Director, Global Biosimilar Operations and Strategy, AstraZeneca
May 2314:20
Conference pass

Anti-biosimilars or pro-safety? Addressing the truth about ensuring cost savings and patient safety

COMMERCIALIZATION
  • Cost savings vs patient safety – How can we sustain a balance between the two?
  • Understanding the need for robust and comprehensive post-market tracking and reporting systems
  • Incorporating the patient voice into the development of biosimilar drugs to ensure a promising future
Lawrence LaMotte, Principal Consultant, Advocacy Options
May 2314:40
Conference pass

How improved analytical techniques and outsourcing manufacturing needs help drive the accuracy in our data

DEVELOPMENT AND MANUFACTURING
  • What technologies will help us distinguish structural features of biosimilar products?
  • Weighing the benefits of improved analytical techniques such as HR-MS and 2D-NMR to detect protein glycosylation or peptide modification
  • Evaluating the potentials of outsourcing analytical and manufacturing needs for faster and more accurate analytical data
Parastoo Azadi, Technical Director of Analytical Services and Senior Research Scientist, Complex Carbohydrate Research Center
May 2314:40
Conference pass

Leveraging the NHS to facilitate studies that will generate real-world evidence and help understand the variability in patient uptake

COMMERCIALIZATION
  • Evaluating the uptake and use of biosimilars in patients across both ordinary diseases and oncology
  • Capturing patient experiences of both being prescribed from first time biosimilars and also switching activities
  • Clinician driven or patient driven – How can we justify the variability in patient uptake?
Matt Cooper, Business Development and Marketing Director, NIHR Clinical Research Network
May 2315:00
Conference pass

Clinical development of biosimilars - the importance of making your clinical trials as specific, consistent and sensitive as possible

DEVELOPMENT AND MANUFACTURING
  • Case study example of pegfilgrastim biosimilar clinical trial design
  • Understanding how we can build a bridge between the originator and biosimilar product using a specific, consistent and tailor-made approach
  • The importance of study population, study design, endpoints and statistics
  • Collaborating with regulatory affairs and making clinical studies as sensitive to differences as possible
Ruediger Jankowsky, Managing Director, Cinfa Biotech
May 2315:00
Conference pass

Uptake of biosimilars – understanding Kaiser’s expectations and experiences with incorporating these important medicines

COMMERCIALIZATION
  • Evaluating Kaiser’s experiences with incorporating biosimilars
  • How clinician education and awareness of biosimilars can continue evolving and contribute to uptake
  • Understanding the complexities of contract negotiations and what is needed to increase market share and overall uptake
Jennifer Day, Coordinator, Emerging Therapeutics Strategy Program, Kaiser Permanente
Ambrose Carrejo, Pharmaceutical Contracting Leader, Kaiser Permanente
May 2315:20
Conference pass

Exploring the need for additional clinical trial experience (post-marketing and/or ISS) and real-world data to establish clinical confidence among US HCPs

DEVELOPMENT AND MANUFACTURING
  • Exploring components that are necessary to establish clinical confidence in biosimilar products
  • What additional clinical information is needed to help establish clinical confidence among US HCPs?
  • Implementation of strategies to disseminate clinical data on biosimilars for awareness and familiarization of HCPs
Gerry Hoehn, Medical Director, Oncology, Teva Pharmaceuticals U.S.A.
May 2315:20
Conference pass

Distinguishable names for biologics and their role in supporting pharmacovigilance

COMMERCIALIZATION
  • Analyzing the ability of current pharmacovigilance systems to trace specific biologics
  • Evaluating the current naming system and how this effects patient safety and monitoring
  • How can industry, agency and stakeholders collaborate to address the burdens that can be inflicted?
Jason Awe, Scientific Affairs Senior Manager, Amgen
May 2316:15
Conference pass

Sponsored IP/Litigation session

Keynotes
Hosted by Knobbe Martens
William Adams, Partner, Knobbe Martens
May 2316:30
Conference pass

Understanding the main barriers to approval and market entry and analyzing partnerships that will help us address them

Keynotes
  • Delays in market entry – Addressing where we are today and analyzing current affairs
  • Reviewing new guidelines, current pipelines and the patent landscape
  • What kinds of partnerships will help us speed up approval and market entry?
Chrys Kokino, Head Global Bioloigcs & Insulins - Commercial, Mylan Inc.

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May 2409:00
Conference pass

Keynote: Samsung Bioepis' perspective on the development and manufacturing of biosimilars

Keynotes
  • Overview of Samsung Bioepis' portfolio strategy and competitiveness in biosimilar development
  • Exploring technology innovation in process development and manufacturing control
  • Exploring opportunities in emerging markets and understanding their regulatory updates
Brian Hosung Min, Vice President, Process Team, Samsung Bioepis
May 2409:20
Conference pass

Keynote: Why having a complete understanding of the innovator product is critical to develop a highly similar molecule

Keynotes
  • Exploring the complexities of understanding the innovator and how this can make or break your biosimilar product
  • Analyzing the analytical, structural and functional characteristics of the innovator product
  • Utilizing state-of-the-art analytical and functional techniques to optimize the characterization process
Vladimir Vexler, EVP, Analytical and Translational Sciences, Coherus Biosciences
May 2409:40
Conference pass

Keynote stakeholder panel – Providing balanced and consistent information to patients and providers

Keynotes
Moderator: Tiffany Fletcher, Executive Director of Government Affairs, Biosimilars, Sandoz
Cheryl Koehn, President, Arthritis Consumer Experts
Jennifer Day, Coordinator, Emerging Therapeutics Strategy Program, Kaiser Permanente
May 2411:40
Conference pass

Exploring China – navigating the risks and maximizing the opportunities

Keynotes
  • Why China has major potential for biosimilar drugs
  • Exploiting China’s disease burden to tap into a robust domestic market
  • Forming strategic alliances and partnerships with local Chinese manufacturers to address associated risks
Yi Du, Director, Strategic Alliances, Huahai Pharma
May 2412:00
Conference pass

Thoroughly evaluating your emerging markets portfolio and choosing regions that will maximize your strengths

Keynotes
  • What factors should we consider when evaluating our emerging markets portfolio?
  • Understanding what diseases are most prevalent and costly for payers to treat
  • Examining the unmet needs of patients and leveraging internal strengths that can meet those needs
Don Stewart, President and Chief Executive Officer, PlantForm
May 2412:20
Conference pass

Biosimilars in Brazil – Commercialization complexities and the role of government

Keynotes
  • The commercialization of biosimilar antibodies in Brazil – Exploring its current state
  • Understanding the role of government in Brazil and how it dictates biosimilar uptake
  • Evaluating switching complexities and analyzing the public/private market
Andrew Simpson, Scientific Director, Orygen Biotecnologia
May 2412:40
Conference pass

ROUNDTABLES

Keynotes
Andrew Simpson, Scientific Director, Orygen Biotecnologia
Maria Nishi, Director, Merck & Co
Julio Baez, Former Head, Technology, Cipla BioTec
May 2414:20
Conference pass

How your biosimilars development strategies are translated into a full program management

DEVELOPMENT AND MANUFACTURING
  • How new approaches to development dictate the entire project management of biosimilars
  • Understanding the complications associated with the alignment of development projects with FDA and EMA expectations
  • Comparing agency expectations and evaluating the components necessary to have agency buy-ins
Klemen Spaninger, Director of Project Management, Polpharma Biologics
May 2414:20
Conference pass

How biosimilar developers can utilize CAR technology to extend the value of their antibody portfolio

COMMERCIALIZATION
  • Providing the biosimilar industry with an avenue into the CAR T cell space
  • Evaluating preclinical anti-tumor data of biosimilar drug candidates
  • Utilizing CAR technology to increase the effectiveness of a biosimilar antibody
Ronald Dudek, Director, Technology Development and Marketing, Lentigen Corporation
May 2414:40
Conference pass

High productivity cultures and innovative manufacturing for the production of affordable biosimilars

DEVELOPMENT AND MANUFACTURING
  • Utilizing high productivity culture and single-use technology to achieve required costs
  • Implementing a distributed manufacturing approach and modular construction to enable global commercialization
  • Integrating bioanalytics and bioprocessing to achieve required quality
Julio Baez, Former Head, Technology, Cipla BioTec
May 2414:40
Conference pass

Biologic Nomenclature: Implementation of an Internationally Harmonized System

COMMERCIALIZATION
  • Perspectives on the feasibility of naming harmonization and the potential implementation of a proposed systems of naming biosimilars
  • The SuffixAudit tool to facilitate compliance with naming standards set forth by FDA and World Health Organization
  • A method enabling manufacturers and regulators to quickly test a potential suffix against established naming rules for biologics
Philip Schneider, Advisory Board Chair, Alliance for Safe Biologic Medicines
last published: 21/May/18 20:45 GMT
 
 
 

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