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Medical Affairs and Scientific Communications Forum


Speakers

  • Dannis  Chang, PharmD

    Dannis Chang, PharmD

    • Executive Director, Head of Medical Capabilities
    • Mirati Therapeutics , United States

    Dannis Chang is currently the Executive Director and Head of Medical Affairs Capabilities at Mirati Therapeutics, where he is responsible for leading strategic efforts for implementation of Medical Information and Communication services, overall medical operations infrastructure, policies, technical information and procedures, as well as delivering the development and execution of medical education and sponsorship efforts, congress management and internal training efforts across the organization. He received a doctorate of pharmacy degree from University of Southern California and a post-doctoral fellowship from Rutgers University.

  • Robert  Tamburri, PharmD, MBA

    Robert Tamburri, PharmD, MBA

    • Director, Medical Information ad Knowledge Integration
    • Janssen Scientific Affairs, LLC, United States

    Robert is Director of the Medical Information Communication Channels team at Janssen. In his current role, Rob is responsible for providing leadership in developing, shaping and implementing Medical Information Communication strategies as well as oversight of operations and related omnichannel modes of communications for the Medical Information Contact Center (internal and external) at Janssen. In addition to his 13 years of pharmaceutical industry experience, Rob also has 11 years of experience as a practicing pharmacist in various pharmacy practice settings. Rob earned his Bachelor of Science in Pharmacy from Temple University School of Pharmacy, his Doctor of Pharmacy degree from Shenandoah University, and his MBA from Drexel University.

  • Andrea Tuttle Meyers

    Andrea Tuttle Meyers

    • Senior Vice President, Medical Writing
    • Syneos Health, United States

    Ms. Meyers is the Senior Vice President of Medical Writing at Syneos Health. She has led global medical writing teams for more than two decades in both CRO and sponsor organizations. Ms. Meyers has authored documents across all phases of clinical development for pharmaceutical products as well medical devices, including regulatory dossiers and submissions. In addition, she has also led regulatory and clinical development, leading two oncology products to NDA submission and subsequent approval. Prior to her career in clinical research, Ms. Meyers practiced neuropsychology. In 2020, Ms. Meyers was honored to be named a Healthcare Businesswomen's Association Luminary in recognition of her 25+ years of service in Clinical Research.

  • Sonja  Hokett, PharmD, MS

    Sonja Hokett, PharmD, MS

    • Executive Director/Head of Medical Managed Care
    • BioXcel Therapeutics, United States

    Sonja Hokett, PharmD MS, currently works at BioXcel Therapeutics as Head of National Medical Managed Care (MMC) Team within the Chief Development Officer organization. During her 16 years in pharma industry, Sonja has held both Field and Headquarter Medical Affairs positions (Jazz, Intercept, and Genentech). Most recently she hired and directed multiple field teams (Medical Managed Care Field Directors & Health System Medical Directors). In her headquarters positions she developed Medical Affairs Training, Operations & Specialty Pharmacy Teams.

  • Darshan  Kulkarni, JD, PharmD, MS

    Darshan Kulkarni, JD, PharmD, MS

    • Principal Attorney
    • The Kulkarni Law Firm, United States

    Dr. Kulkarni is Principal Attorney for the Kulkarni Law Firm which focuses on providing legal and regulatory solutions to pharmaceutical companies and their providers. He is a pharmacist & lawyer and advises clients on bringing their product to market, focusing on post IND thru commercialization and genericization.

  • Marie-Ange  Noue, PhD

    Marie-Ange Noue, PhD

    • Senior Director, Head of Scientific Communications
    • EMD Serono, Canada

    Marie-Ange Noue is a PhD chemist trained at Curie University in Paris and at the University of Houston. She started her career working as a research scientist in petrochemicals. She later found her niche upon joining EMD Serono in 2008, where she’s held a number of positions of increasing responsibility. In her current role as Senior Director, Head of US Scientific Communications, she provides strategic leadership and oversight for activities related to Medical Information, Medical Communication, Medical Training, and Medical Education for the US. Marie-Ange chairs the Board of Directors of the Canadian Medical information network, and serves as Vice President on the Executive Board of PhactMI.

  • Sonia  Sandhu, PharmD

    Sonia Sandhu, PharmD

    • Senior Director, Medical Information
    • Gilead Sciences, Inc., United States

    Sonia is a Senior Director of Global Medical Information at Gilead Sciences, where she oversees the Virology and Established Products portfolios. She is a leader in medical insights, heading up her department's first patient insights initiative, and presenting the findings at DIA and other patient engagement forums. Throughout her career, Sonia has acquired extensive knowledge in various therapeutic areas and has published articles on medical information. Sonia has been a member of DIA since 2019 and has actively participated in the organization, serving on the DIA planning committee for the past two years.

  • Elizabeth  Brown, MS, PMP

    Elizabeth Brown, MS, PMP

    • Director - Oncology Medical Writing
    • Merck Sharp & Dohme LLC , United States

    Elizabeth Brown is a Managing Medical Writer at Merck & Co near Philadelphia, PA. She has led regulatory projects and initiatives in the pharmaceutical industry for 20 years, first as a laboratory scientist, then a clinical researcher, and currently as a medical writer. Elizabeth brings a project management focus to her role as a regulatory medical writer with her PMP certification. With this focus, she has developed a passion for advising teams, providing strategic guidance how to deliver efficient, effective, and high-quality documents. She is a presenter and workshop leader for Lean Authoring through both AMWA and DIA, setting the industry standard for document simplification.

  • Diane  Cleverley, PhD

    Diane Cleverley, PhD

    • Senior Regulatory Writer
    • Synchrogenix, a Certara Company, United States

    Dr. Cleverley has more than 20 years experience in the medical publication field, which she entered shortly after earning her PhD in Microbiology and Molecular Genetics as a joint degree from Rutgers and UMDNJ. During that time, she proposed the “glycine hinge” theory. She has contributed editorial support for publications for prestigious higher tier journals such as NEJM and JCO. Dr. Cleverley has also written award-winning patient literature, clinical trial materials, and healthcare provider education. She currently is lending her writing talents to the regulatory field. She developed a patient advocacy tool for making diagnosis more effective. Dr. Cleverley has been an active team member of AMWA, ISMPP, and MAPS, and holds a CMPP.

  • Lisa  DeTora, PhD, MS

    Lisa DeTora, PhD, MS

    • Associate Professor, Director of STEM Writing
    • Hofstra University, United States

    Lisa is an assistant professor of Writing Studies at Hofstra University, where she teaches in multiple departments, including biology and chemistry. Her research interests include vaccination policy, medical humanities, publication ethics, regulatory writing, and theories of the body. As a member of the ISMPP ethics and standards committee, Lisa runs its publications subteam. Lisa has presented on topics such as authorship, ethics, ghostwriting, and data sharing at TIPPA. Her publications have appeared in various medical journals and books. A recent paper, which appeared in The International Journal of Clinical Practice, discusses the negative impact of ghostwriting on practicing physicians.

  • Elizabeth  Froom, PharmD

    Elizabeth Froom, PharmD

    • Senior Director, Medical Writing and Healthcare Communications
    • Evidera, United States

  • Paul  Minne, PharmD, RPh

    Paul Minne, PharmD, RPh

    • Director, MSL Team
    • Neurocrine Biosciences, United States

    Paul Minne has over 20 years of experience in medical affairs within the biopharmaceutical industry. During his career, he has had substantial experience with all phases of drug development and support, multiple new product launches, and management of MSL Teams. He has earned a BS from Drake University and a Doctor of Pharmacy from the University of Colorado Health Sciences Center, is a licensed pharmacist and preceptor with the State of Colorado, and is an adjunct professor at the University of Colorado Skaggs School of Pharmacy. Paul resides in Parker, Colorado.

  • Kay  Uttech, PharmD, MA, RPh

    Kay Uttech, PharmD, MA, RPh

    • VP, Strategic Initiatives
    • Indegene, United States

    Kay Uttech is VP for Strategic Initiatives at Indegene working with companies to build and optimize medical affairs services. She has more than 20 years’ experience in the pharmaceutical and medical device industry. Kay has held roles in Medical Affairs as a MSL and leading MSL teams in North America. Additionally, she has also held other responsiiblities in Medical Communication and Information; development of global scientific knowledge management systems; grants for ISS and medical education; and promotional review. Her current work is focused on leveraging technology to drive efficiency that optimizes the medical and scientiifc expertise of Medical Affairs teams.

  • J. Lynn  Bass, PharmD, RPh

    J. Lynn Bass, PharmD, RPh

    • Senior Director and Head, Medical Science Directors
    • Medexus Pharma, United States

    With 23+ years of experience in Medical Science Liaison and Medical Affairs roles across the pharmaceutical industry, Lynn is currently the Senior Director, Medical Sciences at Medexus Pharma. Her industry career has spanned many therapeutic areas and she has authored/ co-authored several MSL surveys. Lynn is the elected Chair of the Medical Science Liaison Community and serves on the DIA's North America Regional Advisory Council. She is a regular, invited panelist at MSL and Medical Affairs events. Lynn holds B.S. degrees in Biology and Medical Technology. She received her B.S. in Pharmacy from the Medical College of Virginia and her Doctor of Pharmacy degree from the University of South Carolina.

  • Stacey  Follman, PharmD, RPh

    Stacey Follman, PharmD, RPh

    • Director, Global Content Management
    • Pfizer, United States

    Dr. Stacey Follman has spent her 26-year pharmacy career at Pfizer including 15 years in the World-Wide Safety and Regulatory department in Safety Evaluation and Reporting and 11 years in Medical information. Formerly the Director, Student Affairs and currently Director, Global Content Management in Pfizer’s Global Medical Information Department . Dr. Follman has experience overseeing scholarly activities associated with approximately 10 APPE Pharmacy rotational students annually, the Student Summer Worker program and the recruitment and preceptorship of post-doctoral Fellows. In addition, she maintains internal/external partnerships, leading student/fellow initiatives with multiple scientific institutions.

  • Sarica  Klein, PharmD

    Sarica Klein, PharmD

    • Field Director, US Medical, Neuropsychiatry - West
    • Biogen, United States

  • Representative Invited

    Representative Invited

    • United States
  • Dipam  Doshi, PharmD

    Dipam Doshi, PharmD

    • Principal Medical Science Liaison
    • SpringWorks Therapeutics, United States

    Dipam Doshi graduated with his PharmD from University of the Pacific in 2010. After graduating he completed a one year fellowship at Daiichi Sankyo within the Rutgers Pharmaceutical Industry Fellowship program. From 2011-2015, Dipam Doshi has been a Medical Science Liaison with Daiichi Sankyo. From May 2015, Dipam has been a Sr. MSL at ZS Pharma covering Southern California. As one of the first MSLs at ZS Pharma, he helped build develop the MSL team.

  • Representative Invited

    Representative Invited

    • Purdue Pharma L.P., United States
  • Ellen  Whipple, PharmD

    Ellen Whipple, PharmD

    • Owner/Principal Writer
    • EW Associates, LLC, United States

    Ellen is the co-owner of Scientific Content Solutions, LLC and the sole proprietor of EW Associates, LLC. She was previously a director of medical communications with an agency. Ellen has experience with medical information-related documents (e.g., standard letters, FAQs, dossiers, escalated inquiries), continuing education articles, primary author publications, promotional review, payer materials, and advisory board meeting reports. As a member of AMCP Format Executive Committee, Ellen contributed to AMCP Format 4.1. She serves as a Clinical Assistant Professor at the University of Georgia College of Pharmacy. Since 2000, Ellen has been a Medical Advisor for the MS Foundation.

  • Komal  Bawa, PharmD

    Komal Bawa, PharmD

    • Evidence Synthesis Scientist, US Medical Affairs
    • Genentech, United States

    Dr. Komal Bawa has taken on various roles in Medical Affairs at Genentech since joining in 2014. She currently focuses on evidence synthesis in the health economics and outcomes research organization, leading the dossier strategy for the portfolio. Similar to many other pharmacists, Komal started in medical communications before venturing out into other roles to broaden her experience. Prior to joining industry, she worked as an emergency medicine clinical pharmacist at UCSF and Brigham and Women's Hospital. Komal lives in San Francisco where she has been "getting to know" her family a little too well these days, but enjoys cooking with the kids, long walks with her mom, and can't wait to travel again.

  • David  Meats

    David Meats

    • Associate Director, Global Submissions. Regulatory Services Manager
    • Certara Synchrogenix, United States

    David Meats is an Associate Director of global submissions and regulatory services management at Certara Synchrogenix. He has been a medical writer for approximately 20 years working in oncology, immuno-oncology, endocrinology, musculoskeletal, cardiac, hepatic, renal, and infectious disease therapeutic areas on nearly every available clinical document type. He specializes in leading and writing FDA and EMA regulatory submissions and aggregate safety reports. David is the co-chair of the DIA MASC 2022 conference, and has been a member of DIA for 7 years.

  • Matt  Becker

    Matt Becker

    • Advisory Life Science Strategic Advisor
    • SAS, United States

    Matt Becker is an Advisory Industry Consultant with the SAS Global Hosting and U.S. Professional Services division. Matt’s more than 30 years of life science experience includes over 9 years with SAS concentrating on next generation clinical trials, data management, analysis, advanced analytics and deployment options in Life Science. As a leader for developing technology solutions to life science initiatives, Becker addresses the challenges that life science companies are having around the analytics lifecycle. The challenges result from new infrastructures that provide more data points than ever before, content management, compliance, collaboration and analytics.

  • Christy  Cheung, PharmD, RPh

    Christy Cheung, PharmD, RPh

    • Medical Science Liaison
    • Sanofi Genzyme, Canada

    Christy is a Medical Science Liaison, Neurology at Sanofi and co-founder of the AI Collective. She graduated from the University of British Columbia in Canada in 2019 and subsequently completed a Medical Affairs Fellowship. As a digital health enthusiast, she has attended a number of healthcare hackathons, which fuelled her initial curiosity for digital health and led to the beginning of her now passion projects. Aside from her work as an MSL at Sanofi, she also acts as a digital project lead and plays an active role in a volunteer digital innovation group within the organization. Christy has been invited to speak at conferences such as DHX Virtual and as a guest lecturer on the topics of digital health and artificial intelligence.

  • Kent  Christopherson, PhD

    Kent Christopherson, PhD

    • Senior National Director, US Medical Affairs
    • Orchard Therapeutics, United States

    Kent is an accomplished medical affairs leader with >15 years of relevant clinical and scientific experience and four successful product launches within rare and ultra-rare diseases. He brings substantial real-world experience from time spent in academic medical centers and biotech to bear on the current ever-evolving therapeutic landscape of cell and gene therapy. He specializes in the creation and development of highly effective medical affairs teams focused on value proposition for engagement of multiple external stakeholder types. His principal topics of expertise extend to the cross-functional role of medical affairs in clinical insights, clinical development, market access, and patient advocacy in order to drive strategy.

  • Michael  DeLuca, PharmD, MBA, MS, RPh

    Michael DeLuca, PharmD, MBA, MS, RPh

    • Senior Vice President of Medical Affairs
    • Eversana, United States

    Michael has 20 years of healthcare and pharmaceutical industry experience in multiple leadership roles at several pharmaceutical companies. He has extensive experience in medical information, medical communications and in supporting medical review of promotional / non-promotional materials. Throughout his career, Michael has supported multiple product launches across various therapeutic areas, including rare diseases, and he has led MI activities from both a US and global perspective. Michael has led and grown established MI teams and has built a MI department and services from the ground up. Michael's educational background includes Doctor of Pharmacy, Master of Business Administration, and Master of Science in Regulatory Affairs degrees.

  • Purvi  Dunn, MEd, MPA, PMP

    Purvi Dunn, MEd, MPA, PMP

    • Director, Leadership Excellence
    • EMD Serono, United States

    As the Director of Leadership Excellence, Purvi builds a foundation of leadership excellence within North America Medical Affairs at EMD Serono, a critical investment in enhancing current and future leaders’ skills, abilities and confidence. Purvi brings 20+ years’ experience, with the last 7 years as a Senior Executive Consultant at the FDA, helping the agency develop their leadership development strategy and approach. As an ICF-certified coach, Purvi has worked with leaders at all levels, helping them gain important insights and empowering them to operationalize who they want to be as leaders. Purvi holds a BS in Health Science from the Univ. of Texas HSC, a MEd in Public Health Ed from Univ. of Houston, and a MPA from George Mason Univ.

  • Sheryl  Flores, PhD, MBA

    Sheryl Flores, PhD, MBA

    • Managing Medical Writer
    • Merck & Co., Inc., United States

    Sheryl Flores is a Director and TA Lead of Vaccines Medical Writing at Merck near Philadelphia, PA. She has 18+ years of pharmaceutical industry experience, ranging from designing late stage clinical programs to leading global regulatory submissions. Sheryl focuses on building high performing teams by cultivating cross-functional relationships and providing opportunities to develop medical writer talent in support of clinical programs and worldwide regulatory dossiers. With this focus, she leads teams through strategic discussions while leveraging her passion for growth and development, to maximize each team members’ ability to prepare clear, effective, and high-quality clinical and regulatory documentation.

  • Julia  Forjanic-Klapproth, PhD

    Julia Forjanic-Klapproth, PhD

    • Senior Partner/President
    • Trilogy Writing & Consulting, Germany

    After receiving her PhD in Developmental Neurobiology, Julia became a medical writer in 1997. In 2002, she co-founded Trilogy Writing & Consulting, a company specialized in medical writing of regulatory documentation. She is now Senior Partner and CEO, and continues to bring her enthusiasm and experience to client projects, writing a wide array of clinical documents. She has twice been President of the European Medical Writers Association (EMWA), is an experienced trainer of medical writers, and runs workshops for EMWA, AMWA, DIA, and pharma companies around the world.

  • Shoshana   Lipson

    Shoshana Lipson

    • President & Executive Director
    • Hope in Pain INC, United States

  • Dima  Qato, PharmD, PhD, MPH

    Dima Qato, PharmD, PhD, MPH

    • Director, Program on Medicines and Public Health
    • USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States

  • Evelyn R. Hermes-DeSantis, PharmD

    Evelyn R. Hermes-DeSantis, PharmD

    • Director, Research and Publications
    • phactMI, United States

    Evelyn Hermes-DeSantis, PharmD, BCPS, the Director of Research and Publications for phactMI and Professor Emerita at the Ernest Mario School of Pharmacy at Rutgers, the State University of New Jersey. She received her undergraduate and graduate degrees from Rutgers University and completed Specialized Residency in Drug Information Practice at the Medical College of Virginia Hospital in Richmond, Virginia. Prior to joining phactMI in 2020, a non-profit collaboration of medical information leaders, Evelyn was a Clinical Professor at the Ernest Mario School of Pharmacy at Rutgers, the State University of New Jersey and Director of Drug Information Services at Robert Wood Johnson University Hospital for 25 years.

  • Randy  Levitt, PhD

    Randy Levitt, PhD

    • Director, Pharmacovigilance and Medical Affairs
    • Paladin Labs Inc., Canada

    Randy Levitt is the Director of Pharmacovigilance and Medical Affairs at Paladin. He is also the local compliance champion and works closely with the legal and compliance teams at Endo, the parent company of Paladin. He joined Paladin in 2011 as Manager, Scientific Communications and Publications after Paladin’s acquisition of Labopharm, where he had worked in the medical department since 2008. Randy completed his undergraduate and graduate degrees at McGill University, graduating with his PhD in Experimental Medicine in 2006.

  • Blake  Schouest, PhD

    Blake Schouest, PhD

    • Scientific Medical Writer
    • Aroga Biosciences, United States

    Blake is a Scientific Medical Writer at Aroga Biosciences, Inc. with experience authoring INDs, nonclinical study reports, IBs, DSURs, and FDA information requests. Blake also serves as Secretary of the San Diego Regulatory Affairs Network (SDRAN) and has completed the Regulatory Affairs Essentials Program at UC San Diego Extension. Prior to joining Aroga, Blake worked as a research scientist at Inovio Pharmaceuticals, Inc., serving as lead scientist on multiple nonclinical research programs. Blake conducted his postdoctoral training at La Jolla Institute for Immunology and holds a PhD in Biomedical Sciences from Tulane University School of Medicine.

  • Lisa  Ambrosini Vadola, PhD, MA

    Lisa Ambrosini Vadola, PhD, MA

    • Senior Writer and Associate Manager
    • Whitsell Innovations, Inc., United States

    Lisa Ambrosini Vadola has been a Medical Writer and Consultant at Whitsell Innovations, Inc. since 2013. In this role, she supports clients in the pharmaceutical and biotechnology industries with the preparation of clinical regulatory documents. She has experience in multiple therapeutic areas, including oncology, infectious diseases, dermatology, and inflammatory diseases. Before joining Whitsell Innovations, Inc., Lisa earned a PhD in Chemistry from Columbia University and completed a postdoctoral fellowship in the Laboratory of Chemical Biology and Microbial Pathogenesis at the Rockefeller University.

  • Ezinneka  Imoh

    Ezinneka Imoh

    • Senior Manager, Scientific Communications, Global Medical & Scientific Affairs
    • Karyopharm Therapeutics, United States

  • Elizabeth  Miller, PharmD

    Elizabeth Miller, PharmD

    • Senior Director Medical Information
    • SciMax Global, United States