World Orphan Drug Congress USA 2020
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Dr. Reena Kartha, Board Director – IndoUSrare, is a panel speaker on “How to increase patient access to diagnostic programs and treatments in emerging rare disease market”
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Rajesh Gooty
Rajesh Gooty is an Executive VP of a Professional IT Services Firm Serving Both Public & Private Sectors, Headquartered in Washington DC. His seasoned expertise in Enterprise strategic planning, management & professional consulting led to several successful business transformation, procurement transformation, operational process improvement, organization design, operating model design, business case development, strategic sourcing & eProcurement change initiatives resulting in substantial operational efficiencies and cost-saving benefits for corporate clients in diverse verticals of Health Care, Pharmaceuticals, Financial Services, Government, Insurance, Hi-Tech, Oil and Gas, Entertainment and Manufacturing.
An Accomplished Business Partner, Forceful influencer, Strategic Thinker who thrives on tough challenges & translates visions and strategies into Actionable Deliverables, Value Added, and Result Oriented goals. Stays abreast of evolving business, leadership & human resource trends to gain a competitive edge. Effectively identifies compliance issues for business risk mitigation. As a Business & Technology Professional, Focused in Sales & Staffing Strategies, building Customer relationships, leveraging the knowledge of Client, Culture, and Business, facilitate change, and improve employee performance from fast-paced start-ups to Large Reputed organizations in both Public & Private Sectors of Diverse Verticals. He organizes & synthesizes data for effective business analyses, readily gains trust & credibility within varied, diverse levels in an organization, Forges Partners effectively with all levels of management, upon identifying & leveraging Synergies. With An Extensive knowledge of procedures for business transactions within the Federal Government & State Level Agencies.
A Driven Senior Leader With two Decades of Demonstrated Success, Seasoned Expertise & Exceptional Competence in Sales, Strategy & Talent Acquisition. Innovative, Resourceful, Skillful at executing strategy & bringing forth a commitment from Team Members to Achieve Excellence. The Realm of Seasoned experience has evolved from Government Contract Management (Onsite Project Management / Proposal Writing) to Corporate Division / Service Offering Management (Program Management, Proposal Management) Translating To A Strategic Business Development Executive that excels at Capture & Change Management executing, supporting full life cycle Multi-Million Revenues. He established a successful track record of designing & delivering large cross functional business transformation initiatives from strategy through execution while building strong collaborative team environments.
Stephen Groft, Pharm.D.
Dr. Stephen Groft is a Senior Advisor to the Director, NCATS at NIH. He helped establish the Office of Orphan Products Development at FDA in 1982, a rare diseases initiative at NIH in 1989, Director of the Office of Rare Diseases Research (ORDR) from 1993-2014. Activities included the development of the Genetic and Rare Diseases Information Center (GARD), IRDiRC, ICORD, the RDCRN, assistance with the Undiagnosed Diseases Program and expanding the ICD XI to include more rare diseases.
His major focus has been on stimulating research with rare diseases and orphan products and developing information for patients, families, health care providers, research investigators, the biopharmaceutical industry, and the public. The emphasis included information about rare diseases, active and completed clinical trials, ongoing research, and patient advocacy groups. He has authored 85 journal articles, book chapters and the co-editor of 2 books on Rare Diseases Epidemiology. He has also made more than 320 presentations on rare diseases.
Akkaraju Sarma, MD, Ph.D., FAAFP
Dr. Akkaraju V. Sarma is a family medicine doctor in Bensalem, Pennsylvania. He received his medical degree from Universidad Autonoma de Ciudad Juarez and has been in practice for more than 20 years.
Life long commitment to help needy and enhanced my abilities being a physicians. Likewise, help structuring health sustaining programs like National Marrow Drive Registries, American Red Cross Blood Drives and similar activities.
Nisha Venugopal, Ph.D.
Post-Doctoral Consultant, Bangalore, India
Nisha Venugopal is Program Manager at IndoUSrare. She has a PhD in Life Sciences from the CSIR – Centre for Cellular and Molecular Biology (CCMB), India, where she studied the role of the primary cilium in adult skeletal muscle stem cells. Her postdoctoral research at the Institute for Bioinformatics and Applied Biotechnology, India involved a detailed analysis of global clinical trial registries. Nisha hopes to use her experience in the cell biology of rare diseases and policy research to support and help patients gain access to life saving therapies through research, outreach and advocacy efforts to drive policy changes in favor of rare disease patients in India.
Sundeep Agrawal, MD
Dr. Agrawal is currently a Managing Director at Colt Ventures, a diversified family office focused on investing in private and public securities. He is a physician with extensive experience in healthcare investment banking, venture capital/private equity, clinical medicine and research. Previously, he was a Vice President at Longitude Capital, a $1.2B healthcare investment firm focused on public and private investments in life sciences, where served on company boards and made investments.
Prior to Longitude, he was an Executive Director in Healthcare Investment Banking at Oppenheimer & Co. where he worked on numerous public and private transactions in healthcare. Dr. Agrawal completed his clinical training at Lenox Hill Hospital. He has extensive clinical and basic science research experience with publications in leading journals and has been the recipient of several national research awards and grants.
Dr. Agrawal holds an M.D. from the George Washington School of Medicine and a B.A. in Biology from George Washington University. He grew up in Dallas, TX and currently lives in New York City
Reena Kartha, M.S., Ph.D.
Reena Kartha is an Assistant Professor in the Department of Experimental and Clinical Pharmacology and Associate Director of Translational Pharmacology in the Center for Orphan Drug Research (CODR), College of Pharmacy, University of Minnesota. She has a Masters in Biotechnology from Tamil Nadu Agricultural University, India and a Ph.D. in Cellular and Molecular Biology from the Indian Institute of Science, Bangalore. Her research focuses on understanding the pathophysiological role of oxidative stress and inflammation in rare inherited metabolic disorders as well as the pharmacology of agents that target these molecular pathways. She has mentored and supervised undergraduate, graduate and pharmacy students conducting directed research and direct the CODR research seminars during the school year. She completed a rare disease clinical research training program supported by the NIH Rare Disease Clinical Research Network and was the recipient of the 2017 University of Minnesota Clinical and Translational Sciences Institute Outstanding Junior Mentor of the year award. Her career goal is to help patients with rare diseases by developing affordable and accessible therapies, train the next generation of healthcare providers and increase awareness about rare diseases
Harsha K. Rajasimha M.S., Ph.D.
Dr. Rajasimha has authored 15 high impact journal publications, 2 book chapters, and inventor on 2 patents. He is often a keynote speaker, convener of #DigitalOMICS meetup around the Capital Beltway and part of numerous conference organizing committees. Dr. Rajasimha has received numerous Awards for his work in genomics, precision medicine and rare diseases including a travel award to join the NGO Committee on Rare Diseases at the United Nations headquarters, New York City in Feb 2019, Lead India Foundation 2020 Award for leadership and outstanding achievement in rare diseases, NTT DATA Healthcare Life Sciences Silver award for outstanding achievement 2017, Sanofi Genzyme patient advocacy leadership award 2016, Bioscience company of the year 2014, NEI director’s innovation award 2012 for building their genomics cyber infrastructure.
Harsha earned his M.S. in Computer Science (2004) and Ph.D. in Genetics, Bioinformatics and Computational Biology (2007) from Virginia Tech.
Driven by a personal cause in 2012, Dr. Rajasimha decided to apply his years of post-doctoral clinical genomics data research experience at National Institutes of Health and industry product development experience to develop products and solutions to help accelerate clinical research.
Nara Govindarajan, M.S.
Nara Govindarajan is a Techie & a Leader in Software Development. He currently works in a leadership role at UWorld LLC in Texas. He is a volunteer for numerous non-profit organizations and charitable causes.
Nara holds a Master’s degree in Computer Science from Virginia Tech. He did his Bachelor’s degree in Computer Science and Engineering from PSG College of Technology, Bharathiyar University, Coimbatore, India.
Charles Andres, Ph.D., RAC
Charles Andres, Ph.D., RAC, is an associate in the Washington, D.C., office of Wilson Sonsini Goodrich & Rosati (WSGR). He focuses on patent prosecution, strategic patent counseling, IP due diligence, drug and medical device FDA regulatory counseling, invalidity and non-infringement opinions, life-cycle management, Supreme Court and Federal Circuit amicus briefs, and related business matters.
Charlie has significant experience drafting patent applications, prosecuting patent applications in the U.S. and abroad, and evaluating the claims of issued patents. He has won cases before the Board of Patent Appeals and Interferences by brief and on oral argument. Patents Charlie has obtained have been listed in the Orange Book and asserted against a generic pharmaceutical manufacturer, and he has drafted and filed multiple applications for patent term extension. Companies he has obtained patents for have been sold for a cumulative total of approximately $4 billion.
Charlie has also drafted and prosecuted patents covering three FDA approved drugs. He represented a client at a U.S. Senate HELP Committee full hearing on electronic health records and was part of a team that defended a generic pharmaceutical manufacturer in an Actavis reverse payment enquiry at the Federal Trade Commission.
In addition, Charlie has authored and reviewed numerous freedom-to-operate, invalidity, and non-infringement opinions, including opinions supporting Paragraph IV certification for ANDA filers under the Hatch-Waxman Act. He has advised companies on the use of post-grant U.S. Patent and Trademark Office proceedings to achieve IP goals.
Prior to becoming a patent professional, Charlie spent a decade as a medicinal chemist and early-phase project co-chair at Bristol-Myers Squibb Company, where he won a Presidential Award, among other accolades. He holds Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society.
Frank J. Sasinowski, M.S., M.P.H., J.D.
Frank J. Sasinowski, M.S., M.P.H., J.D., assists sponsors and patient organizations in developing new medicines and has helped secure FDA approval for hundreds of new drugs, including more than 65 new molecular entities, often for serious and/or rare diseases. Frank joined FDA in 1983 as regulatory counsel in the Center for Drugs and Biologics, where he was key to implementing both the 1983 Orphan Drug law and the 1984 Hatch-Waxman law. In 1987, he left the FDA as Deputy Director of the health policy staff in the Commissioner’s office and joined this firm.
In its March 2012 issue, the Drug Information Journal published Frank’s seminal analysis on therapies for rare disorders: “Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs: Cataloguing FDA’s Flexibility in Regulating Therapies for Persons with Rare Disorders.” Other papers on Accelerated Approval and Orphan Drugs are cited by FDA officials as well. Since December 2014, Frank has been an Adjunct Professor of Neurology at the University of Rochester Medical Center.
Frank’s work has been widely recognized by industry and political leaders, as well as notable organizations. For example, Frank was asked by both political parties to testify at the May 2014 inaugural hearing of Congress 21st Century Cures Initiative. In August 2018 Frank was appointed to the Board of Directors for the Alliance for Regenerative Medicine Foundation for Cell and Gene Medicine. In May 2013, the National Organization for Rare Disorders (NORD), which represents the 30 million Americans with rare diseases, awarded Frank its first ever NORD Lifetime Achievement Award. In 2000, Frank was elected to NORD’s Board of Directors, where he served as Chair and as Vice Chair, and where he remained on the Board until 2016. In October 2012, President Obama recognized Frank’s contributions to the President’s Council of Advisors on Science and Technology (PCAST) report, “Propelling Innovation in Drug Discovery, Development and Evaluation.” Based on his extensive experience with FDA, from both the agency and client side, Frank possesses a detailed understanding of the regulatory process. He regularly shares his insight on drug development issues with physicians, scientists, and regulators, and has served on the boards of several biotechnology companies. Frank has been Chair of the Food and Nutrition Section of the American Public Health Association (APHA) and has taught health law at American University. Frank has also served on the Board of Directors of the United States Pharmacopeia (USP).