IndoUSrare Info Session for US Patient Advocacy Groups
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Agenda
1. Introduction to IndoUSrare
2. Team IndoUSrare
3. Our Key Programs
4. Membership Program feedback
5. Q & A
Tags: Event
Dr. Krishna Ramaswamy
Dr. Krishna Ramaswamy is a life science professional with experience in research, management consulting, and business development in academia and industry. She has a Ph.D. in Biological Sciences from University at Buffalo, SUNY, and pursued postdoctoral research in cell biology from the University of Southern California, Los Angeles. She has worked as a consultant for the biotech/pharma industry and worked with Dr. Harsha and ORDI in the past for about 2 years. Dr. Krishna currently resides in Hyderabad India and has a keen interest in the rare diseases space and would like to bring awareness about the various diseases, diagnoses and treatments that are available and those in the pipeline. She first began working in the rare disease space during her postdoctoral training and has worked on peroxisome biogenesis disorders under the guidance of Dr. Joe Hacia at USC.
Ms. Neerja Sonowal
Neeraja is in her junior year of high school, studying at a School in Gurgaon, India. She has completed all 8 grades in a set of vocal examinations conducted by Trinity College as the captain of the Student Council in her school, currently serving the post of House Captain. Neeraja aims to find solutions to the problems associated with the fields of healthcare, technology, and sustainable development. She is passionate about teenage welfare and has founded a youth-centric organization called ‘Discover Yourself’ through which she aims to inspire, and collaborate with young people across the world and wants to bring awareness regarding various teenage and adolescent issues
Nisha Venugopal, M.S., 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.
Ms. Preethi Krishnaraj
Ms. Preeti Krishnaraj has graduated from SRM University, India, and postgraduation from Tzu Chi University, Taiwan. She has experience working National Center of Biological Sciences (NCBS) India, as a JRF wherein she was working on a project related to early embryogenesis. Currently, she is in the third year of her Ph.D. at Max Planck Institute for Heart and Lung Research Germany exploring the concepts of genetic robustness and understanding the mechanisms behind the same.
Ramya Tejasimha Karur
Ramya Tejasimha Karur is Bangalore-based research professional with Masters (MSc) in Biotechnology and Graduation in Microbiology from Bangalore University with post-graduate certification in Public Health nutrition. She has worked on various research projects ranging from Breast and Nasopharyngeal Cancer genetics, Asthma and COPD genetics, Genetic toxicology, and Public Health Nutrition, to Maternal and Child Health, and Epidemiology. She was also involved in public health research projects during her work at the Institute of Health Management Research Bangalore, India (IIHMR); Unilever, King’s College, London; and Southampton General Hospital UK.
Her interest lies in neonatal research and aspires to do a Ph.D. in studying the risk factors associated with congenital deaths due to rare diseases.
As a Project Associate at IndoUSrare, Ramya hopes to help patients in India gain access to life-saving therapies through research, outreach, and advocacy efforts and to drive policy changes in favor of rare disease patients in India.
Ms. Sapna David
Ms. Sapna David is a rising junior at the University of Maryland studying Public Health Science. She has experience in vaccine research and a strong interest in public health work. They will be working on a number of different projects during their time with IndoUSrare including the Patient Concierge, Advocacy initiatives, creation of resources including disease-specific patient stories, prep work for Corporate Alliance, and analysis of orphan drugs available in India, US, and globally.
Mr. Srikar Ramshetty
Mr. Srikar Ramshetty is a recent graduate in Neuroscience from the University of California, with experience working on various community health projects. He will be working on several different projects during their time with IndoUSrare including the Patient Concierge, Advocacy initiatives, creation of resources including disease-specific patient stories, prep work for Corporate Alliance, and analysis of orphan drugs available in India, the US, and globally.
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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.
Anish Bhatnagar, M.D.
Dr. Anish Bhatnagar is currently the Chief Executive Officer of Soleno Therapeutics (NASDAQ: SLNO). Soleno is dedicated to the development of treatment for rare diseases. Their lead program is for DCCR, a once-a-day tablet, for the treatment of Prader Willi Syndrome. Dr. Bhatnagar is a physician with over 20 years of experience in the biopharmaceutical, medical device, and diagnostic industries. His experience spans the development of biologics, drugs, drug-device combinations, and diagnostic as well as therapeutic medical devices. His prior experience includes working at Coulter Pharmaceuticals, Inc. from 1998 to 2000 and Titan Pharmaceuticals, Inc., and Capnia Inc. He is the author of several peer-reviewed publications, abstracts, and book chapters. He obtained his medical degree at SMS Medical College in Jaipur, India, and completed his Residency and Fellowship training in the U.S. at various institutions, including Georgetown University Hospital and the University of Pennsylvania.
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).
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.
Ms. Juhi Naithani, MBA
Juhi Naithani is principal at bGlobal Consulting and provides support to organizations ready to Go Global. She has public and private sector experience in business strategy across a range of disciplines, with her first job in India in B2B industrial sales, and subsequent experience in the United States in consulting, academia and economic development.
Prior to founding bGlobal Consulting, Juhi was Assistant Director of International Business Investment at the Fairfax County Economic Development Authority (FCEDA), Virginia, USA, where she managed the India office of FCEDA, implementing new outreach strategies and events to bring emerging technology companies to the United States.
Juhi has served as visiting faculty of marketing and international business at numerous universities over the last 20 years, fostering higher education at the undergraduate and graduate levels.
A strong proponent of entrepreneurship, Juhi was a member of the Board of Directors of the TiE (The Indus Entrepreneur) DC chapter for four years through 2022.
Juhi has an undergraduate degree from Delhi University, India and an MBA from Quinnipiac University, Connecticut, USA.
Narayanan Govindarajan, MS
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.
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
Sundeep Agrawal, M.D.
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
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.
Dr. Bhaskar Sonowal M.B.B.S, MBA
Managing Director of HED Healthcare Pvt. Ltd. based in Gurgaon, India. Brings more than 20 years of rich experience in innovative business development, creating access projects, formulating policy changes, and serving the people of India – as a Clinician and a Program Manager for some of the country’s largest healthcare programs. He is credited with creating and leading large-scale market development strategies, which have impacted businesses, patients, and society for high-end biotechnology products and medical devices. Rare Diseases, Cancer, Vaccine Preventable Diseases, Musculoskeletal conditions, and Nutritional imbalances.
Mr. Jeff Anders
Jeff Anders is the Founder and Principal of Jeffrey Anders Government Strategies, LLC, a Washington, D.C.-based strategic consulting firm, focusing on federal and state government affairs, public policy, alliance development, and stakeholder engagement in the healthcare sector.
Before creating his consulting firm in 1998, Jeff served in a leadership role in government affairs and policy at the Pharmaceutical Research and Manufacturers of America (PhRMA), representing the nation’s leading research-based pharmaceutical and biotechnology companies. Jeff began his public policy career working on the professional staff of the United States Senate, serving as Committee Counsel to both the Health Education Labor and Pensions (HELP) Committee and the Budget Committee, as well as Legislative Counsel to U.S. Senator Christopher J. Dodd ( D- Connecticut). Jeff earned his B.A. degree in History and Political Science ( magna cum laude) from Duke University and his J.D. degree from Duke University School of Law.
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.
Ravi Mistry, M.S, MBA
Ravi Mistry is a leader, entrepreneur, angel investor, educator, and mentor. His professional career has spanned several industries, including life sciences, technology, non-profits, and academics, in various capacities as Founder, Board Chairman/Director, President, Vice President, Sr. Director, Manager, and Adjunct Professor.
Currently, Ravi serves as Funds Management and Operations Officer of Impact India Investment Partners, LLC (3iPartners), a Silicon Valley based fund investing in early-stage impact-oriented startups in India with focus on AgriTech, HealthTech, EduTech, and Livelihoods. Ravi served as Vice President of Business Development & Operations at MedTree LLC, a Silicon Valley based life sciences start-up. Prior to MedTree, Ravi served as Founding Executive Director of Indian Institute of Technology Gandhinagar (IIT GN) Foundation. Ravi was member of founding team of Virident Systems, a Silicon Valley based technology startup that was acquired by HGST/Western Digital in 2013. Prior to Virident, he held management positions in the life sciences industry at DiscoveRx and BioImagene.
Ravi is an active angel investor and member of the TiE Angel Group Silicon Valley and TiE Global Angels. He is Former President and Board Member of EPPIC Global Network, an all-volunteer life science professional organization in Silicon Valley/Bay Area. He has been active with other Bay Area biopharma organizations such as California Life Sciences Association (CLSA – previously known as BayBio), a life sciences organization representing California bio industry, Chinese Bioscience Association (CBA), and Chinese-American Bio/Pharmaceutical Society (CABS). Ravi also advises and mentors IIT GN alumni both in India and in the US.
He is Gold Medalist from Gujarat University, India from where he holds BE degree in Civil Engineering. He holds Master’s degree in Structural Engineering from Stanford University, and an MBA in Finance from CSUEB.
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.