Plenary Keynote Sessions
Monday, August 12
3:55 Chairperson’s Remarks
Sue Behrens, PhD, Senior Director, Process Design, IPS, and President, SB Executive Consulting, LLC & Sponsorship Chair, Women in Bio
4:00 Biologic Therapies in the Upcoming Decade: Modalities and Development Strategies
Yatin Gokarn, PhD, Vice President, Global Head, Biologics Drug Product Development, Sanofi Pharmaceuticals
The pharmaceutical landscape is in the midst of a transformation led by the continuing success of biologics-based therapies. Biologic drugs are diverse ranging from oligomeric peptides, nucleotides to small proteins, monoclonal antibodies and whole cells and viruses. Unlike traditional small molecule drugs, which are predominantly taken orally, biologics necessitate parenteral administration, which poses unique challenges and opportunities, particularly with patient self-administration. The presentation will focus on current and emerging trends in biologics-based drug products, and associated challenges and opportunities in their production and delivery.
4:30 The Future of Bioprocessing – A Digital Era Awaits
Anthony Mire-Sluis, PhD, Head, Global Quality, AstraZeneca Pharmaceuticals
Industry in general is facing a revolution that the Pharmaceutical Industry will need to adopt if it is to remain agile and innovative. The digitalization of our manufacturing processes and procedures will enable real time data for more intelligent decision making and process control. Digitised processes allow for predictive and prescriptive analytics. Advanced automation will eliminate human intervention and wearable technology and biometrics will guide work and assure data integrity. How to adopt these new technologies within our regulated industry won’t be without challenges and partnering with Regulators will be essential.
5:00 Grand Opening Reception in the Exhibit Hall with Poster Viewing
Wednesday, August 14
4:45 Chairperson’s Remarks
John Sterling, Editor, Genetic Engineering & Biotechnology News (GEN)
4:50 Evolving Trends in mAb Production Processes
Sanchayita Ghose, PhD, Director, Biologics Process Development, Bristol-Myers Squibb Co.
Monoclonal antibodies (mAbs) still continue to dominate the biologics therapeutic landscape despite the advent of many new therapeutic modalities in the recent years. Manufacturing processes for mAbs have evolved significantly over time since the first approval more than three decades ago. This talk will highlight some of the key challenges and drivers that are driving the design of today’s antibody processes. Furthermore, this talk will showcase the various aspects of continuous manufacturing being incorporated in BMS’ biologics manufacturing plant (particularly for mAbs) to address its growing pipeline needs.
5:25 Today’s Challenges and Opportunities in Biomanufacturing
Judy Chou, PhD, Senior Vice President and Global Head, Biotech, Bayer Pharmaceuticals
With the demands to increase the productivity and flexibility of biological production; to address the various technical, supply and regulatory needs globally; and to embrace the emerging new modalities, the challenges of biomanufacturing are escalating day by day. Along with it, a lot of new opportunities are thriving. The key topics will be illustrated in this presentation.
6:00 Taste of New England Reception in the Exhibit Hall with Poster Viewing