2020 Speakers for the Preparing for Science-Based Non-Traditional Careers Course
February 26 - Paul Carlson, Ph.D.
Principal Investigator, Laboratory of Mucosal Pathogens and cellular Immunology, CBER, FDA
Topic: "Research and Regulation of novel biologic products at the FDA's Center for Biologics Evaluation and Research"
Dr. Paul Carlson is a principal investigator in the Laboratory of Mucosal Pathogens and Cellular Immunology, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, CBER, FDA. He received his PhD from the University of Pittsburgh and performed postdoctoral research at the University of Michigan in the laboratory of Phil Hanna. Since starting his laboratory at FDA in 2015, Dr. Carlson’s research has focused on infections caused by the enteric pathogens Clostridium difficile and Vancomycin resistant Enterococcus species. The laboratory has projects researching mechanisms of C. difficile pathogenesis, development of genetic tools to study C. difficile, host response to C. difficile, and bacteriophage therapy against VRE. His regulatory responsibilities include product review for fecal microbiota transplantation (FMT) and defined live biotherapeutic products as well as bacteriophage therapies.
Topics to be covered:
- Researcher/reviewer model at FDA's CBER
- Types of positions at CBER
- What is regulatory work?
- Examples of research ongoing in CBER
March 4 - Rosemarie Truman
Founder and CEO of the Center for Advancing Innovation
Topic: "Alternative Careers for PhDs - In Particular Consulting"
Rosemarie Truman is an entrepreneur, growth strategist, distinguished corporate executive, angel investor and prolific startup catalyst. Rosemarie Truman is Founder and CEO of the Center for Advancing Innovation (CAI), a 501c3 non-profit which has been coined “Tinder for Startups” and “Shark Tank on Steroids.” CAI’s mission to identify breakthrough inventions and maximize their commercial potential. With over 25 years of experience in entrepreneurship, executive leadership, and philanthropy, Rosemarie’s specialty is growth and investment strategy, having led growth strategies for 50 of the global Fortune 100 companies in over 15 countries. The strategies that Rosemarie led have resulted in $300+ billion in “net new” top line yearly revenue and 190+ new products on the market.
For her clients and CAI, Rosemarie pioneers innovative, award-winning, disruptive innovation platforms. One of her recent endeavors is a novel challenge-accelerator model that has established a new paradigm for commercializing federally-funded inventions, galvanizing ecosystems, and creating knowledge-based jobs. In three short years, Rosemarie’s challenge-accelerator model has created 300+ companies, 3000 + entrepreneurs, 25+ partnerships, collaborations across federal labs and government agencies, and new business model architectures for obtaining inventions. With this recent initiative, Rosemarie also conceived of, engineered and launched five “first of a kind” challenges to crowdsource startup teams to advance federally funded inventions through CAI. These challenges produced 80 new startup companies, 60% of which are led by women founders.
Under Rosemarie’s leadership, CAI has earned numerous awards and recognition from Health and Human Services, the White House, the Federal Laboratory Consortium and more. CAI has also been featured in the Washington Post, Wired, Huffington Post, Nature, and several other publications. Rosemarie also serves as Director of the DC-metro chapter of the Founder Institute, the world’s largest startup accelerator program. Prior to launching her own firm, Rosemarie spearheaded IBM’s Innovation strategy practice globally. At IBM, she was awarded IBM’s most laudable honor, the Golden Circle Award. In addition, she has also held notable leadership roles at Booz Allen Hamilton, Oracle, PRTM, and Marsh & McLennan, where she served as VP of global strategy. Rosemarie began her career at Goldman Sachs. Her core competencies are in leadership, strategy consulting, investment banking and entrepreneurship.
March 18 - Juergen Klenk, Ph.D.
Principal in Deloitte’s Federal Health Sector, Deloitte, VA
Title: “What to do with a PhD in the Consulting Industry”
Dr. Juergen Klenk is a Principal in Deloitte’s Federal Health Sector. He has a deep technical expertise combined with strong business acumen and a track record of over 20 years of experience in leadership, strategic planning, business development, consulting, project management, science and technology, analytics, and research. Dr. Klenk is a highly experienced entrepreneur and thought leader who has demonstrated the ability to start up, grow, and successfully establish innovative businesses in the Health sector. He has successfully led teams across a wide variety of health and science focused organizations. Throughout his career, Dr. Klenk has worked with some of the leading organizations in health care and life sciences, including the federal government (e.g., NIH, FDA, CDC, CMS, and VA), academic medical centers, commercial health care providers, pharmaceutical and biotech companies, and nonprofit organizations. For the past 15 years his work was focused on topics including precision medicine, health data integration and analysis, clinical trials support and optimization, health outcomes research, and scientific research and innovation. Dr. Klenk has authored numerous publications in peer-reviewed journals, holds multiple patents, and has been invited to present at multiple international conferences. He holds a Ph.D. in Mathematics and a master’s degree in Mathematics and Physics from Eberhard-Karls-Universität Tübingen (Germany). He spent his academic career at Eberhard-Karls-Universität Tübingen, the Australian National University, and Yale University.
March 25 - Michele Gunsior, Ph.D.
Title: "Translational Science in Biotect: Small Biotech vs Large Pharmaceutical"
Dr. Gunsior is a Principal Scientist in the Translational Sciences group within Viela Bio, a small biotech focused on developing life-changing therapies for autoimmune and severe inflammatory diseases. As part of Translational Sciences, Dr. Gunsior is responsible for delivering TS objectives to support all stages of a therapeutic drug program. Dr. Gunsior began her career with a PhD in Chemistry from The Johns Hopkins University. She did her post-doctoral work in the laboratory of Dr. Paul Goldsmith at the National Cancer Institute working on antibody and protein purification and immunoassay development. Her post-doctoral training led to a Principal Investigator position at Covance, a contract research organization that partners with pharmaceutical and biotech companies to bring therapeutics to market. Prior to joining Viela Bio, Dr. Gunsior worked in the Translational Sciences Department at MedImmune/AstraZeneca leading bioanalytical immunoassay method development for nonclinical and clinical programs. While at MedImmune Dr. Gunsior lead the Network of Women Employee Resource Group-Gaithersburg and planned the annual Women’s Summit event for 5 years. Michele is currently Chair of the Women in Pharmaceutical Sciences Community within AAPS.
April 1 - Liam Bradley, Ph.D., Lisa Wright, Ph.D., and Felix Yu, Ph.D.
Title: "A Booz Allen Perspective: The Consulting Life After Completing a Ph.D./Post-doc”
Liam Bradley, PhD is an Associate at Booz Allen Hamilton on the Civil Health Team. He has more than 8 years’ experience in scientific research and management consulting. Prior to Booz Allen finished his bachelor’s degree in Biology from St. Mary’s College of Maryland and PhD in Cell and Molecular Biology at the Perelman School of Medicine at the University of Pennsylvania. At Penn, he studied the innate immune response to the intracellular, zoonotic pathogen, Coxiella burnetii. After graduating, Liam worked at the Boston Consulting Group in the New Jersey office, focusing on optimization of the supply chain and inventory for a US auto parts company and a re-design of the internal commercial review process for a medium sized US biotech company to increase accuracy, legal compliance, and review efficiency. At Booz Allen he supports the Center of Drug Evaluation and Research (CDER) at the FDA where he implements various technology initiatives to modernize and streamline the drug review process. He also supported the standup of the Office of Laboratory Safety, focusing on efforts to establish an internal inventory of chemical and other hazardous materials housed across laboratories at FDA.
Lisa Wright, MS, RAC is a Lead Associate at Booz Allen Hamilton on the Civil Health Team. She has 6 years’ experience in consulting and 11 years’ experience in scientific research. Prior to Booz Allen she obtained her bachelor's degree in Biology from University of Maryland College Park, and master’s degree in biotechnology and Bioinformatics from Johns Hopkins University. She previously worked for NCI's Laboratory of Cancer Biology and Genetics (LCBG) (PI: Stuart Yuspa) using microarray analysis to understand in mechanisms of carcinogenesis with emphasis on signaling pathway alterations in premalignant lesions with a complete absence of EGFR. In addition, the research used the mouse skin carcinogenesis models to study molecular events that illustrated the impact of chronic inflammation on tumor promotion in keratinocytes. After leaving NCI, she worked for a consulting firm that provided regulatory strategy and submissions to pharma and biotech companies that had drugs for rare diseases in development. At Booz Allen, she has supported projects for Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) at FDA in areas of business process improvement, program evaluations and digital transformation initiatives.
Felix Yu, PhD is a Senior Consultant and Health Data Subject Matter Expert at Booz Allen Hamilton. Prior to Booz Allen, Felix completed his bachelor’s degree in Chemistry and Ph.D. in Chemical Biology from Texas A&M University and Johns Hopkins University respectively. At Hopkins (PI: Jun O. Liu), he discovered a novel small molecule activator of actin-dependent YAP signaling as a potential drug lead for regenerative medicine. As a graduate student, Felix has also led multiple student-ran organizations raising over $30K in total funding and spearheaded six pro-bono consulting projects, including works with Pfizer and the Baltimore City Council. In the final years of his graduate career, Felix interned with Booz Allen, where he worked on capturing NIH-NCI opportunities, securing partnership with nationwide voluntary health organizations, and developing native language processing capabilities for life science research tools. As a full-time employee, Felix continues to offer his scientific research and healthcare expertise to support Booz Allen’s businesses and clients in the federal health space. Felix is currently assisting FDA’s Center for Drug Evaluation and Research (CDER) in adopting modernized technology to improve efficiency and decision-making during drug review processes.
Topics to be covered:
- Booz Allen Hamilton's Business: overall missions, federal business, innovative engineering, commercial business
- History of Booz Allen Hamilton in life science research and public health
- Career at Booz Allen Hamilton - life of a scientist or a PhD/Fellow with basic science background.
April 8 - Alexander Putman, Ph.D.
Pharmacologist, Division of Hematology Oncology Toxicology, CDER, FDA
Title: “Role of a pharmacology/toxicology reviewer at the U.S. Food and Drug Administration”
Dr. Putman received his PhD in Pharmacology and Toxicology from Virginia Commonwealth University School of Medicine. As a pharmacology/toxicology reviewer with the U.S. Food and Drug Administration, Dr. Putman reviews and evaluates results from non-clinical studies submitted to the Office of Hematology Oncology Products, in support of Investigational New Drug applications (INDs) and New Drug Applications (NDAs). This includes evaluating the toxicological potential of investigational drugs to support proposed clinical trials or dosage regimens for marketing drugs, developing drug labeling as it pertains to non-clinical studies and safety, and communicating with industry representatives to provide advice and guidance regarding non-clinical studies.
Topics to be covered:
- Drug development timeline
- Non-clinical study requirements for INDs and NDAs
- Role of a pharmacology/toxicology reviewer
- Skills needed to be a pharmacology/toxicology reviewer
- Application recommendations
April 15 - Fatima Ali-Rahmani, Ph.D.
Title: Details to be added later.
May 6 - Raed Samara, Ph.D.
Global Product Manager, QIAGEN, Washington, DC
Title: “Insights into project and product management in the private sector”
Raed Samara is a Global Product Manager at QIAGEN of several genetic profiling lines of products, mainly those used for targeted DNA and RNA sequencing. In this role, he is responsible for go-to-market and launch activities for new products. In addition, he manages day-to-day activities to support existing products. Prior to this position, Raed was a scientist in the R&D Project Management department of QIAGEN, where he managed and coordinated multiple life sciences product development projects across R&D, Marketing, and Operations teams. Prior to his roles with QIAGEN, Raed was a postdoctoral fellow at the National Cancer Institute (NCI) in the United States conducting research in the field of cancer immunology with emphasis on identifying strategies to boost the efficacy of cancer vaccines. Raed earned his PhD degree in Cancer Biology from Georgetown University.
Topics to be covered:
- Day-to-day responsibilities in Project and Product Management
- Skills needed in industry
- Differences between academia and industry
- Culture in Industry
- What industry looks for in applicants?
- Career Progression
- Job security
- What you need to do