Faculty – 2nd Medical Affairs Seminar

Pravin Chaturvedi, Ph.D.
Chairperson, Scientific Advisory Board, NAPO PHARMACEUTICALS

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Dr. Pravin Chaturvedi serves as the Chair of the Scientific Advisory Boards (SAB) for San Francisco – headquartered Napo Pharmaceuticals, where he previously served as the President and Chief Scientific Officer. He is also the co-founder and Chief Executive Officer of Oceanyx Pharmaceuticals, an emerging, privately-held, Florida-based biotech entity. He is a drug development veteran and a serial entrepreneur and has founded or co-founded multiple biotech enterprises. Most recently, he served as the President & Chief Executive Officer of Pivot Pharmaceuticals, Inc., which acquired IndUS Pharmaceuticals, a company founded by Dr. Chaturvedi. Prior to his tenures at Oceanyx, Pivot, IndUS, and Napo, he was the President and Chief Executive Officer of Boston-based Scion Pharmaceuticals, which was acquired by Wyeth (now Pfizer). Dr. Chaturvedi currently serves on the boards of Oceanyx, IndUS, Sindu Research Laboratories, Cellyanx and FuelEd Schools. He has previously served on the boards of Pivot, Scion, and Sindu Pharmaceuticals as well as Bach Pharma, PRADAN USA, and TiE Boston. He is an adjunct faculty member at Georgetown Medical School and also serves on the advisory boards of several entities including Springboard Enterprises, a non-profit organization promoting women’s entrepreneurship.

Over his career, he has participated in the successful development and commercialization of several new drugs for the treatment of CNS, viral and gastrointestinal disorders. Dr. Chaturvedi has participated in drug development initiatives focused on novel drugs targeting CNS disorders such as epilepsy and neuropathic pain, as well as developed novel anticancer, antiviral and gastrointestinal drugs. Prior to his leadership roles at Pivot, IndUS, Napo, and Scio, he also spent several years at Vertex Pharmaceuticals as the Head of Lead Evaluation and was in the preclinical group at Alkermes. He started his career in the Product Development group at Parke-Davis/Warner-Lambert Company (now Pfizer). Dr. Chaturvedi holds a Ph.D. in Pharmaceutical Sciences from West Virginia University and has an undergraduate degree in Pharmacy from the University of Bombay.

Kerry Costello, MBA
Marketing Strategy Consultant, KC CONSULTING LLC

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Kerry Costello is an independent consultant with extensive commercial experience and expertise across the spectrum of drug development from target selection through to product launch. Kerry founded Kerry Costello Consulting, LLC in 2016 with the goal of helping pharmaceutical and biotech organizations build the foundation for commercial success for new market opportunities. Her practice focuses on helping her clients evaluate market opportunities for both early stage and clinical stage products.

Prior to starting her own consulting practice Kerry spent over twenty years in the pharmaceutical industry, most recently as Director of Global Marketing at Vertex Pharmaceuticals. At Vertex, Kerry gained a deep understanding of the rare disease space and of patient-centric issues as the global brand lead for KALYDECO and ORKAMBI, two novel, break through therapies for the treatment of Cystic Fibrosis (CF). Across the span of her industry career, Kerry held a variety of positions of increasing responsibility in program management, market research, new product planning and strategy, and global brand development, with experience across a range of therapeutic areas.

Kerry has a Master’s Degree in Business Administration (MBA) from Boston College and a Bachelor’s Degree in Clinical Laboratory Science from the University of Massachusetts. She is a member of the Healthcare Businesswomen’s Association (HBA). Kerry also provides volunteer support/guidance for the University of Massachusetts DifferenceMaker Program, a campus-wide program that engages UMass Lowell students in creative problem solving, innovation and entrepreneurship. Finally, Kerry is a Girl Scouts Troop leader.

Mark De Rosch, Ph.D.
SVP Regulatory Affairs, Quality Assurance, and CMC, AKEBIA THERAPEUTICS

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Mark De Rosch, Ph.D., FRAPS, joined Akebia as Vice President of Regulatory Affairs in August 2014. Dr. De Rosch brings to Akebia over two decades of experience guiding global regulatory strategies for clinical, nonclinical and chemistry, manufacturing and controls (CMC) in multiple therapeutic areas including renal, hemophilia, autoimmune, pulmonary and oncology/hematology, among others. Most recently, Dr. De Rosch served as Vice President, Regulatory Drugs/Biologics & Head, U.S. Operations for Voisin Consulting Life Sciences, where he served as the organization’s lead U.S. Food & Drug Administration (FDA) regulatory expert. Previously, Dr. De Rosch served as Vice President, Head of Global Regulatory Affairs for Inspiration Biopharmaceuticals, Inc., leading the development and implementation of global regulatory strategies for the hemophilia-focused company. He also served in multiple key roles at Vertex Pharmaceuticals, Inc., including Senior Director, Global Clinical Regulatory Strategy, where he led the regulatory strategy and submissions process for Kalydeco® in cystic fibrosis leading to approvals in the U.S. and E.U.

Elizabeth Dorn, Ph.D.
Director Medical Affairs, VERTEX PHARMACEUTICALS

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Elizabeth Dorn is Director for Medical Affairs at Vertex Pharmaceuticals Incorporated. She is responsible for medical strategy, collaborations with external advisors, and providing medical guidance to commercial marketing and managed markets teams as brand lead for an investigational medicine for the treatment of cystic fibrosis. Elizabeth has experience leading and supporting several brands through product launch and label expansions, including the recent groundbreaking FDA expansion of KALYDECO for people with cystic fibrosis that was based on in vitro rather than clinical data. Elizabeth has experience in rare disease, oncology, and infectious disease. Elizabeth earned her B.S. in genetics from the University of Wisconsin-Madison and holds a Ph.D. in biochemistry and biophysics from the University of North Carolina-Chapel Hill.

Shahin Gharakhanian, M.D., DPH

Former Vice President, Medical Affairs, VERTEX PHARMACEUTICALS

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Shahin Gharakhanian (SG) M.D., DTM&H, DPH, has expertise in Pharmaceutical Medicine, Leadership & Management, blending a record of achievements in the United States & Europe. His focus is Medical Affairs and Clinical Development. SG started working in the pharmaceutical industry in 1991 and progressed to become Vice-President of Vertex Pharmaceuticals Inc., Medical Affairs/Medicines Development Group in Cambridge MA, USA. Overall, in this industry, he has held positions ranging from the General Manager of a full-service CRO to Program Executive leading product development, regulatory approval, and launch. He has thus handled projects for 12 different companies, ten different brands and four drug launches, in different therapeutic areas and geographic regions [Asia, USA, EU]. As an MD, SG is specialized in Internal Medicine and Infectious Diseases. Completed his residency/fellowship in Paris Public Hospitals [AP-HP] academic medical centers, one of the world’s largest single-administered medical networks, where, subsequently he practiced medicine. SG holds degrees in Public Health, Tropical Medicine & International Health from University of Paris, France and has obtained United States ECFMG Certification. SG is CME trained at Harvard Medical School Programs in Boston, MA, 1992-2017. He is principal/founder of Shahin Gharakhanian MD Consulting LLC, a US/EU network of experts, focused on novel drugs & vaccines, both the developmental and scientific affairs aspects. Thus, since 2011, his group has collaborated globally with companies including Genzyme (USA), GSK/ViiV Healthcare (UK/USA), Novartis (Switzerland/USA), Orchard Therapeutics (UK), Transgene (France) as well as numerous Biotech Start-Ups. He is currently Interim Global Head of Clinical Development and Medical Affairs for Stallergenes Greer plc. Dr. Shahin Gharakhanian’s consultancy practice is based at the Cambridge Innovation Center (CIC), Cambridge, MA 02142, USA.

Barry Lubarsky, Ph.D.
Senior Medical Director, Medical Affairs, ALKERMES

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Barry Lubarsky is currently Senior Medical Director for Medical Affairs at Alkermes, Inc. where he is responsible for medical strategy and launch preparations for a novel drug combination under investigation for the treatment of major depressive disorder. Prior to Alkermes, Barry was at Ocular Therapeutix, Inc. where he led the build-out of the medical affairs group to support a pipeline and launch of innovative ophthalmic therapies. Before Ocular, Barry was at Vertex Pharmaceuticals Incorporated, where he led a medical director group that supported the launches of two personalized genetic medicines for the treatment of patients with cystic fibrosis. Barry also has medical affairs experience in the areas of hemophilia, inflammation, and dermatology. Barry holds a Ph.D. in Biochemistry from Stanford University.

Eric Olson

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Eric has more than 25 years of experience in the life sciences industry with a proven record of translating scientific discoveries into breakthrough medicines. Prior to Syros, he was Research Vice President for respiratory diseases at Vertex Pharmaceuticals, spearheading the company’s efforts in cystic fibrosis (CF). During his 12 years there, he was instrumental in bringing KALYDECO, the first CF treatment resulting from the discovery of the CF gene to patients, leading research, development and commercial teams. In addition to his work at Vertex, Eric has also held positions as the Director of Antibacterials and Molecular Sciences departments at Warner-Lambert/Pfizer, as well as a research scientist, focused on gene expression systems with The Upjohn Company. Eric earned his B.S. in microbiology from the University Minnesota and a Ph.D. in microbiology and immunology from the University of Michigan. He is published in more than 40 academic journals.

Kanchan Relwani, M.D.
Vice President, Medical Strategy, Medical Affairs, ALKERMES

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Kanchan Relwani, M.D., is currently Vice President Medical Strategy, Medical Affairs for Alkermes Inc. In this role, Kanchan is responsible for the Medical Affairs product strategies, as well as leading the field medical organization. Kanchan is an experienced Medical Affairs leader who has held positions of increasing responsibility, including heading the North American Medical Affairs group at Vertex Pharmaceuticals, and subsequently, leading the Medical Affairs and Clinical Teams at Stallergenes Greer. She has launched multiple products across different therapeutic areas and has a proven track record of leading successful, collaborative, cross-functional teams. Kanchan is an ophthalmologist by training and also has clinical research experience from UCL London, UK, and Harvard Medical School.

Jeff Rosenbaum, MBA

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Jeff Rosenbaum is a Co-Founder and Partner at Dovetail Consulting Group. Jeff brings a unique approach to his client engagements—partnering with pharmaceutical and biotechnology companies to bring deep real-world experience coupled with structured consulting discipline to provide pragmatic and realistic solutions.

Before founding Dovetail Consulting Group, Jeff was the Chief Compliance and Risk Officer at Shire. He was responsible for the company’s Global Compliance and Risk Management function, including Corporate and Healthcare Compliance; Privacy; Employee, Health, and Safety (EHS); Corporate Security; and Enterprise Risk Management (ERM).

Prior to joining Shire, Jeff was responsible for developing, implementing, and monitoring global compliance programs, first at Novartis Oncology as the Global Head of Ethics & Compliance, and then at Vertex Pharmaceuticals, where he was the Chief Compliance Officer.

Earlier in his career, Jeff was a Director in Global Pharmaceutical Advisory Practice at PricewaterhouseCoopers. While there, he advised pharmaceutical, biotechnology, and medical device companies regarding matters of corporate governance, non-financial risk, and regulatory compliance.

Jeff began his career in the pharmaceutical industry at Wyeth Pharmaceuticals, where he worked in product marketing, business development, and field sales. Jeff holds an M.B.A. from the University of Virginia’s Darden School of Business and a B.A. from the University of Pennsylvania

Rick Russell

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Richard Russell brings more than 20 years of experience as a leader of small- to mid-sized commercial organizations in the pharmaceutical and biotechnology industries in North America and the European Union. Formerly trained as a Chemist, his work includes successfully leading organizations through change and developing and implementing sales and marketing activities for major pharmaceutical brands.

Mr. Russell joined Ares Allergy Holdings, Inc. (AAH) in October 2014 as President and Chief Executive Officer. In this role, he successfully managed a private equity portfolio of three small-sized biotechnology companies focused in Allergy Immunotherapy backed by the Bertarelli family. Through his leadership and business acumen, he led the consolidation of the portfolio into one operating company, GREER Laboratories, with total combined revenue of $100+ million and 400 employees. He also led the successful merger of GREER Laboratories, with a European based company, Stallergenes, to create Stallergenes Greer, a unified global leader, and innovator in Allergy Immunotherapy. He currently serves as President and CEO of Stallergenes Greer, Inc., the North American subsidiary of Stallergenes Greer, PLC.

Previously, Mr. Russell held the position of Chief Commercial Officer at Sunovion / Sepracor, where he led commercial operations in the U.S., Europe, and Canada for a portfolio of eight products generating $1.5 billion in revenue. Prior to joining Sunovion, Mr. Russell held the position of U.S. Executive Vice President, Neurodegenerative Diseases and Rheumatology at EMD Serono, where he managed all sales and marketing activities for the multiple sclerosis franchise. Prior to his role at EMD Serono, Mr. Russell was Vice President, Marketing at Sanofi-Aventis leading Plavix, one of the largest pharmaceutical products in the United States. Earlier in his career, Mr. Russell held several roles in sales and marketing leadership in the U.S. and Europe. His pharmaceutical experience spans many therapeutic areas ranging from central nervous system (CNS) disorders, women’s health, cardiovascular disease and neurodegenerative disorders.

Mr. Russell holds a B.A. in Chemistry from Bates College and an M.S. in Organic Chemistry from the University of New Hampshire.

Gigi Shafai, Pharm.D.
Director of Medical Affairs, AKEBIA THERAPEUTICS

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Gigi Shafai received a Pharm.D. from Northeastern University in Boston, MA and completed an industry fellowship in Clinical Study Management with Roche Labs. With over 12 years of experience, she brings a versatile clinical background from hospital and retail pharmacy to cross-functional pharmaceutical industry experience in a variety of therapeutic areas, including gastroenterology and nephrology. Previous employment at companies of various stages, include Ironwood, Salix, Genzyme (now Sanofi), Roche, and American Regent (a Daiichi Sankyo company).

Currently, as Director of Medical Affairs at Akebia Therapeutics, she is building the bridge between Clinical Development and Medical Affairs. She is responsible for establishing the infrastructure around medical information and scientific competitive intelligence, field medical team deployment and KOL identification, along with business development and alliance management with corporate partners. She also leads data generation and research initiatives to support pipeline advancement and health economic strategy. Gigi serves on the French-American Biotech Springboard (healthcare arm of the French-American Chamber of Commerce of New England), an internationally recognized committee that mentors healthcare companies that are expanding between U.S. and France. She regularly mentors pharmacy students and is involved in several industry societies including the Healthcare Businesswomen’s Association-Boston Chapter and Drug Information Association.

Diana Stefani-Hunyady, MD, MBA
Sr. Medical Advisor, Global Immunology, Medical Affairs Launch, ELI LILLY

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Diana brings with her over 22 years of extensive and diverse experience in clinical research, academia, and biopharmaceutical industry. A Medical Doctor trained in Europe, Diana specialized in Internal Medicine
and Gastroenterology. Specialization within GI and hepatology include Barrett’s esophagitis, IBD, IBS, eso-gastric and intestinal motility, chronic hepatitis and rare GI diseases. She also holds an MBA degree in
Global Management, earned in the US.

Prior to transitioning to the biopharmaceutical industry in 1994, Diana was Professor Assistant and staff principal in a University Hospital setting. She continued to evolve in roles of increasing responsibility, in Europe, then in US and globally, at various stages of products life-cycle, in companies such as Schering-Plough, Bayer, Agenus, Onyx Pharmaceuticals and Shire.

In addition to her original fields of specialization, Diana gained expertise in Oncology, Immuno-oncology, Rare Diseases, Cardio-vascular surgery and anticoagulation, Diabetes and Anti-Infectives. Diana also held a CME speaker position for the Agency of Healthcare Research and Quality (AHRQ) in the US, working on the Comparative Effectiveness and Patient Centered Outcomes Programs and KOL management systems. She also chaired the first Patient Registries Summit in Orlando in early 2016.

(She is also certified as an Executive Master Coach, Public Speaking Trainer and speaks fluently English, Italian, Romanian, medium level French and Spanish.

Diana was recognized by the International Association of Internists, as a 2013 leading physician and top Integrative Medicine specialist.)

John White, M.S.
V.P. Field-Based Medical Programs, THE MEDICAL AFFAIRS COMPANY

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John has had many years of experience in a variety of healthcare environments. After practicing pharmacy in different hospital settings, gaining expertise in several disease states as well as clinical practice management, John spent ten years working in the home infusion industry, starting as a clinical pharmacist and achieving the position of Branch Manager for Caremark. He managed $30 million in annual revenue with a team of over 100 employees. Moving into a more specialized health care role (HIV, organ transplant, serious mental illness), John spent four years with Stadtlanders Pharmacy, a national leader in specialty mail order pharmacy, where he left as the East Coast Director of Operations.

John joined Science Oriented Solutions (SOS) in 2000 as a Clinical Liaison, where he provided support to GSK in their HIV initiative. After an expansion of the program, John was promoted to MSL Program Director, with primary responsibility for managing a team of fifty HIV specialists across the country. While gaining experience in other disease states (MS, oncology, diabetes, ADHD) and managing additional MSL programs, John was promoted to Vice President of MSL Programs where he functioned as part of the executive planning team.

After his departure from SOS, John accepted a position as Director, MSL Programs at The Medical Affairs Company where he continued to initiate and manage field-based medical programs in a variety of disease states. In 2014 John was selected as one of PharmaVoice’s Top 100 people.

David Rowe Wood, Ph.D.
Director MSLs; Pulmonology, Rheumatology and Ophthalmology, MALLINCKRODT PHARMACEUTICALS

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David Wood is the current National MSL Director for Pulmonology, Rheumatology, and Ophthalmology at Mallinckrodt Pharmaceuticals, having formerly served as the Medical Director for Pulmonology. He leads in the development and implementation of US Field Medical strategies, including the research platform and lifecycle management goals for Pulmonology. Though his career started in gene therapy and stem cell research, he has since established a career track-record as an entrepreneur and medical scientist leader, experienced in academic and industry research across a broad range of therapeutic areas. David has a particular passion for building and empowering high performing Medical Affairs teams. He operates under a leadership philosophy of serving those he leads and always with the ultimate needs of the patient in mind.