Indiana Life Sciences Manufacturing 2024 Summit

Event Date: March 7, 2024
Location: 16Tech, 1210 Waterway Blvd. Indianapolis, IN 46202
Priority: No
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The Indiana Life Sciences Manufacturing Summits convene industry, academia, state and local governments, and other relevant organizations to promote life sciences manufacturing, research, education, and business development in Indiana. Now in their third year, the Summits discuss trends, challenges, and opportunities, how to forge global solutions with regional resources, and workforce development strategies needed to keep pace with onshoring and emerging technologies. The theme of the 2024 Summit is Regulatory Perspectives on Life Sciences Manufacturing Innovation.

Keynote Speakers

Dr. Patrizia Cavazzoni, M.D., is the director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration. Dr. Cavazzoni received her medical degree from McGill University and was later appointed to the Faculty of Medicine at the University of Ottawa. Dr. Cavazzoni then worked in the pharmaceutical industry for several years, holding senior executive positions in clinical development, regulatory affairs, and safety risk management in large companies across multiple therapeutic areas, before joining the FDA in 2018. She will be joined in her presentation by Dr. Sau Lee, Ph.D., Deputy Director of Science, Office of Pharmaceutical Quality, CDER.

Dr. Lee is currently Deputy Super Office Director for Operations who oversees research, quality surveillance, policy, quality assurance, and administrative operation functions in CDER's Office of Pharmaceutical Quality. Dr. Lee has been with the FDA since 2005, serving as a regulatory scientist, team lead, Associate Director for Science, Deputy Office Director, Office Director, and Deputy Super Office Director of Science. He has provided exemplary leadership in developing OPQ science, research and testing programs to support quality assessment, inspection, surveillance, and policy. In 2016, Dr. Lee was appointed to the Senior Biomedical Research Service (SBRS) because of his extensive regulatory and scientific contributions to manufacturing science, complex drug substances and products, and emerging pharmaceutical technologies. Prior to joining the FDA, Dr. Lee received a B.S. degree in Chemical Engineering from the University of Virginia with a minor in Materials Science and a Ph.D. in Chemical Engineering from Princeton University.

Registration for the Indiana Life Sciences Manufacturing 2024 Summit is now open. Click the link below to register. Please note that space is limited.

Dr. Patrizia Cavazzoni, M.D.

Dr. Patrizia Cavazzoni, M.D.

Director of the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration
Dr. Sau Lee, Ph.D.

Dr. Sau Lee, Ph.D.

Deputy Director of Science, Office of Pharmaceutical Quality, CDER

Sponsor Organizations

  • Purdue's William D. and Sherry L. Young Institute for the Advanced Manufacturing of Pharmaceuticals
  • Biocrossroads

Agenda

8:30-9:20 AM
Breakfast and Registration
Indiana Bioscience Research Institute Conference Room (first floor)
9:20-9:30 AM
Welcome and Introduction
Elizabeth Topp, Director, William D. Young Institute for Advanced Manufacturing of Pharmaceuticals, Purdue University
9:30-10:10 AM
CDER's Perspective and Update on Advanced Manufacturing
Keynote Speakers (Virtual):
  • Patrizia Cavazzoni, Director, Center for Drug Evaluation and Research, Food and Drug Administration
  • Sau (Larry) Lee, Deputy Director of Operations, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration
10:10-10:40 AM
A Strategic Triad—Lilly, Government, and Academia—Powering Lilly Manufacturing to Deliver the Next Generation of Quality by Design Facilities
Edgardo Hernandez, Executive Vice President and President, Manufacturing Operations, Eli Lilly and Company
Johna Norton, Executive Vice President, Global Quality, Eli Lilly and Company
10:40-11:00 AM
Break
11:00-11:30 AM
Flexible Manufacturing: Innovating to Reduce Time to Patients
Rich Osifchin, Associate Vice President, Pharmaceutical Sciences and Clinical Supply, Merck Research Laboratories
11:30-12:00 PM
Indiana CDMO Environment, Panel Discussion
Moderator:
  • Brad Beach, Senior Director, Pharma and Biotech Portfolio, Office of Industry Partnerships, Purdue University
Panelists:
  • Pat Adams, Plant Manager, Bloomington, Simtra BioPharma Solutions
  • David Wilhite, Executive Vice President, Commercial Operations, Genezen
  • Daniel Fricker, Vice President and Site Manager, Evonik
12:00-12:30 PM
Indiana's EDA Tech Hub
Andrew Kossack, Executive Vice President, Partnerships and General Counsel, Applied Research Institute
12:30-1:30 PM
Lunch and FDA Consortium Proposal and Breakout Session (led by Liz Topp, Purdue)
1:30-1:40 PM
16 Tech Innovation District
Emily Krueger, President and CEO, 16 Tech Innovation District
1:40-2:20 PM
A Journey to Implement Continuous Manufacturing for Biologics
Keynote Speaker
  • Lucy Chang, Associate Vice President, Global Regulatory Affairs CMC Biologics, Merck & Co., Inc.
2:20-3:00 PM
AI and Pharmaceutical Manufacturing Innovation, Panel Discussion
Moderator:
  • Doug Kiehl, Senior Director, Eli Lilly and Company
Panelists:
  • Lucy Chang, Associate Vice President, Global Regulatory Affairs CMC Biologics, Merck & Co., Inc.
  • Gaurav Chopra, Director, Merck-Purdue Center; Associate Professor of Chemistry, Purdue University
  • Dan Isaacs, CTO and GM: Digital Twin Consortium; Chief Strategy Officer, Object Management Group
3:00-3:15 PM
Break
3:15-3:45 PM
Transforming Pharmaceutical Manufacturing: The Evolution of Digital Twins and AI's Vital Role
Dan Isaacs, CTO and GM: Digital Twin Consortium; Chief Strategy Officer, Object Management Group
3:45-4:15 PM
Indiana's Key Role in Radiopharmaceutical Manufacturing
Kevin Haehl, Chief Development Officer, Nucleus RadioPharma
4:15-4:45 PM
The Future of Indiana's Life Science Sector and Closing Remarks
Ann Lathrop, Chief Strategy Officer, Indiana Economic Development Corporation (IEDC)

Speakers


Photo of Pat Adams

Pat Adams
Plant Manager, Bloomington
Simtra BioPharma Solutions

With nearly 20 years of experience in the pharmaceutical manufacturing industry, Pat Adams is the Plant Manager of Simtra BioPharma Solutions' Bloomington, Indiana facility. Simtra BioPharma Solutions is a sterile injectable contract development and manufacturing organization (CDMO). Pat's pharmaceutical industry experience is exclusively in the sterile fill finish CDMO space and he has lead teams in operations, technical transfer, project management and commercial or business management. Pat earned his BS in Business Operations and a BS in Human Resource Management from Indiana University's Kelley School of Business.


Photo of Brad Beach

Brad Beach
Senior Director - Pharma and Biotech Portfolio
Office of Industry Partnerships
Purdue University

Brad supports the pharma industry from Purdue's Office of Industry Partnerships, where we aim to put Purdue's extensive network of assets to work in support of the pharma industry's key challenges. He brings 20 years of industrial operations, engineering, and tech transfer experience in both the oilfield services and pharma manufacturing industries.


Photo of Lucy Chang

Lucy Chang, Ph.D.
Associate Vice President, Global Regulatory CMC Biologics
Merck & Co. Inc.

Lucy Chang is currently the Associate Vice President in Global regulatory CMC biologic at Merck. Lucy joined Merck in 2016 and has taken on roles of increasing responsibility from leading the pre-approval team to leading Keytruda franchise that is responsible for the regulatory strategy, global submissions for biologics portfolio from development to commercialization and life cycle management at Merck. Lucy is also responsible for supporting all the new technology development and facility for the future for Biologics at Merck, leading various engagement with global HAs to pave the regulatory pathway for implementation.

Lucy Chang obtained her Ph.D. in Pharmaceutics from University of Connecticut and has more than 20 years of experience in biologics/vaccine field across multinational pharmaceutical companies, which includes GSK, Pfizer, Teva, Actinum and Sanofi prior to joining Merck.


Photo of Gaurav Chopra

Gaurav Chopra, Ph.D.
Associate Professor, Departments of Chemistry and Computer Science
AnalytiXIN Fellow in Life Sciences and Manufacturing
Director, Merck-Purdue Center
Purdue University

Gaurav Chopra is a tenured Associate Professor in the Departments of Chemistry and Computer Science at Purdue University and AnalytiXIN Fellow in Life Sciences and Manufacturing. As the Director of the Merck-Purdue Center, an initiative supported by Merck, Chopra oversees projects spanning Purdue University. Chopra's laboratory works in the area of Molecular Artificial Intelligence and develops AI platforms/copilots for closed-loop laboratory automation, digital healthcare and conducting experimental validations in cancer- and neuro-immunology for drug discovery and development. Chopra received his undergraduate degree in Mechanical Engineering from the Indian Institute of Technology (IIT), Delhi, India and his M.S. in in Mechanical Engineering from the University of California, Irvine. Chopra received his PhD in Computational Mathematics with Professor Michael Levitt (2013 Nobel Laureate in Chemistry) at Stanford University - School of Engineering and was a JDRF Fellow developing immune tolerance therapies with Professor Jeffrey Bluestone at the University of California - San Francisco, School of Medicine. Chopra's research program is funded by several federal agencies and companies, such as National Institutes of Health, Department of Defense, Defense Threat Reduction Agency, National Science Foundation, to name a few. He has given over 100 invited lectures nationally and internationally to universities, companies and FDA related to AI-based automation, immunology and drug discovery. Recently, Chopra led a team that won the ASPIRE Grand Prize by the National Center for Advancing Translational Science (NCATS) for developing AI-guided drug discovery and automation platform. His current work with NCATS includes developing large language model (LLM)-based AI infrastructure to plan, execute, analyze and automate chemical and biological experiments to accelerate drug discovery and development. Outside of academia, Chopra has co-founded two companies - Meditati Inc. and BrainGnosis Inc. Chopra is dedicated to fostering diversity in academia, developed a virtual reality-based drug discovery game, MINT, and organized outreach events for K-12 and university students, promoting a love for science and inclusivity in scientific endeavors.


Photo of Jane Dunigan-Smith

Jane Dunigan-Smith
Senior Vice President and Chief Strategy Officer
BioCrossroads

Jane Dunigan-Smith is Senior Vice President and Chief Strategy Officer of BioCrossroads, where she is also Fund Manager of its seed funds. Jane leads strategy development and efforts in workforce training and talent development as well as communications, events and programming. Before joining BioCrossroads, she worked at Eli Lilly and Company in mostly commercial roles including US and global marketing, corporate strategy and central capabilities. Jane earned an MBA from Indiana University's Kelley School of Business with concentrations in marketing and strategy and a Bachelor of Science degree in accounting and finance also from Indiana University.

Early in her career, she was a CPA and audit manager at PricewaterhouseCoopers in Chicago. Jane holds a bachelor's degree in accounting and finance as well as an MBA from the Kelley School of Business at Indiana University.


Photo of Daniel Fricker

Daniel Fricker
Vice President and Site Manager
Evonik Corporation

Daniel Fricker is the Vice President & Site Manager at Evonik Corporation in Lafayette, Indiana. A graduate of the Universite de Technologie de Compiegne, he has served many roles during his nearly 18 years with Evonik including site manager for Evonik New Orleans, Project Responsible for a Middle East green field project with Evonik Saudi Arabia, and General Manager/President of Evonik France and Evonik Rexim SAS. .


Photo of Kevin Haehl

Kevin Haehl
Chief Development Officer
Nucleus RadioPharma

Kevin joined Nucleus RadioPharma in 2022, bringing over three decades of pharmaceutical industry expertise to the table, most of it in the Hoosier state. His journey included a variety of roles at Eli Lilly and Company, Evonik, Endocyte, and Novartis. As a Purdue alumnus and licensed Professional Engineer, he is engaged in building the infrastructure to bring breakthrough targeted radiotherapies to patients.


Photo of Edgardo Hernandez

Edgardo Hernandez
Executive Vice President and President of Manufacturing Operations
Eli Lilly and Company

Edgardo Hernandez is executive vice president at Eli Lilly and Company and president of manufacturing operations.

Ed served as senior vice president of global parenteral drug product, delivery devices and regional manufacturing from 2018 until 2021. In this role, he was responsible for global parenteral manufacturing, emerging markets manufacturing, drug-product contract manufacturing, packaging, and distribution operations. Ed provided oversight for manufacturing sites in 12 countries across North America, South America, Europe, and Asia; that manufacture the final parenteral product (non-oral) formulations of Lilly medicines.

Previously, Ed was vice president of FegersheimOperations for Lilly's manufacturing site located in France. Before that, he served as site head for two other Lilly manufacturing sites: Indianapolis Active Pharmaceutical Ingredient manufacturing from 2014 until 2016, and PR06 in Puerto Rico from 2012 until 2014. Ed joined Lilly in 2005 as an engineering services leader for Lilly del Caribe in Puerto Rico, after working for several years in positions for Pfizer and Pharmacia.

Ed is a native of Puerto Rico and holds bachelor's and master's degrees in chemical engineering from the University of Puerto Rico and North Carolina State University, respectively.


Photo of Daniel R. Isaacs

Daniel R. Isaacs
CTO and GM: Digital Twin Consortium
Chief Strategy Officer, Object Management Group

Dan Isaacs is Chief Technology Officer and General Manager of Digital Twin Consortium (DTC™), where he is responsible for driving the technical direction for the Member Consortium, liaison partnerships and business development support for new memberships. Dan is also the Chief Strategy Officer for Object Management Group (OMG), where he develops and implements a comprehensive strategy to align OMG consortia (AREA, CISQ, DTC, OMG Standards Development Organization, and Responsible Computing).

Previously, Dan was Director of Strategic Marketing and Business Development at Xilinx where he was responsible for emerging technologies including AI/Machine Learning, including defining and executing the ecosystem strategy for the Industrial IoT. Prior to joining the Digital Twin Consortium, Dan was responsible for Automotive Business Development focused on Automated Driving and ADAS systems.

Dan represented Xilinx to the Industrial Internet Consortium (IIC). He has more than 25 years of experience working in automotive, Aerospace and consumer-based companies including Ford, NEC, LSI Logic and Hughes Aircraft.

An accomplished speaker, Dan has delivered keynotes, presentations and served as panellist and moderator for IIC World Forums, Industrial IOT Global conferences, Embedded World, Embedded Systems, and FPGA Conferences. He is a member of international advisory boards and holds degrees in Computer Engineering: EE from Cal State University, B.S. Geophysics from ASU.


Photo of Douglas Kiehl

Douglas Kiehl
Senior Director
Disruptive/Transformative Technologies Team (DT3) CDTO
Digital Twin Center of Excellence
Eli Lilly and Company

Doug Kiehl is a Senior Director at Eli Lilly and Company and leads the Disruptive/Transformative Technologies Team (DT3) and Digital Twin Center of Excellence with focus on digital transformation, automation, extractables/leachables and next-gen bioprocess. He serves as a member of the United States Pharmacopeia (USP) Packaging and Distribution Expert Committee, Chair for the Product Quality Research Institute (PQRI) Development Technical Committee, PhRMA Topic Lead for the International Council for Harmonisation (ICH) Q3E Guidance Expert Working Group, Board of Directors for the Extractables/Leachables Safety Information Exchange (ELSIE) Consortium, Chair for the International Society for Optics and Photonics (SPIE) Defense and Commercial Sensing Conference, Executive Governing Council for the Nano-Bio Materials Consortium (NBMC/SEMI) and founding member of the Biomolecule Reactivity Consortium. He has published his work in several peer-reviewed and trade journals, and has organized, chaired and presented at numerous conferences.


Photo of Andrew Kossack

Andrew Kossack
Executive Vice President of Partnerships and General Counsel
Applied Research Institute

Andrew Kossack is the Executive Vice President of Partnerships and General Counsel at the Applied Research Institute. In this role he leads ARI's strategy to cultivate a diverse and engaged network of public, private, nonprofit, and academic entities in furtherance of ARI's mission. Andrew also leads ARI's strategy regarding the Heartland BioWorks Regional Technology and Innovation Hub (Regional Tech Hub), which was designated by the U.S. Department of Commerce Economic Development Administration as one of 31 Regional Tech Hubs nationwide from nearly 400 applicants. Before his tenure at ARI, Andrew held several appointments in federal and state government, including State Director and Counsel to U.S. Senator Todd Young, Associate Counsel to then-Vice President Mike Pence at the White House, and Commissioner of the Indiana Department of Revenue.


Photo of Emily Krueger

Emily Krueger
President and CEO
16 Tech Community Corporation

Emily Krueger is the President and CEO of 16 Tech Community Corporation, the nonprofit responsible for catalyzing the physical and programmatic development of the 16 Tech Innovation District, a growing destination for innovation and entrepreneurship.


Photo of Ann Lathrop

Ann Lathrop
Chief Strategy Officer
Indiana Economic Development Corporation

Ann Lathrop, chief strategy officer for the Indiana Economic Development Corporation (IEDC), joined the IEDC in November 2021 and was appointed to join Governor Eric J. Holcomb's cabinet in August 2023. In her role, Lathrop oversees Indiana's integrated approach to business development, aligning external engagement, workforce, business development, foreign direct investment, federal engagement, government-to-government relations, defense, foreign policy and trade to meet the needs and speed of the market. Her extensive expertise encompasses business development, sales, finance, marketing, and brand management. Beyond her professional endeavors, Lathrop has made impactful contributions to the state by participating on various boards.


Photo of Johna L. Norton

Johna L. Norton
Executive Vice President, Global Quality
Eli Lilly and Company

Johna Norton is executive vice president of Global Quality for Eli Lilly and Company.

Johna joined Lilly in 1990 as an analytical chemist. She went on to hold positions with increasing responsibility in quality assurance and quality control, supporting manufacturing and process development at both Lilly facilities and with Lilly's external manufacturing partners. Throughout her career, she has worked at multiple Lilly manufacturing sites, including sites in Indiana, Ireland and Puerto Rico. Prior to her current role, Johna was vice president, Quality, for Lilly's Active Pharmaceutical Ingredient (API) manufacturing network, Puerto Rico manufacturing, and Product Research and Development.

She holds a Bachelor of Science in chemistry from Gannon University and a Master's in analytical chemistry from Miami University.

In 2017, FiercePharma named Johna one of the Top Women in Life Sciences.

She serves on the board of directors for United Way of Central Indiana.


Photo of Rich Osifchin

Rich Osifchin
Associate Vice President, Pharmaceutical Sciences and Clinical supply (PSCS)
Merck Research Laboratories

Rich Osifchin is an Associated Vice President within the Pharmaceutical Sciences and Clinical supply (PSCS) organization in the Merck Research Laboratories. He's responsible for leading drug product operations in support of product development and clinical supply manufacture, provided by a global network of internal Merck sites and contract manufacturers. Rich earned his Ph.D. in Chemical Engineering from Purdue University, after which he embarked on a 30-plus year career at Merck. He served in a range of roles in both the research and manufacturing divisions. This includes leading the development and commercial launch of multiple Merck products, and he's authored numerous publications, presentations and patents associated with his work.


Photo of Elizabeth M. Topp, Ph.D.

Elizabeth M. Topp, Ph.D.
Professor, Industrial and Molecular Pharmaceutics and Chemical Engineering
Director of the William D. and Sherry L. Young Institute for the Advanced Manufacturing of Pharmaceuticals

Elizabeth Topp is a Professor of Industrial and Molecular Pharmaceutics and Chemical Engineering at Purdue University in West Lafayette, Indiana, where she also serves as the Director of the William D. and Sherry L. Young Institute for the Advanced Manufacturing of Pharmaceuticals. She holds a position as a principal investigator at the National Institute for Bioprocessing Research and Training (NIBRT) in Dublin, Ireland. Her research addresses the formulation and stability of protein drugs and other biologics, with a particular focus on the amorphous solid state. She is a Fellow of the American Association of Pharmaceutical Scientists.


Photo of David Wilhite

David Wilhite
EVP Commercial Operations
Genezen

Dave worked as a medicinal chemist for Pfizer before pursuing his MBA from Purdue University. He then joined Indiana University's Innovation and Commercialization Office. Dave joined Genezen in 2018 and is responsible for overseeing client relationships/program management, academic partnerships, and marketing.