02172021

BrainQ gets FDA Breakthrough status for its device for reducing disability following stroke
by Drug Discovery NewsRegulatory News

The Breakthrough Device designation, which comes after new trial data, is expected to expedite the device’s path to market.

BrainQ, the Israeli start-up with a therapeutic solution to reduce disability following stroke, announced today that the United States Food and Drug Administration (FDA) has designated its AI-powered technology as a Breakthrough Device. The designation, which was based on BrainQ’s latest randomized controlled clinical trial results for ischemic stroke patients, provides BrainQ with the opportunity to work closely with the FDA to expedite development plans and premarket clearance. Breakthrough status also gives BrainQ access to the new Medicare Coverage of Innovative Technology (MCIT) pathway, allowing for Medicare coverage to be provided concurrently with FDA market authorization.

Stroke is one of the leading causes of disability, affecting 800,000 people every year in the United States alone. In the days and weeks following stroke, the brain attempts to repair damaged neural pathways and develop new ones to restore function, but often with limited success. This results in chronic disability for about 50-70% of survivors.

BrainQ is developing an AI-powered electromagnetic field therapy that aims to enhance recovery and reduce disability after neurological damage caused by stroke. The therapy is based on biological insights retrieved from brainwaves, using proprietary machine learning algorithms that translate into a frequency-tuned low intensity electromagnetic field. BrainQ’s therapy is delivered via a cloud-connected wearable device, the non-invasive BQ System, and is designed for scalable and portable treatment, with the flexibility to be accessed from home.

“We’re excited that the FDA has granted BrainQ a Breakthrough Device Designation,” said BrainQ CEO and Co-founder Yotam Drechsler. “Stroke is a debilitating condition with limited recovery options, creating a huge unmet need in the US. Covid-19 has only made things worse by limiting patients’ access to treatment facilities. FDA Breakthrough Designation is an important milestone in our mission to reduce disability for these patients and treat them in the comfort of their homes.”

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BioPharma Global is a mission-driven corporation, operating like a not-for-profit, dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with a high unmet medical need. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

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02162021

Forge Biologics Receives FDA Fast Track, Orphan Drug, and Rare Pediatric Disease Designations for FBX-101 Gene Therapy for Patients with Krabbe Disease
by Drug Discovery NewsRare Disease NewsRegulatory News

– The FDA has granted Fast Track Designation, Rare Pediatric Disease Designation, and Orphan Drug Designation to FBX-101 for treatment of patients with Krabbe disease

– FBX-101 is a first-in-human gene therapy utilizing an adeno-associated virus (AAV) to deliver a functioning copy of the GALC gene intraveniously to cells in the central nervous system (CNS) and peripheral organs

– FBX-101 GMP manufacturing is completed and clinical trial enrollment is active

Forge Biologics Inc., a fully integrated clinical stage gene therapy manufacturing and development company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track, Orphan Drug, and Rare Pediatric Disease (RPD) designations to FBX-101 for the treatment of patients with Krabbe disease. Forge is now actively recruiting patients for enrollment in the RESKUE phase 1/2 clinical trial of FBX-101, a novel, first-in-human AAV gene therapy for the disease. FBX-101 is the first intravenious gene therapy program for patients with Krabbe disease and marks a major step forward in building out the company’s hybrid model as a gene therapy manufacturing and development engine.

“FDA’s decision to grant these designations to our first-in-human investigational gene therapy highlights the urgency of developing a treatment for Krabbe patients,” said Timothy J. Miller, Ph.D., CEO, President and Co-Founder of Forge Biologics. “Krabbe is a devastating disease, and it is imperative to develop  treatment options like FBX-101 that may address all manifestations of the disease.”

Fast Track Designation is given when the FDA determines that a drug demonstrates the potential to address unmet medical needs for a serious or life-threatening disease or condition. This designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions, and may also allow for priority or rolling review of a company’s Biologics License Application (BLA).

The FDA grants Orphan Drug designation to drugs and biological products intended for the treatment of patients with rare diseases that affect fewer than 200,000 people in the United States. RPD designation is granted by the FDA to encourage treatments for serious or life-threatening diseases primarily affecting children 18 years of age and younger and fewer than 200,000 people in the United States. On December 27, 2020, the Rare Pediatric Disease Priority Review Voucher Program was extended by Congress after it was scheduled to sunset in 2020. Under the newly extended RPD program, if FBX-101 is approved by the FDA, Forge Biologics will qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product.

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BioPharma Global is a mission-driven corporation, operating like a not-for-profit, dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with a high unmet medical need. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

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021120211

FDA grants breakthrough designation to Roche Elecsys GDF-15 assay
by Drug Discovery NewsRegulatory News

The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Roche’s Elecsys GDF-15 assay as a companion diagnostic (CDx) in cancer treatment.

The in vitro diagnostic immunoassay is designed for measuring Growth Differentiation Factor-15 (GDF-15) in cachectic adult patients with solid tumours for treatment with Pfizer’s investigational drug PF-06946860.

Cachexia is a metabolic disorder and comorbidity that occurs with various chronic diseases such as cancer, heart failure, chronic obstructive pulmonary disease (COPD), and chronic kidney disease (CKD).

It manifests as marked involuntary body weight loss, muscle atrophy, and reduced appetite, advancing to functional impairment and high death risk.

Cachexia is a common complication of cancer, and affects more than half of cancer patients globally.

As elevated GDF-15 is linked to cachexia in cancer patients, successful cachexia treatment can potentially lead to better cancer treatment.

Roche Diagnostics CEO Thomas Schinecker said: “We are pleased to partner with Pfizer to address this unmet medical need in oncology through strong companion diagnostics.

“The FDA BDD grant for the Elecsys GDF-15 assay shows the importance of these strong partnerships.

To Read the Complete Article at Medical Device Network, Click Here

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BioPharma Global is a mission-driven corporation, operating like a not-for-profit, dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with a high unmet medical need. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

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02102021

Elevar Therapeutics Announces Orphan Drug Designation for Rivoceranib (Apatinib) for the Treatment of Adenoid Cystic Carcinoma (ACC)
by Drug Discovery NewsRare Disease NewsRegulatory News

Elevar Therapeutics, Inc. (“Elevar”), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced that the U.S. Food and Drug Administration (FDA) has granted rivoceranib (apatinib) with orphan drug designation for the treatment of adenoid cystic carcinoma (ACC), a rare form of cancer that most commonly develops in the salivary glands or other regions of the head and neck. Approximately 1,200 new cases of ACC are diagnosed each year in the United States. 

The FDA’s Office of Orphan Drug Products grants orphan status to medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S.

“We are pleased by the FDA’s recognition of the critical need to develop treatments for adenoid cystic carcinoma (ACC) given the progressive nature of the disease,” said Alex Kim, chief executive officer of Elevar. “The orphan drug designation provides further momentum for the rivoceranib development program, which we are committed to advancing as quickly as possible for patients in need.”

ACC is considered a slow growing but relentless cancer that is characterized by nerve invasion and metastases. Although good local control is usually achieved by resection of the primary tumor and adjuvant radiation therapy, more than half of patients eventually have recurrent and/or metastatic disease. Currently, no curative treatments are available for these patients which underscores the need for effective new therapies.

“With no approved treatments for adenoid cystic carcinoma (ACC), a significant unmet need remains for therapies that slow or stop this relentless disease,” said Mark Gelder, M.D., chief medical officer of Elevar. “The orphan drug designation from the FDA reinforces the urgency of Elevar’s work with rivoceranib in ACC and our commitment to improving treatment experiences and outcomes for patients who have limited or inadequate therapeutic options.”

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BioPharma Global is a mission-driven corporation, operating like a not-for-profit, dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with a high unmet medical need. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

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02092021

Theratechnologies’ Lead Peptide Drug Conjugate TH1902 Receives FDA Fast Track Designation for the Treatment of Sortilin-expressing Cancers
by Drug Discovery NewsRegulatory News

Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, is pleased to announce that the United States Food and Drug Administration (FDA) has granted fast track designation to TH1902 as a single agent for the treatment of patients with sortilin positive recurrent advanced solid tumors that are refractory to standard therapy.

“Receiving fast track designation for TH1902 at this early stage of development is a significant recognition for our SORT1+ Technology™ and further supports the future development of TH1902. The designation, which applies to all solid tumours expressing sortilin, also highlights the broad applicability and immense medical need for innovative, targeted, and potentially more effective and better-tolerated therapies for cancer,” said Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer, Theratechnologies.

Phase 1 clinical trial of TH1902
Theratechnologies announced on January 7, 2021 that it had received a “Study May Proceed” letter from the FDA for the Phase 1 clinical trial of TH1902.

The proposed Phase 1 trial design includes a dose escalation study to evaluate the safety, pharmacokinetics, maximum tolerated dose (MTD) and preliminary anti-tumor activity of TH1902 administered once every three weeks in patients with advanced solid tumors refractory to available anti-cancer therapies. Once the MTD is determined, it is planned that a total of 40 additional patients will be enrolled to evaluate the potential anti-tumor activity of TH1902 in patients with endometrial, ovarian, colorectal, pancreatic and triple negative breast cancers where it has been estimated that the sortilin receptor is expressed in 40 to 90% of cases. The Phase 1 trial is expected to be initiated in the second quarter of calendar year 2021 and is designed to identify a recommended dose for Phase 2 development.

Funda Meric-Bernstam, M.D., Chair of the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center is the Lead Principal Investigator of the Phase 1 trial for TH1902. The detailed study protocol is available at ClinicalTrials.gov under the identifier number: NCT04706962.

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BioPharma Global is a mission-driven corporation, operating like a not-for-profit, dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with a high unmet medical need. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

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02082021

FDA Grants Orphan Drug Status to M6P Gene Therapy
by Drug Discovery NewsRare Disease NewsRegulatory News

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to two gene therapies that M6P Therapeutics is developing — one intended for Gaucher disease, the other aiming to treat the inherited metabolic disorder mucolipidosis.

The regulatory agency also awarded six rare pediatric disease designations to various investigational therapies that M6P Therapeutics is developing to treat lysosomal storage disorders, which include Gaucher and mucolipidosis.

“We are grateful to the FDA for these multiple orphan and rare pediatric disease designations that highlight the need for new and improved therapies to address unmet needs,” Pawel Krysiak, president and CEO of M6P Therapeutics, said in a press release.

Lysosomal storage disorders are conditions in which the function of the lysosome — necessary for cell maintenance — is impaired due to missing or defective enzymes. These conditions usually result from mutations in the genes that code for those enzymes. Often described as the cellular “garbage disposal” or “recycling machinery,” lysosomes are responsible for breaking down certain cellular products.

In these disorders, lysosomes do not work properly, causing cellular components to build up to toxic levels. For example, in Gaucher disease, a lack of the lysosomal enzyme beta-glucocerebrosidase leads to a buildup of the cellular component glucocerebroside.

Mannose 6-phosphate, or M6P, is a small sugar molecule that can be attached to lysosomal enzymes. The company’s approach of increasing the mannose 6-phosphate content of gene therapies or enzyme replacement therapies is meant to improve treatment delivery into lysosomes by binding to specific receptors.

To Read the Complete Article at Gaucher Disease News, Click Here

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BioPharma Global is a mission-driven corporation, operating like a not-for-profit, dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with a high unmet medical need. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

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02042021

Veralox Therapeutics Announces FDA Orphan Drug Designation for VLX-1005
by Drug Discovery NewsRare Disease NewsRegulatory News

Veralox Therapeutics, a biotechnology company developing first-in-class small molecule therapeutics that treat the underlying pathologies of diseases with significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for VLX-1005 for the treatment of heparin induced thrombocytopenia (HIT).

“We are pleased the FDA has granted Orphan Drug Designation for VLX-1005 for prophylaxis of thrombosis in patients with heparin-induced thrombocytopenia,” said Jeffrey W. Strovel, PhD, Chief Executive Officer of Veralox Therapeutics. “This is a significant regulatory milestone for our company, and in the development of this investigational new drug product and recognition of the clear unmet medical need for patients who suffer from this devastating disease.”

“We believe VLX-1005, with its novel mechanism of action, has great potential to be the first disease modifying therapy for HIT in over 20 years,” said Matthew B. Boxer, PhD, Chief Operating Officer of Veralox Therapeutics.

The FDA, through its Office of Orphan Products Development (OOPD), grants orphan status to drugs and biologic products that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or conditions that affect fewer than 200,000 people in the United States, or that affect more than 200,000 people but are not expected to recover the costs of drug development and marketing. Orphan drug designation provides eligibilityfor certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval.

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Disclaimer: BioPharma Global is not responsible for, and expressly disclaims all liability for, damages of any kind arising out of use, reference to, or reliance on any information contained within the article. Content available through the site may contain links and information to other websites. Links from BioPharma Global to third-party sites do not constitute an endorsement by BioPharma Global of the mentioned parties.

BioPharma Global is a mission-driven corporation, operating like a not-for-profit, dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with a high unmet medical need. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

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02032021

M6P Therapeutics Receives Six Rare Pediatric Disease Designations from the U.S. FDA for Company’s Deep Pipeline of Programs for Lysosomal Storage Disorders
by Drug Discovery NewsRare Disease NewsRegulatory News

– U.S. FDA Also Grants Two Orphan Drug Designations for the Company’s Gene Therapy Programs for Gaucher Disease and Mucolipidosis –

M6P Therapeutics, a privately held life sciences company developing next-generation recombinant enzyme and gene therapies for lysosomal storage disorders (LSDs), today announced that the U.S. Food and Drug Administration (FDA) granted six rare pediatric disease designations (RPDDs) for various programs within its development pipeline for LSDs, including four recombinant enzyme and two gene therapy programs. In addition, the FDA granted two orphan drug designations (ODDs) for its gene therapy programs for Gaucher disease and mucolipidosis.

M6P Therapeutics is developing an innovative technology that regulates the natural mechanism for trafficking enzymes to lysosomes. The company’s bicistronic-S1S3 platform enables improved biodistribution of recombinant enzymes to target tissues and efficient cross-correction for gene therapies. LSDs, which can present in infancy, childhood or adulthood, are a group of approximately 50 rare genetic disorders that are associated with high morbidity and mortality. Currently, there are no cures for any of these disorders.

“LSDs are progressive and represent significant burden for patients, their families, and the healthcare systems,” said Pawel Krysiak, president and chief executive officer of M6P Therapeutics. “Our innovative platform enables efficient trafficking of either a recombinant enzyme or gene therapy product to the affected cells and tissues and has the potential to generate best-in-class treatments for LSDs. We are grateful to the FDA for these multiple orphan and rare pediatric disease designations that highlight the need for new and improved therapies to address unmet needs.”

Under the RPDD program, the FDA grants a Priority Review Voucher (PRV) to the sponsor who receives a product approval for a “rare pediatric disease,” defined as a serious or life-threatening condition of fewer than 200,000 Americans that primarily affects individuals from birth to 18 years. M6P Therapeutics may be eligible to receive a PRV for each RPDD that gains marketing approval. The vouchers may be sold or transferred or redeemed for subsequent marketing applications.

Designation as an orphan drug serves to advance drug development for rare diseases. The FDA grants the designation to drugs or biologics that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions that affect fewer than 200,000 Americans. Orphan designation provides development and commercial incentives including exemption from FDA user fees and eligibility for a seven-year period of market exclusivity upon approval in the U.S.

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Disclaimer: BioPharma Global is not responsible for, and expressly disclaims all liability for, damages of any kind arising out of use, reference to, or reliance on any information contained within the article. Content available through the site may contain links and information to other websites. Links from BioPharma Global to third-party sites do not constitute an endorsement by BioPharma Global of the mentioned parties.

BioPharma Global is a mission-driven corporation, operating like a not-for-profit, dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with a high unmet medical need. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

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02022021

Amgen Announces Breakthrough Therapy Designation Granted For Sotorasib In China
by Drug Discovery NewsRegulatory News

Amgen (NASDAQ: AMGN) today announced that its investigational KRASG12C inhibitor sotorasib was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The designation is for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy. This is the first BTD submission for Amgen in China, as well as the first under Amgen’s strategic collaboration with BeiGene. 

NSCLC is the most common form of lung cancer, accounting for approximately 80-85% of all cases worldwide.1 KRAS G12C is the most common KRAS mutation in NSCLC.2,3 The mutation is a biomarker of poor prognosis in Chinese NSCLC patients, which may be improved by G12C-specific inhibitors.4 Research has shown that about 3-5% have the KRAS G12C mutation – found most commonly in smokers.4,5

“Given that Breakthrough Therapy Designation is a new pathway in China, we are pleased to receive this designation for sotorasib,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “This designation underscores the importance of sotorasib and we look forward to working with regulatory authorities in China to bring the first potential targeted therapy to NSCLC patients with the KRAS G12C mutation.”

The Breakthrough Therapy Designation is supported by the positive CodeBreaK 100 Phase 2 results in patients with advanced NSCLC whose cancer had progressed despite prior treatment with chemotherapy and/or immunotherapy. In the study, treatment with sotorasib demonstrated durable anticancer activity with a positive benefit-risk profile.6 These results will be presented at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) Presidential Symposium from 3:50-4 p.m. PST on Friday, Jan. 29.

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Disclaimer: BioPharma Global is not responsible for, and expressly disclaims all liability for, damages of any kind arising out of use, reference to, or reliance on any information contained within the article. Content available through the site may contain links and information to other websites. Links from BioPharma Global to third-party sites do not constitute an endorsement by BioPharma Global of the mentioned parties.

BioPharma Global is a mission-driven corporation, operating like a not-for-profit, dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with a high unmet medical need. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

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02012021

Mundipharma and Cidara’s rezafungin gets Orphan Drug Designation in EU
by Drug Discovery NewsRare Disease NewsRegulatory News

The European Commission (EC) has adopted the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) recommendation to grant Orphan Drug Designation (ODD) to Mundipharma and Cidara Therapeutics’ rezafungin for treating invasive candidiasis (IC).

IC is a severe, life-threatening Candida infection of the bloodstream and / or deep / visceral tissues.

A novel, once weekly echinocandin, rezafungin is currently in Phase III trials for treating severe fungal infections.

Mundipharma holds exclusive rights to develop and market the drug in all markets except the US and Japan, where Cidara retains the rights.

Mundipharma chief scientific officer Brian Sheehan said: “Orphan drug designation is an important milestone in the development of rezafungin, which is currently in Phase III clinical trials.

“Fungal infections still pose a major threat to the lives of hospitalised or immunocompromised patients. We are proud that patients affected with invasive candidiasis may have an additional treatment option to treat this potentially life-threatening condition.”

The latest development comes after rezafungin was granted the US Food and Drug Administration’s (FDA) Qualified Infectious Disease Product (QIDP) with Fast Track status and ODD for use in treating IC, including candidaemia.

Cidara Therapeutics president and CEO Jeffrey Stein said: “We are pleased by the decision of the EMA to grant orphan drug designation to rezafungin, further supporting its potential as the first new antifungal for the treatment of serious invasive Candida infections in nearly 15 years.”

To Read the Complete Article at Pharmaceutical Technology, Click Here

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BioPharma Global is a mission-driven corporation, operating like a not-for-profit, dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with a high unmet medical need. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

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