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Pharmaceutical & Medical Device Regulatory Affairs Director

Collidion, Inc. and it’s subsidiaries,  Plex Pharmaceuticals & Avenlogics, Inc has an immediate full-time position open for Pharmaceutical & Medical Device Regulatory Affairs Director.

Position: Full-time

Location: Flexible

To apply, visit www.collidion.com/careers

 

Founded in 2015, Collidion, Inc. is a private healthcare company with two subsidiaries, Avenlogics, Inc. and Plex Pharmaceuticals. Collidion strives to improve the future of global healthcare through the acquisition, licensing, development, and commercialization of drugs and medical devices for various markets.  Collidion invests industry expertise and capital to develop these technologies into recognizable solutions for patients and medical professionals. Collidion values innovation, scientific rigor, collaboration and a passion for change.

 

Avenlogics, Inc., Collidion’s subsidiary, is focused on the development and commercialization of several anti-infective based products.  The Company’s pipeline of antimicrobial products addresses a growing need for alternative therapies to effectively treat infections caused by antimicrobial resistant pathogens. Collidion’s solutions include several antimicrobial platforms with potential applications in human and animal medicines, wound care, surface disinfection, and improved safety for the food supply chain. The company is located alongside with Collidion, Inc in Petaluma, CA.

 

Plex Pharmaceuticals is a scientifically-driven company with a vision to improve the lives of patients with complex diseases and conditions. The company is focused on the treatment of diseases generally caused by protein misfolding: ALS, Parkinson’s disease, and cataracts.  The company was founded in 2009.  Plex has a rich pipeline of drug discovery programs and a dedicated scientific team. Plex’s drug discovery lab and operations are located in San Diego, California.

 

PHARMACEUTICAL AND MEDICAL DEVICE REGULATORY AFFAIRS DIRECTOR

 

  • Regulatory representation and leadership to cross-functional product development teams, development of regulatory strategies and support for clinical and non-clinical development programs and marketing applications. 
  • Responsible for project timelines and management of 510K, PMA, IND, NDA and global regulatory submissions. 
  • Lead regulatory activities including planning and reviewing of CMC, clinical and nonclinical sections of regulatory submissions. 
  • Plan, direct and prepare regulatory submissions (IND, NDA, IDE, 510(k), PMA) to ensure compliance with FDA and international regulations and guidelines. 
  • Develop and maintain SOPs with an emphasis on drug and device regulations. 
  • Perform research regarding regulatory strategic recommendations, and new and revised governmental regulations. 
  • Conduct successful negotiations and interactions with domestic and foreign regulatory agencies on assigned projects. 
  • Provide regulatory guidance with regard to preparation, review and approval of labeling and promotional materials. 
  • Prepare and assist with applicable regulatory audits. 
  • Statistical techniques. 

 

 

EDUCATION REQUIREMENTS:  

 

  • Minimum of B.S. in life sciences, engineering, or equivalent required. 
  • Advanced degree preferred. 

 

 

EXPERIENCE REQUIREMENTS: 

 

  • Minimum 5-7 years of experience in regulatory affairs for pharmaceutical and medical device biopharmaceutical companies. 
  • Veterinary product experience highly desirable. 
  • Experience with successful FDA and international agency negotiations and audits. 
  • Experience in developing and submitting successful 510(k), PMA, IND/NDA submissions with a thorough understanding of the drug and device development processes, FDA regulations and ICH guidelines. 
  • Excellent verbal and written communication skills. 

 

 

OTHER QUALIFICATIONS: 

 

  • Detail oriented with well-developed organizational and analytical skills. 
  • Experience with submitting documents in CTD and eCTD format. 
  • Suited to working in a fast-paced, small company environment. 

 

 


Fully equipped 1000-1500 Sq. Ft. laboratory space available for sub-lease in Sorrento Mesa area

Plex Pharmaceuticals is interested in sub-leasing 1000-1500 Sq. Ft. of laboratory space on a month-to-month or long-term basis. The sub-lessee will have access to common laboratory equipment, chemical fume hood, tissue culture and other general lab instruments. Lab bench with 3-5 knee holes, dedicated office space, wi-fi, shared conference room, common kitchen and reception area. Interested parties please contact Sridhar Prasad at 858-733-0858 or email: sprasad@plexpharma.com


Attend Thomas Insel's talk: How Will Technology Change Healthcare? July 24, 2018 at 2:30pm

Presentation by Dr. Tom Insel on July 24th at the Illumina Theater, Alexandria at Torrey Pines. Appetizers and drinks sponsored by Neuropore Therapies.

About the event:

Dr. Insel will talk about leading edge technologies that may one day be of impact to the care of patients suffering from psychiatric conditions. He will discuss the advent of digital phenotyping, modern cognitive and linguistic assessments, and powerful computational approaches applied to complex data which now permit a deeper analysis of behavior than would have been possible even five years ago. Will this phenomic analysis in psychiatry serve the same role as molecular profiling in oncology? Will subgroups selected by modern phenomics be predictive of treatment response or clinical course? This presentation will argue that a detailed analysis of behavior and cognition combined with functional connectomics can become a pathway to precision medicine for psychiatry.

About Dr. Insel:

Thomas R. lnsel, M.D., a neuroscientist and psychiatrist, leads the Mental Health Team at Verily (formerly Google Life Sciences) in South San Francisco, CA. From 2002-2015, Dr. Insel served as Director of the National Institute of Mental Health (NIMH). In that role he also served as Chair of the Interagency Autism Coordinating Committee (IACC) as well as co-lead of the NIH BRAIN Initiative. Prior to serving as NIMH Director, Dr. lnsel was Professor of Psychiatry at Emory University where he was founding director of the Center for Behavioral Neuroscience and director of the Yerkes Regional Primate Center in Atlanta. Dr. Insel’s research has examined the neural basis of complex social behaviors, including maternal care and attachment. A member of the National Academy of Medicine, he has received numerous national and international awards and served in several leadership roles at NIH.

Networking after:

Don't miss the networking event outside the Illumina Theater right after the presentation. Drinks and appetizers are sponsored by Neuropore Therapies, Inc.

About Sponsor:

Neuropore Therapies, Inc. is a San Diego, California based biopharmaceutical company that is focused on the discovery and development of novel small molecule therapeutics for the treatment Parkinson’s disease and other neurodegenerative disorders. The approaches being taken by Neuropore Therapies target the core pathological processes underlying these disorders including the intracellular accumulation of neurotoxic misfolded proteins and the associated neuroinflammation. As such, the therapeutics being developed by Neuropore may provide the first effective means for slowing the unremitting progression of these devastating diseases.

Learn more and register here


Neuropore Therapies receives 2nd grant from The Michael J. Fox Foundation for Parkinson's research!

The Michael J. Fox Foundation for Parkinson's research awarded Neuropore Therapies a second grant on its TLR2 antagonist Program for Parkinson's disease.  READ MORE:  https://www.businesswire.com/news



Michael Swit announces re-launching of his FDA regulatory law practice.

The Law Offices of Michael A. Swit, devoted to Solving FDA Legal Challenges for the Life of a Life Sciences Company

Please visit our website at www.fdacounsel.com

Happy Holidays!


Looking for Lab Clean Room 2,000-3,000 square foot

An international bio-tech company is looking urgently for lab space (plus office space of 2,000-3,000 square foot) to buy or lease. They would prefer a setting where the clean room space is already built, but will consider any location where the building is properly zoned and has the utilities to support tenant improvement.

As a member of SDEE I would highly appreciate any help from the community. Please reach out to me at contact@interculturalservices.com if you have any information on potentially available lab space.



Fibromyalgia Therapeutics: Why has progress has been slow?

Fibromyalgia is a common medical condition characterized by chronic widespread muscle pain, fatigue, and sleep disturbance affecting two to three percent of the total population. It is five to ten times more common in women than men, increases with age and can also be worsened by many factors, including physical trauma and emotional stress. In this post, I share a few thoughts on why advances in the field have been slow and what developments may be coming soon.

Fibromyalgia involves central amplification of peripheral sensory signals, so that otherwise normal sensations are perceived as painful. Most patients afflicted with fibromyalgia also experience excessive tenderness, fatigue, sleep disturbances, problems concentrating, and functional impairment. A major obstacle to diagnosis is the absence of specific laboratory or imaging tests for fibromyalgia, although lab testing can be used to rule out other conditions associated with fatigue. Since the symptoms of fibromyalgia are shared with other conditions, patients should also be evaluated for mood disorders and sleep impairment.

In the decades prior to the introduction of the American College of Rheumatology’s (ACR) classification criteria in 1990, there was considerable skepticism about fibromyalgia as a legitimate medical condition. The 1990 ACR criteria ushered in an era of increased recognition of fibromyalgia and provided a standardized diagnostic approach. This was a boon for academic rheumatologists and even more so for researchers looking to test the efficacy of drugs. Despite widespread dissemination of the diagnostic criteria, skepticism abounded. For example, the very year ACR published the criteria for fibromyalgia, the British Journal of Rheumatology and the Canadian Family Physician journal published papers questioning the existence of fibromyalgia. However, the ACR criteria provided a major boost to research, resulting in the 2006 FDA approval of pregabalin (Lyrica®); the 2008 approval of duloxetine (Cymbalta®); and the 2009 approval of milnacipran (Savella®), which remain the only FDA-approved medicines for the treatment of fibromyalgia.

Although the ACR classification system was a major advance, it proved problematic in a number of ways. First, it required assessment of tenderness on pressure (tender) points in at least 11 of 18 specified sites and the presence of widespread pain for a diagnosis of fibromyalgia. Second, tender point assessment failed to address the symptoms that bothered patients. And finally, digital palpation of 18 tender points was hard for most non-rheumatologists to perform. It became apparent that primary care physicians had neither the time nor the training to perform extensive tender point assessment. Therefore, in 2010, the ACR simplified its criteria, eliminating tender point assessment, and changed the definition of fibromyalgia to an illness characterized by self-reported multiple painful regions and core symptoms such as such as fatigue, sleep disturbances and impaired cognition. In 2011, the ACR provided a self-report version for survey and clinical research purposes, thus spurring further testing of treatments for fibromyalgia. In December 2016, ACR released a further revision to the 2010/2011 criteria to reduce misclassification of regional pain disorders and improve diagnostic clarity. The 2016 modifications provide physician-based criteria for patient diagnosis and self-report criteria for research studies.

Although there are no definitive treatments for fibromyalgia, evidence indicates that lifestyle changes including relaxation, patient education, counseling, and exercise all improve symptoms and should therefore be an active part of any management program. In recent years, several promising drug treatments have failed in clinical trials, although companies such as Astellas, Daiichi Sankyo, Zynerba and SWITCHBIOTECH are pursuing new treatments for fibromyalgia. As awareness is raised and research studies continue, the contributing causes of fibromyalgia will be better understood and allow for the development of superior treatments. Najib Babul, PharmD, MBA



Alzheimer's Disease Year-in-Review 2016

Journey with me through this mini and wholly incomplete Alzheimer's disease 2016 year-in-review.

For the full post on LinkedIn, please see: http://tinyurl.com/hx28m3j


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