Clinical pharmaceutical scientist

Scilex Holding Company Announces New Data From Deeper Skin Penetration Studies to Support SP-103 (lidocaine topical system) 5.4%, a Triple Strength Formulation of ZTlido®, in Treatment of Musculoskeletal Pain Disorders

Retrieved on: 
Thursday, November 2, 2023
Chronic pain, MDPI, Low back pain, MD, Diclofenac, Trigeminal neuralgia, Lidocaine, Skin, PALO, Biomedical Research, Clinical pharmaceutical scientist, Pain, Dermis, AAPS, Medical imaging

A set of studies assessed drug delivery from SP-103, ZTlido and control (Pennsaid®, 2% diclofenac) using open flow microperfusion.

Key Points: 
  • A set of studies assessed drug delivery from SP-103, ZTlido and control (Pennsaid®, 2% diclofenac) using open flow microperfusion.
  • Interstitial fluid from the dermis, subcutaneous adipose tissue, and muscle was continuously sampled to assess drug penetration in all tissue layers.
  • Current results of skin penetration studies for the first time had demonstrated uptake of lidocaine by muscle tissue via a passive diffusion through the skin.
  • We are very excited about these results supporting our clinical development plans,” said Dmitri Lissin, MD, Chief Medical Officer at Scilex.

Global Small Molecule Innovator CDMO Market Poised for Strong 6.5% CAGR Through 2031, Fueled by Rising Outsourcing Demand in Pharmaceutical Development - ResearchAndMarkets.com

Retrieved on: 
Wednesday, October 18, 2023
Other Science, Science, Molecule, Drug development, Pharmaceutical innovations, Infection, Metabolic disorder, Lonza Group, Catalent, Confidentiality, Small molecule, Therapy, Recipharm, Johnson & Johnson Pharmaceutical Research and Development, Patheon, European Journal of Pharmaceutical Sciences, Neurology, Metabolism, CDMO, Research, Journal, Outsourcing, Pharmacy, Growth, Respiratory disease, COVID-19, Commercial, Cardiovascular disease, Cambrex Corporation, Thermo Fisher Scientific, Clinical pharmaceutical scientist, Small, Flexible, Intellectual property, IP, Compound annual growth rate, AAPS, Fine chemical, Pharmaceutical industry, Biotechnology

Increasing Demand for Outsourcing Services in Drug Development: Pharmaceutical companies are increasingly outsourcing complex and resource-intensive processes such as drug substance synthesis and drug product manufacturing to CDMOs.

Key Points: 
  • Increasing Demand for Outsourcing Services in Drug Development: Pharmaceutical companies are increasingly outsourcing complex and resource-intensive processes such as drug substance synthesis and drug product manufacturing to CDMOs.
  • Intellectual Property and Confidentiality Concerns: Intellectual property (IP) and confidentiality concerns pose a restraint on the Small Molecule Innovator CDMO market.
  • The Small Molecule Innovator CDMO market is segmented into product types, stage types, customer types, therapeutic areas, and regions.
  • Notable segments include:
    Product: Small Molecule API and Small Molecule Drug Product, with Small Molecule API exhibiting the highest CAGR during the forecast period.

Angel Reyes Joins Altasciences as General Manager of CDMO Services

Retrieved on: 
Friday, October 6, 2023
Science, Biotechnology, Research, Pharmaceutical, Health, Consulting, Professional Services, Clinical Trials, Multimedia, CGMP, Catalent, CDMO, Chemistry, University, Clinical pharmaceutical scientist, Management

Altasciences is pleased to welcome Angel Reyes as General Manager, Contract Development and Manufacturing Organization (CDMO) Services.

Key Points: 
  • Altasciences is pleased to welcome Angel Reyes as General Manager, Contract Development and Manufacturing Organization (CDMO) Services.
  • View the full release here: https://www.businesswire.com/news/home/20231006361142/en/
    Angel joins Altasciences having previously been the Director of Operations at Catalent.
  • I am confident he will have a significant impact on the organization,” said Ben Reed, Executive General Manager, CDMO Services, Altasciences.
  • As General Manager, Angel is responsible for overseeing day-to-day operations in analytical and manufacturing services and managing client relations.

Simulations Plus Chief Science Officer Dr. Viera Lukacova Honored as Fellow by the American Association of Pharmaceutical Scientists (AAPS)

Retrieved on: 
Thursday, August 24, 2023
Research, Public Relations, Investor Relations, Communications, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Education, SLP, PBPK, AAPS, Pharmacokinetics, Simulations Plus, Patient, Clinical pharmaceutical scientist, Medical device

“Viera stands out as an eminent figure whose profound contributions have significantly shaped the landscape of physiologically based pharmacokinetics (PBPK) modeling,” said John DiBella , President of the SLP Division at Simulations Plus.

Key Points: 
  • “Viera stands out as an eminent figure whose profound contributions have significantly shaped the landscape of physiologically based pharmacokinetics (PBPK) modeling,” said John DiBella , President of the SLP Division at Simulations Plus.
  • “Her scientific insights have advanced the capabilities of software platforms like GastroPlus® , DDDPlus™ , and MembranePlus™ that scientists use every day to develop safe and effective treatments for patients worldwide.
  • A tireless advocate, her impact also extends beyond research into the realms of publication, presentation, and education.
  • Joining Dr. Lukacova as 2023 AAPS Fellows are Dr. Shaukat Ali, Dr. Ben Boyd, Dr. Maria Croyle, Dr. Otilia Koo, Dr. Xiuling Lu, Dr. Wellington Pham, and Dr. Patrick Ronaldson.

Lineage to Present at 2023 AAPS National Biotechnology Conference

Retrieved on: 
Tuesday, April 18, 2023
Science, Stem Cells, Biotechnology, Research, Pharmaceutical, General Health, Health, Genetics, Doctor of Philosophy, AAPS, Genentech, Immunophenotyping, Intellia Therapeutics, TASE, NYSE American, Lineage Cell Therapeutics, Therapy, Clinical pharmaceutical scientist, Conference, Pharmaceutical industry

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that Brian M. Culley, Lineage’s Chief Executive Officer, will present at the 2023 American Association of Pharmaceutical Scientists (AAPS) National Biotechnology Conference , on April 25th, 2023 at 10:00 am Eastern Time, as part of “The Evolution of Cellular Therapy Symposium,” moderated by Sebastian Guelman, Ph.D., Senior Principal Scientist, Genentech, Inc.

Key Points: 
  • Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that Brian M. Culley, Lineage’s Chief Executive Officer, will present at the 2023 American Association of Pharmaceutical Scientists (AAPS) National Biotechnology Conference , on April 25th, 2023 at 10:00 am Eastern Time, as part of “The Evolution of Cellular Therapy Symposium,” moderated by Sebastian Guelman, Ph.D., Senior Principal Scientist, Genentech, Inc.
  • The “Advances in Therapeutic Development Across Modalities” panel, will also feature presenters from Intellia Therapeutics and Takeda Pharmaceutical Company Ltd., who will be discussing the rapid advancement of technologies and practices for monitoring exposure, immunophenotyping, and clinical endpoints around cellular modalities as well as considerations around allogeneic versus autologous cell therapies.
  • The 2023 AAPS National Biotechnology Conference is taking place at the Philadelphia Marriott Downtown Hotel, April 23-26, 2023.

TFF Pharmaceuticals Reports Fourth Quarter 2022 and Full Year 2022 Financial Results

Retrieved on: 
Tuesday, March 7, 2023
Corporation, Freezing, Growth, Moses Austin, Clinical pharmaceutical scientist, TAC, The Alfred Hospital, General Administration of Press and Publication, UDS, Safety, Administration, Pulmonary drug delivery, Conference, Immunology, R, University, Research and development, Research, TFF, Special, Patient, AAPS, G&A, Medication, Insurance, Risk, Pharmaceutical industry, Cryptocurrency, Fine chemical, Lithium

FORT WORTH, Texas, March 07, 2023 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported fourth quarter and full year 2022 financial results.

Key Points: 
  • FORT WORTH, Texas, March 07, 2023 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported fourth quarter and full year 2022 financial results.
  • In February 2023, the Company provided updated guidance for the TFF VORI and TFF TAC clinical programs on its Corporate Strategy Conference Call .
  • For the quarter ended December 31, 2022, compared to quarter ended December 31, 2021
    Research and Development (R&D) expenses: R&D expenses for the fourth quarter of 2022 were $4.1 million, compared to $6.9 million for the comparable period in 2021.
  • Net Loss: TFF Pharmaceuticals reported a net loss for the fourth quarter of 2022 of $7.4 million, compared to a net loss of $10.0 million for the comparable period in 2021.

Larimar Therapeutics Appoints Dr. Gopi Shankar as Chief Development Officer

Retrieved on: 
Tuesday, February 7, 2023
Drexel University, Disease, MBA, Master of Science, Friedreich's ataxia, Employment, Research, University, Food, MAA, Food and Drug Administration, Janssen Biotech, Fellow, IND, Gopi Shankar Madurai, Janssen Pharmaceuticals, CDO, Larimar, Financial compensation, European Medicines Agency, Clinical pharmaceutical scientist, Immunogenicity, Oklahoma State University–Stillwater, Option, Head, FA, BLA, Patient, Janssen, AAPS, Growth, Philip, Johnson & Johnson, Doctor of Philosophy, Therapy, Pharmaceutical industry, Science, MD

BALA CYNWYD, Pa., Feb. 07, 2023 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the appointment of Gopi Shankar, PhD, MBA, FAAPS, to the newly created position of Chief Development Officer (CDO).

Key Points: 
  • BALA CYNWYD, Pa., Feb. 07, 2023 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the appointment of Gopi Shankar, PhD, MBA, FAAPS, to the newly created position of Chief Development Officer (CDO).
  • Dr. Shankar will report directly to Chief Executive Officer Carole Ben-Maimon, MD, and will be responsible for the strategic development of the Company’s clinical and R&D programs, including additional applications of the Company’s platform technology.
  • “We are thrilled to welcome Dr. Shankar to Larimar and look forward to benefiting from his extensive expertise in biologics development, immunology, PK/PD, and bioanalysis,” said Dr. Ben-Maimon.
  • He also previously worked as Senior Director and Head, Bioanalytical Sciences and Immunogenicity at Janssen Research & Development.

TFF Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Monday, November 14, 2022
The Alfred Hospital, Skin, UDS, Research and development, International Union of Biochemistry and Molecular Biology, AAPS, Inhalation, Corporation, Risk, International Congress on Tuberculosis, TFF, Therapy, Tacrolimus, Freezing, Toxic leukoencephalopathy, FEV1, Nose, Aspergillus, Insurance, Patient, Moses Austin, FVC, FDA, Growth, Lung, University, G&A, R, Government, Annual report, Eastern Time Zone, Australian Taxation Office, Powder, Webcast, Lung transplantation, Tax, Clinical pharmaceutical scientist, Calendar, Safety, Voriconazole, General Administration of Sport of China, Special, Administration, Medication, Absorption, Call, Vaccine, Pharmaceutical industry, Video game, Fine chemical, Conference

FORT WORTH, Texas, Nov. 14, 2022 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported financial results for the third quarter of 2022 and provided an update on recent corporate and clinical developments. The Company will discuss the highlights on a conference call and webcast, scheduled for today, Monday, November 14, 2022, at 4:30 PM ET.

Key Points: 
  • We have recently announced positive proof of concept data from two patients in our TFF Voriconazole compassionate use program, said Glenn Mattes, Chief Executive Officer of TFF Pharmaceuticals.
  • The Company will host a conference call today, Monday, November 14, 2022, at 4:30 PM, Eastern Time, to discuss third quarter 2022 financial results and the business update.
  • For the quarter ended September 30, 2022, compared to quarter ended September 30, 2021
    Cash Position: As of September 30, 2022, TFF Pharmaceuticals reported cash and cash equivalents of $13.1 million.
  • Net Loss: TFF Pharmaceuticals reported a net loss for the third quarter of 2022 of $7.3 million, compared to a net loss of $8.7 million in 2021.

TFF Pharmaceuticals Announces Presentation of Data Featuring Applications of Thin Film Freezing Technology at AAPS PharmSci 360 Meeting

Retrieved on: 
Tuesday, October 11, 2022
Lung, Freezing, Therapy, Risk, Government, Vaccine, Annual report, TFF, Inhalation, Research, Powder, Nose, Technology, Clinical pharmaceutical scientist, Company, Industry, Nicotine, American Association, Association, Absorption, Safety, AAPS, Toxicity, Skin, FDA, COVID-19, Pharmaceutical industry

FORT WORTH, Texas, Oct. 11, 2022 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today shared further details on the poster presentations featuring the Company’s Thin Film Freezing Technology at the American Association of Pharmaceutical Scientists (AAPS) PharmSci 360 Meeting, which is being held in Boston from October 16-19, 2022.

Key Points: 
  • TFF Pharmaceuticals proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations exhibiting unique characteristics and benefits.
  • Laboratory data suggests the aerodynamic properties of the powders created by Thin Film Freezing can deliver as much as 75% of the dose to the deep lung.
  • The advantages of Thin Film Freezing can be used to enhance traditional delivery or combined to enable next-generation pharmaceutical products.
  • TFF Pharmaceuticals, Inc.is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines into potent dry powder formulations for better efficacy, safety and stability.

TFF Pharmaceuticals Announces Acceptance of Multiple Abstracts Featuring Applications of Thin Film Freezing Technology at the Upcoming AAPS PharmSci 360 Meeting

Retrieved on: 
Thursday, September 22, 2022
Nicotine, Therapy, Safety, Freezing, Clinical pharmaceutical scientist, COVID-19, Risk, TFF, FDA, Company, American Association, Industry, Nose, Powder, Government, Inhalation, Technology, Vaccine, AAPS, Annual report, Toxicity, Lung, Research, Association, Skin, Absorption, Pharmaceutical industry

FORT WORTH, Texas, Sept. 22, 2022 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced the acceptance of multiple abstracts featuring application of the Company’s Thin Film Freezing Technology at the upcoming American Association of Pharmaceutical Scientists (AAPS) PharmSci 360 Meeting, which is being held in Boston from October 16-19, 2022. Research from two abstracts has been selected for presentation as part of the “Special Poster Collections” at the meeting.

Key Points: 
  • TFF Pharmaceuticals proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations exhibiting unique characteristics and benefits.
  • Laboratory data suggests the aerodynamic properties of the powders created by Thin Film Freezing can deliver as much as 75% of the dose to the deep lung.
  • The advantages of Thin Film Freezing can be used to enhance traditional delivery or combined to enable next-generation pharmaceutical products.
  • TFF Pharmaceuticals, Inc.is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines into potent dry powder formulations for better efficacy, safety and stability.