Nov 20019
Greg Simon is an American political aide who supported Vice Presidents Joe Biden and Al Gore. His private sector work is concentrated in the pharmaceutical, biotechnology, and telecommunications sectors. Simon is credited with advancing key federal health care and telecommunications policies.[1]
Simon was a rock 'n roll drummer until he was thirty.[2] He received his J.D. degree from the University of Washington School of Law in 1983 where he was a member of the Law Review and the Moot Court. He has a B.A. in history from the University of Arkansas.[1]
Simon was an aide to Vice President Al Gore, eventually working as his Chief Domestic Policy Advisor (‘93-’97) where he shepherded the 1996 Telecommunications Reform Act, crafted regulations for the biotech industry, and represented VP Gore on the National Economic Council.
Simon left the White House to found lobbying firm Simon Strategies. With his firm Simon lobbied for energy companies Enron and Southern Company, and telecom companies such as Sony, Netscape, Motorola, Global Crossing, AOL, and Cisco.[3][2][4] [5]Simon also lobbied for domain registrar Network Solutions.[6]While maintaining his lobbying practice, Simon was a bundler and top advisor for Gore’s 2000 presidential campaign.[2][7]
Simon served as Executive Director for both the Biden Cancer Initiative (‘17-’19) and the White House Cancer Moonshot Task Force (2016).[citation needed] He also served on the Health and Human Services review team for the Obama-Biden transition in 2008.[8]
After working on the Obama-Biden transition team, Simon joined Pfizer as a Senior Vice President in charge of worldwide policy and patient engagement (2009-12).[1]
Greg Simon was a panelist for The Forum’s discussion on Rare Cancers.
Mr. Simon serves as President of the Biden Cancer Initiative at the Biden Foundation. Previously, he was the Executive Director of the White House Cancer Moonshot Task Force, a position created by President Barack Obama and for which he was chosen by Vice President Joe Biden in March 2016. As Executive Director, Greg assembled and led a team of eight professionals to support the work of the Vice President in developing and promoting the goals of the Cancer Moonshot in numerous meetings and presentations and to coordinate the work of the Task Force comprised of twenty cabinet and sub-cabinet offices.
Over the past ten months Greg and his team worked across the Task Force, academia and the private sector to create over seventy innovative collaborations. On October 17th, 2016, Greg joined the Vice President to present the Cancer Moonshot reports to President Obama in an Oval Office briefing. On December 7, 2016, the passage of the 21st Century Cures Act provided $1.8 billion for the Cancer Moonshot over the next seven years.
In his career, Greg has held senior positions in both chambers of Congress, was Chief Domestic Policy Advisor to Vice President Al Gore, was a senior strategy consultant to a variety of international technology CEO’s, co-founded and led FasterCures and the Melanoma Research Alliance, was the Senior Vice President at Pfizer for worldwide policy and public engagement and was the CEO of Poliwogg, a financial services company creating unique capital market opportunities in healthcare and life sciences. He has developed a reputation as a visionary strategist, a dynamic public speaker and writer, and as a knowledgeable analyst of emerging trends in healthcare, information technology, innovative drug research and development and patient advocacy.
Greg came to Washington, DC in 1985 as General Counsel and then Staff Director of the Investigations Subcommittee of the House of Representatives’ Science, Space and Technology Committee. During his years with the Science Committee, Greg organized a series of investigatory hearings on biotechnology policy and was involved in hearings and investigations related to NASA and the Challenger explosion, scientific misconduct, the use of human biological materials in research and the artificial heart program.
Mr. Simon served as Sen. Gore`s Legislative Director from 1991 to 1993 before joining him in the White House as his Chief Domestic Policy Advisor. He was the lead staffer for the Clinton-Gore Administration for development and passage of the Telecommunications Reform Act of 1996 as well as development of the National and Global Information Infrastructure. He represented the Vice President on the National Economic Council, helped negotiate the US-Russia agreement on the International Space Station and oversaw a number of key initiatives, including programs at the National Institutes of Health, the National Cancer Institute, the Food and Drug Administration, and the Human Genome Project. He was also instrumental in crafting the regulatory framework that is now the foundation for the biotechnology industry.
Following his White House service Greg was CEO of Simon Strategies and provided strategic advice to CEO’s of major firms such as Sony, Cisco, Netscape, Motorola, Sega and AOL.
Starting in 2003, Mr. Simon worked with Mike Milken to co-found FasterCures/The Center for Accelerating Medical Solutions. FasterCures has become an organization valued and recognized for catalyzing systematic change in the process of discovery and development and of new therapies for deadly and debilitating diseases.
Under Greg’s leadership, FasterCures created the FasterCures Philanthropy Advisory Service, with funding from the Robert Wood Johnson Foundation and the Bill & Melinda Gates Foundation. This initiative accelerates and increases the flow of philanthropic support to nonprofit medical research organizations by providing in-depth data on the methods, goals, and potential impacts of nonprofit medical research organizations engaged in specific disease areas. He also created The Research Acceleration and Innovation Network (TRAIN) to promote innovation in disease research and to support the activities of organizations engaged in cutting-edge research.
While at FasterCures Greg co-founded the Melanoma Research Alliance with Leon and Debra Black.
From 2009-1012 Simon was Senior Vice President for Worldwide Policy and Patient Engagement at Pfizer, Inc. He led a global team of professionals in: 1) worldwide government policy, 2) science policy, 3) economic policy and research, and 4) international policy. He advised the CEO on the company’s efforts in Healthcare Reform. He also focused on engaging patients more productively in research and clinical trials and on helping Pfizer develop policies, practices, and medical solutions to improve health, happiness and productivity.
Prior to becoming Executive Director of the Cancer Moonshot, Greg was the CEO of Poliwogg, a financial services company creating unique capital market opportunities in healthcare and life sciences. Poliwogg’s first index, the Poliwogg Medical Breakthroughs Index, was the basis for the best performing health Exchange Traded Fund, “SBIO,” in 2015.
The journal Nature Medicine named Greg one of “Ten People to Watch” in health care policy, noting that he was among “a handful of influential people who quietly keep the wheels of biomedical science turning.” In 2010 he received the Genetic Alliance’s “Art of Advocacy” award. In May 2011 Greg was invited to be the second lecturer in the Constantin Spiegelfeld Lecture series of the Research Center for Molecular Medicine of the Austrian Academy of Sciences. He is the recipient of the Arab American Institute’s 2017 Najeem Halaby Public Service Award established by Queen Noor in memory of her father. He is a regular presenter at the Milken Institute Global Conference, the OECD, the Washington Campus (a nonprofit educational institution in Washington, D.C.) and at health conferences and academic institutions around the country.
He received his law degree from the University of Washington in 1983 where he was a member of the Law Review and the Moot Court. He has a B.A. in history from the University of Arkansas.
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Mr. Simon entered government service in 1985 as General Counsel and then Staff Director of the Investigations Subcommittee of the House of Representatives' Science, Space and Technology Committee, organizing some of the earliest investigatory hearings on biotechnology policy. Mr. Simon was Sen. Al Gore’s Legislative Director from 1991 to 1993, before joining his White House administration as Chief Domestic Policy Advisor. While at the White House, Mr. Simon helped develop the Telecommunications Reform Act of 1996 as well as National and Global Information Infrastructure initiatives and was instrumental in crafting the foundational regulatory framework for the biotechnology industry.
[...]
Others in the White House inner circle will be Bruce Lindsay, a longtime friend of Mr. Clinton, who will be in charge of personnel; David Watkins, the campaign's director of operations, will head the office of Administration and Management; Christine Varney, the campaign's counsel, will be Cabinet secretary; John Podesta, a Democratic political consultant, will be staff secretary, and Nancy Hernreich, a longtime executive assistant to Mr. Clinton, will be in charge of appointments and scheduling.
The head of legislative affairs will be Howard Paster, Washington director of a public relations firm, and the head of public liaison will be Alexis Herman, who was chief executive of the Democratic convention.
Margaret A. Williams, a former communications director for the Children's Defense Fund, will be Mrs. Clinton's chief of staff. Vice President-elect Al Gore's chief of staff will be Roy Neel, his longtime top Senate aide.
Other White House appointments announced today were:
Office of the Counsel: Vince Foster, deputy counsel; Ron Klain and Cheryl Mills, assistant counsels.
Office of the First Lady: Melanne Verveer, deputy chief of staff; Lisa Caputo, press secretary; Ann Stock, social secretary, and Patty Solis, scheduling director.
Domestic Policy Council: Bruce Reed and William Galston, deputy assistants, and Shirley Sagawa, special assistant.
National Economic Council: Gene Sperling and W. Bowman Cutter, deputy assistants.
National Security Council: Nancy Soderberg, staff director.
Senior Adviser for Policy Development: Ira Magaziner.
Office of Communications: Ricki Seidman, David Dreyer and Jeff Eller, deputy assistants; Bob Boorstin, Michael Waldman, David Kusnet, Anne Walker and Keith Boykin, special assistants.
Legislative Affairs: Susan Brophy, deputy director, and Steve Richetti, special assistant.
Scheduling and Advance: Marcia Hale, director, Isabelle Rodriguez Tapia, deputy director.
Public Liaison: Doris Matsui, deputy director; Mike Lux and Amy Zisook, special assistants.
Political Affairs: Joan Baggett, deputy director, and Elaine Weiss, special assistant.
Intergovernmental Affairs: Regina Montoya, director, and Jeff Watson, deputy director.
Office of Vice President: Thurgood Marshall Jr., legislative affairs coordinator; Greg Simon, domestic policy adviser; Marla Romash, communications director; Leon Fuerth, national security; Jack Quinn, counsel, and Katie McGinty, special assistant for environment.
With the first two genetically engineered crops a few months away from American food stores, a scientific policy organization called on the Government yesterday to delay commercial approval until the United States better understands the potential risks the plants may pose to the environment.
In a study intended to provoke the Clinton Administration into reconsidering policies that were instituted in the Reagan and Bush years, the organization, the Union of Concerned Scientists, said that the new plant technologies were not being adequately controlled by the Government.
Responding to the study, Greg Simon, the Administration's top biotechnology policy coordinator, said most of the issues it raised had been debated extensively within the Government and among scientists.
"The Department of Agriculture has done a very good job with the review of genetically engineered plants and on the environmental assessments of those plants," said Mr. Simon, the chief domestic policy adviser for Vice President Al Gore.
Roger Salquist, the chief executive officer of Calgene Inc., a plant biotechnology company in Davis, Calif., said that since 1986, when the Government instituted new procedures for testing genetically engineered plants outdoors, not a single experiment had indicated that the crops were an environmental threat. "If there had been even the slightest problems, they would have appeared in one of those tests," said Mr. Salquist, whose company developed a new tomato that is awaiting approval by the Food and Drug Administration so it can be marketed.
An F.D.A. spokesman said yesterday that the agency was expected to complete its review some time in the next two weeks, and the new tomato could be in food stores in a few months. A variety of squash is also near final approval.
The study, "Perils Amidst the Promise," is part of a new project at the Union of Concerned Scientists to identify technologies and develop policies to help make modern agriculture less destructive of the environment. In a preface, the chairman of the group, Henry W. Kendall, said he hoped the report would provoke "serious public discussion of whether transgenic crops are likely to advance or retard progress towards a more sustainable agriculture."
In the study, Dr. Margaret G. Mellon, a molecular virologist, and Dr. Jane Rissler, a plant pathologist, indicated that they had doubts that biotechnology would be as safe as the Government and the industry have said. Both scientists recently moved to the Union of Concerned Scientists from the National Wildlife Federation, one of the nation's largest conservation groups, where they were well-known critics of biotechnology.
Among the many concerns that Dr. Mellon and Dr. Rissler raised about the safety of plant biotechnology were two basic issues: the unknown effects of using genetic material from plant viruses, and the possibility of creating plants that were so hearty they could become pests themselves.
They said scientists are inserting genes from plant viruses into crops as a way of enhancing immunity to plant diseases. Dr. Mellon and Dr. Rissler argue that not nearly enough research has been conducted to say whether the technique is entirely safe, especially when used on a commercial scale of thousands of acres of new crops. There is the potential, they said, for genetic engineering to lead to the formation of new plant viruses that threaten crops across an entire region.
"There are experiments you could do to determine whether risks are real or not," said Dr. Mellon. "We are not doing them. We are assuming the risks are nonexistent, and with a technology this new, that's not good enough."
Dr. Rod Townsend, a plant pathologist, and director of regulatory affairs at Pioneer Hi-Bred International, a crop breeding company in Des Moines, said that scientists had studied this issue and that field testing of crops with viral genes had not produced any problems.
Dr. Mellon's and Dr. Rissler's second main concern involved the potential creation of a sort of super plant that could outcompete its natural relatives and itself become a weed. The two scientists urged the Government to require more extensive testing to prevent such a possibility.
Since 1987, the Department of Agriculture has regulated the outdoor testing of genetically engineered crops. The department reports that in that time, almost 500 such crops have been field tested and none have resulted in environmental damage.
But Dr. Mellon said the field tests had been conducted under conditions too carefully prescribed to determine long-range environmental risks. For instance, if the Government was interested in knowing whether a genetically engineered crop might become a weed, it should require that some plants be placed at the edges of a field near real weeds.
https://www.c-span.org/video/?60573-1/national-information-infrastructure
SEPTEMBER 30, 1994
National Information Infrastructure
A communications executive and two policy advisors talked about technology improvements and regulatory approvals which will contribute to the development of the national information superhighway. They said ultimately, competition, not mergers, will create the superhighway. close
During the past three years, however, the FDA's biotechnology policy has undergone a sea change. This was accomplished in several ways. First, it is no coincidence that FDA Commissioner David Kessler is the only senior political appointee from the Bush administration still in government. He has survived by being willing to craft any policy, make any decision, cut any corner, in order to satisfy his political masters. Second, the vice president's influence is pervasive. Instructions from the Clinton administration are relayed from Gore's senior adviser for domestic policy, Greg Simon, via FDA's political commissar, a former Gore Senate s*affer named Jerold Mande, and several other senior off*cials with close personal or family ties to the vice president. Directives from the White House pertain to regulatory policies, decisions on individual products, and personnel changes. Their effect has been to undermine the scientific paradigm that has governed FDA policy for 15 years.
[ .... }
FDA's recent actions are damaging enough, but they leave the door open to oth ers that would be positively nefarious. If t he White House has directed agencies' decisions for reasons of ideology, how far-fetched is the idea that it might do so for reasons of politics? Who would be surprised, say, by White House encouragement to delay approval of a product made by a company known for giving generously to Republican causes or to expedite a product made by a company friendly to the administration? To those who would say that such unethical and illegal actions are unthinkable, particularly in an administration that promised its leaders would be moral exemplars, read on.
Since A1 Gore became vice president, he and Greg Simon have been intolerant of any challenge to their view of science policy. They have gone to extremes that Hazel O'Leary could only dream of, in order to purge their enemies -- extremes reminiscent of the Nixon administration.
To control science and technology policy and to rid the civil service of dissent, Gore and Simon have interfered improperly in personnel matters. Thus, while working for the vice president, Simon threatened a high-ranking official at the Department of Energy with retaliation if she hired the former assistant director of the National Science Foundation, David Kingsbury. Simon and Kingsbury had clashed on biotechnology policy in earlier years; while a congressional staffer, Simon had hounded Kingsbury from government with unsubstantiated charges of conflict of interest. Also while working for the vice president, Simon improperly ordered FDA to remove a senior civil servant from his position. An FDA official admitted that this was retribution for the " transgression" of having implemented Reagan-Bush-era policies. Gore himself dismissed Will Happer, a senior scientist at the Department of Energy, because Happer refused to ignore scientific evidence that conflicted with the vice president's theories on ozone depletion and global warming. Similar incidents have occurred at the departments of State, Energy, and Interior, and at EPA, where civil servants have been moved to less visible positions or temporarily replaced during interactions with the White House for their own "protection."
One has to wonder how much of this the president knows. The vice president's policies and actions conflict, after all, with Clinton's repeated promises to give the country "leaner, but not meaner," government. It is possible, of course, that on that point, as on others, Clinton has changed his mind.
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Mr. Mike McCurry and others briefed reporters on various issues, including a Cuban-American memorial ceremony for the victims of the recent aircraft downing, the extension of the Whitewater investigation and President Clinton’s meeting with television industry executives about a ratings system. close
https://www.c-span.org/video/?70224-1/white-house-daily-briefing
1998-09-29-nytimes-the-business-of-persuasion-thrives-in-nation-s-capital.pdf
By Jill Abramson / Sept. 29, 1998
Dollars on Parade - A World Awash With Big Money
The Million-Dollar Man - A Tax Analyst Joins the Fold
Show Us the Money - Fat Paychecks For Everyone
A Bipartisan Bazaar - Peddling on Both Sides of the Fence
Field Draws Many - The Experienced And the New Too
The Right Connections - Gore or Gingrich: Gucci Gulch Ties
Thomas K. Downey, a New York Democrat, came to Washington in 1974 as the youngest of the Watergate Babies, the Young Turks who were elected to clean up Washington the year of President Nixon's resignation.
No longer a young reformer, Mr. Downey, who lost his seat in 1992, heads a lobbying firm, Downey & Chandler, that earned more than $2 million last year from clients like the Boeing Company, Microsoft and Time Warner Inc.
The former New York Congressman is also the most important member of Vice President Al Gore's kitchen cabinet of advisers. All of the members of this informal advisory group are expected to play pivotal roles in his Presidential campaign in 2000 and many are charter members of the K Street elite. The group includes top Democratic fund-raisers like Mr. Knight and Mr. Dutko and two former domestic policy advisers to Mr. Gore, Roy Neel and Greg Simon, who both lobby for telecommunications interests. Another member is Jack Quinn, the former White House counsel who was also Mr. Gore's chief of staff. Mr. Quinn was a lead lobbyist for a coalition of computer companies that pressed for a new administration policy, announced earlier this month by Mr. Gore, that loosened regulations on the export of sensitive software and hardware that shields information from public scrutiny.
In an interview, Mr. Downey said he kept his lobbying separate from his friendship with Mr. Gore, with whom he frequently socialized. (Mr. Gore tore a muscle while playing basketball with Mr. Downey in the House gym).
And far from feeling like he has sold out his old principles, Mr. Downey said, ''I do more interesting things now than I did as a member of Congress.'' One thing that is different is how he lives. When he served in Congress, his family had a cramped Capitol Hill town house. They now live in a large home near the National Cathedral, a house with a hand-painted dining room mural, that, he joked, ''looks like one of my fund-raisers should be living in it.''
Mr. Gore's coziness with lobbyists is hardly unusual. The Federal Election Commission has been investigating whether the House majority whip John A. Boehner's weekly tete-a-tetes with business lobbyists involved unlawful coordination of their political activities, allegations that Mr. Boehner has denied.
Former Representative Vin Weber is among the most successful of a new crop of Republican lobbyists. Working as a tag team of political influence, Mr. Weber often pairs up with Mr. Downey for clients, including Microsoft. He works out of the gleaming offices of Clark & Wienstock, a Wall Street consulting firm that did not have a Washington outpost until Mr. Weber opened one in 1994, after he retired from Congress.
Cancer survivors and health care industry representatives testified about cancer research and patient care. Topics included research funding and innovation, the quality of patient care, preventative medicine, early detection, and access to care for uninsured and minority groups. They also spoke about quality of life and survivors' concerns. close
https://www.c-span.org/video/?205238-1/cancer-research-patient-care
https://www.youtube.com/watch?v=ej7jPaRNqGI
Video channel "Genetic alliance" ... He says "patient engagement" is the big change, not genetics
WASHINGTON — Vice President Joseph R. Biden Jr. will announce on Friday a corporate executive to lead his “moonshot” cancer initiative, selecting an expert who began work in 2003 to lower barriers between science and cures.
Greg Simon, 64, who will be named executive director, took a job he may get to keep for only the last 10 months of the Obama administration. Mr. Simon, who is battling cancer himself, said he understood the urgency of the task.
“There are so many things in the cure process that take too long,” he said.
In June 2014, Mr. Simon received a diagnosis of chronic lymphocytic leukemia, a blood and bone marrow disease, and six months ago completed his first round of chemotherapy. He is now healthy, but while fighting the illness one of his close friends died, leaving two young children.
“The vice president has a chance to change the culture of science,” Mr. Simon said. “And if we can create new approaches that are a step away from the road scientists have long been traveling, in a year or two it will be a different road.”
Mr. Simon was an aide to Vice President Al Gore from 1991 to 1997, eventually leaving as his top domestic policy adviser to set up a lobbying and advisory firm. In 2003, he was lured by Michael R. Milken to start FasterCures, a charity intended to speed the translation between basic research and lifesaving medicines. In 2009, Mr. Simon left FasterCures to become senior vice president for patient engagement at Pfizer. He left Pfizer in 2012, and has been working since then as the chief executive of Poliwogg, a financial services company focused on investing in life sciences.
“With his amazing breadth of experience, both in the public and private sector, he will bring an invaluable knowledge of the health care landscape to the task force,” Mr. Biden said in a statement.
At FasterCures, Mr. Simon was a prominent voice for the potentially transformative effects of sequencing the human genome.
“In the lifetime of my generation, most of the diseases we are dealing with, if not cured, should be turned into treatable chronic diseases,” Mr. Simon said in 2007, speaking of a notion that was widely held at the time but that most researchers now believe was wildly optimistic. But even then, Mr. Simon said that to achieve such breakthroughs, “we have to have a new system.”
Mr. Simon has been critical of the Food and Drug Administration and the National Institutes of Health, organizations where, he once said, “curing disease is a byproduct of the system and not a goal.” He will now have to work closely with both agencies, which have representatives on the task force. Mr. Biden, whose son Beau died from cancer last year, is the chairman of the initiative, which hopes to promote a decade’s worth of advances in cancer research in five years. But with just $195 million in new funding, the task force is considered an exceedingly modest effort.
Mary Wooley, the president of ResearchAmerica, an advocacy group, said Mr. Simon had an unusual ability to bring together diverse groups of people to focus on a problem.
“Maybe with persistence, we can overcome the legacy systems and thinking that slow things down,” Ms. Wooley said.
Elizabeth Marie Walsh, a daughter of Dr. Marie B. Walsh and Michael S. Walsh of Baton Rouge, La., was married May 21 to Michael Reid Simon, the son of Margo L. Reid and Gregory C. Simon of Bethesda, Md. The Rev. Andrew D. Sutton, a friend of the couple and a minister of the First United Methodist Church of Lafayette, La., officiated at the Carnegie Institution for Science in Washington.
Ms. Walsh, 26, is keeping her name. She is the associate director of product management at Evolent Health, a health care technology and services company in Arlington, Va.
Her father is a partner in Taylor, Porter, Brooks & Phillips, a law firm in Baton Rouge. Her mother is the director of the Louisiana Local Technical Assistance Program at the Louisiana Transportation Research Center on the campus of Louisiana State University. The program finances highway safety improvements in Louisiana.
Mr. Simon, who is also 26 and is known as Reid, works in Reston, Va., as a software development consultant with Microsoft.
His mother is a Bethesda-based consultant to arts and environmental organizations, including, most recently, the Glen Echo Park Partnership for Arts and Culture, the former amusement park in Glen Echo, Md., that is now an arts center. His father, who works in Washington, is the executive director of the White House Cancer Moonshot Task Force led by Vice President Joseph R. Biden Jr.
Ms. Walsh and Mr. Simon met in September 2008 during a pre-semester convocation at the University of Pennsylvania, from which they later graduated, she with two bachelor’s degrees, in international relations and political science, and he with a bachelor’s degree in systems science and engineering.
“In the brief time that we spoke, I found her to be smart, sassy and very confident,” Mr. Simon said.
They soon realized that they lived a floor apart in the same dormitory. “It wasn’t really where the cool kids were,” Mr. Simon said. They became fast friends.
“He was very kind and very smart, creative and inclusive,” Ms. Walsh said. “He had all the qualities you would want in a friend, especially when you’re trying to make other friends.”
In July 2009, he flew to visit her at her family’s home in Baton Rouge, where he stayed for three days, leading their families to “start becoming skeptical about our so-called friendship,” as Mr. Simon put it.
“I distinctly remember my mom being suspicious,” she said. “Moms just know.”
When she returned the favor by visiting his family for Thanksgiving, “nobody believed that we were just friends anymore,” Mr. Simon said.
By December, they were dating steadily, and were still dating in January 2011, when Ms. Walsh, now in her junior year, went on a five-month study-abroad program to Cape Town. In March, Mr. Simon boarded a plane for Cape Town.
“Getting together in South Africa was a sign of our deep commitment,” he said. “We were both very ambitious and very driven people who, by that time, felt very comfortable around each other.”
After graduation, both landed jobs in Washington, and last October, he proposed on a frigid, blustery day at Shenandoah National Park in Virginia, where they went hiking. As they began their descent in the face of fierce, cold winds, Mr. Simon suddenly dropped to one knee and pulled out an engagement ring.
“He was so nervous about dropping the ring that he was not willing to let it out of his hands,” she said, laughing. “I had to kind of fight him for it, and I finally managed to take it away and slip it on my finger.”
General Session: Greg Simon, Biden Cancer Initiative; Acting President, MediMergent
Channel HLTH
HLTH is the leading platform bringing together the entire health ecosystem, focused on health innovation and transformation.
260 views Nov 11, 2019
Can You Hear Me Now?: Engaging Patients in Accelerating the Development of New Cancer Therapies: Wednesday, October 30, 2019
Our Company
We are a newly organized blank check company incorporated in Delaware, formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses, which we refer to throughout this prospectus as our initial business combination. We have not selected any specific business combination target and we have not, nor has anyone on our behalf, engaged in any substantive discussions with respect to a potential initial business combination with us. While we may pursue an initial business combination with a company in any sector, we intend to focus our search on life science companies that are using artificial intelligence (“AI”), machine learning (“ML”) and big data to create and power a new model of drug discovery through research and development that is far faster, less expensive and more predictable than the decades-old system of drug development we still follow today.
With a broadening set of applications for biotechnology that includes research tools and infrastructure, diagnostics, therapeutics, data, and industrial outputs, we believe the life sciences sector offers compelling opportunities for investors who possess a broad overview and understand the trends and themes. We combine a unique team of thought leaders who have deep experience and national reputations within academia, government and industry that will enable us to attract and evaluate the over 250 companies utilizing these new tools across the life sciences industry.
The Human Genome Project Meets Moore’s Law
In 1996, it took all night to download a 1 MB image over a traditional phone line. Today, internet speeds are basically instantaneous, computing power is growing according to Moore’s Law and data storage is practically unlimited.
In 1996, it took 10 to 12 years and hundreds of millions of dollars to bring a drug to market. Today, it still takes 10 to 12 years, but now over $2.5 billion to develop a successful drug. This cost consists of approximately $1.4 billion out-of-pocket expenses and $1.2 billion of time costs.
We believe the need for a new system of drug discovery is obvious. According to the NIH, there are about 8,000 diseases but only 500 of which have FDA approved treatments. The vast majority of these treatments manage but do not cure, such as insulin for diabetes and statins for cholesterol. We cannot afford the time or money to develop therapies for all of these diseases at 10 to 12 years and billions of dollars each.
To address these unmet needs with cures and lower their associated costs requires a new approach to drug discovery. The advent of true AI and ML, combined with big data from millions of medical records and millions of compounds, provides the opportunity to re-engineer the drug discovery process to dramatically reduce the time between discovery and clinical trials, to develop new biomarkers and diagnostic tools, to design drugs that are more likely to work without being toxic, to more accurately predict the results of clinical trials and to provide better outcomes for millions of people. That is why many research organizations are predicting that all drugs will be developed using AI by 2030.
This is possible because Moore’s Law is finally meeting the Human Genome, the mapping of which was completed in 2002. We now have the ability to harness genetics, proteomics (the study of proteins) and big data to create the biopharma research and discovery engine for the 21st Century.
Market Opportunity
Healthcare costs in the United States have been rising faster than inflation for more than a decade. Total healthcare expenditures exceeded $4 trillion in 2020, representing nearly 19% of gross domestic product. At the same time, “baby boomers” have begun to enter the years of their life with the highest medical costs. Baby boomers are now 57 to 75 years of age and number approximately 75 million. The average senior citizen will spend nearly $400,000 on healthcare costs during their remaining lifetimes.
Pharmaceutical expenditures represent approximately 10% of the nearly $4 trillion healthcare expense as currently estimated. A substantial portion of those funds are spent to treat chronic conditions (such as
hypertension, high cholesterol and diabetes) and congenital lifelong conditions (including chronic kidney disease and sickle cell anemia). A large portion of the remainder is spent on the treatment of various forms of cancer.
A significant portion of the drugs developed over the past 30 years by large pharmaceutical companies are designed to treat the symptoms of chronic disease. More recently, the biotech industry has developed biologic treatments that interfere in the mechanisms of disease and in some cases can prevent disease altogether.
Of the 8,000 known diseases in the world, almost 7,000 are rare diseases (these are diseases with a patient population of less than 200,000, and while each disease is “rare,” collectively they impact millions of people). The majority of the more than 7,000 rare diseases were until very recently considered “undruggable,” either because they were based in the genetic code or because the mechanism of the disease was not understood. Since the Human Genome Project finished mapping the human genome in 2002, scientists have developed the capability to map and understand the genetic footprint of many diseases. They are no longer undruggable. Medical professionals have developed tools, such as CRISPR, which allow doctors to correct mistakes in the genome that cause disease. Suddenly, in just the past ten years, scientists have the ability to seek treatments that potentially lead to the cure of many diseases that have previously been undruggable. Curing a disease eliminates the substantial costs of chronic treatment.
While scientists now have the ability to create hundreds or even thousands of new drugs, the drug development process has not kept up with the advances in understanding biology. 2020 was a record year for novel drug approvals by the FDA, when 53 drugs were approved. An incredible amount of time and money goes into drug development. Bringing the average drug to market costs more than $2.5 billion and can take 10 to 12 years. This capital cost means the drugs must be expensive in order for the manufacturer to recoup its outlays, especially over a multi-year investment horizon. The singular focus on developing a few dozen drugs a year leaves many people untreated: estimates are that at least 150 million Americans have at least one chronic illness.
Utilizing AI and ML can accelerate the process dramatically while at the same time reducing costs and, more importantly, create drugs that are more effective with less side effects and toxicities. The venture capital community has recognized this potential. Healthcare AI startups were able to raise over $2 billion in the third quarter of 2020, with most of that money going to companies seeking to streamline the drug development process. Over the past five years, more than 250 startups have been funded in the AI/drug discovery space, raising almost $10 billion of venture capital.
AI and ML have already delivered substantial innovations in our society. Google Maps, digital assistants and e-payments have all become possible through AI and ML. Now, healthcare professionals are applying this science to drug discovery and development. Electronic health records have created massive data sets that can now be analyzed to accelerate the discovery of new targets for treatment. Along with scans of existing medical literature and genetic data sets, scientists can discover gene-disease associations identifying even more targets.
According to a study by researchers from the London School of Economics conducted on Food and Drug Administration (the “FDA”) approved data from 2009 to 2018, the average cost of bringing a drug to market was $1.3 billion (after accounting for the cost of failures). During this ten-year period, the FDA approved 355 drugs. When most diseases were thought to be undruggable, this rate of approval appeared sufficient. We believe that it no longer is. The development period for these drugs is at least 10 to 12 years and in some cases more than a decade. Both capital and time are gating issues in garnering drug approval. We believe that many millions of people will cost the healthcare system trillions of dollars suffering from diseases that could be mitigated or cured during their lifetimes. Instead of spending $1 billion per drug and taking several years, we need to (and likely can) reduce both the time and cost significantly through AI and ML.
As outlined above, the traditional drug development process is complex and lengthy. Developing a drug for any disease requires a lengthy preclinical and clinical development process. In short, the preclinical stage is an experimental stage of four to seven years including many steps in the current state-of-the-art process that requires a high level of educated guessing to reach an effective drug that can enter into clinical trials. These steps include:
identifying one of the molecules (genes/proteins) that are responsible for the disease through experimental discovery;
(2)
finding a drug that targets this molecule based on its three-dimensional structure, which requires a lengthy process of making the protein and developing its crystal structure;
(3)
experimentally screening arrays of millions of drugs and compounds that are publicly available, or synthesizing new drugs by predicting their structures on the basis of the protein’s three-dimensional structure, to identify the one that can target the molecule and correct or stop its function; and
(4)
refining the identified compounds to be suitable for human use by decreasing their potential toxicities and enhancing their functionality through modifying and synthesizing hundreds or even thousands of new forms of the compounds and experimentally conducting arrays of assays and animal experiments — a process that undergoes many cycles until a suitable one is identified.
The drug then moves to the clinical stage of an additional four to six years of three stages of clinical trials development: phase 1 to identify the spectrum of tolerability and dose that patients can be treated with; phase 2 to identify the efficacy of the drug in certain conditions; and phase 3 to establish the superiority of the new drugs over standard therapy. This lengthy, highly complex and extremely expensive process can be substantially shortened and made more efficient and less expensive through the utilization of AI, which can assist and sometimes replace some of the steps outlined above. This especially decreases the need for certain long and extensive experimentations and substantially increases the level of certainty during the process. Some of the AI contribution includes:
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identifying proper molecular targets in specific diseases though molecular network mining and computer three dimensional modeling; and
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identifying potential drugs through mining of millions of publicly available compounds using computer models of binding of the drug to the targeted molecule and further using specific algorithms and machine learning to improve these drugs and make them more suitable for human use.
This decreases, and in some cases eliminates, the need for lengthy experimental steps and can be much more accurate. On the clinical side, AI can help in identifying the appropriate patients to increase the potential of success in clinical trials.
Moderna Therapeutics is a biotech company that has received a large amount of press throughout 2020 surrounding its development of an mRNA vaccine candidate for COVID-19, mRNA-1273. Founded in 2010, a time when many companies were beginning to undergo digital transformation, of which AI/ML is a fundamental building block, Moderna looked to incorporate digitization as a “core attribute and key enabler” in its business model and infrastructure from inception. By embracing advanced analytics early on, alongside its focus on mRNA-based therapeutics, Moderna has been able to efficiently identify high potential drug candidates for further investment. Machine learning technology further speeds up the development process by optimizing the mRNA sequence for manufacturing and testing. The efficiency this process offers is clearly seen in the development of mRNA-1273, which was ready to initiate phase 1 clinical trials in a record-breaking 42 days and which went through all clinical testing and approval in record time. Given the complexity and cost associated with the traditional drug discovery process, if successful, this approach has the potential to revolutionize drug development and, in turn, the biopharma industry.
We believe that current market dynamics support our differentiated ability to identify and nurture private companies that embody the potential of AI/drug discovery. We believe that we will be an attractive financing alternative for AI companies given the depth and breadth of our team’s experience. Partnering with our company can be an efficient means to unlocking innovation value through the public markets.
Acquisition Strategy
We believe our management team is well-positioned to identify unique opportunities in the healthcare sector, particularly in areas in which AI, quantum computing and biomedicine converge. Our selection process will leverage our extensive network of relationships with senior executives in both private and public
companies, unique access to deal flow from top-tier venture capital and private equity funds and leading investment banking firms. We believe that our management team’s reputation, depth of operating and investing experience, history of structuring and executing mergers and acquisitions and other transactions, will make us a preferred partner for these potential targets.
Consistent with our strategy, we have identified the following criteria to evaluate prospective target businesses. We intend to seek to acquire companies that we believe are characterized by one or more of the themes below:
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data-driven approaches to accelerate the drug discovery and development process;
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the collection and analysis of real world evidence to inform expanded or novel uses of existing drugs; and
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novel biologics in pursuit of solutions for diseases that have largely been considered undruggable to date.
Any company that we target, in addition to being characterized by one or more of the areas of focus described above, should be ready to be a publicly-traded company, with strong management and reporting policies in place. Lastly, we would expect the target to have unrecognized value or growth characteristics that we believe are likely to be appreciated by the market in the short term, thus enabling above-average risk-adjusted returns.
Our Officer
Our officer is Gregory C. Simon (Chief Executive Officer and Chief Financial Officer), who brings a combination of strategic, scientific, technological and operational experience paired with a track record of being at the forefront of technological and scientific advances. We believe our officer’s expertise will make us an attractive partner to potential target businesses, and will bring unique value creation opportunities through his networks.
Gregory C. Simon serves as our Chief Executive Officer, Chief Financial Officer and member of our board of directors. Most recently, Mr. Simon was the Executive Director of the White House Cancer Moonshot Task Force, a position created by President Barack Obama and for which he was chosen by Vice President Joe Biden in March 2016. In 2017, Mr. Simon co-founded and served as President of the Biden Cancer Initiative. Previously In his career, Mr. Simon held senior positions in both chambers of Congress, was Chief Domestic Policy Advisor to Vice President Al Gore, and was a senior strategy consultant to a variety of international technology CEO’s. With Michael Milken, Mr. Simon co-founded and led FasterCures and the Melanoma Research Alliance. He was the Senior Vice President at Pfizer for worldwide policy and public engagement and was the CEO of Poliwogg, a financial services company creating unique capital market opportunities in healthcare and life sciences. Mr. Simon is currently a member of the board of directors of WinSanTor Inc., a biotechnology company focused on the discovery and development of treatments for peripheral neuropathies. He has developed a reputation as a visionary strategist, a dynamic public speaker and writer, and as a knowledgeable analyst of emerging trends in healthcare, information technology, innovative drug research and development and patient advocacy.
Name : Gregory C Simon / [Greg C Simon] / [Gregory C Reid]
Birth Date : Nov 1951
Residence Date : 1977-2020
Address : 9001 Burdette Rd / Bethesda, Maryland, USA / 20817
Second Residence Date : 2014-2019
Second Address : 425 Park Ave S Apt 3a / New York, New York, USA / 10016
Third Residence Date : 1988-2004
Third Address : 710 Hankin St / Silver Spring, Maryland, USA / 20910
Fourth Residence Date : 1998-2002
Fourth Address : 2100 Pennsylvania Ave NW Ste 535 / Washington, District of Columbia, USA / 20037
Name : Gregory C Simon / (Gregory C Reid, Greg B Simon)
BIRTHDATE : 11/18/1951 (71yrs)
LOCATION : Bethesda, MD
8711 Honeybee Ln / Bethesda, MD 20817
710 Hankin St / Silver Spring, MD 20910
9001 Burdette Rd / Bethesda, MD 20817
1001 G St NW Ste 900E / Washington, DC 20001
2100 Pennsylvania Ave NW Ste 535 / Washington, DC 20037
5046 Baker Ave NW / Seattle, WA 98107
3623 Roblar Ave / Santa Ynez, CA 93460
1341 G St NW Ste 1100 / Washington, DC 20005
612 Kent Oaks Way / Gaithersburg, MD 20878
509 7th St NW / Washington, DC 20004
1101 New York Ave NW Ste 620 / Washington, DC 20005
2227 20th St NW Apt 203 / Washington, DC 20009
1414 22nd St NW Apt 52 / Washington, DC 20037
Relatives & Associates
Paul Edward Simon / Age 40s / Bethesda, MD
Jennifer Fielder Younger / Age 70s / Denver, CO
Reid Andrew Simon / Age 30s / Gaithersburg, MD
Sandy J Tyrholm / Age 70s / Santa Ynez, CA
Michael Reid Simon / Age 30s / Bethesda, MD
Sgt Michael Farris Simon ( Sgt, US army, WW2 )
BIRTH : 15 Jan 1910
DEATH 27 Aug 2001 (aged 91)
BURIAL : Elmwood Cemetery / Blytheville, Mississippi County, Arkansas, USA
MEMORIAL ID : 59628376 · View Source
1930 US census - Father "Michael Simonn" born in Georgia .. .grandad from Syria..
https://www.ancestry.com/imageviewer/collections/6224/images/4532443_00269?pId=86903323
Michael Farris Simon ancestry page : https://www.ancestry.com/family-tree/person/tree/161912174/person/362398081916/facts?_phsrc=kyz754&_phstart=successSource
Name :Barry S Simon / [Barry Simon]
Birth Date : 13 Nov 1949
Residence Date : 1993
Address : 8711 Honeybee Ln / Bethesda, MD / 20817-6920
Second Residence Date : 1980
Second Address : 2012 N Kensington St / Arlington, VA / 22205-3210
Barry Steven Simon
BIRTHDATE : 11/13/1949 (73yrs)
LOCATION : Washington, DC
Relatives
Paul Edward Simon / Age 40s / Bethesda, MD
Reid Andrew Simon / Age 30s / Gaithersburg, MD
Gregory C Simon / Age 70s / Bethesda, MD
Michael Reid Simon / Age 30s / Bethesda, MD
M Simon Gregory / Age 80+ / Santa Ynez, CA
Detail Source
Name
Mike Simon
Birth Date
15 Jan 1910
[15 Jan 1913]
Residence Date
1993
Phone Number
763-6117
Address
300 E Missouri St
Residence
Blytheville, AR
Postal Code
72315-2945
Second Residence Date
1993
Second Phone Number
763-6117
Second Address
300 E Missouri St
Second Residence
Blytheville, AR
Second Postal Code
72315-2945
Name
Mike Farris Simon
Gender
Male
Age
28
Relationship to Draftee
Self (Head)
Birth Date
15 Jan 1912
Residence Place
Blytheville, Mississippi, Arkansas, USA
Registration Date
16 Oct 1940
Registration Place
Blytheville, Mississippi, Arkansas, USA