ComplianceOnline Pharma Summit 2016 - Risk Control and Compliance

Dr. Robert Popovian is Sr. Director, US Government Relations at Pfizer Inc. He brings almost two decades of experience in numerous facets of biopharmaceutical and health care industry with a strong track record of expertise, innovation and results in Health Care Policy and Economics, Government Relations, Medical Affairs, and Strategic Planning.

Dr. Popovian has published and presented extensively on the impact of biopharmaceuticals and health policies on health care costs and clinical outcomes, including authorship in clinical and healthcare delivery journals and published expert source in Los Angeles Times, USA Today, Pink Sheet and Bloomberg News amongst many others. He also writes a monthly column published in Morning Consult regarding health policy and economic issues relevant to the biopharmaceutical industry. Dr. Popovian is a frequent speaker at healthcare policy and medical conferences on topics such as payment and delivery reform, use of real world data, policies that enable biopharmaceutical innovation and health economics. He currently serves as a board member for the Global Healthy Living Foundation.

Dr. Popovian is one of the few researchers who has studied and published both clinical and policy related economic analysis as well as one of a handful who have studied and published empirical data regarding emerging payment mechanisms in the US healthcare system. He was also one of the first to secure inclusion of health outcomes data regarding labeled indication of a biopharmaceutical.

Dr. Popovian completed his Doctorate in Pharmacy and Masters of Science in Pharmaceutical Economics and Policy degrees at the University of Southern California with honors. The degree in Pharmaceutical Economics and Policy was the first one conferred by an accredited university in the US. He has also completed a residency in Pharmacy Practice/Adult Internal Medicine and Infectious Diseases at the Los Angeles County – University of Southern California Hospital where he was the head pharmacy resident (primary area of research: gram negative bacteremia) and a fellowship in Pharmaceutical Economics and Policy at University of Southern California (primary area of research: payment reform).

Terri Jollymour is a member of the Operations Readiness & Convergence (ORC) enterprise group, leading strategic efforts in the convergent space for Johnson & Johnson (J&J). Terri works across the three main business sectors: Consumer/McNeil, Janssen Pharmaceuticals, and Medical Device & Diagnostics to ensure safety, quality and sustainability for the convergent space.

Within J&J’s Convergent Space, Terri is responsible for comprehensive engagement with project teams to assess and mitigate new product development for product, process and program risks. This spans across early to late development and pre-launch readiness. Terri is also accountable for strategic leadership initiatives in the Supply Chain organization, such as leading the implementation of the Combination Product CGMPs. Terri’s group is responsible for ad hoc support for convergent programs, to address specific issues or fill in specific roles on teams. Her group is also responsible for rapid tactical reponse for supply chain and/or quality and compliance mitigation issues across the enterprise. Terri leads the Convergent Network at J&J, which brings all three business sectors together for learning, sharing/leveraging and networking within this innovative space.

For over a decade, Terri has held top leadership roles in the convergent space within J&J. She has been responsible for leading large, complex, convergent product development program teams within J&J’s pharmaceutical and medical device & diagnostic sectors. She has been recognized for her outstanding leadership with numerous company recognition awards and executive programs.

Terri earned her degree in Pharmacology at the University of California, Santa Barbara. Prior to J&J, she worked in the diagnostic space at Syva and led controlled release drug-delivery programs (combination products) at ALZA Corporation. She held positions of increasing responsiblities within program management, R&D, analytical sciences and quality assurance over her many years in the health care industry. She is a member of the Healthcare Businesswomen’s Association and is a certified Project Management Professional. Terri is married and has three children and three dogs! She enjoys swimming with her masters team, cycling, hiking and skiing. She resides in Northern California.

As Chairman of the Board for an international medical device company,led successful strategic repositioning work in response to the evolving technology, market and financial environment. The repositioning involved a product transition from hardware to disposables.Lead funding initiatives with private and VC investors. Founded and led an award winning real estate development company. As Board Chair, led the transformation of a quasi-public state agency into a one stop center for small firms lacking access to conventional financing. Led large projects for public and private clients on the impact of regulation on major US industries. He as helped numerous companies and investors evaluate new business opportunities.

Board member of VC backed med tech company bringing slow release long term drug delivery product to market.

MS is a Regulatory Affairs Director at Baxter Healthcare. Based in the Chicago Area, Darin is involved in many facets of the Product Development Lifecycle including regulatory submissions, due diligence, and active participation on industry trade organizations and standards committees. Darin leads a team of regulatory professionals focusing on electromechanical devices and software. His prior background as a Research and Development Scientist focused on pharmaceuticals and medical device diagnostic applications for biomarker and drug discovery. Darin’s undergraduate degree is in Molecular Biology from the University of Tampa. He also holds two Masters Degrees from Johns Hopkins University in Biotechnology and Regulatory Science as well as a graduate Certificate in Biotechnology Enterprise.

Tom has had an extensive history in healthcare. As an Angel Investor, Mentor and Advisor at Keiretsu Forum & Venture-Med and an established operations guy with serial successes with startups, transitional companies and turnaround situations, Tom has had a long career serving in the fields of science, technology and healthcare related industries. He is an active board member in both for-profit and not-for-profit companies. Tom has written numerous articles in the areas of healthcare, health tech, health policy, politics and the economy of healthcare. He is currently the principal author, along with a number of other contributors, of Health Reform 2.0: Beyond partisan divide lies pragmatic solutions – a working whitepaper focused on moving beyond the partisan rhetoric of the ACA (Obamacare) to a simple, efficient, effective, accessible and affordable healthcare system.

Tom has been involved with healthcare reform for many years, going back prior to President Obama’s election. He was active during the debate, advising on how to effectively get services to the underserved. He was a strong advocate for using true patient centered systems to improve the quality of care and patient outcome and was pivotal in the insertion of the concept of coordination of care and benefits as a repeated tenant of the Affordable Care Act. Tom is one of the few people that has read almost every word of every piece of legislation that came out of the various committees, as well as the various versions of the final legislation.

Tom’s understanding of the history of care in America helpes him get others to understand how we got to the non-system we have today, as well as how this system needs to fundamentally change in order to develop into the system we need for tomorrow. Tom's work on this whitepaper, mentioned above has been heralded as a fresh and valid approach to move beyond the ACA, or Obamacare, and get to a truly workable solution.

In the healthcare space, Tom has long maintained a passion for serving the underserved and has founded, supported and worked in various companies to serve the most fragile among us. He has developed a number of detailed approaches to solving the issues in the current, and evolving healthcare system. Because of his understanding and expertise in the business of healthcare, he has been invited to conduct multiple congressional briefings on healthcare reform in Congress, meeting with more than 100 congressional representatives.

Dr. Ron Weissman was vice president of strategy and corporate marketing for Verity, a global leader in corporate information retrieval and knowledge management. During his tenure at Verity, the executive team earned the large company "turnaround of the year" award (1999) from the Turnaround Management Association; Verity gained dominant market share and saw its market capitalization grow from $50 million to more than $1.5 billion. Prior to Verity, Ron spent more than five years at NeXT Computer, where he managed European and corporate marketing. In addition to his work in Silicon Valley, he ran academic computing at Brown University and at the University of Maryland, where he was Associate Professor of History. He is the author of two books on the history of Florence during the Renaissance.

Dr. Tezapsidis is the founder of Neurotez, Inc. and has been the President, Chief Executive Officer and Chairman of the Board of Directors since the company was incorporated in 2005. Nikolaos successfully raised seed funds primarily through non-dilutive capital sources while building the company, recruiting top talent, maintaining top notch research and development programs and establishing a strong patent portfolio. In 2014 he closed a milestone-linked $100 million deal exclusive for China and initiated a partnership for a new memory screening test for Alzheimer’s patients, while last year he partnered with Kinemed for new research efforts. Currently Neurotez is raising funds for clinical trials testing leptin (Memtin) to treat Alzheimer’s. Nikolaos was recently interviewed by The National Herald

Having held several positions at a number of prominent academic institutions internationally, Dr. Tezapsidis has more than 18 years of hands-on biomedical research experience. Prior to forming Neurotez, Dr. Tezapsidis served as a scientific consultant to biotechnology investors, providing highly regarded expertise and establishing a business network.

From 2001 to 2004 he led a research group at Columbia University. Prior to that he held faculty positions at New York University Medical School (2000-2001) and at Mount Sinai School of Medicine (MSSM), New York (1997-1998) and was Laboratory Director at the Institute for Basic Research, New York (1998-2000). He also conducted mentored research at MSSM, the Uniformed Services University of the Health Sciences, Bethesda and at the Imperial College of Science, Technology and Medicine, University of London, UK.

Among his career honors he received two awards from the Alzheimer’s Association, USA and fellowships from the Wellcome Trust and the Science and Engineering Council, UK.

He has several patents issued and pending both in the US and in foreign markets and is the author of more than fifty publications. Dr. Tezapsidis received a Bachelor of Science in Chemistry from the Aristotle University, Greece and completed his Master of Science and Doctor of Philosophy in Biochemistry at the University of Sussex, UK.

Dr. Joseph Gulfo is the Executive Director of the Rothman Institute of Innovation & Entrepreneurship at Fairleigh Dickinson University where he established the Initiative for Patient Centered Innovation. He has more than 25 years of experience in the biopharmaceutical and medical device industries. In 2012, he received the American Business Awards’ Maverick of the Year Award and was an Ernst & Young Entrepreneur of the Year Finalist.

He teaches graduate cancer biology. Prior to this, he served as President & CEO of MELA Sciences (2004-2013) and was Chairman of the Board (2011-2013). He recently testified in front of the Homeland Security and Government Affairs Committee on "Connecting Patients to New and Potential Life Saving Treatments” and his work has been published in the Wall Street Journal, Forbes, CNBC, US News & World Report, and other national publications. He is a regular contributor to The Hill. His latest book, The Care Quotient: Transforming Business Through People will be released on September 13, 2016 and is available for pre-order.

Dr. Subbarao received her Ph.D. in Bio-organic Chemistry from the Indian Institute of Technology, Bombay, India. She has more than 13 years hands-on industrial experience in stability and laboratory cGMP systems for both biologics and conventional drugs. She has extensive experience in evaluation of analytical methods and method validation for products ranging from pre-clinical to clinical and commercial phases. She is an ASQ Certified Quality Auditor with expertise in setup of cGMP/GLP complaint Quality Systems for laboratory and stability programs as well as upgrade of existing Quality Systems for products during development and in commercial phase. She is currently a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems.

Norma Skolnik has over 30 years of regulatory experience working with OTC drugs, Dietary Supplements, and Consumer Healthcare products. Her fields of expertise include advertising, labeling and claims review and advising firms on how best to comply with FDA requirements. She's helped many foreign firms successfully market products in the U.S. in compliance with FDA regulations. Meeting Adverse Event Reporting requirements and reviewing cosmetic claims are other areas of expertise and she's recently helped cosmetic firms market products in compliance with U.S. regulations.

Norma is an effective public speaker who's successfully conducted many seminars and webinars on FDA compliance for OTC drugs and Dietary Supplements and on differences between U.S. and Canadian regulatory requirements.

Kari Loeser, Esq. is senior counsel and senior director in the Corporate Compliance department at Jazz Pharmaceuticals plc. In this role, she advises client groups on legal and compliance matters pertaining to sales, marketing, and promotional matters for the Oncology franchise; medical affairs including clinical/research, publications, and health economic outcomes research; and managed care and reimbursement activities. She also manages a team responsible for federal/state aggregate spend reporting (transparency) and compliance field monitoring.

Prior to Jazz, Kari worked in medical affairs and healthcare compliance at Genentech, a member of the Roche Group. She has published various articles and a book chapter on E-Health and Ethics, and she has presented at various conferences, including the AHLA-HCCA Fraud and Abuse Conference. She is a licensed attorney, and is certified in Healthcare Compliance. She received her JD from DePaul University College of Law, and her BA with Honors from the University of Iowa.

Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.

Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.

More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She was on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Lifesciences industry.