2014 Archived Content

Biologics for Autoimmune Diseases

Day 1 | Day 2 | Download Brochure | Speaker Bios 

The specificity, efficacy and safety profiles of biologics have traditionally made them good candidates for the treatment of autoimmune diseases. Emerging genetic understandings of the mechanisms of these complex disorders are now being combined with exciting new therapeutic formats and strategies in a renewed wave of attention for the use of biotherapeutics in this therapeutic area.  Bispecific and combination therapeutics will provide improved efficacy by impacting multiple targets and processes.  Development of biosimilars and biobetters in this space will build on the success of proven therapeutics, while new technologies will offer expanded options for the application of promising validated targets from the past that were not advanced to the market.

The inaugural Biologics for Autoimmune Diseases presents a focused meeting that will track current clinical progress in the major autoimmune diseases, and then offer an exciting exploration of ways in which the industry is applying new science and technology in the development of a next generation of effective and safe therapeutics.  Set in the context of the 10th annual PEGS, attendees of this meeting will join more than 1,500 colleagues working in the fields of protein engineering and biologics development, offering unprecedented opportunities for networking and scientific collaboration.




Strategy for Entering the Biosimilars Market - View Detailed Agenda 

*Separate registration required

7:00 am Registration and Morning Coffee

» Plenary Keynote Session

8:30 Chairperson’s Opening Plenary Remarks

Kristi Sarno, Chair, Greater Boston Chapter, Women in Bio; Director, Business Development, Pfenex, Inc.

8:40 Harnessing the Patient’s Immune System
to Combat Cancer

Peter CR Emtage, Ph.D., Vice President, Immune Mediated Therapies, MedImmune

With recent FDA approvals, modulation of the immune system is now a clinically validated approach in the treatment of some cancers. At MedImmune, the Oncology Department is developing assets and expertise in Immune Mediated Therapy of Cancer (IMT-C). The challenges from a drug development perspective are multi-fold. The talk will focus on the relevance of preclinical models and translational science to address key issues, including dose selection and rationale combinations.

9:25 Building Regeneron’s Pipeline: From Trap Technology to the VelocImmune Platform to Veloci-Next

George D. Yancopoulos, M.D., Ph.D., President, Regeneron Laboratories; CSO, Regeneron Pharmaceuticals, Inc.

George D. Yancopoulos, M.D., Ph.D. will discuss how he and his colleagues exploited a commitment to science and technology to start the company, withstand years of challenges and failures, and emerge with a pipeline of promising technologies and novel/biologics that are beginning to bring hope to countless patients and their families.


10:10 Grand Opening Coffee Break in the Exhibit Hall with Poster Viewing

11:05 Chairperson's Remarks

RonaldHerbstRonald Herbst, Ph.D., Senior Director, Autoimmune Diseases, MedImmune

» 11:10 Keynote Presentation:

Biologics for Systemic Lupus Erythematosus

WilliamStohlWilliam Stohl, M.D., Ph.D., Professor, Medicine, Rheumatology, Keck School of Medicine, University of Southern California

With FDA approval of a biologic therapeutic for SLE, optimism abounds for approval of additional agents. Candidates include: biologics to effect B cell depletion/inactivation or generation of regulatory B cells; biologics to effect T cell tolerance, blockade of T cell activation/differentiation, or altered T cell trafficking; and biologics targeting individual cytokines. As understanding of SLE pathogenesis continues to expand, additional therapeutic targets will be identified.

Clinical and Preclinical Updates of Biologic Therapies for Autoimmune Diseases 

12:10 pm Embracing Complexity:  Understanding IVIg to Rationally Engineer Novel Therapeutics

Tony ManningTony Manning, Ph.D., Vice President, Research, Momenta Pharmaceuticals

12:40 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own

1:40 Session Break

2:00 Chairperson's Remarks

LawrenWuLawren Wu, Ph.D., Senior Scientist, Immunology, Genentech, Inc.

2:05 NI-0101, a Noncompetitive Inhibitor Targeting TLR4 with the Potential to Become the First Personalized Treatment in Rheumatoid Arthritis (RA)

Kosco-Vilbois_Marie Marie Kosco-Vilbois Ph.D., Chief Scientific Officer, NovImmune SA, Switzerland

As diverse TLR4 activators are upregulated in many diseases, NI-0101, currently in Phase I, blocks TLR4 in a ligand-independent manner.  Synovial fluids from RA patients contain various TLR4 ligands and induce cytokines from patients’ blood- and tissue-derived cells, with the levels correlating to NI-0101’s blocking potential. These results indicate that NI-0101 is a promising strategy for the treatment of RA with levels of TLR4 ligands circulating in patients used as biomarkers to distinguish responders to anti-TLR4 therapy.

2:35 Clinical Update of MEDI 551 (Anti-CD19 Antibody) for Autoimmune Disease

RonaldHerbstRonald Herbst, Ph.D., Senior Director, Autoimmune Diseases, MedImmune

Human cluster of differentiation (CD) antigen 19 is a B cell-specific surface antigen and an attractive target for B cell depletion. MEDI-551 is an affinity-optimized and afucosylated CD19 mAb with enhanced antibody-dependent cellular cytotoxicity (ADCC). MEDI-551 is currently in several phase 1/2 clinical studies, including B cell malignancies, systemic sclerosis (SSc) and relapsing remitting multiple sclerosis (RRMS).

3:05 Cytokine Modulation by Protein Therapeutics in Anterior and Posterior Ocular Disorders

Christian DombrowskiChristian Dombrowski Ph.D., Senior Scientist, Eleven Biotherapeutics, Inc.

Cytokines, chemokines, and growth factors mediate anterior and posterior eye diseases. A novel soluble receptor inhibitor of IL-17A and IL-17A with potential for treating uveitis and AMD was engineered, along with an IL-6 inhibitor with potential for treating diabetic macular edema. Our lead product, EBI-005 was designed and engineered for the topical treatment of dry eye disease and has evidence of biological activity in a clinical study.

3:35 IL-1a/b DVD-Ig™: From Design to Clinic for Autoimmune Indications

TariqGhayurTariq Ghayur, Ph.D., Senior Research Fellow, AbbVie


4:05 Refreshment Break in the Exhibit Hall with Poster Viewing

4:45 Problem Solving Breakout Discussions

These interactive discussion groups are open to all attendees, speakers, sponsors, & exhibitors. Participants choose a specific breakout discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.

Biologic Targets for Autoimmune Diseases

William StohlModerator: William Stohl, M.D., Ph.D., Professor, Medicine, Rheumatology, Keck School of Medicine, University of Southern California




  • B cell-directed biologics
  • T cell-directed biologics
  • Cytokine-directed biologics


Clinical Issues with Biological Therapies for Autoimmune Diseases 

Herman WaldmanModerator: Herman Waldman, Ph.D., Emeritus Professor of Pathology, Therapeutic Immunology Group, Sir William Dunn School of Pathology, University of Oxford, United Kingdom

  • Are randomized blinded studies always possible.
  • How do we get combinations tested where neither one product is licensed?
  • How good are the end points for trials?
  • Are side effects an inevitable feature of a particular treatment-can they be prevented?
  • Will Therapeutic vaccines replace immunosuppressants?

Stem Cell-Based Therapy for Autoimmune Diseases

OrenLevyModerator: Oren Levy, Ph.D., Instructor in Medicine, Harvard Medical School

  • Relevant diseases and potential stem cell-based therapeutic mechanisms
  • End points/cost-benefit - comparison to existing approaches
  • Cell engineering to improve stem cell-based therapy for autoimmune diseases

Development Challenges of Bispecifics

TariqGhayurModerator: Tariq Ghayur, Ph.D., Senior Research Fellow, AbbVie

  • Target pair identification
  • Format differences and functional outcomes
  • Developability (drug-like properties assessment)

In Vivo Pharmacology, Disease Models and Translational Science in Autoimmunity and Inflammation

Patrik StrömbergModerator: Patrik Strömberg, Ph.D., Principal Scientist, Drug Design and Development, Swedish Orphan Biovitrum (Sobi), Sweden

  • How do standard autoimmune- and inflammation models translate human disease?
  • What do regulatory agencies require in terms of in vivo pharmacology documentation?
  • How to address species cross-reactivity (e.g. the value of developing surrogate test articles for rodent studies).
  • Animal studies vs. human ex vivo models.

5:45 Welcome Reception in the Exhibit Hall with Poster Viewing

6:45 End of Day

Day 1 | Day 2 | Download Brochure | Speaker Bios 

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