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Update on US Biosimilar Landscape and Policy Impact on Biopharma Portfolios
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LES New Jersey Chapter Meeting

When: Thursday, October 1, 2015
6:00 PM – 9:00 PM
Where: Dolce Basking Ridge
300 N. Maple Ave
Basking Ridge, New Jersey  07920
United States

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Thursday, October 1, 2015
6:00 PM – 9:00 PM

Dolce Basking Ridge
300 N. Maple Ave
Basking Ridge, NJ

Update on US Biosimilar Landscape and Policy Impact on Biopharma Portfolios

Michael Rice, Senior Consultant, Defined Health

David Dunn, Practice Consultant – Life Sciences Professional Services, IP & Science, Thomson Reuters
Debbie Hart, President& CEO, BioNJ
Ying Li, Patent Attorney, Ropes & Gray
Jim McKay, Director, CDMA, Medical Affairs, Sandoz
Michiel Ultee, Principal Ulteemit BioConsulting, LLC

While over the last decade, the majority of legacy small molecule blockbuster drugs have faced rapid generic erosion, biologics have been a leading growth driver for Biopharma companies.  Biologics now represent seven of the top ten drugs in terms of global revenue.  These large molecule drugs have been a haven for investment due to lower development attrition rates compared to small molecules, high value pricing for specialty indications and more formidable barriers to entry for biosimilars than those for small molecules.  As a result, many biotech companies have been snapped-up by larger pharmaceutical companies seeking biologics capabilities to sustain future growth.  While the US market has not yet experienced much of an impact from biosimilar competition, Europe and the rest of the world has had considerable experience. Ex-US, biosimilars have experienced modest, but steady growth with overall sales expected to break the $1 Billion mark this year.  In the US, the launch of the first true biosimilar growth factor, ZARXIO (filgrastim, Sandoz), has just been announced; and with the expected patent expiration of 12 biologics, several biosimilar insulins and monoclonal antibodies are not far behind in the pipeline.  In response to this considerable threat, innovators of biologic drugs are employing several strategies to maintain their market share, such as:  competitive pricing and couponing; changing product attributes such as improving dosing/scheduling, engineering higher potency or reducing immunogenicity; moving to novel MOAs and other technologies such as next wave biologics and gene/cell therapies.

The panel discussion will focus on these issues from the perspectives of key stakeholders in the biologics market including generic manufactures, large biopharma and biotech innovators. In addition, it will discuss:

  • Emerging biosimilar landscape in the US and what can be learned from the rest of the world:  opportunities and challenges, business models and partnering;
  • Regulatory considerations, nomenclature guidance and legislation policy;
  • Complexity of Biosimilars vs. chemical generics: manufacturer’s perspective;
  • IP and legal issues: Is there room for innovation around biosimilars? Patent dance explained;
  • How Biopharma investment in biosimilars and new technologies may impact the potential of biosimilar business models?
  • Market access considerations? Is there room for small players? How many players any biosimilar can bear?

$65 LES Members in advance (received by 12:00 Midnight EST, Monday, September 28) 
$70 Non-Members in advance (received by 12:00 Midnight EST, Monday, September 28)

$75 LES Members at the door (cash and checks only)
$80 Non-Members at the door (cash and checks only)

Cancellations made after 12:00 Midnight EST, Wednesday, September 30th cannot be reimbursed, but substitutions are welcome! 

6:00 - 7:00 pm Networking Reception
7:00 - 7:10 pm Introductions and Announcements
7:10 - 8:30 pm Panel Discussion
8:30 - 9:00 pm Q&A, Coffee and Deserts

Dress Code:  Business or Business Casual

David Dunn is a Managing Consultant in the Life Sciences and Professional Services group at Thomson Reuters. He has over 20 years of experience in the pharmaceutical and biotechnology industries and works with clients on a broad array of assignments including disease landscape analysis, competitive intelligence, drug target evaluation, technology assessment and trends in research and development.  He has special expertise on business and scientific trends in the biosimilars industry. He has published on the subject of biosimilars strategy and is a recognized expert.  Over the course of his career he has held positions of increasing responsibility at Abbott Laboratories, Pharmacopeia, Wyeth, Hurel and Intrexon. He has worked on a multitude of pre-clinical drug discovery programs from target identification through candidate selection. At Wyeth he was Collegeville site-head for Chemical and Systems Biology; He has developed and applied cutting-edge drug discovery technology. David holds a BS degree in Chemistry from Wake Forest University and Ph.D. in Physical Organic Chemistry from New York University. He completed post-graduate research fellowships in Biophysical Chemistry at Columbia University and Molecular Biology at Harvard Medical School.

Debbie Hart, founding President and CEO of BioNJ, is dedicated to the mission and work of BioNJ. She worked alongside New Jersey’s biotechnology industry leaders to establish BioNJ in 1994. Debbie has been active on the boards and committees of numerous government and academic institutions.

She was recently appointed by Governor Chris Christie and Lt. Governor Kim Guadagno to the Council on Innovation and is a member of the New Jersey Economic Development Authority’s (EDA) Technology Advisory Board.  Debbie has served on the transition teams of two former governors, as Chair of EDA’s Commercialization Center for Innovative Technologies and on the New Jersey Israel Commission.

Debbie is a board member of the Rutgers University Blanche and Irwin Lerner Center for the Study of Pharmaceutical Management and the Advisory Board of the College of Science and Mathematics at Montclair University.  Previously, she was a member or advisor to: The Rothman Institute of Entrepreneurship at Fairleigh Dickinson University; the Science Advisory Board at Rider University; the New Jersey Institute of Technology’s (NJIT) Biomedical Engineering Program; Monmouth University’s School of Science, Technology and Engineering; and the advisory board that guided the establishment of the nationally recognized Monmouth County Biotechnology High School.

Debbie holds an M.S. from the S. I. Newhouse School at Syracuse University where she graduated cum laude and a B.A. from Trenton State College, now The College of New Jersey, where she graduated magna cum laude.

Z. Ying Li counsels biotechnology and pharmaceutical clients on patent portfolio management and strategic development. She has extensive experience in patent prosecution and contentious matters before U.S. and foreign patent offices. Ying helps clients survey the competitive patent landscape and renders opinions on freedom-to-operate, non-infringement, and patent invalidity. She also conducts IP due diligence for venture capital investment and corporate business development. Ying has worked on a wide range of therapeutic areas including cancer and immune disorders, with expertise in antibody therapeutics and molecular diagnostics.

Since joining Defined Health in 2005, Mike Rice has participated on project teams and managed projects pertaining to cardiovascular disease, oncology and a variety of other therapeutic areas, as well as those focused on complex therapeutics such as protein and gene-based therapies for monogenetic diseases.

Mike brings to Defined Health over 10 years of experience as a biotech entrepreneur. Most recently, as Strategic Business Development Analyst for Tapestry Pharmaceuticals, Mike combined technical knowledge and business analytics to evaluate early stage development pipelines for partnering and licensing efforts. He was previously involved in translational research and technology transfer as Project Leader in Genomics at the Delaware Biotechnology Institute. Mike gained exposure to the venture capital community as a technological founder and New Product Development Manager of the genomics and gene therapy firm, Kimeragen, Inc.

Mike studied the molecular basis of cancer at the Kimmel Cancer Institute and is recognized for his extensive intellectual property and publication portfolio pertaining to cancer genetics, DNA repair, human gene therapy, molecular diagnostics, and agricultural trait improvement.

Mike holds an MBA, New Venture Creation, Biotechnology Degree from the Alfred Lerner School of Business and Economics, an MS in Molecular Pharmacology from Thomas Jefferson University and a BS in Biology from the University of Delaware.

Dr. Michiel “Mike” Ultee has more than 30 years of experience in the development of biopharmaceuticals, from research through commercial manufacturing. Recognized as an industry expert on antibodies, fusion proteins and other recombinant proteins, he is a frequent speaker at international conferences and serves on the Editorial Advisory Board of Biopharm International and Bioprocess International.

As the scientific co-founder and CSO of Laureate Biopharma and its successor Gallus Biopharmaceuticals, Dr. Ultee developed dozens of proteins into new biopharmaceuticals. He formed Ulteemit BioConsulting in October 2013 to offer expert consultation in the fields of process development and manufacture of protein therapeutics.


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