January 13 - 17, 2014
Renaissance Hotel and Palm Springs Convention Center Palm Springs, California

A Community Dedicated to the
Evolving Field and Future of Biotherapeutics
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Best Practices and Procedures to Ensure Patient Safety: Toxicological Risk Assessment of Extractables and Leachables

with William P. Beierschmitt, Ph.D., DABT, FATS, Regulatory Strategy Lead, Worldwide Research and Development Drug Safety Research & Development, Pfizer, Inc.


Nandini Kashyap interviews Dr. William P. Beierschmitt, Ph.D., DABT, FATS, Regulatory Strategy Lead at Pfizer on December 20, 2013. Dr. Beierschmitt will be speaking during the 2nd Annual Extractables and Leachable conference taking place January 16-17 as part of PepTalk, January 13-17 in Palm Springs, CA.

Topics include early adoption of toxicological risk assessment, risk assessment strategy, patient safety, safety issues related to extractables and leachables, role of toxicologist, plastic single use bioreactors, single use systems, risk based assessment, extractable testing, flexible manufacturing, process and product development, BPOG, USP, PQRI, standardized E&L testing, predication of leachable, toxicity and safety.




Emerging Drying Technologies: Room Temperature Stable Flu Vaccine Formulation Using Spray Drying

with Jeffrey Breit, Ph.D., Director, Pharmaceutical, Bend Research


Nandini Kashyap interviews Jeffrey Breit, Ph.D of Bend Research on November 15, 2013. Dr. Breit will be speaking during the Lyophilization and Emerging Drying Technologies conference at the PepTalk, January 13-17 in Palm Springs, CA.

Topics include using a vaccine formulation development, room temperature stability, use of spray drying, emerging drying technologies




Unfolded Protein Response: Pathways to Recombinant Protein Production

with Zhimei Du, Ph.D., Senior Scientist, Cell Sciences & Technology, Amgen, Inc.


An-Dinh Nguyen interviews Zhimei Du of Amgen on November 1, 2013. Dr. Du will be speaking during the Recombinant Protein Expression and Production conference at PepTalk 2014, January 13-17 in Palm Springs, CA.

Topics include unfolded protein response, pathways for increasing recombinant protein production and expression yield, understanding cell status, UPR’s dynamic nature and cell line development at Amgen.




Cellular Biology, Biotechnology and Recombinant Protein Production

with Sabine Geisse, Ph.D., Director/NLS, Novartis Institutes for BioMedical Research


An-Dinh Nguyen interviews Sabine Geisse, Ph.D., Director/NLS, Novartis Institutes for BioMedical Research on October 31, 2013. Dr. Geisse will be a keynote speaker during the Transient Protein Production conference at PepTalk 2014, January 13-17 in Palm Springs, CA.

Topics include the importance of considering cellular environments when working on genes and molecular biology, the evolution of biotechnology, recombinant production of increasingly complex biomolecules and more.




Efficient Protein Expression and Engineered Bacteria

with Joseph Kittle, Jr., Ph.D., Assistant Professor, Chemistry and Biochemistry, Ohio University and CSO, Molecular Technologies Laboratories, LLC


An-Dinh Nguyen interviews Joseph Kittle of Ohio University and Molecular Technologies Laboratories, LLC on October 30, 2013. Dr. Kittle will be a speaker during the Engineering Genes, Vectors, Constructs and Clones conference at PepTalk 2014, January 13-17 in Palm Springs, CA.

Topics include problems with plasma-based protein expression, using engineered bacteria and chromosomally inserted genes, integrating current biotech industry knowledge with academic biochemistry and molecular engineering instruction and more.




Simplifying Genomics and Optimizing Protein Expression

with Curtis Knox, Vice President, Marketing & Sales, Lucigen Corp.


An-Dinh Nguyen interviews Curtis Knox of Lucigen on October 14, 2013. Mr. Knox will be a speaker during the Engineering Genes, Vectors, Constructs and Clones conference at PepTalk 2014, January 13-17 in Palm Springs, CA.

Topics include the challenges and advantages of endotoxin reduction in recombinant protein expression processes for drug discovery R&D, high-throughput cloning and expression of target proteins, large insert metagenomic libraries from soil microbes and more.




Protein Expression and Biological Engineering: Bacteria and Beyond

with Sriram Kosuri, Ph.D., Assistant Professor, Chemistry and Biochemistry, University of California, Los Angeles


An-Dinh Nguyen interviews Sriram Kosuri of UCLA on November 11, 2013. Dr. Kosuri will be a keynote speaker during the Engineering Genes, Vectors, Constructs and Clones conference at PepTalk 2014, January 13-17 in Palm Springs, CA.

Topics include the effect of codon usage on protein expression, the reliance on bacteria for biological engineering research, new tools like CRISPR for studying more eukaryotic systems, next-generation gene synthesis, work at the Wyss Institute and more.




Large Volume Injectors for Subcutaneous Delivery: Challenges and Future Perspectives

with William J. Lambert, Ph.D., Fellow, Drug Delivery, Device Development and Commercialization, MedImmune, Inc.


Nandini Kashyap interviews Dr. William J. Lambert of MedImmune on December 6, 2013. Dr. Lambert will be speaking during the 4th Annual Protein Device Combinations conference taking place Jan 15-16, 2014 as part of PepTalk, January 13-17 in Palm Springs, CA.

Protein Delivery, large volume delivery, bolus injections, delivery devices such as pens and auto injectors for drug delivery, high viscosity injectors, protein device combinations, protein and peptide products, pen injectors, pen needles and auto-injectors for self-injection, integration of formation and devices.




Protein Aggregation and Emerging Tools: Mechanism, Challenges, and Future Perspectives

with Thomas Laue, Ph.D., Professor, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire


Nandini Kashyap interviews Prof. Thomas Laue of University of New Hampshire on November 19, 2013. Prof. Laue will be speaking during the Protein Aggregation and Emerging Analytical Tools conference at the PepTalk, January 13-17 in Palm Springs, CA.

Topics include protein aggregation, mechanism of protein aggregation, non-covalent interactions, hydrophobic effect, dipole-dipole interactions, effect of viscosity, development of analytical tools for aggregate detection, progress in the field of protein aggregation.




Amgen’s Case Study on Extractables from Single-Use Bioreactors and Impact on Cell Culture Performance

with Yasser Nashed-Samuel, Ph.D., Principal Scientist, Process and Product Development, Amgen, Inc.


Nandini Kashyap interviews Dr. Yasser Nashed-Samuel, Principal Scientist, Amgen on December 6, 2013. Dr. Yasser Nashed-Samuel will be speaking during the 2nd Annual Extractables and Leachable conference taking place Jan16-17 as part of PepTalk, January 13-17 in Palm Springs, CA.

Topics include a case study on E&L from single use bioreactors, E&L impact on cell culture performance, plastic single use bioreactors, single use systems, risk based assessment, extractable testing, flexible manufacturing, process and product development, , BPOG, USP, PQRI, standardized E&L testing, predication of leachable, toxicity and safety.




Process Analytical Technologies for Freezing and Primary Drying of Biologics

with T.N. Thompson, President, Millrock Technology, Inc.


Nandini Kashyap interviews T.N. Thompson, President, Millrock Technology on December 6, 2013. Mr. Thompson will be speaking during the 7th Annual Lyophilization and Emerging Drying Technologies conference taking place Jan15-16 as part of PepTalk, January 13-17 in Palm Springs, CA.

Topics include freeze drying, process control and monitoring for the freezing and primary drying phases, cycle development and process control, controlled nucleation, heat flow, reduction in drying cycle’s time.




BPOG’s Extractable Protocol Standardization Journey: Update on E&L Collaboration Efforts Between BPOG and Major Industry Groups

with Ken Wong, Ph.D., Deputy Director, MTech, Sanofi Pasteur


Mimi Langley interviews Ken Wong, Ph.D., Deputy Director, MTech of Sanofi Pasteur on November 22, 2013. Dr. Wong will be speaking during the Single-Use Technologies & Continuous Processing in Biopharm Manufacturing conference at PepTalk, January 13-17 in Palm Springs, CA.

Topics include what are the current challenges on E&L, how are industry groups collaborating on this issue, and what are BPOG’s (Biophorum Operations Group) initiatives and efforts on standardization protocol.


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