Medical writing

Third Harmonic Bio Announces First Quarter 2024 Financial Results and Provides Business Update

Retrieved on: 
onsdag, maj 15, 2024
Partnership, Patient, State university system, Pharmacokinetics, Vertex Pharmaceuticals, Genentech, Merck & Co., Clinical trial, University, FDA, IND, Therapy, Safety, University of Minnesota, SAN, Inflammation, Research, CMC, Preclinical development, CSU, Third Rock Ventures, Emory University, Medicine, Drug discovery, Regulatory affairs, File, Biomarker, Medical writing, Toxicology, G&A, Bluebird bio, Harvard University, KIT, NIH, U.S. FDA, Pharmaceutical industry

SAN FRANCISCO, May 15, 2024 (GLOBE NEWSWIRE) -- Third Harmonic Bio, Inc. (Nasdaq: THRD), a clinical stage biopharmaceutical company focused on advancing the next wave of medicine for dermal, respiratory, and gastrointestinal inflammatory diseases, today announced financial results for the first quarter March 31, 2024, recent business updates, and anticipated milestones.

Key Points: 
  • The Company also announced the appointment and promotion of key executive leaders to the organization.
  • Chris joins Third Harmonic Bio from Kronos Bio, where he was Chief Scientific Officer, responsible for the discovery functions, and played a key role in the company’s initial public offering and partnership with Genentech.
  • Jennifer joined Third Harmonic Bio in November 2022 as Vice President of Regulatory Affairs.
  • Prior to joining Third Harmonic Bio, Jennifer was Vice President of Regulatory Affairs and Medical Writing at Generation Bio, where she was responsible for platform and pipeline regulatory activities.

Congruence Therapeutics Appoints Experienced Drug Developer Michael D. Harvey, Ph.D. as Chief Development Officer

Retrieved on: 
måndag, maj 6, 2024
Clementia, FDA, Congruence, Ipsen, Drug development, AI, Medical writing, Infection, Diabetes, Health Canada, Doctor of Philosophy, Obesity, Novo Nordisk, Patient, CMC, Acquisition, DSM-IV codes, Concordia University, US FDA, Drug discovery, Therapy, Strategic planning

MONTREAL, May 6, 2024 /PRNewswire/ -- Congruence Therapeutics, a leading computationally-driven biotechnology company developing a pipeline of novel small molecules for diseases with significant unmet medical need, announced today the appointment of Michael D. Harvey, Ph.D. as Chief Development Officer.

Key Points: 
  • MONTREAL, May 6, 2024 /PRNewswire/ -- Congruence Therapeutics, a leading computationally-driven biotechnology company developing a pipeline of novel small molecules for diseases with significant unmet medical need, announced today the appointment of Michael D. Harvey, Ph.D. as Chief Development Officer.
  • Dr. Harvey also has strong abilities in strategic planning, execution, and alliance management, including pharma partner collaborations.
  • "I am delighted to welcome Michael as the new Chief Development Officer of Congruence.
  • Michael has the strong expertise we were seeking to lead the strategic development of our novel development candidates to Phase 2 proof of concept," stated Dr. Clarissa Desjardins, CEO of Congruence.

EPNextS Group and Frontage Laboratories, Inc. Announce Collaboration in Early Phase Clinical Trials in the United States to Improve "Drug Lag" and "Drug Loss" Issues in Japan

Retrieved on: 
tisdag, mars 26, 2024
Medical writing, EPS, Patient, Project management, Clinical trial, Drug development, Data management, Pharmaceutical industry

"Our collaboration with Frontage underscores our commitment to advancing clinical research and improving patient access to innovative therapies.

Key Points: 
  • "Our collaboration with Frontage underscores our commitment to advancing clinical research and improving patient access to innovative therapies.
  • EPS and Frontage intend to conduct collaborative business development activities in Japan and the United States to expand market reach and conduct early phase clinical trials in Japanese and non-Japanese populations in the United States.
  • Frontage brings a wealth of experience in early-phase clinical research, including bioanalytical services, clinical pharmacology, and clinical operations.
  • "We are pleased announce this collaboration with EPNextS Group to address the pressing challenges facing the Japanese pharmaceutical industry," said Abdul Mutlib, CEO of Frontage.

ScienceMedia Welcomes Visionary Leaders to Advisory Board, Paving the Way for a New Era of Innovation

Retrieved on: 
torsdag, mars 21, 2024
SCOPE, Software as a service, Growth, AstraZeneca, Patient, SAN, Acquisition, Corporate Affairs, Senior, Clinical trial, Therapy, Summit, Medical writing, Pharmaceutical industry

Their unparalleled insights—from patient-centric approaches to cutting-edge AI advancements—will fuel our mission to drive a transformative revolution in clinical trials."

Key Points: 
  • Their unparalleled insights—from patient-centric approaches to cutting-edge AI advancements—will fuel our mission to drive a transformative revolution in clinical trials."
  • Their insight will accelerate our growth and allow us to continue solving the most challenging therapeutic and clinical issues facing the industry."
  • Bierstein continues, "Embracing the spirit of innovation and collaboration, our esteemed advisory board represents the vanguard of change in the pharmaceutical and biotech sectors.
  • For further insights into ScienceMedia's groundbreaking initiatives and the dawn of a new era in clinical mastery, click here .

Calian Wins Contract to Support Clinical Trial for ZYUS Life Sciences’ Lead Drug Product Candidate

Retrieved on: 
tisdag, februari 20, 2024
CGY, Clinical trial, TSX, Pain, Data management, Learning, Safety, Contract research organization, Chronic pain, Patient, Knowledge, Medical writing, Partnership, Pharmaceutical industry

Calian's full-service Contract Research Organization (CRO) will apply its extensive clinical trial management experience to support a Phase 2 Clinical Trial for Trichomylin softgel capsules.

Key Points: 
  • Calian's full-service Contract Research Organization (CRO) will apply its extensive clinical trial management experience to support a Phase 2 Clinical Trial for Trichomylin softgel capsules.
  • “Calian will apply our industry-leading expertise to support this Phase 2 Clinical Trial and further ZYUS’ pursuit of transformational impact on patients’ lives,” says Derek Clark, President, Calian Health.
  • Calian will provide full-service, end-to-end expertise to support this trial, including medical writing, regulatory affairs, clinical operations, site monitoring, data management, medical monitoring and quality assurance.
  • By collaborating with an industry leading contract research organization with extensive experience in clinical trial management, we can leverage invaluable knowledge and expertise."

MMS Supported MAPS Public Benefit Corporation NDA Submitted to FDA for First Psychedelic-Assisted Therapy for PTSD

Retrieved on: 
onsdag, december 13, 2023
Veterans, Defense, Other Health, Other Science, Pharmaceutical, Research, Software, Mental Health, Professional Services, Data Management, Science, Practice Management, Technology, Physical Therapy, Clinical Trials, Managed Care, Data Analytics, Health, Military, NDA, Medical writing, Post-traumatic stress disorder, PBC, MDMA, MMS, Psychotherapy, MAPS, FDA, New Drug Application, Contract research organization, PTSD, Pharmacovigilance, Pharmaceutical industry, Risk management

MMS, a data-focused Clinical Research Organization (CRO), announced MAPS Public Benefit Corporation (MAPS PBC) submitted a New Drug Application (NDA) to the FDA for MDMA (midomafetamine capsules) used in combination with psychological intervention, which includes psychotherapy, or talk therapy, and other supportive services provided by a qualified healthcare provider.

Key Points: 
  • MMS, a data-focused Clinical Research Organization (CRO), announced MAPS Public Benefit Corporation (MAPS PBC) submitted a New Drug Application (NDA) to the FDA for MDMA (midomafetamine capsules) used in combination with psychological intervention, which includes psychotherapy, or talk therapy, and other supportive services provided by a qualified healthcare provider.
  • MAPS PBC is developing investigational MDMA-assisted therapy for individuals with post-traumatic stress disorder (PTSD).
  • Over a year ago, MAPS PBC selected MMS as its CRO partner for the development of NDA for MDMA-assisted therapy for PTSD.
  • We are grateful to MAPS PBC for entrusting MMS to be a part of this process.”
    As MAPS PBC’s CRO, MMS provided regulatory strategy and operations, pharmacovigilance, medical writing, and biometrics services.

Fortrea Appoints Life Science Executive Dr. John Doyle to Lead Consulting Team

Retrieved on: 
fredag, oktober 13, 2023
Engineering, Columbia University Mailman School of Public Health, Faculty, Consultant, Drug development, Abstract, Vaccine, Doctorate, Publishing, Professional degrees of public health, Columbia University, Outline of health sciences, Business administration, Office for Life Sciences, Public, Growth, Medical writing, Cornell University, Applied economics, Science, Economics, Pfizer, Life, Silicon, Patient, Public health, Pharmaceutical industry, Epidemiology

Doyle will serve on Fortrea’s leadership team and lead a team of consultants and advisors with expertise that spans early development through lifecycle management.

Key Points: 
  • Doyle will serve on Fortrea’s leadership team and lead a team of consultants and advisors with expertise that spans early development through lifecycle management.
  • “Pharmaceutical and biotechnology innovators must constantly navigate complex and fast-changing business and regulatory environments to achieve their mission,” said Tom Pike, chairman and chief executive officer of Fortrea.
  • “John has extensive industry knowledge and distinctive technical skills that translate to tremendous value for customers.
  • “The biopharma industry is relentless in advancing science to improve patient outcomes and Fortrea is uniquely positioned to help,” said Dr. Doyle.

Biologics Consulting Appoints Dr. Margaret K. Vernon As Its New Chief Executive Officer

Retrieved on: 
torsdag, september 21, 2023
Research, Medical Devices, FDA, Consulting, Professional Services, Biotechnology, Pharmaceutical, Health, Science, Other Science, Vaccine, PPD, Communication, Developmental psychology, PRO, Pennsylvania State University, Clinical trial, Statistics, Thermo Fisher Scientific, Consultant, State College, Pennsylvania, Wharton, Medical writing, Management

Biologics Consulting Group, Inc. is pleased to announce the appointment of Dr. Margaret K. Vernon as Chief Executive Officer, effective September 18, 2023.

Key Points: 
  • Biologics Consulting Group, Inc. is pleased to announce the appointment of Dr. Margaret K. Vernon as Chief Executive Officer, effective September 18, 2023.
  • Dr. Vernon joins Biologics Consulting Group after 17 years with Evidera, a business unit of PPD.
  • “We are delighted to welcome Margaret to the Biologics Consulting management team,” stated Dr. Norman W. Baylor, former President, and CEO of Biologics Consulting.
  • Margaret is sure to serve as an excellent leader for the Biologics Consulting team as they help clients to advance the future of vaccines, biologics, drugs, and medical devices.” Dr. Vernon will succeed Dr. Baylor, who will remain as Chair of the Biologics Consulting Board of Directors.

EQS-News: Element unveils fully integrated pharma services platform, strengthening its expanding Life Sciences Division

Retrieved on: 
tisdag, september 5, 2023
West Pharmaceutical Services, GMP, GLP, Laboratory, Drug development, Investigational New Drug, Clinical Laboratory, History, JMI, TIC, Chemistry, San Francisco Bay Area, CLIA, CDMO, Head, Contract research organization, Inspection, Knowledge, Testing, inspection and certification, FDA, IND, Medical writing, Fine chemical, Element, Certification

Element unveils fully integrated pharma services platform, strengthening its expanding Life Sciences Division

Key Points: 
  • Element unveils fully integrated pharma services platform, strengthening its expanding Life Sciences Division
    The issuer is solely responsible for the content of this announcement.
  • Element unveils fully integrated pharma services platform, strengthening its expanding Life Sciences Division
    05 September 2023 – Element Materials Technology (Element), a leading global Testing, Inspection and Certification (TIC) company, has launched an integrated offering for its pharmaceutical services.
  • With the unveiling of our integrated pharmaceutical services platform, Element Life Sciences now stands ready to address these challenges head-on.
  • Element Life Sciences stands as a steadfast partner, empowering pharmaceutical companies to overcome obstacles and advance their groundbreaking innovations in the dynamic and ever-evolving landscape of the life sciences industry.

Avance Clinical at ASCO & BIO 2023: Early Phase Oncology Trials Increasingly Elaborate and Demand More Patients

Retrieved on: 
tisdag, maj 30, 2023
Data management, Telehealth, Reuters, Therapy, GlobalData, Private, Clinical trial, Pharmacokinetics, DCT, Element, ASCO, Global Health, AUS, Science, Patient, SAN, Drug combination, Biostatistics, FDA, Medical writing, Nursing, Management, Pharmaceutical industry, Avance

Avance Clinical's Chief Scientific Officer, Gabriel Kremmidiotis

Key Points: 
  • Avance Clinical's Chief Scientific Officer, Gabriel Kremmidiotis
    According to Avance Clinical's Chief Scientific Officer Gabriel Kremmidiotis who is part of the Avance Clinical team attending ASCO:
    "Recently, Phase I clinical trial designs in Oncology patients have become more elaborate and include elements of dose escalation, dose expansion and assessment of drug combinations.
  • This, in addition to the increasing number of new emerging therapeutics, has increased the demand for fast progress through the early phases of development and a greater demand for access to patients."
  • "Utilizing Australia's regulatory environment and high-quality oncology experts, Avance Clinical is able to facilitate a fast project launch and seamless transition across different parts of modular oncology protocol designs.
  • Avance Clinical is at the cutting edge of clinical trial technology and has recently been ranked as the world leader in decentralised clinical trials (DCT) technology adoption by GlobalData and Clinical Trial Arena in the CRO sector.