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Appendix A: Overview of Selected Collaborations 1

Appendix A: Overview of Selected Collaborations

The following appendix provides an overview of selected collaborations to advance efforts focused in the following areas: Research & Development, Public Health & Improving Patient Outcomes, Manufacturing & Distribution, Improving Access. Partnerships were grouped together based on a singular, or in some cases, overlapping focus area. The selected examples below, provide a brief overview of the collaboration’s purpose, partners, approach used to generate results and any successes yielding from the group’s efforts.

R&D 3 Antimicrobial Resistance (AMR) Action Fund ______3 Alzheimer's Disease Neuroimaging Initiative (ADNI) ______3 AstraZeneca’s Open Innovation ______4 Lung Cancer Master Protocol (Lung-MAP) ______7 Partnership ______7 Northeast ALS Consortium ______8 One Brave Idea ______8 Parkinson’s Disease Education Consortium (PDEC) ______9 Rare Disease Cures Accelerator Data and Analytics Platform (RDCA-DAP) ______10 Target ALS ______10

Public Health & Improving Patient Outcomes 11 Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) ______11 Appendix A: Overview of Selected Collaborations 2

AstraZeneca, CEPI, Gavi, Oxford University and SII COVID-19 Agreement ______11 Combating Antibiotic-Resistant (CARB-X) ______11 Gilead Commitment to Partnership in Addressing HIV/AIDS in Southern States Initiative (COMPASS) Error! Bookmark not defined. Lilly-Indiana University Diabetes Impact Project ______13 National Diabetes Prevention Program (National DPP) ______13 NIH Helping to End Addiction Long-Term (HEAL) Initiative ______14 ______15 Gilead HepConnect ______16

Manufacturing & Distribution 17 Accelerating Medicines Partnership (AMP) ______17 Advanced Regenerative Manufacturing Institute ______18 Critical Path Institute (C-PATH) ______19 Machine learning ledger orchestration for drug discovery (MELLODDY) ______20 Merck Blockchain Partnership ______20 National Cell Manufacturing Consortium (NCMC) ______21

Improving Access 22 Duke-Margolis Value Based Payment (VBP) Consortium ______22 MIT NEW Drug Development ParadIGmS (NEWDIGS) ______23 Adult Vaccine Access Coalition (AVAC) ______24 Gilead Truvada CDC Partnership ______25

Appendix A: Overview of Selected Collaborations 3

R&D Purpose Partners Approach Recent Successes

Antimicrobial Resistance (AMR) Action Fund

• Launched on July 9, 2020 seeking • Nonprofit: International • Expects to invest more than US • Expected to be operational to strengthen and accelerate Federation of Pharmaceutical $1 billion in smaller biotech during the fourth quarter of 2020 research and development of Manufacturers and Associations companies and provide industry antibiotics. (IFPMA), expertise to support the clinical • Aims to bring 2-4 new antibiotics • Industry: Inc., Eli Lilly development of novel antibiotics to patients by 2030. and Company, F. Hoffmann-La • Work with partners to encourage Roche AG, Johnson & Johnson, governments to create market Merck & Co., Novartis conditions that enable sustainable International AG, Novo Nordisk investment in the antibiotic A/S and Inc., pipeline. • Broad alliance of industry and non-industry stakeholders, including philanthropies, development banks, and multilaterals.

Alzheimer's Disease Neuroimaging Initiative (ADNI)

• Launched in 2004 as a multi-site, • Initially funded as private-public • Unites researchers with study • ADNI 3 has been underway since longitudinal, prospective study to partnership with contributions data 2016 with the goal of determining develop clinical, imaging, genetic from 20 companies and 2 • Collect, validate, and utilize data the relationship between the and biomarkers for the early foundations through Foundation (MRI and PET images, genetics, clinical, cognitive, imaging, detection and tracking of for the National Institutes of cognitive tests, CSF and blood genetic, and biochemical Alzheimer’s. Health (NIH) and National biomarkers as predictors of the biomarker characteristics across • Seek to detect AD at earliest Institute on Aging. disease) to develop novel the entire spectrum of AD. possible stage (pre-dementia) and • Government Agencies: treatments and improve • Over 1000 scientific publications identify ways to track disease, The National Institutes of Health understanding have used ADNI data. support advances in intervention, (NIH) and the Foundation for the • Numerous other initiatives related prevention and treatment all while National Institutes of Health to AD and other diseases have maintaining open records for all (FNIH). been designed and implemented scientists around the world • Academic Institutions: The using ADNI as a model. Northern California Institute for • Is there any way we can comment Research and Education on the promise of the pipeline and (NCIRE), The Alzheimer’s perhaps correlate how this Therapeutic Research Institute partnership may have helped? (ATRI) at the University of Too far of a stretch? Southern California and the Laboratory of Neuro Imaging at Appendix A: Overview of Selected Collaborations 4

the University of Southern California, Nonprofits: Accelerate Cure/Treatments for Alzheimer’s Disease (ACT-AD), Alzheimer’s Drug Discovery Foundation, AbbVie Inc., Alector, Inc., Alzheimer’s Association, Industry: Araclon Biotech, Bioclinica, Inc., Cogstate Ltd., Denali Therapeutics, DiamiR, Co., Ltd., , Euroimmun AG, Fujifilm Toyama Chemical Co., Ltd., General Electric Company, , Inc., Janssen Pharmaceutical Companies of Johnson & Johnson, H. Lundbeck A/S, MagQu, Merck & Co. Inc., d.b.a., PeopleBio, Inc., Pfizer Inc., Piramal Group, F. Hoffmann-La Roche AG, Saladax Biomedical Inc, Servier Laboratories, Takeda Pharmaceutical Company Limited

AstraZeneca’s Open Innovation

• Interested in collaborating with • Not listed on their website • Offers testing of compound • 250 collaborations started to date research partners across all libraries, technologies, additional • 250,000 compounds available stages of drug discovery; from the services and AstraZeneca plc/AB from our screening library initial idea through to early clinical expertise. • 19 challenges completed to date development. Seek to accelerate • Possibility to jointly publish in the advancement of medical high-profile journals. science and bring novel therapies to patients • Partner is provided with the results, which it may publish. • Platform provides an open, collaborative approach to link AstraZeneca’s expertise, research tools, optimized molecules and technologies. • Shares R&D challenges for interested parties to collaborate on. • Focus area: Cardiovascular, respiratory and metabolic Appendix A: Overview of Selected Collaborations 5

diseases, oncology, inflammation and autoimmunity

Biomarkers Consortium

• Rapidly identify, develop and • Public-private biomedical • Discover, develop, and seek • BC projects in community- quantify potential high-impact research partnership managed regulatory approval for biological acquired bacterial pneumonia biomarkers to enable by the Foundation for the National markers to support new drug (CABP), acute skin and skin improvements in drug Institutes of Health with development, preventative structure (ABSSSI), development, clinical care and participation from government, medicine and medical diagnostics hospital-acquired bacterial regulatory decision-making industry, academia, and patient pneumonia (HABP), and advocacy and other non-profit ventilator-associated bacterial organizations pneumonia (VABP) including • Founding partners include plans for biomarker use, Foundation for the National biomarker use application and Institutes of Health (FNIH), the biomarker use approvals (?) U.S. Food and Drug • The BC has taken a leading role Administration (FDA), National in driving consensus to define an Institute of Health (NIH), evidentiary framework for Pharmaceutical Research and biomarker qualification Manufacturers of America • 9 publications in the 2019 (PhRMA), Centers for Medicare and Medicaid Services (CMS) and Innovation Organization (BIO)

California Institute for Biomedical Research (Calibr)

• Advancing non-profit biomedical • Nonprofits: Scripps Research, • Creation of new medicines • Gates Global Health initiative research to impact patients while Bill and Melinda Gates accelerated by pairing biomedical (in partnership with BMGF) that reinvesting in further innovative Foundation, Wellcome Trust, research with drug discovery and supports an integrated drug research Juvenile Diabetes Research development discovery platform dedicated to • Research interests span cancer, Foundation (JDRF), Cure SMA • Offer postdoctoral associate diseases with significant impact in autoimmunity and inflammatory and California Institute for training program developing countries. diseases, metabolic and Regenerative Medicine (CIRM), • PRIMER initiative supports cardiovascular diseases, • Industry: taking advanced assets through infectious and neglected (BMS), Intarcia Therapeutics, IND-enabling studies and early diseases, age-related and Sirenas, Merck & Co., Pfizer Inc. clinical development degenerative diseases and ShangPharma Innovation Inc.

Cure Huntington’s Disease Initiative (CHDI) Foundation

• Develop drugs that slow • Work in partnership with biotech • Science management • Sponsor world-side Huntington’s progression of Huntington’s and pharmaceutical companies to organization disease observational study and disease and provide meaningful develop potential drugs registry called Enroll-HD Appendix A: Overview of Selected Collaborations 6

clinical benefit to patients as • Nonprofits: Huntington's Disease • Virtual model that encourages • Anti-sense oligonucleotide quickly as possible Society of America (HDSA), scientific collaboration to connect therapeutic approach that CHDI • Lower barrier to entry for other Healthcare Distribution Alliance academic research, drug helped develop with Ionis not-for-profit entities interested in (HDA), the HSC Health Care discovery, and clinical Pharmaceuticals was subject of collaborating on HD therapeutics System and Critical Path Institute development substantial investment from F. (C-PATH), Huntington’s disease • Act as “collaborative enabler” for Hoffmann-La Roche AG • Exploratory biology for (HD) Legacy identification and validation of any research group by making • Evaluating Pfizer Inc.’s therapeutic targets from drug • Industry: Charles River resources freely available phosphodiesterase 10 inhibitor in discovery to clinical studies and Laboratories Inc., Ionis • Work to build clinical capacity so humans trials Pharmaceuticals, Pfizer Inc. that promising drugs can progress • CHD’s Adult Mental Health team, to clinical trials along with the organization’s property management staff, worked amid a tight deadline to ready two new Group Living Environments (GLEs) in order to have them ready before residents moved in by late June • These new GLEs provide support to women referred by the Mass. Dept. of Mental Health (DMH) with severe mental health needs, some with co- occurring mental health and substance use issues, who have little to no experience living on their own

Collaborative Novel-Novel Combination Therapies (CoNNCT)

• Launched in 2016 with a planning • Academic centers • Develop a new paradigm to workshop establishing the original • Biopharmaceutical companies accelerate and broaden clinical focus on a pilot study testing of drug combinations to • Diagnostic companies • Making it easier to test multiple facilitate early decision and combinations per agent, reducing • Representatives of cancer non- assess effective drug the cost of early investigational profits combinations studies, shortening the time to • U.S. Food and Drug • Test multiple combinations per demonstrate proof of concept Administration (FDA) agent helping to reduce cost of • Collaborative effort to speed the early investigational studies, and decision-making around go/no-go shorten time to demonstrate proof decisions in oncology combination of concept drug development using higher throughput and early signal finding

Appendix A: Overview of Selected Collaborations 7

Lung Cancer Master Protocol (Lung-MAP)

• Launched in 2014, as a clinical • Government Agency: National • Test multiple treatments • Trial offered at more than 650 US trial designed to effectively and Cancer Institute (NCI), National simultaneously under one medical centers and community rapidly test new treatments for Cancer Trials Network (NCTN), umbrella design to flexibility and hospitals advanced non-small cell lung SWOG Cancer Research effectiveness • Registered more than 1,800 cancer Network, Friends of Cancer • Patients who enroll undergo patients across the country • In 2018, the was Research and Foundation for genetic screening to get a National Institutes of Health • Opened and completed eight expanded to include all lung genomic profile to determine drug-centered sub-studies cancer diagnoses in the U.S. • Nonprofit: Addario Lung Cancer genetic alterations or mutations testing 12 novel therapies, • Seek to create efficiency and Foundation, Lung Cancer and are then matched to a additional achievements operate collaboratively to benefit Alliance, LUNGevity Foundation, treatment being tested on Lung highlighted in Lung-MAP’s five- patients Lung Cancer Foundation of Cancer Master Protocol (Lung- year recap America, American Lung MAP). Association, Lung Cancer Research Foundation and American Cancer Society • Industry: Amgen Inc., AstraZeneca plc/AB, Genentech, Merck & Co. Inc., d.b.a. and Pfizer Inc. • Worked with 10 pharmaceutical partners to launch 9 studies, 6 of which are completed. These organizations include: SWOG Cancer Research Network, National Cancer Institute (NCI), Foundation for the National Institutes of Health (FNIH), Friends of Cancer Research, Foundation Medicine, Amgen Inc., AstraZeneca plc/AB.

Multiple Sclerosis Partnership

• Launched in 2015, research • Verily Life Sciences, Biogen Inc., • Developed two research • In 2017, initial results for SysteMS collaboration to explain why and and Brigham and Women’s initiatives to leverage big data study were presented at the how MS progresses differently Hospital (BWH) and provide insight into novel MSParis2017. The use of digital across patients treatment options for a precision biosensors to assess patients • Identify prevention methods to medicine approach. (1) SysteMS outside of the clinic revealed to address disease at onset and study seeks to identify the main assist clinicians with decision- improve patient outcomes factors associated with the making around treatment as severity and progression of MS. differences exist across MS • Identify clinical, radiological, (2) Pilot study to test feasibility of patients.Results also generated biological, behavioral and wearable devices to measure data on the possible utility of environmental factors that predictive biomarkers to inform Appendix A: Overview of Selected Collaborations 8

correlate with MS severity mobility, gait, and dexterity of MS MS diagnosis and ongoing and progression patients. disease monitoring • Sensor data and software to draw insights by pooling data, running queries, and developing a better understanding of biomarkers and safety markers

Northeast ALS Consortium

• Launched in 1995, consortium • Consortium is supported through • Functions as academic research • Since its founding, NEALS has seeks to translate scientific the ALS Association’s TREAT consortium, contracted research grown from 9 academic clinical advances into clinical research ALS Network, Muscular organization, and resource tool for centers to over 100 centers in the and new treatments for people Dystrophy Association, donors ALS community U.S. and internationally with ALS and motor neuron and member sites (medical • In 2020, expanded to Crestwood disease institutions equipped to perform Medical Center through a grant clinical trials for ALS and motor awarded to HudsonAlpha Institute neuron diseases) for Biotechnology • Two “Coordinating Centers” at General Hospital and Barrow Neurological Institute responsible for the management and conduct of “NEALS-affiliated” trials

One Brave Idea

• Launched in 2017, research • American Heart Association, • Team research effort focused on • Phenotype Phorums bring effort seeking to change how Verily Life Sciences, AstraZeneca upstream factors of CHD using stakeholders together to coronary heart disease is plc/AB and Quest Diagnostics the following approach to address discussion major advances in detected, prevented, and treated awarded $75 million research the development of CHD: Deep coronary heart disease • Focuses on the earliest grant to Dr. Calum MacRae, chief Phenotyping; Genomics and prevention, diagnosis and abnormalities in the development of Cardiovascular Medicine at Phenotyping in Clinical Care; treatment of coronary disease ’s Brigham and Women’s Engaging Broad Patient • Most recent Phenotype Phorum Hospital. Populations in Research; Early • Seeks to develop new methods of (11/15/19) discussed the rise in Detection; Integrative new biomarker discovery for quantifying cardiovascular health Computational Research; and disease, and identifying new clinical development and Promoting Non-Traditional regulatory approval of novel biologic mechanisms that Partnerships contribute to coronary disease therapeutics • Engages with patients break down traditional barriers between patient care, research, and their daily lives Appendix A: Overview of Selected Collaborations 9

Parkinson’s Disease Education Consortium (PDEC)

• Alliance that supports the • Parkinson’s Disease Education • Since its initial launch, the alliance • Provide annual education development of educational Consortium (PDEC) is part of the as developed educational campaigns to help promote more resources for the Parkinson’s Michael J. Fox Foundation who programs to increase research effective, patient-centered care for community and conducts patient- aim to find a cure for Parkinson’s participation, bridged the Parkinson’s including: Bridging centered care research studies Disease through research and communication gap between the Communication Gap (2019), a development of improved patients and health care study to better understand the therapies providers, and connected the patient and care partner language • Acadia Pharmaceuticals, Inc., Parkinson's community to of Parkinson’s; Parkinson’s Voyager Therapeutics, Inc., resources through Parkinson's Clinical Trial Companion (2018), a , Inc., IQ + You events suite of toolkits to support patient Adamas Pharmaceuticals, Inc., • Provides ongoing education and trial teams as part of an , Inc., through MJFF website content; ongoing effort to increase patient GE Healthcare Systems, Kyowa "Ask the MD" blog and video participation in clinical trials; Kirin Co., Ltd., H. Lundbeck H/S, series; Monthly interactive online Parkinson’s 360 (2017) serves as Neurocrine Biosciences, events with patient, clinician and an online resource for caregivers Sunovion Pharmaceuticals Inc., researcher panelists discussing and families with videos US WorldMeds. and answering questions on a explaining the basics of the Parkinson's care or research disease and living with the topic; Podcasts with experts who disease delve into a Parkinson's research • 1 million social media followers to question or issue date; 425,000+ email subscribers to date; 335,000+ monthly website visits; 100,000 annual views of “Ask the MD” video series; 22,000 annual attendees to our monthly interactive webinars

PatientsLikeMe-AstraZeneca Collaboration

• Launched in 2015, collaboration • Signed 5-year agreement • AstraZeneca plc/AB will use • Publication (2018): Patient combining access to between AstraZeneca plc/AB and patient-reported data from perceptions of their glycemic PatientsLikeMe’s global network PatientsLikeMe PatientsLikeMe to inform control and its influence on in support of AstraZeneca’s development and help improve type 2 diabetes outcomes/ an patient-driven research initiatives outcomes across its main international survey of online • PatientsLikeMe's seeks to therapeutic areas, with an initial communities improve patient’s lives through focus on respiratory disease, new knowledge derived from lupus, diabetes and oncology shared real-world experience and outcomes

Appendix A: Overview of Selected Collaborations 10

Rare Disease Cures Accelerator Data and Analytics Platform (RDCA-DAP) • Launched September 17,2019, • Funded through a FDA grant • Integrated database and analytics • Presentation entitled “Shortening the platform provides a • Critical Path Institute (C-Path) and hub that provides data-driven the Timeline for Developing centralized and standard National Organization for Rare solutions to help accelerate and New Treatments” (2020) infrastructure to support and Disorders (NORD). optimize drug development accelerate rare disease across rare diseases characterization • Data contributed from clinical • Enables sharing of existing trials, longitudinal observational patient-level data and encourages studies, patient registries, real- standardization of new data world data and negotiate collection agreements between data suppliers

Target ALS • Launched in 2013, to create a • Collaborate with academic • ALS Innovative Ecosystem • 150 research collaborators collaborative framework for institutions, biotech and addresses barriers to progress • 60 pharma and biotech partners scientists and clinicians across pharmaceutical companies, and accelerate drug discovery academia and industry working to patient advocacy groups and and development • 12 therapeutic approaches accelerate the development of other non-profits. • The Innovative Ecosystem is • 2019 publication / see full list of an ALS treatment comprised of various publications • Priority areas include target components including: • The Association for discovery and strengthening collaborative funding, scientific Frontotemporal Degeneration therapeutic pipeline and drug tools and resources, industry (AFTD) and Target ALS development/fast-tracking engagement, independent grant announced a 2019 partnership promising therapeutic areas review, no IP restrictions, and call for proposals to identify in the clinic networking and communication treatments and biomarkers for FTD and ALS ($5 million, multi- year) • Through Innovation Ecosystem, Target ALS helped connect consortium leaders with Karyopharm Therapeutics to validate drug that was acquired by Biogen Inc. (2018)

Appendix A: Overview of Selected Collaborations 11

Public Health & Improving Patient Outcomes Purpose Partners Approach Recent Successes

Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)

• Launched on April 17, 2020 to • Launched on April 17, 2020 to • Launched on April 17, 2020 to • Launched on April 17, 2020 to develop a coordinated research develop a coordinated research develop a coordinated research develop a coordinated research strategy for developing a COVID- strategy for developing a COVID- strategy for developing a COVID- strategy for developing a COVID- 19 treatment or vaccine 19 treatment or vaccine 19 treatment or vaccine 19 treatment or vaccine • Develop a collaborative, • Develop a collaborative, • Develop a collaborative, • Develop a collaborative, streamlined forum to identify streamlined forum to identify streamlined forum to identify streamlined forum to identify preclinical treatments for COVID- preclinical treatments for COVID- preclinical treatments for COVID- preclinical treatments for COVID- 19. 19. 19. 19. • Accelerate clinical testing of the • Accelerate clinical testing of the • Accelerate clinical testing of the • Accelerate clinical testing of the most promising vaccines and most promising vaccines and most promising vaccines and most promising vaccines and treatments for COVID-19. treatments for COVID-19. treatments for COVID-19. treatments for COVID-19. • Improve clinical trial capacity and • Improve clinical trial capacity and • Improve clinical trial capacity and • Improve clinical trial capacity and effectiveness for a COVID-19 effectiveness for a COVID-19 effectiveness for a COVID-19 effectiveness for a COVID-19 treatment. treatment. treatment. treatment. • Accelerate the evaluation of • Accelerate the evaluation of • Accelerate the evaluation of • Accelerate the evaluation of vaccine candidates to enable vaccine candidates to enable vaccine candidates to enable vaccine candidates to enable rapid authorization or approval for rapid authorization or approval for rapid authorization or approval for rapid authorization or approval for a COVID-19 treatment. a COVID-19 treatment. a COVID-19 treatment. a COVID-19 treatment.

AstraZeneca, CEPI, Gavi, Oxford University and SII COVID-19 Agreement

• Launched June 4, 2020, as part of • Coalition for Epidemic • $750m agreement with Coalition • AstraZeneca plc/AB’s COVID a broader commitment to broad Preparedness Innovations (CEPI) for Epidemic Preparedness response efforts include and equitable access to COVID- • Academic Institutions: Oxford Innovations (CEPI) and Gavi, the accelerated efforts in testing new 19 vaccine University and Serum Institute of Vaccine Alliance to support the and existing medicines including India (SII) manufacturing, procurement and the CALAVI and ACCORD trials distribution of 300 million doses of (Calquence/ acalabrutinib) and • Nonprofit: Coalition for Epidemic the vaccine by the end of next DARE-19 trial Preparedness Innovations (CEPI) year (Farxiga/dapagliflozin) • Industry: AstraZeneca plc/AB • Licensing agreement with SII to supply one billion doses for low and middle-income countries

Combating Antibiotic-Resistant Bacteria (CARB-X)

• Launched in 2016, to accelerate • Affiliated with Boston University • Up to $500 million available to • 30 active projects as of July 31, antibacterial research in order to invest in pipeline of new 2019. Projects are in the early Appendix A: Overview of Selected Collaborations 12

address the global rising threat of • Funding partners: Biomedical antibiotics, diagnostics, vaccines stages of preclinical development drug-resistant bacteria Advanced Research and and other life-saving products to through the end of Phase 1 • Eliminate inappropriate use of Development Authority (BARDA), address drug resistant bacterial • In the 2018-19 fiscal year, antibiotics Office of the Assistant Secretary announced seven new awards for for Preparedness and Response • Portfolio consists of high-quality product developers. Also • Use alternative approaches to (ASPR), National Institute of reduce the need for antibiotics antibacterial products focused on announced funding for more than Allergy and Infectious Diseases, the most serious drug-resistant 20 new projects has been • Ensure that antibiotics are UK Aid Direct, Bill & Melinda bacteria identified by the WHO approved, awaiting finalization of available to those in need Gates Foundation, Wellcome and CDC the contracts. Trust, Germany’s Federal Ministry of Education and Research • Global Accelerator Network • 47 projects to date funded provides scientific and business • 10 accelerators worldwide • Accelerators/Other Partners: support to speed up the California Life Sciences Institute development of products. The • Of the $500 million available to (CLSI), Centre for Cellular and goal is to support these new invest, $133.5 million invested Molecular Platforms (C-CAMP), products through the early stages already Foundation for Innovative New of product development and Diagnostics (FIND), German Phase 1 to help attract private or Center for Infection Research public investment for further (DZIF), Institute for Life Sciences clinical stage development Entrepreneurship (ILSE), Massachusetts Biotechnology Council (MassBio), RTI International, Cystic Fibrosis Foundation, The Defense Threat Reduction Agency, Medicines for Malaria Venture.

Gilead and Satcher Health Leadership Institute at Morehouse School of Medicine Partnership

• Launched in 2020, to better • Satcher Health Leadership • Gilead initially provided $1 million understand the racial disparities Institute at Morehouse School of to support resources for tracking that are occurring during the Medicine, , Inc. health inequities. Also supports COVID-19 pandemic the creation of a Black Health • Develop a real time, public-facing Equity Alliance which will help and comprehensive health equity coordinate COVID-19 education, data platform to help track and training, information exchange address the impact of COVID-19 and dissemination, and policy and other diseases on analysis communities of color in the United States

Appendix A: Overview of Selected Collaborations 13

Lilly-Indiana University Diabetes Impact Project

• Launched in May 2018, and is a Implementing partners: • The $7 million, five-year pilot has • Community health workers hired neighborhood-based, data-driven and actively connecting residents • Eli Lilly & Company a multipronged approach targeting pilot in Indianapolis. to care. • Indiana University Richard M. primary to tertiary prevention of • Seeks to address high incidence Fairbanks School of Public Health type 2 diabetes and utilizes • Resident-led steering committees of diabetes by focusing on three conducting monthly meetings to (project lead) community health workers to: neighborhoods with significant advance Diabetes Impact Project, health disparities and diabetes • Eskenazi Health o help identify people with including identification of primary diabetes and connect them prevalence rates that are • Local Initiatives Support prevention focus areas for each substantially higher than state and Corporation Indianapolis with quality care. neighborhood, such as food national estiamtes o reduce complications and access, physical activity and life • Marion County Public Health improve quality of life of people stressors affecting health. • Builds off existing efforts Lilly has Department developed in lower-income living with diabetes • Pilot is adapting to COVID-19 communities in Mexico, India and o increase awareness of risk pandemic with community health South Africa factors for diabetes and workers increasing virtual encourage people at high risk connections to enroll patients and to be screened so they can leveraging social media for take action to prevent future communications. Resident-led steering committees continue to complications. meet virtually. o The pilot also includes resident-led • Global Lilly employees neighborhood steering committees participating in pilot through to: volunteer opportunities. o assist the community health workers in reaching residents, • Part of Lilly’s 30×30 goal to reach 30 million people in resource- and limited settings annually by 2030. o to foster an environment (physical and social) that supports greater health and well-being for all residents.

National Diabetes Prevention Program (National DPP)

• Launched in 2010, to address the • Partnership of public and private • Collaboration develops lifestyle • 2016 ICER report concludes that increasing burden of prediabetes organizations including, federal change programs, a key the DPP programs provided “an and type 2 diabetes in the U.S. agencies, state and local health component of the National DPP incremental or better” net health through evidence-based, departments, national and • These programs must meet benefit affordable and high-quality community organizations, certain standards in order to be • CMS finalized 2016 rule to lifestyle change programs employers, public and private formally recognized by the CDC expand coverage of DPP program • Provides a framework for diabetes insurers, health care (called the Medicare Diabetes professionals, university • Programs are required to use the prevention efforts to help prevent CDC-approved curriculum Prevention Program) Appendix A: Overview of Selected Collaborations 14

type 2 diabetes and improve community education programs, regarding the duration, intensity • CDC expands DPP overall patient health businesses that focus on wellness and reporting requirements. infrastructure in 2017 to 12 • Does not publicly disclose any • Programs seek to train corporative agreements for a 5 direct biopharmaceutical community organizations so that year timeframe to build out the partnerships they can run the lifestyle change National DPP infrastructure in underserved areas in an effort to • Collaboration is the largest program effectively; increase referrals to and participation in reduce health disparities for adults national preventative effort to with prediabetes or at high risk for address type 2 diabetes. CDC-recognized lifestyle change programs; Increase coverage by type 2 diabetes employers, public and private insurers • Programs are research-based and focus on healthy eating and physical activity

NIH Helping to End Addiction Long-Term (HEAL) Initiative

• Launched in 2018, the trans- • National Institutes of Health (NIH) • Study areas of focus include • HEAL has contributed $500 agency initiative seeks to provide engaged in a yearlong therapeutic options for opioid million annually to over 400 scientific solutions to the national consultation with patients, addiction, overdose prevention, research projects crisis of opioid misuse, overdose advocates, academic experts, and reversal; Treatments for • Research highlights span across and addiction by accelerating private sector leaders, and federal infants with NAS/NOWS; the following areas: Translation of research, discovery and partners to identify the greatest prevention and treatment research to practice for the preclinical development of non- research needs and areas of strategies for opioid addiction; treatment of opioid addiction; New addictive treatments for pain to opportunity to address the opioid biological underpinnings of strategies to prevent and treat address the opioid crisis crisis chronic pain opioid addiction; Enhanced • Initiative seeks to inform and • Government Agencies: National • Initiative supports the full outcomes for infants and children establish the best pain Institutes of Health (NIH), Center spectrum of research efforts to exposed to opioids; Novel management strategies for acute for Drug Evaluation and Research improve pain management and medication options for opioid use and chronic pain conditions (CDER), U.S. Food and Drug enhance treatment for opioid disorder and overdose; Clinical Administration (FDA) misuse and addiction research in pain management; • Academic Institutions: Preclinical and translational University of California – San research in pain management Francisco, UPenn Medical School, Harvard Medical School, University of Washington, University of Utah, Washington University, University of Vermont, University of California- , University of North Carolina, Northwestern University, Virginia Commonwealth University • Nonprofits: Advanced Medical Technology Association (AdvaMed), American Medical Appendix A: Overview of Selected Collaborations 15

Association (AMA), Biotechnology Innovation Organization (BIO), Chronic Pain Research Alliance, Pharmaceutical Research and Manufacturers of America (PhRMA) • Insurer: Kaiser Permanente • Industry: Amgen Inc., Avid Radiopharmaceuticals Inc., Janssen Pharmaceutical Companies of Johnson & Johnson, Pfizer Inc., Indivior PLC, plc.

Operation Warp Speed

• Launched on May 15, 2020, • Partnership effort among • The partnership will • Efforts to support vaccine partnership aims to deliver 300 components of the Department of accelerate the development, development as of 8/7/20: million doses of COVID-19 Health and Human Services manufacturing, distribution of • Treatment candidates include vaccine by January 2021, as part (HHS), including the Centers for COVID-19 countermeasure Johnson & Johnson, , of a broader strategy to accelerate Disease Control and Prevention • Partnership will select the most Inc., and AstraZeneca plc/AB, the development, manufacturing, (CDC), the Food and Drug promising countermeasure Regeneron Pharmaceuticals, and distribution of COVID-19 Administration (FDA), the National candidates and provide Novavax, Inc., Pfizer Inc., countermeasures (vaccines, Institutes of Health (NIH), and the coordinated government support GlaxoSmithKline plc. therapeutics, and diagnostic) Biomedical Advanced Research to accelerate development while and Development Authority • Manufacturing capacities granted • Support investment and maintaining standards for safety to Johnson & Johnson, Moderna, coordination of countermeasure (BARDA), and the Department of and efficacy Defense (DoD). OWS engages Inc., AstraZeneca plc/AB, development allowing for • Through federal government Emergent BioSolutions, Texas accelerated delivery to patients with private firms and other federal agencies, including the investment, manufacturing A&M University and Fujifilm while adhering to standards for capacity for selected candidates is Holdings Corporation, Grand safety and efficacy Department of Agriculture, the Department of Energy, and the advanced while they are still in River Aseptic Manufacturing Inc., Department of Veterans Affairs. It development, rather than scaled (GRAM) will coordinate existing HHS-wide up after approval or authorization; • Distribution efforts include efforts, including the NIH’s • Partnership will expand domestic ApiJect, Systems, Corp. Accelerating COVID-19 manufacturing and supplies of and SiO2 Materials Science. Therapeutic Interventions and specialized materials and Vaccines (ACTIV) partnership, resources, such as glass vials, NIH’s Rapid Acceleration of that can be necessary for Diagnostics (RADx) initiative, and distribution work by BARDA. • Congress has directed almost $10 billion to this effort through supplemental funding, including the CARES Act, and Congress Appendix A: Overview of Selected Collaborations 16

has appropriated other flexible funding.

Gilead HepConnect

• Five year initiative to help address • 44 grantees representing local • In partnership with community • In 2019, HepConnect announced the increase in Hepatitis C community based organizations organizations, the initiative 44 grantees representing $5.3 and support community in Indiana, Kentucky, Tennessee provides grants to develop and million in local support across partnerships in Indiana, and North Carolina implement evidence-based Indiana, Kentucky, Tennessee Kentucky, Tennessee and North • Grantees range from non-profits solutions the meet the needs of and North Carolina. Carolina. to local health departments and people most affected by the opioid ministries. crisis • Expand screening and linkage to care by testing for the virus and ensuring those who need it can access appropriate care • Support harm reduction and community education • Activate healthcare infrastructure by building resources know-how and capacity in communities where the need is greatest • Grantee funding for harm reduction services and new strategies to engage and educate the community on harm reduction

Appendix A: Overview of Selected Collaborations 17

Manufacturing & Distribution Purpose Partners Approach Recent Successes Accelerating Medicines Partnership (AMP)

• Launched in 2014 with three • Government: National Institutes of • Identify novel way of validating focus areas: address relevant Health (NIH), U.S. Food and Drug promising biological targets for challenges to rheumatoid , Administration (FDA). diagnostic and drug development systemic lupus erythematosus, • Industry: AbbVie Inc., Biogen Inc., • Initial focus on RA and lupus with Alzheimer’s disease, and type 2 Bristol Myers Squibb (BMS), potential to expand 2018 project diabetes Corporation, on Parkinson’s disease • Generate pre-competitive, GlaxoSmithKline plc, Janssen disease-specific data that will be Pharmaceutical Companies of made publicly accessible to the Johnson & Johnson , Eli Lilly and broad biomedical community Company, Merck & Co. Inc., • Enhanced systems-level d.b.a., Pfizer Inc., Pasteur, understanding of gene expression Takeda Pharmaceutical Company and signaling in specific tissues Limited, Verily Life Sciences from affected end organs and • Non-profit: Alzheimer’s blood cells Association, Alzheimer’s Drug • Ascertain and define biological Discovery Foundation, American pathways in order to identify Diabetes Association, Arthritis relevant drug targets for the Foundation, Foundation for the treatment of autoimmune National Institutes of Health diseases (FNIH), Geoffrey Beene Foundation, Juvenile Diabetes • Increase number of new Research Foundation (JDRF), diagnostics and therapies for Lupus Foundation of America, patients and reduce time and cost Alliance for Lupus Research, The of developing them Michael J. Fox Foundation for Parkinson’s Research, Pharmaceutical Research and Manufacturers of America (PhRMA), Rheumatology Research Foundation, US Against Alzheimer’s

Appendix A: Overview of Selected Collaborations 18

Advanced Regenerative Manufacturing Institute

• Seeks to make practical the • Manufacturing USA (MII) • Regulatory and preclinical • 2019 developments: Announced the large-scale manufacturing of initiated BioFabUSA program consulting are some of the Fall 2019 Project and are seeking engineered tissues and tissue- and is sustained in-part by the member support services applications. Projects are divided into related technologies, to benefit Advanced Regenerative Advanced Regenerative three areas: Education and Workforce existing industries and grow new Manufacturing Institute (ARMI) Manufacturing Institute (ARMI) Development, Technology, and the ones. and the Department of Defense provides to its members as part Tissue Foundry. • Develop disruptive cell- and (DoD). of the Advanced Regenerative tissue-based technologies • Industry: Advanced Silicon Manufacturing Institute’s across five thrust areas Group, Advanced Solutions Life BioFabUSA program. • Produce modular and scalable Sciences, Boston Scientific • Regulatory and preclinical GMP-compliant manufacturing Corporation, Cell X consulting services seek to processes and integrated Technologies, CollPlant support the Advanced technologies across technology Ltd., Curable, Regenerative Manufacturing and manufacturing-readiness DEKA Research and Institute’s BioFabUSA program levels Development, Embody, Inc., as part of ARMI’s larger mission Fibercell Systems Inc, GE to support existing industries and • Develop and standardize Healthcare, Johnson & Johnson, grow new ones. manufacturing best practices Mayo Clinic, Medtronic plc, throughout the industry • Advanced Regenerative Corporation, Manufacturing Institute’s • Close the skills gap in tissue and Miromatrix Medical, Inc., O2M BioFabUSA integrates innovative organ manufacturing by Technologies, OrganaBio, STEL cell and tissue cultures with providing training opportunities Technologies, LLC, Rockwell advances in biofabrication, to interested students Automation Inc., Rooster Bio automation, robotics, and Inc., • Disseminate knowledge and analytical technologies to create Corporation, Pluristyx, Inc., disruptive research and enabling technologies to Trailhead Biosystems Inc. encourage continued innovation. development tools and • Academics: Arizona State manufacturing processes. University, University of California Los Angeles, Carnegie Mellon University, University of Connecticut, University of Massachusetts Lowell, University of New Hampshire, Texas Heart Institute, University of Virginia, Worcester Polytechnic Institute

Appendix A: Overview of Selected Collaborations 19

Critical Path Institute (C-PATH)

• Launched in 2005 seeking to • U.S. Food and Drug • Acts as an independent third • COA Qualification from U.S. Food and speed up and reduce the costs Administration (FDA), University party to form and lead public- Drug Administration for Asthma of medical product development of Arizona, State of Arizona, private consortia/programs in a Daytime Symptom Diary (ADSD) by creating new data standards, SFAZ – Science Foundation of pre-competitive collaboration and Asthma Nighttime Symptom measurement standards, and Arizona and data sharing effort Diary (ANSD) methods standards to aid in the • Partnership with CDISC (Clinical • Consortium model helps to de- • Qualification of drug-induced kidney scientific evaluation of the Data Interchange Standards risk decision during development injury (DIKI) clinical safety biomarker, efficacy and safety of new Consortium) to form CFAST and regulatory review process composite measure therapies (Coalition For Accelerating for novel medical products • COA Qualification from U.S. Food and • Created under the FDA’s Critical Standards and Therapies) in • Unique expertise working to Drug Administration for the Non-Small Path initiative program 2012 achieve outlined core Cell Lung Cancer Symptom • Additional partnerships listed in competencies: Regulatory Assessment Questionnaire (NSCLC- annual reports qualification of preclinical, and SAQ) clinical biomarkers and novel • COA qualification from FDA for methodologies for safety, the Symptoms of Major Depressive efficacy, and trial enrichment; Disorder Scale (SMDDS) Development and qualification of clinical outcome assessment • PKDOC Secures EMA Qualification tools; Development of Opinion for Enrichment Biomarker in quantitative modeling and ADPKD simulation tools; Regulatory • More listed under successes and acceptance of nonclinical tools timeline for medical product development; Clinical data standards development; Provision of large-scale data solutions for scientific research; Forming and managing large international consortia; Impact on Regulatory Science

Appendix A: Overview of Selected Collaborations 20

Machine learning ledger orchestration for drug discovery (MELLODDY)

• Launched in 2019, seeks to • Industry: Amgen Inc., Astellas • Three-year project from • Announced successful enable research across a Pharma Inc., AstraZeneca Innovative Medicines Initiative deployment of the platform and decentralized and highly plc/AB, Bayer AG, Boehringer funded in part by the European have completed the platform’s proprietary database of Ingelheim, GlaxoSmithKline plc, Commission first federated learning runs. This annotated chemical libraries for Janssen Pharmaceutical • Consortium effort to develop a federated learning can help the purposes of accelerating Companies of Johnson & machine learning platform accelerate the process through drug discovery and improving Johnson, Merck & Co. Inc., containing multiple sets of which drugs enter clinical trials. patient outcomes d.b.a., Novartis International AG, proprietary data without • Improve collaboration across Servier Laboratories comprising privacy or security biopharmaceutical companies • Public/Non-profits: Budapest • Develop a multi-task predictive participating University of Technology and machine learning algorithm, • Improve predictability of a Economics, Katholieke without exposing proprietary molecular compound’s potential Universiteit Leuven, information in later stages of drug discovery • Private organizations: Iktos, • Leverage a collection of over 10 and development Katholieke Universiteit Leuven, million small molecules with Kubermatic, Corporation, known biochemical or cellular Owkin, Inc., Substra Foundation activity to improve the accuracy of predictive models increase efficiencies in drug discovery

Merck Blockchain Partnership

• Pilot program to leverage • International Business Machines • Shared blockchain network that • Program completed in 2019 and blockchain technology to Corporation (IBM), Merck & Co. allows real-time monitoring of provided a report to the FDA in improve security of prescription Inc., d.b.a., Inc., KPMG products in pharmaceutical 2020 outlining the success of the drug supply and distribution International Limited supply chain pilot. The pilot met the objectives • Intended to assess blockchain • The project was selected by the • Builds off of work done by to demonstrate that blockchain as a suitable technology to U.S. Food and Drug International Business Machines can provide a common record of address needs of the Administration (FDA) in an effort Corporation (IBM), and Walmart product movement by pharmaceutical supply chain to implement the US Drug Inc. in retailer’s system for connecting disparate systems Supply Chain Security Act tracking fresh produce and meat and improve patient safety by • Potential to reduce time needed triggering product alerts. to track and trace prescription (2013) drugs, improve access to reliable distribution information and ensure products are handled appropriately and stored at the right temperature while being distributed

Appendix A: Overview of Selected Collaborations 21

National Cell Manufacturing Consortium (NCMC)

• Consortium effort focused on • First U.S.-based national • Through a collaborative process, • The 2019 roadmap reports developing, maturing, and consortium the initiative produced a national progress in the following areas: implementing technologies that • Over 25 companies, 15 roadmap on cell therapy Improving understanding of the can enable large-scale, cost- academic, clinical facilities, manufacturing to advance efforts cell types present in various cell effective manufacturing of private foundations, and across the following therapies and the properties of therapeutic cells government agencies. workstreams: Cell Processing these cells, Documenting • Seek to transform the and Automation, Process impacts of trace elements in • National Cell Manufacturing Monitoring and Quality Control, culture media on product quality, manufacturing process for cell- Consortium (NCMC) was based therapeutics into a large- Supply Chain and Transport Designing and developing established through the Logistics, Standardization, closed, automated, small- scale, lower-cost, reproducible, Advanced Manufacturing and high-quality engineered Regulatory Support, and Cost footprint cell processing Technologies (AMTech) grant Reimbursement, Workforce systems, Developing allogeneic process, for broad industry and from the National Institute of clinical use Development and universal T-cell therapies, Standards and Technologies Improving the scale of (NIST) • Released a 2019, 2017, and 2016 roadmap each designed to mesenchymal stem cell (MSC) • NCMC initiative is in partnership serve as an update to the production, Increasing with the National Science previous version understanding of the limits of Foundation (NSF) Engineering population doubling, Research Center (ERC) for senescence, and exhaustion, Cell Manufacturing Using synthetic biology to better Technologies (CMaT) control development of cell therapies • Government Agencies: National Institute of Standards and Technologies (NIST) • Industry: ACEA Biosciences, Inc., Axion BioSystems, , Inc., ArunA Bio, Bristol Myers Squibb (BMS), CDI Laboratories, Inc., Century Therapeutics, Cytiva Life Sciences, Etaluma Inc., Evolved Analytics Inc., Janssen Pharmaceutical Companies of Johnson & Johnson, Lonza Group AG, Lucid Scientific, MilliporeSigma, Nucleus Biologics, RoosterBio, Inc., , Inc., Terumo BCT, Inc., and ViCapsys, Inc.

Appendix A: Overview of Selected Collaborations 22

Improving Access Purpose Partners Approach Recent Successes

Duke-Margolis Value Based Payment (VBP) Consortium

• Improve the value of health care • Partners also include academic • The Consortium hosts regularly • Publication: Advancing Value- by developing evidence-based institutions, patients and providers scheduled events to convene Based Payment for policy solutions including: Aetna Foundation, stakeholders on value-based Transformative Therapies • Develop approaches to payment American College of Cardiology payment • Publication: Overcoming Legal reform that support better Foundation, Behavioral • Develop conceptual frameworks and Regulatory Hurdles to outcomes for patients and better Economics and Healthy Food for structuring VBP arrangements Value-Based Payment Choice Research (BERC) Center value across the system • Facilitate stakeholder input and Arrangements for Medical at Duke University, Laura and Products • Seeks to overcome current John Arnold Foundation, Bass support barriers to VBP arrangements by Connections, Center for Health • Lead health policy research • Publication: Clarifying Medicaid identifying and developing Policy & Inequalities Research at efforts to explore other novel Best Price Regulations In the solutions to legal and regulatory Duke University, Center for approaches leading to greater Context of Value-Based issues, and by addressing Medicare and Medicaid value Payment Arrangements operational challenges such as Innovation, The Commonwealth • Focus on healthcare • Publication: Value-based fragmented and difficult-to-track Fund, Duke Cancer Institute, Payment Consortium Explores patient outcome data. Duke Clinical Research Institute, transformation, biomedical innovation, global health policy, Novel Payment Arrangements Duke Global Health Institute, for Transformative Therapies Duke Population Research education and workforce Institute, Global Health development Technologies Coalition, The Health Foundation, Medical Device Epidemiology Network, Merck & Co., Inc., d.b.a., U.S. Food and Drug Administration (FDA), World Innovation Summit for Health. • Industry: plc, BioMarin Pharmaceutical Inc., Novartis International AG, bluebird bio, inc., Pfizer Inc., Spark Therapeutics, Amgen Inc., Gilead Sciences inc., GlaxoSmithKline plc, Regenxbio Inc., Medtronic plc, Boston Scientific Corporation, , Edwards Lifesciences Appendix A: Overview of Selected Collaborations 23

• Non-profits: National Health Council, FasterCures, Kaiser Permanente, • Insurers: Employees’ State Insurance (ESI), Harvard Pilgrim Health Care, HCA Healthcare, Anthem, Inc.

MIT NEW Drug Development ParadIGmS (NEWDIGS) • Focused on enhancing the • Members and Collaboration • Bring together diverse multi- • Publication: Payer Perspectives capacity of the global biomedical Partners include: Government stakeholder to participate in case- on Reimbursement of One-Time innovation system to improve Agency: The National Institutes based simulation exercises High-Cost Durable Therapies reliability, sustainability, for Health (NIH), Nonprofits: • Provides a pre-competitive • Publication: Are Payers Ready, affordability and access Alliance for Regenerative “laboratory” to help advance Willing, and Able to Provide • Develop solutions for systemwide Medicine (ARM), American hands-on collaborative system re- Access to New Durable Gene impediments to biomedical College of Rheumatology, engineering Therapies? innovation and patient care FasterCures Center, Innovative Medicines Initiative (IMI), IQVIA, • The Adaptive Biomedical • Publication: Leaping Together • All initiatives seek to drive Milken Institute, NORD (National Innovation project seeks to align Toward Sustainable, Patient- sustainable patient-centered Organization for Rare Disorders), stakeholders in an effort to Centered Innovation: The Value innovation Insurers: Anthem, Inc., Humana advance sustainable patient- of a Multistakeholder Safe Inc., Kaiser Permanente, Industry: centered innovation by applying Haven for Accelerating System AveXis/ Novartis International AG, the principles of continuous Change bluebird bio, Inc., Biogen Inc., learning and improvement across • Publication: Alternative State- BioMarin Pharmaceutical Inc., the product life span in ways that: Level Financing for Hepatitis C Bristol Myers Squibb (BMS), (1) optimize benefit/minimize Treatment- The " Model” Cardinal Health ,Inc., Janssen: harm for patients, (2) Pharmaceutical Companies of progressively enhance knowledge Johnson & Johnson, Merck & Co., and reduce uncertainties about Inc., d.b.a., Orchard the treatment, and (3) incorporate Therapeutics, Academic acceptable tradeoff decisions for Institutions: Johns Hopkins all stakeholders University, Massachusetts • The FoCUS project seeks to General Hospital, Dana-Farber collaboratively address the need Cancer Institute. for novel financing and reimbursement models for durable therapies in the US that ensure (1) patient access for needed treatments; (2) affordability for public and private payers; and (3) the sustainability of innovation by manufacturers • The LEAPS project provides the opportunity for various Appendix A: Overview of Selected Collaborations 24

stakeholders to collaborate on the design and piloting of an innovation ecosystem for a specific disease. In a series of 2 meetings (in 2017 and 2018), elements of the strategic vision of the program, as well as several diseases for the pilot programs were discussed. The 2-year pilot design phase of LEAPS, using rheumatoid arthirits as the primary focus of the Pilot program was launched in January 2018

Adult Vaccine Access Coalition (AVAC)

• Work to address lack of • Numerous groups including health • Improve reporting of adult • Advocacy: AVAC Support information about recommended care providers, vaccine makers, vaccinations to state Letter: Protecting Seniors vaccines, financial hurdles, pharmacies, public health immunization registries Through Immunization Act technological and logistical organizations, patient and • Encourage greater utilization of • Production of educational challenges adults often face when consumer groups. health information technology to materials: Fact Sheet: Financial they seek access to and coverage • Industry: GlaxoSmithKline plc, track adult vaccination status and Barriers to Adult Immunization for vaccines. Merck & Co. Inc., d.b.a., Novavax, improve patient outcomes and • AVAC has cited concerns about • Seek to develop legislative and Inc., Pfizer Inc., Sanofi Pasteur, care. the proposed reduction in vaccine regulatory solutions to strengthen Takeda Vaccines, Pte. Ltd. • Establish additional federal administration reimbursement and and enhance access to and • Nonprofit: Biotechnology benchmarks and measures to is also concerned about the utilization of adult immunization Innovation Organization (BIO), encourage health plans to track, Pneumonia Vaccination Status for services across the health care Pharmaceutical Research and report, and achieve increased Older Adults measure (ACO #15) system. Manufacturers of America adult immunization rates. in the Medicare Shared Savings • Committed to improving adult (PhRMA). Program (MSSP’s) but applauds immunization rates among the the addition of zoster, general and at-risk populations. pneumococcal and influenza measures in several Alternative Payment Models (APMs) as well as a number of specialty provider measure sets. Numerous worries about CMS-1717-P Medicare Program). • Most recent update regarding COVID-19: AVAC led a diverse group of stakeholders in a letter sent to Congressional leadership providing recommendations on how Congress should invest in immunization infrastructure to Appendix A: Overview of Selected Collaborations 25

for the allocation, distribution, and administration of a new COVID-19 pandemic vaccine

Gilead Truvada CDC Partnership

• Launched May 9, 2019, large • Government Agency: Centers • Gilead Sciences, Inc. will provide supportive donation seeking to for Disease Control and to Centers for Disease Control support the CDC national effort to Prevention (CDC) and Prevention (CDC) up to 2.4 help prevent HIV and end the • Industry: Gilead Sciences, Inc. million bottles of Truvada® epidemic annually for uninsured Americans. • The donation, which extends up • Part of Gilead’s broader ongoing to 2030, will transition to initiatives to ensure all patients Descovy®, if it is approved for can access PrEP (COMPASS) use as PrEP

• This donation will support a greatly accelerated effort to reach these individuals, as well as create an opportunity for state and local partnerships to develop and implement protocols that are intended to ensure uninsured people at risk for HIV are given access to PrEP at no cost

Appendix B: Publicly Available Press Releases 26

Appendix B: Publicly Available Press Releases

The following appendix provides a list of publicly available press releases on selected biopharmaceutical collaborations to advance efforts focused on the COVID-19 Response. This is a selected list of examples of collaborations at the date of report publication. For the latest on the Biopharmaceutical Industry’s Efforts to Beat Coronavirus please visit www.phrma.org/Coronavirus.

• AbbVie, Harbour BioMed, Utrecht University and Erasmus Medical Center Announce Collaboration to Develop Therapy to Prevent and Treat COVID-19, June 5, 2020 (Company press release) • Amgen and Adaptive Biotechnologies Announce Strategic Partnership To Develop a Therapeutic To Prevent or Treat COVID-19, April 2, 2020 (Company press release) • AstraZeneca and Oxford University announce landmark agreement for COVID-19 vaccine, April 30, 2020 (Company press release) • AstraZeneca advances response to global COVID-19 challenge as it receives first commitments for oxford’s potential new vaccine, May 21, 2020 (Company press release) • Bristol Myers Squibb and The Rockerfeller University Announce License Agreement for SARS-CoV-2 Neutralizing Monoclonal Antibody Combination for the Treatment of COVID-19, February 2, 2021 (Company press release) • CoVIg-19 Plasma Alliance Builds Strong Momentum Through Expanded Membership and Clinical Trial Collaboration, May 7, 2020 (CSL Behring, Takeda press release) • CureVac and Bayer join forces on COVID-19 vaccine candidate CVnCOV, January 7, 2021 (Company press release) • DAARPA’s Early Investment in COVID-19 Antibody Identification Producing Timely Results, November 10, 2020 (DARPA press release) • Department of Justice Issues Business Review Letter to Monoclonal Antibody Manufacturers To Expedite and Increase The Production of Covid-19 Mab Treatments, July 23, 2020 (Press release) • FUJIFILM Diosynth Biotechnologies Texas Facility to Support COvID-19 vaccine candidate Manufacturing, July 27, 2020 (Company press release) • Gilead Sciences and Satcher Health Leadership Institute at Morehouse School of Medicine Partner to Study Racial Health Inequities Associated with COVID-19, July 28, 2020 (Company press release) • GSK and CureVac announce strategic mRNA technology collaboration, July 20, 2020 (Company press release) • IAVI and Merck Collaborate to Develop Vaccine Against SARS-CoV-2, Mary 26, 2020 (Company press release) Appendix B: Publicly Available Press Releases 27

• Johnson & Johnson Announces a Lead Vaccine Candidate for COVID-19; Landmark New Partnership with U.S. Department of Health & Human services; and Commitment to Supply One Billion Vaccines Worldwide for Emergency Pandemic Use, March 30, 2020 (Company Press Release) • Johnson & Johnson Announces Collaboration with the Beth Israel Deaconess Medical Center to Accelerate COVID-19 Vaccine Development, March 13, 2020 (Company press release) • Johnson & Johnson Announces Collaboration to Expand Manufacturing Capabilities For its COVID-19 Vaccine Candidate in Support of the Company’s Goal to Supply More than One Billion Vaccine Doses Globally, April 23, 2020 (Company press release) • Life Science Companies Commit Expertise and Assets to the Fight Against COVID-19 Pandemic Alongside Bill & Melinda Gates Foundation, March 25, 2020 (Company press release)1 • Lilly and Amgen Announce Manufacturing Collaboration for COVID-19 Antibody Therapies, September 17, 2020 (Company press release) • Lilly and UnitedHealth Group partner on pragmatic study of neutralizing antibody (LY-CoV555) for COVID-19, December 4, 2020 (Company press release) • Members of the COVID R&D Alliance and Quantum Leap Healthcare Collaborative Enroll First Patients in I-SPY COVID Trial, August 3, 2020 (AbbVie, Amgen, Takeda press releases) • Merck and institute for Systems Biology Collaborate to Define Molecular Mechanisms of SARS-coV-2 infection and Identify Potential prognostic Biomarkers, April 27, 2020 (Company press release) • Moderna Announces Expansion of BARDA Agreement to Support Larger Phase 3 Program for Vaccine (mRNa-1273) Against cOVID-19, July 26, 2020 (Company press Release) • NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options, April 17, 2020 (Press release) • Novartis signs initial agreement to provide manufacturing capacity for Pfizer-BioNTech COVID-19 vaccine, January 29, 2021 (Company press release) • Sanofi and GSK to join forces in unprecedented vaccine collaboration to fight COVID-19, April 14, 2020 (Company press release) • Sanofi and GSK to support COVAX with 200 million doses of adjuvanted, recombinant protein-based COVID-19 vaccine, October 28, 2020 (Company press release) • Sanofi joins forces with U.S. Department of Health and Human Services to advance a novel coronavirus vaccine, February 18, 2020 (Company Press Release) • Sanofi to provide support to BioNTech in manufacturing their COVID-19 vaccine to help address public health needs, January 27, 2021 (Company press release) • World’s leading Life Science Companies Now Enrolling Community, A Global, Platform Trial for Hospitalized Patients with COVID-19, November 30, 2020 (AMGEN, Takeda, UCB press releases)

1 Press releases announcing collaboration also found on websites of: , Bristol-Myers Squibb, Eisai, Eli Lilly, Gilead, GSK, Johnson & Johnson, Merck, Pfizer and Sanofi