Category Archives: Pharmaceutical Development

A Phase 2/3 Clinical Trial of Trigriluzole for Alzheimer’s Disease

The first patient has been enrolled in a Phase 2/3 clinical trial of trigriluzole (BHV-4157), a novel glutamate modulator for the treatment of mild-to-moderate Alzheimer’s disease (AD). The trial is a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of trigriluzole in patients diagnosed with AD of mild-to-moderate severity (Mini-Mental State Examination scores of 14-24 at screening), and is being conducted in collaboration with the Alzheimer’s Disease Cooperative Study (ADCS) at sites throughout the USA.Howard Feldman, MD, FRCP, Director of the ADCS and Professor of Neurosciences at University of California San Diego School of Medicine added, “The preclinical evidence for the active metabolite of trigriluzole to modulate glutamate and confer neuroprotective effects in patients with AD is compelling, and the new formulation of trigriluzole should improve its pharmaceutical properties with potential for efficacy in AD.”

Alzheimer’s disease is a progressive, fatal neurodegenerative dementia that accounts for 60 ? 80 percent of dementia cases. Alzheimer’s disease currently has no cure. Although there are FDA-approved medications for symptomatic treatment of AD, their clinical benefits are generally limited. Novel therapeutic approaches aimed at normalizing synaptic and extra-synaptic glutamate levels, such as trigriluzole, may offer the potential for symptomatic benefit in AD by improving cognitive function, as well as the potential for disease modification by preventing the loss of synapses.

The Phase 2/3 clinical trial (clinicaltrials.gov identifier NCT03605667) is a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of trigriluzole in patients diagnosed with AD of mild-to-moderate severity (Mini-Mental State Examination scores of 14-24 at screening). Patients who have been taking stable doses of FDA-approved AD medications (AchEI also known as acetylcholinesterase inhibitors and/or memantine) for a minimum of three months prior to screening and who are willing to remain on the same regimen for the duration of the trial may be eligible to participate. Approximately 292 patients will be randomized on a 1:1 basis to receive 280 mg of trigriluzole or placebo, taken orally at bedtime. Duration of treatment will be 48 weeks.

About Trigriluzole
Trigriluzole is a third-generation prodrug and new chemical entity that modulates glutamate, the most abundant excitatory neurotransmitter in the human body. Trigriluzole has a wide range of pharmacological actions, including interactions with several types of ion channels, cellular signaling mechanisms and facilitation of glutamate reuptake. Some potential targets related to trigriluzole’s mechanism of action include (1) reducing presynaptic glutamate release through actions at the voltage-gated ion channels, (2) facilitating glutamate uptake via EAATs located on glial cells, (3) enhancing transmission through synaptic AMPA receptors, (4) altering GABAergic neurotransmission, and (5) effecting neurotrophic agents such as BDNF. Several of these targets of trigriluzole balance abnormalities observed in human AD post-mortem tissue as well as in AD animal models. As such, trigriluzole potentially offers neuroprotective effects at the level of the synapse as well as improved synaptic functioning, mechanisms that could exert both symptomatic and disease-modifying effects in AD.

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Finding New Treatments for Breast Cancer with Brain Metastases

As if Breast Cancer or Brain Cancer alone were not enough to combat — patients with both now?have new hope in light of fledgling research that is showing progress.

Once breast cancer metastasizes into other areas of the body, particularly the brain, it becomes much more dangerous. And while the National Cancer Institute spends more than $500 million dollars per year on breast cancer research, only two to five percent of this funding goes to study how the disease spreads.

A clinical trial is open nationwide through the Academic Breast Cancer Consortium (ABRCC), giving access to an exciting novel drug therapy combination. The tucatinib, palbocilib and letrozole trial is coordinated by ABRCC and currently open for enrollment at the University of Colorado Cancer Center; University of Texas Health and Science Center in San Antonio, TX; Stony Brook University, NY; University of Arizona, Tucson, AZ; and University of New Mexico, Albuquerque, NM and will also be accruing patients at Northwestern University, Chicago, IL.

There are three well-established predictive markers of breast cancer. They are estrogen receptors (ER), progesterone receptors (PR), and the growth factor receptor HER2, these receptors may be blocked with targeted drugs to stop cancer growth. Breast cancers lacking these three markers are referred to as ?triple-negative? but clinicians and scientists are quickly learning more about cancers that have all three receptors, which are often called ?triple-positive.? There are treatments against each target individually, but when multiple drivers are present, as in ?triple-positive? breast cancer, blocking one often results in cancer nimbly switching to driving its growth with the other two.

The study combines tucatinib, which inhibits HER2, with letrozole targeting ER and PR hormone receptors, and the drug palbociclib, which targets CDK proteins that help cancer cells rush through the process of replication. The three had not been tried together until Elena Shagisultanova, MD, PhD, a breast cancer specialist at UCH, hypothesized there could be a way to target all three drivers at the same time with better results than targeting combinations of any two.

?When metastatic cancer spreads to the brain, it can be especially challenging,? says Dr Peter Kabos, the National Medical Director of the Academic Breast Cancer Consortium (ABRCC) and the Kabos Research Lab for Breast Cancer at UC Denver. ?Many medications aren?t effective in the brain, but exciting early clinical trial data for tucatinib shows that it may be one of the drugs that can penetrate the blood-brain barrier to combat brain metastases.

The trial is funded by the Pfizer ASPIRE Award in Breast Cancer Research. Cascadian Therapeutics and Pfizer are providing the study drugs tucatinib and palbociclib. For more information about trial eligibility and participation, contact brad.mackay@ucdenver.edu or emily.berens@ucdenver.edu

Article excerpted with permission from the University of Colorado Cancer Center blog — for the complete story, click here.

Orphan Drug Designation for Treatment of ALS – Amyotrophic Lateral Sclerosis

On March 29, 2018 the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development granted Orphan Drug Designation (ODD) to experimental therapeutic EH301 for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s Disease.

The Orphan Drug Designation submission included data from a 2017 double-blind placebo-controlled European pilot study in humans. To expand on the results of the pilot study, Elysium Health expects to initiate a placebo-controlled study in collaboration with Mayo Clinic to evaluate EH301 in up to 150 adults with ALS by the fourth quarter of 2018. The granting of ODD to EH301 does not alter the standard regulatory requirement through adequate and well-controlled studies to support FDA approval, and there is no guarantee EH301 will be approved for the treatment of ALS by FDA.

Elysium Health Chief Scientist Dr. Leonard Guarente remarked that “There is a great deal of work to be done to address the need for continued research to better understand and to treat all neurodegenerative diseases. We believe that the FDA’s granting of Orphan Drug Designation for EH301 for ALS underscores the need for novel treatments for this rare condition.”

ALS is a rare neurodegenerative disease that affects nerve cells that control voluntary muscles throughout the body to produce movements including talking, eating, walking, and breathing. ALS is progressive, meaning it gets worse over time. As the nerves lose the ability to control muscles, the muscles become weak and eventually lead to paralysis. Most people with ALS succumb to respiratory failure, usually within three to five years from when symptoms first appear. Please visit the ALS website for more information.

The FDA’s ODD program provides orphan status to drugs intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. It is estimated that there are approximately 15,000-20,000 Americans with ALS. Please see the NIH ALS Fact Sheet for details.

Additional information can be found on the Christopher & Dana Reeve Foundation website regarding current therapies and disease trends.

Disclosure: Mayo Clinic has a financial interest in Elysium Health. All revenue Mayo Clinic receives will be used to fund its not-for-profit mission in medical research and education.

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Huntington’s Disease Molecule Can Kill Cancer Cells

Scientists have destroyed numerous types of human cancer cells with a toxic molecule characteristic of fatal genetic illness Huntington?s disease.

The researchers hailed the molecule?which has killed both human and mouse ovarian, breast, prostate, liver, brain, lung, skin and colon cancer cell lines in mice?as a ?super assassin.? Their results were published in the journal EMBO Reports.

Huntington?s disease is a progressive illness caused by an excess of a specific repeating RNA sequence in the Huntington gene, which is present in every cell. The defect causes the death of brain cells, and gradually worsens a person?s physical and mental abilities. The disease has no cure.

Researchers believe that the defect may be even more powerful against cancer cells than nerve cells in the brain, and the team hopes it can be harnessed to kill cancer cells without causing Huntington?s symptoms.? ?This molecule is a super assassin against all tumor cells,? said senior author Marcus Peter, a professor of cancer metabolism at Northwestern University Feinberg School of Medicine, Chicago, in a press statement. ?We?ve never seen anything this powerful.?

Peter collaborated with Feinberg colleague Shad Thaxton, associate professor of urology, to deliver the molecule in the form of nanoparticles to mice with human ovarian cancer. The targeted molecule decreased tumor growth with no toxicity to the mice.

First author Andrea Murmann, a research assistant professor who discovered the cancer-killing mechanism, used the molecule to kill numerous other human and mouse cancer cell lines. Building on previous research into a cancer ?kill switch?, Murmann looked to diseases associated with low rates of cancer and a suspected RNA link.? ?I thought maybe there is a situation where this kill switch is overactive in certain people, and where it could cause loss of tissues,? Murmann said in the statement. ?These patients would not only have a disease with an RNA component, but they also had to have less cancer.?

There is up to 80 percent less cancer in people with Huntington?s disease than the general population.? Murmann recognised similarities between the kill switch and the toxic Huntington?s disease RNA sequences.? Based on their results, the team believe the ?super assassin? molecule could be used to fight cancer in humans. ?We believe a short-term treatment cancer therapy for a few weeks might be possible, where we could treat a patient to kill the cancer cells without causing the neurological issues that Huntington?s patients suffer from,? Peter said.? The scientists next aim to refine the molecule?s delivery method to improve tumor targeting, and to stabilize the nanoparticles for storage.

By Katherine Hignett – Displayed with permission from Newsweek via RePubHub License; Cancer Cells courtesy of PixaBay FREE LIC CC0?

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ABRCC Consortia MD Elena Shagisultanova Targets Treatment-Resistant Breast Cancer

Metastatic triple-positive breast cancer frequently resists treatments. Scientists at the University of Colorado Cancer Center are testing a unique combination of medications to change that.

Growth of breast cancer cells is often propelled by one of three receptors ? estrogen receptors (ER), progesterone receptors (PR) or the growth factor receptor called HER2. Treatments exist targeting each of these receptors individually. However, when all three receptors are present ? this ?triple-positive? breast cancer ? blocking any single receptor is not enough. ?Treatments that block hormonal (estrogen and progesterone) receptors may be not very effective because tumor cells may use HER2 receptor to grow. The drugs that block HER2 receptors may not work as well because the cells will use hormonal receptors to survive. Chemotherapy works against triple-positive breast cancers, however, it has multiple side effects. Previous clinical trials have been largely unsuccessful in defining a well-tolerated targeted drug combination that blocks all avenues for growth of triple-positive breast tumors.

?Under the current guidelines, patients with triple-positive metastatic breast cancer have two options as a first line of treatment and neither is a great option,? says Elena Shagisultanova, MD, PhD, investigator at the CU Cancer Center and assistant professor in the University of Colorado School of Medicine?s Division of Medical Oncology. ?One approach is to start an anti-hormonal pill, which is generally non-toxic. However, the response usually lasts only three to four months. The other choice is to start chemotherapy combined with HER-2 targeted agents. This option is effective, but it has multiple side effects.?

Shagisultanova is the principal investigator on the multi-institutional trial.? It is also?an investigator-initiated trial which allows physician/scientists to test treatments that their hands-on experience in the lab and clinic indicate may offer meaningful results. Shagisultanova believes she and CU Cancer Center colleagues may have another option: a regimen using three pills, each targeting a different pathway of the disease. The?trial combines tucatinib, which inhibits HER2, with letrozole targeting hormone receptors, and the CDK4/6 inhibitor palbociclib.

?We think hormone receptor and HER-2 signals are coming together to help cancer cells resist treatment,? says Shagisultanova. ?The CDK4/6 inhibitor palbociclib can block these converging signals in the nucleus. We believe that if we can inhibit the signaling deeper in the tumor cell using this triple blockade, patients will have longer lives and better quality of life.? ?Tucatinib, palbociclib and letrozole tend to have different side-effects, leading Shagisultanova to believe the triple combination of targeted agents will be well- tolerated.

Early clinical trials often exclude patients whose cancer has already metastasized to the brain, in large part due to the inability of anti-cancer drugs to penetrate the blood-brain barrier to reach the disease in the central nervous system. However, because tucatinib has proven effective in shrinking HER2-positive breast tumors that have spread to the brain, patients with brain metastases are, in fact, included in the current trial.

?Metastatic disease in the brain is one of the most dangerous complications of triple-positive breast cancer. If we can prevent development of brain metastases, or effectively treat metastatic disease in the brain, it will improve the lives of many patients,? Shagisultanova says.? ?There are many challenges in designing and delivering clinical trials,? says Christopher Lieu, MD, CU Cancer Center?s deputy associate director for clinical research. Lieu also leads CU Cancer Center?s efforts in further developing an Investigator-Initiated Trials Committee.

?We are fortunate at CU Cancer Center to have innovative clinicians who are analyzing data to find novel and innovative strategies to target malignancies that are in serious need of better therapies,? Lieu adds.? ?Trials like this one are critical in moving cancer science forward and finding effective, non-toxic therapies.?

This trial is currently open for enrollment at the ABRCC Consortia Academic sites of: University of Colorado Cancer Center, Northwestern University, Chicago, IL; University of Texas Health and Science Center in San Antonio, TX; Stony Brook University, NY; University of Arizona, Tucson, AZ, and University of New Mexico, Albuquerque, NM.

The trial is funded by the Pfizer ASPIRE Award in Breast Cancer Research. Cascadian Therapeutics and Pfizer are providing the study drugs tucatinib and palbociclib.

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AI-Driven Discovery of Novel Predictors of Parkinson’s

The discovery was powered by patient data from the Parkinson’s Progression Markers Initiative, sponsored by the Michael J. Fox Foundation for Parkinson’s Research.

GNS Healthcare (GNS), a leading precision medicine company, announced the discovery of genetic and molecular markers of faster motor progression of Parkinson’s Disease (PD) patients, the LINGO2 gene together with a second genetic variant, along with demographic factors.

The publication describing the discovery, titled “Large-scale identification of clinical and genetic predictors of Parkinson’s disease motor progression in newly-diagnosed patients: a longitudinal cohort study and validation,” appears in the journal The Lancet Neurology. This discovery may accelerate the development of new drugs and better match new drugs to individual patients.

“Being able to use these predictors in the clinical setting will lead to faster and significantly cheaper clinical trials and accelerate the availability of new Parkinson’s Disease drugs for patients in need,” said Colin Hill, Chairman, CEO, and co-founder of GNS Healthcare. “A major hurdle in Parkinson’s research is that rates of progression are extremely varied. Some patients progress very quickly while others do not. With accurate predictors of rates of progression, we will be able to remove uncertainties from drug development and patient response, reduce the number of clinical trial enrollees required by as much as twenty percent, and speed up the development of effective new drugs.”

REFS?, the GNS causal machine learning (ML) and simulation platform was used to transform the longitudinal genetic and clinical patient data from 429 individuals (312 PD patients and 117 controls) into computer models that connect the genetic and molecular variation of patients to motor progression rates. These computer models were used to simulate the future effects of the genetic and prognostic variables on motor outcomes, essentially predicting the motor progression rate for each patient. The models were validated in an independent longitudinal study, and clearly demonstrated the ability to prospectively differentiate between patient progression rates.

“There is still so much to understand about the progression of chronic, debilitating illnesses like Parkinson’s disease,” said Jeanne C. Latourelle, D.Sc., a co-author of the study and Director of Precision Medicine, GNS Healthcare. “The validation of our models in this study underscores the power of our REFS? technology and its ability to accelerate the development of effective therapies for patients in need.”

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Vaccine for Meningitis Shows Some Protection Against Gonorrhea

Scientists have not been able to develop a vaccine against the sexually transmitted disease gonorrhea, despite working toward one for more than 100 years.? However, they may have stumbled onto something that could provide clues to advance the development of such a vaccine.

Decades ago, in the late 1990s, a strain of meningitis B was reaching epidemic proportions in New Zealand. A vaccine, MeNZB, was developed to protect young people who were at the highest risk of getting this particular type. It did not provide protection against any other strain.

Between 2004 and 2006, MeNZB was given to anyone under the age of 20. Babies and preschoolers were routinely immunized until 2008. People with a high medical risk continued to get the vaccine until 2011. Once the epidemic was over, the vaccination program was stopped.

However, scientists noticed that the meningitis vaccine also seemed to offer some protection against gonorrhea. A study published in the Lancet last month showed that one-third of the people who had received MeNZB did not get gonorrhea, compared to a control group who was not inoculated. The lead author noted that the bacteria causing both diseases share between 80 and 90 percent of their primary genetic sequences.

Dr. Steven Black, an infectious disease expert at Cincinnati Children?s Hospital, noted, ?This is the first time it?s been shown that you could have a vaccine that would protect against gonorrhea. And if these results are confirmed in another setting, that would mean that it would be very reasonable ? to go forward with developing perhaps a more targeted vaccine.? Black’s comments were published in the current issue of JAMA, the Journal of the American Medical Association.? The JAMA article concludes that ultimately, a preventive vaccine could be the only sustainable solution to a fast-changing bug that has proven adept at developing resistance.

The World Health Organization reports?that gonorrhea is becoming harder, and sometimes impossible, to treat, warning that it could become incurable in the not-too-distant future. At the moment, there no new antibiotics being developed to treat this disease.

The U.S. CDC reports that gonorrhea is the second most commonly reported notifiable disease in the United States. All known cases must be reported to the CDC, but officials there estimate that they are notified of fewer than half of the 800,000 new cases each year.

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IMMUNO-ONCOLOGY: Targeting the immune system, not the tumor

Immuno-oncology is based on the concept of harnessing the body’s own immune system to fight cancer.

One of the most exciting areas of cancer research today is immuno-oncology, and while it’s an approach that scientists first considered more than 100 years ago, recent scientific discoveries and clinical advances have ushered in a truly historical time in cancer research.

Immuno-oncology Video Capture

Image Courtesy of PhRMA (Video Capture)

Recently, PhRMA released a new video highlighting immuno-oncology, which is currently being researched and developed by Bristol-Myers Squibb and several other bio-pharmaceutical companies.

Cancer is clever and has found ways to outwit the immune system. Rather than killing these cancer cells directly with traditional tools like radiation or chemotherapy, immunotherapy seeks to intensify the immune system’s power to eliminate them. Immuno-oncology is already improving outcomes and survival rates for some patients, including melanoma, kidney and lung cancer, and researchers are urgently working to gain new insights into the complex interactions between patients’ immune systems and the cancer cells growing in their bodies with the goal of markedly improving outcomes in many more tumor types.

While the science has advanced rapidly in recent years, there is more work to do. Researchers hope to replace chemotherapy as the first line treatment for many cancers and help as many patients as possible achieve long-term survival. This new treatment approach has the potential to help patients live longer, healthier lives.

Learn more about advancements in science at From Hope to Cures.

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New Drug Holds Promise Against Zika

MV-4 Based On Research That Unlocks Key to Breaking Down Viruses

A New York pharmaceutical company, TGV-Laboratories, says it has unlocked the key for breaking down the protective barriers of viruses, a breakthrough that it believes can be developed into antiviral drugs to treat Zika and host of life-threatening viruses, including Ebola, HIV and Bird Flu.? The company’s lead researchers, Victor and George Tetz, said lab tests show their discovery, called MV-4, can break down the protective barriers of both enveloped and non-enveloped viruses, indicating it can be developed into targeted synthetic antiviral drugs to kill a wide variety viruses.

ZIKA Virus WordleArtIn laboratory tests, the researchers said they were able to kill influenza viruses, HIV, Herpes viruses, polio and adenoviruses, and are eager to test their discovery against Zika, Ebola and Bird Flu.? In a letter to the CDC, the researchers outlined their findings, and offered their help in developing new treatments against these global health threats.

“We are very excited about our findings to date, and are eager to expand the testing of our drugs on these dangerous and highly contagious viruses,” said Victor Tetz, scientific head of TGV-Laboratories. The Zika virus is primarily a mosquito-transmitted infection. However, it was recently isolated from semen, and there is evidence it can be transmitted through sexual intercourse — opening new frontiers for global spreading and raising the need for an antiviral drug that can attack it at many levels. “The studies we have conducted to date show MV-4 can inactivate viruses in the outer environment, on human skin and at intravenous administration, so we believe discovery shows huge promise against Zika, Ebola and Bird flu.”

TGV Laboratories, along with its Institute of Human Microbiology, are finalizing a paper that details their discovery and what they believe to be its strong potential for safely treating a broad range of life-threatening and non-life threatening viruses. Currently, there are no broad-spectrum antiviral drugs.? MV-4 is the second broad-spectrum drug candidate developed by TGV Laboratories, whose Mul-1867 has shown potential for being developed into drugs that can treat an extensive range of antibiotic-resistant bacterial and fungal infections. TGVs subsidiary, TGV-Inhalonix, recently filed an application with the Food and Drug Administration seeking Orphan Drug Status for Mul-1867 to be tested on cystic fibrosis patients with life-threatening antimicrobial-resistant pulmonary infections.

“Developing broad-spectrum drugs that can treat viruses and the growing list of antibiotic-resistant infections is one of the most important, but elusive, goals in infectious research today,” said George Tetz, head of research for the Institute of Human Microbiology. “With MV-4 and Mul-1867, we believe we have unlocked the key for developing the next-generation of antibiotics and anti-viral drugs.”

The drugs in TGV’s pipeline were discovered as the result of years of research by Victor and George Tetz using a new concept they developed called Pangenome, (http://www.ncbi.nlm.nih.gov/pubmed/15990697), which acts like a guide that helps mark new therapeutic targets for drugs. The Institute of Human Microbiology assisted TGV with Mul-1867’s discovery.

TGV-Laboratories Group of Companies. (http://tgv-labs.com) is a research-based pharmaceutical company headquartered in New York that provides a broad range of innovative products to treat currently untreatable infectious, autoimmune and neurodegenerative diseases. TGV operates under two divisions: the Division of Drug Discovery & Development and the Division of Medical & Industrial Microbiology.

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Quick Takes: the Pharma C-Suite with John Hudak, President: Outsourcing & Strategic Partnerships

In the recent PharmaVoice Feb 2016 PV MagCover FEB16 issue highlighting Outsourcing, PV asked Pharma’s KOL’s to answer some key questions regarding the current state of Outsourcing & Strategic Partnerships.

John Hudak, President & Founder of Criterium Inc Global CRO

John Hudak, President & Founder of Criterium Inc Global CRO

John M. Hudak, President and Founder, Criterium Inc., Global CRO answered these 2 questions for them:

  • What barriers continue to limit CROs and sponsors from becoming true development partners?

Sponsors can have unrealistic expectations of CRO partners. Most partnerships work top-down at both Sponsors and CROs, and are evidenced in timelines and budgets. But top-down management may not always translate into trickle-down commitment. There are some discouraging figures out there about the high percentage of studies that don?t meet their timelines. When timelines and budgets are estimated to satisfy board members or project committees, it?s imperative to include all key factors that affect early planning stages, and be grounded in fiscal reality.

  • What are the key ingredients to a successful outsourcing partnership?

Planning needs transparency and communication, in concert. Sponsors can sometimes have impractical expectations regarding timelines and budgets. And CROs can end up having the same unrealistic expectations of study sites. Everyone wants to meet expectations and win the job ? but this sometimes results in unworkable time estimates and budgets. There needs to be more open discussion among stakeholders, Sponsors, CROs and sites regarding the environments in which studies are conducted — and realistic strategies for successful completion.

About John M. Hudak, MBA, President and Founder
John has more than 40 years of experience in the pharmaceutical research and business development arena serving the pharmaceutical and contract clinical services sectors. He has extensive expertise in strategic planning and competitive analysis, market development, promotional planning and tracking, proposal design and custom-services development, international project management and clinical study completion, protocol design and implementation, electronic data capture, and market communications and has worked with drugs, biologics, generics and medical devices.

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