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Speakers

  • Kevin  Appareti, MBA

    Kevin Appareti, MBA

    • Senior Director, Global Medical Science Liaison
    • Philips HealthTech, United States

    Kevin Appareti is Senior Director, Global Medical Science Liaison in the Chief Medical Office at Royal Philips. He leads the Key Thought Leadership Program and works across Philips' businesses, markets, and research to build strong internal and external relationships with key thought leaders and influencers. Kevin partners with internal business, market, and research leaders to develop strategic Key Thought Leader (KTL) engagement programs to deliver strategic guidance, leverage clinical and scientific knowledge, foster peer-to-peer relationships, and support clinical and marketing evidence development in support of Philips meaningful innovations.

  • Anne  Arvizu, PharmD

    Anne Arvizu, PharmD

    • CEO & Medical Affairs Advisor
    • RxER Communications, United States

    Anne is founder and CEO of RxER Communications Corp. With 20 years of progressive leadership in the pharma/biotech industry, she has served in key roles, such as Global Head & Director of Medical Information for Baxter; Global Head & Senior Director of Medical Information, Literature Services & Knowledge Management, Baxalta; Member Executive, PhactMI; and Regional Head & Director of Medical Information & Medical Communications, GlaxoSmithKline. As a seasoned C-suite executive consultant, she currently engages biotech clients with Medical Information & Medical Affairs operational capabilities build, launch and scale. She is an advocate for community health and wellness and serves as Vice Chair, South Florida YMCA, Board of Directors.

  • J. Lynn  Bass, PharmD

    J. Lynn Bass, PharmD

    • Director, Medical Science Liaisons, Americas
    • Santen, Inc., United States

    Lynn has over 19 years of experience in Medical Science Liaison and Medical Affairs roles across the pharmaceutical industry. She is currently the Director, MSLs (Americas) at Santen, Inc. Previously, Lynn worked in management and individual contributor MSL roles at Jazz Pharma, Baxter/ Baxalta, Amgen, and Lilly. Her industry career has spanned several therapeutic areas and has included a variety of leadership opportunities. Lynn has authored/ co-authored several MSL surveys which have highlighted and assessed both evolving and future considerations of the Medical Science Liaison role. Currently, Lynn is the elected Chair of the DIA Medical Science Liaison Community.

  • Peter  Baumeister, PhD

    Peter Baumeister, PhD

    • Senior Manager, Global Scientific Communications
    • Amgen Inc., United States

    Peter is currently a senior manager and the lead for Strategy and Operations, Global Scientific Communications at Amgen, Inc. He has led projects that have developed innovative solutions for all aspects of medical communications and scientific exchange. He received his PhD in Molecular Biology and Biochemistry from USC and lives in Thousand Oaks, CA, where he enjoys skateboarding, surfing, and watching his 3 kids fail and succeed over and over again.

  • Poonam A. Bordoloi, PharmD

    Poonam A. Bordoloi, PharmD

    • I&I Lead: Research & Early Pipeline Medical Communications
    • Celgene Corporation, United States

    Poonam Bordoloi is currently at Celgene Global Medical Information in the Strategic Medical Communications and Innovation group. Prior to joining Celgene, Poonam worked at Sanofi MI for 12 years. She is actively involved with DIA, is a DIA planning board member, and continues to chair and speak at meetings. She has over 22 years of experience in the Medical Information setting and has 2 publications regarding Social Media and Medical Information Trends. Prior to Sanofi, Poonam worked in the Global Competitive Intelligence group with Johnson and Johnson and in the Medical Information Department at Parke-Davis. She also has experience in managed care with her work as a Formulary Director at a Pharmacy Benefits Management Company.

  • David  Bowers, PharmD

    David Bowers, PharmD

    • Director, Medical Communications
    • PPD, United States

    David Bowers has 15+ years of experience managing pharmaceutical contact center programs at PPD. As Director of Operations, David supports global medical information for pharmaceutical, biotechnology and medical device clients. He has a background in pharmacy, with a Doctorate of Pharmacy from the University of North Carolina in the United States. During his time at PPD, David has worked with over 30 client contact center programs providing medical information, pharmacovigilance and product complaint processing, patient adherence programs, REMS support and other services. David’s recent experience includes implementing contact center operations in the US, Europe, Mexico and Brazil.

  • Kathryn  Bucci, PharmD

    Kathryn Bucci, PharmD

    • Medical Governance Lead
    • Pfizer, Inc., United States

    Kathryn K. Bucci, PharmD, FASHP, BCPS is Senior Director, Global Medical Governance Lead at Pfizer, Inc. Prior to assuming this role, she was a field-based medical colleague at Pfizer for 15 years. Dr. Bucci earned her B.S.Pharm. and Pharm.D. degrees at St. John's University. She completed an ASHP accredited Residency in Hospital Pharmacy Practice at the Medical College of Virginia Hospitals and a Fellowship in Clinical Pharmacy Practice in Family Medicine, Medical University of South Carolina. Prior to joining Pfizer in 2000 she was faculty in the Department of Community and Family Medicine at Duke University Medical Center and in the Department of Pharmacy Practice, Campbell University.

  • Stephanie L. Byrdé, BSN, MS, RN

    Stephanie L. Byrdé, BSN, MS, RN

    • Manager, Clinical Pharmacology Scientific Communications
    • Eli Lilly & Company, United States

    Stephanie Byrdé is an Advisor in Clinical Pharmacology for Eli Lilly and Company. During her tenure with Lilly, she has held various roles in clinical development, project management, and scientific communications, spanning early phase through late phase submissions and launches.

  • Ivy Lee Chang, PharmD

    Ivy Lee Chang, PharmD

    • Associate Director, Medical Communications
    • Genentech, Inc., A Member of the Roche Group, United States

    Ivy has 16+ years of experience in the pharmaceutical industry. She is an Associate Director in Medical Communications at Genentech where she has oversight of products in rheumatology and immunologic diseases. Prior to joining Genentech, she was a Clinical Pharmacist in General Surgery, Surgical Subspecialties, and Solid Organ Transplant at the University of California San Francisco (UCSF) Medical Center, and an Assistant Clinical Professor with the UCSF School of Pharmacy. Ivy Chang received her Doctor of Pharmacy degree from the University of Tennessee in Memphis and completed a residency in Pharmacy Practice at UCSF.

  • Michael  Church, MA

    Michael Church, MA

    • Senior Director, Medical Writing
    • Syneos Health, United States

    Currently Senior Director of Medical Writing for inVentiv Health Clinical, Michael has 15 years of industry experience and oversees one of the largest medical writing FSPs in the country, which includes teams of regulatory and commercialization writers, editors, and regulatory publishers. This is his second year on the planning committee for the DIA scentific communications annual meeting.

  • David B. Clemow, PhD

    David B. Clemow, PhD

    • Advisor, Scientific Communications Information Strategy
    • Eli Lilly and Company, United States

    David is an Advisor Scientific Communications Information Strategy at Eli Lilly and Company with over 20 years of regulatory, publication, and promotional scientific communications experience in the pharmaceutical industry. His work has included document authoring, team management, operations consulting, clinical research, and medical affairs. David is Chair of DIA’s Medical Writing Community and Community Leadership Council, as well as the American Medical Writers Association Medical Writing Certification Commission.

  • Rebecca  Falcone, PharmD

    Rebecca Falcone, PharmD

    • Global Medical Information Systems Lead, GMI Operations
    • Sanofi, United States

    Rebecca Falcone, PharmD has over 17 years of pharmaceutical industry experience and is currently the Global Medical Information (GMI) Systems Lead for the GMI Operations group at Sanofi. Prior to that, she was a Senior Manager in the Sanofi Medical Information department where she provided medical information support for the Oncology/Hematology/Transplant products. Rebecca was a Core Curriculum faculty member at the DIA Medical Affairs and Scientific Communications Forum (MASC) for 3 years. She has also been a speaker at sessions for both the DIA Annual and MASC meetings.

  • Maureen  Feeney, PharmD, MBA, RPh

    Maureen Feeney, PharmD, MBA, RPh

    • Head Global Medical Information
    • Shire Pharmaceuticals, United States

    Dr. Feeney has over 18 years of experience in Medical Affairs, including leadership roles in Medical Information and Medical Communications. She is currently the Head of Global Medical Communications, as well as the Head of the Industry Fellowship Program, at Shire. Prior to joining Shire, Dr. Feeney led the development and implementation of a new Medical Information Department and Call Center, at Incyte. She held various positions of increasing responsibility including, Director of Medical Information at GlaxoSmithKline. Prior to joining industry, Dr. Feeney was a Clinical Pharmacist at Thomas Jefferson University Hospital in Philadelphia, PA.

  • Eileen  Girten, MS

    Eileen Girten, MS

    • Principal Medical Writer
    • PRA Health Sciences, United States

    Eileen M. Girten, MS, is a Principal Medical Writer with inVentiv Health where she writes regulatory and publications deliverables and mentors writers. Eileen earned a BA in Chemistry from Rosemont College, an MS in Psychology from Saint Joseph’s University, and an MS in Biomedical Writing from the University of the Sciences in Philadelphia. She is an Adjunct Assistant Professor in Biomedical Writing at the University of the Sciences and currently serves as the Medical Writing Track Co-chair of the 2017 Medical and Scientific Communications Annual Forum. Eileen also has previously served as the Chair of the DIA Medical Writing Community, Education Committee and has served as a Training Instructor for DIA.

  • Kathleen M Guindon, PhD, MS, RN

    Kathleen M Guindon, PhD, MS, RN

    • Director, Clinical Science Liaison
    • Puma Biotechnology, United States

    Kathleen Guindon, Director, Medical Science Liaison team at Puma Biotechnology is responsible for supervision of a team of six United States Based MSL’s. Kathy also maintains a territory within the US with her MSL team. Kathleen is a qualified registered nurse and holds the a Master’s degree from State University of New York at Buffalo in Oncology Clinical Nurse Specialist, and a doctoral degree from the University of Phoenix in Management and Organizational Leadership. She holds current memberships in NAPW, DIA, ASCO, ASH, & AACR. Kathleen’s varied background includes oncology nursing, oncology medical affairs, oncology clinical R&D, organizational management, public speaking, and publication in peer reviewed medical journals.

  • Jennie G. Jacobson, PhD

    Jennie G. Jacobson, PhD

    • Lead Medical Writer
    • Fishawack Communications, United States

    Jennie G. Jacobson works for Eli Lilly and Company, where she writes about their wide range of therapies for diabetes and is active in process improvement. In her 17 years as a medical writer, she has written about infectious disease, mental health, health outcomes research, and diabetes. What Jennie loves most about being a medical writer is the ongoing opportunities to learn new things. She earned her BA at Swarthmore College, her PhD at Harvard University, and her Certificate in Medical Writing at the University of Chicago. She lives in the Philadelphia area with her family.

  • Darryl Zachary L'Heureux, PhD, MPharm, MSc

    Darryl Zachary L'Heureux, PhD, MPharm, MSc

    • Medical Writing Manager
    • Bristol-Myers Squibb, United States

    As a member of both the DIA and AMWA, Dr. L’Heureux serves as a conference chair, present lectures and leads roundtables at professional and educational events. He received his PhD in Cancer Biology and Masters in Pharmacy, Quality Assurance and Regulatory Affairs from Temple University in Philadelphia, PA. Upon graduation, he continued his research in cancer biology and clinical oncology working across the cooperative group structure of the NCI. He has consulted with academic partnerships to develop biomarkers for diagnosis, prognosis, and disease surveillance. Working across the range of small biotech to large pharmaceutical companies, Dr. L’Heureux has returned to his early research interest in immuno-oncology and tumor biology.

  • Jeff  Mathews, MPH

    Jeff Mathews, MPH

    • Director, Medical Information
    • Gilead Sciences, United States

    Jeff is the Director of US Medical Information at Gilead Sciences, where he is responsibility for developing and executing strategies to deliver medical information services across all Gilead products in the US. He has nearly 14 years of Medical Communications experience with roles in Scientific Communications, Publication Planning, and Medical Information at Eli Lilly, Sunovion Pharmaceuticals, and Vertex Pharmaceuticals. He holds a Masters of Public Health in Epidemiology from Indiana University and is a Certified Medical Publication Professional (CMPP).

  • David  Meats

    David Meats

    • Global Scientific and Regulatory Documentation
    • Syneos Health, United States

    David Meats is a cellular and developmental biologist working as a Principal Medical Writer for a major CRO. David has 17 years of experience as a regulatory and scientific writer for both device and pharmaceutical submissions. David has recently championed the development of processes and tools for clinical trial lay summaries with a number of clients.

  • Robert  Paarlberg, MS

    Robert Paarlberg, MS

    • Principal
    • Paarlberg & Associates LLC, United States

    Robert Paarlberg is the Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob created and directed global regulatory policy and intelligence functions at UCB and Pharmacia (Upjohn). Bob is also current Chair of DIA’s Clinical Trial Disclosure Community. Bob has more than 35 years of pharmaceutical industry experience with the vast majority of his experience in US and international regulatory affairs.

  • David A. Price, PhD

    David A. Price, PhD

    • Consultant – Office of Medical Professional Development (MSL Trainer)
    • Eli Lilly and Company, United States

    David Price, PhD has been employed with Eli Lilly and Company since 2011. Since joining the industry at Lilly, David has served as Medical Liaison supporting multiple therapeutic areas, including: Psychiatry, Urology and Musculoskeletal. In these roles, David developed and maintained TL relationships in the Midwest/Great Plains and Southwest/Mountain regions. In 2014, David joined Lilly’s Field Medical Operations team providing Strategy & Capabilities support for the US Medical Liaisons. David currently is a Consultant – Field Medical Excellence for Lilly’s US BioMedicines Medical Liaison teams.

  • Robin  Whitsell

    Robin Whitsell

    • President
    • Whitsell Innovations, Inc., United States

    Founder and president of Whitsell Innovations (WI), Inc., a medical writing firm headquartered in Chapel Hill, NC with employees in 13 states. She has 20 years experience, specializing in medical writing and regulatory submission strategies for the life sciences. Prior to founding WI, Ms. Whitsell was the assistant director of preclinical & clinical development at Inspire Pharmaceuticals, a team lead at GlaxoWellcome (now GlaxoSmithKline), and a CRA at Parexel International. Ms. Whitsell served on the boards of the Diversity Alliance for Science and the Healthcare Businesswomen’s Association. She has degrees in biophysics and physics from Miami University in Oxford, OH, and interned at Los Alamos National Laboratory.

  • Robin L. Winter-Sperry, DrMed, MD

    Robin L. Winter-Sperry, DrMed, MD

    • Head, Global Field Based Medical Excellence
    • Sanofi Genzyme, United States

    Robin Winter-Sperry, MD, Head, Global Field Based Medical Excellence & Insights, Sanofi Genzyme, has a distinguished career. She joined Sanofi in Global MS Medical Affairs, Strategy & Tactics and previous to that position, she was President and CEO of Scientific Advantage, LLC. She created Novartis’ MSL department of Scientific Operations and Sanofi-Synthelabo’s (predecessor to Sanofi) Medical Therapeutic Liaison division. She has pioneered the recognition of MSLs as a specialty in the biopharmaceutical and device industry and is responsible for creating and developing many of the industry’s leading Medical Affairs and Medical Liaison teams.

  • Ann M Winter-Vann, PhD

    Ann M Winter-Vann, PhD

    • Senior Medical Writer and Consultant
    • Whitsell Innovations, Inc., United States

    Ann Winter-Vann earned her PhD in Molecular Cancer Biology from Duke University, where she was a predoctoral fellow of the Howard Hughes Medical Institute. Following a postdoctoral position in the Pharmacology Department at UNC-Chapel Hill, Ann joined Whitsell Innovations, Inc. as a medical writer. She has extensive experience in clinical regulatory writing, and also provides consultations and training in medical writing. Since 2008, Ann has co-taught a science writing course for first-year biomedical graduate students at UNC-Chapel Hill. Ann is a past president of the Carolinas chapter and is on the national Board of Directors for the American Medical Writers Association (AMWA).

  • Pamela  Cyrus, MD

    Pamela Cyrus, MD

    • Vice President and Head of Medical Governance, Pharmaceuticals
    • Bayer Healthcare Pharmaceuticals, Inc., United States

    With 20+ years in pharmaceutical industry, Pam has led and managed large teams across different therapeutics areas (neurology, pulmonary, biologics, oncology, anti-infectives, cardiovascular, metabolics, diagnostic imaging, and women’s healthcare). She has had responsibilities in both clinical development and medical affairs. Since July 2014, she has served as Vice President and Head of Global Medical Governance. This role has oversight responsibility to protect the interests of patients in accordance with all relevant legislation and guidelines including EU, FDA and country directives, Medicines Law, the Pharmaceutical Industry Code of Practice, and company standard operating procedures. This role reports to the Bayer CMO.

  • Paul  Grant

    Paul Grant

    • Healthcare Engagement Strategist
    • United Kingdom

    Paul Grant has been involved in digital media since the inception of the public Internet. For much of the past 11 years, he has been based in London U.K., where he produced digital engagement strategies and social media insights for the leading health and pharmaceutical organizations in the world. Until his return to Australia, he was faculty lecturer in social media for the European Center of Pharmaceutical Medicine, an advisor in pharmaceutical guidance for digital communications, and Chief Innovation Officer for a global health consultancy. Paul is passionate about inspiring and motivating organizations towards an empowered and sustainable future capability.

  • Craig J. Klinger, RPh

    Craig J. Klinger, RPh

    • Consultant, Field Medical Liaison Strategy and Capabilities - Trainer
    • Lilly USA, LLC, United States

    Craig has been an employee of Eli Lilly and Company for 22 years. He has worked in various positions while at Lilly in multiple therapeutic areas including neuroscience, diabetes and women’s health. Craig was a founding member of the Medical Science Liaison program at Lilly where he was a Senior Consultant Medical Liaison for Musculoskeletal Health in the New York City Metropolitan area for over 13 years. Craig currently is the Global Medical Science Liaison Trainer. Craig serves on the DIA planning committee for its Medical Liaison Community.

  • Ed  Cunningham, PharmD

    Ed Cunningham, PharmD

    • Director, Medical Science Liaison Lead
    • Sunovion Pharmaceuticals Inc., United States

    Ed Cunningham, PharmD is Senior Director and Neurology Medical Science Liaison (MSL) Lead at Sunovion Pharmaceuticals Inc. Ed is based in Milwaukee, WI, and is responsible for overseeing the US Neurology MSL team. Prior to joining Sunovion, Ed was the Director of Specialty Care MSLs at Eisai Inc., leading the company’s Neuroscience and Metabolic MSL teams. Ed obtained his PharmD degree from Philadelphia College of Pharmacy and completed a 1-year Drug Information Residency with Janssen Pharmaceutica. Ed has been in the pharmaceutical industry for 14 years, working in a variety of Medical Affairs functions, including Medical Information, Medical Education, Investigator Initiated Studies, and MSLs.

  • Rebecca A. Vermeulen, RPh

    Rebecca A. Vermeulen, RPh

    • Head, Customer Strategy Global Medical Affairs
    • Hoffmann-La Roche Ltd., Switzerland

    Rebecca Vermeulen R.Ph. brings a variety of experiences and capabilities to her role as Customer Strategy for Global Medical Affairs at Roche. She has spent 25 years in the pharmaceutical industry and has served in a variety of functions including Medical Affairs, Clinical Research, Sales, Medical Communications, Medical Science Liaisons, Medical Education, Digital Communications, and Six Sigma. Rebecca is currently on the Global Board of Directors for the Drug Information Association and also serves as Vice-Chair for the HBA (Healthcare Businesswomen’s Association) Corporate Board of Directors.

  • Jim R. Wilkinson, PhD

    Jim R. Wilkinson, PhD

    • Executive Director, Hem-Onc Regional Medical Liaisons, Global Scient
    • Amgen, Inc., United States

    Jim Wilkinson is an Executive Director of Global Medical Affairs at Amgen with over 16 years of experience in Medical Information, Medical Communications, and Medical Science Liaisons. His work includes managing Departments focused on contact centers, global publication planning, congresses, scientific advisory boards, creation of MSL resources, and promotional review committees across several therapeutic areas. Most recently, Jim was the TA Head for the Hematology-Oncology Regional Medical Liaisons at Amgen with accountabilities including the overall field-based strategy, creating strategic scientific engagement plans for opinion leaders (OLs), disease state and product discussions, clinical research support and formulary support.

  • Alicia Alexander Cadogan, PharmD, RPh

    Alicia Alexander Cadogan, PharmD, RPh

    • Director, Oncology Medical Information
    • Pfizer, Inc., United States

    Alicia is Director and North America Team Lead for Oncology Medical Information at Pfizer Inc. Alicia has participated in the Core Curriculum for DIA both as faculty and Chairperson, and in 2010 served as Chairperson for the Annual Medical Communications Workshop. Alicia received her BS in Pharmacy from St. John’s University, and her PharmD from Albany College of Pharmacy. She spent 4 years at The University of Pittsburgh School of Pharmacy as a Nephrology Fellow and then Assistant Professor of Pharmacy and Therapeutics. Alicia also worked in Medical Communications at Wyeth Pharmaceuticals and as Medical Director at CoMed Communications.

  • Paul  Berg, MS

    Paul Berg, MS

    • Principal Research Scientist
    • Eli Lilly & Company, United States

    Paul has been a statistician at Eli Lilly for 19 years and worked across a variety of therapeutic areas, in both management and individual contributor roles. Besides working on clinical trials, he has also worked in leadership development and quality systems within the statistics organization. Paul earned his B.S. in mathematics from the University of Notre Dame and his M.S. in biometry and epidemiology from the Medical University of South Carolina.

  • Kendra  Bolt, PhD

    Kendra Bolt, PhD

    • Manager of Scientific Communications
    • Audentes Therapeutics, United States

  • TK  Booker Porter

    TK Booker Porter

    • Senior Manager Global Regulatory Writing, Protocol Authoring Lead
    • Amgen, Inc., United States

    TK Booker Porter leads the protocol authoring group at Amgen, Inc. As the business process owner for protocols, she is passionate about continuous improvement in an ever-changing environment due to shifting global regulatory requirements, trends with patient input, and advances in technology. She led implementation of the technology-enhanced version of the TransCelerate Common Protocol Template (CPT) at Amgen, as well as efforts to expand the SMART technology to other document types. She is an active member of TransCelerate’s CPT initiative, with interest and involvement on multiple fronts including content reuse, compliance with EU CTR, and data digitalization.

  • David H Brown, MA, MSc

    David H Brown, MA, MSc

    • Associate Director, Medical Communications Science
    • AstraZeneca Pharmaceuticals LP, United States

    David Brown manages regulatory medical writers involved in CTD production and is involved in development of company best practice. He has 17 years of experience in regulatory medical writing and is a graduate of Oxford and Sheffield Universities in the UK.

  • Cyndi  Carr, PhD

    Cyndi Carr, PhD

    • Senior Manager, Medical Writing
    • Ventana Medical Systems, Inc. A Member of the Roche Group, United States

    Cyndi currently works as a senior manager in the clinical science function at Roche Tissue Diagnostics. She leads a team of medical writers responsible for preparing clinical trial protocols and clinical study reports. Her experience includes medical writing for in vitro diagnostic clinical trials supporting multiple 510k and PMA submissions to FDA. Cyndi holds a BS in Molecular and Cellular Biology and a PhD in Neuroscience with a minor in Pharmacology from the University of Arizona. She has completed the American Medical Writers Association basic and advanced curriculums and has over 15 years of clinical research experience.

  • Michelle  Clausen, PharmD, RPh

    Michelle Clausen, PharmD, RPh

    • Senior Director, Chief Medical Office- Strategy & Innovation Team
    • Pfizer, Inc., United States

    Michelle Clausen is Senior Director and lead of the Pfizer Medical Strategy and Innovation Team which supports the Chief Medical Office at Pfizer. Michelle has 17 years experience in industry working across various roles within Medical Communications and now leads a team with a mission of driving strategy through innovation and insights to accelerate and advance the value of division’s contribution towards a healthier world. The team focuses on data & analytics, strategic communications, and innovative projects in collaboration with the groups they support. Michelle has her Doctor of Pharmacy (Shenandoah School of Pharmacy) and BS in Pharmacy (Rutgers College of Pharmacy).

  • Deborah E. Collyar

    Deborah E. Collyar

    • President
    • Patient Advocates In Research (PAIR), United States

    Deborah Collyar is a leader in patient advocacy, utilizing successful business, leadership and IT skills to bridge gaps between science, research, medicine and patients. Her advocacy work encompasses diseases, programs and policies at grassroots, national and international levels. She regularly advises organizations, institutions, universities, cancer centers, non-profits, government agencies, companies, and most importantly, patients. Deborah and her husband have survived 3+ cancers.

  • Evelyn R. Hermes-DeSantis, PharmD

    Evelyn R. Hermes-DeSantis, PharmD

    • Clinical Professor, Ernest Mario School of Pharmacy
    • Rutgers, The State University of New Jersey, United States

    Evelyn Hermes-DeSantis, PharmD, BCPS, is a Clinical Professor at the Ernest Mario School of Pharmacy, Rutgers, the State University of New Jersey and is the Director of Drug Information Services at Robert Wood Johnson University Hospital. She received her undergraduate and graduate degrees from Rutgers. After completing a Specialized Residency in Drug Information at the Medical College of Virginia Hospital, she practiced at the University of Utah Hospital before returning to Rutgers. Over the years she has trained over 25 Specialized Residents in Drug Information and has precepted numerous Residents and Industry Fellows.

  • Arlene  Kray, PharmD, PhD

    Arlene Kray, PharmD, PhD

    • Associate Director, Medical Writing
    • PRA Health Sciences, United States

    Arlene Kray, PharmD, PhD has over 10 years of industry experience with increasing levels of responsibility. She received her PhD in Pharmacology from Vanderbilt University. She completed Post-doctoral Training at Carnegie Mellon University and then pursued a PharmD at Duquesne University while working as a clinical scientist and medical writer. She joined inVentiv Health Clinical in 2010 and in 2012 began managing a global team of medical writers supporting Oncology and Emerging Markets. She recently joined PRA Health Sciences where she is overseeing embedded medical writing services for several clients as an Associate Director of Medical Writing. She also teaches Pharmacology to Nursing Students at the local community college.

  • Kathleen  Meyer Ritz

    Kathleen Meyer Ritz

    • Director, Medical Capabilities, Medical Information Contact Centers
    • Bristol-Myers Squibb, United States

    Kathleen Meyer Ritz is the contact for BMS’s Americas (US, Canada, LatAm) and AsiaPacific regions. Previously she served as the Director, Lead for Medical Contact Europe and AsiaPacific regions and prior the Global Medical Customer Centers Operations and Governance Lead, supporting the Medical Information Group within R&D. Previously, Kathleen worked for ICT GROUP for over 25 years, culminating as the Executive VP for Contact Center Operations and Account Management in the HealthCare and Government verticals. Kathleen graduated from St. Joseph’s University with a BS in Marketing. She is a member of DIA and an industry speaker on Contact Center, Operations and QA. She is the recipient of BMS awards for Leadership, PM and Best Practices.

  • Kelly  Pincus, PharmD

    Kelly Pincus, PharmD

    • Dir., Medical Information Cardiovascular, Metabolic, Immunology, Critical Care
    • GlaxoSmithKline, United States

    Kelly T. Pincus, Pharm.D. Therapeutic Area Director, US Medical Information, Specialty, HIV and Classic and Established Medicines GlaxoSmithKline Kelly is the Therapeutic Area MI Director with GSK, supporting Specialty, HIV, and Classic and Established Medicines. She has over 20 years’ experience in the pharmaceutical industry, and has held several positions within GSK. Kelly received her Pharm.D. from Mercer University College of Pharmacy in Atlanta GA. She has also earned a Masters from the College of Business at Western Carolina University. Prior to joining industry, Kelly was an assistant professor in Pharmacy Practice at Creighton University in Omaha, NE.

  • Kirk V Shepard, MD

    Kirk V Shepard, MD

    • Senior Vice President, Head of Global Medical Affairs Oncology
    • Eisai, Inc., United States

    Dr. Kirk Shepard has 25+ years of experience in the pharmaceutical industry. He is a board-certified medical oncologist and hematologist physician. He is currently Senior Vice President, Head of Global Medical Affairs Oncology at Eisai Inc. Dr. Shepard’s experience in multiple therapeutic areas includes operational and strategic product development from Phases I through IV and the diverse disciplines of medical affairs and product commercialization, such as leading compliance and SOP/policy efforts, health economics & outcomes research & patient access, data generation, field-based medical teams (MSLs), PV/safety, medical communication & publications, patient advocacy, and public relations.

  • Darren  Taichman, MD, PhD

    Darren Taichman, MD, PhD

    • Executive Deputy Editor
    • Annals of Internal Medicine, United States

    Dr. Taichman is the Executive Editor of the Annals of Internal Medicine and Vice President of the American College of Physicians. He is an Adjunct Professor of Medicine at the University of Pennsylvania where he practices Pulmonary and Critical Care Medicine. Dr. Taichman also serves as Secretary of the International Committee of Medical Journal Editors. He earned his MD and PhD from the University of Pennsylvania, completed Internal Medicine residency training at the Beth Israel Hospital, Harvard Medical School, Pulmonary and Critical Care Fellowships at the Hospital of the University of Pennsylvania and research / post-doctoral fellowships at the Brigham and Women's Hospital, Boston and the Children's Hospital of Philadelphia.

  • Mark  Barnes, JD

    Mark Barnes, JD

    • Partner
    • Ropes & Gray, LLP, United States

    Mark's law practice at Ropes & Gray focuses on human and animal research, stem cell and genetic research, research grants and contracts, research fraud, and international research. Mark formerly served at Harvard as the Senior Associate Provost for Research, and in 2004 started and directed for several years Harvard's HIV/AIDS treatment programs in Nigeria, Tanzania and Botswana. He has served as chief administrative officer at St. Jude Children’s Research Hospital, and has held senior appointed positions in the New York City and State departments of health. Mark is co-chair of the Subcommittee on Harmonization of Research Regulations, HHS Secretary’s Advisory Committee on Human Subjects Protections.

  • Elizabeth  Blalock

    Elizabeth Blalock

    • Managing Editor, Journal of Investigative Dermatology
    • Society for Investigative Dermatology, United States

  • Amber  Daugherty, MBA

    Amber Daugherty, MBA

    • Sr. Training Manager, Global Learning and Performance – R&D
    • Amgen, Inc., United States

    Amber holds a Bachelor’s degree in Psychology and has a Master’s degree in Business Administration. Amber is a learning and development professional at Amgen. Over the past fourteen years she was served in multiple training roles supporting the Medical Affairs and broader R&D organizations. She specializes in professional development for both individual and leaders.

  • Michelle  Drozd

    Michelle Drozd

    • Deputy Vice President, Policy & Research
    • Pharmaceutical Research and Manufacturers of America (PhRMA), United States

    Michelle Drozd is a Deputy Vice President in the Policy and Research department at the Pharmaceutical Research and Manufacturers of America (PhRMA). Michelle focuses on addressing the barriers to value-based contracting, and policies related to the pharmaceutical supply chain. Prior to joining PhRMA, Michelle worked in quality improvement and business planning at Partners Healthcare, an integrated delivery system. She also worked at RTI International in implementing demonstration projects for the Centers for Medicare & Medicaid Services. Michelle holds a BA in economics and public policy from Duke University and a SM in health policy and management from Harvard School of Public Health.

  • Jenna  Elder

    Jenna Elder

    • Chief Scientific Officer
    • PharPoint Research, Inc., United States

    Dr. Elder is the Chief Scientific Officer at PharPoint Research, Inc., a CRO specializing in data management and biostatistics. Dr. Elder served as the lead statistician on pivotal studies for two novel compounds in a new class of antiretroviral medications in indications for the treatment of HIV and viral hepatitis. She participated in the completion of several NDA, MAA, sNDA, and IND applications and provided strategic consulting, clinical program development planning, and statistical analysis oversight for over 100 projects. Additionally, her experience includes providing statistical support for several pharmaceutical industry sponsored pregnancy registries and phase I through IV clinical trials.

  • Joyce P. Fairclough, PharmD

    Joyce P. Fairclough, PharmD

    • Senior Manager, Medical Information Services
    • Sanofi, United States

    Medical Information within the Pharmaceutical Industry for over 15 years. Currently working on the Sanofi US MI team, responsible for MI support and strategy for the Diabetes insulin product portfolio including standard response development and review, compendia review and submission, AMCP dossier development, insight generation and metric reports. Other teams/groups I am active with include: Sanofi Global Medical Information with a focus on global content and insights and analytics; Sanofi Patient Engagement Working Group; PhactMI Standards Subteam. Education: Graduate of the University of Connecticut School of Pharmacy Undegraduate Program, Idaho State University College of Pharmacy Doctor of Pharmacy Program.

  • Tim  Fish, MBA

    Tim Fish, MBA

    • Director, Global Medical Information
    • Sarepta Therapeutics, Inc., United States

    Dr. Fish is the Director of Global Medical Information at Sarepta; a Registered Nurse with 25 years of experience and a unique professional in healthcare systems leadership and worldwide process collaborations. He has launched new medical information department in Europe, North and South America, as well as consultation support in Asia/Pac. Dr. Fish has presented and published on medical affairs best practices and optimizing nurses in medical information on several occasions. Currently also volunteers as a board member and COO for HandReach, developing international programs to support pediatric burn survivors and performed a healthcare systems capabilities assessment in Ghana, Africa.

  • Taren  Grom

    Taren Grom

    • Founding Partner/Editor
    • PharmaVOICE, United States

    Taren Grom is co-founder of PharmaLinx LLC and editor of PharmaVOICE magazine. With more than 20 years of experience in covering the life-sciences, she has extensive knowledge of the issues and trends — from molecule to market — impacting the industry. Grom also is a dedicated volunteer for the Healthcare Businesswomen’s Association, having served on multiple committees for more than 12 years.

  • Ryan Thomas Hietpas

    Ryan Thomas Hietpas

    • Consultant, Global Scientific Communications
    • Eli Lilly and Company, United States

    Ryan Hietpas, PhD, formerly a bench scientist in biochemistry, is a medical writer focusing on device regulatory documents at Eli Lilly and Company.

  • Cynthia Louise Hooper, MA

    Cynthia Louise Hooper, MA

    • Advisor, Biometrics Business Management
    • Eli Lilly & Company, United States

    Cynthia Hooper is an Advisor for Biometrics Business Management at Eli Lilly and Company. She is responsible for business planning, resource management, and external sourcing for Global Statistics and Scientific Communications. She previously held management and writing roles in Scientific Communications, where she led submissions and launches; was a vendor relationship lead; and held research positions at the Institute of Mental Health Research in Ottawa, Canada. She holds psychology degrees from Bishop's University and the University of Guelph, a certificate in alliance management, is a Six Sigma Black Belt, and completed the Harvard Business School CORe: Credential of Readiness program.

  • Lisa  Iacono Sheehan

    Lisa Iacono Sheehan

    • Prinicipal Documentation Lead
    • Bristol-Myers Squibb, United States

    Lisa has been at Bristol-Myers Squibb for almost 14 years. Her first 10 + years was spent in Clinical Pharmacology where she ran clinical pharmacology studies and provided support for oncology and metabolic drug development. For the last 3 + years Lisa has been a Documentation Lead supporting Clinical Pharmacology aspects of worldwide oncology submissions.

  • Monica A. Kwarcinski, PharmD

    Monica A. Kwarcinski, PharmD

    • Head of External Medical Affairs
    • Purdue Pharma L.P., United States

    Monica Kwarcinski is the Head of External Medical Affairs at Purdue Pharma and is responsible for Medical Information, Medical Science Liaisons, Patient & Professional Relations, Clinical Communications, and External Medical Affairs Operations/Compliance. Monica previously led the Purdue Medical Services Department and held various positions with increasing responsibilities within Abbott Laboratories Medical Services Department. She received her PharmD from Creighton University in Omaha, NE followed by a Drug Information Residency at Glaxo and University of North Carolina, Chapel Hill. Monica has over 20 years of industry experience and frequently presents on topics related to Medical Communications compliance and department processes.

  • Gregory  Maglinte

    Gregory Maglinte

    • WWHERO Oncology Lead
    • Bristol-Myers Squibb, United States

    Experienced Health Economics and Outcomes Researcher (HEOR). Currently Director World-Wide HEOR and Immuno-Oncology Lead at Bristol-Myers Squibb, and previously at Allergan and Amgen. Has supported pipeline, launch, and in-line assets for end-stage renal disease, heart disease, migraine, schizophrenia, and prostate, colorectal, gastric, and esophageal cancers. Trained in epidemiology and health services research, with an MPH and PhD from UCLA. Dissertation focused on preference-based health related quality of life (HRQOL) measures, including the EQ-5D, SF-36, HUI, and QWB. Experience validating and developing patient-reported outcomes (PRO) measures, and conducting preference studies (i.e., discrete choice experiments).

  • Raleigh E. Malik, PhD

    Raleigh E. Malik, PhD

    • Senior Scientific Liaison
    • DIA, United States

    Dr. Raleigh Malik is a Sr. Scientist at DIA in Washington, DC, where she supports the advancement of DIA’s global content strategy by providing scientific expertise related to therapeutic drug development and regulatory disciplines. Prior to joining DIA, Dr. Malik supported medical and commercialization functions within pharma as both a medical writer and medical reviewer. Dr. Malik has a PhD in Molecular Biology and Biochemistry from Indiana University School of Medicine and a BS in Cell Biology and Biochemistry from Bucknell University.

  • Diane  Moniz Reed, PharmD

    Diane Moniz Reed, PharmD

    • Immuno-Oncology Early Assets, Biomarker Publications and Scientific Content
    • Bristol-Myers Squibb, United States

  • Lori  Mouser, PharmD

    Lori Mouser, PharmD

    • Global Head, Medical Science Liaisons
    • F. Hoffmann-La Roche Ltd., Switzerland

    Lori Mouser brings over 15 years of experience in leading Medical Science Liaison teams to her role as Global Head of MSLs for Roche Product Development-Medical Affairs. Lori thrives on collaborating across teams to find clever approaches to challenging situations.  She strives to genuinely understand what each individual brings to a project so that the outcome of the work can be effective and meaningful. After an academic career as an Associate Professor in Clinical Pharmacy at Washington State University, Lori joined Aventis (Sanofi) Pharmaceuticals as an MSL. She quickly gravitated to managing MSL teams and remained at Sanofi for 13 years. In 2012, she moved to Genentech as an MSL leader in BioOncology and joined the Roche family.

  • Hiren  Patel, PharmD, RPh

    Hiren Patel, PharmD, RPh

    • Director, Medical Information
    • Sunovion Pharmaceuticals Inc., United States

    Hiren Patel is Director of Medical Information at Sunovion Pharmaceuticals Inc. During the past 3 years, Hiren has primarily supported the Psychiatry franchise and is now responsible for overseeing the US Medical Information team. Prior to joining Sunovion, Hiren spent 7 years at Janssen Pharmaceuticals, which included completion of a 1-year Medical Information and Education Residency with Janssen Pharmaceuticals in conjunction with the University of the Sciences in Philadelphia. During this time, he supported the Pediatric, Psychiatry, and Metabolic franchises at Janssen Pharmaceuticals. Hiren obtained his PharmD degree from the University of the Sciences in Philadelphia.

  • Meera  Patel, PharmD

    Meera Patel, PharmD

    • Associate Director, Medical Information
    • Janssen Pharmaceuticals, Inc., United States

    Meera has 14+ years of experience in Medical Information in the pharmaceutical industry. She is an Associate Director in Medical Information at Janssen Pharmaceuticals where she has oversight of products in infectious diseases. Prior to joining Janssen, she was a Medical Information Manager at Schering Plough. Meera Patel received her Doctor of Pharmacy degree from the University of Sciences in Philadelphia and completed her fellowship at Schering Plough focusing on Medical Information, Regulatory, and Health Outcomes.

  • Theresa  Shalaby, MSN, RN

    Theresa Shalaby, MSN, RN

    • Senior Regulatory Writer
    • Synchrogenix; A Certara Company, United States

    Ms. Shalaby has 20+ years of experience in the clinical research and drug development industry. Throughout those 20 years, she held several writing roles including lead author and contributing writer for investigator’s brochures (IBs), phase 2 and phase 3 clinical study reports (CSRs), investigational new drug applications (INDs), new drug applications (NDAs), study protocols, informed consent forms (ICFs), lay summaries, periodic benefit-risk evaluation reports (PBRERs), and literature reviews. She has experience in the therapeutic areas of pediatrics, neonatology, pediatric and adult oncology, hematology, gastroenterology, pulmonary and respiratory disesases, genetic diseases, cardiology, multiple sclerosis, and vascular diseases.

  • John  Warwick, PharmD

    John Warwick, PharmD

    • Director , Medical Information
    • GRIFOLS Inc., United States

  • Isabelle C. Widmer, MD

    Isabelle C. Widmer, MD

    • Medical Affairs Consultant
    • elytra GmbH, Switzerland

    Isabelle is a life-science consultant, physician, and pharmaceutical industry professional. Her experience spans research, hospital, academia and Global and Regional Medical Affairs Leadership Roles at Roche. Trilingual, internationally trained and versed in science, healthcare and pharma Isabelle coaches teams to excellence across disciplines, cultures and geographies. She helps clients improve efficiency, compliance and service levels, as well as to design, run and implement Global Medical Information transformation programme. Pragmatically, sustainably cost-effectively. Isabelle is a past Program Director and current faculty member (Basel University) in Pharmaceutical Medicine, a DIA programme committee member and published author.

  • Tanya  Basu, JD, PharmD

    Tanya Basu, JD, PharmD

    • Director, Medical Communications
    • Shire, United States

    Tanya Basu, PharmD, JD Group Leader, Medical Shared Services - Neurosciences & Opthalmology Shire, Lexington, Massachusetts

  • Michael  Bourque, MS

    Michael Bourque, MS

    • Director of Global Submissions
    • Synchrogenix, a Certara Company, United States

    Michael Bourque has over 18 years of medical writing and clinical research experience across a wide range of therapeutic areas including infectious diseases, vaccines, pain, oncology, and pediatric medicine. He is currently Director of Global Submissions at Synchrogenix. In addition to serving as a lead author, he provides guidance to project teams on the strategic development of regulatory documents in order to best position their submission to achieve approval from regulatory authorities.

  • Ari  Gnanasakthy, MBA, MS, MSc

    Ari Gnanasakthy, MBA, MS, MSc

    • Head, Patient Reported Outcomes
    • Novartis Pharmaceuticals Corporation, United States

    Ari Gnanasakthy, MBA, MSc, is Head of Patient-Reported Outcomes at RTI HS. He has 30+years of experience in the pharmaceutical industry. After receiving his bachelor's degree in mathematics, statistics, and computing, Mr. Gnanasakthy joined Rothamsted Experimental Station (UK), where he was responsible for the statistical analysis of survey data of agricultural soil in England and Wales. Mr. Gnanasakthy's extensive experience in the field of statistics and outcome research has resulted in numerous abstracts and almost 40 publications. Mr. Gnanasakthy has developed and validated over a dozen patient-reported outcomes instruments and currently serves in the editorial board of Cancer Clinical Trials.

  • Amy  Holbrook

    Amy Holbrook

    • Director of Medical Writing
    • Keryx Biopharmaceuticals, United States

    Amy has worked in drug development for over 20 years, working as a study site coordinator at the Massachusetts Eye and Ear Infirmary, a study manager and site monitor for multiple industry sponsors, and a clinical scientist, before finding her true home in medical writing. She is currently the Director of Medical Writing at Keryx Biopharmaceuticals in Boston, developing the medical writing functional area as the company expands.

  • Michael S. Labson, JD

    Michael S. Labson, JD

    • Partner
    • Covington & Burling LLP, United States

    Mike is a partner in the Food, Drug and Device practice at Covington & Burling LLP. He provides strategic advice to pharmaceutical and biotechnology clients in dealing with FDA and other agencies. He has litigated life sciences cases, and works actively on transactional and legislative matters. Mike graduated magna cum laude from Harvard College, and magna cum laude from Harvard Law School, where he was an officer of the Harvard Law Review. He clerked for the Honorable David M. Ebel on the U.S. Court of Appeals for the Tenth Circuit. He is a Fellow of the American Bar Association, and a member of Covington’s Management Committee.

  • Randy  Miller, PharmD

    Randy Miller, PharmD

    • National Director, Medical Science Liaisons
    • Alnylam Pharmaceuticals, United States

    Randy Miller, PharmD, is Director of Medical Science Liaisons at Alnylam Pharmaceuticals. His pharmacy career began in community practice and included 3 years in academia. Randy spent 15 years at Boehringer Ingelheim where he focused on MSL excellence and capability development along with medical affairs business process definition, compliance, governance and training.

  • Carri  Taylor, MBA

    Carri Taylor, MBA

    • Associate Director, Medical Writing
    • Syneos Health, United States

    Carri Taylor is an Associate Director of Medical Writing at INC Research/inVentiv Health and manages a group comprised of managers, writers, and editors who support regulatory and publication documents, CM&C, lay summaries, and publishing. She received a B.A. degree in English Literature from Purdue University and an M.B.A. in Business from Ball State University. As a leader in the medical writing and project management fields for 20 years, she has championed projects across multiple therapeutic areas and phases.

  • Kelly  Vaillant

    Kelly Vaillant

    • Global Head, Clinical Trial Disclosures & Data Transparency
    • Gilead Sciences, Inc., United States

  • Jonathan Todd Weiner, PharmD, MBA

    Jonathan Todd Weiner, PharmD, MBA

    • Director of Innovation in Scientific Exchange
    • Sanofi, United States

  • Rania  Gaspo, PhD

    Rania Gaspo, PhD

    • Director, Global Therapy Area Lead, External Medical Communications
    • Pfizer Canada Inc, Canada

    Rania Gaspo earned her Pharmacy Degree and her PhD at University of Montreal, Faculty of Pharmacy. She served as a Post-Doctoral fellow at Montreal Heart Institute before moving into industry in 1998 as a Senior Scientist within Merck Research Laboratories. Rania joined Pfizer in 2003 where she held positions in medical information, medical affairs and clinical development in various therapeutic areas. She also served as a guest speaker for 24 years at University of Montreal and gave lectures to students. In her current role Rania leads a team of Medical Information Managers within Neuroscience and Pain category leadership in US and Canada. Rania authored/co-authored peer-reviewed publications and scientific communications.

  • Rebecca J. Williams, PharmD, MPH

    Rebecca J. Williams, PharmD, MPH

    • Assistant Director, ClinicalTrials.gov, NCBI
    • National Library of Medicine, NIH, United States

    Rebecca Williams, PharmD, MPH, is Assistant Director, ClinicalTrials.gov at the National Library of Medicine, National Institutes of Health. In this role, she oversees the results submission process, outreach and education, policy development, and conducts research. Her prior experience was in the area of prescription drug advertising and promotion at FDA and then as a consultant. She received her Pharm.D. from the University of Wisconsin-Madison and MPH from Johns Hopkins University.

  • Holly  Zoog, PhD

    Holly Zoog, PhD

    • Exec Dir, Medical Writing
    • Ultragenyx, United States

    Holly Zoog, PhD, ELS, is Executive Director and Head of Medical Writing at Ultragenyx Pharmaceutical Inc. where she grew the department from an N of 1 to a team supporting clinical and regulatory writing, scientific publications, clinical trial transparency, and digital content. Prior to Ultragenyx, Holly was Director, Medical Writing at Amgen leading a team supporting publications in the Bone Therapeutic Area. Holly received a PhD in Nutritional Biochemistry from the University of Wisconsin and a BS in Biochemistry from Penn State University.

  • Matthew  Robillard

    Matthew Robillard

    • Senior Director, Regulatory Strategic Writing
    • AbbVie, United States

    Matthew Robillard is a Senior Director of Regulatory Strategic Writing for AbbVie, based in North Chicago, IL. Matt began his career with Abbott Laboratories in 1992 in Technical Communications, and in 1996 became a Medical Writer in the Hospital Products Division. His career has progressed (as have many in Medical Writing) through an individually owned business, through CROs and back within industry; most recently with Takeda Pharmaceuticals (2006 to 2016) and PRA Health Sciences (2017). He currently leads a team of Medical Writers dedicated to handling regulatory interactions and communications at AbbVie. He is happily married and resides in a northwest suburb of Chicago.