The health and safety of the PCPV summit registrants is our number one priority. Due to the uncertainty of the impact of COVID-19, we have made the difficult decision to postpone the PCPV Summit to Sept. 14–15th 2022. In the interim, we will be launching a speaker series discussing PV challenges with PCPV Summit speakers and PCPV Board members. Be sure to click Stay Informed below for more updates about the speaker series and PCPV Summit 2022.

Speakers

Speakers

Evan Blander

Vice President, Drug Safety at Exelixis, Inc.
PCPV Summit Program Board Member

Evan Blander is the VP of Drug Safety at Exelixis, Inc. For over five years he has been responsible for Drug Safety Operations, Quality Management, Systems, and Medical Review at Exelixis. Prior to Exelixis, Mr. Blander was the Director, Drug Safety Systems and Quality Management at Onyx Pharmaceuticals until it was acquired three years later by Amgen Inc. Previous to his work at Onyx Pharmaceuticals, Mr. Blander held multiple roles at Amgen Inc. spanning the drug development life cycle from research to pre-clinical through to clinical development and commercial manufacturing and was heavily focused on Information Systems before transitioning to Global Regulatory Affairs and Safety (GRAAS). Mr. Blander began his career holding multiple positions at IBRD-Rostrum Global. He graduated Cal State Northridge with a Bachelors of Science in Mathematical Statistics and UCLA with a Masters of Science in Biostatistics.

Dr. James Buchanan

President of Covilance, LLC
PCPV Summit Program Board Member

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.

Shelley Gandhi

Director—Pharmacovigilance and Drug Safety at NDA Group AB
PCPV Summit Program Board Member

Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions including safety governance models. Former senior manager at MHRA for over 19 years and represented the UK on EMAs EudraVigilance Expert Working Group. Shelley now supports clients with QPPV, Risk Management, Inspection Readiness and implementation of global PV systems.

Seema Jaitly

Managing Director and Owner, Essjay Solutions

Dr Seema Jaitly qualified in Medicine from Charing Cross and Westminster Medical School in 1992 and worked in general medicine and psychiatry for four years. She has worked in the pharmaceutical industry for over 23 years at CROs, large and small companies spanning clinical research, medical affairs, pharmacovigilance and as the EU QPPV. She has held posts in safety with GSK, and Ipsen, safety and clinical with Sanofi and was VP medical and scientific affairs and EU QPPV for Stiefel. In 2010 she set up Essjay Solutions Ltd primarily to offer pharmacovigilance services and to provide consultancy and contracting services to the pharmaceutical industry. Additionally Seema has set up PV systems and helped implement EU legislation in various organisations and transition from pre authorisation to post authorisation PV requirements. She also provides in-depth PV training and has extensive experience in the totality of product benefit:risk. She has a diploma in management studies and an MSc in epidemiology with the London School of Hygiene and Tropical Medicine.

Stephen Knowles, MD, MRCP

Chief Medical Officer at Halozyme Therapeutics
PCPV Summit Program Board Member

Steve received his MD from the University of Newcastle Upon Tyne, UK and worked in the UK National Health Service for 17 yrs. He joined Halozyme in 2018 as Vice President, Drug Safety & Pharmacovigilance. Prior to this, Steve worked at Eli Lilly for 16 years, 12 years of which was in drug safety in various roles of increasing responsibility involving case management and safety surveillance.

Mayur Patel

Vice President, Patient Safety Oncology/ImmunoOncology Therapy at AstraZeneca

Dr. Mayur Patel is an experienced drug developer and pharmacovigilance professional with 20+ years in biopharmaceutical industry. Currently, Dr. Patel is the Vice President Patient Safety for the Oncology Therapy Area at AstraZeneca. Prior to his current role, he was Vice President Patient Safety for Respiratory, Inflammation, Autoimmune, Infection & Vaccines Therapy Area and prior to that VP/Head of Patient Safety at MedImmune. He started his career at Warner Lambert / Parke-Davis Pharmaceuticals in Drug Discovery working in the Molecular Biology group before transitioning to pharmacovigilance at Elan Pharmaceuticals supporting development and post marketing safety of products in Neurology and Autoimmunity therapy areas. In his career, he has experienced and managed complex safety issues as a safety lead/project leader managing safety activities from early development through commercialization for numerous compounds in different therapeutic areas and modalities (including monoclonal antibodies, antibody drug conjugates, peptides, small molecules and vaccines). He has significant experience in building safety organizations based in US, UK, EU and India and working/managing interfaces with external collaborators, co-development partners, business process outsourcing providers, and contract research organizations. Dr Patel currently sits on the Transcelerate PV Steering Committee and has worked in a number of industry working groups in the past including Biotechnology Industry Organization (BIO) Benefit Risk Working Group, CIOMS Vaccine PV Working group and PML Consortium.

Ed Tucker, M.D.

Chief Medical Officer at Mirum Pharmaceuticals

Ed Tucker, M.D., is chief medical officer at Mirum Pharmaceuticals. Dr. Tucker most recently served as chief operating officer at Acerta Pharma LLC where he was responsible for business and operational activities across the heme-oncology pipeline. During his tenure at Acerta, Dr. Tucker helped create and build the medical safety, quality, compliance and clinical development groups, growing the company and enabling the U.S. approval and launch of Calquence in 2017. Prior to joining Acerta, Dr. Tucker held leadership positions in clinical development, medical safety and medical affairs at Bayer AG, Janssen Pharmaceutica and Genentech, Inc.

Bethany Van Veen

CEO and Founder, Perspective Pharmacovigilance, Inc.
PCPV Summit Program Board Member

Bethany Van Veen, has over twenty years of experience in Pharmacovigilance including 18 years in leadership roles and is considered an industry leader by many of her peers. She founded Perspective Pharmacovigilance three years ago following several years of independent PV consulting. She recognized the need for a PV think tank made up of PV experts to collectively engage in developing solutions for PV challenges facing the industry. During her consulting career she has advised over 25 pharmaceutical and biotech companies of varying sizes and stages in development and commercialization. Prior to her consulting work, Bethany was the Sr. Director of PV Operations at InterMune where she built the PV infrastructure to support the company’s first global product launch. She has held PV leadership positions at Johnson & Johnson, Millennium Pharmaceuticals, and Elan Pharmaceuticals. She is also an adjunct professor at San Francisco State University teaching the Safety Monitoring Course for the Clinical Trials Design and Management Certification.

Evan Blander

Vice President, Drug Safety at Exelixis, Inc.
PCPV Summit Program Board Member

Evan Blander is the VP of Drug Safety at Exelixis, Inc. For over five years he has been responsible for Drug Safety Operations, Quality Management, Systems, and Medical Review at Exelixis. Prior to Exelixis, Mr. Blander was the Director, Drug Safety Systems and Quality Management at Onyx Pharmaceuticals until it was acquired three years later by Amgen Inc. Previous to his work at Onyx Pharmaceuticals, Mr. Blander held multiple roles at Amgen Inc. spanning the drug development life cycle from research to pre-clinical through to clinical development and commercial manufacturing and was heavily focused on Information Systems before transitioning to Global Regulatory Affairs and Safety (GRAAS). Mr. Blander began his career holding multiple positions at IBRD-Rostrum Global. He graduated Cal State Northridge with a Bachelors of Science in Mathematical Statistics and UCLA with a Masters of Science in Biostatistics.

Dr. James Buchanan

President of Covilance, LLC
PCPV Summit Program Board Member

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.

Shelley Gandhi

Director—Pharmacovigilance and Drug Safety at NDA Group AB
PCPV Summit Program Board Member

Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions including safety governance models. Former senior manager at MHRA for over 19 years and represented the UK on EMAs EudraVigilance Expert Working Group. Shelley now supports clients with QPPV, Risk Management, Inspection Readiness and implementation of global PV systems.

Seema Jaitly

Managing Director and Owner, Essjay Solutions

Dr Seema Jaitly qualified in Medicine from Charing Cross and Westminster Medical School in 1992 and worked in general medicine and psychiatry for four years. She has worked in the pharmaceutical industry for over 23 years at CROs, large and small companies spanning clinical research, medical affairs, pharmacovigilance and as the EU QPPV. She has held posts in safety with GSK, and Ipsen, safety and clinical with Sanofi and was VP medical and scientific affairs and EU QPPV for Stiefel. In 2010 she set up Essjay Solutions Ltd primarily to offer pharmacovigilance services and to provide consultancy and contracting services to the pharmaceutical industry. Additionally Seema has set up PV systems and helped implement EU legislation in various organisations and transition from pre authorisation to post authorisation PV requirements. She also provides in-depth PV training and has extensive experience in the totality of product benefit:risk. She has a diploma in management studies and an MSc in epidemiology with the London School of Hygiene and Tropical Medicine.

Stephen Knowles, MD, MRCP

Chief Medical Officer at Halozyme Therapeutics
PCPV Summit Program Board Member

Steve received his MD from the University of Newcastle Upon Tyne, UK and worked in the UK National Health Service for 17 yrs. He joined Halozyme in 2018 as Vice President, Drug Safety & Pharmacovigilance. Prior to this, Steve worked at Eli Lilly for 16 years, 12 years of which was in drug safety in various roles of increasing responsibility involving case management and safety surveillance.

Mayur Patel

Vice President, Patient Safety Oncology/ImmunoOncology Therapy at AstraZeneca

Dr. Mayur Patel is an experienced drug developer and pharmacovigilance professional with 20+ years in biopharmaceutical industry. Currently, Dr. Patel is the Vice President Patient Safety for the Oncology Therapy Area at AstraZeneca. Prior to his current role, he was Vice President Patient Safety for Respiratory, Inflammation, Autoimmune, Infection & Vaccines Therapy Area and prior to that VP/Head of Patient Safety at MedImmune. He started his career at Warner Lambert / Parke-Davis Pharmaceuticals in Drug Discovery working in the Molecular Biology group before transitioning to pharmacovigilance at Elan Pharmaceuticals supporting development and post marketing safety of products in Neurology and Autoimmunity therapy areas. In his career, he has experienced and managed complex safety issues as a safety lead/project leader managing safety activities from early development through commercialization for numerous compounds in different therapeutic areas and modalities (including monoclonal antibodies, antibody drug conjugates, peptides, small molecules and vaccines). He has significant experience in building safety organizations based in US, UK, EU and India and working/managing interfaces with external collaborators, co-development partners, business process outsourcing providers, and contract research organizations. Dr Patel currently sits on the Transcelerate PV Steering Committee and has worked in a number of industry working groups in the past including Biotechnology Industry Organization (BIO) Benefit Risk Working Group, CIOMS Vaccine PV Working group and PML Consortium.

Ed Tucker, M.D.

Chief Medical Officer at Mirum Pharmaceuticals

Ed Tucker, M.D., is chief medical officer at Mirum Pharmaceuticals. Dr. Tucker most recently served as chief operating officer at Acerta Pharma LLC where he was responsible for business and operational activities across the heme-oncology pipeline. During his tenure at Acerta, Dr. Tucker helped create and build the medical safety, quality, compliance and clinical development groups, growing the company and enabling the U.S. approval and launch of Calquence in 2017. Prior to joining Acerta, Dr. Tucker held leadership positions in clinical development, medical safety and medical affairs at Bayer AG, Janssen Pharmaceutica and Genentech, Inc.

Bethany Van Veen

CEO and Founder, Perspective Pharmacovigilance, Inc.
PCPV Summit Program Board Member

Bethany Van Veen, has over twenty years of experience in Pharmacovigilance including 18 years in leadership roles and is considered an industry leader by many of her peers. She founded Perspective Pharmacovigilance three years ago following several years of independent PV consulting. She recognized the need for a PV think tank made up of PV experts to collectively engage in developing solutions for PV challenges facing the industry. During her consulting career she has advised over 25 pharmaceutical and biotech companies of varying sizes and stages in development and commercialization. Prior to her consulting work, Bethany was the Sr. Director of PV Operations at InterMune where she built the PV infrastructure to support the company’s first global product launch. She has held PV leadership positions at Johnson & Johnson, Millennium Pharmaceuticals, and Elan Pharmaceuticals. She is also an adjunct professor at San Francisco State University teaching the Safety Monitoring Course for the Clinical Trials Design and Management Certification.

Focusing on real-world solutions to everyday pharmacovigilance challenges.

September 14–15, 2022

Hilton San Francisco Airport Bayfront
600 Airport Blvd.
Burlingame, CA 94010

Hosted by Perspective Pharmacovigilance.
To learn more, click here:

Focusing on real-world solutions to everyday pharmacovigilance challenges.

September 14–15, 2022

Hilton San Francisco Airport Bayfront
600 Airport Blvd.
Burlingame, CA 94010

Hosted by Perspective Pharmacovigilance.
To learn more, click here:

Focusing on real-world solutions to everyday pharmacovigilance challenges.

September 14–15, 2022

Hilton San Francisco Airport Bayfront
600 Airport Blvd.
Burlingame, CA 94010

Hosted by Perspective Pharmacovigilance.
To learn more, click here: