Plenary Keynote Sessions

Monday, August 12

Leading to Tomorrow’s Advances


Chair: Sue Behrens3:55 Chairperson’s Remarks

Sue Behrens, PhD, Senior Director, Process Design, IPS, and President, SB Executive Consulting, LLC & Sponsorship Chair, Women in Bio

Yatin Gokarn4:00 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.

Mire-Sluis_Anthony4:30 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

Solving Today’s Challenges

Harborview Ballroom

Chair: John Sterling4:45 Chairperson’s Remarks

John Sterling, Editor, Genetic Engineering & Biotechnology News (GEN)

Sanchayita Ghose4:50 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. 

Judy-Chou5:25 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