10th Biosimilars Americas

Anita M. O’Connor, MS, PhD, has over 20 years of experience in regulatory affairs and drug development for the pharmaceutical, medical device, food, and animal drug industry. She worked for FDA for 16 years in the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Veterinary Medicine (CVM), the Center for Food Safety and Applied Nutrition (CFSAN) and the Office of the Commissioner (OC). As an FDA pharmacology and toxicology reviewer in CBER, she specialized in drugs produced by biotechnology.
From 2005 to 2008 Dr. O’Connor created a private consulting practice, ANITA O’CONNOR CONSULTING, LLC, which specializes in biopharmaceutical development. In 2008, Dr. O’Connor joined MDS Pharma Service (later Celerion) as Senior Director for Biopharmaceutical Development in Development & Regulatory Services (DRS). In 2011, she rejoined her consulting practice, ANITA O’CONNOR CONSULTING, where she continues to advise clients on the regulatory and drug development process for innovator biopharmaceuticals and biosimilars.

Mr. Leicher is Senior Vice President and General Counsel at Momenta Pharmaceuticals Inc., an innovator biotechnology company engaged in development of complex generic products, biosimilars, interchangeable biologics and novel products. Mr. Leicher bring has advised biotechnology companies for over 20 of his 30 years of legal experience. Mr. Leicher is a frequent lecturer on biotechnology law. Before joining Momenta, he served in senior legal positions at Altus Pharmaceuticals Inc., Antigenics Inc., Millennium Pharmaceuticals, Inc., Curis, Inc., Genetics Institute, Inc. and Wyeth. In private practice, he served as the Co-Chair of the Life Sciences Practice Group at Hill and Barlow, and was an attorney at Hale and Dorr and Butler & Binion after receiving his J.D. from Georgetown University Law Center and his B.A. from the University of Rochester.

Mr. Chowdhury's career has focused on global market access issues across six continents, split evenly between emerging markets (BRIC-MT and through the top 72 emerging markets) and developed markets (EU-5, Japan, Australia and Canada). His achievements include successful assignments in pharmaceutical and medical technology price integrity, payer partnerships, innovative access schemes, patient access programmes, customer value approach, and portfolio-level global market access strategies. While with Genzyme, he developed the company’s first parallel trade pricing defense strategy. While with Cambridge Pharma Consultancy (now part of IMS), Mr. Chowdhury played an integral role in launching the firm's Greater China market access consulting operations, spending much of his time focusing on pan-Asian issues. Additionally, Mr. Chowdhury served as a research specialist with the London School of Economics, WHO and European Observatory on Health for Central and Eastern Europe.

Dirk Reitsma, M.D., is vice president and head of oncology global product development at PPD. He established and leads the company's biosimilar services development group, which brings together cross functional, global expertise and resources in the development of large molecule biologic drugs.
Dr. Reitsma has extensive clinical development experience, having joined PPD from MedImmune, where he served as vice president of clinical development since 2004. At MedImmune, he led the company's active clinical oncology programs in biologics and oversaw the expansion of its oncology clinical development department. Dr. Reitsma's experience also includes serving as vice president of clinical affairs and medical director at Antigenics, and as associate director and senior clinical research physician in oncology at Novartis Pharmaceuticals.

Frank A. Scappaticci, MD, PhD is a clinical oncologist & hematologist working at Genentech / Roche. Dr. Scappaticci obtained his undergraduate degree at Yale University in biochemistry. Subsequently, he trained at the University at Buffalo / Roswell Park where he obtained his medical and graduate degrees. He completed his internship and residency in Internal Medicine at the University of Pennsylvania. Following this, he obtained his Medical Oncology and Hematology training at Stanford University Medical Center. After a short period on faculty at Stanford and the University of California / Davis, he joined Genentech approximately 8 years ago and has been working on late stage clinical trial development for Avastin. He has led numerous filings for Avastin that eventually led to approval for Avastin in colorectal, non-small cell lung, and renal cancers. Recently, Dr. Scappaticci was appointed as the clinical science leader on the Roche Biosimilar Task force.

Gillian Cannon is Vice President of Commercial Operations for Merck BioVentures. She has over 25 years experience in the pharmaceutical industry in European, US and Global roles. Gillian has held leadership positions at Merck across a range of disciplines including Sales, Marketing, Pricing, Outcomes Research, and Strategy Development. In addition to her commercial experience, Gillian has a demonstrated track record of successfully implementing new business initiatives at Merck. Gillian holds an undergraduate degree in Biochemistry from the University of Edinburgh and a PhD in Health Administration from Temple University.

Jill M. Carton, Ph.D. is currently a Director in Biologics Research, Biotechnology Center of Excellence at Janssen Research and Development, LLC, in Radnor PA. She received a B.S. in Biology from Fairfield University, Connecticut and an M.S. and Ph.D. in Molecular and Cellular Biology from Fordham University, New York. While at Fordham, Jill identified and characterized novel interferon-regulated genes and the role the gene products play in interferon's antiviral and anti-proliferative activities. Following graduate school, Jill was a post-doctoral fellow at Johnson & Johnson, Pharmaceutical Research Institute in Raritan, NJ. She identified potential inflammatory disease drug targets through differential display and microarray chip technologies. Since joining Janssen R&D, Jill's work has focused on therapeutic antibody discovery. Currently, Jill heads the Molecular and Protein Biosciences group at Janssen supporting the biologics discovery portfolio.

Katherine concentrates her practice in intellectual property law, with a particular emphasis in biotechnology. She provides strategic patent portfolio management for clients in the biotechnology, pharmaceutical, chemical, and medical device industries. Her work in this area includes patentability assessment, strategic filing, and coordinated prosecution of worldwide patent applications, including prior art management, PTO examiner interviews, appeals, and oppositions. She also is experienced in licensing transactions, intellectual property due diligence for technology and licensing transactions, mergers and acquisitions, product launches and public offerings, including freedom-to-operate, landscape, infringement and validity analysis and opinions. Katherine also counsels clients on developments in the law related to biologic molecules, including proposed regulation of biosimilars (follow-on biologics), patentable subject matter as it relates to gene patents and diagnostic methods, and licensing.

Kay Holcombe is Senior Policy Advisor at Genzyme, a Sanofi Company. From Genzyme's Washington, DC, government relations office, Kay participates in developing and implementing corporate policies and responses to government regulatory and policy initiatives. She works with members of Congress and their staffs and with officials of government agencies.
Before joining Genzyme, Kay was Executive Vice President of Policy Directions Inc., a government relations firm specializing in strategic planning and legislative and regulatory advocacy regarding health care and related issues. She represented a variety of clients in academia and in the pharmaceutical and biotechnology, food, and consumer products industries.

Kristie Kuhl, JD is senior vice president and deputy health practice leader at Makovsky, a leading integrated communications company. Utilizing her legal background, she counsels biotech and pharmaceutical companies on communications and advocacy. She bridges the divide between public relations and public affairs and has worked in the biosimilar space since 2005. Among Kristie's many accolades, the Healthcare Business Women's Association named her a "Rising Star" in 2002. Kristie holds a Juris Doctorate from Quinnipiac University School of Law in Hamden, Connecticut, where she was the recipient of the school’s highest honor, the Dean’s Award.

Ms. Martin de Bustamante’s career has focused on pharmaceutical global market access issues for specialty biologic drugs across diverse therapeutic areas. Her time has been apportioned between the emerging and developed markets, with a strong focus on Latin America (Mexico, Argentina, Colombia, Brazil), Asia (China, India, Philippines, Thailand) and Southern Europe (Spain, Italy). Through in-depth primary research conducted in the countries’ native languages Ms. Martin de Bustamante has fortified her understanding these markets’ rapidly evolving cost-containment policies.

Much of Ms. Martin de Bustamante’s work to date has centred around understanding the barriers to access and reimbursement challenges posed by developing economies in the emerging markets and the continuous reforms throughout the EU5. She has extensive international experience in price integrity, global market access strategies, biosimilar defense or development strategy, value proposition, and patient assistance programs.

Onesmo Mpanju, Ph.D., is Director of Global Regulatory Affairs at PPD currently based in Beijing, China. Dr. Mpanju has more than ten years of regulatory science experience and has managed numerous regulatory submission projects for PPD’s commercial clients. He also provides regulatory advice concerning the development of biosimilar pharmaceuticals and consulting on product development and regulatory strategy; regulatory authority interaction; and chemistry, manufacturing, and controls (CMC) development. In addition, Dr. Mpanju advises PPD’s noncommercial clients, such as government and public health organizations, on key regulatory matters. Prior to joining PPD, Dr. Mpanju was a review scientist at the US Food & Drug Administration, Center for Biologics Research & Review (CBER).

Dr. Mpanju obtained his Ph.D. from the University of British Columbia in Canada, in 2001, and has authored and co-authored several publications and scientific presentations in the molecular virology of retroviruses and filoviruses, as well as in regulatory science.

Peter Pitts is President of the Center for Medicine in the Public Interest. From 2002-2004 A former member of the United States Senior Executive Service, Peter was FDA's Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner. He supervised FDA's Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and Advisory Committee Oversight and Management. He served on the agency's obesity working group and counterfeit drug taskforce and is a Special Government Employee (SGE) consultant to the FDA's Risk Communications Advisory Committee where he is advising the FDA on regulatory issues in the sphere of social media.
In 2010, he was named by Modern Healthcare magazine as one of the 300 "most powerful people in American healthcare."

Shefali Kakar is a Senior Fellow in the Oncology Clinical Pharmacology division at Novartis. Dr. Kakar is responsible for pharmacokinetics and pharmacokinetics/pharmacodynamics aspects of multiple oncology projects including early development to Biosimilars. Prior to Novartis, Dr. Kakar worked at Pfizer for 5 years supporting small and large molecules and was an Adjunct Associate Professor at the Brown Medical School. Dr. Kakar has been involved in the discovery and development of more than 25 Protein Biotherapeutics.
Dr. Kakar received her Ph.D. in Pharmacology from University of Michigan.