32nd Pharmacovigilance 2023
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WHY SHOULD YOU ATTEND?
• 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
Speakers
KHAUDEJA B
Amgen
KHAUDEJA B
Amgen
KHAUDEJA BANO, Vice President, Combination Product Quality, Amgen
Khaudeja is a Physician with a Masters in Clinical Research, Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional.
Khaudeja has more than 25 years’ professional experience, including clinical practice. She has held several global medical positions at Guidant, Abbott, and AbbVie Inc. Her career includes global medical / clinical and safety leadership roles in devices, diagnostics, pharmaceuticals and combination products.
She currently serves as the chair for the Post Marketing Safety working group for the Combination Product Coalition (CPC).
BRUNO MENDEZ
Sanofi
BRUNO MENDEZ
Sanofi
BRUNO MENDEZ, VP Global Quality Head Pharmacovigilance, Sanofi
JEREMY J
Bristol-Myers Squibb
JEREMY J
Bristol-Myers Squibb
JEREMY JOKINEN, VP Global Risk Management & International Patient Safety, Bristol-Myers Squibb
Jeremy is the Vice President and Head, Global Risk Management and International Patient Safety at Bristol Myers Squibb. In this role, he leads a global team of risk management and safety science leaders responsible for insights, evidence generation, and risk minimization efforts ensuring the safety of patients worldwide. Jeremy is also active within numerous cross-industry pharmacovigilance initiatives for DIA, TransCelerate, and ICH.
CARMIT STRAUSS
Takeda Pharmaceuticals
CARMIT STRAUSS
Takeda Pharmaceuticals
CARMIT STRAUSS, Executive Director, Head of Risk Management and Organ Toxicity, Takeda Pharmaceuticals
SHARON REID
Pfizer
SHARON REID
Pfizer
SHARON REID, Director, Risk Management Product Lead, Pfizer
• Sharon Reid is a Director, Global Risk Management Process Analyst for 8 years at Pfizer Risk Management Center of Excellence where she is responsible for providing strategic guidance for assisting Pfizer product teams with development and implementation of risk management programs.
• She is currently the business project lead on the development of an integrated single solution for the management of Risk Management Plans and Commitments. Prior to joining Pfizer, Sharon worked with Bristol-Myers Squibb for 20+ years as Director Pharmacovigilance, Quality and Inspection Readiness. She was a co-lead involved in the initial development of the Corporate Adverse Reaction Evaluation System.
• Sharon is licensed as a registered nurse holds a BSN from Thomas Edison State College and an MSfrom Temple University.
AYSE BAKER
Innocoll
AYSE BAKER
Innocoll
AYSE BAKER, Vice President of Regulatory Affairs, Innocoll
ALEX QIU
Bristol-Myers Squibb
ALEX QIU
Bristol-Myers Squibb
ALEX QIU, Executive Director, Bristol-Myers Squibb
• Over 30 years’ experience in the oncology field from clinical practice, basic research, preclinical drug discovery, clinical development strategy, and drug safety.
• 20 years pharmaceutical industrial experience ranging from drug discovery, clinical development, pharmacovigilance, and NDA & BLA submission.
• 10 years pharmacovigilance experience, balanced experience for products in the clinical development stage and in the post marketing stage. Therapeutic area included oncology, autoimmune-diseases, cardiovascular diseases, dermatology, and infectious diseases; as the clinical pharmacology lead or safety lead, led over 25 projects in the clinical development stage ranging from Phase I to phase III, and three post-marketing products (notably, two of them exceeded billion dollars annual revenue, Tarceva and regadenoson).
• For oncology drug development, indications included and not limited to: None small lung cancer, endometrial cancer, prostate cancer, gastric cancer, pancreatic cancer, head & neck cancer, ovary cancer, HCC, multiple myeloma, AML, CLL, Lymphoma, etc.
• In term of submission: as lead safety physician: Cilta-cel (Car-T for multiple myeloma) was approved in 2022
• As the lead safety physician: Dostarlimab: PD-1 antibody to treat endometrial carcinoma treatment in 2021
HUMAIRA Q
Qinecsa Solutions
HUMAIRA Q
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.
MARITESS E
Genentech
MARITESS E
Genentech
MARITESS ESGUERRA, Senior PV Process Director, Genentech
With 25 years experience in the pharmaceutical, biotechnology and academia, Maritess Esguerra has extensive experience in drug safety covering numerous product types (innovators, generics, biosimilar, medical device, product-device combination, and advanced therapeutic medicinal products) in various therapeutic areas, spanning from investigational stage to post-market settings. She is currently a Senior Pharmacovigilance Process Director at Genentech, a member of the Roche group, where she has served as business lead and global process owner of safety processes, systems and tools. She is an active Core Member of the TransCelerate’s Interpretation of PV Guidances and Regulations (IGR PV) Workstream and also served as its Regulatory Council Liaison.
Previously, Maritess had a progressive career and held various global and regional safety positions at Alliance Pharmaceutical, Chugai Pharma USA, Amgen, and Puma Biotechnology. Prior to joining the industry, Maritess worked at the University of California San Diego Health Bone Marrow Transplant Unit, coordinating and monitoring clinical trials, and had also conducted epidemiological and pre-clinical research.
FARIDA ABANE
Deciphera Pharmaceuticals
FARIDA ABANE
Deciphera Pharmaceuticals
FARIDA ABANE, Senior Medical Director, Pharmacovigilance, Deciphera Pharmaceuticals
GRAEME LADDS
PharSafer
GRAEME LADDS
PharSafer
GRAEME LADDS, CEO, PharSafer
• With a first degree in Biochemistry and Pharmacology, and a Ph.D. focusing on drug metabolism and Pharmacokinetics, Graeme has worked in the areas of Drug Safety and Medical services for over 30 years.
• Working as a Head of Global Pharmacovigilance for a multi-national innovator Company and EU QP PV for several of the top ten Pharma Companies, large generic and smaller innovative Pharma, Graeme is the CEO and Owner of PharSafer® – a position held for the last 19 years – and he has taken many products from bench to clinical to post-marketing in many global markets; helping many small start-up Companies (Biotech, Advanced Therapy, Medical Device, Biologic, Generics, Herbal, OTC) in their planning and growth, due-diligence activities for product in-licensing and marketing, and development strategies with partner and distributor Companies.
• Graeme has also been involved in many global audits (conducted) and inspections (taken part in) for clients and also database designs and development.
MARCIN VON G
Takeda Pharmaceuticals
MARCIN VON G
Takeda Pharmaceuticals
MARCIN VON GROTTHUSS, Principal Scientist, Investigative Toxicology, Takeda Pharmaceuticals
Principal Scientist in Investigative Toxicology with 20 years of experience executing multidisciplinary translational projects, including 8 years contribution to pioneering research on the analysis of clinical, molecular, and genomic data for drug development and safety evaluation for rare and common diseases, and precision medicine applications, initially, at The Broad Institute of MIT and Harvard and, currently, at Takeda Pharmaceuticals. Marcin von Grotthuss received a Ph.D. in bioinformatics at Radboud University Nijmegen, Netherlands, and gained professional experiences at Sanford-Burnham Institute (La Jolla), University of Washington (Seattle), Harvard University, University of Cambridge (UK), University of California Irvine, and the Brigham and Women’s Hospital / Harvard Medical School.
KAL ELHOREGY
Amneal Pharmaceuticals
KAL ELHOREGY
Amneal Pharmaceuticals
KAL ELHOREGY, Director, Risk Evaluation and Mitigation Strategy (REMS) Programs, Amneal Pharmaceuticals
• Kal Elhoregy is an accomplished healthcare industry executive with 24+ years’ experience focused on implementation of Risk Minimization Programs, Quality Management Systems (QMS) and Pharmacovigilance (PV) Compliance within the pharmaceutical industry. In his current role as a Director, Risk Evaluation and Mitigation Strategy (REMS), Regulatory Affairs Clinical at Amneal Pharmaceuticals, he manages all risk management programs and ensures the entity’s full compliance with risk management standards and guidelines.
• As a strategist and accessible leader with experience in PV & Quality Risk Management (QRM), he helped multiple disciplines to effectively manage compliance risk in accordance with regulatory guidelines and increasing organizational capacity through streamlining complex processes.
• He is a registered and licensed Pharmacist and holds a Bachelor of Science, Accounting from the Faculty of Commerce, Ain Shams University and Bachelor of Science of Pharmacy from Arnold & Marie Schwartz College of Pharmacy, Long Island University, New York.
His experience within the Health Care settings as a lead infusion Pharmacist, including Pediatric Intensive Care Units and Critical Care Unit Pharmacies. Also, his experience within the Pharmaceutical industry includes a strong expertise and leadership in PV Compliance, QRM and Quality System of PV, REMS, Risk Management Plan (RMP), GVP / CSV Risk Based Audit and Inspection Readiness.
• Kal believes in leadership and teamwork and focuses on what is important to achieve successful results in ensuring patient safety and regulatory compliance.
ELIZABETH S
Aris Global
ELIZABETH S
Aris Global
ELIZABETH SMALLEY, Director, Product Management, Aris Global
Elizabeth is the Director of Product Management, Data & Analytics at ArisGlobal. With over 15 years of experience across data analytics, Elizabeth has a passion for exploring the intersection of data science and human reasoning, with experience bringing AI-powered software to market to drive safety and clinical outcomes for patients and clinicians. In her current role, she leads the teams managing the Data Platform, LifeSphere Clarity, LifeSphere Signals, and Risk Management product lines.
NANCY DUBOIS
Merck-EMD Serono
NANCY DUBOIS
Merck-EMD Serono
NANCY DUBOIS, Head of Global Patient Safety US, Merck-EMD Serono
NICOLE BAKER
Biologit
NICOLE BAKER
Biologit
NICOLE BAKER, CEO, Biologit
• CEO at biologit, a Technology Company focused on Artificial Intelligence for Active Safety Surveillance.
• 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 10 years.
• Over 20 years’ experience gained within Academia, Pharmaceutical Industry, Regulatory Authority, Clinical Research Organisation, and more recently Start-up.
YILONG JIA
Sunovion
YILONG JIA
Sunovion
YILONG JIA, Senior Manager, Pharmacovigilance Informatics, Sunovion
• Yilong Jia joined Sunovion’s Pharmacovigilance and Risk Management team in 2019, and has since been actively exploring modern technologies in PV and understanding industry trends to improve efficiencies and optimize PV processes and activities. He’s passionate about the advancements of Robotic Process Automation and Artificial Intelligence.
• Yilong obtained two Masters of Science degrees from Indiana University – Chemistry, and Bioinformatics. He also graduated from Business in Life Sciences program at Indiana University Kelley School of Business.
NISHITH J
Pfizer
NISHITH J
Pfizer
NISHITH JOBANPUTRA, Disease Area Cluster Lead, Worldwide Safety, Pfizer
GURPREET SINGH
Freyr Solutions
GURPREET SINGH
Freyr Solutions
GURPREET SINGH, Vice President, Global Head of Pharmacovigilance, Freyr Solutions
CAMILLE DISS
EDGYN
CAMILLE DISS
EDGYN
CAMILLE DISS, CPO, EDGYN
Camille is Arjo Solutions’ CPO, acting as a solution designer in digital authentication since more than 8 years, she has deployed authentication and traceability project across among others spirits, pharma, cosmetics, precious metal
BEN LOCWIN
Black Diamond Networks
BEN LOCWIN
Black Diamond Networks
BEN LOCWIN, Vice President, Project Solutions, Black Diamond Networks
• Dr. Ben Locwin is an international speaker and expert on healthcare strategies and development programs to increase business performance and improve patient-centricity and patient safety. He has been featured in The Wall Street Journal, Forbes, The Associated Press, and other media outlets. His work has created some of the current best practices in pharmacovigilance and risk management which have improved drug outcomes and regulatory success across clinical trials.
• Dr. Locwin is a member of the Advisory Board for ATD’s Healthcare Community of Practice, which is helping to improve healthcare practices worldwide. He also serves as an expert media contact for the American Association of Pharmaceutical Scientists (AAPS).
BILL HADDOCK
Ovid Therapeutics
BILL HADDOCK
Ovid Therapeutics
BILL HADDOCK, VP Pharmacovigilance & GXP Quality, Ovid Therapeutics
• Bill is a biotech professional with more than 18 years’ experience in the industry with expertise in pediatrics, public health, pharmacovigilance (benefit-risk management), GXP Quality, and epidemiology.
• He is VP of Safety and GXP Quality at Ovid Therapeutics, a small biotech focused on therapeutics for epilepsy. 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).
• 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.
NIBHA MISHRA
CSL Seqirus
NIBHA MISHRA
CSL Seqirus
NIBHA MISHRA, Investigator II, Principal Toxicologist, CSL Seqirus
Nibha Mishra is a Toxicologist, currently working with CSL Seqirus. Her passion is to work with RNA therapies. She is trained as a Neuropharmacologist. Accoladed with several awards and published number of peered reviewed articles during her academic and industrial journey.
AJINKYA I
BioNTech SE
AJINKYA I
BioNTech SE
AJINKYA INAMDAR, Senior Director (Global Medical Safety Strategy), BioNTech SE
Ajinkya has over 15 years in the pharma industry with leadership in the development of vaccines, cell and gene therapies and the planning and conduct of clinical trials. He has valuable experience in vaccine safety strategy from Sanofi, Janssen, and BioNTech where his product portfolio included vaccines against Influenza, meningitis, COVID-19, Ebola, HIV, Tuberculosis, malaria, HSV, monkeypox and E. coli. His products included vaccines in various stages of development (including FIH as well as marketed products). He has worked on products based on multiple platforms (recombinant protein, adenoviral, inactivated, and mRNA). In addition to many years of experience in safety strategy in clinical development, safety crisis management, Ajinkya has also consulted on small as well as large PV projects to build safety teams and to establish safety databases integrating automated case management and automated report generation where his clients included Sanofi, Novartis, Takeda, and JNJ.
Besides infectious diseases, he has previously worked in Oncology, Cell and Gene Therapy. Ajinkya completed his Medical Education (MBBS) from Shivaji University, India, a Master of Science (MS) in Molecular Biology from the University of Alabama (UA), followed by a Master of Business Administration (MBA) at UA. Before coming to the US, Ajinkya managed his own clinic, worked at a hospital as a General Physician and taught at a medical school. Besides Pharmacovigilance and Vaccine Development, Ajinkya is passionate about finding solutions to stress management, preservation of nature, and improving the quality and length of human life.
TEODORA D
Janssen R & D
TEODORA D
Janssen R & D
TEODORA DOHERTY, Global Medical Safety (GMS), Medical Safety Officer, Janssen Research & Development
• Pharmaceuticals Medical Safety Officer (MSO), a physician with training or experience in Medical Safety, reporting into the Medical Safety Organization and has accountability for assessing the medical safety of neuroscience products or product families and the reasonable mitigation of risk associated with such products.
• Sixteen years of experience in the pharmaceutical industry in drug safety, clinical, drug development, regulatory affairs, product labeling, clinical research and people management
• Five years of academic and clinical experience as an Assistant Professor in Cardiology and Rheumatology at an academic tertiary referral hospital
• Proven ability to build productive work relationships with agency officials and co-workers, motivate and develop staff, and deliver results on time. Excellent interpersonal, problem-solving, and leadership skills.
LINA OGBU
Arcus biosciences
LINA OGBU
Arcus biosciences
LINA OGBU, Medical Director Drug Safety & Pharmacovigilance, Arcus biosciences
• Dr Lina Ogbu is an experienced Physician-Scientist with years of experience in biotechnology and pharmaceutical industrial. Dr Ogbu is the Medical Director, Safety and Pharmacovigilance at Arcus Biosciences.
• Dr Ogbu has led the research and clinical development of multiple types of therapeutic agents, including immune-oncology and gene therapies.
• Dr Ogbu received her M.D degree from Windsor university school of Medicine, her post-graduate clinical training at the University of West Indies and her MPH degree at Walden University.
KAPIL BHUTADA
Consultant
KAPIL BHUTADA
Consultant
KAPIL BHUTADA, Consultant
• Kapil Bhutada MS BPharm, currently a Director, PV compliance, Training and Strategy at Medicago is Pharmacist by training and have Masters in Regulatory Affairs. Kapil have been in PV Industry for 15 years and worked in CRO, Big, Midsize and Small Pharma and biotech. He has experience in ICSR Processing, Training and Compliance, Signal management, Auditing and Inspection Hosting.
• In his current role, he is working on Covid-19 vaccine and supporting Medicago team with Benefit/Risk Management, Signal Management, Coordinating Real World Evidence Studies (Safety/Efficacy) and Inspection Readiness and Compliance activities.
BENJAMIN B
ASP
BENJAMIN B
ASP
BENJAMIN BROWN, Executive Director, American Society of Pharmacovigilance
• A driven entrepreneur; relentless, innovative, passionate and always focused on results Benjamin Brown is Co-Founder and Executive Director of the American Society of Pharmacovigilance, a member-based organization redefining how America thinks about adverse drug events. In his role, he sets the organization’s vision, oversees the strategic direction of the Society, supports its leaders and forges cross-sector partnerships, collaborations and coalitions uniting key stakeholders to address shared-challenges and advance the promise of precision medicine. In 2020,he co-created and founded the Standardizing Laboratory Practices in Pharmacogenomics Initiative (STRIPE), which is the nation’s first and only Collaborative Community for Pharmacogenomics, recognized and supported by the FDA’s Center for Devices and Radiological Health and Center for Drug Evaluation and Research.Additionally, he is actively involved in pharmacogenomics at the National Institute of Health’s, National Human Genome Research Institute, serving as member on the PGX working group (ISCC-PEG) to improve genomic literacy of healthcare providers and enhance the effective practice of clinical genomic medicine by facilitating interactions among the key stakeholders in genomics education.
• He is very active in the precision medicine community, and currently co-chairs the Pharmacogenomics, Access and Reimbursement Coalition, a global gathering of precision medicine focused professionals creating new ways of thinking at the intersection of health economics, precision medicine and value-based care.
• His unique, rich professional background spans from his start in investment banking, portfolio management, and sales working as a financial professional at the world’s top investment banks where he focused on providing asset and risk management solutions for families, business owners, and foundations that control significant pools of wealth and liquidity.
JESSICA VAUGHN
Wiley Rein
JESSICA VAUGHN
Wiley Rein
JESSICA VAUGHN, Attorney at Law, Wiley Rein
Jessica is an associate in Wiley’s Food & Drug practice. She 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) and its European counterparts. She has experience in clinical trial development and review, pre-clinical testing review and protocol development, expedited program applications, and Investigational New Drug (IND) application and New Drug Application (NDA) planning, drafting, and filing.
With a doctorate in toxicology and over 10 years of experience in pharmaceuticals, Jessica brings a unique perspective to FDA and drug development issues. Prior to joining Wiley, she served as in-house counsel at a biotech company, and can provide an insider view to the issues facing pharmaceutical clients. Jessica’s scientific research experience allows her to review and advise on both early and late stage drug development issues, as well as allowing her to provide a critical eye during pharma and biotech transactional due diligence and litigation discovery activities.
Sample Attendees
Conference Schedule
Meet and to network with your conference colleagues.
09:30 – Chairperson opening remarks
BEN LOCWIN, Vice President, Project Solutions, Black Diamond Networks
SAFETY
09:40 – IVDR and its impact to PV / Safety going forward
KHAUDEJA BANO, Vice President, Combination Product Quality, Amgen
10:20 – Sanofi experience to close affiliate to evolve to distributor/ service provider: how to ensure Patient safety first and being compliant?
BRUNO MENDEZ, VP Global Quality Head Pharmacovigilance, Sanofi
11:00 – Morning Coffee / Tea & Discussion
MARKET TRENDS & WAY FORWARD
11:20 – Keynote Panel Discussion: Challenges and Opportunities for better future of Pharmacovigilance
• What comes next for the industry?
• Automating pharmacovigilance: Are we ready for the upcoming future?
• Outsourcing – Best Practices, Challenges and key consideration in choosing right vendor
• How global PV impacts day to day operations?
• Proper communication between – Sponsor – Site – CRO – Patients
• Best practices and lessons learnt from the pandemic
Moderator
KHAUDEJA BANO, Vice President, Combination Product Quality, Amgen
Panellists
JEREMY JOKINEN, VP Global Risk Management & International Patient Safety, Bristol-Myers Squibb
MARITESS ESGUERRA, Senior PV Process Director, Genentech
GURPREET SINGH, Vice President, Global Head of Pharmacovigilance, Freyr Solutions
AJINKYA INAMDAR, Senior Director (Global Medical Safety Strategy), BioNTech SE
12:10 – Case Processing – The Perils, Pitfalls and Solutions
• Reviewing the current industry landscape for clinical and post marketing drug safety
• Identifying and highlighting of key issues Companies face and how this influences safety data capture and processing
• Exploring how AI & Automation can provide a complete solution
GRAEME LADDS, CEO, PharSafer
12:30 – Networking luncheon
QUALITY – SAFETY – SIGNAL DETECTION
13:30 – Panel Discussion – Quality, Safety & Signal Detection – Best practice
• Developing a global safety intelligence process
• Exploring patient support and marketing research programs from a safety perspective
• Statistical signal detection as a routine pharmacovigilance practice
• Implementing signal detection in RWD: the necessary steps.
• Moving towards a better future: bigger and better
• Lessons learned from covid-19 vaccine related to signal detection and evaluation, and its vast impact on both global HAs’ and MAHs’ safety concerns and responses
Moderator
BEN LOCWIN, Vice President, Project Solutions, Black Diamond Networks
Panellists
NANCY DUBOIS, Head of Global Patient Safety US, Merck-EMD Serono
MARCIN VON GROTTHUSS, Principal Scientist, Investigative Toxicology, Takeda Pharmaceuticals
NISHITH JOBANPUTRA, Disease Area Cluster Lead, Worldwide Safety, Pfizer
BILL HADDOCK, VP Pharmacovigilance & GXP Quality, Ovid Therapeutics
14:20 – Fit for future sourcing for Pharmacovigilance
HUMAIRA QURESHI, President, Qinecsa Solutions
14:50 – “Challenges in developing safety strategy for newer therapies-brief overview”
• Understanding newer therapies adverse events
• Developing preclinical models and guidelines for safety evaluation
• Special requirements in manufacturing and storage conditions to control impurities
• Post marketing strategies to predict drug mediated adverse events
NIBHA MISHRA, Investigator II, Principal Toxicologist, CSL Seqirus
15:30 – Afternoon Tea / Coffee
PRE-CLINICAL & CLINICAL TRAILS
15:50 – Merging adverse events throughout clinical trails and post marketing surveillance
• Building the continuum of pharmacovigilance across pre-marketing and post-marketing
• Emerging challenges to monitoring adverse drug events in clinical trials Challenges in monitoring adverse drug events in clinical trials
• Establishing key performance indicators for making timely safety reports and continuous quality improvements
• Future of outsourced phase I, II and III trials and post-marketing studies
• Targeted event collection
• Strengthening the link between a drug and its related adverse events from pre-clinical to post-marketing
LINA OGBU, Medical Director Drug Safety & Pharmacovigilance, Arcus biosciences
16:20 – We can all do better with AI
NICOLE BAKER, CEO, Biologit
16:50 – Closing remarks by chairperson
17:00 – End of day 01 conference
09:20 – Chairperson opening remarks
BEN LOCWIN, Vice President, Project Solutions, Black Diamond Networks
SIGNAL MANAGEMENT
09:30 – Signal Management from small company perspective
• Importance and relevance of Signal Management in the current environment
• Developing and implementation of signal management process
• Signal communications – measures and challenges
• Signaling regulations and guidelines and practical applications of regulatory requirements
FARIDA ABANE, Senior Medical Director, Pharmacovigilance, Deciphera Pharmaceuticals
10:00 – New and modern approach from technology perspective: Mobile Applications Use in Pharmacovigilance Adverse Event Reporting
In the contemporary era of the proliferation of new technologies, mobile applications have been utilized by regulatory agencies and drug manufacturers to facilitate adverse event reporting. This presentation reviews some recent uses of mobile apps and elaborates on the benefits of having apps as a new reporting channel in addition to traditional adverse event reporting routes. It will also cover the technical details, best practices, unique opportunities, and associated challenges of mobile apps use in pharmacovigilance.
YILONG JIA, Senior Manager, Pharmacovigilance Informatics, Sunovion
10:30 – Why the fingerprint technology has taken over physical solutions in brand protection?
CAMILLE DISS, CPO, EDGYN
11:00 – Morning Coffee / Tea & Discussion
PATIENT SAFETY
11:20 – Keynote Panel Discussion: Securing patient safety and monitoring in PV
• Prioritising patients – Ensuring patient safety first
• Protecting patients and pharmacovigilance compliance in extraordinary circumstances
• Inducing patient centricity into your PV plans
• Encouraging patient support programs in Pharmacovigilance
• A practical approach to reshaping patient safety
• Next generation pharmacovigilance for enhanced patient safety
• What has this pandemic thought us towards patient safety
Moderator
BEN LOCWIN, Vice President, Project Solutions, Black Diamond Networks
Panellists
SHARON REID, Director, Risk Management Product Lead, Pfizer
NIBHA MISHRA, Investigator II, Principal Toxicologist, CSL Seqirus
BENJAMIN BROWN, Executive Director, American Society of Pharmacovigilance
12:10 – Proactive Signal Detection with RWD
Join this powerful session to learn why sponsors and regulators are moving from acceptance towards reliance of RWD/RWE and how this new paradigm makes embracing proactive signal detection and advanced cognitive computing for signal analysis a critical component to the future of drug development.
ELIZABETH SMALLEY, Director, Product Management, Aris Global
12:40 – Networking luncheon
RISK MANAGEMENT & PLANNING
13:40 – Panel Discussion- Risk Management – Proper plans for a perfect tomorrow
• What is the appropriate time to start the Risk Management Planning?/ When should you start working on RMP?
• Risk Evaluation and Mitigation Strategies(REMS) – New challenges and chances
• Risks of a half hearted approach in Risk Managemt and pitfalls of not having the culture of patient safety.
• Benefit-Risk profile; Is it deductive of or interactive with CDP/TPP?
• One RMP to fit all or all to fit within one RMP?
• Benefit/Risk ratio: the common denominator
Moderator
BEN LOCWIN, Vice President, Project Solutions, Black Diamond Networks
Panellists
CARMIT STRAUSS, Executive Director, Head of Risk Management and Organ Toxicity, Takeda Pharmaceuticals
SHARON REID, Director, Risk Management Product Lead, Pfizer
KAL ELHOREGY, Director, Risk Evaluation & Mitigation Strategy (REMS) Programs, Amneal Pharmaceuticals
TEODORA DOHERTY, Global Medical Safety (GMS), Medical Safety Officer, Janssen Research & Development
14:40 – Methodologies used in prediction of severe infection in relapsed and refractory multiple myeloma patients
Grade ¾ or higher of infection is a common safety concern in new drug discovery to treat relapsed and refractory multiple myeloma patients. To mitigate this risk, we used machine leaning and logistic regression modeling to analyze the baseline risk factors which will put patient at higher risk to develop severe infection. We used the internal clinical study data set, performed the risk factor analysis, the results enabled us to develop a risk predication algorithm to help investigator to apply adequate anti-microbial strategy to mitigate the severe infections.
ALEX QIU, Executive Director, Bristol-Myers Squibb
15:10 – Afternoon Tea / Coffee
AUDITS & INSPECTIONS
15:40 – Panel Discussion – Managing Pharmacovigilance Audits & Inspections
• Staying ahead in the race – Current trends for and future guidelines
• How to prepare and what to expect?
• Remote audits and inspections – Logistical issues
• PV Inspection readiness: Keeping on the right side of inspectors
• Methodologies, scope and oversight
• Boldly shaping the future
• What has this pandemic thought us towards audits and inspections?
Moderator
BEN LOCWIN, Vice President, Project Solutions, Black Diamond Networks
Panellists
BRUNO MENDEZ, VP Global Quality Head Pharmacovigilance, Sanofi
KAPIL BHUTADA, Consultant
REGULATION OVERVIEW & UPDATE
16:20 – Panel Discussion – PV – Regulatory Updates
• Key current changes and their impact on current PV
• Pharmacovigilance and the role of regulatory affairs: How to achieve compliance across the business
• Future Legislation: Pharmacovigilance – Industry Vision
• PV System Legislation Updates
• Enhancing communication between regulators, regional authorities and patients
• What’s next? Ways to proceed forward.
Moderator
BEN LOCWIN, Vice President, Project Solutions, Black Diamond Networks
Panellists
AYSE BAKER, Vice President, Regulatory Affairs, Innocoll
JESSICA VAUGHN, Attorney at Law, Wiley Rein
17:00 – Chairperson’s closing remarks and end of conference
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Sponsors & Partners
We wouldn’t be able to host our conferences without help from these amazing companies.
A huge thanks to all our sponsors and partners!
PharSafer
PharSafer
• Founded in 2003 by Dr Graeme Ladds, PharSafer® is a Global Contract Research Organisation (CRO) specialising in Global Clinical and Post Marketing Drug Safety, and Medical Services.
• We offer an extensive range of vigilance services, ranging from Pharmacovigilance; Cosmetovigilance; Materiovigilance; Vaccine Vigilance; Nutrivigilance; Veterinary Pharmacovigilance; assisting with audit preparedness; performing global medical services; running industry training courses for industry professionals – ranging from introductory, through to intermediate and advanced – and more.
• Together with our sister company SaPhar Training®, PharSafer® continuously seek new and innovative ways to provide added value for our clients, with the aim of optimising the processes and procedures involved with clinical and post marketing drug safety reporting.
• With reporting procedures in place and ready to meet safety reporting regulations (clinical and post marketing) in over 130 countries, we ensure all of our activities and communications are conducted with full transparency, guiding our clients through the maze of global safety and medical affairs legislation, in the interest of patient safety.
• PharSafer® are more than a provider. Like a family, we care deeply about our customers; our service; our reputation; our customer’s reputation and our people.
• We love what we do. We love finding solutions.
• Quite simply, we are by far… Your leading partner in drug safety
Visit our website: www.pharsafer.com
EDGYN
EDGYN
• EDGYN, formerly Arjo Solutions and spin-off of former leading banknotes manufacturer Arjowiggins Security, has been active for more than 20 years in the protection of brands and products, supporting its customers, in the private or governmental sectors, in fighting against illicit trade, securing of their revenues and protecting consumers.
• EDGYN develops and industrializes highly innovative physical or digital authentication solutions and has developed a portfolio of 100+ patents.
• EDGYN is notably a pioneer in digital fingerprint solutions, enabling to authenticate products with a smartphone.
• EDGYN is active in the pharmaceutical, cosmetics, spirits, luxury, agrochemicals and automotive sectors providing security solutions to the leading players in each sector.
• EDGYN is also active in the governmental sector, providing security solutions for tax stamps, ID document or precious metals.
Visit our website: www.edgyn.com
Qinecsa Solutions
Qinecsa Solutions
• 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: www.qinecsa.com
ArisGlobal
ArisGlobal
• ArisGlobal is transforming the way today’s most successful Life Sciences companies develop breakthroughs and bring new products to market.
• Our end-to-end drug development technology platform, LifeSphere®, integrates our proprietary cognitive computing engine to automate all core functions of the drug development lifecycle.
• Designed with deep expertise and a long-term perspective that spans more than 30 years, LifeSphere® is a unified platform that boosts efficiency, ensures compliance, delivers actionable insights, and lowers total cost of ownership through multi-tenant SaaS architecture.
Visit our website: www.arisglobal.com
Biologit
Biologit
• We, biologit, unite deep expertise in multivigilance incuding human, veterinary, cosmetics and nutraceuticals, as well as biomedical, all combined with artificial intelligence to deliver solutions that unlock safety and efficacy information faster, without compromising on quality, with the goal to keep drug products safe for all.
• Our mission is to develop technology to enable users enjoy, learn, and more efficiently deliver meaningful results in line with global regulatory requirements and to prevent harm.
• Our vision is to ensure safety by simplifying the detection of risks and events from development to post-market.
• Our values are to innovate transparently and ethically, do good with integrity, do together.
Visit our website: www.biologit.com
Freyr Solutions
Freyr Solutions
Visit our website: www.freyrsolutions.com
Freyr Solutions is the largest, global, Regulatory solutions and services company that offers end-to-end Regulatory solutions to life sciences industries. The services include Regulatory affairs, pharmacovigilance, clinical research, quality management, and technology solutions such as Regulatory information management systems and Regulatory data integration. Freyr’s expertise in Regulatory affairs makes it a trusted partner for life sciences companies seeking to navigate the complex Regulatory landscape.
Virtue Insight
CONCEPTUALISED BY
Virtue Insight
CONCEPTUALISED BY
Virtue Insight equips business professionals around the world with the latest indepth industry knowledge and provides networking opportunities in the telecom, infrastructure and pharmaceutical industry. Our aim is to provide a platform to share knowledge and insights and provide our event attendees to network effectively and deliver maximum ROI by make new business alliances. We strive to produce high quality conferences which include the latest topics which are delivered by world class leaders of the industry.
Our motto is to offer our customers the expertise and connections for a profitable business. Our events encompass an optimum chance to gain maximum value in terms of networking and an opportunity to sponsor and exhibit to attract new business alliances.
Clocate
SUPPORTED BY
Clocate
SUPPORTED BY
Event Brite
SUPPORTED BY
Event Brite
SUPPORTED BY
Testimonials
A huge thanks to all our sponsors, attendees and partners!
u201cI found it to be very well structured, focused on topics of interest for every PV professional. All the speakers were amazing and I look forward attending your future conferencesn“},{“name”:”Pfizer”,”designation”:”Country Safety Lead UK & Ireland”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/08/PFizer.png”,”id”:17219,”size”:””,”alt”:””,”source”:”library”},”_id”:”3b8df8f”,”quote”:”
The Legal regulatory session on Day was very good. Informative -
“},{“name”:”Boehringer Ingelheim”,”designation”:”Emerging Markets”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/08/Boehringer-Ingelheim-1.png”,”id”:17221,”size”:””,”alt”:””,”source”:”library”},”_id”:”34ab65e”,”quote”:”
Very well organised & very interesting topics selected. Time management & allowing to ask questions were very sufficient as well. - Head of Clinical Operations
“},{“name”:”Takeda”,”designation”:”Regulatory Inspection Lead, Safety & International Global Quality”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/08/Takeda.png”,”id”:17222,”size”:””,”alt”:””,”source”:”library”},”_id”:”eb31001″,”quote”:”
Great opportunity for networking and to learn different industry perspectives on PV systems, challenges & regulations.
“},{“name”:”Teva Pharmaceutical”,”designation”:”PhV Manager”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/08/Teva.png”,”id”:17223,”size”:””,”alt”:””,”source”:”library”},”quote”:”
Insightful sessions, well structured presentations and speakers sharing highly valuable knowledge and experience. Learned a lot even through the networking breaks.
“,”_id”:”fa6a78d”},{“name”:”CSL Behring”,”designation”:”Director, Clinical Safety Physician”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/08/CSL-Behring.png”,”id”:17224,”size”:””,”alt”:””,”source”:”library”},”quote”:”
Excellent Meeting. Thanks for the great efforts.
“,”_id”:”d52541d”},{“name”:”Vifor Pharma”,”designation”:”Global Head Medical & Clinical Drug Safety”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/08/VI-for-pharma.png”,”id”:17225,”size”:””,”alt”:””,”source”:”library”},”quote”:”
Good networking opportunity. Balanced topics, good mix of well known speakers and new ones. Interesting Panels.
“,”_id”:”c0a15a1″},{“name”:”Amgen”,”designation”:”Safety Executive Director “,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/08/Amgen.png”,”id”:17226,”size”:””,”alt”:””,”source”:”library”},”quote”:”
Good opportunity to network with colleagues. Mostly the speakers/panel members were of high calibre and experienced.
“,”_id”:”60de521″},{“name”:”Shire Pharmaceuticals”,”designation”:”Safety Executive Director “,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/08/shire-pharmaceuticals.png”,”id”:17240,”size”:””,”alt”:””,”source”:”library”},”quote”:”
Safety & International Director, Regulatory Inspections, R&D QA&C
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“I found it to be very well structured, focused on topics of interest for every PV professional. All the speakers were amazing and I look forward attending your future conferences
Bausch Health PhV Manager
The Legal regulatory session on Day was very good. Informative –
Pfizer Country Safety Lead UK & Ireland
Very well organised & very interesting topics selected. Time management & allowing to ask questions were very sufficient as well. – Head of Clinical Operations
Boehringer Ingelheim Emerging Markets
Great opportunity for networking and to learn different industry perspectives on PV systems, challenges & regulations.
Takeda Regulatory Inspection Lead, Safety & International Global Quality
Insightful sessions, well structured presentations and speakers sharing highly valuable knowledge and experience. Learned a lot even through the networking breaks.
Teva Pharmaceutical PhV Manager
Excellent Meeting. Thanks for the great efforts.
CSL Behring Director, Clinical Safety Physician
Good networking opportunity. Balanced topics, good mix of well known speakers and new ones. Interesting Panels.
Vifor Pharma Global Head Medical & Clinical Drug Safety
Good opportunity to network with colleagues. Mostly the speakers/panel members were of high calibre and experienced.
Amgen Safety Executive Director
Safety & International Director, Regulatory Inspections, R&D QA&C
Shire Pharmaceuticals Safety Executive Director
Venue Details
Venue:
The Conference Center at Waltham Woods,
Waltham (Boston-MA)
Address: 860 Winter St, Waltham, MA 02451, USA
Contact: 781.434.7499
Get Involved
Speaking Opportunities
Fen Castro
fen@virtueinsight.co.in
+91 44 42108101
Sponsor / Exhibit / Delegate Bookings
Piyush Patel
piyush@virtueinsightevents.com
+44 20 3509 3779
