Volume 23, Issue 45. © 2019 CenterWatch. All rights reserved.

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see Sponsors, CROs Doing Better on page 6 »

see ICH Overhauls on page 5 »

November 25, 2019

Industry Briefs…2

Up and Coming…3

Drug & Device Pipeline News…8Twenty-four drugs and devices have entered a new trial phase this week.

CWMarketPlace…10

CenterWatchWeekly

By Leslie Ramsey

The ability of sponsors and CROs to meet the needs of their sites has im-proved slightly in recent years, accord-

ing to a new CenterWatch survey, but sites say they need to see more progress in almost all aspects of their working relationships.

More than 4,000 sites responding to CenterWatch’s 2019 Global Site Relationship Survey rated the performance of the spon-sors and CROs they work with on 37 to 40 key attributes. The respondents gave high marks to only about half of sponsors and CROs. The biggest problem areas for both groups were contracting and budgeting, the survey shows.

Sponsors’ average “excellent” rating rose 5 percent overall from 2017 — up to 53 percent in 2019 from 48 percent. CROs’ margin of

improvement was narrower — 51 percent in 2019, up from 48% in 2017.

Sponsor and CRO attributes sites named as “very important” in 2019 remained largely the same as in 2017:

}} Has professional, knowledgeable and well-trained monitors/CRAs;

}} Is organized and prepared; }} Provides good overall protocol design;}} Staff is easily accessible;}} Offers timely drug availability;}} Maintains open communication;}} Sets realistic project timelines;}} Is responsive to inquiries; }} Has professional medical staff in clinical

operations; }} Works effectively with sponsors/CROs; and

Sponsors, CROs Doing Better, Sites Say, But More Work Is Needed

By Leslie Ramsey and Colin Stoecker

For the first time in 22 years, the Interna-tional Council on Harmonization (ICH) is almost completely overhauling the

guideline ICH E8 — General Considerations for Clinical Studies, the international standard for designing and developing trials.

The major rewrite of the 1997 guide-line, which is expected to go into effect in June 2020, would replace the develop-ment methodology section of the original document with five new sections that apply the quality-by-design method to trial development:

}} Designing quality into clinical studies;}} Drug development planning;}} Design elements for clinical studies;}} Conduct and reporting; and

}} Considerations in identifying critical-to-quality factors.

According to the draft, “the quality-by-design approach to clinical research involves focusing on critical-to-quality factors to ensure the protection of study subjects, the generation of reliable and meaningful results, and the management of risks to those factors.”

Critical-to-quality factors, according to Leslie Sam, principal consultant of Wool Consulting Group, “are considered to be critical because if their integrity were under-mined by errors of design or conduct, the reliability or ethics of decisionmaking would also be undermined.”

Designing quality into trials, said Sam in a recent CenterWatch webinar, should begin

ICH Overhauls 22-Year-Old Clinical Studies Guideline

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CenterWatch Weekly (ISSN 1528-5731)

Beth Belton Editorial Director Colin Stoecker ReporterStephanie Akers ProductionRussell Titsch Business Development Director

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Industry Briefs

FDA Revises Policy for Certificates of ConfidentialityThe FDA on Friday issued a new draft guid-ance that would formalize its current process for issuing discretionary Certificates of Confidentiality (CoC) for commercial sponsors that seek to prohibit disclosure of identifiable information about a research participant.

In the past, a CoC protected a researcher from being compelled to disclose identifiable in-formation about a research participant. The 21st Century Cures Act changed that, by affirmatively prohibiting CoC holders from disclosing such information unless a specific exemption applies.

The FDA typically approves about 150 such requests a year and doesn’t expect that number to change, although the agency warned sponsors that recent technological innovations make it easy for other parties to easily deduce a patient’s identity from deidentified data of a trial, including genomic data and biospecimens.

The guidance lists cases in which a researcher is legally permitted to disclose identifying data, including:

}} If the disclosure is required by federal state or local law as a reportable disease;

}} If the information is medically necessary to treat the participant with his or her consent; or

}} If the researcher strips the identifiers from the data and uses it anonymously without consent.

The guidance recommends that CoC re-questors evaluate the risk of privacy breaches by examining the type of information col-lected, whether the information is retained for further use, the extent of the information and the security of the data.

Comments on the draft are due by Jan. 8, 2020.

Read the draft version here: https://bit.ly/2qCiVbx.

Hahn Sails Through Senate Confirmation HearingIn his mostly smooth Senate confirmation hearing on Wednesday, the administration’s

nominee for FDA commissioner said that patient-focused endpoints of clinical trials were of particular interest to him.

“We have to be pragmatic, we have to make sure that they are validated end-points,” said Stephen Hahn. “I am interested in working with all stakeholders on this.”

Members of the Health, Education, Labor, and Pensions (HELP) committee showed clear bipartisan support for Hahn, while probing for his views on topics including new drug approvals, drug pricing and opioids.

The five most recent former FDA commis-sioners, including Scott Gottlieb, have thrown their support behind Hahn’s confirmation, telling Senate leaders in a letter late last week that the agency “urgently needs a well-quali-fied permanent commissioner,” and that they hope Hahn can bring his experience to the agency “as soon as possible.” The commission-ers had previously supported the selection of former acting FDA Commissioner Ned Sharpless for the permanent post.

Committee chair Lamar Alexander (R-Tenn.) announced that the committee will vote on advancing Hahn’s nomination to the full Senate on Dec. 3.

Large Sponsors Take Longer to Qualify Vendors But Have Higher Success RatesMore than 90 percent of all drug sponsors’ vendor assessments result in approval of the vendor, according to a new benchmark study.

According to the survey from the Tufts Center for the Study of Drug Development (CSDD), large sponsors take a much longer

time than smaller sponsors to evaluate clini-cal trial providers and specialty labs. Large sponsors also use more complex processes with completion-to-contract stages than other smaller companies.

The average cycle time from a request to a signed contract was 19 weeks for vendors providing a single service compared to 26 weeks for multiservice providers.

Large sponsors have the highest rates of vendors failing to qualify (11.5 percent) due to deeper inquiry into vendor practices com-pared to 5 percent for medium-sized sponsors and 5.9 percent for small sponsors, according to the study.

The vendor qualification survey is the first industrywide benchmark study on the subject and measures sponsor metrics on the evalua-tion of clinical trial and specialty lab vendors.

The study was conducted in conjunction with the Avoca Group and was based on an analysis of data from 76 sponsors — 50 per-cent pharma companies, 38 percent biotech companies, 4 percent devicemakers and 4 percent other. In 2018, developers worldwide spent about $375 million on clinical trial ven-dor qualification and requalification.

Get a copy of the report here: https://bit.ly/2QHR18G.

EU Parliament Raises Concerns About Delays to CT Portal The EU Parliament’s public health commit-tee is concerned that repeated delays in the development of a new clinical trials database will postpone the effective date of new EU

see Industry Briefs on page 4 »

© 2019 CenterWatch. CWW2345

This feature highlights changes in clinical research organizations’ personnel.

Abbott Abbott has named Robert Ford chief executive officer, effective March 31, 2020. Ford was most recently appointed president and chief operating officer at the company.

AbingworthNeil Cooper has been named chief financial officer at Abingworth LLP. Cooper previously served as finance director at Kennet Partners Ltd.

ArrowheadArrowhead Pharmaceuticals, Inc. has named Javier San Martin chief medical officer and Curt Bradshaw chief scientific officer. San Martin recently served as senior vice presi-dent and head of global clinical develop-ment at Ultragenyx. Bradshaw was president and CSO at Tollnine.

CuteraFuad Ahmad has been appointed interim chief financial officer at Cutera, Inc. Ahmad is a partner at FLG Partners.

CyclerionAndy Busch has been appointed chief in-novation officer at Cyclerion Therapeutics, Inc. Busch previously served as head of research and development at Shire.

Dalrada HealthDalrada Health has appointed Payal Kes-warpu chief medical officer. Keswarpu last served as clinical lead for oncology informat-ics and genomics at Philips in India.

Diverse BiotechDiverse Biotech has named Stella Vnook chief executive officer. Vnook was most re-cently vice president of managed markets and trade at Assertio Therapeutics, Inc.

EntasisDavid Altarac has been appointed chief medical officer at Entasis Therapeutics Holdings Inc. Altarac was most recently senior vice president, head of regulatory, safety R&D quality and compliance at Shire.

EyePoint PharmaceuticalsEyePoint Pharmaceuticals, Inc. has named George Elston chief financial officer and head of corporate development. Elston was formerly CFO and head of corporate develop-ment at Enzyvant Therapeutics.

Human LongevityThomas Caskey has been appointed chief medical officer at Human Longevity, Inc. Caskey is a professor of molecular and human genetics at the Baylor College of Medicine, and past president of the Ameri-can Society of Human Genetics and Human Genome Organization.

InozymeInozyme Pharma has named Pedro Huer-tas chief medical officer, Gus Khursigara vice president of medical affairs and operations and Catherine Nester vice president of physician and patient strate-gies. Huertas was most recently CMO of Sentien Pharmaceuticals. Khursigara is the former vice president of global medical af-fairs at Biohaven Pharmaceuticals. Nester was senior oncology business director at Incyte Pharmaceuticals.

InsmedInsmed Inc. has appointed Roger Adsett chief operating officer. Adestt was most recently chief commercial officer with the company.

IpsenIpsen has expanded its senior management team with the appointment of Howard Mayer as chief of research and develop-ment. Mayer was most recently senior vice

president, chief medical officer and head of research and development at Shire’s neuro-science division.

iQ Group GlobalJonathan Arambula has been appointed vice president of research at OncoTEX Inc., a member company of iQ Group Global. Aram-bula was previously a research associate and lecturer in the department of chemistry at the University of Texas.

Jaguar HealthIan Wendt has been named vice president of commercial strategy at Jaguar Health. Wendt previously led strategy and tactical development for a national team focused on policy and protocol development within HIV at Gilead Sciences.

mytaptrackJenny Klein-Sosa has been named chief research officer at mytaptrack. Klein-Sosa is a psychologist and neuropsychological evaluator for the Integrated Center for Child Development, and previously served as chief executive officer of GENED Educational Services, LLC.

Nurix TherapeuticsChristine Ring has been named general counsel, Christiana Guiducci head of immunology and oncology research, Jean Chang head of clinical program man-agement and asset strategy and Gwenn Hansen senior vice president of research at Nurix Therapeutics, Inc. Ring was previous-ly senior vice president of legal at Dermira, Inc. Guiducci previously served as vice president of oncology research at Dynavax Technologies. Change was oncology proj-ect lead and vice president of corporate development at Dynavax Technologies. Hansen was previously the senior director of drug discovery technologies with Nurix before her promotion.

WCG | CWWeekly November 25, 2019 3 of 10

Up and Coming

see Up and Coming on page 4 »

© 2019 CenterWatch. CWW2345

WCG | CWWeekly November 25, 2019 4 of 10

Rentschler BiopharmaRentschler Biopharma SE has expanded its leadership team with the addition of Her-mant Kumar as vice president for process sciences and Lorraine Blackman as head of human resources for the U.S. Kumar was previously senior vice president of process development and manufactur-ing operations at AnaptysBio. Blackman was director of human resources at IDT Biologika.

SavaraBadrul Chowdhury has been named chief medical officer at Savara Inc. Chowdhury was previously senior vice president and chief phy-sician scientist for respiratory, inflammation and autoimmunity late stage development

in biopharmaceuticals research and develop-ment at AstraZeneca.

Science 37David Coman has been appointed chief medi-cal officer at Science 37, a company that special-izes in fully decentralized clinical trials. Coman previously served as chief strategy officer and lead of data and analytics business at ERT.

Sema4Sema4 has named Joel Sendek chief financial officer. Sendek was formerly CFO at Spero Therapeutics.

TheragnosticsDaniel Stevens has been named chief medical officer at Theragnostics Inc. Stevens’ most recent appointment was as a global development lead at Ipsen.

VerisysVerisys has appointed Srini Chillara chief technology officer. Chillara was most recently vice president of software development at Experience Healthcare.

Vireo HealthVireo Health has named Shaun Nugent chief financial officer and Amber Shimpa chief administrative officer. Nugent pre-viously served as managing director at 16Vente Advisors. Shimpa was most recently CFO at Vireo Health.

Yumanity TherapeuticsYumanity Therapeutics has appointed Brigitte Robertson chief medical officer. Robertson was most recently vice president of global clinical development and therapeutic area head within Shire’s neuroscience division.

Up and Comingcontinued from page 3

clinical trials regulations. The regulations are scheduled to go into effect in early 2020.

The new database, the Clinical Trials Information System (CTIS), will aggregate all European clinical trial data for access by spon-sors, investigators and the public.

The European Medicines Association (EMA) management board endorsed a delivery timeframe in December 2015 for the CTIS to go live, but that date has been postponed multiple times due to technical difficulties with the development of the IT systems, ac-cording to the EMA.

In October, the EMA’s management board endorsed a six-month monitoring and audit of the CTIS developer’s performance with the goal of getting the new database up and run-ning as soon as possible.

Petition to FDA Questions Prisoner Device TrialA recent citizens petition to the FDA asks the agency to investigate a possible illegal

clinical trial conducted in a Louisiana prison last spring.

In May 2019, BioCorRX implanted an inves-tigational addiction device into one prisoner at the Louisiana Department of Corrections. The prisoner was unaware that the implant was not approved by the FDA for use and also that he was part of an experiment.

The company discontinued the trial after implanting only one of 10 intended partici-pants. Neither the prison nor the sponsor had applied for IRB approval. The company was also planning on testing the device in homeless patients in Philadelphia.

BioCorRX says that it was in full compliance with the law in testing the device on inmates.

The FDA has yet to respond to the petition.Read the full petition here: https://bit.

ly/2D5uhaB.

Janssen’s Remote Trial Uses Wearables for Heart Study Janssen has launched its first-ever com-pletely decentralized mobile clinical trial using wearable device technology.

The phase 3 heart failure study is a randomized, double-blind, placebo-con-trolled, interventional superiority study that requires no in-person visits at a site. Instead, it relies on app-based clinical question-naires, smartphones and wearable devices to measure activity.

Alkermes Picks Up Rodin for CNS TherapiesBiotech company Alkermes will acquire Rodin Therapeutics’ pipeline of drugs for central nervous system (CNS) diseases.

Rodin is currently conducting trials of oral brain-permeating drugs for CNS indica-tions. Alkermes intends to build on Rodin’s pipeline to develop neuropsychiatric, neurodegenerative and neurodevelopment disorder drugs for Alzheimer’s, Huntington’s, dementia and depression.

Alkermes will also continue Rodin’s pre-clinical program on dementia patients and other work in hematology and cancer.

Dublin-based Alkermes is acquiring Rodin, based in Boston, for $950 million.

Industry Briefscontinued from page 2

© 2019 CenterWatch. CWW2345

WCG | CWWeekly November 25, 2019 5 of 10

Features

ICH Overhaulscontinued from page 1

with identification and prioritization of these factors. Once critical-to-quality factors are determined, it is then the responsibility of the study team to design a protocol that consid-ers impact on the factors, risks to subjects and data integrity, and whether risks can be accepted or mitigated, she said.

Trials also should engage patients in study design, the draft says, to provide input on ethical, cultural and regional issues.

Drug development planning does not need to be tied to fixed-time clinical trial phas-es, the guideline says, but could be driven by other design elements, such as study objec-tive. “Drug development is ideally a logical, step-wise process in which information from small early studies is used to support and plan later larger, more definitive studies.” The pro-

gression should be from human pharmacol-ogy studies, to exploratory and confirmatory studies, to post-approval studies.

The draft revision also offers guidance on design elements for trials, including choosing inclusion and exclusion criteria with study objectives in mind, deciding whether the intent of the study is to test or merely observe the effects of a treatment, and identifying methods to reduce or assess bias.

The draft includes three new annexes on types of studies, how E8 fits with other ICH efficacy guidelines and selected examples of critical-to-quality factors.

The examples in the critical-to-quality annex is a good starting point for designing a study protocol, Sam said, but shouldn’t serve as a checklist.

“That’s not the intention at all. They are intended to be used to facilitate a conversa-

tion,” she added. “It’s a great opportunity to bring together the right people to exercise quality culture, so they have a con-versation and identify risks to not having those factors.”

At an Oct. 31 FDA public meeting on the revision, critical-to-quality factors was the top concern of industry groups and the public.

“It was interesting how many patient advo-cacy groups shared their voice on the draft guideline,” said Sam. Generally, the patient groups wanted the guideline to place more importance on patient input, protocols and study designs.

The new guideline is slated to go into effect in June 2020 after it is adopted by the FDA and a number of regulatory agencies in other countries.

Read the draft of ICH E8(R1) here: https://bit.ly/2rb0ZF0.

Sandra “SAM” Sather, MS, CCRC

The CRC’s Guide to Coordinating Clinical Research

FOURTH EDITION The guide covers key topics like specific GCP regulations, principles of informed consent, writing and training on SOPs, IRB requirements and more:

n Site feasibility studiesn Study initiation, monitoring and

closeoutn Devices and biologics research

n Documentation & data integrityn Investigational product

accountabilityn Adverse event reporting

n Interacting with sponsors, CROs and clinical trial monitors

n Study protocols and case report forms

A vital resource for both novice and experienced clinical research coordinatorsThis new edition of The CRC’s Guide is a one-volume training masterpiece that covers the roles and responsibil-ities of all key parties involved in managing clinical trials.

Order today at www.centerwatch.com/crcguide

© 2019 CenterWatch. CWW2345

WCG | CWWeekly November 25, 2019 6 of 10

Features

Sponsors, CROs Doing Bettercontinued from page 1

}} Provides clear study initiation visit and training.

The attribute on which sponsors scored highest is “has professional medical staff,” with 55 percent of them rated “excellent.” Sponsors scored high on four other attri-butes — having well-trained CRAs, main-taining open communications, offering timely drug availability, and being organized and prepared — with 53 percent of spon-sors receiving ratings of “excellent” on each.

Some of the lowest scores sponsors received were related to protocols. Only 39 percent of sponsors received a rating of “excel-lent” for actively soliciting feedback on the protocol design as well as actively engaging patients/patient groups in protocol design.

Forty percent of sponsors were rated “excellent” for flexibility and willingness to modify protocols. And 42 percent of sponsors received an “excellent” rating for providing protocols that require minimal amendments.

Survey respondents showed the most satisfaction with CROs in the area of overall project support, with 43 percent of CROs receiving a rating of “excellent.” Still, that number is down eight percentage points from the 2017 survey.

CROs’ handling of contracts and budgets consistently has received the lowest scores in recent years, but in 2019 fell to 37 percent after receiving a small boost in 2017 (44 percent) compared to 2015 (40 percent). In the specific attributes of prompt payment, realistic payment schedules and fair overall payment amounts, slightly more than one-third of CROs, 36 percent, received “excellent” ratings.

Only 37 percent of CROs were rated “excel-lent” for flexibility and willingness to modify protocols and budgets. And the same percent of CROs received an “excellent” rating for providing patient recruitment planning and implementation assistance.

Survey responses were submitted by investigators for 53 percent of sites, and study coordinators/nurses made up 34 percent of respondents.

Among sites responding to the survey, rat-ings by site type were fairly consistent, rang-ing from 52 percent to 59 percent of sponsors/CROs rated “excellent.” Ratings were gathered from independent research centers, private physician practices, academic medical centers, government-funded hospitals and clinics, and for-profit hospitals and clinics.

Independent research centers reported conducting the most industry-sponsored trials, approximately 12 per year with a total of 223 pa-

tients. For-profit hospitals followed with about nine trials per year and a total of about 118 patients. Academic medical centers conducted nine trials with a total of about 84 patients.

Looking at responses by region, sites in North America conduct about 14 trials per year with a total of almost 300 patients. In second place, African sites conduct about 10 trials per year with a total of 174 patients, edging out Asia Pacific with about nine trials and 86 patients.

European sites reported conducting about eight trials with a total of 90 patients, and South American sites about six trials with 89 patients.

Of all respondents in 2019, the number of sites conducting cardiology research was highest at 26 percent, followed by endocrinol-ogy at 25 percent and pulmonary diseases at 23 percent. Other therapeutic areas represent-ed by this year’s respondents include:

}} Rheumatology with 16 percent of respondents;

}} Neurology with 14 percent;}} Gastroenterology with 13 percent;}} Pediatrics with 9 percent;}} Immunology and infectious diseases

with 8 percent; and}} Oncology with 7 percent.

To order a copy of the sponsor or CRO report, click here: https://bit.ly/2OCjoTa.

Average Sponsor/CRO Ratings, 2019

n = 2,253

Source: CenterWatch 2019 Global Site Relationship Benchmark Survey

CROSponsorPoor2% Below average

3%

Fair12%

Above average30%

Excellent53%

Poor1%

Fair15%

Above average30%

Excellent51%

Below average3%

© 2019 CenterWatch. CWW2345

WCG | CWWeekly November 25, 2019 7 of 10

For more than years we have overseen more research than all other IRBs combined.

Learn more about working with the gold standard in IRB review: www.wcgclinical.com/services/irb/

wcgclinical.com

More than 10,000 protocols

Nearly 24,000 investigators

More than 112,000 sites

Every day, WCG supports:

With Five Decades of Clinical Research Experience – We Are the “Gold Standard” in Ethical Review

Consider - WCG participates in over 90% of all FDA New Drug Approvals.

© 2019 CenterWatch. CWW2345

WCG | CWWeekly November 25, 2019 8 of 10

Drug & Device Pipeline News

Company Drug/Device Medical Condition Status Sponsor ContactCStone Pharmaceuticals

ivosidenib relapsed or refractory acute myeloid leukemia

Phase 1 trial initiated enrolling subjects with IDH1 mutant relapsed or refractory acute myeloid leukemia (R/R AML)

cstonepharma.com

Seelos Therapeutics, Inc.

SLS-002 Central Nervous System (CNS) disorders and rare diseases

Phase 1 trial initiated enrolling 48 healthy volunteers

seelostherapeutics.com

Spring Bank Pharmaceuticals, Inc.

SB 11285 advanced solid tumors Phase 1 trial initiated at multiple sites in the U.S.

springbankpharm.com

Celldex Therapeutics, Inc.

CDX-0159 chronic idiopathic urticaria (CIU) Phase 1a trial initiated enrolling 32 healthy subjects

celldex.com

Medivir AB MIV-818 liver cancer Phase 1a trial initiated enrolling nine subjects with advanced liver cancer

medivir.com

Enlivex Therapeutics Ltd.

Allocetra severe sepsis Phase 1b trial initiated enrolling 10 subjects

enlivex.com

Phoenix Molecular Designs

PMD-026 triple negative breast cancer Phase 1/1b trial initiated enrolling subjects with metastatic breast cancer and triple negative breast cancer at sites in the U.S.

phoenixmd.ca

Sensei Biotherapeutics

SNS-301 in combination with pembrolizumab

ASPH positive head and neck cancer

Phase 1/2 trial initiated enrolling 30 subjects

senseibio.com

Axial Biotherapeutics

AB-2004 Autism Spectrum Disorder (ASD) Phase 1b/2a trial initiated enrolling 25 male adolescent subjects

axialbiotherapeutics.com

Inotrem S.A. nangibotide septic shock Phase 2b trial initiated enrolling 450 subjects with septic shock at 48 sites across five countries in Europe and the U.S.

inotrem.com

Viking Therapeutics VK2809 non-alcoholic steatohepatitis Phase 2b trial initiated enrolling 340 subjects with biopsy-confirmed NASH and fibrosis ranging from stages F1 to F3 at multiple sites

vikingtherapeutics.com

BiondVax Pharmaceuticals Ltd.

M-001 universal flu vaccine Phase 3 trial initiated enrolling 12,463 subjects ages 50 years and older, including 6,291 ages 65 and older at 83 sites in eastern European countries

biondvax.com

Achillion Pharmaceuticals, Inc.

danicopan (ACH-4471)

paroxysmal nocturnal hemoglobinuria (PNH) in patients who are not adequately responding to a C5 inhibitor

PRIME Designation granted by the EMA

achillion.com

Carestream Focus 35C Detector with Image Suite Software

medical imaging 510(k) Clearance Granted by the FDA

carestream.com

For news on trial results, FDA approvals and drugs in development, Join the LinkedIn Drug Research Updates group!

continues on next page »

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WCG | CWWeekly November 25, 2019 9 of 10

Drug & Device Pipeline News (continued from page 8)

Merit Medical Systems, Inc.

WRAPSODY stenosis within the central veins of the outflow circuit of an arteriovenous fistula (AVF) up to the superior vena cava

Breakthrough Device Designation granted by the FDA

merit.com

Siemens Healthineers

SOMATOM X.cite single-source computed tomography (CT) scanner

Clearance granted by the FDA siemens-healthineers.us

AstraZeneca Calquence chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Supplemental Approval granted by the FDA

astrazeneca.com

BeiGene BRUKINSA (zanubrutinib)

mantle cell lymphoma (MCL) Accelerated Approval granted by the FDA

beigene.com

CooperVision MiSight 1day contact lens

myopia in children eight to 10 years of age

Approval granted by the FDA coopercos.com

Pfizer Abrilada (adalimumab-afzb)

rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis

Approval granted by the FDA pfizer.com

CeraPedics, Inc. i-FACTOR Peptide Enhanced Bone Graft

degenerative cervical disc disease PMA Approval granted by the FDA

cerapedics.com

Novartis Adakveo (crizanlizumab)

sickle cell disease Approval granted by the FDA novartis.com

Q Biomed Inc. Strontium-89 skeletal metastases caused by cancer

Approval granted by the FDA qbiomed.com

Alnylam Pharamceuticals, Inc.

GIVLAARI (givosiran) injection

acute hepatic porphyria (AHP) Approval granted by the FDA alnylam.com

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This collection of 26 SOPs is easily customized to match your culture and internal processes. Highlights include:

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WCG | CWWeekly November 25, 2019 10 of 10

CWMarketPlace

CWMarketPlace is a monthly section featuring a range of clinical research service providers who have Industry Provider Profile pages posted on CenterWatch.com. Included in their annual subscriptions, company profiles are randomly selected to appear in this section, providing added exposure for their products and services. To learn more about becoming an Industry Provider Profile page subscriber, contact Sales at 617.948.5100 or sales@centerwatch.com.Click on any provider to view the company’s complete online profile or click here to search more profiles.

Symphony Clinical Research Vernon Hills, IL866.333.1550info@symphonyclinicalresearch.com

Symphony Clinical Research is the leading global provider of specialized in-home and alternate-site clinical services, bringing study visits to patients in all phases and therapeutic areas of clinical trials.

Promedica International Costa Mesa, CA 714.460.7363 Ext. 17thopton@promedica-intl.com

More than two decades of experience shapes PMI’s understanding of the many clinical and regulatory challenges facing healthcare providers and the healthcare industry today.

Medpace Cincinnati, OH513.579.9911info@medpace.com

Medpace employs approximately 2,500 people across 35 countries and provides Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.

Celerion Lincoln, NE402.476.2811 info@celerion.com

Celerion is a global early clinical research provider with over 40 years of experience, three facilities globally and 600 global clinic beds.

DZS Clinical Services Bound Brook, NJ 732.764.6970 gambra@dzs.com

DZS combines a unique brand of flexibility from its services division with its proprietary ClinPlus eClinical Platform. They provide services to global pharmaceutical companies and small biotech start-ups.

Complion Cleveland, OH800.615.9077contact@complion.com

Leading sites, hospitals, academic medical centers, health systems and cancer centers around the country use Complion to go paperless, improve compliance and streamline operations.

Wake Research Associates Raleigh, NC 919.781.2514 contactus@wakeresearch.com

Wake Research Associates, established in 1984, is a nationally recognized professional research organization specializing in conducting pharmaceuticals, device and nutrition trials.

Summit Research Network Management, Inc. Portland, OR 503.972.9818 jhockley@summitnetwork.com

Since 1976, Summit Research, an independent medical research organiza-tion with an outpatient facility, has worked in cooperation with pharmaceu-tical companies to develop medical treatments for a variety of conditions.

PMG Research, Inc. Winston-Salem, NC919.746.7106kcole@pmg-research.com

PMG Research is an Integrated Site Network (ISN) of 12 clinical research facilities. Since its founding in 1979, PMG has conducted over 7,700 research studies.

Evolution Research Group, LLC New Providence, NJhveeder@ergclinical.com

Evolution Research Group is the largest, independent clinical research site company in the U.S., and the leader in CNS clinical study execution.

CONTRACT RESEARCH ORGANIZATION INVESTIGATIVE SITE NETWORKS

INVESTIGATIVE SITE NETWORKS (NON SMO)

SITE CONSORTIUM

TECHNOLOGY SOLUTIONS