Conference on Rare Disease and Orphan Drugs
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Our Founder Dr. Harsha Rajasimha will be speaking at the Conference on Rare Disease and Orphan Drugs on Oct 2nd, 1:45 pm ET on a session on Social Entrepreneurship in Rare Diseases
Dr. Krishna Ramaswamy
Ms. Neerja Sonowal
Nisha Venugopal, M.S., Ph.D.
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
Ramya Tejasimha Karur
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
Mr. Srikar Ramshetty
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Charles Andres, Ph.D., RAC
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.
Frank J. Sasinowski, M.S., M.P.H., J.D.
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.
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
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 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.
Sundeep Agrawal, M.D.
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
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
Mr. Jeff Anders
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.
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
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.
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.