11252020

PolyPid Granted Breakthrough Therapy Designation from FDA for D-PLEX₁₀₀ for the Prevention of Surgical Site Infections in Colorectal Surgery
by with No Comment Drug Discovery NewsRegulatory News

PolyPid Ltd. (Nasdaq: PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that D-PLEX100 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of surgical site infections (SSIs) in patients undergoing elective colorectal surgery.

Breakthrough Therapy Designation is an FDA process designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition so patients may have access to therapies through FDA approval as soon as possible. This designation is granted based on preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

“The Breakthrough Therapy Designation in the field of anti-infective drugs is rather rare, and further supports the urgency to develop new innovative therapies to prevent SSIs,” said Amir Weisberg, PolyPid’s CEO. “It also reflects on the promising clinical data of D-PLEX100 in the prevention of SSIs in complex surgical settings, such as colorectal abdominal surgeries. We are looking forward to working closely with the FDA to make D-PLEX100 available to surgeons and patients as quickly as possible. Our ongoing Phase 3 pivotal studies in abdominal surgery – SHIELD I and SHIELD II – are on track.”

The Breakthrough Therapy Designation for D-PLEX100 is based on conclusive positive results from a Phase 2 clinical trial evaluating D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal colorectal surgery. The Phase 2 clinical trial was a prospective, multicenter, randomized, controlled two arm study in 201 patients and demonstrated that the local administration of D-PLEX100 resulted in a statistically significant decrease in SSIs of 59 percent in the Intent to Treat (ITT) population (p=0.0086), and a decrease of 69 percent in the Per Protocol population (n=179; p=0.0024), as compared to the standard of care alone.

D-PLEX100 previously received two Fast Track Designations from the FDA for the prevention of post-abdominal surgery incisional infections and for the prevention of sternal wound infections post-cardiac surgery, as well as two Qualified Infectious Disease Product designations (QIDP’s) in the same indications.

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11242020

Theralase Granted FDA Fast Track Designation for NMIBC Phase II Clinical Study
by with No Comment Drug Discovery NewsRegulatory News

Theralase® Technologies Inc. (“Theralase” or the “Company“) (TSXV:TLT) (OTCQB:TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds (“PDC“) and their associated drug formulations used to safely and effectively destroy various cancers, bacteria and viruses announced today that the U.S. Food and Drug Administration (“FDA”) has granted Theralase® Fast Track Designation (“FTD“) for its Phase II Bacillus Calmete Guérin (“BCG“)-Unresponsive Non Muscle Invasive Bladder Cancer (“NMIBC“) Carcinoma In Situ (“CIS“) clinical study (“Study II“).

As a Fast Track designee, Theralase® will have access to early and frequent communications with the FDA to discuss Theralase’s development plans and ensure timely collection of the appropriate clinical data to support the approval process. The accelerated communication with the FDA potentially allows, TLD-1433, in combination with the TLC-3200 medical laser system (“TLC-3200“), to be the first intravesical patient-specific Ruthenium-based PDC for the treatment of patients with BCG-Unresponsive NMIBC CIS, with or without papillary Ta or T1 tumours. FTD can lead to an Accelerated Approval and Priority Review, if certain criteria are met, which the FDA has previously defined to the Company to represent approximately 20 to 25 patients enrolled and treated, who demonstrate significant safety and efficacy clinical outcomes.

Michael Jewett MD, FRCSC, FACS, Inaugural Farquharson Clinical Research Chair in Oncology, Departments of Surgery (Urology) and Surgical Oncology, Princess Margaret Cancer Centre, University Health Network (“UHN“), stated “By awarding Fast Track Designation to the photosensitizer drug TLD-1433 activated by the laser TLC-3200, currently being assessed in a Phase II clinical study for the treatment of NMIBC, the FDA has recognized Theralase®’s potential to meaningfully improve patient outcomes for this life-threatening disease. This is a significant accomplishment for the Company. This latest milestone complements the clinical development strategy to provide urologists, uro-oncologists and patients with the tools to combat BCG-Unresponsive NMIBC, safely and effectively.”

Shawn Shirazi PhD, Chief Executive Officer, Theralase®, stated, “FDA’s FTD for our lead drug candidate, TLD-1433, activated by the TLC-3200, is another important milestone for Theralase®, as it can potentially speed the development of this drug-device combination for NMIBC patients. The TLD-1433 – TLC-3200 technology represents a paradigm shift in medical technology and an advanced approach to treat NMIBC. We are excited by the progress the Company has delivered in Study II, as we continue to enroll and successfully treat patients. The Company continues to work towards launching new clinical study sites in Canada and the US with a mandate to enroll and treat all patients for their first Study II treatment in 2021”.

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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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11232020

BrainEver Receives FDA Orphan Drug Designation for BREN-02, (human recombinant Engrailed 1) for the Treatment of Amyotrophic Lateral Sclerosis (ALS)
by with No Comment Drug Discovery NewsRare Disease NewsRegulatory News

BrainEver, a biotechnology company dedicated to the research and development of innovative therapies for the treatment of neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its product BREN-02, the recombinant human homeoprotein Engrailed 1 (rhEN1), for the treatment of amyotrophic lateral sclerosis (ALS).

ALS (also known as Charcot disease) is a severe neurodegenerative disease affecting motor neurons, resulting in progressive muscle weakness leading to paralysis, with a vital prognosis of approximately 2-4 years from onset. ALS is diagnosed in approximately 16,000 people each year in Europe and North America.

“In ALS, motor neurons degenerate and die, leading to progressive muscle paralysis that includes respiratory muscles. In preclinical studies, we have observed that the intrathecal lumbar administration of rhEN1, in the early symptomatic stages, restores muscle function and prevents motor neuron death”, said Prof. Alain Prochiantz, neurobiologist at the Collège de France and co-founder of BrainEver:

BREN-02 is expected to be administered in clinical trials in ALS patients in the second half of 2021, subject to preclinical toxicity results and regulatory review. Preclinical studies have shown that the homeoprotein hEN1 is essential for the survival and maintenance of spinal cord alpha motor neurons that innervate muscles throughout the body.

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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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11202020

ExeGi Pharma Announces FDA Orphan Drug Designation for EXE-346 Live Biotherapeutic
by with No Comment Drug Discovery NewsRare Disease NewsRegulatory News

ExeGi Pharma LLC, a company focused on developing live biotherapeutic (“LBP”) drugs and probiotics, announced today that its biologic drug candidate, EXE-346, has received an orphan drug designation from the U.S. Food and Drug Administration (FDA) for the prevention of disease relapse in pouchitis. This designation grants certain benefits to drugs and biological products intended to treat diseases which affect less than 200,000 patients in the U.S. EXE-346 is an LBP which contains a fixed-proportion of 8 strains of live probiotic bacteria which are intended for oral administration.

Pouchitis is a condition which impacts patients whom have had a surgical procedure to remove their colon. The surgery, called a pouch anastomosis, creates an intestinal “J-Pouch” with a portion of the lower intestine. While this procedure enables patients to pass stool normally, one challenge is pouchitis, a condition in which the reservoir becomes inflamed. While it’s not clear what causes pouchitis, studies suggest that an abnormal immune response to the bacterial microflora of the pouch may play a role in its development. The most common pouchitis symptoms are an increased number of bowel movements, abdominal pain, joint pain, cramps, and fever. There is currently no approved treatment for managing the symptoms associated with pouchitis or for helping patients reach remission. EXE-346 is intended to decrease this inflammation of the pouch and prevent active disease flare-ups. Antibiotics such as Ciprofloxacin are commonly used to treat the active form of the disease, suggesting a clear connection to a dysregulated pouch microbiome.

“The J-Pouch surgery is a great option for many people that have long suffered from ulcerative colitis and other rare conditions, but pouchitis can occur in a significant portion of these patients,” commented Dr Paolo Gionchetti of the University of Bologna in Italy. “I am pleased to see that the U.S. FDA has granted this product Orphan status because these patients need new treatment options to help maintain a normal quality of life.” 

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11192020

F2G Receives Second US FDA Breakthrough Therapy Designation for Olorofim
by with No Comment Drug Discovery NewsRegulatory News

F2G Ltd, a UK- and Austria-based biotech company developing novel therapies for life-threatening systemic fungal infections, announced today that the US Food and Drug Administration (FDA) has granted an additional Breakthrough Therapy Designation to its lead first-in-class candidate, olorofim, for the indication of ‘Treatment of Central Nervous System (CNS) coccidioidomycosis refractory or otherwise unable to be treated with standard of care therapy’. This is the second Breakthrough Therapy Designation for olorofim; a designation was granted previously on 11 November 2019 for ‘Treatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory orintolerant tocurrently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species’. Olorofim (formerly F901318) is the first antifungal agent to be granted Breakthrough Therapy Designation.

Olorofim has orphan drug designation in the United States for coccidioidomycosis, an endemic fungal infection with a geographic distribution focused mainly in the desert Southwest of the United States but also including Mexico, Central America, and South America. Infection begins by inhalation and can spread to any part of the body, even in otherwise healthy individuals. Spread to the brain is particularly feared as it produces a devastating illness that cannot always be controlled with any currently available agent.

Patients with coccidioidomycosis are being studied in an ongoing open-label single-arm Phase 2b study (ClinicalTrials.gov Identifier: NCT03583164) in patients with proven invasive fungal disease (IFD) or probable invasive aspergillosis (IA) and either refractory disease, resistance, or intolerance to available agents. Olorofim has been well tolerated across more than 30 years of cumulative patient dosing days with a median therapy duration of 12 weeks. Preliminary data from this study were provided to the FDA as part of the Breakthrough Therapy Designation submission.

Breakthrough Therapy Designation is an FDA process designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition and is granted based on preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

Breakthrough Therapy Designation conveys all the features of fast track designation, more intensive FDA guidance on an efficient drug development program, an organisational commitment by FDA to involve senior managers, and eligibility for rolling review and priority review.

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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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11182020

Aruvant Receives Orphan Designation from European Medicines Agency for Gene Therapy ARU-1801 for Sickle Cell Disease
by with No Comment Drug Discovery NewsRare Disease NewsRegulatory News

Aruvant, a clinical-stage biopharmaceutical company focused on developing and commercializing transformative gene therapies for the treatment of rare diseases, today announced that the European Medicines Agency (EMA) has granted orphan designation for ARU-1801, an investigational lentiviral gene therapy. The U.S. Food and Drug Administration (FDA) previously granted Orphan Drug and Rare Pediatric Disease Designations to ARU-1801 for the treatment of sickle cell disease (SCD).

“The EMA orphan designation highlights the importance of ARU-1801, our potentially curative gene therapy for individuals living with severe SCD,” said Will Chou, M.D., chief executive officer of Aruvant. “We are encouraged by the preliminary clinical data from our ongoing Phase 1/2 study that demonstrates ARU-1801, administered with only reduced intensity conditioning, can achieve durable reductions in disease burden.”

Orphan drug designation in the European Union (EU) is granted by the European Commission based on a positive opinion issued by the EMA Committee for Orphan Medicinal Products. To qualify, an investigational medicine must be intended to treat a seriously debilitating or life-threatening condition that affects fewer than five in 10,000 people in the EU, and there must be sufficient non-clinical or clinical data to suggest the investigational medicine may produce clinically relevant outcomes. EMA orphan drug designation provides companies with certain benefits and incentives, including clinical protocol assistance, differentiated evaluation procedures for Health Technology Assessments in certain countries, access to a centralized marketing authorization procedure valid in all EU member states, reduced regulatory fees and 10 years of market exclusivity upon marketing authorization.

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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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11172020

FDA grants fast track designation to CPI-613 for pancreatic cancer
by with No Comment Drug Discovery NewsRegulatory News

The FDA granted fast track designation to devimistat for the treatment of pancreatic cancer, according to the agent’s manufacturer.

Devimistat (CPI-613, Rafael Pharmaceuticals) targets enzymes in the mitochondria of cancer cells that are involved in cancer cell energy metabolism.

The agent is designed to selectively target the mitochondrial tricarboxylic acid cycle in cancer cells. This process is essential to tumor cell multiplication and survival.

“Receiving fast track designation is a significant milestone in our fight against pancreatic cancer,” Sanjeev Luther, president and CEO of Rafael Pharmaceuticals, said in a company-issued press release. “This designation further stresses the severe unmet need in treatment options for this aggressive and devastating disease.”

The FDA gave Rafael Pharmaceuticals approval to begin pivotal phase 3 trials in pancreatic cancer and acute myeloid leukemia.

“Pancreatic cancer is notoriously challenging to treat and long overdue for a new approach,” Philip A. Philip, MD, PhD, FRCP,professor of oncology at Barbara Ann Karmanos Cancer Institute at Wayne State University and a medical adviser to Rafael Pharmaceuticals, said in the release. “We have remained hopeful throughout our pancreatic cancer trials and, now with fast track designation, our optimism is further fueled. We believe with this designation, cancer metabolism is truly being propelled forward, with devimistat at the helm.”

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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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11162020

Agios Announces FDA Orphan Drug Designation Granted to Mitapivat for Treatment of Sickle Cell Disease
by with No Comment Drug Discovery NewsRare Disease NewsRegulatory News

Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company’s first-in-class pyruvate kinase R (PKR) activator mitapivat for the treatment of patients with sickle cell disease. Mitapivat is an investigational, oral, small molecule allosteric activator of wild-type and a variety of mutated PKR enzymes.

“Receiving orphan drug designation for mitapivat in sickle cell disease is an important recognition of the tremendous unmet need among this patient community, which has historically been underserved,” said Chris Bowden, M.D., chief medical officer at Agios. “As the pioneers in PKR activation, we believe this mechanism has the potential to transform the course of sickle cell disease and are researching mitapivat’s ability to improve red blood cell energy, health and longevity. We look forward to continued partnership with the sickle cell disease community and expect to initiate our Phase 3 study next year.”

The FDA’s Office of Orphan Drug Products grants orphan status to support the development of medicines for rare disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees and tax credits for qualified clinical trials.

Mitapivat was previously granted orphan drug designation by the FDA and the European Medicines Agency for the treatment of pyruvate kinase (PK) deficiency, a rare, debilitating, hemolytic anemia, and by the FDA for the treatment of thalassemia.

Mitapivat Clinical Development
Mitapivat is being evaluated as a potential treatment for sickle cell disease under a Cooperative Research and Development Agreement (CRADA) with the U.S. National Institutes of Health. Mitapivat has been shown to decrease 2,3-diphosphoglycerate (2,3-DPG) and increase adenosine triphosphate (ATP), and through this mechanism, it may reduce hemoglobin S polymerization and red blood cell sickling. Preliminary clinical data establishing proof-of-concept for mitapivat in sickle cell disease were disclosed in June 2020, and updated data from this trial will be presented at the American Society of Hematology (ASH) Annual Meeting, which is being held virtually December 5–8, 2020. Agios expects to initiate a Phase 3, global, pivotal study of mitapivat in sickle cell disease in 2021.

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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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11132020

FDA approves prescription-only Apple Watch app for PTSD nightmares
by Drug Discovery NewsRegulatory News

The majority of post-traumatic stress disorder (PTSD) patients suffer from frequent traumatic nightmares that can deeply disrupt sleep patterns and have been linked with significantly higher rates of suicide. The U.S. Food and Drug Administration (FDA) has now approved a platform called NightWare, designed to help improve sleep in PTSD patients suffering from such recurrent nightmares. The system is an app that runs on Apple Watches and will only be available by prescription.

“Disruptive and persistent traumatic nightmares associated with post-traumatic stress are significantly underreported and undertreated, and there are no consistently effective treatment options,” explains retired US Army General and NightWare advisor Peter Chiarelli. “A device such as the NightWare therapeutic platform that performs the necessary reconnaissance of the mind to identify and interrupt post-traumatic stress-associated nightmares represents a transformational step forward in how we can begin to better support our veterans and active service members suffering from this disabling condition.”

The NightWare system is essentially a sophisticated app that works with an Apple Watch and linked smartphone, and initially spends up to 10 nights learning a user’s sleep patterns. Once a unique sleep profile has been created, the system tracks heart rate and body movement data to detect when a user is experiencing a nightmare. If a nightmare is detected the system triggers mild vibrations through the Apple Watch that are designed to gently disrupt the nightmare without waking the user.

The system was tested in a sham-controlled clinical trial that recruited 70 PTSD patients. The control group received exactly the same intervention as the active group. They used the app and wore a connected Apple Watch, except they received no vibratory stimulation.

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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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11122020

Surface Oncology Announces FDA Fast Track Designation Granted by U.S. Food and Drug Administration for SRF388 to Treat Liver Cancer
by Drug Discovery NewsRegulatory News

Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SRF388 for the treatment of patients with hepatocellular carcinoma (HCC), or liver cancer, who have been previously treated with standard therapies, such as vascular endothelial growth factor targeted agents and programmed death-ligand (PD-L1) blockade.

“Liver cancer is the most rapidly increasing type of cancer in both men and women in the U.S., with incidences tripling since 1980.1 2 There is a significant need to expedite the development of new therapies to treat liver cancer as the five-year survival for patients with unresectable or metastatic liver cancer is less than five percent,”2 said Rob Ross, M.D., chief medical officer. “SRF388 targets IL-27, an immuno-suppressive cytokine that has been found to be elevated in patients with liver cancer, as well as kidney cancer, and we believe SRF388 has the potential to be an effective treatment option for these patients, as monotherapy or in combination with anti-PD-1 therapies.”

SRF388 is currently enrolling patients with advanced solid tumors in a Phase 1 monotherapy dose escalation study with planned expansions in liver and kidney cancer to further evaluate SRF388 as a monotherapy and in combination with other cancer therapies.

The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs that are being developed to treat serious conditions and fill an unmet medical need. The purpose of the designation is to bring important new drugs to patients earlier across a wide range of diseases.

SRF388 recently received orphan-drug designation for treatment of hepatocellular carcinoma from the FDA.

About SRF388:

SRF388 is a fully human anti-IL-27 antibody designed to inhibit the activity of this immuno-suppressive cytokine. Surface Oncology has identified particular tumor types, including liver and kidney cancer, where IL-27 appears to play an important role in the immuno-suppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors. SRF388 targets the rate-limiting p28 subunit of IL-27, and preclinical studies have shown that treatment with SRF388 blocks the immuno-suppressive biologic effects of IL-27, resulting in immune cell activation in combination with other cancer therapies and potent anti-tumor effects as a monotherapy. Furthermore, Surface Oncology has identified a potential biomarker associated with IL-27 that may be useful in helping identify patients most likely to respond to SRF388.

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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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