DOCSLIB.ORG

2019 FDA Science Forum

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
2019 FDA Science Forum 2019 FDA Science Forum Transforming Health : Innovation in FDA Science September 11 & 12, 2019 • 2019 FDA Science Forum Transforming Health: Innovation in FDA Science Wednesday, September 11, 2019 & Thursday, September 12, 2019 FDA White Oak Campus, Great Room www.fda.gov/scienceforum • Table of Contents A Message from FDA’s Acting Commissioner, Ned Sharpless, MD . 6. A Message from FDA’s Chief Scientist, RADM Denise Hinton . 8. Opening Remarks from Amy Abernethy, MD, PhD, FDA Principal Deputy Commissioner, Chief Information Officer. 10 Keynote Speaker: Francis Collins MD, PhD, Director, National Institutes of Health FDA and NIH: Partners in Transformation . 11. 2019 FDA Science Forum Agenda . 12. Speakers Bios and Abstracts | Concurrent Session 1: Precision Health Regulatory Perspective on Digital Health for Precision Medicine . 20 Sex and Gender Differences in Health and Disease . 21 Clinical Trials In 200 Microliters – Extending Approval in Rare Diseases Using In Vitro Data. .23 Genomic Biomarker Use in Cardiovascular Disease Clinical Trials . .24 Learning Healthcare Systems and Big Data: Advancing the Goal of Precision Pain Medicine . 25 Speakers Bios and Abstracts | Concurrent Session 2: Advanced Techology Accelerating Innovation in Manufacturing Technology for Biomanufactured Products: Manufacturing U.S. and NIST . 27 MetagenomeTrakr Pilot Program for Rapid Foodborne Pathogen Detection . 29 The Promise of Microbial Genomics: How Microbiology is Standing Up to the Many Challenges of a 21st Century Food Supply . .30 Editing the Genome without DNA Breaks. .31 Computational Modeling for Medical Devices . 32 Avian Influenza A Susceptibilities to Pulmonary Surfactant Protein D: Confirmation of N-glycan sub-type as a Pathogenic Factor in Influenza . 33 Panel Q & A, Advanced Tehcnology at FDA: Potential Utility and Requlatory Challenges . .35 Speakers Bios and Abstracts | Concurrent Session 3: Product Accessibility, Integrity, and Security Violent Non-State Actor Use of Food as a Delivery System: Comparing ideological and Non-Ideological Perpetrators . 36 Product Availability: A Drug Shortage Perspective . 37 Bio-Terrorism Regulations and Food Security . 38 FDA Food Defense Efforts – A Preventive Approach to Food Terrorism. .40 On the ‘Cyber-Securability’ of Medical Devices . 42 Speakers Bios and Abstracts | Concurrent Session 4: Predictive Tools Developing Digital Measures from Person-Generated Health Data . 43 MRI In Nonclinical Safety Assessment . 44 The VICTRE Project: The First All-In-Silico Imaging Clinical Trial . 45 Use of The MHC Associated Peptide Proteomic Assay to Understand the Immunogenicity Risk of Therapeutic Proteins . 46 Cardiac and Hepatic Cellular Systems to Model Human Drug Effects . 47 C. elegans for Rapid Developmental Neurotoxicity Assessment of Mixtures . .48 Determination of Seafood Decomposition by Mass Spectrometry with Sensory-Driven Modeling . 49 Speakers Bios and Abstracts | Concurrent Session 5: Advancing Digital Health and Artificial Intelligence Assessment of Devices that Rely on Artificial Intelligence/Machine Learning . 51 Deep Learning for Polypharmacy and Drug Repurposing . 52 FDA’s Real-World Evidence Program – Technology and Innovation as a Cornerstone . 54 Assessment of Devices that Rely on Artificial Intelligence/Machine Learning . .56 AI at FDA: Potential Utility and Regulatory Challenges . .57 Speakers Bios and Abstracts | Concurrent Session 6: Outbreak! Innovation in Science: Protecting People from Emerging Infectious Disease Threats . 59 Foodborne Outbreak Investigations in the Whole Genome Sequencing Era . 60 Immune Responses to Zika Infections . 62 Tracking antibiotic resistance in Salmonella: The role of the National Antimicrobial Resistance Monitoring System . 63 Emerging & Pandemic Threat Preparedness . 64 Strengthening Regulatory Science to Support the Development of Medical Countermeasures for Emerging Infectious Diseases. .65 Speakers Bios and Abstracts | Concurrent Session 7: Addiction Drug Abuse in the U.S. 67 FDA Response to the Opioid Crisis . 68 Assessing the Structural and Pharmacological Similarity of Newly Identified Drugs of Abuse to Controlled Substances Using PHASE . 69 Preclinical Pharmacology of Novel Synthetic Opioids Appearing in Clandestine Drug Markets . 70 FDA Assessment of the Abuse Potential of Drugs, Including Opioids . 71 Speakers Bios and Abstracts | Concurrent Session 8: Impacting Public Health Through Electronic Media: Empowering Consumers, Patients, and Other Stakeholders Tobacco Regulatory Science – Understanding the Role of Flavor in E-Cigarette Marketing. .72 Using Content Analysis to Understand Tobacco Industry Use of Technology to Engage Consumers . 73 Consumers’ Use of Personal Electronic Devices in the Kitchen . 75 Assessment of Patient Perspective on Risks and Benefits Associated with High Intensity Focused Ultrasound (Hifu) for The Ablation of Prostate Tissue in Men With Localized Prostate Cancer . 76 Clinical Outcome Assessments in Medical Product Development . 78 Collect Once, Use Many Times: Challenges and Opportunities for the Use of Real-World Evidence to Improve Healthcare. .79 Poster Session 1 | Topic: Precision Health (Day 1, A.M.) . 80. Poster Session 1 | Topic: Advanced Technology (Day 1, A.M.) . .99 . Poster Session 2 | Topic: Advanced Technology (Day 1, P.M.) . 131. Poster Session 2 | Topic: Product Accessibility, Integrity, and Security (Day 1, P.M.) . 159 Poster Session 2 | Topic: Predictive Tools (Day 1, P.M.) . 175 Poster Session 3 | Topic: Predictive Tools (Day 2, A.M.) . .183 . Poster Session 3 | Topic: Advancing Digital Health and Artificial Intelligence (Day 2, A.M.) . 228. Poster Session 4 | Topic: Advancing Digital Health and Artificial Intelligence (Day 2, P.M.) . 234. Poster Session 4 | Topic: Outbreak! (Day 2, P.M.) . .237 . Poster Session 4 | Topic: Addiction (Day 2, P.M.). 269 Poster Session 4 | Topic: Empowering Consumers, Patients, and Other Stakeholders (Day 2, P.M.) . .272 Poster Guidelines . 285. Schedules. 286 Acknowledgements . .287 . Map of Building 31, Great Room . 291. A Message from FDA’s Acting Commissioner Norman E. “Ned” Sharpless, MD Acting Commissioner, FDA I’m honored to welcome you to FDA’s 2019 efficient risk-based monitoring. Science Forum. The Science Forum gives our As these transformative technologies are outstanding scientists an opportunity to share developed, FDA is increasing our expertise with the public the critical scientific activities and research in these areas to enable optimal and research that we perform daily to protect, review and regulation of products incorpo- promote, and advance public health across rating from cutting-edge technology, and to our entire regulatory portfolio, from medical help us leverage these tools, where appro- products and foods to tobacco products. priate, to maximize our public health impact. As we all know, the pace of scientific innova- FDA’s research is critical for developing the tion is accelerating. In just the past few translational science strategies and regula- years, we’ve seen transformative technolo- tory standards needed to assess innovative gies like artificial intelligence, whole genomic technologies that might not fit into older sequencing, and cell- or gene-based therapies regulatory approaches. Our research is result in FDA-approved or cleared products advancing our understanding of these novel that are advancing precision medicine--deliv- technologies and helping create the modern ering the right intervention to the right patient, regulatory approaches needed to assess their at the right time. safety and performance. What may not be as well appreciated is that I’d like to mention just a few of FDA’s ground- many of these technologies are transforming breaking scientific research efforts highlighted the way FDA conducts our mission, as they in our two-day Science Forum: create new opportunities for us to do our work more effectively and efficiently. For instance, Researchers in FDA’s Center for Food Safety new digital ledger technologies offer the and Applied Nutrition (CFSAN) are developing potential to help FDA determine the source or high-resolution forensic tools to help link origin of foodborne illnesses by tracking and foodborne illnesses that would have previ- tracing food from farm to table in seconds ously gone undetected. These tools, including instead of days or weeks. Predictive artificial whole genome sequencing (WGS), enable the intelligence algorithms can help our investiga- comparison of complete pathogen genomes tors to better target products for examination to better establish commonalties of illnesses and potentially stop unsafe food and medical and assist with determining the source of food products, including illegal drugs, offered for contamination, including individual farms or import at the border, before they reach our facilities and specific geographic locales. communities; identify facilities that should To support this effort, FDA created Genome- be prioritized for inspection; or to predict and Trakr, an integrated network of state and analyze risks in clinical trials to support more federal laboratories that uses whole genome 2019 FDA Science Forum 6 Transforming Health: Innovation in FDA Science sequencing to enhance traceback of foodborne always grab headlines like these other efforts, pathogens. GenomeTrakr comprises several but it is equally vital, and this Science Forum government food safety agencies and nearly gives us an ideal opportunity to show you three-dozen state, academic, and international
Load more

Recommended publications
  • The Honorable Francis Collins the Honorable Anthony S. Fauci
    The Honorable Francis Collins The Honorable Anthony S. Fauci Director Director National Institutes of Health National Institute of Allergy and Infectious Diseases Building 1 5601 Fishers Ln 9000 Rockville Pike Rockville, MD 20852 Bethesda, MD 20892 August 25, 2020 Dear Director Collins and Director Fauci, I want to first thank you for your tireless work to ensure that we win the fight against COVID-19. This insidious virus is not only a public health crisis, but also a crisis that is having devastating consequences on our economy. Due to the urgent nature of this pandemic, it is vitally important that we develop effective treatments and vaccines to minimize the virus’ impact and ultimately eradicate it. While I am encouraged about the progress of vaccine development for COVID-19, including the Moderna vaccine which has entered phase 3 trials, I am concerned that those living in underserved communities, especially communities of color, will not be able to easily participate in these trials. I strongly urge you to consider an additional site in Los Angeles closer to and more accessible for my demographically diverse constituents – representing populations that are desperately needed to participate in these trials. The COVID-19 crisis affects all of us, but it is the latest disease to infect and kill communities of color at higher rates than people in the rest of the population. When conducting clinical trials for treatments and vaccines for COVID-19, there needs to be an emphasis to ensure that those who are participating in the trials are racially diverse, so that there are not any disparities in terms of the effectiveness of the treatment.
    [Show full text]
  • Proposed National Center for Advancing Translational Sciences Working Group
    FINAL - September 21, 2011 National Institutes of Health Advisory Committee to the Director Proposed National Center for Advancing Translational Sciences Working Group SUMMARY OF FINDINGS Members: Maria Freire (chair), Julian Adams, Lee Babiss, Brook Byers, William Chin, Susan Desmond-Hellmann, David Ginsburg, Victoria Hale, Helen Hobbs, Robert Langer, Stelios Papadopoulos, Mary Pendergast, Moncef Slaoui, Marc Tessier-Lavigne, David Valle (full titles and affiliations can be found in Appendix A) Dr. Francis Collins convened a Working Group of the Advisory Committee to the NIH Director (ACD) to help identify innovative research areas and activities whereby the proposed National Center for Advancing Translational Sciences (pNCATS) can substantially contribute to catalyze, invigorate and streamline translational sciences nationally and globally (the full charge to the Working Group can be found in Appendix B). The Working Group met four times over the course of nine months. Its first meeting, on February 4, 2011, was held with members of the NIH Institute and Center Directors Working Group on pNCATS in Bethesda, Maryland. The Working Group also met via teleconference on May 24, 2011, and September 14, 2011, and held an in-person meeting in San Francisco, California, on July 15, 2011, where the group hosted two panel sessions to consult experts in project management and cross-sector partnerships (a list of participants can be found in Appendix C). The following represents the summary findings of the ACD-pNCATS Working Group over the course of these meetings. Revolutionize the Process of Translation: Goals for NCATS The creation of NCATS affords NIH a historic opportunity to catalyze, enable, and implement ground-breaking advances in translational sciences – innovations that will benefit all invested in improving human health.
    [Show full text]
  • The Committee of Prominent Health Researchers and Nobel Laureates
    PRESS RELEASE New York, NY, June 14, 2018 FOR IMMEDIATE RELEASE Committee of prominent health researchers and Nobel laureates renames the Prix Galien Pro Bono Humanum Award to recognize the global health leadership of Dr. Roy Vagelos was also the first recipient of the original Pro Bono Humanum Award, established in 2007 under the sponsorship of the late Foundation Honorary President and 1986 Nobel Peace Prize recipient, Pr. Elie Wiesel. That first award cited Dr. Vagelos for his unprecedented decision as CEO of a major global pharmaceutical company to donate the drug Mectizan to patients in 34 countries The Prix Galien USA Committee announced today to treat and prevent river blindness (onchocerciasis), that the Prix Galien Pro Bono Humanum Award a parasitic disease that ranks as a leading cause for individual service to improve the state of of preventable blindness in developing countries, human health will be renamed in honor of for “as much and as long as necessary.” Dr. P. Roy Vagelos, Retired Chairman and CEO, Merck & Co., Inc. Chairman of the Board, As result of this historic act of moral leadership, Regeneron Pharmaceuticals. The Roy Vagelos more than two billion treatments for 250 million Pro Bono Humanum Award for Global Health people in affected areas of the globe have been Equity will be presented at the annual Prix Galien donated by Merck & Co. over the past 30 years, USA Awards ceremony recognizing outstanding resulting in the eradication of the parasite in achievement in innovative medicines discovery on numerous countries in Africa and Latin America. Thursday, October 25, at the American Museum of Natural History in New York City.
    [Show full text]
  • Four Square Construction
    +91-7971471102 Four Square Construction https://www.indiamart.com/foursquare-com/ Four Square Constructions was established to respond to the growing needs for contemporary and stylish residences, commercial and industrial requirements. About Us Four Square Constructions was established to respond to the growing needs for contemporary and stylish residences, commercial and industrial requirements.The partnership firm was started by two experienced professionals T.S. Murali and C.M. Rajinikanth in the year 2007. Their professionalism and steadfast commitment to quality standards and unparalleled knowledge about every nuance of the real estate industry, has enabled our team to make our presence felt in the Chennai cityscape in the shortest possible time. We are fully geared to work towards fulfilling the dreams and needs of its customers by delivering aesthetically appealing, functionally efficient and decidedly up-market real estate solutions. For more information, please visit https://www.indiamart.com/foursquare-com/profile.html RENOVATION SERVICES O u r S e r v i c e s Commercial Building Residential Building Renovation Service Renovation Service Old Bungalow Renovation Bathroom Renovation Service Service O u r OTHER SERVICES: S e r v i c e s Painting Renovation Service EA License Holder Industrial Electrical Works Industrial Flooring Service O u r OTHER SERVICES: S e r v i c e s Epoxy Flooring Service Industrial Building Constructions Heavy Electrical Service Commercial Building Constructions F a c t s h e e t Year of Establishment : 2017 Nature of Business : Service Provider Total Number of Employees : 11 to 25 People CONTACT US Four Square Construction Contact Person: C.M.
    [Show full text]
  • Plant Biology 2012…Going Communicating Plant Biology to the Mobile! General Public AAAS Fellows Class of 2011 Life Is About Choices
    ASPB News THE NEWSLETTER OF THE AMERICAN SOCIETY OF PLANT BIOLOGISTS Volume 39, Number 2 March/April 2012 President’s Letter Inside This Issue Walk the Talk to Spread the Word Plant Biology 2012…Going Communicating Plant Biology to the Mobile! General Public AAAS Fellows Class of 2011 Life is about choices. plant biology is at the grocery store, where there’s TAB Articles Now Indexed on PubMed Resources (for most always a rich diversity of safe and relatively inex- of us) are limited, and pensive food. So where’s the problem we so urgently Steve Huber Teaching Tools in Plant every day we must each need to fix, one might ask. Changing this public Biology Seeks Freelance make decisions about where and how we spend perception will require innovative platforms and the Science Editors our time, efforts, and money. Likewise, federal and efforts of all ASPB members as “citizen advocates.” state governments face the continual challenge of We not only can help the public recognize there are prioritizing needs, which is especially important in many potential problems and challenges just ahead times of economic downturn when immediate and that require our action now, but also we must do “pressing” problems tend to receive heightened at- continued on page 5 tention and increased resources. One pressing problem many plant scientists wor- ry about is the sustainable production of sufficient Do you have ideas about how we (and sufficiently nutritious) food for a rapidly grow- can use social media to foster ing global population, especially in light of ongoing dialogue with the public? If so, I climate change.
    [Show full text]
  • Final Results
    CHENNAI DISTRICT ATHLETICS CHAMPIONSHIP 2014 CHENNAI, 20 – 21 JUNE 2014 JAWAHARLAL NEHRU STADIUM Organised by: CHENNAI DISTRICT ATHLETIC ASSOCIATION Under the auspices of Tamil Nadu Athletic Association FINAL RESULTS Courtesy – Chennai District Athletic Association Page | 1 CHENNAI DISTRICT ATHLETICS CHAMPIONSHIP 2014 20-21 June 2014, Jawaharlal Nehru Stadium, CHENNAI Organised by: Chennai District Athletic Association BOYS Place Name of the Athlete Fathers Name D O B Club / Institution Performance BOYS U-14: 100M 1 SURIYARAJ KRISHNA KUMAR 03-12-2000 SBOA Jr 2 ADRAIN JOSEPH AMAL RAJ 06-04-2001 ROYAL ATHLETIC CLUB 3 SAAIRAGAVENRA SANKARANARAYANAN 12-10-2000 KARLMARX 4 RAHUL 20-04-2001 ISPA 5 NITISH 18-12-2000 ISPA 6 AKASH 10-09-2000 KARLMARX 7 VAISHAK 17-05-2000 U/A 8 RAHUL RAO 01-12-2000 ROYAL BOYS U-16: 100M 1 NOEAL FRANCIS LOUIS MARIA JOSEPH 16-12-1998 ELSHADDAI 2 MANOJ KUMAR SHAKTHIVEL 26-03-1999 SDAT 3 NITHIN SEIDANANDH 12-04-1999 USF 4 SUMIT SHARMA 07-10-1998 ELSHADDAI 5 MUHAMMED MUFLIH 22-08-1999 SDAT 6 SAI VIKARAMAN 18-09-1998 RUN BIRD 7 MURALI 28-03-1997 KOLA 8 DEEPAK 06-12-1999 ROYAL BOYS U-18: 100M 1 SATHISH KUMAR 31-08-1996 RUN BIRD 2 SHIEK ABDUL KADHAR 27-12-1996 RUNBIRD 3 PRAVEEN RAJ 26-08-1996 KARL MARX 4 KIRAN 18-11-1996 USF 5 DILLI BABU 16-04-1997 RUNBIRD 6 MOHAN RAJA 23-03-1997 KARL MARX 7 SARAVANAN 06-01-1997 DOLPHIN CLUB 8 BENESTR FERNANDO 09-01-1997 USF BOYS U-20: 100M 1 HARIHARAN 07-01-1996 KANNIAH 2 RAKESH 03-09-1996 ELSHADDAI 3 GOKULA KRISHNAN 08-07-1994 SDAT 4 MANOJ 03-07-1995 ROYAL 5 DEENADAYALAN KOLA 6 DIVAKAR 01-12-1994 RUN BIRD 7 VIGNESH 02-05-1996 ISPA 8 VIGNESH 04-07-1997 USF Page | 2 BOYS U-14: 600M 1 SHARAN LAKSHMANAN 28-09-2000 KARL MARX 2 PRAVEEN 05-06-2001 SDAT 3 LAWJEET 31-07-2000 SDAT 4 IYAPPAN 12-11-2001 SPEEDY 5 RUDRA MURTHY 03-06-2001 USF 6 SAI PRASANTH 01-10-2000 SBOA JR.
    [Show full text]
  • SR NO First Name Middle Name Last Name Address Pincode Folio
    SR NO First Name Middle Name Last Name Address Pincode Folio Amount 1 A SPRAKASH REDDY 25 A D REGIMENT C/O 56 APO AMBALA CANTT 133001 0000IN30047642435822 22.50 2 A THYAGRAJ 19 JAYA CHEDANAGAR CHEMBUR MUMBAI 400089 0000000000VQA0017773 135.00 3 A SRINIVAS FLAT NO 305 BUILDING NO 30 VSNL STAFF QTRS OSHIWARA JOGESHWARI MUMBAI 400102 0000IN30047641828243 1,800.00 4 A PURUSHOTHAM C/O SREE KRISHNA MURTY & SON MEDICAL STORES 9 10 32 D S TEMPLE STREET WARANGAL AP 506002 0000IN30102220028476 90.00 5 A VASUNDHARA 29-19-70 II FLR DORNAKAL ROAD VIJAYAWADA 520002 0000000000VQA0034395 405.00 6 A H SRINIVAS H NO 2-220, NEAR S B H, MADHURANAGAR, KAKINADA, 533004 0000IN30226910944446 112.50 7 A R BASHEER D. NO. 10-24-1038 JUMMA MASJID ROAD, BUNDER MANGALORE 575001 0000000000VQA0032687 135.00 8 A NATARAJAN ANUGRAHA 9 SUBADRAL STREET TRIPLICANE CHENNAI 600005 0000000000VQA0042317 135.00 9 A GAYATHRI BHASKARAAN 48/B16 GIRIAPPA ROAD T NAGAR CHENNAI 600017 0000000000VQA0041978 135.00 10 A VATSALA BHASKARAN 48/B16 GIRIAPPA ROAD T NAGAR CHENNAI 600017 0000000000VQA0041977 135.00 11 A DHEENADAYALAN 14 AND 15 BALASUBRAMANI STREET GAJAVINAYAGA CITY, VENKATAPURAM CHENNAI, TAMILNADU 600053 0000IN30154914678295 1,350.00 12 A AYINAN NO 34 JEEVANANDAM STREET VINAYAKAPURAM AMBATTUR CHENNAI 600053 0000000000VQA0042517 135.00 13 A RAJASHANMUGA SUNDARAM NO 5 THELUNGU STREET ORATHANADU POST AND TK THANJAVUR 614625 0000IN30177414782892 180.00 14 A PALANICHAMY 1 / 28B ANNA COLONY KONAR CHATRAM MALLIYAMPATTU POST TRICHY 620102 0000IN30108022454737 112.50 15 A Vasanthi W/o G
    [Show full text]
  • Spectacle Spaces: Production of Caste in Recent Tamil Films
    South Asian Popular Culture ISSN: 1474-6689 (Print) 1474-6697 (Online) Journal homepage: http://www.tandfonline.com/loi/rsap20 Spectacle spaces: Production of caste in recent Tamil films Dickens Leonard To cite this article: Dickens Leonard (2015) Spectacle spaces: Production of caste in recent Tamil films, South Asian Popular Culture, 13:2, 155-173, DOI: 10.1080/14746689.2015.1088499 To link to this article: http://dx.doi.org/10.1080/14746689.2015.1088499 Published online: 23 Oct 2015. Submit your article to this journal View related articles View Crossmark data Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=rsap20 Download by: [University of Hyderabad] Date: 25 October 2015, At: 01:16 South Asian Popular Culture, 2015 Vol. 13, No. 2, 155–173, http://dx.doi.org/10.1080/14746689.2015.1088499 Spectacle spaces: Production of caste in recent Tamil films Dickens Leonard* Centre for Comparative Literature, University of Hyderabad, Hyderabad, India This paper analyses contemporary, popular Tamil films set in Madurai with respect to space and caste. These films actualize region as a cinematic imaginary through its authenticity markers – caste/ist practices explicitly, which earlier films constructed as a ‘trope’. The paper uses the concept of Heterotopias to analyse the recurrence of spectacle spaces in the construction of Madurai, and the production of caste in contemporary films. In this pursuit, it interrogates the implications of such spatial discourses. Spectacle spaces: Production of caste in recent Tamil films To foreground the study of caste in Tamil films and to link it with the rise of ‘caste- gestapo’ networks that execute honour killings and murders as a reaction to ‘inter-caste love dramas’ in Tamil Nadu,1 let me narrate a political incident that occurred in Tamil Nadu – that of the formation of a socio-political movement against Dalit assertion in December 2012.
    [Show full text]
  • August 12, 2021 the Honorable Francis Collins, M.D., Ph.D. Director National Institutes of Health 9000 Rockville Pike Rockvil
    August 12, 2021 The Honorable Francis Collins, M.D., Ph.D. Director National Institutes of Health 9000 Rockville Pike Rockville, MD 20892 Dear Director Collins: On May 20, 2021, we sent you a letter requesting information on the National Institutes of Health’s (NIH) 2014 funding pause on gain of function research.1 Your July 29, 2021, response failed to fully address the questions in our letter. Further, NIH’s response to us appears to be nearly identical to your response to another senator’s separate oversight request.2 Your refusal to provide detailed responses that fully address each oversight request is unacceptable. Specifically, the May 20, 2021 letter included 17 requests for documents and information on the 2014 gain of function moratorium.3 Rather than provide detailed responses to each request, NIH only offered a summary about the gain of function research moratorium and its review process for such research.4 Further, NIH claimed that no National Institute of Allergy and Infectious Diseases (NIAID) funding was approved to support gain of function research at the Wuhan lab.5 Yet, your response appeared to suggest that even approved experiments could result in a virus with a gain of function.6 Without any more detailed information, it is unclear whether this has ever occurred. NIH’s lack of response to the May 20 letter shows a complete disregard for congressional oversight and transparency. Congress and the American people have a right to know the complete truth about NIH’s role in funding potentially risky gain of function research. We expect you to specifically address all of our previous information requests and the additional requests below by no later than August 26, 2021: 1 Letter from Ron Johnson, U.S.
    [Show full text]
  • Long View of the Human Genome Project BOOKS & ARTS
    Vol 466|19 August 2010 BOOKS & ARTS Long view of the Human Genome Project A bold attempt to tell the complicated story behind the human DNA sequence highlights that social change is needed before personalized medicine can take off, finds Jan Witkowski. Drawing the Map of Life: Inside the Human TTY E Genome Project by Victor K. McElheny Basic Books: 2010. 384 pp. $28, £16.99 S. JAFFE/AFP/G S. In 1985, Robert Sinsheimer, then chancellor of the University of California, Santa Cruz, convened a workshop to discuss sequencing the human genome. It was an audacious proposal: the longest genome that had been sequenced at the time was that of the Epstein- Barr virus, at 172,282 base pairs compared with 3 billion in human DNA. Sinsheimer’s initiative failed. Yet the idea gained momentum when, in 1988, James Watson was appointed associate director of the Office of Genome Research, part of the US National Institutes of Health (NIH). Watson declared 1990 the official start of the publicly funded NIH Human Genome Project (HGP). In 1998, Craig Venter and his company Celera Genomics, then in Rockville, Maryland, joined the race. Ten years ago in June, both projects announced a finish-line draw from President Bill Clinton’s White House. Febru- ary 2011 will mark a decade since the draft sequences were published. Genome-project pioneers: (left to right) Eric Lander, Robert Waterston, James Watson and Francis Collins. In Drawing the Map of Life, science jour- nalist and author Victor McElheny relates McElheny traces the various stages of the In 2000, HGP and Celera jointly announced the story of the HGP, from its methods to the HGP and the power struggles it engendered.
    [Show full text]
  • Signature of Controversy
    I n “In this volume Granville Sewell provides “As the debate over intelligent design grows T delightful and wide-ranging commentary on increasingly heated... it is refreshing to find a HE the origins debate and intelligent design... discussion of the topic that is calm, thoughtful, Sewell provides much needed clarity on topics and far-ranging, with no sense of having to B e ignature f that are too often misunderstood. His discussion advance an agenda or decimate the opposition. G I S o of the commonly confused problem of entropy In this regard, Granville Sewell’s In the NNI is a must read.” Beginning succeeds brilliantly.” Cornelius G. Hunter, Ph.D. William A. Dembski, Ph.D. N author of The Design Inference author of Science’s Blind Spot G ontroversy A N c In this wide-ranging collection of essays on origins, mathematician Granville Sewell looks at the D big bang, the fine-tuning of the laws of physics, and the evolution of life. He concludes that while O there is much in the history of life that seems to suggest natural causes, there is nothing to support THER Responses to critics of signature in the cEll Charles Darwin’s idea that natural selection of random variations can explain major evolutionary E S advances (“easily the dumbest idea ever taken seriously by science,” he calls it). Sewell explains S A Y why evolution is a fundamentally different and much more difficult problem than others solved s ON by science, and why increasing numbers of scientists are now recognizing what has long been I obvious to the layman, that there is no explanation possible without design.
    [Show full text]
  • Banner Name Proprietor Partner BANNER LIST
    BANNER LIST Banner Name Proprietor Partner 1234 Cine Creations C.R.Loknath Anand L 1895 Dec 28 the World Ist Movie Production S.Selvaraj No 2 Streams Media P Ltd., Prakash Belavadi S.Nandakumar 21st Century Lions Cinema (P) Ltd., Nagathihalli Chandrashekar No 24 Frames Pramodh B.V No 24 Frames Cine Combines Srinivasulu J Gayathri 24 Frames Movie Productions (p) Ltd K.V.Vikram Dutt K.Venkatesh Dutt 3A Cine Productions Sanjiv Kumar Gavandi No 4D Creations Gurudatta R No 7 Star Entertainment Studios Kiran Kumar.M.G No A & A Associates Aradhya V.S No A B M Productions P.S.Bhanu Prakash P.S.Anil Kumar A' Entertainers Rajani Jagannath J No A Frame To Frame Movies Venkatesh.M No A.A.Combines Praveen Arvind Gurjer N.S.Rajkumar A.B.C.Creations Anand S Nayamagowda No A.C.C.Cinema - Shahabad Cement Works. M.N.Lal T.N.Shankaran A.G.K.Creations M.Ganesh Mohamad Azeem A.J.Films R.Ashraf No A.K.Combines Akbar Basha S Dr. S.R.Kamal (Son) A.K.Films Syed Karim Anjum Syed Kalimulla A.K.K. Entertainment Ltd Ashok Kheny A.Rudragowda (Director) A.K.N.D.Enterprises - Bangalore N.K.Noorullah No A.L.Films Lokesh H.K No A.L.K.Creations C.Thummala No A.M.J.Films Janardhana A.M No A.M.M.Pictures Prakash Babu N.K No A.M.M.Pictures Prakash Babu N.K No A.M.Movies Nazir Khan No A.M.N.Film Distributor Syed Alimullah Syed Nadimullah A.M.V.Productions Ramu V No A.N.Jagadish Jagadish A.N Mamatha A.J(Wife) A.N.Pictures U.Upendra Kumar Basu No A.N.Ramesh A.N.Ramesh A.R.Chaya A.N.S.Cine Productions Sunanda M B.N.Gangadhar (Husband) A.N.S.Films Sneha B.G B.N.Gangadhar (Father) A.N.S.Productions Gangadhar B.N No A.P.Helping Creations Annopoorna H.T M.T.Ramesh A.R.Combines Ashraf Kumar K.S.Prakash A.R.J.Films Chand Pasha Sardar Khan A.R.Productions K.S.Raman No A.R.S.Enterprises H.M.Anand Raju No A.S.Films Noorjhan Mohd Asif A.S.Ganesha Films Dr.T.Krishnaveni No A.S.K.Combines Aruni Rudresh No A.S.K.Films A.S.Sheela Rudresh A.S.Rudresh A.T.R.Films Raghu A.T.
    [Show full text]