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Life Sciences Future – BioPharm 

Speakers

Ambassador Deborah L. Birx, M.D.

Ambassador Deborah L. Birx, M.D.

White House Coronavirus Response Coordinator

Fireside Chat | 10:15 am – 11:00 am, Wednesday, September 30

 The White House has appointed world-renowned global health official and physician Ambassador Deborah Birx to the Office of the Vice President to aid in the whole of government response to COVID-19 as the Coronavirus Response Coordinator.

Ambassador-at-Large, Deborah L. Birx, M.D., is the Coordinator of the United States Government Activities to Combat HIV/AIDS and U.S. Special Representative for Global Health Diplomacy. Ambassador Birx is a world-renowned medical expert and leader in the field of HIV/AIDS. Her three-decade-long career has focused on HIV/AIDS immunology, vaccine research, and global health. As the U.S. Global AIDS Coordinator, Ambassador Birx oversees the implementation of the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the largest commitment by any nation to combat a single disease in history, as well as all U.S. Government engagement with the Global Fund to Fight AIDS, Tuberculosis and Malaria. Serving as the U.S. Special Representative for Global Health Diplomacy, she aligns the U.S. Government’s diplomacy with foreign assistance programs that address global health challenges and accelerate progress toward: achieving an AIDS-free generation; ending preventable child and maternal deaths; and preventing, detecting, and responding to infectious disease threats.

In 1985, Ambassador Birx began her career with the Department of Defense (DoD) as a military-trained clinician in immunology, focusing on HIV/AIDS vaccine research. From 1985-1989, she served as an Assistant Chief of the Hospital Immunology Service at Walter Reed Army Medical Center. Through her professionalism and leadership in the field, she progressed to serve as the Director of the U.S. Military HIV Research Program (USMHRP) at the Walter Reed Army Institute of Research from 1996-2005. Ambassador Birx helped lead one of the most influential HIV vaccine trials in history (known as RV 144 or the Thai trial), which provided the first supporting evidence of any vaccine’s potential effectiveness in preventing HIV infection. During this time, she also rose to the rank of Colonel, bringing together the Navy, Army, and Air Force in a new model of cooperation – increasing the efficiency and effectiveness of the U.S. Military’s HIV/AIDS efforts through inter- and intra-agency collaboration. Then known as Colonel Birx, she was awarded two prestigious U.S. Meritorious Service Medals and the Legion of Merit Award for her groundbreaking research, leadership, and management skills during her tenure at DOD.

From 2005-2014, Ambassador Birx served successfully as the Director of CDC’s Division of Global HIV/AIDS (DGHA), which is part of the agency’s Center for Global Health. As DGHA Director, she utilized her leadership ability, superior technical skills, and infectious passion to achieve tremendous public health impact. She successfully led the implementation of CDC’s PEPFAR programs around the world and managed an annual budget of more than $1.5 billion. Ambassador Birx was responsible for all of the agency’s global HIV/AIDS activities, including providing oversight to more than 400 staff at headquarters, over 1,500 staff in the field, and more than 45 country and regional offices in Africa, Asia, Caribbean, and Latin America. Recognized for her distinguished and dedicated commitment to building local capacity and strengthening quality laboratory health services and systems in Africa, in 2011, Ambassador Birx received a Lifetime Achievement Award from the African Society for Laboratory Medicine. In 2014, CDC honored her leadership in advancing the agency’s HIV/AIDS response with the highly prestigious William C. Watson, Jr. Medal of Excellence.

Ambassador Birx has published over 220 manuscripts in peer-reviewed journals, authored nearly a dozen chapters in scientific publications, as well as developed and patented vaccines. She received her medical degree from the Hershey School of Medicine, Pennsylvania State University, and beginning in 1980 she trained in internal medicine and basic and clinical immunology at the Walter Reed Army Medical Center and the National Institutes of Health. Ambassador Birx is board certified in internal medicine, allergy and immunology, and diagnostic and clinical laboratory immunology.

Luis Jodar, MD

Luis Jodar, MD

Chief Medical Officer for Vaccines Medical Development and Medical/Scientific Affairs, Pfizer

Closing Speaker: The COVID-19 Vaccine Race: An Update | 12:30 pm – 1:00 pm, Friday, October 2

Dr. Luis Jodar is Chief Medical and Scientific Affairs Officer for Pfizer Vaccines. In this capacity, he heads Pfizer’s vaccines medical development, clinical and scientific affairs worldwide comprising around 200 MD, PhD vaccinologists. Dr. Jodar joined Pfizer after serving as Executive Director for Clinical and Scientific Affairs for the Asia Pacific region at Wyeth.

Before joining industry, Dr. Jodar was Deputy Director General at the International Vaccine Institute (IVI) in Seoul, Korea, an organization established by the United Nations, as well as an adjunct professor at Seoul National University. At the IVI, he was responsible for directing the Translational Research Division, which conducts programs of interdisciplinary research, including clinical trials, epidemiological research, studies of the economics of vaccine introduction, and sociobehavioral and policy research on vaccines.

Previously, Dr. Jodar worked at the World Health Organization (WHO) leading the global vaccine research and introduction of meningococcal vaccines, activities related to adverse events allegations and quality, safety and correlates of protection of vaccines.

Dr. Jodar is a neuroimmunologist with doctoral and post-doctoral training in Madrid, Osaka and Nagasaki Universities. He has worked in vaccine-related programs in more than 50 countries, published in the most accredited peer-review journals, and served on a number of advisory groups on vaccines to WHO, the EU, vaccine manufacturers and governments. He teaches at the Institut Pasteur, ADVAC and Columbia University and has a long track-record in launching and coordinating public private vaccine development partnerships to accelerate the development and introduction of vaccines of public health importance for developing and middle-income countries. He has also been awarded several honors including the “cross of officer of the order of civil merit” from the King of Spain for his work in developing countries.

Janet Woodcock, M.D.

Janet Woodcock, M.D.

Director, Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA)

Fireside Chat | 9:00 AM – 9:45 AM, Thursday, October 1

 Janet Woodcock is Director of the Center for Drug Evaluation and Research (CDER), at the Food and Drug Administration (FDA). In 2015, Dr. Woodcock also assumed the role of Acting Director of CDER’s newly formed Office of Pharmaceutical Quality, (OPQ). Dr. Woodcock first joined CDER in 1994. For three years, from 2005 until 2008, she served FDA’s Commissioner, holding several positions, including as Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations, and Chief Operating Officer. Her responsibilities involved oversight of various aspects of scientific and medical regulatory operations. Before joining CDER, Dr. Woodcock served as Director, Office of Therapeutics Research and Review, and Acting Deputy Director in FDA’s Center for Biologics Evaluation and Research. Dr. Woodcock received her M.D. from Northwestern Medical School and completed further training and held teaching appointments at the Pennsylvania State University and the University of California in San Francisco. She joined FDA in 1986.

Bruce Levine

Bruce Levine

Barbara and Edward Netter Professor in Cancer Gene Therapy at the University of Pennsylvania Perelman School of Medicine

From the Heart of Cellicon Valley: An Update | 11:40 am – 12:10 pm, Thursday, October 1

Dr. Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, is the Founding Director of the Clinical Cell and Vaccine Production Facility (CVPF) in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania. He received a B.A. (Biology) from Penn and a Ph.D. in Immunology and Infectious Diseases from Johns Hopkins. First-in-human adoptive immunotherapy trials include the first use of a lentiviral vector, the first infusions of gene edited cells, and the first use of lentivirally-modified cells to treat cancer. Dr. Levine has overseen the production, testing and release of 3,000 cellular products administered to >1,200 patients in clinical trials since 1996. He is co-inventor of the first FDA approved gene therapy (Kymriah), chimeric antigen receptor T cells for leukemia and lymphoma, licensed to Novartis. Dr. Levine is co-inventor on 27 issued US patents and co-author of >180 manuscripts and book chapters with a Google Scholar citation h-index of 87. He is a Co-Founder of Tmunity Therapeutics, a spinout of the University of Pennsylvania. Dr. Levine is a recipient of the William Osler Patient Oriented Research Award, the Wallace H. Coulter Award for Healthcare Innovation, serves as President of the International Society for Cell and Gene Therapy, and serves on the Board of Directors of the Alliance for Regenerative Medicine. He has written for Scientific American and Wired and has been interviewed by the NY Times, Wall Street Journal, Washington Post, NPR, Time Magazine, National Geographic, Bloomberg, Forbes, BBC, and other international media outlets.

Michelle McMurry-Heath, M.D., Ph.D.

Michelle McMurry-Heath, M.D., Ph.D.

President & CEO, BIO

Breakfast with the CEO | 8:00 AM – 8:45 AM, Thursday, October 1

Michelle McMurry-Heath assumed the leadership of the Biotechnology Innovation Organization (BIO) as President and CEO on June 1, 2020. A medical doctor and molecular immunologist by training, Dr. McMurry-Heath becomes just the third chief executive to steward the world’s largest biotechnology advocacy group since BIO’s founding in 1993.

BIO represents 1,000 life sciences companies and organizations from 30 countries. The organization’s mission is to support companies that discover and deploy scientific breakthroughs that improve human heath, environmental stewardship, and sustainable agriculture.

The common thread in McMurry-Heath’s work across academia, government and industry has been her focus on broadening access to scientific progress so more patients from diverse backgrounds can benefit from cutting-edge innovation. Driven by her own past family experiences navigating clinical trials and funding uncertainties within the rare disease community, McMurry-Heath calls “the distribution of scientific progress the social justice issue of our age.”

She comes to BIO from Johnson & Johnson where she served as Global Head of Evidence Generation for Medical Device Companies and then Vice President of Global External Innovation and Global Leader for Regulatory Sciences. She was also instrumental in bringing J&J’s incubator, JLabs, to Washington, DC. She led a global team of 900 with responsibilities in 150 countries around the globe.

Prior to her time at J&J, Dr. McMurry-Heath was also a key science policy leader in government. The Obama-Biden transition team tapped her to conduct a comprehensive analysis of the National Science Foundation’s policies, programs and personnel. President Obama then named her associate science director of the FDA’s Center for Devices and Radiological Health under Commissioner Peggy Hamburg. In that role, she championed clinical trial evolution, the use of real-world evidence in product evaluation, and an embrace of the patient’s voice in health research so new medical products deliver outcomes that matter to them.

McMurry-Heath was the founding director of the Aspen Institute’s Health, Biomedical Science, and Society Policy Program, where she promoted personalized medicine and bolstered international preparation for pandemic disease threats. She received her early training in science policy from the Robert Wood Johnson Foundation and later served as Senator Joe Lieberman’s top legislative aide for science and health. In that role, she drafted legislation to protect the country from biological attacks.

McMurry-Heath received her MD/PhD from Duke’s Medical Scientist Training Program, becoming the first African-American to graduate from the prestigious program. She spent 12 years working at the research bench before taking policy and leadership roles in government and industry.

McMurry-Heath lives in Washington, D.C. with her husband Sebastian Heath, a veterinarian, and their daughter, Isabella. To relax, she enjoys yoga, snorkeling and her daughter’s sporting events.

Stephen Pitt, Ph.D.

Stephen Pitt, Ph.D.

Head of Johnson & Johnson Innovation, JLABS US North East

An Introduction to JLABS: Who We Are, What We Do | 11:05 AM – 11:35 AM, Thursday, October 1

Stephen Pitt, Ph.D. is the Head of Johnson & Johnson Innovation, JLABS US North East which includes the JLABS @ NYC, JPOD @ Boston, JLABS @ LabCentral, JLABS @ M2D2 and JPOD @ Philadelphia. He is responsible for external engagement, innovation sourcing, company onboarding, portfolio management, operational excellence, educational programming and P&L. He catalyzes and supports the translation of science and technology into valuable solutions for patients and consumers across the pharmaceutical, medical device, consumer and healthtech sectors.

Steve joined JLABS from GlaxoSmithKline, where he was Senior Director of Emerging Science Innovation and Head of the Digital Innovation Hub R&D Team. At GSK, Steve led externally focused R&D teams that shifted pipeline strategies from basic symptom relief to holistic disease management to transform self-care. He also created partnerships with academic institutions, start-ups, corporate partners, hospital systems, and other novel outsourcing collaborators with the aim to build breakthrough technology platforms and products.

Prior to GSK, he continually increased his responsibility as an R&D leader over 15 years in drug discovery, pharmaceutical development and consumer healthcare at Johnson & Johnson, Pfizer, Bayer, and in biotech. His experiences include drug discovery and advancing compounds to clinical trials, pharmaceutical development and commercialization of novel Rx Drugs, and consumer health product development in upstream innovation groups to shape and launch new external technologies.

Steve earned his Ph.D. in Molecular Pharmacology from Cornell Medical School and Memorial Sloan Kettering Cancer Center in New York City. At Cornell, Steve pioneered computational molecular dynamic drug discovery approaches. He also holds several patents and has published in top scientific journals.

Keith Mazza

Keith Mazza

Senior Director, Pfizer

Company Reverse Pitch | 10:50 AM – 11:20 AM, Wednesday, September 30

Keith Mazza is currently a Senior Director on Pfizer’s Corporate Development team, focused on leading out-licensing and corporate transactions. Keith joined Pfizer in 2011 as part of the team that values Pfizer’s external licensing, partnering and M&A opportunities. Keith became the head of the external valuation group in 2016, before transitioning to his current role in early 2019.

Prior to joining Pfizer, Keith was an Associate in J.P. Morgan’s Investment Bank and an Analyst at MCG Capital, a boutique investment firm. Keith received his MBA from the Darden School of Business at the University of Virginia and his undergraduate Finance degree from Georgetown University.

Chris Garabedian

Chris Garabedian

Chairman and CEO, Xontogeny LLC

Driving Win-Win Investment Collaborations with Entrepreneurs and Scientific Founders | 11:45 AM – 12:15 PM, Wednesday, September 30

 Chris Garabedian founded Xontogeny in June of 2016 to support multiple promising technologies from early development through clinical proof of concept. In 2017, Chris joined Perceptive Advisors to develop their Venture Fund strategy and launched the Perceptive Xontogeny Venture Fund in 2018 to support early stage companies seeded and incubated at Xontogeny and other ventures.

Chris has a broad base of experience and a track record of success over his decades long experience in the biopharma industry. Chris served as the President and CEO of Sarepta Therapeutics from 2011 to 2015, overseeing the turnaround of a company that is now a commercial stage leader in the genetic technology space after leading the development of the company’s Duchenne Muscular Dystrophy program. Prior to Sarepta, Chris led Corporate Strategy for Celgene from 2007 to 2010. Prior to Celgene, Chris served in a number of global commercial and corporate development leadership roles at Gilead from 1997 to 2005.

Chris serves on a number of Boards of life sciences companies and speaks at industry conferences on a wide range of important issues. Chris is also on the Board of Directors of MassBio and serves as a Senior Advisor for the Boston Consulting Group.

Eric B. Kmiec, PhD

Eric B. Kmiec, PhD

Director, Gene Editing Institute, Helen F. Graham Cancer Center & Research Institute, ChristianaCare

Can CRISPR-based technologies lessen disparities in access to equitable healthcare? | 9:30 AM – 10:00 AM, Friday, October 2

Eric B. Kmiec, Ph.D., is the Founder and Director of the Gene Editing Institute (GEI) at the Helen F. Graham Cancer Center & Research Institute at Christiana Care Health System. The Gene Editing Institute has recently been endowed by the Ammon Foundation. His research centers on understanding the process of gene repair and gene editing with a focus on CRISPR-directed genome engineering in human cells. He is widely recognized for his pioneering work in the fields of molecular medicine and gene editing having discovered many of the molecular activities that regulate the efficiency of human gene editing. Throughout his professional career, Dr. Kmiec has led research teams in developing gene editing technologies and genetic therapies for inherited disorders such as Sickle Cell Disease. Research efforts in GEI now centers on the mechanism of action, the genotoxicity and the regulation of gene editing based and how best to translate these discoveries into novel therapeutics for Sickle Cell Disease, Non-Small Cell Lung Carcinoma and Melanoma using a patient-centered approach.

Dr. Kmiec received his BA in Microbiology from Rutgers University, MS in Cell Biology from Southern Illinois University and his Ph.D. in Molecular Biology and Microbiology from the University of Florida School of Medicine. His Post-doctoral training was done at University of Rochester. Dr. Kmiec holds faculty appointments at the University of Delaware and the Wistar Institute. He has also held faculty appointments at Thomas Jefferson University, University of California at Davis and Georgetown University School of Medicine.

Dr. Kmiec has served as the Principal Investigator for research projects supported by the National Institute of Health (R01, COBRE and R21 grants), the National Science Foundation, the NIST-BIRD Foundation, the March of Dimes, the State of Delaware and the American Cancer Society for over 35 years. He serves on numerous editorial boards, has authored 165 peer-reviewed publications as primary or senior author, numerous reviews and has edited several books and journals in gene therapy.

Dr. Kmiec has been the primary thesis mentor for 18 Ph.D. students, 4 MS students and numerous postdoctoral fellows and residents. He has held or holds major administrative posts on various NIH regional and State biomedical research grants, including IDeA Network of Biomedical Research (INBRE) and Centers of Biomedical Research Excellence (COBRE) as well as NIH study sections. Dr. Kmiec was also honored as the Eminent Scholar in residence at Marshall University (Huntington, West Virginia) in 2009-2011 and was elected as an Honorary Medical Commander of the 436th Air Wing at Dover Air Force Base in Dover, Delaware for in 2013 and again in 2014. Dr. Kmiec has 15 issued patents, has founded two biotechnology companies and has received numerous service medals and awards, including the Genome Canada Lectureship, the Proudford Research Award in Sickle Cell Disease, multiple Delaware Bio Science Innovation Awards, and the Philadelphia- Israeli Chamber of Commerce Life Science Innovator Award.

Anjali Kumar, Ph.D.

Anjali Kumar, Ph.D.

External Innovation Search and Evaluation, Eastern US, Johnson & Johnson Innovation

Company Reverse Pitch | 11:40 AM – 12:10 PM Thursday, October 1

Anjali leads External Innovation Search and Evaluation in Eastern US for therapeutics and platform technologies at J&J Innovation. She is responsible for developing an external early-stage innovation pipeline aligned with the strategies of the businesses.

Prior to J&J, Anjali spent 25 years in the industry working for 20 of them in R&D at large and small companies, including The Upjohn Company, Genetics Institute/Wyeth, Critical Therapeutics, Clinquest Inc. and Flexion Therapeutics, where she held roles with increasing responsibilities in drug discovery and development and program leadership across multiple therapeutic areas, advancing programs from early discovery all the way through to regulatory approval. She then moved to Corporate Development at Shire Pharmaceuticals where she led large cross-functional due diligence teams performing integrated assessments for incoming M&A and in-licensing opportunities. She helped navigate opportunities in support of all Shire franchises and also played a key role in integration, establishing and leading alliances.

Anjali holds a PhD in Bioengineering from Georgia Tech, Atlanta, GA, and a Bachelor’s in Chemical Engineering from the Indian Institute of Technology, Roorkee, India.

Marla A. Phillips, Ph.D.

Marla A. Phillips, Ph.D.

Director, Xavier Health, Xavier University

COVID-19 Impacts on Supply Chain | 12:25 pm – 12:55 am Thursday, October 1

Marla founded Xavier Health in 2008 at Xavier University, where she advances the industry with FDA officials and Pharmaceutical and Medical Device professionals. Marla began working in the pharmaceutical industry for Merck in 1996 where she took on roles of increasing responsibility, culminating in the position of Head of Quality Operations at the Merck North Carolina facility. Additionally, Marla is the Founder, CEO and President of Pathway for Patient Health, leading the implementation of a Quality Science Education program that is free for undergraduate and graduate students around the world, and is working with Chief Quality and Operations Officers to Mobilize Enterprise-wide Effectiveness. Marla holds a B.S. in Chemistry from Xavier University, and a Ph.D. in Organic Chemistry from the University of North Carolina – Chapel Hill.

Chris Sasiela, PhD, RAC

Chris Sasiela, PhD, RAC

Senior Regulatory Specialist, Innovator Support Team Lead, SEED (Small Business Education and Entrepreneurial Development), Office of Extramural Research, NIH

SEED and SBIR Programs – Latest Updates | 12:25 PM – 12:55 PM, Thursday, October 1

Dr. Sasiela has over a decade of experience providing support and consultation to academic innovators and small businesses engaged in therapeutic, device, and diagnostic development programs. As the Innovator Support Team Lead in SEED (Small business Education and Entrepreneurial Development) in the Office of Extramural Research at the National Institutes of Health, Chris coordinates the activities of a team of seasoned professionals with experience in product and business strategy, business development, fundraising, partnerships, reimbursement, and regulatory affairs. Chris is passionate about enabling NIH’s innovator community to progress their discoveries as far as science and human biology permit. Starting her career as a researcher, Chris worked in basic research at the University of Southern California and the University of Maryland, and in drug discovery, development, and improvement groups at Baxter, the Department of the Army, and the National Cancer Institute. Chris transitioned from a research to a regulatory career path via an Interagency Oncology Taskforce Fellowship at the US Food and Drug Administration. Continuing her regulatory career path at Social & Scientific Systems, the National Institute of Allergy and Infectious Diseases, and the National Heart, Lung, and Blood Institute, Chris deepened her experience working with product development researchers understand, develop, and execute regulatory plans to get their innovative technologies from ideas to first-in-human and beyond. She regularly conducts project-focused consultations, delivers educational seminars, and develops regulatory resources for internal and external audiences. Dr. Sasiela earned a bachelor’s degree in chemistry from Whittier College, a Ph.D. in Pharmaceutical Sciences from the University of Maryland, School of Pharmacy, and has maintained Regulatory Affairs Certification status from the Regulatory Affairs Professional Society since 2011.

Stephanie Read

Stephanie Read

Vice President, Corporate Strategy & Business Development, CSL Behring

Company Reverse Pitch | 12:15 PM – 12:45 PM, Wednesday, September 30

Steph Read is a global Vice President leading search, evaluation and execution of biotechnology M&A, late phase in-licensing, and build-to-buy investments in strategically-aligned biotechnology and platform companies (CSL Mkt cap: $135 Billion AUD).

Steph joined CSL from AstraZeneca (MedImmune), where she held a number of positions of increasing responsibility within R&D, Alliance Management, Specialty Care Sales and Marketing Leadership, and Corporate Development.

She holds a Bachelor of Science in Biology from Virginia Tech, and a Master of Science in Biotechnology from The Johns Hopkins University. Steph joined the biotechnology industry in 1998, and she has learned something new, every day since.

Jim Fries

Jim Fries

CEO, Rx-360

Supply Chain Virtual Audits: Temporary Change or Permanent Impact? | 10:15 am – 10:45 am, Wednesday, September 30 

Jim Fries is a success based executive with over 25 years of experience building medical device and diagnostic companies. He became CEO of Rx-360 in February of 2018. Jim’s dedication to healthcare supply chain security and patient safety has always been his personal mission. In 2020 Rx-360 also founded the Rx-360 Education and Research Foundation (501c3) that is dedicated to bringing awareness of patient safety to everyone worldwide through educational programs and research. His personal vision coupled with the Rx-360 mission brings a wealth of awareness and success to all Rx-360 members and the industry as a whole.

Amy Manley

Amy Manley

Head of Clinical and Medical Operations, Paratek Pharmaceuticals

Clinical Trials: How to Move Forward During COVID-19 | 10:50 am – 11:20 am, Friday, October 2

 

Mittie Doyle, MD, FACR

Mittie Doyle, MD, FACR

Vice President, Clinical Research and Therapeutic Area Strategy- Immunology, CSL Behring

Update On Plasma Therapies | 8:55 AM – 9:25 AM, Friday, October 2

Mittie Doyle, MD, FACR joined CSL Behring in 2017 and currently serves as Vice President and Clinical Co-Lead overseeing Immunology Clinical and Therapeutic Strategy. Mittie earned her M.D. at Yale School of Medicine, completed her Internal Medicine training at Massachusetts General Hospital and her Rheumatology fellowship at Brigham and Women’s Hospital. She is a board-certified rheumatologist with over 25 years of experience in both academic medicine and the pharmaceutical industry. She previously served on the faculties of Harvard and Tulane Medical School and the adjunct faculty at the University of Pennsylvania Medical School.

Her clinical development expertise spans first in human clinical trials and proof of concept through successful BLA submission. She began her industry career at Centocor/Janssen supporting numerous large molecule programs including Remicade® and Simponi®. She also led the Stelara® psoriatic arthritis program. Following her tenure at Janssen, she gained experience at two smaller biotech companies; first in the Early Development / Translational Medicine group at Alexion as a Senior Medical Director in complement biology and then as Vice President of Clinical Research and Development at Flexion Therapeutics for the Zilretta® program. Prior to joining CSL Behring she served as Vice President, Global Development Team Leader in Immunology at Shire.

In addition to her strong background in Immunology, Mittie brings extensive experience in orphan drug development, indication selection, corporate strategy and business development to her role at CSL Behring.

Stephen E. Yoder, MD, MBA

Stephen E. Yoder, MD, MBA

Vice President, Business Development, Taiho Oncology

Company Reverse Pitch | 10:00 AM – 10:30 AM, Thursday, October 1

Steve joined Taiho Oncology Inc. as Vice President, Business Development in June 2020. In this newly created role, he is leading the company’s efforts to in-license and acquire additional oncology marketed products and late-stage development therapeutic candidates for treating solid tumors and hematological malignancies. These partnered assets will be added to Taiho Oncology’s expanding portfolio of internally discovered candidates and approved products addressing the needs of cancer patients in North America.

Dr. Yoder received his Doctorate of Medicine from the University of Virginia and completed a residency in Internal Medicine at Pennsylvania Hospital in Philadelphia. He subsequently received a Masters of Business Administration in Health Care Management at the Wharton School, University of Pennsylvania. Steve has over 25 years of experience in the biopharmaceutical industry, including work in a variety of roles in Strategic Planning, New Product Development, and Marketing at Pfizer. More recently, he served in leadership roles in Search & Evaluation at both Bristol-Myers Squibb and Celgene Business Development, and has been involved in completing many transactions involving therapeutic candidates and collaborations.

Steve serves on the Board of Directors of Life Sciences Pennsylvania.

George Khalife

George Khalife

Vice President, Midwest U.S., Toronto Stock Exchange & TSX Venture Exchange

Company Reverse Pitch | 10:50 AM – 11:20 AM, Friday, October 2

George Khalife is the Vice President of Capital Formation leading the TSX’s efforts across the Midwest U.S. Based out of Chicago, George works closely with innovation companies at varying stages to explore the opportunity of raising public capital as a financing option for accelerating growth. Previous to joining the TSX, George led the marketing & business development for a growing FinTech startup called owl.co and prior to that, led the business development for a boutique tech-focused M&A firm called Sampford Advisors. On the side, George co-founded an app called BookBack for students to buy and sell books more easily (which cracked the top 100 charts for free apps), as well as hosts a top 200 entrepreneurship-focused podcast called Let’s Grab Coffee which features the stories of successful founders across different industries.

Paul Larkin

Paul Larkin

Manager, IBD Ventures, Crohn's & Colitis Foundation

Company Reverse Pitch | 10:15 AM – 10:45 AM, Friday, October 2 

Paul is the Manager of the IBD Ventures program at the Crohn’s & Colitis Foundation. IBD Ventures seeks to accelerate the development of products that improve the quality of life of patients with inflammatory bowel disease by investing in new product development across therapeutics, devices, diagnostics and digital health. Prior to joining the Crohn’s & Colitis Foundation, Paul worked in commercialization of life science in consulting, venture capital, tech transfer and business development roles. Paul completed his PhD at UCSF and postdoctoral studies at Stanford.

Lisa Gonzalez

Lisa Gonzalez

Chief‌ ‌Meditation‌ ‌Officer,‌ ‌Meditation4Leadership‌

Leading from Within: How Meditation Can Make You a More Effective Leader | 12:20 PM – 12:50 PM, Wednesday, September 30 

Lisa Gonzalez has been teaching in a variety of roles for over 15 years. As a former school teacher, Lisa understands the importance and relevance of yoga, meditation and mindfulness. She serves as Meditation4Leadership’s Chief Meditation Officer training leaders in the corporate world how to effectively use meditation as a tool to develop a deeper awareness, enhance their connections, broaden their perspective and achieve their greatest potential both professionally and personally. She has studied yoga and meditation from world renowned yoga teacher Jonny Kest. Lisa is also a “teacher of teachers” as she leads some of the most successful Yoga Teacher Trainings in the nation for LifeTime Fitness.  Recently completing her first 10 Day silent Vipassana Meditation, she considers the late S.N. Goenka one of her greatest teachers.

Mike Krepps

Mike Krepps

Principal, BrightEdge Investments, American Cancer Society

Company Reverse Pitch | 11:00 AM – 11:30 AM, Wednesday, September 30

 

Susan Van Meter

Susan Van Meter

Executive Director, AdvaMedDx

COVID-19 Testing: What You Need to Know Now | 10:15 AM – 10:45 AM, Friday, October 2

Susan Van Meter is executive director of AdvaMedDx. AdvaMedDx represents manufacturers of in vitro diagnostic (IVD) tests and technologies. AdvaMedDx member company innovations allow early detection of disease, facilitate evidence-based medicine, improve patient health and health care, and enable personalized medicine, while often lowering overall health care costs. AdvaMedDx is the only advocacy organization exclusively addressing policy issues facing diagnostics manufacturers in the U.S. and around the world.

AdvaMedDx operates as a division of AdvaMed, the Advanced Medical Technology Association. AdvaMed is the world’s largest medical technology association, with over 400 member companies that develop medical devices, diagnostic tools, and health information systems.

Prior to joining AdvaMedDx in 2018, Ms. Van Meter served as senior vice president at the Healthcare Association of New York State (HANYS), focused on hospital and health system policy, payment, quality and health information technology priorities. Ms. Van Meter has an undergraduate degree in Political Science and French from Villanova University and a MA in Political Science from Boston University.

Albert W. DeRitis

Albert W. DeRitis

Assistant Clinical Professor at Drexel LeBow College of Business, Drexel University

Supply Chain Globalization or Localization in a Post-Pandemic Era? | 11:05 AM – 11:35 AM, Thursday, October 1

Mr. Albert DeRitis is an Assistant Clinical Professor at Drexel LeBow College of Business. He brings over thirty-five years of unique & diversified experience in accounting, finance, and supply chain in the healthcare industry. He has an in-depth understanding of domestic and international marketplace dynamics across Supply Chain, Commercial Sales & Marketing, and R&D organizations.

Most recently, he served as Worldwide Supply Chain Product Management Director for Johnson & Johnson, where he was responsible for all aspects of Life Cycle Management and End-to-End (E2E) supply chain for J&J’s top selling pharmaceutical product across 111 markets, impacting 2.7 million patients worldwide.

Mr. DeRitis previously served as Worldwide Financial Controller for a French Pharmaceutical company. He possesses knowledge in both Chemical (small molecule) and Biologic (large molecule) API business models, and has manufacturing plant experience in both environments.

  • Executive Faculty Member for LeBow College of Business
  • MBA from St. Joseph’s University Haub School of Management
  • Certified Public Accountant (CPA), Certified Supply Chain Professional (CSCP), and Chartered Global Management Accountant (CGMA).
  • Courses include: Essentials of Financial Reporting for MBA/EMBA, Operations & Supply Chain Management, Cost Accounting, Advanced Cost Accounting, Strategic Cost Management, Integrating Supply Chain with Financial Management, and Strategy & the Master Budgeting Process
Ben Doranz, Ph.D., MBA

Ben Doranz, Ph.D., MBA

President and CEO, Integral Molecular

COVID-19 Mutation: What the Scientists Are Seeing | 10:15 AM – 10:45 AM, Wednesday, September 30 

Ben Doranz co-founded Integral Molecular in 2001 and has led all aspects of the company’s growth since its inception, bringing five different technologies from research to market and growing the company into a profitable commercial entity. He is an inventor on six of the company’s patents, the principal investigator on over 30 NIH grants, and an author on over 90 publications, including articles published in Cell, Science, and Nature.

Dr. Doranz is an established life science entrepreneur previously responsible for directing the biotechnology program at the Port of Technology business incubator and helping create startups at the University of Pennsylvania. Dr. Doranz earned a Ph.D. in Cellular and Molecular Biology from the University of Pennsylvania where he led the discovery of the coreceptor for HIV (CCR5), an MBA at Wharton where he co-founded the Penn Biotech Group, and a BA at Cornell University.

Michael‌ ‌Flaschen

Michael‌ ‌Flaschen

‌Head of Headquarters‌ ‌Transactions‌ ‌Group‌ , Merck‌

Company Reverse Pitch | 10:00 AM – 10:30 AM, Thursday, October 1

Michael Flaschen leads the Headquarters Transactions Group at Merck (MSD outside of the United States and Canada). Michael’s group handles a wide range of transactions from research stage through commercialized products. Prior to Merck, Michael worked for Aduro Biotech, Amgen, Johnson & Johnson and Kirkland and Ellis. Michael has a J.D. from NYU and an undergraduate degree from Tulane University.

David B. Nash, M.D., M.B.A.

David B. Nash, M.D., M.B.A.

Founding Dean Emeritus at Jefferson College of Population Health, Thomas Jefferson University

Closing Speaker – COVID-19: Are We in the Second Wave Yet? | 11:30 AM – 12:30 PM, Friday, October 2

David B. Nash is the Founding Dean Emeritus, and he remains on the full-time faculty as the Dr. Raymond C. and Doris N. Grandon Professor of Health Policy, at the Jefferson College of Population Health (JCPH). His 11 year tenure as Dean completes 30 years on the University faculty. JCPH is dedicated to developing healthcare leaders for the future.  After voluntarily stepping down as Dean, Jefferson Health asked him to take on some additional responsibilities as “Special Assistant” to the Chief Physician Executive, and a member of the board of our ACO, one of the largest in the nation, effective July 2019.

A board-certified internist, Dr. Nash is internationally recognized for his work in public accountability for outcomes, physician leadership development, and quality-of-care improvement.  More recently, he has achieved wide acclaim for his Covid19 thought leadership and has been named as the Chief Health Advisor for the Philadelphia Convention and Visitor’s Bureau.

Repeatedly named to Modern Healthcare’s list of Most Powerful Persons in Healthcare, his national activities cover a wide scope.  Dr. Nash is a principal faculty member for quality of care programming for the American Association for Physician Leadership (AAPL) in Tampa, FL.  He served for a decade on the John M. Eisenberg Award Committee for The Joint Commission.  He also is a founding member of the AAMC-IQ Steering Committee, the group charged with infusing the tenets of quality and safety into medical education.

Dr. Nash has governance responsibilities for organizations in the public and private sectors.  He has chaired the Technical Advisory Group (TAG) of the Pennsylvania Health Care Cost Containment Council (HC4) for more than 20 years and he is widely recognized as a pioneer in the public reporting of outcomes.  Dr. Nash has been a hospital trustee for 20 years.  He served on the Board of Trustees of Catholic Healthcare Partners (now Mercy Partners), in Cincinnati, OH (1998–2008), where he was the inaugural chair of the board committee on Quality and Safety.  He concluded his tenure (2009-2017) on the board of Main Line Health, a four-hospital system in suburban Philadelphia, PA, where he also chaired the board committee on Quality and Safety.  He now serves on the board of the Geisinger Commonwealth School of Medicine (GCSOM). In 2018 he joined the board of the National Investment Center for Senior Housing and Care (NIC) – a national not-for-profit to enable housing choices for elders. Finally, in 2019, he joined the AMGA Foundation Board in Arlington, VA. 

In the for-profit sector, he very recently completed nearly a decade as a member of the Board of Directors for Humana, Inc., one of the nation’s largest publicly traded healthcare companies.  In 2014 he joined the board of InfoMC, a leading information technology company in suburban Philadelphia.  He is on the health care advisory board for Arsenal Capital Partners in NYC and just joined the board of Tract Manager, a portfolio company of Arsenal.  In late 2018 he joined the board of ANI Pharmaceuticals, a publicly traded generic drug manufacturer, headquartered in Baudette, MN.  Finally, he is a board member of FOX Rehab, a portfolio company of Blue Wolf Capital.

Dr. Nash has received many awards in recognition of his achievements.  He received the top recognition award from the Academy of Managed Care Pharmacy (1995), the Philadelphia Business Journal Healthcare Heroes Award (1997), and was named an honorary distinguished fellow of the American College of Physician Executives (now AAPL) in 1998.  In 2006 he received the Elliot Stone Award for leadership in public accountability for health data from NAHDO.  Wharton honored Dr. Nash in 2009 with the Wharton Healthcare Alumni Achievement Award and in 2012 with the Joseph Wharton Social Impact Award. Also in 2012, he received the Philadelphia Business Journal award for innovation in medical education.  

Dr. Nash’s work is well known through his many publications, public and virtual appearances, and online column on MedPage Today.  He has authored more than 100 peer-reviewed articles and edited 25 books, including The Quality Solution, Demand Better, and most recently Population Health: Creating a Culture of Wellness (3rd edition).  He was the inaugural Deputy Editor of Annals of Internal Medicine (1984-1989).  Currently, he is Editor-in-Chief of American Journal of Medical Quality, Population Health Management, and American Health and Drug Benefits. He is also on the founding editorial board of TeleHealth and Medicine Today.

Dr. Nash received his BA in economics (Phi Beta Kappa) from Vassar College; his MD from the University of Rochester School of Medicine and Dentistry and his MBA in Health Administration (with honors) from the Wharton School at the University of Pennsylvania.  While at Penn, he was a former Robert Wood Johnson Foundation Clinical Scholar and Medical Director of a nine-physician faculty group practice in general internal medicine.  He has received honorary doctorates from Salus University in Philadelphia, GCSOM, and the University of Rochester.  Dr. Nash has delivered a score of endowed and named lectures across the country.

Dr. Nash lives in Ardmore, PA, with his wife of 40 years, Esther J. Nash, MD.  They have 3 adult children.  He enjoys tennis, jogging, biking, and yoga.

Ian L. Valerio, M.D., M.S., M.B.A., FACS, Commander (CDR), Medical Corps, U.S. Navy

Ian L. Valerio, M.D., M.S., M.B.A., FACS, Commander (CDR), Medical Corps, U.S. Navy

Plastic and Reconstructive Surgeon at Harvard Medical School and Massachusetts General Hospital

The Continuing Story: COVID-19 Direct from the Front Lines | 9:00 AM – 10:00 AM, Wednesday, September 30

CDR Valerio grew up in Northeastern Ohio and attended Case Western Reserve University (BS, BA, MS 1998) and Cleveland State University College of Business Administration (MBA 2000). He was commissioned as an Ensign in the Naval Reserves in 2000 and attended the University of Kentucky College of Medicine (MD, 2004) on the Health Professions Scholarship Program (HPSP). He then completed his residency in Plastic and Reconstructive Surgery at the University of Pittsburgh Medical Center (2004-2010) prior to completing additional international fellowships in craniofacial and microsurgery at Chang Gung Memorial Hospital (CGMH), Linkou, Taiwan. After completion of his graduate medical education and training, Dr. Valerio was commissioned into Active Duty service as a Lieutenant Commander (LCDR 2010) and began his tour as an attending surgeon at the National Naval Medical Center (NNMC), Bethesda, MD.

During his Active Duty tour, he was present through the joint merger of Walter Reed Army Medical Center (WRAMC) with NNMC in formation of the joint service military treatment facility – Walter Reed National Military Medical Center (WRNMMC), Bethesda, MD. At WRNMMC, CDR Valerio served as the Director of the WRNMMC/Johns Hopkins/University of Maryland Plastic and Reconstructive Surgery Residency Combined Program, the Director of Plastic Surgery Research Programs, the Co-Director of the Reconstructive Microsurgery Program, and was a founding member and Co-Director of the Center for Advancements and Innovations in Regenerative Surgery (MISSION CAIRS). Through his leadership and commitment as a dedicated surgeon-scientist, CDR Valerio was able to secure and oversee a budget of more than $50 million in competitively awarded intramural and extramural Department of Defense (DoD) funding for various regenerative medicine projects as well as basic science, translational, and clinical trials in regenerative and reconstructive surgery.

With regard to operational experience and leadership, CDR Valerio deployed as an Individual Augmentee (IA) in support of Operation Enduring Freedom (OEF). During his deployment, he was selected and served as the Department Head of Surgical Services at the NATO Role III Multinational Medical Unit, Kandahar Airfield, Afghanistan (2012-13). After his deployment, he returned to WRNMMC and successfully completed his five-year active duty tour (2010-2015).

CDR Valerio then entered the Active Reserve Component of the US Navy (2015). He was assigned to Expeditionary Medical Facility, Bethesda (EMF – Bethesda) and cross assigned to EMF- Great Lakes. During his EMF tour, he served as an Officer-in-Charge (OIC) and Senior Medical Officer (SMO) for Detachment X, NOSC Youngstown (2017-2019). In 2019, he was selected for promotion to Captain (CAPT-sel) and assumed his current duties as a Senior Medical Executive (SME) for Operational Health Support Unit, Portsmouth Headquarters, NOSC Norfolk. As SME, he directed 77 Medical Corps officers in delivery of medical services to 901 Sailors in 15 regional detachments. In 2020, CDR Valerio mobilized with the Navy Medical Support Team (NMST) as an IA during Operation Gotham in support of the joint response to COVID-19 in New York City. During this mobilization, he served as a Senior Medical Executive (SME) and as an Acting Naval Liaison Officer (LNO) in the logistics and integration of 200 Navy Medical and Nurse Corps personnel deployed to 11 regional medical centers and the 2500 bed military field hospital located at the Javits Center.

CDR Valerio is board certified in Plastic and Reconstructive Surgery and currently serves as the SME at OHSU Portsmouth. He is a physician executive, a nationally and an internationally recognized surgeon-scientist, and a subject matter expert in reconstructive and regenerative surgery. He has authored more than 150 peer reviewed professional publications, has given over 300 national and international societal presentations, and has been a recipient of numerous national academic and educational awards. In 2019, CDR Valerio was awarded the Military Health Systems Research Symposium (MHSRS) Individual/Academia Award for Excellence in Research Accomplishment. CDR Valerio holds hospital privileges at the Massachusetts General Hospital (MGH) and holds academic appointments at Harvard Medical School, the University of Pittsburgh, and the Uniformed Services University of the Health Sciences. His military decorations include a Defense Meritorious Service, two Navy and Marine Corps Commendation, a Navy Unit Commendation, the National Defense Service, an Afghanistan Campaign, the Global War on Terrorism, a NATO, Navy and Marines Overseas, and Expert designation for both the Rifle and Pistol Marksmanship Medals, respectively.

Questions?

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