Agenda
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The primacy of patient safety: Establishing the value of Safety/PV across the biopharmaceutical industry
Keynotes
- Safety/PV as a critical and valued cross-functional partner
- The importance of pre-competitive industry PV collaboration
- The promise of technology and automation in PV
Jose Vega, Chief Safety Officer, Merck & Co., Inc.
Producers remarks
Keynotes
Edward Glanville, Project Director, Terrapinn
Chair's opening remarks
Keynotes
Susan Welsh, Chief Safety Officer, CSL Behring
The primacy of patient safety: Establishing the value of Safety/PV across the biopharmaceutical industry
Keynotes
· Safety/PV as a critical and valued cross-functional partner
· The importance of pre-competitive industry PV collaboration
· The promise of technology and automation in PV
Jose Vega, Chief Safety Officer, Merck & Co., Inc.
The committee experience: How AbbVie is leveraging technologies and developing IND for every product as part of standard protocol
Keynotes
- How AbbVie is driving the future of PV by implementing the schedule and technologies of tomorrow today
- Understanding the need to adopt new technologies in PV - what are the efforts behind implementation?
- How to partner with and develop a new generation of PV specialists
Fabio Lievano, Vice President Safety Sciences, Medical Safety Evaluation, Abbvie Pharmaceuticals Inc
Disruptive innovation in Pharmacovigilance: Exploring new analytical techniques and signal detection strategies to stay ahead of the curve
Keynotes
- How new analytical techniques in PV have enabled us to delve deeper into signal management
- Implement or die: how do we use design thinking to enable the implementation of new technologies?
- Collaboration is key: leveraging cloud computing, data sharing and signal detection methodologies to benefit the patient
Felix Arellano, Global Head Pharmacovigilance and Drug Safety, Roche
Enabling Agile Technology Advancement in Delivering Great Efficacy Patient Safety Operations
Keynotes
- Platforms in Patient Safety Operations
- Robotics in Patient Safety Operations
- AI and Cognitive Intelligence in Patient Safety Operations
- Data Visualization and Lean Six Sigma Patient Safety Operations
Post-market safety reporting for combinational products: getting ready for July 2018
BigData & PV
- Device meets drug – evaluating the necessary industry considerations
- Non-traditional approaches of engaging with the patient to maximize outreach
- Leveraging existing Title 21 federal regulated processes and structures to stay compliant
Moderator: Khaudeja Bano, Senior Medical Director, Abbott Diagnostics
Kirsten H. Paulson, Sr. Director Global CMC-Medical Devices, Pfizer
Mike Thomas, Medical Director Pharmacovigilance, United Therapeutics
The value of machine learning in safety
NEXT GENERATION TECH IN PV
- What is drug safety signal identification?
- Current methods of signal identification, pros, and cons
- Used cases of machine learning and signal identification
Anupam Agarwal, Head, Global Drug Safety and Pharmacovigilance, Zogenix
CAR-T: Spearheading the launch of a new therapy class
PATIENT CENTRIC PV
- Safety issues with cellular therapies
- Challenges in analyzing safety issues with different CAR T products
- Post marketing registries for monitoring the safety for CAR T
David Chonzi, VP, Patient Safety and Risk Management, Kite, A Gilead Company
Automation in ICSR Processing – Selection, Lessons Learned, and Future State
NEXT GENERATION TECH IN PV
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Rationale for automating case processing
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Technology selection
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The importance of proof of concept programs
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Our experience with proof of concept programs
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Lessons learned
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Challenges
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Future path
Analyzing the new ICH E19 guidelines on optimization of safety data collection: what are the implications for your organization?
PATIENT CENTRIC PV
- Harmonized guidance on targeted approaches to safety data collection in late-stage pre- and post-marketing studies
- How the guideline aims to improve global health by encouraging studies on long-term effects, rare events and new indications of drugs while optimizing resources
- Understanding the challenges in implementation of such a guideline
Jeremy Jokinen, Senior Director, Safety Decision Analytics, AbbVie
A Study of Cognitive Computing in Detecting Adverse Events
NEXT GENERATION TECH IN PV
- What is cognitive computing?
- How can it be applied to pharmacovigilance?
- Training a model to detect adverse events
Tarak Thakker, Pharmacovigilance Leader, IBM Watson Health
The value story: The business-critical rational to invest in drug safety early in the product lifecycl
PATIENT CENTRIC PV
- Demonstrating value of treatment to move the discussion past pricing
- Preparing for early launch success by answering the questions associated with value earlier in the development stage
- How CSL Behring demonstrated the value of high cost rare disease treatment with greater emphasis on patient value
Debbie Drane, Senior Vice President Global Commercial Development, CSL Behring
ROUNDTABLES
Keynotes
1) Applying Technology to the Challenges of Pharmacovigilance: A Cross-Sharing of Novel Approaches
Leann Fieldstad, PharmD Global Solutions Executive Watson for Patient Safety, IBM Watson for Patient Safety
10) Reference Safety Information- RSI used in Clinical Trials based on the CTFG RSI Q&A Document and the EFPIA Draft Paper in response to such document
11) What Is Your Company Doing to Use Enabling Technology to Advance Patient Safety?
2) PV and Outsourcing - Understanding how to evaluate and implement sourcing alternatives for PV business processes and underlying technologies
Kostas Kidos, VP, Head Global Drug Safety Operations, Shire Pharmaceuticals
3) International regulation- Understanding the current regulatory landscape
Armughan (Armie) Khan, Associate Director, Safety Science, Drug Safety, Celgene
Elena Yureneva, Principal Scientist, Clinical Safety & Risc Management, MSD
Omar Aimer, Pharmacovigilance and drug safety specialist, Rymond Poincaré Hospital - APHP
4) AI in PV- How can AI transform your PV processes
Steven Bailey, Vice President, Worldwide Safety Strategy, Pfizer Pharmaceuticals
5) Patient centric PV- How to deliver a patient centric pharmacovigilance program
Michele Hooper, Senior Director Drug Safety, Kite, A Gilead Company
Jay Duhig, Head, Risk Communication and Behavioral Systems, AbbVie
6) Harmonizing PV- How do you harmonize your PV across a global network and cross functionally effectively?
Rawad Antoun, Manufacturing Site Pharmacovigilance Representative, CSL Behring
Esther Perez, Associate Director, Clinical Project Management, Eli Lilly and Company
7) CAR-T- Understanding the safety requirements and monitoring processes for this new therapy class
8) Risk Management – How to evaluate risk management requirements?
Mariam Abouhossein, Safety Scientist, Genentech
Sarah Mycroft, Director, Clinical Safety Physician, CSL Behring
Kevin Darryl (KD) White, Senior Director, Regional Head (NA) Global Regulatory Affairs, CSL Behring
9) Updated on ICH- Following up on recent ICH updates across the PV space
Peishan Liu-Snyder, Drug Safety Program Manager, Alkermes Inc
Michele Walsh, Manager, Regulatory Affairs, CSL Behring
Eric Hudimac, Associate Director, Intarcia Therapeutics Inc
Shelly Brewster, Pharmacovigilance Operations Manager, Intarcia Therapeutics Inc
Jeremy Jokinen, Senior Director, Safety Decision Analytics, AbbVie
Advanced text mining techniques: Tapping into rich unsourced data to gain rapid insights into AEDs
BigData & PV
- Breaking into untapped patient forums such as Patients Like Me and Yahoo Health
- Benefitting from social mediacovering large and diverse populations to give a real-time deep dive into adverse drug reactions
- Utilizingunsolicited, uncensored data directly from patients
Veronica Urdaneta, Senior Principal Scientist/ Physician, Merck
Automation is transforming pharmacovigilance. Is your organization ready?
NEXT GENERATION TECH IN PV
- Is AI hype or reality?
- Do you have the organizational discipline to transform your organization?
- How do you find appropriate opportunities in the space?
- Steps involved in implementing a PV AI strategy
Vivek Ahuja, Vice President of Global Pharmacovigilance, ArisGlobal
Meaningful Approaches to Patient Engagement: Adding the Right Tools to Your Toolbox
PATIENT CENTRIC PV
- Trends in patient engagement
- Importance of engaging patients as partners
- Maintaining patient engagement long term
- Driving culture change
Using RWE: Predictive analytics to impact patient safety and shorten phase III trials
BigData & PV
- How to monitor quality and compliance, in near real-time, to address potential issues as quickly as they are identified?
- Bridging data access and analytics between study-based safety and post-marketing
- Using RWE to shorten phase III and accelerate approval procedures
- Adapting PV departments into cross-functional teams in order to derive expected benefit and value from controlled studies
Challenges in PV and building a safety organization for new therapy classes such as RNAi and other nanotechnologies
NEXT GENERATION TECH IN PV
- Showcasing the first in class RNAi therapy to make it to phase III clinical trials with full primary and secondary end points hit
- Balancing early market access to new drugs with the need for benefit/risk data
- Nanotechnology-based Delivery Strategies for RNAi- reducing risks using new delivery systems
Adrian Dana, Vice President, Global Patient Safety and Risk Management, Alnylam Pharmaceuticals
Intersection of patient support programs and Drug Safety:
PATIENT CENTRIC PV
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Understand increasing importance of and focus on patient support programs
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Review current safety compliance challenges with PSPs/MRPs
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Discuss strategies to get better control of safety reporting from these commercial programs
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Analyze opportunities to ensure smart set up of these programs to streamline AE reporting
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Review opportunities for new technologies to enhance data gathering, to reduce resource burden and compliance risks
Mariette Boerstoel, Senior Vice-President, Head Global Drug Safety, Shire Pharmaceuticals
Using Machine Learning to Reliably Identify ICSRs in Scientific Literature. A Zero False Negative Approach
BigData & PV
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The results of our research into improving the efficiency of literature review by reliably identifying ICSRs in scientific literature using deep learning and other machine learning techniques.
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Our approach to introduce an ICSR identification engine for the Literature Review workflow that will ultimately allow MAHs to automatically reduce the volume of references required to be human reviewed, without running the risk of missing relevant literature cases.
Delivering better operational services via automation: what’s the Reality today?
NEXT GENERATION TECH IN PV
- Examples of automation based case processing success stories
- What can be achieved through case processing automation?
- Safety Analytics
- Managing expectations: separating the reality from the fantasy
Fran Bates, Vice President of Technology Services, Sciformix Corp
Drawing a Straight Line from a Regulatory Change to Patient Centered Pharmacovigilance
NEXT GENERATION TECH IN PV
- Examples of automation based case processing success stories
- What can be achieved through case processing automation?
- Safety Analytics
- Managing expectations: separating the reality from the fantasy
Understanding the key aspects of Benefit Risk Assessments from a regulatory perspective and how the patient is involved in the discussion
BigData & PV
- How benefit-risk assessments form the fundamental basis of regulatory decision making?
- Benefit-Risk Assessment initiatives: How to move away from separate contributions of efficacy evidence and risk data to a consolidated meaningful database
- The patient voice in Benefit-Risk Assessments: How do you include the patient in the benefit: risk assessment at an early stage in drug development?
Pharmacovigilance Challenges with Common Technology Platforms - viral vectors to lipid nanoparticles
NEXT GENERATION TECH IN PV
- A regulatory overview of the legal framework toward granting ATMP marketing authorization
- Discussing differences in regulatory pathways across Europe and the US to aid in driving your Advance Therapy into the clinic
Barbara Morollo, Head, Pharmacovigilance Operations, Moderna Therapeutics
Patient engagement in the precision era- making safety personal through the developing of patient centered frameworks
PATIENT CENTRIC PV
- Embedding a patient centered culture within a drug safety organization in a new era of personalized medicine
- Developing a framework to engage with patients in an effective manner using technology such as reporting apps
- Implementing patient centered drug safety and pharmacovigilance in PV operations
Mike Liu, Senior Medical Director, Clinical Safety/PV, AbbVie
Challenges in PV and building a safety organization for new therapy classes such as RNAi and other nanotechnologies
NEXT GENERATION TECH IN PV
- Showcasing the first in class RNAi therapy to make it to phase III clinical trials with full primary and secondary endpoints hit
- Balancing early market access to new drugs with the need for benefit/risk data
- Nanotechnology-based Delivery Strategies for RNAi- reducing risks using new delivery systems
Adrian Dana, Vice President, Global Patient Safety and Risk Management, Alnylam Pharmaceuticals
The patient's voice in Pharmacovigilance: pragmatic approaches to building a patient- centric drug safety organization
PATIENT CENTRIC PV
- Actively driving patient centricity into your Pharmacovigilance program through cultural changes to deliver the strongest possible results
- Collecting and analyzing patient-generated ADR reports for signal detection and evaluation purposes
- Distinguishing factors in patient engagement, risk communication and patient preference assessment in the highly competitive pharmaceutical industry landscape
Kala Jayaram, Drug Safety Medical Director, BioMarin Pharmaceutical Inc.
The adoption of Pharmacogenomics leading to patient benefit
BigData & PV
- Overviewing the increasing acceptance and adoption of Pharmacogenomics internationally
- Translating the power of Pharmacogenomics into direct benefits for the patient to reduce ADEs
- Methodologies for raising patient awareness and understanding of the potential benefits linked to Pharmacogenomics
PV technology disruption in a pragmatic way
NEXT GENERATION TECH IN PV
- Innovative PV Solutions (EVDAS Integration, Automated Real time Metrics, All-In-One Solution for Case Intake Automation)
- Pharmacovigilance in the Technological Age (Big Data, Artificial Intelligence, Machine Learning)
- Advanced technology stack and its applications - PV efficiency gains and High capability-to-cost ratio
- Machine Learning and NLP for extraction of relevant information (from unstructured information to cases)
- Model driven approaches for risk and signal management – detection, evaluation and validation
The new E2B R3: a reflection on experience to date
PATIENT CENTRIC PV
- Describing some of the challenges faced and the considerations for implementation
- How does R3 compare with R2 and what are the implications during transition
- Share our practical experience and the potential impact on workflow
Suzanne Berresford, Product Manager, Springer Nature
Think globally. Report locally: Technology-enabled Global Harmonization of Safety Reporting using Local Laws
Keynotes
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How Roche is saving $80m annually by precision distribution of Safety Reports to Sites and Ethics Committees according to Local Laws
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How to achieve Global Harmonization of Safety Reporting by creating the Illusion of Simplicity
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How to overcome fragmented processes, multiple interpretations of Local Law, and lack of Quality Oversight and Accountability
Brexit: Outlining the effects on QPPV and the drug safety community internationally
Keynotes
- Assessing the likely outcomes on UK pharmacovigilance after departure from EU frameworks and structures around drug safety regulations
- Discussing potential contingency plans for QPPV leaders and organizations in the UK stakeholder environment
- What are the international implications of Brexit on the pharmacovigilance field?
Virginia Acha, Executive Director, Association of the British Pharmaceutical Industry-ABPI
Aggregate Safety Assessment Planning in Drug Development can
Keynotes
- Strengthen cross-disciplinary communication and collaboration
- Enhance the ongoing understanding and characterization of the product safety profile
- Inform preparation for the integrated safety-related filing documents
William Wang, Executive Director, Clinical Safety Statistics, MSD
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Opening Remarks
Keynotes
Susan Welsh, Chief Safety Officer, CSL Behring
Why Reciprocity Is Key to The Future of Pharmacovigilance
Keynotes
- The reality of implementing AI to transform pharmacovigilance operations
- Why transformation isn’t the responsibility of just a sole company
- Rethinking how we administer and implement technology; uncovering the real barriers to change we face as an entire industry
- How to give away some control in order to partner with others and do that which cannot be done alone
Edward Mingle, Executive Director, Celgene
Danielle Abatemarco, PV Innovation Specialist, Celgene
Predictive drug safety: Investing in and developing systems for predicting human drug toxicity safety throughout the drug discovery and development process
Keynotes
- What is the rationale behind implementing predictive drug safety and is it worth the investment?
- How to capitalize on the explosion of data linking drugs, proteins, and pathways with safety events through developing integrative systems approaches to large-scale predictive drug safety
- Case studies of predictive drug safety in action – who are the key players that you should be watching?
Mitigating the effects of dramatic changes to big data and safety technology
Keynotes
- Strategies for streamlining uptake of new PV technology and ensuring seamless responses to the resulting changes
- Assessing the impact of new signal detection methodologies implemented by the FDA
- Collaborating with wide networks of colleagues and vendors to harmonize uptake of new technologies in PV
William Wang, Executive Director, Clinical Safety Statistics, MSD
Milbhor D'Silva, VP and Head of Global PV Sciences, Astellas
Improving risk:benefit assessment with comprehensive data and a quality, compliant safety system
Keynotes
- Access a range of information from literature, regulatory filings and post-market reports to evaluate safety signals
- Leverage relevant scientific data to design more effective trials and make strategic risk assessment decisions
- Effectively manage literature screening with a GxP compliant, inspection-ready system
EudraVigilance: How to empower your organization by leveraging the EMA’s new safety platform
BigData & PV
- Delivering simplified reporting, better quality data and improved searching, enhanced analysis and tracking functionalities
- Winning extended access for marketing authorization holders
- Streamlining implementation with EMA assistance
Walter Straus, Associate Vice-President and Therapeutic Area Head, Infectious Diseases, Vaccines, Medical Devices & Combination Products, Merck And Company
Using machine learning systems to Identify ICSRs and harness the power of digital media in PV
NEXT GENERATION TECH IN PV
- Machine Learning systems to Identify Individual case safety signals from Social/Digital Media
- Performance of Machine Learning Systems for ICSR causality determination
- Regulatory perspectives on the use of AI/Machine Learningto assist with pharmacovigilance activities
Shaun Comfort, Assoc Director of Risk Management, Genentech A Member of the Roche Group Inc
Real World Data for biosimilars
PATIENT CENTRIC PV
- Comparing the key differences between biosimilar PV strategy and generic PV
- Evaluate the readiness of current PV systems for the influx of new biosimilars
Niraj Chhaya, Lead Risk Management, Global Pharmacovigilance, Boehringer Ingelheim Pharma GmbH & Co. KG
Navigating the complexities of reference safety information regulation: How to react to the latest guidance’s in GRFG RSI
BigData & PV
- Review of the November 2017 clinical trial facilitation group reference safety information question and answer document
- Discussion of reference safety information complexities and navigating the changing environment
- Perspectives on operationalizing reference safety information in the setting of global clinical trial conduct
Safety Intake Made Easy
NEXT GENERATION TECH IN PV
- How a US Pharmaceutical company reduced costs, increased quality and compliance
- Review the technology solution and processes that were implemented to achieve these results
- What comes next for the industry and for this customer of Vitrana
Scaling patient-centric throughout your product lifecycle- utilizing behavioral science and novel analytical techniques to get the best for your organization
PATIENT CENTRIC PV
- Adopting patient centricity at scale through cultural and technological challenges
- Implementing new surveillance systems whilst maintaining a central focus on the patient
- Engaging with patients effectively and consistently throughout the process of pharmacovigilance practice
Jay Duhig, Head, Risk Communication and Behavioral Systems, AbbVie
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BigData & PV
Do you have a solution you would like to share with our audience?
Contact Michael Shackil now on: michael.shackil@terrapinn.com or call at +1 646.619.1809
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NEXT GENERATION TECH IN PV
Do you have a solution you would like to share with our audience?
Contact Michael Shackil now on: michael.shackil@terrapinn.com or call at +1 646.619.1809
Are those side effects due to my drug? - The case for clinical toxicology and drug testing in clinical trials
PATIENT CENTRIC PV
- Pharmacogenomics - considerations towards inclusion in clinical trial lab testing
- Adverse events - case law and laboratory centric aspects for improvement and safety
- The impact of the opioid epidemic on drug safety and clinical trials
Martin Bluth, Founder, Bluth Bio Industries
ROUND TABLES
Keynotes
1) Brexit and QPPV- what are the effects?
Patrick Puplampu, QP&S Manager, Janssen Pharmaceutical
Virginia Acha, Executive Director, Association of the British Pharmaceutical Industry-ABPI
10) Social Media Signal Detection- How has it worked?
Lilyan Wright, Senior Scientist of Drug Safety Risk Management, Genentech
Christine Durkan, Sr. Scientist - CSRM, Merck
2) China and PV- Implementing a Pharmacovigilance Support Model following acquisition of a local Company in China
Rawad Antoun, Manufacturing Site Pharmacovigilance Representative, CSL Behring
William Wan, Head of PV Services, Taimei Medical Technology, Shanghai, China
3) Pharmacovigilance for ATMPs – Developing an understanding of advanced therapy PV methodologies and requirements
Rawad Antoun, Manufacturing Site Pharmacovigilance Representative, CSL Behring
Barbara Morollo, Head, Pharmacovigilance Operations, Moderna Therapeutics
4) Automation of PV- Success sorties and current impacts
5) Defining Value- What is the value of PV in a pharmaceutical company and the importance of investing?
Michael Lusiola, Director, Patient Safety, AstraZeneca
6) Electronic Trial Data Capture- tricks learnt whilst implementing
Mary Furnari, Associate Director, Trial Safety Science, Celgene
Shelly Brewster, Pharmacovigilance Operations Manager, Intarcia Therapeutics Inc
Elizabeth Squiers, SVP PV and Clinical Development, Deputy CMO, Quark Pharmaceuticals
7) EudraVigilance - Pharmacovigilance in EEA Data Security- How do you secure your PV data
Suzanne Skarzynski, Global Safety Clinical Risk Management Team Leader, Merck And Company
Tricia Frantz, Clinical Risk Management Associate Principal Scientist, Drug Safety, Merck
8) Drug Safety Pharmacology- New approaches to drug safety
9) Social Media Signal Detection- How has it worked?
Quantitative Methods of Benefit-Risk Assessment (MCDA, SMAA): What, Why, How, When, and Who?
BigData & PV
- What is quantitative benefit-risk assessment (qBRA)? What are the major methods?
- Why would we use qBRA in addition to traditional descriptive B-R assessment?
- How do we do these analyses?
- When can we utilize these analyses?
- Who are using these tools? Who should?
PHARMACOVIGILANCE IN CHINA SHOWCASE Navigating PV in new lands- studies and discussions on the implementation of PV in China
NEXT GENERATION TECH IN PV
- Implementing a Pharmacovigilance Support Model following acquisition of a local Company in China
- The evolution of PV regulations and processes under pharmaceutical industry reform in China
- Approaches to Pharmacovigilance Support Models based on business- Local market vs Global market in China
William Wan, Head of PV Services, Taimei Medical Technology, Shanghai, China
Cooperative approaches to developing pharmacovigilance strategies in emerging markets
PATIENT CENTRIC PV
- The importance of post-market safety surveillance in global health programs- where have we been missing the mark?
- Cooperative Approaches to developing PV systems in LMIC’s – working with local health systems to reduce ADEs
- Thinking outside the box- challenges and solutions to developing reporting systems across pharmaceutical companies in different LMIC’s- lessons learnt
Jens-Ulrich Stegmann, Vice President Head Clinical Safety and Pharmacovigilance, G.S.K Biologicals
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BigData & PV
Do you have a solution you would like to share with our audience?
Contact Michael Shackil now on: michael.shackil@terrapinn.com or call at +1 646.619.1809
Pharmacovigilance in the future: artificial intelligence driving innovation in adverse event monitoring
NEXT GENERATION TECH IN PV
- Identify the impact of rapidly advancing technology on adverse event monitoring
- Challenges and opportunities that AI can bring
- Where are current efforts focusing on?
Wenda Brennan, Head of PV, PharmaLex GmbH
Can drug safety get good data while running highly automated processes today?
PATIENT CENTRIC PV
- Dealing with large data gaps in the quality and completeness of adverse events and associated complaints
- While for listed, non-serious events on established products this could be considered acceptable, it poses a significant risk to the management of newly marketed products
- An outline of how a dynamic intake and workflow solution can combine with downstream AI and provide a first step towards a successful implementation and utilisation of an end to end solution for Drug Safety
Structured BR assessments: Industry perspectives on an evolving field
BigData & PV
- The DOING, and the CHALLENGES of structured BR assessments
- Benefit-Risk Management and impact in the enterprise/outside the enterprise
- The future of BR assessments
Moderator: Barbara Silva-Tillmann, Senior Medical Director, Benefit Risk Management, AbbVie Ltd
Susan Colilla, Senior Director of Epidemiology and Benefit-Risk Evaluation, Sanofi
Sophia Goodison, Director, Benefit Risk Evaluation, GSK
Reference Safety Information
NEXT GENERATION TECH IN PV
- Overview of RSI and RSI documents
- Summary of recent CTFG Q&A clarification document dated Nov 2017
- Crossed linked documents, harmonization
- Impact and Regulatory challenges
Leveraging genetic diversity In Vitro: evolution or revolution in cardiac safety assessment?
PATIENT CENTRIC PV
- Predicting clinical adverse events (AEs) in preclinical studies
- Providing proof of concept for preclinical trials by recapitulating AES susceptibility in volunteer populations
- Reducing clinical attrition by leveraging genetic diversity in preclinical testing
Bernard Fermini, Chief Scientific Officer, Coyne Scientific (Former Pfizer).
Thought processes of middle east pharmacovigilance regulators
NEXT GENERATION TECH IN PV
- How to submit ICSF in different regions of the middle east
- How to submit aggregate reports in different regions of the middle east
- What are regulators looking for registration and re-registration of products from a pharmacovigilance point of view
Advances in CV and CNS safety pharmacology, the use of predictive in vitro and in silico tools
PATIENT CENTRIC PV
- MEA based assays for identification of cardiac electrophysiological effects and CNS seizure liability
- Demonstrations of In silico modeling for predictive cardiac electrophysiological parameters
- Newer complex in vitro assays on horizon
Tony Bahinski, Global Head, Safety Pharmacology, GSK
Are those side effects due to my drug? - The case for clinical toxicology and drug testing in clinical trials
BigData & PV
- Pharmacogenomics - considerations towards inclusion in clinical trial lab testing
- Adverse events - case law and laboratory centric aspects for improvement and safety
- The impact of the opioid epidemic on drug safety and clinical trials
Martin Bluth, Founder, Bluth Bio Industries
Safety signal management and Pharmacovigilance system compliance – key points to drive success from a European Perspective
NEXT GENERATION TECH IN PV
- Risk mitigation during Medicines products life cycle-New Era for pharmacovigilance compliance
- Stakeholders’ engagement strategy in healthcare industry – decision making hierarchy
- Medicinal products benefit risk assessment - Health authorities’ cluster activities
Safety Science: an integrative approach to patient safety
PATIENT CENTRIC PV
- Investing in safety- How failures in safety programs have resulted in in of more than half of all project closures in pharmaceuticals?
- How to predict clinical reactions to the drugs by integrating pharmacology, subject’s predisposition, and drug structure to mitigate ADE’s
- How a thorough understanding of target, drug structure, and pharmacology at discovery can help predict up to 75% of the adverse drug reactions in the market
last published: 09/Apr/18 20:25 GMT
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Robert Kane, Vice President & U.S Head, Life Science Industries,
Tata Consultancy Services
Mr. Kane is currently an executive and head of TCS's business in United States for the Life Sciences Industry business unit In this capacity, Mr. Kane is responsible for the growth, oversight, client service and development of TCS’ business spanning the...
Tracey Boone, Assistant Director of Medical Safety Surveillance and Pharmacovigilance,
AbbVie
Tracey Boone is an Interim Associate Director for Business Technology in AbbVie’s Case Processing Center of Expertise, which is responsible for delivering real time adverse event reporting to regulators, affiliates, and internal stakeholders. In this role, she is responsible for the Skynet...
Steven Troy, Senior Manager, PPS Digital Transformation,
AbbVie
Steven Troy is a Senior Manager in AbbVie’s Business Technology Solutions, leading Digital Transformation aligned to Pharmacovigilance and Patient Safety. In this role, he is responsible for technology solutions and partnering with the business to increase efficiency in case processing through...
Maritess Esguerra, Principal Pharmacovigilance Process Leader,
Genentech
Maritess Esguerra has been in the pharmaceutical and biotechnology industry for 18 years, most recently as a Principal Pharmacovigilance Process Lead at Genentech, a member of the Roche group, where she has served as process owner (for both reference safety information and signal management) and...
Robert Kane, Vice President & U.S Head, Life Science Industries,
Tata Consultancy Services
Mr. Kane is currently an executive and head of TCS's business in United States for the Life Sciences Industry business unit In this capacity, Mr. Kane is responsible for the growth, oversight, client service and development of TCS’ business spanning the...
Mehul Patel, ,
Kite, A Gilead Company
Pharm.D. with 14+ years of experience in Pharmacovigilance, Quality, & Compliance roles at both large and small pharma/biotech. Currently at Kite, A Gilead Company, serving as PV Compliance Director.
Paul Coplan, Executive Director Risk Management and Epidemiology,
Purdue Pharmaceutical Products LP
A seasoned professional with over 28 years of work in analytic research in public health and development of pharmaceutics, vaccines, and therapeutic biologics, with the following track record:• Currently Head of Medical Affairs Strategic Research at Purdue Pharma and Adjunct Assistant Professor at...
Anders Lindholm, Vice President and Head of Drug Safety Therapeutic Area Inflammation and Immunology,
Celgene
Anders received his medical degree and certification at the Karolinska Institute in Stockholm, from which he also earned a PhD in Clinical Pharmacology and Transplantation Surgery. He practiced as a transplantation surgeon in Sweden and was appointed Associate Professor in Transplantation...
Jill McNair, National Director,
CISCRP
Jill McNair, MBASenior Director, Patient EngagementThe Center for Information & Study on Clinical Research Participation (CISCRP)Jill has worked in the non-profit sector for over 20 years. She is the Senior Director, Patient Engagement at The Center for Information and Study on Clinical...
Ale (Maria) Vazquez-Gragg, VP, Head Global Patient Safety,
Intarcia Therapeutics Inc
Dr. Vazquez-Gragg has extensive experience developing and driving safety-regulatory and medical organizations while combining pharmacovigilance, epidemiology and real-world data to quickly develop a lifecycle risk-benefit product profile and generate evidence to support regulatory initiates.
Mark Drinkwater, Director, Business Development,
ProQuest
Mark Drinkwater, Director, Business Development For the last 20 years, Mark Drinkwater has worked with Biopharmaceutical companies helping them perfect how to manage published scientific literature containing information about their drugs. In 2002, Mark cofounded Pi2 Solutions to address the...
Angus McCulloch, Senior Vice President: Safety and Regulatory Solutions,
Bioclinica
Angus McCulloch is an experienced leader in the Pharmacovigilance industry with 30 years of experience in the management and delivery of operational excellence results. He has driven numerous transformation programs in Drug Safety, Regulatory Affairs, Clinical Development, and R&D, and was also ...
Bettina Doepner, Director, Therapeutic Area Lead EU Region Global Regulatory Affairs,
CSL Behring
Dr Bettina Doepner is a Director Regulatory Affairs. She started her career in the pharmaceutical industry more than 20 years ago. In global as well as the European regional roles in headquarters of several pharmaceutical companies she gathered comprehensive professional experience in the areas of...
Andrew Purchase, Associate Director, Safety and Risk Management - Global Patient Safety,
PRA
Andrew holds a Bachelor’s of Science (Hons) in Forensic Science from the University of Glamorgan, United Kingdom. Andrew has over 5 years’ experience in Pharmacovigilance in addition to 3 and a half years’ experience in Data Management. Andrew initially joined PRA Health Sciences in May 2006 as ...
Raj More, CEO,
Rxlogix
RxLogix is the foremost provider of business and technology services for Safety and Pharmacovigilance. Our team of experts has spent many years focusing in this domain and brings experience of best practices across all areas. RxLogix Solutions have been developed by the leading experts on the...
Steven Beales, Senior Vice President of Information Technology,
ePharmaSolutions
Steven Beales is the Senior Vice President of IT and the Market Owner of Safety Solutions at ePharmaSolutions, a WIRB-Copernicus Group (WCG) Company. An expert in the field of safety reporting technology, Mr. Beales has 25 years of experience in IT, and has spent over 16 years in the pharmaceutical ...
Bruce Donzanti, Senior Group Director, Regulatory Pharmacovigilance Policy,
Genentech
Bruce has a PhD in pharmacology with 25+ years experience in the pharmaceutical industry following military service and a period in academics. The majority of his time in the industry has been in drug safety but he also has held various positions in pre-clinical pharmacology/toxicology and...
William O'Brien, Chairman of Medical Surveillance Team and Virology, Global Pharmacovigilance and Epidemiology,
Bristol Myers Squibb
Bill O’Brien has served as Medical Safety Assessment Physician at BMS for three years, acting as Safety Lead for early Cardiovascular and Fibrosis products. Preceding work on Medical Safety, Bill served as Director, Worldwide Medical Affairs, HCV, and was the Worldwide Medical lead for coinfection...
Ale (Maria) Vazquez-Gragg, VP, Head Global Patient Safety,
Intarcia Therapeutics Inc
Dr. Vazquez-Gragg has extensive experience developing and driving safety-regulatory and medical organizations while combining pharmacovigilance, epidemiology and real-world data to quickly develop a lifecycle risk-benefit product profile and generate evidence to support regulatory initiates.
Sherry Winter, Product Marketing Manager,
Elsevier
As a Senior Solution Marketing Manager at Elsevier, Sherry is responsible for delivering insights on markets and customers for a portfolio of preclinical/clinical and post-market life science solutions that enable improved Drug Development and Pharmacovigilance.Sherry received her PhD in Medical...
Andrea Best, Executive Medical Director, Pharmacovigilance and Patient Safety,
AbbVie
Dr. Andrea Best is an Executive Medical Director in Pharmacovigilance and Patient Safety at AbbVie in the suburbs of Chicago where she is responsible for Clinical Trial Safety Excellence. Andrea has over 20 years of experience in academia and industry across a variety of roles (clinical...
Kubra Borgardt, Director,
AbbVie
Kubra Borgardt is a Director in Pharmacovigilance and Patient Safety at Abbvie where she is responsible for clinical study safety case processing adverse event process. Kubra has over 18 years of experience in industry. She is responsible for quality and compliance, interpretations of industry...
Francois Audibert, VP of US Operations,
Vitrana
As a VP of US Operations at Vitrana, and before as Vice President of Global Consulting, VP of Pharmacovigilance and Solution Strategist, Francois Audibert enabled business transformations and keep teams on track, for simplifying business processes and leveraging adequately technologies. His...
Kevin Tynan, Consultant, Pv Operations Global Clinical Safety and Pharmacovigilance,
CSL Behring
Kevin Tynan, Executive Consultant, KPT Services LLC is currently working with the Global Clinical Safety & Pharmacovigilance department at CSL Behring. Dr. Tynan is owner of KPT Services LLC which specializes in delivering consulting services for the Healthcare industry with expertise in...
Richard Wolf, Head of I.C.S.R. Case Management and Evaluation Regions and Pv Systems,
C.S.L. Behring Gmbh
Rich Wolf, Senior Director, Regions & Pv Operations in the Global Clinical Safety and Pharmacovigilance group at CSL Behring, directs Case Management, Medical Evaluation, Pv Systems (Argus), Manufacturing Site Pv, and the Global Regions organization responsible for Pv in affiliates around...
David J Lewis, Global Head of Pharmacovigilance,
Novartis
Dr Dave Lewis joined Novartis in March 2007 following 20 years’ pharmacovigilance at GSK and at Shire Pharmaceuticals. He was appointed EU QPPV at Novartis Pharma AG from April 2009 then moved to Global Head of Pharmacovigilance Systems and Data Management, followed by Global Head of...
Quazi Ataher, Senior Director, Epidemiology. Worldwide Safety and Regulatory,
Pfizer
Quazi Ataher is a Senior Director of Epidemiology in Worldwide Safety Strategy at Pfizer. He is the Epidemiology Group Lead for Pfizer Essential Health and Pfizer Consumer Health businesses. He leads a group of epidemiologists responsible for developing and executing pharmacoepidemiology programs...
Richard Wolf, Head of I.C.S.R. Case Management and Evaluation Regions and Pv Systems,
C.S.L. Behring Gmbh
Rich Wolf, Senior Director, Regions & Pv Operations in the Global Clinical Safety and Pharmacovigilance group at CSL Behring, directs Case Management, Medical Evaluation, Pv Systems (Argus), Manufacturing Site Pv, and the Global Regions organization responsible for Pv in affiliates around...
Kevin Tynan, Consultant, Pv Operations Global Clinical Safety and Pharmacovigilance,
CSL Behring
Kevin Tynan, Executive Consultant, KPT Services LLC is currently working with the Global Clinical Safety & Pharmacovigilance department at CSL Behring. Dr. Tynan is owner of KPT Services LLC which specializes in delivering consulting services for the Healthcare industry with expertise in...
Andrea Best, Executive Medical Director, Pharmacovigilance and Patient Safety,
AbbVie
Dr. Andrea Best is an Executive Medical Director in Pharmacovigilance and Patient Safety at AbbVie in the suburbs of Chicago where she is responsible for Clinical Trial Safety Excellence. Andrea has over 20 years of experience in academia and industry across a variety of roles (clinical...
Raj Long, Deputy Director, Integrated Development, Global Health,
The Bill & Melinda Gates Foundation
Raj is a senior executive with over 20 years of experience in drug development. Raj brings a unique strategic expertise blending private heath and public heath sectors including having worked with the EU EMA, US FDA, China CFDA, India DCGI and other regulatory authorities. She is currently a Deputy ...
Andrew Rut, CEO and Founder,
MyMeds&Me
Andrew is the Chief Executive Officer and founder of MyMeds&Me. He is responsible for the delivery of product and company direction, ensuring strong customer experience for all MyMeds&Me clients and building a strong team of enthusiastic, industry specialists who are able to deliver high...
Anders Lindholm, Vice President and Head of Drug Safety Therapeutic Area Inflammation and Immunology,
Celgene
Anders received his medical degree and certification at the Karolinska Institute in Stockholm, from which he also earned a PhD in Clinical Pharmacology and Transplantation Surgery. He practiced as a transplantation surgeon in Sweden and was appointed Associate Professor in Transplantation...
Quazi Ataher, Senior Director, Epidemiology. Worldwide Safety and Regulatory,
Pfizer
Quazi Ataher is a Senior Director of Epidemiology in Worldwide Safety Strategy at Pfizer. He is the Epidemiology Group Lead for Pfizer Essential Health and Pfizer Consumer Health businesses. He leads a group of epidemiologists responsible for developing and executing pharmacoepidemiology programs...
Essam Ghanem, Head of Drug Safety and Pharmacovigilance (DSPV),
VIGI-CARE
Essam GHANEM is an experienced physician and Qualified Person for Pharmacovigilance with almost 34 years of experience in clinical research and drug development in academic institutes, Pharmaceutical Industry and Clinical Research Organisations. Around 8 years working experience as EUQPPV and as...
Priya Jain, Medical Director,
Alkermes
Priya has global experience of over 20 years in health care industry and over 15 years in the research. Priya is currently a Medical director of Drug safety and Pharmacovigilance at Alkermes. Her focus has been CNS, Cardiology and Oncology. After practicing Medicine in India Priya moved to London...
Syed Zaferuddin, Deputy QPPV,
Jamjoom Pharmaceuticals
Syed Zaferuddin is a much known Pharmacovigilance activist in Middle East because of his NGO follow-up reporter involved in collection and reporting of ADR/AE to concern authorities in Middle East. His NGO got a free license from MSSO for MedDRA as a token of love for his efforts in Middle East. He ...
Essam Ghanem, Head of Drug Safety and Pharmacovigilance (DSPV),
VIGI-CARE
Essam GHANEM is an experienced physician and Qualified Person for Pharmacovigilance with almost 34 years of experience in clinical research and drug development in academic institutes, Pharmaceutical Industry and Clinical Research Organisations. Around 8 years working experience as EUQPPV and as...
Alexandre Kiazand, Safety Sciences Global Head,
AstraZeneca
An internist by training, Alex Kiazand heads the Safety Science Department at AstraZeneca. Alex graduated with a medical degree from Claude Bernard University, Grange Blanche School of Medicine in France, and completed a post-doctoral fellowship in molecular biology at Stanford University, School...
