Life science product development services company.
The Indiana Medical Device Manufacturer’s Council (IMDMC) is hosting an event featuring a panel of experts on the legal implications of the new Sunshine Law.
Topic: Sunshine Law Final Rule: How to Ensure Compliance
When: March 27, 2013
Where: Montage Meeting Facility, 8580 Allisonville Pointe Blvd, Indianapolis, IN
Cost: Members: $125 Nonmembers: $175
For more information and to register, click here.
Therapeutic proteins can sometimes elicit a harmful immune response, compromising patient health and product efficacy. In response to this, FDA recently issued draft guidance entitled, “Immunogenicity Assessment for Therapeutic Proteins,” aimed to assist manufactures and clinical investigators in the development of risk assessment strategies for therapeutic protein products, per an article from in-pharmatechnologist.com. In the guidelines, FDA recommends sponsors to take a risk based approach method to assess the immune response to therapeutic proteins and establish clinical phase risk mitigation strategies. According to FDA, the guidance will encourage the development of therapeutic proteins, since risk factors and risk management strategies will identified early on. To read the full article on in-pharmatechnologist.com, click here. Contact us at 317-899-9341 if you need help with a protein therapeutic clinical study.
The FDA adopted a Q&A from the International Conference on Harmonisation (IHC) to clarify the industry guidance, “E3 Structure and Content of Clinical Study Reports” (IHC E3), according to a recent article on outsourching-pharma.com. The purpose of the Q&A is to help contract research organizations (CROs) and sponsors draft clear and concise clinical study reports. The Q&A addresses various points of confusion in the 1995 IHC E3 guidance, including definitions of key terms and how to properly display adverse event data in clinical study reports. To read the full article, click here. Need help with a clinical study? Contact us at 317-899-9341.
Industry professionals, academics and FDA all agree that the cost of drug development is unsustainable, according a recent article on the San Francisco Business Times. To tackle the problem, FDA is looking at ways to change the drug development process. At the Personalized Medicine Conference, FDA’s Dr. Janet Woodcock described some of the ways FDA is accelerating the clinical trial process. Woodcock discussed everything from creating standing trial networks to the new “breakthrough therapies” initiative process. According to Woodcock, the initiative could cut the drug approval process to one stage with 30 to 50 patients. She also mentioned the need for more collaboration between industry, academia and patient groups. To read the full article, click here. Need help with a clinical trial? Contact us at 317-899-9341.
Last week, FDA released draft guidance entitled, “Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease,” which addresses the FDA’s view regarding the selection of patients with early Alzheimer’s Disease (AD), or at risk patients for clinical trial enrollment. According to a recent article on outsoucingpharma.com, the more flexible regulations provide more treatment opportunities for patients and create for a potentially easier path for CROs. To read the complete draft guidance, click here. To read the full article on outsourcing-pharma.com, click here. For help with clinical trials contact us at 317-899-9341.
In an effort to decrease manufacturer’s admin, prevent possible drug shortages and encourage globalization, the US requested exemption from the new European Union (EU) import laws for active pharmaceutical ingredients (API)s. The exemption would place the US FDA on a list of ‘third countries’’ considered to have good manufacturing practice (GMP) rules equivalent to those in the EU, according to a recent article on in-pharmatechnologist.com. Other countries to request exemption include Australia, Singapore, Brazil, Japan and Switzerland. The Official Journal of the European Union recently published the assessment criteria, which includes examination of a country’s manufacturing guidelines, inspection resources, alert and crisis management systems and ability to communicate information to the EU. To read the full article on in-pharmatechnologist, click here. For further information on the assessment criteria, click here. Need assistance in managing your global supply chain including quality oversight of your API suppliers? Call us at 317.899.9341.
The FDA released a list of guidance documents that it is planning to publish in the 2013 calendar year. Guidance on quality agreements for contract manufacturing organizations (CMOs) and biosimilar developers in 2013 is included in the list. To see the FDA list of future guidance, click here. To read more about the topic on in-pharmatechnologist, click here.
A recent report by Greenleaf Health consultancy indicates that the Center for Devices and Radiological Health (CDRH) has increased enforcement activity compared to previous years per an article on mddionline.com. The report, led my former FDA associate commissioner for regulatory affairs, Michael Chappell, focuses on four specific areas of medical device enforcement data: FDA inspections, FDA Form-483 observations, warning letters and product recalls. The report found nearly a 40% increase in CDRH inspections since 2008 and more than 250% increase in device recalls since 2007. These findings may be the result of the FDA commissioner, Margaret Hamburg ordering a more thorough agency-wide effort on compliance and enforcement. To purchase Greenleaf Health’s full report, click here. To read a free abbreviated report, click here.
The FDA published a final rule entitled Current Good Manufacturing Practice Requirements for Combination Products to provide clarification of cGMP requirements for products that are made up of a combination of devices, drugs and/or biologics. The new guideline applies to both already existing and new combination products, yet the FDA plans to issue guidance to help manufactures modify systems for products already on the market, as needed. The final rule also clarifies the cGMP requirements for “single-entity” and “co-packaged combination products.” To read an article in MassDevice, click here and to view the final rule on FDA’s website, click here.
Need help with regulatory interpretation of the new final rule? Contact us at contact@pearlpathways.com
INDIANAPOLIS (Jan. 29, 2013) – Pearl IRB, LLC d/b/a Pearl Pathways, a life sciences product development and regulatory consultant company, announced plans today to expand its operations here, creating up to 38 new jobs by 2016.
“Founded by Hoosier researchers and growing impressively, Pearl Pathways is a prime example of a dynamic life sciences company that will help advance our economy, while raising the average income for hard-working Hoosiers,” said Eric Doden, president of the Indiana Economic Development Corporation. “Indiana continues to be recognized around the globe as a place where starting and growing a life sciences business just makes sense.
The homegrown-Hoosier company, which provides clinical, regulatory and quality compliance services for the life sciences industry, will invest $355,000 to lease and equip a 2,000 square-foot facility located at 29 E. McCarthy St. in downtown Indianapolis. Pearl Pathways, which plans to move into the new facility in March, is currently hiring additional regulatory affairs, quality compliance and clinical trial specialists.
“We are proud to be one of the expanding companies that positions Indiana near the top in the life sciences industry,” said Diana Caldwell, president and chief executive officer of Pearl Pathways. “Our growth is fueled by our passion to help our clients expedite the development of life saving diagnostics and therapeutics. While we serve clients coast to coast and globally, the strong client base we have developed in Indiana and favorable business environment make this an ideal place to expand.”
Founded in 2010 by former Eli Lilly employees Diana Caldwell and Gretchen Miller Bowker, Pearl Pathways is a life science services company that provides research and product development services for drug, biologic and medical device companies through its three business units: Pearl IRB, Pearl ReGXP and Pearl IDEAS. The company is a certified women-owned business by the Women’s Business Enterprise National Council.
The Indiana Economic Development Corporation offered Pearl IRB, LLC up to $750,000 in conditional tax credits and up to $75,000 in training grants based on the company’s job creation plans. These tax credits are performance-based, meaning until Hoosiers are hired, the company is not eligible to claim incentives. The city of Indianapolis supports this project at the request of Develop Indy.
“Pearl Pathways’ investment in Indianapolis strengthens our role as a leader in life sciences technology,” said Indianapolis Mayor Greg Ballard. “I congratulate Pearl Pathways and wish the company much continued success. We look forward to continuing our commitment to cultivating a community of growth in which businesses can thrive.”
The Hoosier State’s life sciences industry includes the corporate headquarters of such giants as Eli Lilly, Biomet, Cook Group and Dow AgroSciences. The total economic impact of the industry in Indiana is estimated at $50 billion a year by BioCrossroads in a report released earlier this month. More than 1,600 life sciences companies that employ 55,000 Hoosiers call Indiana home.
To read the full press release on the State of Indiana’s website, click here.
Pearl Pathways, LLC
351 W. 10th Street, Suite 511
Indianapolis, IN 46202
Phone: 317-899-9341
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