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Name: Genetic Counseling for Rare Diseases: A Global Perspective
Start: 2023-12-18T20:30:00-05:00
End: 2023-12-18T20:30:00-05:00

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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).

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.

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Genetic Counseling for Rare Diseases: A Global Perspective