Courtesy of Omni La Costa Resort & Spa

6th International Conference on Accelerating Biopharmaceutical Development (AccBio 2019)

February 17-20, 2019

This conference series is dedicated to strategies, technologies and capabilities that accelerate biopharmaceutical development.

Abstract Submissions are open until February 15, 2019.

Submit an Abstract Registration Info

Sessions:

  • Advanced Manufacturing Technologies
  • Interactive Workshop on Advanced Manufacturing Technology Priorities: Perspectives from FDA, BARDA, Industry, Vendors, Academia
  • Digital and Data Technologies
  • Novel Modalities
  • Leadership and Workforce development in Biopharma
  • Patient Centric/Focused Development

Keynote Speakers:

Invited Speakers:

Conference Co-Chairs:

  • Aine Hanly, Vice President, Drug Substance Process Development, Amgen
  • Stefanie Pluschkell, Executive Director, Business Strategy & Operations, Pfizer

Scientific Advisory Committee:

  • Dana Andersen, Denali Therapeutics
  • Hanne Bak, Regeneron
  • Tim Charlebois, Pfizer
  • Jon Coffman, Boehringer-Ingelheim
  • Charles Cooney, Massachusetts Institute of Technology
  • Rohini Deshpande, AMGEN
  • Brendan Hughes, Bristol-Myers Squibb
  • Brian Kelley, VIR Biotechnology, Inc.
  • Kelvin Lee, University of Delaware
  • Christopher Love, Massachusetts Institute of Technology
  • Gregg Nyberg, Merck
  • Dean Pettit, Just Biotherapeutics
  • Arup Roy, Lilly
  • Jeffrey Salm, Pfizer
  • Eugene Schaefer, Janssen
  • Nigel Titchener-Hooker, University College London
  • Ganesh Vedantham, AMGEN
  • Nick Warne, Pfizer

Featured Speakers

Regina Barzilay

Regina Barzilay is a Delta Electronics professor in the Department of Electrical Engineering and Computer Science and a member of the Computer Science and Artificial Intelligence Laboratory at the Massachusetts Institute of Technology. Her research interests are in natural language processing, applications of deep learning to chemistry and oncology. She is a recipient of various awards including the NSF Career Award, the MIT Technology Review TR-35 Award, Microsoft Faculty Fellowship and several Best Paper Awards at NAACL and ACL. In 2017, she received a MacArthur fellowship, an ACL...Read more

Patrick Bastek

Patrick Bastek is Sr. Director for Gene Therapy Process Development at Pfizer where he leads teams to develop drug substance manufacturing processes.  The team develops and transfers processes and technologies to enable clinical and commercial-scale manufacturing while seeking to increase productivity and consistency to enable this emerging modality.

Prior to joining Pfizer, Patrick worked at Novartis Vaccines (then Seqirus) developing, establishing, and improving cell-based influenza manufacturing.  Patrick had increasing responsibilities building and leading a...Read more

Pascal Becotte

Dr. Pascal Bécotte co-leads the Russell Reynolds Associates’ global Corporate Officers Sector (Global Functions) and leads the global Operations & Supply Chain Officers Practice. Pascal is also a key member of the Healthcare and Industrial Sectors, where he advises clients across the globe on their overall talent strategy, particularly with respect to leadership assessment, succession planning and the recruitment of directors, CEOs and other senior executives. He splits his time between the Toronto and New York offices.

Pascal received a BS in Engineering Physics from the Royal...Read more

Kurt Brorson

Kurt Brorson, Ph.D. is Vice President, Technical, at PAREXEL Consulting where he provides a full range of consulting services for the quality of biopharmaceuticals, with specific expertise in biomanufacturing, therapeutic monoclonal antibodies, biosimilars and viral safety/viral clearance.  He also acts as a trusted advisor to clients, often on issues that lack precedent or are not clearly defined.

Prior to joining PAREXEL, Dr. Brorson was a Lab Chief in CDER/OPQ/Office of Biotechnology Products (OBP) at the FDA.  Dr. Brorson received his BA. in Biology from University of...Read more

Vijay Chiruvolu

Vijay Chiruvolu is Vice President at Kite Pharma, a Gilead Sciences company, and leads the Process Development organization.  The Process Development group at Kite is responsible for process design of autologous, allogeneic, neoantigen and vector products, analytical development, tech transfer, validation, comparability, technology development, and Manufacturing Science & Technology (MSAT functions. 

Vijay joined Kite in Sept 2014, and since that time he has built a strong team dedicated to process and product understanding, clinical and commercial manufacturing...Read more

Matthew James Clemente

Matthew James Clemente currently serves as the Senior Director of Delivery Systems Engineering & Technology at Eli Lilly & Company. He is responsible for the leadership of the research and development organization responsible for the engineering and design of Eli Lilly’s delivery, device and connected solutions portfolio. Previously as the Director and Chief Technology Officer, he developed an emerging portfolio of electromechanical delivery devices, applications and algorithms that serve a variety of therapeutic areas and formulations. He has served this organization since October...Read more

Chetan T. Goudar

Chetan T. Goudar is an Executive Director of Process Development at Amgen. His team is responsible for developing Drug Substance processes for all molecules in Amgen’s polymodal late-stage pipeline and enabling progression of these assets to commercial licensure. His team is also engaged in advancing drug substance manufacturing through the application of continuous principles across both synthetic and biologic modalities. Prior to joining Amgen in 2012, Chetan spent 13 years at Bayer HealthCare’s Process Development group in Berkeley. He is a recipient of the ACS BIOT and the Biochemical...Read more

Robert Guenard

Dr. Guenard leads the Global Process Analytics Group (GPA) at Biogen where he has been for 3 years.   The GPA team has the mission to deliver data analytics and PAT solutions for development and manufacturing across all product modalities including biologics, antisense oligonucleotides, pharmaceuticals and gene therapies.   He currently the sponsor for several Biogen initiatives and projects to help modernize manufacturing in the Biopharm Industry.  Rob has more than 21 years’ experience in the field of process analysis and control with prior experience at Merck...Read more

Guenter Jagschies

Dr. Günter Jagschies has been with GE Healthcare Life Sciences for 33 years and has held senior management positions in Business functions and R&D with the BioProcess division of the company. In his current role he is working  globally with industrial R&D collaborations and  as business advisor  for the GE BioProcess teams. Externally, Günter has as an ambassador role for GE BioProcess and is a frequent speaker in conferences and author in publications directed at the biopharmaceutical industry. He is co-author of “Process Chromatography”, and co-editor of “...Read more

Tushar Jain

Tushar Jain is a Principal Scientist at Adimab. For the past 9 years at Adimab, Tushar has worked on developing machine learning and statistical models to predict developability characteristics of antibodies to ultimately design antibody libraries with favorable downstream and PK characteristics. In addition, Tushar has a keen interest in interpreting insights obtained from such approaches using structural models to better drive our understanding of antibody behavior.

Tushar Jain holds a PhD in Chemical Engineering from the University of Wisconsin - Madison

 ...Read more

Rick St. John

Rick St. John is Associate Director of Process Development Engineering at Genentech and global lead for digital transformation in Roche Pharma Technical Development.  The digital transformation initiative aspires to capture, store, and display development data from three major process development sites in our network across large molecules and small molecules.  As the head of Process Development Engineering, Rick leads a group of development engineers focused on data management, automation, and process engineering.  Prior to leading the development engineering group, Rick...Read more

Michael Kamarck

Michael Kamarck, PhD, is Chief Technology Officer at Vir. Vir integrates recent innovations in science, technology and medicine to transform the care of people with serious infectious diseases. Vir is taking a multi-modality approach to applying these breakthroughs, including the development of treatments that induce protective and therapeutic immune responses.

Vir’s initial focus is in three areas of significant unmet need: chronic infectious diseases including hepatitis B, tuberculosis and HIV; respiratory disease, including influenza, RSV, MPV; and the identification of host-...Read more

Andreas Kuhn

Andreas Kuhn has worked in the field of RNA biochemistry and molecular biology for more than twenty-five years. His work on RNA-based immunotherapies began in 2007 in the academic group of Ugur Sahin at the University Clinic Mainz, and Andreas joined BioNTech RNA Pharmaceuticals GmbH shortly after its founding in 2008. In his current role as Vice President RNA Biochemistry & Manufacturing the main focus is expanding proprietary technologies to increase the efficacy of RNA-based therapies and to optimize GMP-compatible manufacturing processes for RNA with one focus on individualized...Read more

Donna Luisi

Dr. Donna Luisi earned a Ph.D. in Chemistry from the State University of New York at Stony Brook, with thesis work on protein folding, followed by postdoctoral training at Yale University. Donna joined Pfizer (then Wyeth Biopharma) in 2001 where she has focused on formulation development of biologics and dosage form design with an emphasis on biophysical characterization. During her time at Pfizer she has served as a group lead, lead the Biophysical Center of Emphasis and contributed to a number of licensures specifically in the area of oncology. Along with current project leadership...Read more

Todd Luman

Todd Luman is currently Associate Director, Cell Culture in the Process Sciences Group at Boehringer Ingelheim. Prior to his role at Boehringer Ingelheim he was at Amgen for 18 years. At both companies he has led and contributed to a number of initiatives exploring process intensification and continuous bioprocessing technologies. In addition to these technology development initiatives, he has been a CMC Lead for a number of early and late stage programs. These experiences have driven his passion for exploring bioprocessing solutions that create value across the entire life cycle of...Read more

Muthiah (Mano) Manoharan

Dr. Muthiah (Mano) Manoharan serves as Senior Vice President of Innovation Chemistry and a Distinguished Research Scientist, and a member of the Scientific Advisory Board at Alnylam Pharmaceuticals, Cambridge, Massachusetts, USA.  Dr. Manoharan joined Alnylam in 2003. He built the chemistry group at Alnylam and pioneered the discovery of GalNAc-conjugated siRNAs for RNA interference-based human therapeutics. Dr. Manoharan has had a distinguished career as a world-leading chemist in the areas of oligonucleotide chemical modifications, conjugation chemistry, and delivery platforms...Read more

Steven Oh

In his role, Dr. Steven Oh leads the effort to reach regulatory decisions on product safety and quality of cellular and gene therapy products, tissue-engineered products, and point-of-care devices submitted to Office of Tissues and Advanced Therapies in CBER. Dr. Oh is actively engaged in developing regulatory policies and guidelines that address challenges involving combination products, cross-cutting science, and emerging technologies in regenerative medicine therapy. He also participates in efforts to develop standards for manufacturing and testing cellular, tissue-engineered, and gene...Read more

Atul Patel

Atul heads the Global Medical Device and Packaging team, at Biogen. With Biogen focussing on multiple modalities such as Proteins, Small Molecules, Antisense Oligonucleotide and Gene Therapy in the Neurodegenerative and Rare diseases area, his team leads technology development and manufacturing technology support of drug delivery systems like, Lyo IV delivery, Syringes, Pen, Autoinjectors, On Body Drug Delivery systems, Implantable drug delivery devices, with a focus on delivery to Central Nervous System CNS.His team is also engaged in Clinical activity monitoring digital devices.

...Read more

Shailen Singh

Shailen Singh is a director at Merck and leads the upstream commercialization activities within biologics process development & commercialization group in Manufacturing Division. He has over 10 years of experience in upstream process development, commercialization and manufacturing science & technology activities. Before Merck he was at Medimmune leading similar activities.  Shailen has a PhD from University of California Riverside and masters/bachelors from IIT Delhi in Biochemical Engineering....Read more

Arun Tholudur

Arun Tholudur is an Executive Director of Process Development at Amgen where he leads the Drug Substance Technologies and Engineering organization that is accountable for ensuring successful implementation of multi-modality drug substance processes in the GMP environment from first-in-human clinical to commercial manufacturing across Amgen's internal and external manufacturing network.  The team’s responsibilities span technology transfer, process validation, process monitoring, regulatory submission authoring and inspection support, continued process optimization for yield and...Read more

Brian Turner

Brian Turner has worked in the biopharmaceutical industry for thirty-two years and is Senior Director in Manufacturing Sciences and Technologies at Sanofi Genyzme in Westborough, MA. His current focus is on process Life Cycle Management and simplification and harmonization of Control Strategies and CMC dossier packages. Prior to (re)joining Sanofi Genzyme, he spent most of his career at what is now Abbvie, where he developed manufacturing processes for Humira and other biologics. He received his Ph.D. in chemical engineering from Purdue University in 1986.

Read more

Cenk Undey

Dr. Undey joined Amgen in 2003 and has held positions of increasing responsibility in Process Development which included providing manufacturing support, continuous process improvement of commercial products, and technology transfers. He has formed the Digital Integration and Predictive Technologies in 2013, a corporate group with a mission to transform Amgen business from data rich to decision smart. His group’s aim is to improve process and product understanding, process optimization, reduce process development cycle time hence increasing speed to market with reduced development costs...Read more

Michael W. Vandiver

Michael (Mike) Vandiver is Vice President, Manufacturing & Plant Design at Just Biotherapeutics. Mike has over 30 years of biopharmaceutical process development and manufacturing experience that includes direct involvement in the development and transfer of commercial processes for Enbrel®, Vectibix®, and Prolia®/XGEVA®. At Just Biotherapeutics, he has led the effort to bring J.Plant and J.Pod™ clinical and commercial biomanufacturing facilities online. These rapid, low-cost, facility designs leverage continuous manufacturing technologies to significantly reduce the cost of goods...Read more