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Virtual

Nov 15, 2021 10:00 AM - Nov 18, 2021 1:15 PM

(US Eastern Standard Time)

The Impact of Project Management in Healthcare Product Development

This event is now offered in a new entirely virtual format.

Speakers

Karla  Childers, MS

Karla Childers, MS

Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States

Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility has been the support and coordination of J&J’s Clinical Trial Data Transparency Initiative. She is the Chair of the J&J Bioethics Committee and serves as a bioethics subject matter expert for internal and external policy work. Ms. Childers began her career in industry as a chemist and then project manager for global drug development teams. Ms. Childers is also the co-chair of the DIA Bioethics Community.

Nita  Ichhpurani, PMP

Nita Ichhpurani, PMP

Consultant To Daiichi Sankyo, Inc. , Phase One Forward, Consultant, Canada

At Pharmacia (now Pfizer), Nita was a discovery Chemist and then PM in Clinical Pharmacology in oncology and CNS research. At MDS PS, she managed Global Central lab teams and later become the Latin American Lab Manager. At MDS PS and Celerion, she managed drug development consulting programs from discovery to Phase III for Pharma and Biotech clients. She later had oversight of all special populations clinical projects and oversaw a global clinical project management team. As a consultant, Nita is supporting clients and companies in project leadership, operations and clinical technology. Nita is a DIA program committee member (for pre/early clinical track chair and new PM conference) and co-chair of the MRCT CPM compentencies project.

Mark  Kryah, PMP

Mark Kryah, PMP

Executive Director, Program Team Leader, Program and Portfolio Management, Ultragenyx Pharmaceutical Inc., United States

Mark Kryah is an Executive Director at Ultragenyx, leading rare disease development programs. He has been leading global development projects for 20+ years, with extensive international and partnership experience. Mark has been involved with DIA for 20 years, contributing as a presenter/session chair at many Annual Meetings, and served on the Annual Meeting Program Committee from 2013-2018, and 2024. He was Chair of the Project Management Community from 2018-2022 and served on the DIA Community Leadership Council. Kryah obtained Project Management Professional (PMP) certification from PMI (Project Management Institute) in April 1999 (current). He received a Bachelors in Chemical Engineering from Case Western Reserve University.

Leigh  Shultz, PhD, PMP

Leigh Shultz, PhD, PMP

Executive Director, Human Health Commercial Operations, Merck & Co., Inc., United States

Pharmaceutical professional with more than 20 years of experience in R&D strategy, planning, and both R&D and commercial operations.

Elizabeth  Somers, MS

Elizabeth Somers, MS

Executive Director, Global Project and Alliance Management, Merck Sharp & Dohme LLC, United States

Liz is an Executive Director in Global Project and Alliance Management at Merck focusing on Discovery PM. She manages a team focused on Discovery projects including complex collaborations which leverages her experience managing complex cross functional drug development programs and her background as a bench scientist. In a prior role, Liz was the Director of the PMO at the Icahn Genetics Institute at Mt Sinai where she led a team of PMs who had oversight of innovative research projects. Liz has been in the pharmaceutical industry for over 25 years and has worked in project management for the past 10 years. Liz is the Chair of the DIA PM community member and a member of the Annual Meeting Steering Committee.

Mark  Boaz, PhD, MS

Mark Boaz, PhD, MS

Executive Director, Pfizer Vaccines Research and Development, Pfizer Inc, United States

Executive Director, Group Lead for Vaccine Development management with Pfizer Vaccines R&D. Biopharmaceuticals Program & Strategy Leader with 19 years end-end development experience. Sustained success leading high profile vaccines/biologics cross-functional teams thru clinical & technical development, regulatory submissions & manufacturing, as evidenced by licensure/authorization of 3 vaccines incl. most recently for COVID-19. As executive director provide portfolio level strategic input across the vaccine portfolio; lead a group of Program Directors responsible for driving vaccine program strategy & teams thru development and governance, in addition to Program Managers responsible for operational cross functional integration within teams.

Jeremy  Baker, MBA, PMP

Jeremy Baker, MBA, PMP

Pharma Project Management, Eli Lilly & Co., United States

Jeremy works in late-phase pharmaceutical drug development as a Pharma Project Manager for Indiana-based Eli Lilly and Company. He has recent experience in phase-3, global submission, regulatory response, and launch activities. He has an MBA in International Management and his Project Management Professional (PMP) certification through the Project Management Institute (PMI).

Matt  Clark, PhD, PMP

Matt Clark, PhD, PMP

Senior Policy Advisor and Director of International COVID Response Operations, White House COVID Response, United States

COL Matt Clark serves as the Vaccine Portfolio Program Manager in the Countermeasures Acceleration Group (formerly Operation Warp Speed). He focuses on vaccine development, guiding PMs, engaging the FDA and other agencies, and collaboration and coordination across six vaccine Program Coordinating Teams. He previously served as Army Director of Medical Systems for ASA(ALT); Joint Program Manager in Medical Chemical and Biological Defense; Director of the Eisenhower Leader Development Program at West Point; Deputy Director of Plans, Programs, Analysis and Evaluation at the Medical Research and Materiel Command; and a Legislative Assistant in the Congressional Orientation Program, among other positions in Army Medicine over the last 21 years.

Kristi  Huntington, MS

Kristi Huntington, MS

Sr. Advisor, Pharmaceutical Project Management, Eli Lilly and Company, United States

Kristi has been leading the COVID-19 Neutralizing Antibody program as Chief Operating Officer since early March 2020. Within this role, Kristi is responsible for developing the strategic framework, leading program implementation, and establishing external partnerships to expand Lilly’s capabilities and enhance speed to innovation. Throughout Kristi’s 21+ years at Eli Lilly and Company, she had held various roles leading cross-functional teams within the US, Puerto Rico and Ireland, supporting manufacturing, research and development, and external innovation.

Priya  Kannan, PhD, MS

Priya Kannan, PhD, MS

Head, Business Planning and Operations, Office of CMO and Late Stage Oncology, Astra Zeneca, United States

Priya leads global business planning & operations for late development oncology at Astrazeneca (AZ). In this role, she is responsible for managing strategic initiatives, driving operational excellence, and building strong partnerships. Prior to this, Priya was the director of global project management, where she lead multiple project advancements in Lung & Breast cancer. Priya has lead several alliance projects including the largest one with Daiichi Sankyo, a cornerstone for AZ’s breast cancer portfolio. Priya has also held leadership roles in early oncology & regulatory submissions management. Prior to joining AZ, she held senior positions in licensing and alliance management at Dupont and Bayer. Priya has a PhD in genetics from Texas A&M.

Dara  Meyer, MS, PMP

Dara Meyer, MS, PMP

Senior Project Manager, Icahn School of Medicine at Mount Sinai, United States

Dara Meyer is a Senior Project Manager in the Department of Genetics and Genomic Sciences at the Icahn School of Medicine at Mount Sinai. She was instrumental in the launch of the Mount Sinai Clinical Intelligence Center and serves as Lead Project Manager and Head of Operations with the primary goal of translating data science tools, products, and solutions from the research side into clinical practice. After obtaining her B.S. in Biology from Gettysburg College and M.S. in Pharmaceutical Biochemistry from Montclair State University, Dara transitioned to a career in project management and continues to focus on leveraging her scientific background to partner with scientists and clinicians and spark positive change in the healthcare space.

Sandy  Milligan, JD, MD

Sandy Milligan, JD, MD

Board of Director Member, Gossamer Bio; Principal, Innovex Strategies, United States

Sandra Milligan is the executive vice president and head of Research and Development, Organon, focused on improving the everyday health of every woman. Prior to this role, she served as senior vice president and head of Global Regulatory Affairs and Clinical Safety (GRACS), consisting of global Regulatory, Safety and CMC functions at Merck & Co., Inc. From 2011 to 2017, Sandy served on the board of directors and executive committee of the DIA. In 2017, Sandra was recognized as a DIA Fellow and was appointed to the Science Advisory Council in 2018. She is a graduate of George Washington University School of Medicine and Georgetown University Law Center.

Athena S Papas, DMD, PhD

Athena S Papas, DMD, PhD

Distinguished Professor Diagnostic Sciences, Tufts School of Dental Medicine, United States

Dr. Athena Papas is a Distinguished Professor of Diagnostic Sciences and the Erling Johansen Professor of Dental Research at Tufts University School of Dental Medicine in Boston, Massachusetts. With expertise in the oral healthcare of medically compromised, Sjögrens, cancer and bone marrow transplant patients, Dr. Papas has been the principal investigator of over 100 clinical trials. Dr. Papas was selected as the 2009 recipient of the International Association of Dental Research PTT Distinguished Scientist Award and has been the President of PTT. She also has received the Gavel and Pierre Fauchard awards and is a life fellow of the American College of Dentists. She received DMD from Harvard and PhD from MIT in Oral Biology.

Laura  Pittman, MBA, MSc

Laura Pittman, MBA, MSc

Associate Partner, McKinsey & Company, United States

Laura is an Associate Partner in McKinsey's Life Sciences Practice. She is passionate about helping pharma organizations achieve speed and agility to better serve the rapidly changing needs of patients and healthcare providers. Laura works with pharma companies to support their transformation towards agile ways of working and increase cross-functional collaboration and transparency, and enable faster delivery of healthcare solutions through a test-and-learn approach.

Farhana  Pruthi, MS, PMP

Farhana Pruthi, MS, PMP

Associate Director, Program Management, Bristol Myers Squibb Company, United States

Hana is an Associate Director in Translational Medicine at Bristol Myers Squibb. She has 25 years of experience in the pharmaceutical and biotech industries with a career transition from research and development as a bench scientist to supporting clinical development teams as a project manager.

Doug  Carney, MBA

Doug Carney, MBA

Business Development Manager, Northrop Grumman Corporation, United States

I have had a wide-ranging career with many opportunities to lead – at times in a formal position, and others in an informal capacity or matrixed role. In my early career, I was an Air Force officer and fighter pilot. After retirement, I became a project manager primarily involved with technology development for the Pentagon and the intelligence community. I later served as a drug development project manager at Merck, focused on vaccines, with some work in oncology. I now do business development, working with the DoD’s leading technology developer, the Defense Advanced Research Projects Agency, whose mission is to make pivotal investments in breakthrough technologies for national security.

Gina  Chevalier, MS, PMP

Gina Chevalier, MS, PMP

Senior Manager Strategic Projects, Office of the Chief Medical Officer, Johnson & Johnson, United States

Gina Chevalier, MS, PMP is a Senior Manager, Strategic Projects for the Office of the Chief Medical Office (OCMO) at Johnson & Johnson. Since joining J&J in 2015 Gina has worked in both Medical Safety and in Medical Affairs supporting the Medical Device sector. In 2019 Gina moved to the SRG group in OCMO where she currently leads efforts that supports cross-sector strategy, is the decision support leader for two enterprise governance committees and provides project management expertise.

Teresa  Lamantia, MSN, RN

Teresa Lamantia, MSN, RN

Senior Vice President, Operational Transformation & Performance, IQVIA, United States

Teresa Lamantia is Sr. Vice President, Operational Transformation and Performance at IQVIA, the world’s largest CRO and healthcare data science company. In this role she oversees the metrics and reporting team as well as the lifecycle transition management team for research and development solutions. She also serves as the global head of the COVID-19 Task Force. Prior to taking this role she serves as the head of Global Quality and Transformation, for Q2 Solutions, IQVIA laboratories, established in 2016. In this role she oversaw global quality assurance and transformation activities including continuous improvement, operational excellence, and integration/transformation strategic deliverables.

Matt  Lawlor, PhD, PMP

Matt Lawlor, PhD, PMP

Executive Director and Interim Lead, Global Program Management, Novavax, Inc, United States

Since 2013, Matt has worked in the Global Program Management department at Novavax to support vaccine development programs through licensure and commercial launch. His initial areas of focus included RSV vaccine development for use in pregnant women and older adult populations. Since January 2020 he has served a central role in driving the Novavax COVID-19 vaccine from project start through regulatory submissions. Prior to joining Novavax, Matt served as a Project Officer at the Biomedical Advanced Research and Development Authority (BARDA). He received his Ph.D. in molecular microbiology and microbial pathogenesis from Washington University in St. Louis, and his B.A. in biology from Swarthmore College.

John  Nuckols, PhD, MS

John Nuckols, PhD, MS

Defense Assiste Acquistioin Product Lead - Screening and Diagnostics, U.S. Department of Defense, Joint Program Executive Office For Chemical, Biologi, United States

COL John T. Nuckols, Ph.D., is a Distinguished Military Graduate of the Texas A&M University-Corpus Christi, ROTC program. He later attended The University of Texas Medical Branch, Galveston, Texas, earning a doctor of philosophy degree in Experimental Pathology. His military assignments include a deployment to Iraq with the 4th Infantry Division, multiple clinical Laboratory Manager assignments, and Product Manager for biodefense vaccine development. His recent assignment to the DOD COVID-19 Task Force found him in charge of expanding U.S. diagnostic industrial manufacturing capacities for swabs, test kits, reagents, pipette tips and other diagnostic consumables.

Victor A. Suarez, MS

Victor A. Suarez, MS

, United States

25+ years active duty service as a US Army Medical Service Corps and Acquisition Corps Officer Recently served as Operation Warp Speed Vaccine Program Manager (Moderna Project Coordination Team) Former Chief of Staff of Walter Reed Army Institute of Research, DOD’s largest biomedical research lab Former PM, Joint Vaccine Acquisition Program (DOD Biodefense) Currently serves as Commander of 6th Medical Logistics Management Center, Fort Detrick, MD Certified Materials and Resources Professional® BS, UCLA and MS, Central Michigan University Public Health Fellowship, GWU Milken Institute SPH Cornell Pharmaceutical Management Program Tufts Center for the Study of Drug Development (CSDD) Defense Acquisition Certified (STM, PM, LCL)

Andrea  Vresilovic, MS

Andrea Vresilovic, MS

Senior Director, Project and Alliance Management, Nexstone Immunology, United States

Tamei  Elliott, MS

Tamei Elliott, MS

Associate Director, Scientific Programs, DIA, United States

Tamei Elliott, MS, serves as the Associate Director of Scientific Programs for the Americas region at DIA. In this pivotal role, she is responsible for identifying and prioritizing content areas and topics crucial to DIA constituents. Tamei assesses the implications of significant regulatory and health policy changes, seamlessly integrating relevant content into the development and advancement of DIA conferences and courses. Her responsibilities extend to overseeing content development and strategy within the Americas region.

Christine  Garrett, PhD, PMP

Christine Garrett, PhD, PMP

Vice President, Head of Late Development Project Management, Bristol-Myers Squibb Company, United States

Christine Garrett, Ph.D., PMP, is VP and Head of Late Development Project Management at Bristol Myers Squibb where she leads a function comprised of Project Managers, Project Planners, and PM Therapeutic Area Heads. Chris has over 20 years professional experience. Prior to BMS, Chris was Head of Global R&D – Program Leadership at LEO Pharma as well as Chief of Staff to the Head of Global Development. She led project teams at Celgene in Research and Early Development and before that she spent 16+ years at Novartis. There her roles spanned pre-clinical to end-of-lifecycle, developing and executing program and CMC strategies.

Sue  Glaskey, MA, PMP

Sue Glaskey, MA, PMP

Executive Program Director, Project Management Leadership Group, Inc., United States

With over 30 years of successful project management experience across a wide range of projects, Sue now consults and instructs internationally. She has led Project Management Maturity Assessments for several large, organizations and successfully implemented PMOs. As a lead instructor Sue has taught over 6,000 graduates of the Certified Project Manager Boot Camp. While PMLG is known for their experiential training programs, in 2020 they pivoted and successfully transformed their training into the virtual, live instructor-led format. Her certifications include the CPM, PMP and PPMC. Sue holds both a master’s certificate in Evidence Based Coaching and an MA in Organizational Management and Development from Fielding Graduate University.

Koji  Ishizuka, MBA, MSc

Koji Ishizuka, MBA, MSc

Senior Director, Oncology Alliance Management, Daiichi Sankyo, Inc, United States

For over 16 years, Koji Ishizuka has been working in Clinical Development, Clinical Operations, and Alliance Management spaces. He has worked for various oncologic and antibiotic drugs in Daiichi Sankyo Japan and moved to US in 2014. Since then, he has been based in NJ, USA. As an Alliance Manager, he commits to establish right environment and relationship under alliance. He was a graduate of Tokyo Institute of Technology, majored in Bioengineering, and University of Massachusetts Lowell, majored in business administration. He has also been working in doctoral research in Tokyo University since 2021.

Heather  Lawlor, MSc, PMP

Heather Lawlor, MSc, PMP

Director, Global Portfolio and Project Management , AstraZeneca, United States

Heather Lawlor is an Associate Director of Global Portfolio and Project Management at AstraZeneca, managing projects in various phases of development, most recently the SARS-CoV-2 monoclonal antibody and vaccine projects. Prior to joining AstraZeneca she served as a Senior Project Manager at the Vaccine Research Center of the National Institutes of Health, managing early stage programs aimed at preventing infectious diseases including Influenza, Zika and Ebola. She also spent 15 years at MedImmune as a scientist working on early stage discovery projects focused on infectious disease vaccines. She holds a B.Sc. in Life Sciences, an M.S. in Microbiology and is PMP certified.

Erik  Mogalian, PharmD, PhD

Erik Mogalian, PharmD, PhD

Vice President, Program Executive, COVID, Vir Biotechnology, Inc., United States

Erik is currently Vice President and COVID-19 Program Executive at Vir Biotechnology. For the entirety of his career, Erik has been part of discovery and development of medicines for infectious diseases, including HCV, HIV, HBV, influenza, and other respiratory viruses, leading to approval of 6 medicines. Prior to his industrial career, Erik acquired a PharmD and served as an acute care clinical pharmacist at a large non-profit hospital, and after completing a PhD focused on drug delivery and pharmacokinetics, worked in multiple roles that spanned the entirety of research and development activities, including drug discovery, lead optimization, product and process development, translational and clinical development, and program leadership.

Radha  Ramkumar, PhD, MBA

Radha Ramkumar, PhD, MBA

Executive Director, Global Project Management & Leadership, Daiichi Sankyo, Inc., United States

Radha Ramkumar is Executive Director, Global Project Management & Leadership, at Daiichi Sankyo. She is a group leader in Oncology with oversight and leadership of the 3 lead assets in DSI’s ADC portfolio. Radha brings over 18 years of experience leading all aspects drug development through project, portfolio & alliance management. Her experience spans preclinical to launch globally and across multiple therapeutic areas, including Oncology, Rare Diseases & Stroke Radha holds a PhD in Biochemistry from the Indian Institute of Science in Bangalore, India, Postdoctoral fellowship from Mount Sinai School of Medicine, NY and an MBA from Rutgers University.

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