Advances in Biologics Development and Delivery

Thursday, March 24, 2016 • 8:00 AM to 7:00 PM (PDT)

UCSF Mission Bay Campus, Byers Auditorium, Genentech Hall, San Francisco, CA


The Catalent Institute experts from Catalent Pharma Solutions, Ionis Pharmaceuticals, Pure MHC, Sevion, UC Berkeley, and Applied Molecular Transport will present on the latest developments in development of biological therapies and delivery. This event is designed to cater to Vice Presidents, Directors, Principal Scientists and Graduate Students joining us from leading pharmaceutical companies and universities.

The expert panel, moderated by Professor Carolyn Bertozzi (Stanford University), will focus on providing solutions for biologic development challenges facing every R&D team today. Participants are encouraged to bring their toughest development challenges and discuss with the expert panel.

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8:00 AM – 8:30 AM | Registration & Breakfast

8:30 AM – 8:45 AM | Welcome & Introduction

8:45 AM – 9:30 AM | Asialoglycoprotein receptor mediated delivery of antisense oligonucleotides to hepatocytes enhances potency >10-fold in animals

9:30 AM – 10:15 AM | Monoclonal Antibodies To HLA/Peptide Tumor Antigens

10:15 AM – 10:30 AM | BREAK

10:30 AM – 11:15 AM | Antibody Drug Conjugates Using SMARTag Technology

11:15 AM – 12:00 PM | Ultralong CDR3s Of Cow Antibodies: Biology And Engineering

12:00 PM – 1:30 PM | Networking Lunch & Meet The Experts

1:30 PM – 2:15 PM | Construction Of Versatile Carriers For Therapeutic Cargo Using Viral Capsids

2:15 PM – 2:30 PM | Latest Trends And Development In Non-Invasive Macromolecule Delivery

2:30 PM – 3:15PM | Microneedle Systems For Intradermal Delivery Of Proteins, Peptides and Vaccines

3:15 PM – 3:30 PM | BREAK

3:30 PM – 4:30 PM | Expert Panel Discussion: Trends In The Development And Delivery Of Biologics
Moderated by: Prof. Carolyn Bertozzi
• Kent Iverson, Biotechnology Consultant and Contractor
Dr. Douglas Crawford, Managing Director, Mission Bay Capital and General Manager, QB3@953
• Dr. Greg Bleck, Global Head R&D, Biologic, Catalent Pharma Solutions
• Dr. Mark Tomai, Head of TLR and Microneedle Business Development, 3M Drug Delivery Systems

4:30 PM – 4:45 PM | Closing Remarks

Please join us for a cocktail reception following the session from 5:00 PM – 7:00 PM

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Dr. Cornell Stamoran, Ph.D.

Catalent Institute Board Member, Vice President, Strategy & Corporate Development, Catalent Pharma Solutions

Dr. Stamoran has spent nearly 25 years engaged with the healthcare industry, and has experienced the realities of patient adherence and outcomes enhancement from almost every stakeholder perspective: from direct engagement with retail and hospital pharmacists; medical professionals; specialty pharmacies and clinics; and pharmacy benefit managers and payers. He has directly participated in adherence and outcomes enhancement strategies for more than 150 drugs over the last 10 years.

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Carolyn Bertozzi, Ph.D.

Professor of Chemistry, Stanford University

Carolyn Bertozzi is the Anne T. and Robert M. Bass Professor of Chemistry and Professor of Chemical & Systems Biology and Radiology at Stanford University, and an Investigator of the Howard Hughes Medical Institute. Prof. Bertozzi’s research interests span the disciplines of chemistry and biology with an emphasis on studies of cell surface glycosylation pertinent to disease states. Her lab focuses on profiling changes in cell surface glycosylation associated with cancer, inflammation and bacterial infection, and exploiting this information for development of diagnostic and therapeutic approaches, most recently in the area of immuno-oncology. Prof. Bertozzi has been recognized with many honors and awards for both her research and teaching accomplishments.

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Punit Seth, Ph.D.

Exec Director, Medicinal Chemistry, Ionis Pharmaceuticals

Dr. Punit Seth currently heads the medicinal chemistry group at Ionis Pharmaceuticals. Dr. Seth is co-inventor of Ionis’ Gen 2.5 platform which employs high affinity nucleoside modifications to enhance potency of antisense oligonucleotides (ASOs) in the liver and in extra-hepatic tissues. Dr. Seth is also co-inventor of Ionis’ LICA (ligand conjugated antisense oligonucleotides) platform which enhances ASO potency by targeted delivery to cells and tissues of interest. Dr. Seth has extensive experience with using medicinal chemistry strategies to modulate the activity, pharmacokinetics and toxicological properties of ASOs. Dr. Seth is listed as co-author on >60 peer-reviewed publications including articles in Cell, PNAS, J. American Chemical Society, Angewandte Chemie Int. Ed., Nucleic Acids Research and Molecular Therapy. He is also listed as a co-inventor on ~40 issued US patents and on >60 international patent applications. He serves on the Scientific Advisory Council of the Oligonucleotide Therapeutic Society (OTS) and has a Ph.D in synthetic organic chemistry from The Ohio State University.

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William Hildebrand, Ph.D.

Founder/Chief Scientist, Pure MHC

Dr. Hildebrand earned his PhD from Southern Illinois University in 1990 and conducted post-doctoral research at Stanford University under Dr. Peter Parham. He is a Presbyterian Health Foundation Endowed Professor and a George Lynn Cross Research Professor in the Department of Microbiology and Immunology at The University of Oklahoma Health Sciences Center. Dr. Hildebrand founded Pure Protein, LLC in 1999 and still serves as its Chief Scientific Officer. He founded two additional subsidiary companies, Pure Transplant and Pure Vaccine Solutions in 2003 which, when merged with the technology of Receptor Logic Inc. in 2013, gave rise to the creation of Pure MHC, LLC. He has been awarded over $40M in grants. To date, he has authored over 120 publications, reviews, and book chapters in peer-reviewed industry works as well as popular science journal. Dr. Hildebrand holds 77 patents in fields related to the discovery and use of the soluble HLA protein technology he has developed.

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Vaughn Smider, M.D., Ph.D.

Chief Scientific Officer, Sevion

Dr. Vaughn Smider has been our Chief Scientific Officer since May 2014 and was the founder and president of Fabrus, Inc. He is also a faculty member at The Scripps Research Institute, where he has directed protein engineering research since 2005. Before Scripps he was Chief Scientific Officer at Integrigen, Inc from 2001-2005. Dr. Smider received his MD and PhD degrees from Stanford University School of Medicine. Dr. Smider is on the Leadership Council for The American Cancer Society in San Diego and is a founder and board member of The Elizabeth Smider Foundation.

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Matt Francis, Ph.D.

Professor of Chemistry, UC Berkeley

Matt Francis received his undergraduate degree in Chemistry from Miami University in 1994. From 1994-1999 he attended graduate school at Harvard University, working in the lab of Prof. Eric Jacobsen. His Ph.D. research involved the development of combinatorial strategies for the discovery and optimization of new transition metal catalysts. He then moved to UC Berkeley, where he was a Postdoctoral Fellow in the Miller Institute for Basic Research in Science. He worked under the guidance of Prof. Jean Fréchet, focusing on the development of DNA-based methods for the assembly of polymeric materials and the application of dendrimers for drug delivery. Matt started his independent career in the UC Berkeley Chemistry Department in 2001, and has built a research program involving the development of new organic reactions for protein modification. These new chemical tools have then been used to modify biomolecular assemblies to prepare new materials for diagnostic imaging, wastewater treatment, and solar cell development. Over the years, Matt has received the Dreyfus Foundation New Faculty Award, an NSF Career Award, and a GlaxoSmithKline Young Investigator Award. He has also received the Departmental Teaching Award on two occasions, the Noyce Prize for Excellence in Undergraduate Teaching, and the 2009 University Distinguished Teaching Award.

 Dr. Rabuka

David Rabuka, Ph.D.

Global Head of R&D Chemical Biology, Catalent Pharma Solutions

Dr. Rabuka assumed the role of Catalent Pharma Solutions’ Global Head of R&D Chemical Biology in October 2014, following Catalent’s acquisition of Redwood Bioscience Inc., where he had previously acted as President and Chief Scientific Officer. Prior to pursuing his Ph.D., Dr. Rabuka worked at the Burnham Institute synthesizing complex glycans and later at Optimer Pharmaceuticals, which he joined as an early employee, focused on the development of glycan and macrolide based antibiotics. Dr. Rabuka graduated with double honors B.S. in Chemistry and Biochemistry from the University of Saskatchewan where he received the Dean’s Science Award and holds a M.S. in Chemistry from the University of Alberta. Dr. Rabuka received a Ph.D. in Chemistry at the University of California, Berkeley as a Chevron Fellow in the lab of Professor Carolyn Bertozzi.  His research included developing and applying Redwood’s platform technology to cell surface modification. He is an author on over 20 major publications as well as numerous books chapters and patents.

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Randy Mrsny, Ph.D.

CSO & Co-Founder, Applied Molecular Transport, Professor of Pharmacy and Pharmacology, University of Bath

Randall Mrsny obtained a BS degree in Biochemistry and Biophysics and a PhD degree in Anatomy and Cell Biology from the University of California at Da avis undergraduate and medical school campuses, respectively. As an NIH post-doctoral fellowship he studies membrane lipid-protein interactions at the Institute of Molecular Biology located in the University of Oregon Eugene campus. Prior to taking Professors’ post in Cardiff University and now the University of Bath, Randy led research groups in two companies: ALZA and Genentech. He has been involved in starting two new biotech companies through the acquisition of venture capital funding. Randy has been elected president of an international society and organized international meeting. He currently serves as a reviewer or advisor for multiple international agencies and companies.

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Mark Tomai, Ph.D.

Head of TLR and Microneedle Business Development, 3M Drug Delivery Systems

Mark Tomai has a PhD in immunology from the University of Minnesota and has worked in the Pharmaceutical Industry for 25 years. Most recently, he has been Head of Toll-like Receptor (TLR) and Microneedle Business Development at 3M Drug Delivery Systems. He has been involved with numerous licensing deals involving both of these technologies. During his first 16 years at 3M he held various positions in Drug Discovery and Preclinical Development focused on the development of TLR 7/8 agonists for a variety of applications. He was the lead immunologist for development of the TLR7 agonist, AldaraTM for the treatment of warts and skin cancer. He also is an inventor on 12 issued patents. 

 Kent Iverson

Kent Iverson, B.Sc.

Biotechnology Consultant and Contractor

Kent Iverson is an independent consultant specializing in CMC development of recombinant protein drugs.  Kent’s academic training is in Fermentation Science (U.C. Davis).  Kent has over 30 years of experience in the biopharmaceutical industry, in roles ranging from front line Manufacturing execution to Process Development and Technical Operations leadership positions.  Kent has participated in the development of seven FDA-approved biopharmaceuticals, and has been employed by Genentech, Immunex, Coulter Pharmaceutical and Corixa prior to starting his consulting practice in 2002.

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Douglas Crawford, Ph.D.

Managing Director, Mission Bay Capital and General Manager, QB3@953

Douglas Crawford’s goal is to help entrepreneurial scientists create successful startups to meet California’s needs for better health, a sustainable environment, and economic growth—particularly jobs. To this end, Crawford and his colleagues have systematically lowered the barriers between great ideas and successful companies. For instance, Crawford created and manages the first incubator within the University of California, the QB3 Garage@UCSF. The QB3 incubator program has now grown to five sites and 62 companies, and he has created a partnership to build a new 24,000 square foot life-science incubator in Mission Bay. More recently, QB3 created a program to help entrepreneurs create companies to pursue government grants and private funding. In the first 23 months this program has helped launch 146 companies, 31 of which are already operational. Crawford is also a founder and managing director of Mission Bay Capital, an $11.3M seed-stage venture fund that makes pivotal early-stage investments in bioscience companies. He is a board member of Atreca (observer), Circle Pharma, Delpor, Magnamosis, Magnap, Ocular Dynamics, and Zephyrus. Crawford received his PhD in biochemistry from UCSF.

Greg Bleck.bmp

Greg Bleck, Ph.D.

Global Head of R&D, Biologics, Catalent Pharma Solutions

Dr. Bleck joined Catalent in 1998 as Director of Molecular Biology & Transgenics. He has a broad background in Molecular Biology and Transgenic animals with 12 year’s experience within the organization. Dr. Bleck holds a Bachelor’s degree in Dairy Science and a Doctorate in Endocrinology-Reproductive Physiology from the University of Wisconsin-Madison. He performed postdoctoral work at the University of Illinois-Urbana working in the areas of gene regulation and expression. Greg has published more than 55 research papers and co-authored chapters in three books.