4th Adverse Event Reporting and Safety Strategies Summit -

4th Adverse Event Reporting and Safety Strategies Summit
December 4 - 5, 2017
Philadelphia, PA

Harmonize and Comply with Adverse Event Management Regulations and Enhance Pharmacovigilance Strategies

Faculty – 4th Adverse Event Reporting and Safety Strategies Summit


Deepa Arora
Vice President, Pharmacovigilance and Global Head, Drug Safety and Risk Management, LUPIN LIMITED

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Dr. Deepa Arora is Vice President Pharmacovigilance and Global Head Drug Safety and Risk Management with Lupin Limited. She is a Physician, having more than 18 years of experience in drug safety and clinical development in the pharma industry and academia.

She has successfully set up world class Pharmacovigilance systems for Lupin & Lupin subsidiaries in US, Europe, Japan and Australia. Under her able leadership, Lupin has successfully cleared Pharmacovigilance inspections conducted by regulatory authorities across the world.

She is playing an active role in developing awareness and skills of pharmacovigilance in the region by designing teaching modules in Pharmacovigilance & conducting training for medical institutions. She believes in finding innovative solutions to facilitate the translation of PV regulations in enhanced patient safety. She has authored the book on Pharmacovigilance; “Pharmacovigilance- An Industry Perspective” to help youngsters learn relevant aspects of Pharmacovigilance.


Paul Beninger
Assistant Professor of Public Health and Community Medicine, TUFTS UNIVERSITY SCHOOL OF MEDICINE

Former Vice President, Global Patient Safety, GENZYME

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Dr. Beninger is Assistant Professor of Public Health & Community Medicine at Tufts University School of Medicine, where he is the Director of the MD/MBA and MBS/MBA Programs.

He began his career in drug development in 1987 at the US Food and Drug Administration, first as a reviewer and manager for drugs against HIV/AIDS and opportunistic infections and then as a division director for medical devices. He joined Merck & Company in 1995 and developed experience in regulatory affairs, medical affairs and drug safety in the areas of anti-infective drug and biological products, vaccines, anti-diabetic drug products and oncology drug products, before joining Genzyme as vice-president of pharmacovigilance in 2006; Genzyme was acquired by Sanofi in 2011. Dr. Beninger retired from Genzyme-Sanofi in April, 2017.

Dr. Beninger trained in internal medicine and infectious diseases. He received his MD from the University of California, Davis, his BA from Claremont McKenna College in Claremont, California, his MBA from St Joseph’s University in Philadelphia, Pennsylvania, and his graduate certificate in epidemiology from Tufts. He has published and spoken extensively on regulatory science, drug and vaccine safety, and pharmacovigilance, and he is a fellow of the American College of Physicians and the Infectious Disease Society of America.


Deanna Montes de Oca
Associate Director, PV Operations Clinical Safety and Pharmacovigilance, OTSUKA

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Deanna holds a doctorate in Pharmacy and is a seasoned pharmacovigilance professional who has been leading the Otsuka Global Pharmacovigilance (GPV) department in an effort to harmonize our PV processes over the last 5 years. Deanna is a key member of the Otsuka management team currently leading and supporting many key initiatives. She has over 14 years of operational experience within the global pharmaceutical industry. Dr. Montes de Oca is a subject matter expert in pharmacovigilance operations, quality and analytics, and compliance. She has been a key leader and contributor for successful inspections with the FDA, MHRA, BfArM, and EMA.  Dr. Montes de Oca has extensive experience and knowledge of vendor transition, management and oversight, safety database upgrades, and merging of multiple global safety databases.


Michael von Forstner
Co-Chair, Pharmacovigilance Working Group, MEDICINES FOR EUROPE

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Dr. Michael von Forstner serves as co-chair of Medicine for Europe’s Pharmacovigilance Working Group and is also Managing Director and Head of Risk Management and Pharmacoepidemiology at Mesama Consulting. Michael’s primary activities are in areas of planning, development, implementation and evaluation of (benefit-)risk management solutions, as well as the optimization of processes around benefit-risk management. He is developing and applying (benefit-)risk analysis methodologies in order to make RM planning more formally reproducible. Furthermore, he supports the development and implementation of additional risk minimization and PV measures in the context of RMPs, and is involved in teaching and training activities on pharmacovigilance and pharmacoepidemiology at various European institutions. Michael is former Global Head of Pharmacovigilance at Acino Pharma in Switzerland, where his key responsibility was the creation and maintenance of a compliant global PV system.

Before entering his current role, Dr. Forstner was Head of Regional Pharmacovigilance Europe at Boehringer-Ingelheim. His main focus at BI had been to establish a proactive and highly integrated benefit-risk management organization with strong links to other functions, while maintaining compliance with all local regulations in the 35 countries of his region.

From 2009 to 2013, he was Process Development Leader in Drug Safety and Chair of the global Risk Management Working Group at Roche, Basel, where he was — amongst other duties — responsible for all aspects of global benefit-risk management planning and implementation of RMPs

Prior to this he worked in a variety of positions in pharmaceutical R&D at Pharmacia (Nerviano, Italy) and Novartis (Basel, Switzerland), focusing mostly on signal transduction pathways in oncology and CNS disorders, and in drug liability risk management at Zurich Financial Services. He studied biochemistry and medicine in Graz, Austria; holds a Ph.D. in biochemistry from the Swiss Federal Institute of Technology (ETH) Zurich, Switzerland; did postdoctoral work at UC Berkeley/Lawrence Livermore National Laboratory, California in the area of structural enzymology and biophysics; and was Assistant Professor of Molecular Structural Biology at Sveriges Lantbruksuniversitetet in Uppsala, Sweden. Recently, he also obtained a postgraduate certificate in pharmacovigilance and pharmacoepidemiology from the London School of Hygiene and Tropical Medicine.

In his spare time, Michael loves to spend time outdoors with his children and dogs, and to engage in various activities from skiing and hiking to fishing, hunting, horseback riding and gardening. He is also an avid reader, and loves the opera and music in general.


Stephen A. Goldman
Managing Member, STEPHEN A. GOLDMAN CONSULTING SERVICES

Former Medical Director, MEDWATCH, U.S. FOOD AND DRUG ADMINISTRATION

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Dr. Goldman is Managing Member of Stephen A. Goldman Consulting Services, L.L.C. (Morris Plains, NJ), providing pharmaceutical and medical device companies internationally with safety-related services (consulting; auditing; training) involving clinical trials, postmarketing surveillance/vigilance, signal detection/evaluation, regulatory compliance and risk management (www.sagcs.com). In more than six years at the FDA, Dr. Goldman completed a fellowship in Clinical Pharmacology and Regulatory Drug Evaluation Sciences, and became MedWatch’s first Medical Director. As such, all FDA Centers utilized him as an in-house safety/risk management and communication expert. After federal service, Dr. Goldman was Director, Pharmacoepidemiology at Knoll Pharmaceutical Company (Abbott Laboratories). Dr. Goldman is a Fellow of the Academy of Psychosomatic Medicine and Distinguished Fellow of the American Psychiatric Association.


Andres Gomez
Vice President, Head of Epidemiology, Safety Science and Analytics, BRISTOL-MYERS SQUIBB

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Andres Gomez currently heads the Epidemiology, Safety Science and Analytics (ESSA) team in the Global Pharmacovigilance department in Bristol Myers Squibb. Dr. Gomez has worked at BMS in a variety of roles over the last 14 years focusing on the delivery and execution of real-world evidence studies for regulatory and safety purposes; and the development of new signal detection and data mining methods. Some of the areas of interest include the use of OMOP-like common data models, using claims and EHRs, for the purpose of postmarketing surveillance; and the application of Bayesian approaches to clinical and real-world data to enhance the analytic predictability of specific adverse events. Prior to BMS, Andres worked at GlaxoSmithKline to develop, and execute epidemiology programs to validate the use and predictability of atherosclerotic biomarkers for coronary events and stroke.

Dr. Gomez holds a Ph.D. in epidemiology from the University of North Carolina-Chapel Hill.


Joanne Grego
Global Vendor Management and ICSR Quality Lead, GCSP, CSL BEHRING

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Joanne is responsible for quality and compliance management within Global Clinical Safety and Pharmacovigilance Case Management at CSL Behring, a leading biotherapeutics company specializing in rare diseases. As part of this role, she oversees the global case processing vendor within an innovative flexible sourcing model that relies on a near-shore approach allowing for responsiveness to fluctuations in demand, lower cost, and appropriate oversight.

Joanne has over 15 years of Pharmacovigilance experience, specializing in case operations. Prior to joining CSL Behring in 2013, she was a Pharmacovigilance Operations manager at Cephalon, Inc. She has a Bachelor of Science degree in Nursing with a background in Emergency and Critical Care.


Israel Gutierrez
Senior Director Drug Safety and Pharmacovigilance, PHARMACYCLICS

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Israel is an accomplished Global Executive with 20+ years of experience building multi-therapeutic area medical affairs, clinical development, drug safety, Pharmaceutical teams, inter-academic collaboration, pharmaceutical partner management, and monitoring of drug development.

Has provided leadership of multifunctional groups across many companies including Pharmacyclics,LLC, Exelixis, Inc, Genentech, Inc, Roche Ltd, Celgene, Inc., Pharmion Corp, Neurosystec, Myriad Pharmaceuticals, and Encore Pharma in many company teams, worldwide leadership and organization of multiple resources, medical affairs & KOL development, leadership and creation of focused expert groups and independent foundations to support strategic development, license and assessment of drug candidates, identification and leadership of new product/indication opportunities, team/subteam medical affairs, Pharmaceutical safety and development leader, global product launch and medical/safety officer. Company representation in public forums, industry settings and regulatory authorities (EU- EMA, FDA, PMDA, ANSM, Health Canada, MHRA, etc.).

Has been responsible for many landmark approvals in the Oncology-Hematology indications including Ibrutinib, Cometriq, Erivedge, Thalidomide, and Vidaza. He is a frequent guest lecturer in the areas of benefit-risk assessments, signal detection, risk management and pharmaceutical and device development. Multi-disciplinary clinical practice background, with a unique combination of education, natural business acumen, and tactical expertise. Graduated as a physician and surgeon from the prestigious Universidad Autonoma de Guadalajara, Science Fellow in Cardiology from University of Southern California (USC). Due to his many contributions to society, he was bestowed a Fellow of the Royal Society of Public Health in London, and a Fellow of the Royal Society of Medicine.


Bill Haddock
Head of Safety, OVID THERAPEUTICS

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Bill Haddock, Senior Medical Director, Safety and Benefit-Risk, BIOGEN

Bill is a biotech safety professional with more than 12 years’ experience in the industry with expertise in pediatrics, public health, epidemiology, due diligence, and benefit-risk management. He is currently the Head of Safety at Ovid Therapeutics, a startup with products aimed at neurologic conditions. Prior to this, he was at Biogen as Sr Medical Director in Global Safety leading a team working on the Tysabri (for multiple sclerosis) program. Prior to this role he was at Amgen for 11 years in roles of increasing responsibility as a Global Safety Officer for 9 years, leading teams for products across multiple therapeutic areas including nephrology (Aranesp, Epogen Velcalcetide), heart failure (Aranesp, Omecamtiv), and oncology products (Denosumab, Neulasta, Neupogen).

Prior to this role he was a Clinical Instructor at the UCLA Department of Pediatrics and had a role with the LA County Public Health Department leading quality improvement projects. Bill completed his MD from Emory University, his MPH from the Harvard School of Public health, and his MS in Health Services from UCLA. He completed his internship in Pediatrics at the University of North Carolina followed by a Preventive Medicine and Public Health residency at SUNY-Stony Brook.


Ghazala Haque
Safety Surveillance Manager, DUKE UNIVERSITY MEDICAL CENTER

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Dr. Ghazala Haque, Program Manager of DCRI Safety Surveillance for over a decade, has vast expertise in all aspects of Adverse Event (AE) reporting from clinical studies for drugs, biologics, and devices. She is a subject matter expert in the specifications and implementation of Argus Safety databases. Her academic focus is clinical trial methodology and endpoint classification. Dr. Haque is constantly searching for better, more efficient ways of collecting and evaluating endpoints and AEs while maintaining impeccable data quality. She received her M.D. degree from Sind Medical College in Karachi, Pakistan, and a Master of Health Sciences in Clinical Research from Duke.


Judith Sills
Vice President and Head, Global Pharmacovigilance, THE MEDICINES COMPANY

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Judith M. Sills, Pharm.D. is Vice President and Head, Global Pharmacovigilance at The Medicines Company. Dr. Sills brings more than 25 years of experience in pharmacovigilance in the pharmaceutical industry, FDA, and consulting. Prior to The Medicines Company, she was Vice President and Global Head, Safety Risk Detection and Management at Novartis Pharmaceuticals. Dr. Sills began her career as a Safety Evaluator in the FDA Division of Drug and Biological Experience. Her pharmaceutical industry experience also includes senior roles at Schering Plough Corp. and Warner-Lambert Consumer Healthcare, as well as The Degge Group, a consulting group specializing in pharmacovigilance and risk management.

She received her Bachelor of Science in Pharmacy from Rutgers University and her Doctor of Pharmacy degree from Philadelphia College of Pharmacy and Science.


Gay Steinbrick
Director, Global Clinical Safety and Pharmacovigilance, MERCK

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Dr. Steinbrick started her Pharma career as Assistant Professor of Clinical Pharmacy at Rutgers University. Gay has more than 25 years of professional experience and held various leadership and management positions Schering-Plough including Head of Global Drug Information Services, Director Clinical Quality and Director Chief Medical Office. Since joining Merck & Co she has been involved in clinical risk management and for the past 3 years as Director Medical Devices and Combination Products, Clinical Safety and Risk Management. Gay holds a Doctorate in Pharmacy and completed a post-doctoral residency at the Hospital of the University of Pennsylvania.


Sameer Thapar
Assistant Professor and Advisor, Drug Safety and Pharmacovigilance, RUTGERS

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Dr. Sameer Thapar holds a doctorate of pharmacy, is Oracle Health Science Consulting’s Director of Global Pharmacovigilance, and is on faculty as Assistant Professor for the Drug Safety and Pharmacovigilance track of the Master in Clinical Trial Sciences program at Rutgers University. Dr. Thapar has 18 years of experience in operations within the pharmaceutical, biotech and CRO industries, with cross-functional experience in medical affairs, clinical operations, quality assurance and subject matter expertise in pharmacovigilance operations and compliance. He has built global departments and defended in successful FDA, MHRA and EMA health authority inspections. He is an active advisor in several U.S.-based life science industry conferences and participates as an invited speaker and panelist at global industry conferences.


Susan Welsh
Chief Safety Officer, CSL BEHRING

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CSL Behring is a global company which conducts business in 60 countries and is headquartered in Australia. The company has a remarkable and industry-leading patient-centric approach truly placing patients first and foremost. Currently, the company is experiencing strong growth and is expanding. Susan heads the global PV function at this exciting and dynamic company. She has 28 years of industry experience with over 15 years overseeing PV directly or as part of clinical development/medical affairs roles. Before CSL, Susan served as VP of Safety Strategy at Pfizer, VP Medical Safety at BMS, and Chief Safety Officer at Sanofi.

Earlier in her career, Susan held senior roles in medical affairs, clinical development, general management, finance and IT. She worked as Chief Knowledge Officer at Monsanto and then as Corporate Officer, SVP & Chief Science Officer at Express Scripts, establishing the company by designing formulary strategies, e.g., multi-tier formulary and specialty distribution services and co-founding one of the world’s first real-world evidence companies, Practice Patterns Science. Following this, she served as CEO Charis Pharma and as CEO Snowdon Pharma successfully transferring the companies on when key milestones were achieved.

Susan holds an MBChB (British equivalent MD) and Bachelor of Science from University of Leeds, UK. Her Master’s Information Management is from Washington University, St. Louis, USA, and her MBA is from the University of California at Berkeley, USA. Susan is a licensed physician with UK practicing rights. She is an elected Fellow, Faculty of Pharmaceutical Medicine, Royal Colleges of Physicians UK (FFPM), Member, Royal College of General Practitioners, UK and Royal College of Psychiatrists UK, Diplomate, Royal College of Obstetricians & Gynaecologists UK, and Member, American College of Physicians.

Before industry, Susan practiced medicine for 10 years in the UK serving for six years as a military officer in Britain’s Royal Air Force and completing many military challenges around the world. Upon leaving, she was granted the life-long title of “Squadron Leader (Retired).”


Richard Wolf
Head, GCSP Regions and Pv Operations, CSL BEHRING

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Rich Wolf, Senior Director, Regions and Pv Operations in the Global Clinical Safety and Pharmacovigilance group at CSL Behring, directs Case Management, Medical Evaluation, Pv Systems (Argus), Manufacturing Site Pv, and the Global Regions organization responsible for Pv in affiliates around the world.

Rich joined CSLB in 2014 after 12 years with J&J serving a number of different roles across drug safety and pharmacovigilance. He spent 5 years working across multiple industries as a consultant and manager with Accenture. He holds a BA from the University of Richmond, and MBA from Rutgers University, is Six Sigma certified Black Belt, PMP certified in project management and was an Airborne Ranger qualified officer in the US Army.

CSL Behring is a global leader in the plasma protein biotherapeutics industry. They research, develop, manufacture and market biotherapies that are used to treat serious and rare conditions.


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