Agenda

 

Agenda

Dress Code: Business Casual

 

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Gustavo Mahler, Ph.D., President & CEO, AGC Biologics[fa icon="chevron-down"]

Gustavo_2014_CROPPEDGustavo Mahler joined AGC Biologics (previously CMC Biologics) in 2008 as president. In 2010, he was named global Chief Operations Officer and in January, 2016 he became Chief Executive Officer. Prior to joining AGC Biologics, Gustavo worked for 15 years at Bayer in the United States, Europe and Latin America serving in various manufacturing and general management positions. He received his PhD in Biochemistry from the University of Buenos Aires, and he also has a Master of Business Administration degree from the University UNED of Madrid and an Executive Certification in Management from MIT Sloan.

James Bylund, Vice President/General Manager, Thermo Fisher[fa icon="chevron-down"]
Kirsten Vadheim, Ph.D, BioCompliance Consulting, Inc.[fa icon="chevron-down"]
Kirsten PhotoKirsten is the founding president and principal consultant of BioCompliance Consulting, which has been assisting clients in the biopharmaceutical industry since 2005. Primary areas of focus include late-stage commercialization readiness, GMP compliance gap assessments, and preparation for and responses to FDA inspections. Kirsten earned her Ph.D. in Microbiology from Montana State University with research on cholera vaccines at NIH.  Following post-doctoral work in immunology at Mayo Foundation and in bacterial pathogenesis at the USDA, she joined FDA’s Center for Biologics, where she reviewed biologic and biotech applications and led international inspections of vaccine and biologic manufacturing facilities.  She managed the QA organization at Protein Design Lab’s manufacturing facility, before launching her own consulting company in 2005.  Since then she has partnered with vaccine and biotech manufacturers world-wide to bring new products to the market and improve site GMP compliance.
Byron Kneller, Director, AFD, AGC Biologics[fa icon="chevron-down"]

Byron K2Dr. Kneller is Associate Director of Analytical and Formulation Development at AGC Biologics. He holds a Ph.D. in Chemistry from the University of Washington, where his work focused on stabilizing peptide secondary structures, and did postdoctoral work in drug metabolism in Medicinal Chemistry at the University of Washington. He worked at ICOS Corporation from 2002 through 2006 and has worked at AGC Biologics (previously CMC Biologics) since then. His current role at AGC Biologics is to manage the group responsible for analytical method development and transfer, process development analytical support, and liquid and lyophilized formulation development.

Jin Wang, Ph.D., Site Head and General Manager, AGC Biologics[fa icon="chevron-down"]

Jin joined AGC Biologcs in February 2018 as General Manager and Site Head of AGC Biologics' Seattle Facility and Global Headquarters. Jin brings more than 20 years of leadership experience in the biotechnology and manufacturing industry, most recently serving as Site Head of Bacterial Vaccine Manufacturing, Global Vaccines Industrial Affairs with Sanofi Group in Swiftwater, PA. Prior to Sanofi, Jin held leadership roles within multiple organizations including Bayer HealthCare, the Schering-Plough Research Institute, ImClone Systems, and Covance Biotechnology Services. 

Jin holds a Master of Science and a Ph.D. in Chemical Engineering from Nagoya University.

Kasper Moeller, Site Head and General Manager, CPH, AGC Biologics[fa icon="chevron-down"]

Kasper joined AGC Biologics (previously CMC Biologics) in 2006 as a Scientist, and has held the positions of Principal Scientist (2007) and Department Manager (2008) within development. Beginning in 2010, Kasper lead the Upstream Process Development teams, and in 2011, lead process characterization and validation activities. In 2013, Kasper was appointed Vice President of Manufacturing. Prior to CMC Biologics, he spent five years as an assistant professor and faculty member at the Technical University of Denmark, conducting research and teaching within fermentation technology and metabolic engineering studies.

Kasper has a Ph.D. in Biochemical Engineering from the Technical University of Denmark, and pursued post-doctoral studies at Washington University Medical School in St Louis, Missouri.


 

 

Howard L. Levine, Ph.D., BioProcess Technology Consultants, Inc.[fa icon="chevron-down"]

howard-levine_croppedHoward L. Levine, Ph.D., President and CEO of BioProcess Technology Consultants, Inc. (BPTC), is a pioneer and thought leader in the biopharmaceutical industry with extensive strategic and operational experience in biopharmaceutical product development and commercialization. Before founding BPTC in 1994 and building it into the leading biologics CMC consulting company worldwide, Dr. Levine was Vice President of Manufacturing Operations at Repligen Corporation where he was responsible for all process development and manufacturing activities and Director, Pilot Plant Operations at Xoma Corporation where he was responsible for the development and manufacture of monoclonal antibody products for clinical trial. He has also held positions of increasing responsibility in process development and manufacturing at Genentech and Amgen. Under Dr. Levine’s leadership, BPTC has assisted numerous companies in developing biological products, provided strategic input in the development of new manufacturing technologies, and participated in the successful commercialization of several of these products.

In addition to leading BPTC, Dr. Levine is a member of the Board of Directors of Protein Sciences Corporation and DNX Biopharmaceuticals, Inc. Dr. Levine is also member of the Pall Life Sciences Scientific Advisory Board, a member of the Editorial Advisory Board of BioPharm International Magazine, a frequently invited lecturer on manufacturing strategy, downstream processing, and commercialization of biotechnology products, and an author of numerous, peer-reviewed publications. Dr. Levine holds a Ph.D. in chemistry from the University of Chicago and completed a post-doctoral fellowship at Harvard University.

Douglas Miller, Ph.D, Senior Consultant, BPTC[fa icon="chevron-down"]

Doug-Miller_UpperHalfDouglas Miller, Ph.D., Senior Consultant at BioProcess Technology Consultants, has over 25 years of experience in Process and Product Development in the biotechnology industry.  His experience includes both upstream and downstream process development of protein therapeutics, cell and gene therapy process development, process scale-up and technology transfer, scientific project team leadership, pilot plant operations management, manufacturing technology development, and plant-to-plant operational alignment and governance. His current activities include development and implementation of CMC strategies, CMO selection and management, process and product development for cell and gene therapy and monoclonal antibody products, implementation of single-use technologies, and CMC due diligence.

Prior to joining BPTC, Dr. Miller served as Head of Process Development and Platform Strategy at Juno Therapeutics where he was responsible for process development activities for CARs and TCRs and lentiviral vectors, as well as for development of platform technologies to enable best-in-class manufacturing processes for autologous T-cell therapies.  Dr. Miller held roles of increasing responsibility at Immunex and Amgen for 20 years, including cell culture process development and scale-up, technology transfer, GMP manufacturing technical support, and pilot plant leadership, culminating in the position of Executive Director, Process and Product Development.  He contributed to the development of over 25 monoclonal antibodies/recombinant proteins, and he played a significant role in the development and implementation of single-use bioreactors and technologies for the Manufacturing of the Future platform at Amgen.

Dr. Miller earned his B.S. in Chemical Engineering from Colorado State University and his Ph.D. in Chemical Engineering from the University of California at Berkeley.

Susan Dana Jones, Ph.D., Vice President and Principal Consultant, BPTC[fa icon="chevron-down"]

susan-dana-jones (1)Susan Dana Jones, Ph.D., Vice President and Principal Consultant, is a seasoned biotechnology entrepreneur with experience in biopharmaceutical and vaccine product development, outsourcing, project management, and strategic planning. She co-founded two successful biotechnology companies and has managed multiple discovery and product development programs.

Dr. Jones is a subject matter expert in cell line development and characterization, cell culture, and process development for biosimilar, new biopharmaceutical, and vaccine development programs. She currently advises clients on the manufacturing requirements for advancement of product candidates from early discovery through all stages of clinical development. Dr. Jones also assists clients in applying appropriate cGMP regulations to their CMC programs and preparation of CMC regulatory submissions as well as performing technical due diligence for investors or companies seeking to in-license biopharmaceutical products.

Bill Downey, President, HighTech Business Decisions[fa icon="chevron-down"]
williamdowneyMr. Downey received his Master of Administration degree from Washington University in St. Louis and is a graduate from the University of Michigan in Ann Arbor. He has managed numerous business-to-business market research projects in the areas of electronics and biopharmaceutical contract manufacturing, semiconductor materials and pharmaceutical drug discovery. Mr. Downey has written extensively in “Genetic Engineering News,” “American Pharmaceutical Outsourcing,” and “Contract Pharma” on the topics of contract manufacturing, outsourcing and high throughput screening. Mr. Downey has presented at biopharmaceutical conferences in the North America, Europe, and Asia, and has moderated panel discussions with industry leaders. Mr. Downey has over 25 years of industry experience. He has held various product marketing positions in the semiconductor materials industry. In addition, Mr. Downey has provided financial leadership for both private and public companies.
Holger Wesche, Ph.D., Sr. Vice President Research, Harpoon Therapeutics[fa icon="chevron-down"]
holgerDr. Wesche joined Harpoon Therapeutics with 20 years of biotech experience focused on target validation, drug discovery and drug development as well as multi-site project management in the fields of oncology and inflammation. His previous role was as scientific director at Amgen where he was responsible for cross-functional organization and coordination of the next generation BiTE platform, the industry’s leading T-cell engaging antibody platform. He also led several drug discovery projects through pre-clinical development. Dr. Wesche is co-author of numerous publications and several US patents. Dr. Wesche received his PhD, summa cum laude, in biochemistry and Immunology from the University of Hannover, Germany.
Fred Larimore, Ph.D., AbSci[fa icon="chevron-down"]

Dr. Larimore brings over 30 years of experience in biopharmaceutical manufacturing and process development at leading pharmaceutical companies, includes in management roles at companies such as Cook Pharmica and Eli Lilly. Prior to formally joining AbSci's Scientific Advisory Board, Dr. Larimore advised AbSci on various aspects of biopharmaceutical process development manufacturing scale-up.

Dr. Larimore worked for over 25 years at Eli Lilly, where he served as a Research Fellow and senior scientific leader. He has extensive experience in process design, development, scale-up, and manufacturing, and led manufacturing support of six major biotechnology products in the marketplace, Xigris®, Humulin®, Humalog®, Humatrope®, Forteo® and Recombinant Human Glucagon. He was influential in developing some of the original biologic manufacturing processes, including production of Human Insulin using the chain route (Humulin®), Human Insulin using the proinsulin process (Humulin®), Human Growth Hormone (Humatrope®), Recombinant Human Parathyroid Hormone (Forteo®), Factor IX and several other monoclonal antibodies.

Dr. Larimore is a founding member and Vice President of the Board of Directors of the Society for Bioprocessing Professionals (SBP) and currently serves as the Principal Consultant at Sierra Vista Biotech Consulting. He was also the Vice President of Scientific Affairs and Chief Scientific Officer of Cook Parmica. Dr. Larimore holds a B.A. in Chemistry from St. Olaf College, a Ph.D. in Biochemistry from the University of Minnesota, and completed his post-doctoral training at the Harvard Medical School, Department of Physiology.

Chris Leidel, VP Business Development, FloDesign Sonics[fa icon="chevron-down"]

Chris LeidelProduct and business strategy

BS--Mechanical Engineering & MBA, University of Massachusetts Amherst

Design Engineer at Texas Instruments

Co-founded a medical device spun out of an academic research lab

Enjoys playing basketball (poorly) and brewing beer

Roland Hecht, Sr. Business Development, AGC Biologics[fa icon="chevron-down"]

Roland Hecht is currently Senior Director of Business Development at AGC Biologics. From 2014 - 2017 he was in the same role at Biomeva GmbH , now AGC Biologics Heidelberg. From 2010  - 2014 he was the Vice President of Business Development for CMC Biologics Copenhagen, a global Contract Manufacturing Organization (CMO). Previous to this, from 2003 - 2010, he was Senior Director of International Sales for Rentschler Biotechnologie, an international full-service CMO based in Laupheim, Germany.

From 2002 - 2003, Roland was Director of Sales and Marketing and General Manager of Elchrom Scientific in Germany, a Swiss based start-up company in the field of high resolution DNA Electrophoresis. His first position in the Biologics CMO industry was from 2000 - 2002, when he was a Sales Executive at Excell Biotech (Edinburgh, Scotland). From 1994 - 2000 Roland hold various positions in sales, marketing and technical customer support at Stratagene and Q-Biogene, companies which were active in the field of laboratory instruments and reagents for the Biotech industry.

Roland is graduated as a Master of Science in Biology and Ph.D. in Molecular Biology in 1994, with a three year MBA education.

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Chris Leidel, VP Business Development, FloDesign Sonics[fa icon="chevron-down"]

Chris LeidelProduct and business strategy

BS--Mechanical Engineering & MBA, University of Massachusetts Amherst

Design Engineer at Texas Instruments

Co-founded a medical device spun out of an academic research lab

Enjoys playing basketball (poorly) and brewing beer

Lauren Carter, BS, BA, MS, PM, Institute for Protein Design, University of Washington[fa icon="chevron-down"]

Lauren CarterLauren Carter is a Seattle biotech veteran, with over 16 years of experience in Analytical Biochemistry, Downstream Process Development, Formulation Development, cGMP manufacturing, and Tech Transfer at such companies as Corixa, IDRI, AGC Biologics, and Theraclone Sciences.  Lauren established and currently manages the Protein Production Core Facility for the David Baker lab/Institute for Protein Design at the University of Washington.  The IPD PPF Core produces and characterizes quality proteins for both internal investigators as well as external collaborators, as well as assists in the development and preparation of Tech transfer packages for the transfer of translational projects to CDMOs.  Lauren has a certificate in Biotechnology Project Management and recently completed a MS in Translational Pharmaceutics from the University of Washington Department of Bioengineering (2015).

Mark Melville, Ph.D., Sr. Director Process Development, Corvidia[fa icon="chevron-down"]
Mark_Melville_WMark Melville is the Senior Director of CMC and manages the outsourcing of all development and manufacturing activities for drug substance at Corvidia. Mark previously managed drug substance development and manufacture of a pipeline of biosimilar products at Epirus Biopharmaceuticals, bringing multiple products to the clinical stage. He has been in the in biotherapeutic development and manufacturing for over 16 years with positions at Wyeth Biopharma, Pfizer, and Percivia. Mark received his PhD from the University of Washington.
Sue Behrens, Ph.D., Sr. Director, Process Design, IPS & President, SB Executive Consulting, LLC[fa icon="chevron-down"]
Sue_Behrens1.jpg.pagespeed.ce.DA45mLmpFoDr. Sue Behrens is a consultant with over 25 years’ experience at Merck and SB Executive Consulting, LLC. Her experience is focused on Manufacturing Process Science and Technology for Sterile, Biologics & Vaccine products.  She also leads the Process Design group at IPS, a global provider of Engineering, Construction, Commissioning and Qualification services for technically complex facilities.  She has been involved in global projects in all aspects of scale-up and production of vaccine and biopharmaceutical products.  Sue has been a leader in process development, technology transfer, supply chain strategy, facility design/validation and regulatory CMC support.  Sue is also the founding Sponsorship Chair for the Philadelphia Chapter of Women in Bio.  She earned her BS and PhD degrees in Chemical Engineering from University of Michigan and University of California-Berkeley.
Benjamin Fryer, Ph.D., Founder, Pluristyx[fa icon="chevron-down"]
Fryer Headshot-614493-editedBenjamin Fryer, Ph.D., completed his doctorate in pharmacology and a post-doctoral fellowship in stem cell development at the University of Pennsylvania. Dr. Fryer has almost 20 years of experience in combination product development including 13 years in cell therapy R&D and manufacturing. Dr. Fryer recently founded Pluristyx Inc. to support and advises clients wishing to develop next generation cell and gene therapies and provide pre-expanded, cryopreserved, ready-to-differentiate, pluripotent stem cells (PSC) to support and accelerate clinical grade (GMP) manufacturing of cells for use in research, diagnostics, and therapeutics.
Dr. Fryer began working in cell therapy at Janssen R&D’s BetaLogics developing an array of process operation units including banking, expanding, differentiating, cryo-preserving, thawing and delivering cells to the point of care.  This work included developing stirred tank bioreactor technology for PSC suspension culture, bulk PSC cryo-preservation, and stirred tank differentiation the cells into islet-like clusters. Most recently, Dr. Fryer supported the Heart Regeneration Program at University of Washington leading a team making GMP master and working cell banks of pluripotent stem cells and developing scalable processes to generate and cryopreserve cardiomyocytes for clinical use. 
Michiel E. Ultee, Ph.D., Principal, Ulteemit BioConsulting, LLC[fa icon="chevron-down"]
Ultee-Mike-Oct-2013-368a-214x300Dr. Michiel “Mike” Ultee has more than 30 years of experience in the development of biopharmaceuticals, from research through commercial manufacturing. Recognized as an industry expert on antibodies, fusion proteins and other recombinant proteins, he is a frequent speaker at international conferences and serves on the Editorial Advisory Board of Biopharm International and Bioprocess International. Dr. Ultee has published a wide variety of papers of all aspects of bioprocessing. These include an in-depth review of antibody purification techniques for the Encyclopedia of Industrial Biotechnology, initially in 1999 and then for its second edition in 2010. Other papers have focused on the production and purification of challenging proteins, including fusion proteins and IgM antibodies. More recently he has presented and published on manufacturing challenges of biosimilars, flexibility in bioprocessing, and the effect of cell-culture conditions on protein glycosylation. As the scientific co-founder and CSO of Laureate Biopharma and its successor Gallus Biopharmaceuticals, Dr. Ultee developed dozens of proteins into new biopharmaceuticals. He formed Ulteemit BioConsulting in October 2013 to offer expert consultation in the fields of process development and manufacture of protein therapeutics.
Scott Willett, Ph.D., Vice President, Biopharmaceutical Development, Promedior[fa icon="chevron-down"]

WS Willett Head Shot 1Scott has more than 30 years of experience in the biopharmaceutical industry developing and manufacturing recombinant protein human therapeutics. For the last 12 years at Promedior, Scott has led the development of the company’s lead clinical-stage antifibrotic, PRM-151, from research through Phase 2 clinical manufacturing. Prior to Promedior, he served as Director of Process Development at Neose Technologies, leading development and technology transfer for clinical-phase glycoengineered protein therapeutics. Before joining Neose, he was a Process Development Scientist at Amgen, Thousand Oaks, where he led teams in development of Phase 1 cGMP purification processes for several proteins, in addition to supporting Amgen’s commercial products. Scott holds a PhD in Pharmaceutical Chemistry from the University of California at San Francisco and a BS degree in Chemical Engineering from the University of Michigan at Ann Arbor.

Dr. Claudia Wall, Head of Manufacturing & Technical Development Regulatory Affairs, Affimed GmbH[fa icon="chevron-down"]
Foto-Dr Claudia Wall (2)Dr. Claudia Wall has been the Head of Project Management Regulatory Affairs and Quality Management at Affimed N.V. since 2008. Dr. Wall is responsible for the successful establishment of the cGMP-compliant production processes of both lead projects AFM13 and AFM11. She joined Affimed Therapeutics in 2002 as scientist responsible for the generation and screening of highly diverse antibody libraries. In addition, Dr. Wall managed the successful filings of the respective CTAs and INDs for both programs. Prior to joining Affimed, Dr. Wall worked as a scientific associate from 1997 to 2001 at Hoffmann-LaRoche AG Grenzach-Wyhlen in the neurodegenerative diseases and dermatology unit. She received her undergraduate degree in Biology and a Ph.D. from the Institute of Pathobiochemistry and General Neurochemistry at the Faculty of Medicine at Ruprecht-Karls-University in Heidelberg.
Dr. Mark Schofield, Senior R&D Manager, Pall Life Sciences[fa icon="chevron-down"]

Mark SchofieldDr. Mark Schofield joined the Pall Life Sciences team in 2011. He is a Senior R&D manager at the Westborough Center for Excellence, in Massachusetts. He leads the Chromatography Applications R&D group, and his main focus is driving the development of new solutions for the operation of continuous chromatography. Dr. Schofield earned his B.Sc. in molecular biology from the University of Edinburgh, and his Ph.D. in molecular biology from the University of Dundee. He is an accomplished author, and has been published in several scholarly journals.

Mark Fitchmun, President and Senior Advisor, Somatek[fa icon="chevron-down"]
somatek_mark_fitchmunSince founding Somatek in 2003, Mr. Fitchmun has consulted on over 40 biopharmaceutical and analytical projects including therapeutic antibodies, antibody-drug conjugates, fusion proteins, viruses, and clinical diagnostics. His core strengths are in bioprocess development and analytical methodologies where he has published manuscripts and holds several patents. Prior to founding Somatek, Mr. Fitchmun served as Vice President of Accelagen, Director of Process Development at GenStar, and Group Leader at Desmos. 
Roland Hecht, Sr. Business Development[fa icon="chevron-down"]
Roland Hecht is currently Senior Director of Business Development at AGC Biologics. From 2014 - 2017 he was in the same role at Biomeva GmbH , now AGC Biologics Heidelberg. From 2010 - 2014 he was the Vice President of Business Development for CMC Biologics Copenhagen, a global Contract Manufacturing Organization (CMO). Previous to this, from 2003 - 2010, he was Senior Director of International Sales for Rentschler Biotechnologie, an international full-service CMO based in Laupheim, Germany.

From 2002 - 2003, Roland was Director of Sales and Marketing and General Manager of Elchrom Scientific in Germany, a Swiss based start-up company in the field of high resolution DNA Electrophoresis. His first position in the Biologics CMO industry was from 2000 - 2002, when he was a Sales Executive at Excell Biotech (Edinburgh, Scotland). From 1994 - 2000 Roland hold various positions in sales, marketing and technical customer support at Stratagene and Q-Biogene, companies which were active in the field of laboratory instruments and reagents for the Biotech industry.

Roland is graduated as a Master of Science in Biology and Ph.D. in Molecular Biology in 1994, with a three year MBA education.
Dieter Kramer, Site Head and General Manager, Germany, AGC Biologics[fa icon="chevron-down"]
Dieter Kramer joined in 2018 as the new Managing Director of AGC Biologics GmbH in Heidelberg/Germany. From 2016 - 2018 he was in the same role at Corden BioChem GmbH a Contract Manufacturing Organization (CMO) in the white biotechnology business. From 2011 – 2016 he was Managing Director of Sandoz Industrial Products GmbH a API manufacturing site of the Novartis generic division in Frankfurt am Main/Germany with large-scale fermentation and downstream capabilities. Before this assignment Dieter held various positions in R&D, Manufacturing, Project Management and General Management in the Sandoz/Novartis network in Austria and Germany.

Dieter is graduated as a Master of Science in Biotechnology (1998) and Master of Business Administration in General Management (2006).