Safety2Prosperity LLC is a digital health and healthcare risk-management company focusing on preparation, prevention, mitigation, and control of infectious diseases, such as COVID-19 and its variants, and soon the Flu and Monkey-Pox. In more detail, S2P is a "SaaS, IoT, risk management, and best-of breed-bundle sales and distribution" health and healthcare software infectious disease risk-management company. S2P's current focus is on preventing, mitigating, and controlling, as well as best managing, COVID-19 and variants spread at work and at home, using a special strategy. This strategy is called a "double sanctuary" approach. It uses a complete Program to prevent workers from taking infections from a created safe work environment to home and vice versa). Its most recent challenge is applying its software, strategies, devices, tools, and models to beat the more contagious and overall more dangerous Delta variant. S2P's current chief goals, in addition to its overall chief goal of reducing infectious disease spread, are to eliminate the repeat of two huge past errors: (1) the exercise of the apparent but false "no-alternative need" for closing companies and economies, thereby doing many times more harm than good, AND (2) the failure to exercise, either alone or in combination, a far smarter strategy to eliminate the serious "right-to-work violations" created by solo "Mandated Vaccination Programs,". This latter error is corrected by giving workers a less confrontational and just-as-good alternative: a "COVID-19 and Variants Safety Program.".

Safely 2 Prosperity (S2P) is a company wholly devoted to ensure safety in the Workplace, and/or the Educational arena. S2P offers a wide ranging array of solutions, specific to the Client environment and ecosystem, whereby Personnel, Students, and Staff are healthy both at work and returning home. Solutions are achieved via rigorous, comprehensive, and all encompassing tests, air and surface cleaning, to ensure the most virulent viruses (Covid19, FLU, Covid Variants, and others) are optimally minimized. S2P’s Solutions are chosen, and deployed to ensure both Executive (Litigant Cost Control), Personnel, and their loved ones’ peace of mind. S2P’s Founding, and Leadership are directly from prior U.S. FDA CXO level and senior level personnel.

FDTH’s strategic services include helping clients with their strategic planning, problem-avoidance, and problem-solving, both during the initial approval process and on appeal, or post-marketing. Our clients are often enterprises that have patient-critical products or services that are, or soon will be, facing difficulties with the FDA, Medicare, or the IRS. In some cases, our clients may be facing threats in the legal, regulatory, or public arenas. We perform high-level work for health-related and non-health-related clients. Included are Food, Drug, Biologic, Device, Healthcare-IT, and Other Technology companies. Also, Hospital-System, Clinic, and Hospital organizations, as well as Health-Insurers, and Trade Associations or their members.We have broad and deep inside knowledge and understanding of how large public and private regulators, such as the FDA, State Licensing Boards, and the CMS-Medicare, as well as the EPA, the IRS, and the FBI, really work. This knowledge and understanding is especially strong when it relates to these agencies' decision-making and to what facts or forces influence the nature, timing, and character, as well as the results, durations, and impacts, of their decisions.Tapping this advanced, deep, and highly specialized training, experience, and expertise, our company, "FDTH Regulatory Affairs Strategies, Inc.," helps clients avoid or solve large and/or complex regulatory-affairs and criminal-law driven problems. In doing so, we use specific, insightful, and highly honed strategies and advanced strategic tools. At the same time, we appropriately and aggressively apply these to the task at hand. This includes knowledge and strategic planning, PR, marketing, communications, regulatory-affairs, and government-affairs tools.

Norris Capital (formerly Norris and Norris) is engaged in Corporate Consulting, Expert Work, Coaching, and Advisory Work, with particular expertise in the FDA, Lifesciences, Healthcare, Health Insurance, Technology, IT, and Healthcare-IT sectors. Norris Capital works on general-corporate and major regulatory and other business, especially FDA, finance, research, clinical trial, licensing, contracting, and marketing deals/projects/solutions for large and small Medical Device and Pharma companies, as well as for healthcare delivery and financing organizations, such as healthcare systems, hospitals, nursing homes, and other providers, as well as healthcare payers/insurers. Norris Capital has represented such prominent worldwide companies as Pfizer, Merck, J&J, Mitsubishi, Hitachi, Fujifilm, USHIO, UBIC, Konica Minolta, Ajinomoto, US HHS, Japan’s Kanagawa Prefecture, and Harvard’s Partners HealthCare System.Norris Capital's CEO served on corporate boards and/or committees of large and small organizations, such as Summit Technology, FDA, AMA, Harvard, MIT, Cornell, Rochester, Boston University, Commonwealth of Massachusetts, US HHS, Joint Commission on Accreditation of Hospitals, Japan’s Kanagawa Prefecture (state), Jordan Hospital (now Beth Israel-Plymouth), Ischemix, and Caritas Christi Healthcare System.CEO also worked closely on major multi-year projects/deals/solutions with some of the US’s and Japan’s most-respected current or former CEOs, including Pfizer’s former CEO: Mr. Bill Steere; Partners HealthCare’s former CEO: Dr. Sam Thier; the FDA’s former Commissioner (CEO): Dr. Frank Young; and Kanagawa Prefecture’s (Japan’s largest state) current long-term Governor: Mr. Yuji Kuroiwa.

The Joseph D. Norris, Esq., Health Law and Public Policy Fund supports university or graduate school scholarships/grants for health law and public policy student study/research/training. The fund recruits students and fundraises. The fund is currently seeking outside capital to support and expand its mission.Help lead, manage, and fund the not-for-profit's fundraising activities.

Health Discovery Corporation is a young healthcare-IT software inventor and developer with 70 patents and patents-pending in the pattern-recognition and personalized-medicine domains. It is a public company and a future world-leader in its fields, once its patented products are fully invented and developed. Its healthcare-IT products will provide the analytics engines needed to drive advanced healthcare products in its target IT fields, including x-ray, CT, and MRI products. The company is currently seeking additional funding.Health Discovery Corporation's products will fall within three large analytics buckets: (1) Molecular-diagnostics-analytics, especially prostate, breast, and colon cancer molecular-diagnostics-analytics; (2) Medical-imaging-analytics, especially pathology and radiology medical-imaging-analytics; and (3) Secondary use of electronic-health-record-data-analytics, especially fraud-detection-analytics and drug-target-evaluation-analytics.Helped lead, manage, and fund invention and development of HDC's advanced-analytics products.

Ischemix is an inventor and developer of next-generation heart medicines for advancing ischemia-reperfusion (recovery) therapy. Its drugs will be major advancements from existing therapy. Ischemix is currently awaiting FDA approvals so it might obtain additional funding. Strong patents have been awarded or are pending.Served on the Ischemix Board for five years.Helped lead, manage, and fund invention and development of Ischemix's ischemia-reperfusion therapy products.

Global MedChoices software products and services together represent an important system response to US healthcare reform. GMC operates at the convergence of three highly strategic elements: (1) advanced healthcare-IT, (2) specialty surgical services, and (3) medical tourism located in the Caribbean. It is committed to reducing costs 40% (arbitrage) and improving access, quality, and safety, each by 20%, as compared to US standards. It hopes to accomplish these goals by inventing, developing, and using advanced software and using the world's best surgeons, operating in an advanced off-shore setting.Helped lead, manage, and fund invention and development of GMC's new, more advanced healthcare system and related products. One of the largest investors in GMC.

Needlebot is an inventor and developer of next-generation software search-engines for "unstructured-text" processing, or what is also sometimes called "free-narrative-text" processing. When fully invented and developed, its search engines will be capable of searching the precise content and contextual-meaning of nurses' notes, doctors' notes, general medical records, and clinical-trial records at both the Internet and Enterprise levels, a major advancement on existing technology. Served two years as Board Chairman. Helped lead, manage, and fund Needlebot's general-IT, healthcare-IT, and healthcare-software development activities.

The Caritas Christi Healthcare System, having $8B in revenue and 13,000 employees, was Boston's second-largest health care system, second only to Harvard’s Partners HealthCare System, having some $12B in annual revenue and 74,000 employees, the latter of which I advised the CEO and senior management for several years. Caritas was the largest and most prominent Catholic healthcare system. It included St. Elizabeth's Hospital and Good Samaritan Hospital, two top Boston hospitals. Over five years of board service, I helped to lay the groundwork for the acquisition of Caritas by Steward Healthcare System LLC, a newly formed affiliate of Cerberus Capital Management, L.P. (“Cerberus”) in 2010.

Coprindm Corporation provides pharmaceutical companies with business insights needed to make critical go and no-go decisions related to initiating or ending highly expensive clinical trials of drugs' (or devices') safety and effectiveness, under current or anticipated FDA rules and regulations. Pharmaceutical executives are under tremendous pressure to reduce the time and cost of clinical trials. The conducting of clinical trials is the most expensive phase of the entire life sciences product life cycle. It extends 5-10 years, and involves many institutions, providers, regulators and product scientists. Nearly 90% of clinical trials are completed with significant delays, and one-day delay costs about $1.3 million for a drug destined to make $500M in annual sales. Unfortunately, only 3 of 10 marketed drugs produce revenues that match or exceed average R&D. Coprindm changed its name to DecisionView in 2002.DecisionView is an inventor and developer of Pharma-clinical-trial software solutions. Its dashboards (each different for CEO, CFO, GC, Director, and worker users), analytics, and other tools for optimizing the timing, effectiveness, and cost of clinical trials are directed at setting a new industry standard for patient (subject) and investigator recruitment, enrollment, and management. DecisionView is a Granite and Adobe-Ventures-backed company. It was purchased by IMS in 2012 for an unlisted amount of money.In sum, DecisionView's (Coprindm's) software product substantially reduces the delays, cost, and risks of performing clinical trials, while at the same time it increases their pace, quality, and safety.Served as Board Chairman for three years.Helped lead, manage, and fund invention and development of DecisionView's (formerly named Coprindm) Pharma-clinical-trial-software solution products.

Served as full-time senior faculty member (then part-time member) at Harvard, teaching general and health: policy, law, and regulation. As well as, organization, governance, and structuring. Also, networking, management, and negotiations. And, contracting, payer/insurance, and finance. As well as, planning, reform, and strategy. Also, research, service and product invention and development. And, marketing, IT, and healthcare-IT. As well as, regulatory affairs, and cyber security. Faculty Editor-in-Chief and Founder of Harvard, MIT, and BU based quarterly academic journal: The American Journal of Law & Medicine, which is now (2017) in its 42nd year of publishing. Team-taught with William Curran, Frances Glessner Lee Professor of Law and Medicine at Harvard's Schools of Law, Medicine, and Public Health. Frances Glessner Lee, along with Professor Curran, are widely considered to be the parents of US health law. Dr. Curran was my mentor and sponsor until his untimely death, and he requested that I be his successor.Served on the Harvard Faculty for roughly 10 years, until retired from teaching.

Summit Technology is a US- and World-leading inventor, developer, and manufacturer of laser-eye-surgery products, including "Lasik," "PRK," and "Lasek" (a combination of Lasik and PRK) and "PRK" products, as well as a US and worldwide trainer of ophthalmologists, technicians, and nurses performing these major eyecare procedures. Under the transformational leadership of its senior executives and its board, in 1992 Summit invented a very large global industry now generically known as "laser-eye-surgery"In 2000, Sumit was acquired by Nestle's Alcon Laboratories unit. The purchase price in 2000 dollars was roughly one billion dollars (much more in 2017 dollars). This represented a roughly one-thousand-fold increase in value, at its sale. Co-led negotiations of the roughly billion dollar deal. Served on the Summit Technology Board for eight years.Helped lead, manage, and fund development of Summit's laser-eye-surgery direct products (such as its machines) and its related products (such as its top-level training programs).

Hill and Knowlton (now Hill & Knowlton Strategies) is one of the largest and most prominent US and worldwide marketing-consulting and management-consulting firms. It represents many of the world's premier general-corporate companies, and healthcare, life-sciences, health-insurance, IT, and healthcare-IT companies. Primary focus of my Corporate EVP efforts at H&K were on: rainmaking, leadership, and management of H&K's US and worldwide consulting staff; negotiating and overseeing the budgeting, deployment, oversight, and effectiveness evaluation of H&K's resources spent on client projects; and communicating progress to, and receiving feedback from, H&K's CEO and COO, and its clients' CEOs and COOs and other senior executives.Helped lead, manage, and fund invention and initial-development/further-development/deployment of H&K's current and new general-corporate and FDA/healthcare, life sciences, health insurance, IT, and healthcare-IT marketing-consulting and management-consulting products.

Served six-months as reorganization-consultant and then four-years as Principal Deputy Commissioner, COO (second-in-command), and Board Member of the FDA.The FDA is the world's premier healthcare, life-sciences, and healthcare-IT regulatory organization. It is also the world's premier consumer protection organization. Most governments of advanced countries respect FDA's decisions, and often follow FDA's lead fully or partially. Lead by FDA Commissioner, Dr. Frank Young, and others, I co-led the last major reform of the FDA, now through 2017. The reforms made the FDA produced far more productive, timely, and effective new-market-access product reviews, better blocking of unsafe or ineffective products from US markets, and earlier (and continuous) consumer-access to safe and effective products.These successful reforms also substantially boosted agency-wide work quality, productivity, and morale, and enhanced the FDA's US and worldwide reputation. Many of these reforms are still in place today (2017), some 30 years later.Engaged in high-profile crisis management of the FDA during disasters. Co-led the Chernobyl Disaster for the President, and the J&J Tylenol-Tampering Crisis for the Commissioner.Under the later, worked closely with J&J CEO, James Burke, to quickly invent, develop, approve, and roll-out new "safe-packaging" anti-tampering tools then required by the FDA for use by the Pharma and consumer-products industries to swiftly re-establish consumer-confidence in their products. Tools developed were so effective that they are still in wide-scale use today (2017), some 30 years later. Traveled extensively with Treasury Secretary Jim Baker to Saudi Arabia to assist in producing improved-US-market-access developments. The FDA has an annual budget of $6B and 12,000 employees.Teams acknowledged by the US President for success on all four of the above efforts.

Served for six years as a Board Member and the Chairman of Jordan Hospital's CEO Search Committee where co-led the transformation of the hospital from a small community hospital into its modern form and structure, as a leading Massachusetts South Shore hospital. These improvements paved the way for the acquisition of Jordan Hospital by Beth Israel Deaconess Hospital System in 2014.

Founded and then served as the first Faculty-Editor-in-Chief and board chairman of this academic journal. Ran the publication for roughly 10 years, during which had overall responsibility for editing some 200 articles or abstracts, and publishing roughly 40 quarterly editions. Over that decade, the journal grew massively in size, readership, and national and worldwide prestige--and reputation for containing high quality and carefully edited materials. Then added the topic of government, corporate, and personal "ethics" to the coverage. Given first Lifetime Member Award for outstanding service. Then retired from the editor-in-chief role and was elected Chairman of the Board of the sponsoring organization, The American Society of Law and Medicine. Emeritus faculty-editor-in-chief from 1981 onward.

Specialized in general-corporate and FDA/health/technology law/consulting/coaching at corporate law and advisory firm, where recruited to be full-partner, and then returned full-time to Norris Capital, Inc. (formerly Norris and Norris) to be CEO and then Board Chairman.

Served for five years as a Board Member and Executive Committee Member where co-led the transformation of the Massachusetts 4-H Foundation from a small foundation into its modern form and structure, as a leading Massachusetts foundation and a highly respected member of the 4-H family of organizations.

Specialized in general-corporate and FDA/health/technology law, consulting, and coaching at corporate law and advisory firm, where recruited, and then further recruited to be a full-partner at Powers, Hall, Montgomery, and Weston.Worked closely with The Massachusetts Hospital Association's CEO re consulting-advice and coaching.

Engaged, along with former Harvard Professor, Dr. Charles Boucher, to co-lead major healthcare reform/regulatory-reform project paid for by The Massachusetts Hospital Association (now Health and Hospital Association), US HHS, Massachusetts Government, and The Joint Commission on Accreditation of Hospitals (now Joint Commission), to rewrite and/or edit the full set of Massachusetts hospital licensing and operating regulations, and rewrite and/or edit the full set of national Joint Commission hospital accreditation/certification and operating-compliance standards. The Massachusetts Health and Hospital Association represents nearly 80 licensed member hospitals, many of which are organized within 28 member health systems, in Massachusetts. The Joint Commission accredits and certifies nearly 21,000 health care organizations and programs in the United States.Team acknowledged by Harvard, HHS, MA, and JCAH for quality of work, and completion of the major project on-time and on-budget.Arm of company also was involved in entrepreneurial work related to inventing and developing a highly automated bed-side nursing station. The concept was that this medical device would smartly and insightfully rely upon then available primitive versions of Artificial Intelligence and Predictive Analytics to do good, both for patients and their families—and for nurses who had the unique opportunity, but also the enormous burden and stress, of managing very sick patients. In previous summer, worked for The Massachusetts Health and Hospital Association as a summer intern during break from Cornell Law School and Cornell Business School education and training.During both summers, under intern contract and then under consulting contract, worked closely long-term with Massachusetts Hospital Association CEO: Mr. David Kinzer, and General Counsel: Mr. Patrick Carroll.

For two years, supervisor of seven summer day camps for diversified groups of children, from the most financially or physically challenged to the least financially or physically challenged. Co-supervised one camp for the two years before. Curriculum consisted of checkers/chess training; arts and crafts training; painting training; volley ball training; and softball training; for example.