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• 40+ Speakers including Amgen, Sanofi, J&J, Takeda, Pfizer, Almatica, Qinecsa, Lupin, Genentech, Pharsafer, EDGYN, Medicago, Alexion Pharmaceuticals, Bristol-Myers Squibb & many more
• 100+ Pharmacovigilance & Safety Experts from Pharma, Biotech, Government, Regulators & Vendors
• Global Meet – Speakers and Attendees from USA, Europe, UK & ROW
• In-Person networking: Reconnect with old faces and meet newbies
Bristol-Myers Squibb
MARIETTE BOERSTOEL - STREEFLAND, SVP, Worldwide Patient Safety Officer, Bristol-Myers Squibb
• Mariette Boerstoel-Streefland, MD, MBA, MSc(epi), has been in the pharmaceutical industry for 30 years, and is currentlySVP,World Wide Patient Safety Officer at BMS.
• Mariette joined the pharmaceutical industry from clinical practice in 1989, and had a progressive career, holding various leadership positions in drug safety and medical affairs at Organon (now Merck), Mayne Pharma (now Hospira), Forest Labs (now Abbvie).In 2014 she joined Baxter/Baxalta to establish a new safety organization for the Bioscience division split of. With the Shire acquisition of Baxalta in 2016 she was appointed to integrate and lead the new safety organization. She joined Alexion as head of SVP Global Drug Safety in May 2018 to build out and strengthen the safety function. With the acquisition of Alexion by AZ she was appointed Chief Safety Officer, SVP Global patient safety to integrate, transform and lead the safety function for all therapeutic areas of AZ.
• In August 2023 she joined BMS for a new challenge to be the SVP for Patient Safety, WW PS Officer.
• A common theme across the various roles has been organizational build or re-design, turn around management, change management, efficiency, and quality improvement initiatives.
• Mariette received her MD degree from the University of Utrecht, her master’s degree in Pharmaco-Epidemiology from McGill University Montreal and the University of Utrecht, and her MBA from New York Institute of Technology/Ellis College.
Alnylam Pharmaceuticals
ELENA YURENEVA, Executive Director, Head of Medical Safety & Risk Management, Alnylam Pharmaceuticals
Elena Yureneva MD, MHA is a cardiologist by training, with 10 years of pharmacovigilance experience, serving as an Executive Director, Head of Medical Safety and Risk Management at Alnylam Pharmaceuticals.
Prior to Alnylam Elena worked at Merck and Cubist. Before pursuing her career in the industry, Elena served as a Chief of Staff to the Chief Medical Officer at Children’s National Health Systems in Washington, DC. Elena acquired her MD at the First Moscow State Medical University in Russia, and completed her Master’s Degree in Health Systems Administration at Georgetown University.
Amgen
Sanofi
Bristol-Myers Squibb
LINDA LUM, Senior Director, Global Scientific & Regulatory Documentation, Bristol-Myers Squibb
Linda Lum, PharmD MBA RPh, is a Senior Director in Global Scientific and Regulatory Documentation at Bristol-Myers Squibb (BMS) Company in Princeton, NJ with 25 years of pharmaceutical industry experience. She serves as lead of the scientific writers for the investigator’s brochures, safety aggregate reports, and risk management documents in the Regulatory department.
As project leader for multiple continuous improvement projects, she enjoys developing and implementing innovative processes to create efficiencies while meeting the changes in regulatory requirements. Linda served as a preceptor for the BMS collaboration in the Rutgers Pharmaceutical Industry Fellowship Program.
Amgen
RENA PANDIT, Executive Director, Global Patient Safety Head of PV Compliance & Training, Amgen
Alnylam Pharmaceuticals
COLLEEN WALSH, VP, Global Patient Safety Operations, Alnylam Pharmaceuticals
Colleen Walsh is Vice President, Global Safety Operations, at Alnylam. In her current role she oversees global case processing, affiliate and vendor management, quality and compliance, and process excellence for the Alnylam Global Patient Safety & Risk Management team.
She has worked in the field of pharmacovigilance for over 25 years, holding various leadership positions at companies such as Astra Zeneca, Alexion, Biogen, Vertex, and Alkermes.
Qinecsa Solutions
HUMAIRA QURESHI, President, Qinecsa Solutions
Senior Executive Leader with experience in leading successful Pharmacovigilance businesses in Health and Life Sciences Sector. A leader with strong management, strategic development and business development experience underpinned by extensive domain expertise over a 20+ year period.
PharmaLex
STEPHEN SUN, Vice-President, US Pharmacovigilance, Epidemiology and Risk Managment, PharmaLex
Dr. Sun earned his Bachelors of Science in Chemistry, Food, and Nutrition from Rutgers University, his medical degree from Rutgers-New Jersey Medical School, and his Masters in Public Health from Johns Hopkins. While training in general surgery at Beth Israel Medical Center in New York City, he dedicated his off-hours to developing a medical internet start-up. He eventually left residency to work full-time on his medical knowledge company, Medtower, which delivered relevant late-breaking news to research scientists in the life sciences.
Dr. Sun then transitioned to work for pharmaceutical companies, including Organon, Alpharma, and Reckitt-Benckiser and led up teams in Pharmacovigilance, Clinical Research, and Medical Affairs. With an interest in public health, Dr. Sun served as a Medical Officer in the FDA CDER’s Division of Risk Management (DRISK) and the Controlled Substances Staff (CSS) and led/participated in analysis of the TIRF class REMS, originating a proposed safety surveillance system using mobile technology called Realtime Application for Portable Interactive Devices (RAPID), and defining a proposed decision tree for the assessment of abuse potential of drugs.
While at Syneos Health, his continual interest included the development of a continuously-learning risk management system called WebRACT™ for clinical studies and published a paper on a Net Benefit Score using a Quantitative Model of FDA's Benefit-Risk Framework. He now serves as the VP of Pharmacovigilance, Epidemiology, and Risk Management for Pharmalex-US, Practice Area Lead for Benefit-Risk Management at Cencora-PharmaLex, and plays a lead role in the rapid configuration and deployment of end-to-end safety systems for US and global clients.
Ovid Therapeutics
BILL HADDOCK, VP, Pharmacovigilance & R&D Quality, Ovid Therapeutics
Bill is a biotech safety professional with more than 19 years of experience in the industry with expertise in pediatrics, public health, epidemiology, and benefit-risk management. He is VP of Safety and Quality at Ovid Therapeutics, a small biotech focused on therapeutics for neurologic conditions. Previously, he was at Biogen as Global Safety Lead for Tysabri. Prior to this he was a Global Safety Officer at Amgen for 10 years in roles of increasing responsibility leading teams across multiple therapeutic areas including nephrology (Aranesp, Epogen Velcalcetide), heart failure (Aranesp, Omecamtiv), and oncology products (Denosumab, Neulasta, Neupogen).
Before joining industry, 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.
Takeda
RAMONA BURRESS, Senior Director, Head of Patient Engagement & Insights, Takeda Pharmaceuticals
Ramona Burress is the Head of Patient Engagement and Insights, Center for Health Equity and Patient Affairs (HEPA) at Takeda Pharmaceuticals. She leads the Center’s work with internal Takeda teams to provide global, longitudinal patient insights and increased knowledge of patients’ needs, beliefs and expectations through engagement. Ramona is a licensed clinical pharmacist and accomplished leader with 20+ years of experience in advancing positive patient outcomes and equity within healthcare.
Most recently, Ramona served as Director, Diversity & Inclusion in Clinical Trials, at Janssen Pharmaceutical Companies of Johnson & Johnson, where she designed external stakeholder partnerships critical to increasing participation of underrepresented and underserved populations in clinical research. Her results-driven approach was mastered in a former role as a Healthcare Specialty Supervisor with Walgreens Pharmacy in which she employed her extensive medical and business knowledge to serve the needs of patients with complicated health conditions.
Sumitomo Pharma
ELENA DAVISON, Executive Director, Safety Information Management, Sumitomo Pharma
• Ms. Elena Davison, MPH, MBA, Executive Director, Global Pharmacovigilance Informatics, Sumitomo Pharma America, Inc.
• Ms. Elena Davison, MPH, MBA, leads a global team at Sumitomo Pharma America, Inc. and is responsible for Pharmacovigilance technology, Aggregate Reporting Project Management, and the delivery of regional and global clinical and post-marketing safety data reports, datasets, and analyses required to develop the safety profile of the regionally and globally marketed products.
• Ms. Davison has over 15 years of experience in technology, informatics, data analysis and signal management in life sciences industry and has a unique expertise that spans Clinical, Post Marketing and Safety data systems and aggregation.
• Ms. Davison is a candidate for an MPH in Epidemiology from the Harvard T.F. Chan School of Public Health and holds an MBA with a concentration in Computer Information Systems from Suffolk University. Ms. Davison has presented at various Industry events on the topics of Signal Detection and Risk Management, Mobile AE collection, Clinical Data Standards, Handling of Blinded data in Pharmacovigilance Aggregate reporting, E2B Challenges, Managing a Global Information Management team, and Best Practices in selecting and managing PV data systems.
RxLogix Corporation
RAJ MORE, Chief Architect & CEO, RxLogix Corporation
Raj started his career in PV about 25 years ago at Relsys, the company that developed Argus Safety suite, and was one of the key persons in building Relsys.
Raj started RxLogix Corporation in Dec 2010, now a 13-year-old, 600-person company specialized in developing and implementing Drug Safety platform. Today, RxLogix PV products have been selected by 10 of the top 50 global pharmaceutical & biotech companies.
BMS
KARTHIK MUTHUSAMI, Sr.Director, Head of Expedited Safety Reporting, Bristol-Myers Squibb
• Karthik serves as the Senior Director for Expedited Safety Reporting at Bristol-Myers Squibb (BMS) Company in Princeton, NJ. With 18 years of experience in the pharmaceutical industry, Karthik has held various leadership roles within ICSR operations, Quality & Compliance, and Risk Management.
• He has successfully led multiple projects involving harmonization and integration of ICSR databases/processes. Additionally, Karthik plays a crucial role in overseeing vendor teams and defining the outsourcing strategy. Leading a team of Safety Scientists, Karthik is responsible for the handling and management of Expedited Safety Reports and SUSARs.
• Karthik actively participates in the review and implementation of Regulatory Policy Changes that impact GCP and GVP processes. He has a passion for system automation and is dedicated to implementing innovative processes to enhance operational efficiencies.
• Furthermore, Karthik is an engaged member of cross-functional industry consortiums such as TransCelerate, contributing to collaborative efforts within the pharmaceutical industry.
Azurity Pharmaceuticals
Bristol-Myers Squibb
LAURA RAY RN, Director, Signal Detection Process Lead, Bristol-Myers Squibb
Laura Ray, a registered nurse with over 25 years of pharmacovigilance and drug safety expertise, is a Director in WorldWide Patient Safety at Bristol-Myers Squibb (BMS) Company in Lawrenceville, NJ. She is the Signal Detection, Management, and Documentation Global Process Lead and heads a team who lead and coordinate individual cross-functional Safety Management Teams. Her pragmatic approach and sensible solutions ensure that patients and informed and take medicine that are safe.
Merck
ANKA G. EHRHARDT, Director, Cell-Based Assays / Analytical Research & Development, Merck
Dr. Ehrhardt is a biophysicist with a Ph.D. in human physiology. Throughout her career, she focused on driving biomedical research through efficient application of innovative technologies and strategies. She built and led successful teams in industry, including at Merck, where she headed a laboratory providing leading technologies for cell-based research from early discovery through manufacturing; and at BMS where Dr. Ehrhardt led and grew an international clinical assay team to robustly cover large scale registrational and translational clinical analysis generating clinical decision-driving data and mechanistic insights for immuno-oncology, cardiovascular, immunology, metabolic and rare disease studies. Before returning to Merck, Dr. Ehrhardt fulfilled one of her scientific aspirations at CHDI Foundation, designing and implementing successful clinical biomarker discovery and development strategies for Huntington’s disease. Currently, at Merck, Dr. Ehrhardt is focusing her team on analytical science providing strategic and technical leadership for the development of biologics products.
Bristol-Myers Squibb
LIN CHUNG, Director, Global Scientific and Regulatory Documentation, Bristol-Myers Squibb
Lin Chung, PharmD RPh, is a Director in Global Scientific and Regulatory Documentation at Bristol-Myers Squibb (BMS) Company with 15 years of pharmaceutical industry experience. She began her career as a pharmacovigilance aggregate reporting scientist at Janssen Pharmaceutical Companies of Johnson & Johnson. In her current role, Lin serves as the process lead for investigator’s brochures and manages a team of scientific writers authoring investigator’s brochures, safety aggregate reports and risk management documents. She is passionate about patient safety and is dedicated to deliver innovative medicines to patients.
CSL Behring
ANGELA FARODOYE, Principal Clinical Safety Scientist (US Site Lead), CSL Behring
Angela Farodoye is a pharmacovigilance expert with an industry career spanning 20 years. She began her career as a CRA, then moved into ICSR operations at Schering Plough. She has worked at companies such as Johnson & Johnson, AstraZeneca, and Astellas; also, small biotechnology companies as an independent consultant, helping to build teams and establish PV footprints. Over the years, Angela has held sundry leadership roles within aggregate reporting, safety surveillance, risk management and medical safety. She has contributed to development of processes and related training projects. In her current role, she leads a team of PV scientists in safety monitoring and evaluation of clinical programs as well as marketed assets.
Angela is a strong communicator and results-oriented leader who leveraged her business acuity to co-lead implementation of an innovative outsourcing program for the global safety science organization, allowing for increased efficiency and compliance in safety surveillance and reporting. She continues to provide vendor oversight and foster a successful partnership with managed services providers. Angela enjoys coaching, nurturing talent, and empowering employees. She is passionate about rare disease research and epidemiology and the advancement of safe therapeutic options and positive patient outcomes.
Merck-EMD Serono
CLINEXEL Life Sciences
DEEPA ARORA, CEO, CLINEXEL Life Sciences
Dr Deepa is a physician, with more than 2 decades of industry experience in leadership positions in drug safety and clinical development. She has a strong understanding of early product development with associated extensive and in-depth safety monitoring. She worked with clinical trial sites in the USA, India, UK and Europe to conduct global clinical trials. Dr Arora has a strong understanding of clinical development requirements and regulations. She set-up pharmacovigilance operations for 2 midsize pharma companies where they faced multiple GCP, GVP and PADE inspections from different regulatory authorities without critical or major findings.
Black Diamond Networks
BEN LOCWIN, Vice President, Project Solutions, Black Diamond Networks
Curis
Omega Therapeutics
KAMLESH PRABHU, Sr. Director Safety & Pharmacovigilance, Omega Therapeutics
Kamlesh Prabhu, MS has more than 15 years of experience in Pharmacovigilance within Biotech as well as CRO industry. He is currently the Sr. Director of Pharmacovigilance in Omega therapeutics and is responsible for all of the clinical safety activities. He has previously worked in SQZ Biotech, Takeda, Shire and Sanofi in their Pharmacovigilance departments.
Covilance
JAMES BUCHANAN, President, Covilance
Dr. James Buchanan is presently an independent drug safety consultant. He graduated from the University of California, San Francisco with a PharmD degree in clinical pharmacy. He worked in the area of clinical toxicology at the Bay Area Regional Poison Control Center at San Francisco General Hospital before entering the pharmaceutical industry. Dr. Buchanan began his industry career at Genentech where he worked for 9 years in the areas of medical information and drug safety in the clinical development department. He subsequently moved to Gilead Sciences to establish a drug safety department. After leaving Gilead Sciences, Dr. Buchanan started the drug safety department at Tularik Inc where he acted as Chief Safety Officer until the company was acquired 5 years later by Amgen. Following the merger with Amgen, he moved to Nuvelo to establish a drug safety department and act as Chief Safety Officer where he also had responsibility for clinical operations, biostatistics and data management.
Dr. Buchanan next served with BioSoteria for 5 years as the head of the medical and safety consulting group, which was subsequently acquired by Dohmen Life Science Services. Dr. Buchanan is currently president of Covilance, LLC, a drug safety consulting service. He is also a co-lead of the American Statistical Association Biopharmaceutical Safety Working Group and is a co-lead on the Interactive Safety Graphics taskforce that is developing novel, open-source interactive graphical tools to identify and evaluate safety issues during drug development.
Sunovion
YILONG JIA, Senior Manager, Pharmacovigilance Informatics, Sunovion Pharmaceuticals
Yilong Jia obtained MS degree in chemistry and another MS in bioinformatics from Indiana University before stepping into the biotech and pharmaceutical world as a data professional. Yilong joined Sumitomo Pharma in 2019 and has been with their Pharmacovigilance and Risk Management team. His responsibilities include PV systems, signal management, aggregate reporting and analytics. Yilong has a passion for innovative technology and applying artificial intelligence to PV.
Wiley Rein
JESSICA VAUGHN, Attorney at Law, Wiley Rein
Jessica provides clients with legal and regulatory support needed to design and implement regulatory strategies to advance products, including pharmaceuticals, medical devices, food products, and dietary supplements, through the premarket approval regimen of the U.S. Food and Drug Administration (FDA). With an advanced scientific degree and experience in-house at a global biotechnology company, Jessica provides a unique insight into pharmaceutical and medical device matters.
Representative Matters :-
• Advises clients on early drug development programs, including assistance with the drafting and technical review of preclinical testing protocols.
• Counsels clients on clinical development of new drugs, including review and design of clinical trial protocols and endpoint development, and interactions with contract research organizations.
• Assisted multiple private and publicly traded companies in developing a relationship with regulators, navigating the planning, drafting, and submission of FDA meeting and information requests, and accompanying clients to meetings with regulatory agencies.
• Assists clients with short- and long-term regulatory strategy planning and execution for pharmaceuticals, including drafting Investigational New Drug Applications and New Drug Applications.
• Advises clients on FDA requirements for expedited development and review programs such as orphan drug designations, fast track, breakthrough therapy, and priority review designations, as well as accelerated approval, with a proven track record of successful applications.
• Represents and guides clients in responding to FDA information requests as well as enforcement actions such as Warning Letters, Untitled Letters, Complete Response Letters, recalls, import detentions, and alerts.
• Provides technical expertise and support in due diligence involving the sale and acquisition of companies that produce FDA-regulated products, and provides support to litigation and discovery matters.
• Provides regulatory strategy planning and support for medical devices, including the design and drafting of premarket applications such as 510(k) applications and De Novo classification requests, and provides technical support for medical device development issues.
• Reviews agreements and contracts associated with pharmaceutical and medical device activities.
Professional Experience :-
• Executive Director, Legal/Regulatory/Compliance, CorMedix Inc. (2019-2021)
• Law Clerk (2019), Regulatory Scientist (2012-2019), Private law practice
• Graduate Assistant, New York University School of Medicine, Department of Environmental Medicine (2006-2012)
• Clinical Information Manager, Alpha Physicians Resources (Emergency Medical Associates of NJ) (2004-2012)
Affiliations :-
• American Bar Association
• Food and Drug Law Institute
• Consumer Health Products Association
• Maryland Tech Council
JHU
TAXIARCHIS BOTSIS, Associate Professor, The Johns Hopkins University
Taxiarchis Botsis, MS, MPS, PhD, is an Associate Professor of Oncology and Medicine at the Division of Quantitative Sciences at The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University. His background lies in Medical Informatics, and his research focus is on developing and utilizing advanced modern technologies in pharmacovigilance and precision oncology, natural language processing of clinical texts, normalization and standardization of clinical information, construction of decision support systems, integration of data from multiple sources, and generation of efficient and compelling information visualizations.
Dr. Botsis has received several federal and other awards to improve the efficiency and rigor of pharmacovigilance at the US Food and Drug Administration, as well as work on data standardization, decision-support solutions, and personalized medicine approaches in precision oncology. He is also a principal investigator in the National Cancer Institute’s Informatics Technology for Cancer Research (ITCR) program and a member of the international CIOMS Working Group XIV, formed in 2022 to establish a guidance document for using artificial intelligence in pharmacovigilance.
Social Media:
LinkedIn – linkedin.com/in/TaxiarchisBotsis/
twitter – @TaxiarchisB
Hogan Lovells
LYNN MEHLER, Partner, Hogan Lovells
As Co-Head of the firm's Life Sciences & Health Care industry sector and Head of the Pharmaceuticals and Biotechnology practice, Lynn Whipkey Mehler advises clients on a range of FDA and DEA regulatory matters. She has worked extensively on the approval processes for new drugs and biologics; on safety issues that include Risk Evaluation and Mitigation Strategies (REMS); and on unique regulatory issues raised during the development and marketing of controlled substances.
Drawing on her 12 years with the FDA's Office of the Chief Counsel, Lynn has a deep understanding of the FDA. Her experience as the primary attorney handling all FDA issues related to controlled substances provides her with unique insights into both the FDA's and DEA's regulatory processes for controlled substances. She advised the agency on drug safety matters, including at approval and those leading to labeling changes, REMS, and even product withdrawal, and she applies that understanding to help clients create effective solutions for FDA regulatory matters.
Lynn has worked with a range of clients, getting their products approved, developing and modifying REMS, and negotiating shared REMS with generic applicants. She draws on her deep experience in the FDA approval process to represent pharmaceutical clients in formal dispute proceedings within the agency.
Having counseled the FDA on the Prescription Drug User Fee Act, she now guides clients in the submission of user fee waiver requests and helps them understand the agency's administrative management of drug applications. She has extensive experience in the FDA and DEA drug scheduling process and has worked with clients to effectively manage the process to minimize the delays to product launch. She has a deep understanding of the web of regulatory requirements governing the research and development of controlled substances and guides companies on matters from initial clinical trials to approval and marketing.
Representative experience :-
• Represent multiple innovator companies during the negotiation and development of shared REMS.
• Advising a pharmaceutical client in preparation for, during, and to a successful close-out of an FDA pharmacovigilance inspection.
• Advising a pharmaceutical client through the DEA scheduling process for controlled substances and to successful marketing of the product.
Awards and rankings :-
• FDA Commissioner's Award of Excellence
• FDA Commissioner's Award of Merit
• FDA Outstanding Service Award
Latest thinking and events :-
News : FDA advises on RWE non-interventional study use as evidence of effectiveness or safety - 21 March 2024
Press releases : Hogan Lovells Guides Mind Medicine Inc. on its US$175m Underwritten Offering of Common Shares and Concurrent Private Placement - 14 March 2024
Press releases :Hogan Lovells advises Perspective Therapeutics on a series of strategic transactions with Lantheus and a US$69 million follow-on public offering of equity securities - 26 January 2024
News : Key considerations for responding to a CREATES Act request - 26 January 2024
News : FDA explains “confirmatory evidence” for sponsors seeking approval based on a single clinical trial - 03 October 2023
News :New FDA Guidance on Psychedelic Drug Development - 26 June 2023
Meet and to network with your conference colleagues.
08:50 – Chairperson opening remarks
BEN LOCWIN, Vice President, Project Solutions, Black Diamond Networks
09:00 – Signal Detection learning and prevailing challenges
• How signal detection been evolved?
• What we have learned in last decade? Some best practices in PV using signal detection.
• What are prevailing challenges and practical approach in Pharmacovigilance?
LAURA RAY RN, Director, Signal Detection Process Lead,
09:30 – Behind Every Successful Drug also Stands an Excellent CMC
• The analytical challenge
• Quality guarantees consistent drug
• Data connect the worlds of PV and CMC
ANKA G. EHRHARDT, Director, Cell-Based Assays / Analytical Research & Development, Merck
10:00 - Panel Discussion – PV and Outsourcing - How to evaluate and implement sourcing alternatives?
• Benefits and risks of managing a pharmacovigilance-outsourced organization
• Steps to be taken in order to maintain efficacy and quality
• Outsourcing - Best Practices, Challenges and key consideration in choosing right vendor
• Preliminary set up steps – What are all to be looked into?
• Future of the field of pharmacovigilance, with a focus on how collaborations can work to advance the industry in this space?
• Updates & lessons learned from novel approaches for collaborations while outsourcing
• Outsourcing vs Innovation
• Importance of Proper communication between - Sponsor – Site – CRO – Patients
Moderator
BEN LOCWIN, Vice President, Project Solutions, Black Diamond Networks
Panellists
COLLEEN WALSH, VP, Global Patient Safety Operations, Alnylam Pharmaceuticals
HUMAIRA QURESHI, President, Qinecsa Solutions
KARTHIK MUTHUSAMI, Sr.Director, Head of Expedited Safety Reporting, Bristol-Myers Squibb
SUZANNE GUIDERA, Executive Director PV Operations & Compliance, Xenon Pharmaceuticals
PHILISHA MACK, Director Drug Safety, Azurity Pharmaceuticals
ANGELA FARODOYE, Principal Clinical Safety Scientist (US Site Lead), CSL Behring
10:50 – Morning Networking Coffee / Tea & Discussion
11:20 – Real World Data to Real World Evidence
• Importance of real world data for answering regulatory questions
• Benefits and challenges of evidence derived from real world sources compared to clinical trials.
• Real World Evidence: How Does its Use challenge quality and compliance programs?
• Obtaining patient-centric using RWE
• What are complications that will rise by inserting new data source? Breakup in data?
• Identify the challenges involved in incorporating real world evidence into a structured benefit-risk assessment.
WILLIAM A. BLUMENTALS, Sr. Director, Head of Pharmacoepidemiology, Sanofi
11:50 – Ushering in a new era for pharmacovigilance
HUMAIRA QURESHI, President, Qinecsa Solutions
12:20 – Networking luncheon
13:20 – Panel Discussion – Quality, Safety Evaluation & Signal Detection – Important Considerations - Analise to Adapt
• Developing a global safety intelligence process
• Exploring patient support and marketing research programs from a safety perspective
• Develop an aggregate safety assessment planning (ASAP) process – Its importance
• Expectations for quality and compliance in pharmacovigilance process and systems
• What is now essential for both good quality management and to drive continuous improvement?
• How safety protocols impact REMS
• Implementing signal detection in RWD: The necessary steps.
• Statistical signal detection as a routine pharmacovigilance practice
Moderator
BEN LOCWIN, Vice President, Project Solutions, Black Diamond Networks
Panellists
BILL HADDOCK, VP, Pharmacovigilance & R&D Quality, Ovid Therapeutics
LAURA RAY RN, Director, Signal Detection Process Lead, Bristol-Myers Squibb
TEODORA DOHERTY, Global Medical Safety (GMS), Medical Safety Officer, Janssen Research & Development
LINA OGBU, Medical Director Patient Safety & Pharmacovigilance, Arcus Biosciences
DAVID LILIENFELD, Independent Consultant
14:10 – Beyond the Hype! Leveraging Generative AI for Risk Mitigation with Practical Considerations
• What is Generative AI, how is it different, why that matters and what’s coming next
• Working with LLMs as a tech vendor and as biopharma
• How can Generative AI support Risk Minimization
• Navigating AI Safely - including lessons from adjacent industries
ANDREW MITCHELL, Senior Director, Vigilance Product Management, IQVIA
14:40 – Modern Technologies Change the Landscape for Essential Processes in Pharmacovigilance
• Is Artificial Intelligence Ready for Prime Time and Routine Use in Pharmacovigilance?
• Advanced Approaches to Improve Data Quality and Offer Deeper Insight into Real World Data
• Intelligence Augmentation Applications to Decision-making – A Complete Platform for Drug Safety Monitoring at the US Food and Drug Administration
• Quality Assurance Framework for the Appropriate Use and Evaluation of AI-based Technologies in Pharmacovigilance
TAXIARCHIS BOTSIS, Associate Professor, The Johns Hopkins University
15:00 - Afternoon Networking Coffee / Tea & Discussion
15:20 – Keynote Panel Discussion: New Era of PV’s Challenges / Opportunities - Turning strategy into execution
• Discussion on strategies to address pharmacovigilance challenges in the long-term
• What comes next for the industry?
• Automating pharmacovigilance: Are we ready for the upcoming future?
• Moving forward in Drug Safety – Where are we heading and which is the right direction?
• Current challenges and goals in the field and to identify ways for betterment
• Moving towards a better future: bigger and better
• Best practices & lessons learnt today
Moderator
BEN LOCWIN, Vice President, Project Solutions, Black Diamond Networks
Panellists
KHAUDEJA BANO, Vice President, Combination Product Quality, Amgen
LINDA LUM, Senior Director, Global Scientific & Regulatory Documentation, Bristol-Myers Squibb
YILONG JIA, Senior Manager, Pharmacovigilance Informatics, Sunovion Pharmaceuticals
ASHISH JAIN, Sr. Director, Clinical Safety & Pharmacovigilance, Curis
TAXIARCHIS BOTSIS, Associate Professor, The Johns Hopkins University
16:10 – Navigating through the NexGen Tech and Safety Database
• Predictive Pharmacovigilance focusing on AI, Automation, NLP, ML techniques
• Model driven approaches for Case Intake, Reporting Risk and signal management – All in One, One Integrated, End-to-End Platform
• Advanced technology stack and its applications - PV efficiency gains and High capability-to-cost ratio
• Outcomes of completed Risk Minimization measures by going with End-to-End platform , Automated Real time Metrics, Automated dashboards
• Future perspectives
RAJ MORE, Chief Architect & CEO, RxLogix Corporation
16:30 – PV Ecosystem is continuously evolving-Combination Products and now Diagnostics and Digital
• How do we as an industry partner with the Regulatory bodies and agencies to share our voice
• People / Processes and Technology – as enablers to maintain the patient-centric approach
• How do we truly ensure that safety is our priority – regardless of its source – Drug, Device, Diagnostic or Digital therapeutics
KHAUDEJA BANO, Vice President, Combination Product Quality, Amgen
17:00 – Closing remarks by chairperson and End of day 01 conference
17:10 – 18:00 – Networking Drinks
09:00 – Chairperson opening remarks
BEN LOCWIN, Vice President, Project Solutions, Black Diamond Networks
09:10 – Challenges for PV in Gene therapy clinical development:
• What is the current state of gene therapy development activities?
• What are the major safety issues seen so far?
• New areas to monitor: Off-target toxicity, Immunogenicity, Secondary malignancies etc.
• What are the challenges/opportunities for the PV community with regards to gene therapy development?
KAMLESH PRABHU, Sr. Director Safety & Pharmacovigilance, Omega Therapeutics
09:40 – Setting the Right Expectations: the key to a successful adoption of AI-driven automation in Pharmacovigilance
• What are the key expectations to include to deliver value across your PV organization?
• What are the problematic expectations to set
TIM HOWARD, CEO, Arietta.ai
10:10 – Panel Discussion- Risk Management – Planning for a risk free tomorrow
• Implementation and maintenance of RMP’s – Overcoming its challenges
• One RMP to fit all or all to fit within one RMP?
• Benefit/Risk ratio: the common denominator
• Implementing a Risk-Based Monitoring Solution: Understanding the basics of a sustainable model
• Key considerations in evaluating the impact of uncertainty on the quality of the benefit-risk assessment decision
• The “Next Generation” risk management tools
• Risk Evaluation and Mitigation Strategies (REMS): Lessons to learn today
Moderator
BEN LOCWIN, Vice President, Project Solutions, Black Diamond Networks
Panellists
ELENA YURENEVA, Executive Director, Head of Medical Safety & Risk Management, Alnylam Pharmaceuticals
DEEPA ARORA, CEO, CLINEXEL Life Sciences
LYNN MEHLER, Partner, Hogan Lovells
11:00 – Morning Networking Coffee / Tea & Discussion
11:20 – Enhancing Pharmacovigilance through Patient Experience Data: Integrating Patient Focused Drug Development (PFDD)
• Emphasize the importance of collecting Patient insights and thus Patient experience data
• Outline how to select the appropriate qualitative and/ or quantitative methodologies to collect insights and experience data
• Present case-examples that highlight the benefits of understanding, analyzing, and synthesizing of social determinants of health (SDOH) challenges into PFDD strategies
RAMONA BURRESS, Senior Director, Head of Patient Engagement & Insights, Takeda Pharmaceuticals
11:50 – Topic TBC
Speaker TBC
12:20 – Networking luncheon
13:20 – Keynote Panel Discussion: Enhancing patient centricity & patient safety
• The What, Why, and How - Reduce Barriers and move towards prioritising patients
• Protecting patients and pharmacovigilance compliance in extraordinary circumstances
• Next generation pharmacovigilance for enhanced patient safety
• Strategy for improving your organization’s patient-facing communications
• Discuss specific methodologies frequently used in the development of patient safety program
• Encouraging patient support programs in Pharmacovigilance
• A practical approach to reshaping patient safety
• Educating stakeholders via patient stories
Moderator
MARIETTE BOERSTOEL - STREEFLAND, SVP, Worldwide Patient Safety Officer, Bristol-Myers Squibb
Panellists
RENA PANDIT, Executive Director, Global Patient Safety Head of PV Compliance & Training, Amgen
NANCY DUBOIS, Head of Global Patient Safety US, Merck-EMD Serono
RAMONA BURRESS, Senior Director, Head of Patient Engagement & Insights, Takeda Pharmaceuticals
STEPHEN SUN, Vice-President, US Pharmacovigilance, Epidemiology and Risk Managment, PharmaLex
14:10 – New Novel Open-Source Interactive Safety Graphical Tools for Data Exploration and Signal Detection
• An Adverse Event Volcano Plot with Drill-Down Capabilities
• The Renal Explorer for Detection of Instances of Acute Renal Injury
• A Clinical Workflow to Guide Exploration of Renal Data and Understanding Possible Mechanisms of Renal Injury
• A Patient Profile Display to Augment Other Interactive Safety Tools
JAMES BUCHANAN, President, Covilance
14:40 - Integrating Novel Network Analysis with MGPS to differentiate products within a class for Signal detection and management.
ELENA DAVISON, Executive Director, Safety Information Management, Sumitomo Pharma
15:10 – Panel Discussion: PV - Regulatory Updates – Transforming regulatory strategy to meet the evolving landscape
• Key current changes and their impact on current PV
• Pathways and programs for patient stakeholders to engage with FDA
• Examine the global regulatory landscape for safety evaluation
• Integrating patient focus into the regulatory mindset
• PV system legislation updates
• Improving communication between regulators, regional authorities and patients
• RWD Quality for regulatory decision-making
• Standardizing and streamlining the regulatory process
• What’s next? Ways to proceed forward.
Moderator
BEN LOCWIN, Vice President, Project Solutions, Black Diamond Networks
Panellists
LIN CHUNG, Director, Global Scientific and Regulatory Documentation, Bristol-Myers Squibb
JESSICA VAUGHN, Attorney at Law, Wiley Rein
LYNN MEHLER, Partner, Hogan Lovells
15:50 – Chairperson Closing Remarks
16:00 - Afternoon Networking Tea / Coffee & End of conference
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Qinecsa is a trusted partner to global life science companies. We bring together best-in-class technology and scientific expertise to connect life science companies to the right safety solutions.
Patient safety is at the forefront of pharmacovigilance. In a demanding and constantly evolving field, life science companies need expert partners with the right people, processes, and technologies, to generate vital safety insights, rapidly.
Through our unique insight into the challenges of pharmacovigilance, we have created industry-leading, end-to-end solutions for capturing, managing, and evaluating drug safety data, more efficiently and accurately. Working with life science companies we drive progress to continue protecting lives.
We are Qinecsa. Advancing drug safety solutions to the next level.
Visit our website: https://qinecsa.com/
As one of the world's leading pharmacovigilance (PV) organizations, IQVIA brings extensive domain expertise and deep regulatory knowledge to every program. Our safety teams leverage automation, artificial intelligence (AI) and machine learning to design, build and execute end-to-end safety solutions. Powered by IQVIA Connected Intelligence – integrated, scalable technologies combined with global data, advanced analytics, and deep domain expertise – our innovative Safety solutions help PV organizations do more with less.
Visit Our Website: www.iqvia.com
RxLogix is a global pharmacovigilance company providing cutting-edge software solutions designed to streamline pharmacovigilance processes, increase compliance, drive efficiency, productivity, excellence, and quality across the entire drug safety value chain through a combination of advanced technology and expert consulting.
Our team of experts provide valuable insights and guidance to pharmacovigilance and risk management professionals, helping them navigate complex regulatory landscapes and achieve optimal outcomes.
We are located across Europe, US, and Japan with our Headquarter in Princeton, NJ.
Visit Our Website: www.rxlogix.com
Arrietta.ai a company committed to innovation, and at the core of our mission is a dedication to responsible AI for the Life Science sector.
We equip pharmaceutical organizations and their service providers with state-of-the-art, time-saving tools that not only represent advancements in AI but also enhance the capabilities of medical experts without replacing them. We recognize the benefits of speed combined with quality in healthcare, and our solutions are engineered to accelerate processes while ensuring compliance through the exercise of responsible AI practices. We provide robust, scalable, and compliant solutions that seamlessly enhance your existing workflows without disruption. Arietta.ai is a strategic partner to those who strive for safer medications with our LucidPV offering.
Visit Our Website: www.arietta.ai
PharmaLex is now part of Cencora, a leading global healthcare company with a foundation in pharmaceutical distribution. Together, PharmaLex and Cencora offer end-to-end product commercialization, including global market access strategy and execution, to drive patients’ healthier futures wherever they are in the world.
PharmaLex complements Cencora’s existing suite of services by continuing to service the pharma, biotech and medtech industries, guiding clients from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology-elevated solutions to support clients through the entire product lifecycle.
Visit Our Website: www.pharmalex.com
Clinexel is a midsize CRO with office in India and a business office in the USA. Clinexel is a full service CRO providing clinical research and pharmacovigilance services. Clinexel team provides post marketing Pharmacovigilance services as well as safety monitoring services during clinical trials. Clinexel is providing end to end, full service safety and pharmacovigilance services, as well as functional services as required. Our strengths include professionally qualified, trained staff with strong knowledge of GVP and experience of facing regulatory inspections as well as several client audits. Clinexel expertise includes Pharmacovigilance, Safety Monitoring in Clinical Development, Early Phase Clinical Development and Medical Monitoring together with strong regulatory, clinical operations and medical writing skills.
Visit Our Website: www.clinexel.com
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