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Esther |
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King |
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Senior Director Safety Operations |
IQVIA |
https://proventainternational.com/wp-content/uploads/2022/04/Esther-King.jpg |
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Alisa |
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Hummings |
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Senior Director, Medical Information and CEVA |
IQVIA |
https://proventainternational.com/wp-content/uploads/2021/10/Alisa-Hummings_Webinar_-Headshot-square-Apr-5-2021-1.jpg |
As Senior Director of Medical Information and Clinical Event Validation and Adjudication (CEVA) at IQVIA, Alisa Hummings leads all operational aspects of Medical Information, including Local Adverse Event (AE) Intake, and CEVA. Previously, she established the LCS PV Solutions department, providing project management across all scopes within Lifecycle Safety and served in a leadership capacity in Lifecycle Safety case processing operations. Prior to IQVIA, Ms. Hummings served in leadership roles at Syneos, establishing the DSMB/DMC Management, PV Regulatory Reporting and Medical Affairs Business Operations functions and gained experience in Clinical Project Management. Ms. Hummings earned her Bachelor of Arts degree in English from the University of North Carolina, Chapel Hill. |
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Dr. |
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Jane Reed |
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Director, Life Sciences |
Linguamatics, an IQVIA company |
https://proventainternational.com/wp-content/uploads/2022/04/Jane-Reed.jpg |
Dr. Jane Reed is Director, Life Sciences, at Linguamatics, an IQVIA company. Jane is responsible for developing the strategic vision for Linguamatics’ growing product portfolio and business development in the life science domain. Jane has extensive experience in life sciences informatics. She has worked for more than 15 years in vendor companies supplying data products, data integration and analysis and consultancy to pharma and biotech – with roles at Instem, BioWisdom, Incyte, and Hexagen.
Also can we add to the IQVIA bio the below information for IQVIA NPL as they are a separate department
IQVIA NLP (formerly Linguamatics NLP), delivers market-leading Natural Language Processing-based AI for high-value knowledge discovery and decision support from text. We empower our customers to speed up drug development and improve patient outcomes by breaking down data silos, boosting innovation, enhancing quality, and reducing risk and complexity. Our award-winning NLP (natural language processing) is proven across multiple real-world use cases. IQVIA NLP has been trusted for over 15 years to deliver actionable insights that address your most pressing bench-to-bedside challenges with quantifiable ROI. |
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Vivek |
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Kalagara |
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CEO |
Datafoundry AI |
https://proventainternational.com/wp-content/uploads/2021/09/Vivek-e1645539838373.jpg |
Vivek has over 22+ years of experience building innovative technology solutions to solve business problems in the Life Sciences industry. He has worked with several big pharma companies in technology leadership roles focused on Data Sciences before founding Datafoundry in 2016. Vivek sees himself as an AI and Data Science evangelist and has focused Datafoundry’s efforts on building innovative solutions for Life Sciences and Health Care using the power of AI/ML. Vivek strives to make things simple and is passionate about giving back to society. Patient-centricity, Customer- focus and Employee delight are the mantras he lives by. |
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Narasimha |
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Kumar |
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Chief of Product Strategy and Commercialisation |
Datafoundry.AI |
https://proventainternational.com/wp-content/uploads/2022/02/Narimsha-Kumar.jpg |
With over 22 years of global experience in the Life Sciences industry across consulting, business enablement, product and program management, and quality management leadership roles, Narasimha brings depth and breadth to any engagement. A technologist at heart, with business innovation focus, Narasimha drives Product Strategy at Datafoundry. He has previously worked at TCS and Parexel International and is passionate about leveraging AI for better health outcomes. |
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Martin |
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Holm Petersen |
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CEO |
Insife |
https://proventainternational.com/wp-content/uploads/2022/02/Martin-H.jpg |
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Philip |
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Gill |
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Managing Partner |
Explic8 Limited |
https://proventainternational.com/wp-content/uploads/2022/03/Philip-Gill-e1647434050814.png |
Philip has significant experience across several blue-chip companies with full P&L responsibilities for delivering bottom-line benefits. With over 25 years of Change management experience across B2B, Pharmaceutical, Medical Devices, Manufacturing and Supply Chain. |
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Al |
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Friedle |
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Managing Partner |
Explic8 Limited |
https://proventainternational.com/wp-content/uploads/2022/03/Al-Friedle–e1647434076251.png |
Al has a long track record of successfully directing the execution of tactical operating plans across many industries. Al has over 30 years in consultancy, the last 19 primarily focused in Medical Devices and Pharmaceuticals, with a strong passion for Lean and Continuous Improvement. |
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Nicole |
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Baker |
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CEO |
Biologit |
https://proventainternational.com/wp-content/uploads/2021/12/Nicole-Baker.jpg |
Immunologist and Pharmacovigilance Professional with strong focus on innovation and extensive knowledge in global legislation and guidelines for Medical Affairs, Regulatory Affairs, Pharmacovigilance and Clinical Trials, gained by leading and managing global, multi-disciplinary teams. Extensive experience in providing strategic, operational and scientific leadership throughout the product life-cycle, from pre-clinical to post-marketing. Experience gained supporting or fulfilling the role of EEA QPPV and RPPV in Clinical Trials over the past 9 years. Over 20 years’ experience gained within Academia, Pharmaceutical Industry, Regulatory Authority, Clinical Research Organisation, and more recently Start-up. |
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Fatima |
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Bhayat |
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Vice President, Patient Safety |
Amgen |
https://proventainternational.com/wp-content/uploads/2021/08/Fatima-Bhayat-Amgen.jpg |
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Kapil |
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Bhutada |
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Director Pharmacovigilance Compliance & Training |
Medicago |
https://proventainternational.com/wp-content/uploads/2022/05/Kapil-Bhutada-Medicago.jpg |
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Steve |
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Dingman |
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President, Drug Safety and Pharmacovigilance |
Alkermes |
https://proventainternational.com/wp-content/uploads/2021/09/Steve-Dingman.jpg |
Dr. Dingman currently serves as Vice President, Drug Safety and Pharmacovigilance at Alkermes accountable for the strategic leadership and operational oversight/management of Medical Safety, Epidemiology and Safety Operations segments of the organization. He has over 20-plus years’ experience in the industry in various roles of increasing responsibilities leading safety strategy and surveillance in pharmacovigilance for both marketed and development products. Before joining Alkermes, Steve worked for Clovis Oncology, AbbVie, and UCB providing safety oversight for cardiorenal, ID, and CNS products, and 6- years leading mid-size CRO PV operational and medical strategy consulting for numerous US/EU smaller biotech and pharma companies. |
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Steven |
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Gallagher |
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Process Improvement & Innovation Lead |
CSL Behring |
https://proventainternational.com/wp-content/uploads/2022/04/Steven-Gallagher.jpg |
Steven Gallagher is the Pharmacovigilance Process Improvement & Innovation Lead for CSL Behring based in Philadelphia, PA. Steve has spent his entire career working in pharma, starting as an Analytical Chemist in Drug Development at Cephalon. After attaining an MBA with an option in Biotechnology and Health Industry Management, he became a Brand Manager in Marketing and then a certified Lean Six Sigma Black Belt for Teva North America Specialty Medicines.
Recently, Steve has deployed GxP RPA bots into production and is progressing the automation roadmap for CSL’s Pharmacovigilance department. In addition, he is responsible for PV integrations via M&A. |
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Israel |
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Gutierrez |
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Vice President, Pharmacovigilance & Drug Safety |
Compugen |
https://proventainternational.com/wp-content/uploads/2021/08/Israel-Gutierrez-Geron-Corporation.png |
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Karen |
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de Jong |
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Executive Director, Global Patient Safety- GPV Case Management |
Boehringer Ingelheim |
https://proventainternational.com/wp-content/uploads/2022/04/Karen-S-De-Jong.jpg |
Karen de Jong is a pharmacovigilance expert with 21 years of experience in end to end Pharmacovigilance, health care, clinical research, as well as business process and Organizational transformation design. Karen is leading the Global Case Management organization within Boehringer Ingelheim PV Operations & Systems. She has experience with USA, Europe, and Japan regulatory, operations and safety surveillance activities in pharmaceutical companies. Provided subject matter expertise, leadership, oversight, and global project coordination to clients in risk management, periodic reporting, signaling, ICSR handling, PV and risk management training, system implementations, and business process analysis. Led the Product Management team in the next generation PV Platform designed with automation and artificial intelligence as well as built a PV department (operations, surveillance, and vendor management) from the bottom-up within 8 months. |
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Barbara |
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Morollo |
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Executive Director, Head of Global Safety Science, DSPV |
Ultragenyx |
https://proventainternational.com/wp-content/uploads/2021/09/barbara-morollo.jpeg |
Barb Morollo has broad experience in establishing both early and late-stage Pharmacovigilance and Risk Management systems with ATMPs. She has held leadership positions in both small biotech and larger pharma companies, contributing to the development of small molecules, biologics, biologic/device combination products, CAR-T cell therapies, lentiviral and AAV gene therapies, and mRNA platform delivery systems. Throughout her career she has focused almost exclusively on the development of advanced therapeutics and bringing novel therapies to patients with unmet medical needs and limited treatment options. |
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Edwin |
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Raj |
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Vice President, Head of Drug Safety |
Karuna Therapeutics |
https://proventainternational.com/wp-content/uploads/2020/08/EDWIN-RAJ.jpg |
Edwin Raj is currently the Vice President, Head of Drug Safety at Karuna Therapeutics. Prior to joining Karuna Tx, he was the Head of PV at Covis Pharma. He held vital positions in other companies such as AMAG, Baxalta and Shire where he was the Head of PV operations and Head of Global PV compliance. Edwin was at Novartis for nearly 10 years where held several positions of increasing responsibilities. Edwin has a PhD in Public Health Epidemiology and MBA in Information Systems. |
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Jeff |
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Roncal |
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Vice-President, Head of Safety and PV |
Jounce Therapeutics |
https://proventainternational.com/wp-content/uploads/2020/08/Screenshot-2020-08-24-at-4.49.59-PM.png |
Jeff P. Roncal, MD has over 20 years of industry experience, and has held multiple leadership Drug Safety and Pharmacovigilance positions in different pharmaceutical and biotechnology companies. He has broad experience in addressing safety issues in all phases of clinical development through post-marketing, including, but not limited, to medical evaluation, safety operations, signal detection, safety assessment, risk management, IND/NDA/BLA submission, aggregate reports, health hazard evaluations, process improvement, regulatory inspections, due diligence activities, and responding to and presenting safety data to regulatory authorities. He has worked on multiple therapeutic areas in small, mid-sized, and large companies, including oncology, immunology, hematology, metabolic, respiratory, dermatology, vaccines, and contrast media. Jeff currently serves as Vice-President and Head of Safety and Pharmacovigilance at Jounce Therapeutics. |
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