Until Oct. 8, 2021, the FDA is seeking public comment on its plans to transition some drugs to device status. The agency's intended implementation will affect not only new products meeting both drug and device statutory definitions in connection with the approval process but also existing products on the market that may have been improperly classified as drugs.
- C>'s : A Roadmap To Solving 6 Challenges Over The Next Decades
- CMS Restructured The CAR-T DRG – What It Means For Manufacturers & 4 Strategies Forward
- 5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations
- Biotech Patenting: 4 Tips & Personal Experiences
- FDA Issues Final Rule On Intended Use For Drugs & Devices After A Complicated History
- Harnessing Lab Deviations For Performance Transformation In Vaccine Manufacturing
- How To Find & Manage Biotech Consultants Effectively
C>'s : A Roadmap To Solving 6 Challenges Over The Next Decades
This past year has seen remarkable progress in the growth of C>'s. Advances in cell reprogramming, genetic editing, and manufacturing mean affordable C>'s will be available for a range of diseases and uses. However, the pathway ahead will need planning. This article reviews six major issues affecting the C> space and provides recommendations for companies to be successful.
CMS Restructured The CAR-T DRG – What It Means For Manufacturers & 4 Strategies Forward
In August 2021, the Centers for Medicare and Medicaid Services (CMS) expanded the chimeric antigen receptor T-cell (CAR-T) diagnosis-related group (DRG). While industry generally views this change as a positive development, significant uncertainties remain as to the specific immunotherapies included and how payment will change over time. To prepare, you should adjust your launch strategies.
5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations
Data integrity (DI) issues in pharma and medical devices have always been there, but in my experience as a consultant, these issues have increased in frequency more recently, thus moving them to the forefront. In this article, I explain five misconceptions about data integrity in our industry.
Biotech Patenting: 4 Tips & Personal Experiences
When you file for patent protection for your discoveries, keep these 4 tips in mind. I also share some of my personal experiences with patenting from over the course of the last 28 years, from when I cofounded 180 Life Sciences through now.
FDA Issues Final Rule On Intended Use For Drugs & Devices After A Complicated History
On Sept. 1, 2021, the FDA’s final rule on intended use for drugs and devices became effective. The rule has a complicated history and has been the subject of controversy over the last 6 years. The final rule provides clarity to manufacturers, but many stakeholders are still unsatisfied with the evidentiary standard for determining intended use, perhaps forecasting legal challenges to the regulation.
Harnessing Lab Deviations For Performance Transformation In Vaccine Manufacturing
Deviations in the pharmaceutical process generally lead to non-compliance and issues meeting demand, so they require careful tracking, monitoring, and remediation. The presence of deviations may seem inevitable, yet COVID has brought to light the question of how vaccine manufacturing sites can manufacture more vaccines, more efficiently. This article explains how.
How To Find & Manage Biotech Consultants Effectively
The roles being filled by biotech consultants have grown considerably, as companies are becoming more familiar with working with consultants and more people are interested in pursuing a consultant career. But how do we find good consultants, and how do we ensure that our consultants are as committed and engaged as our full-time employees? Here's how to accomplish that.
What’s The Role Of Interim Consultants In The Life Sciences & How Do We Use Them Effectively?
When life sciences companies need new talent, they typically have two options: bring in a consultant or hire a full-time employee. Usually, this decision is dictated by the permanence of the role, but sometimes, timelines complicate things. In this situation, an interim consultant can be the solution. But what is the interim consultant's role, really, and how do we use them effectively?
PHARMA ONLINE WHITE PAPERS
The Importance Of An Integrated Informatics Solution For Life Science Organizations
Over the last few decades, replacement of outdated paper-based data management systems has been identified as a means to accelerate this process. While the implementation of electronic systems led to reduced cycle times and compliance risk, issues remain with systems existing in departmental silos and non-standardization of data across the drug development continuum. To satisfy the requirement of drug development companies for efficient data and technology transfer, standardization of data and technology transfer across the entire pharmaceutical product lifecycle is needed.
It Hasn’t Been Easy For Pharma To Be Green10/2/2020
Most of the drugs coming to market today are acquired by large or mid-size pharma companies from small biotech companies. Partnering with a CDMO proficient in green chemistry and manufacturing can help a biotech create the most attractive drug package – one that includes a proven commercialization process minimizing toxic waste that pose safety concerns or require costly remediation.
Organoids: Ideal Model Systems For Disease And Drug Screening?6/22/2021
Successful organoid formation is dependent on many factors, all of which are crucial in fulfilling the potential of this powerful new tool for personalized medicine.
Quality With Clarity: Bringing Modern Quality Systems Into Focus8/24/2021
Modern pharmaceutical regulatory and manufacturing models have made great advances assuring and confirming quality of products for all of us. Early in the process, industry responded by making a large-scale effort to develop and implement quality practices designed to assure or confirm product quality. The further industry moves from the initial application of the early practices and subsequent systems, the more challenging it has become to differentiate between the many facets of quality concepts. The intent of this white paper is to clarify those concepts and bring their fundamentals into focus.
Enabling Lyophilization Scale-Up From Formulation To Full Commercial Production7/29/2020
Biologic drugs have shown great promise in curing many life changing diseases, even some that were once thought incurable. However, due to the sensitive nature of biological material it requires specialized development and manufacturing processes. Stabilization by lyophilization is attractive to retain the product’s biological activity, structural integrity and homogenous quality, all of which are crucial to the success of the product. This white paper describes the challenges associated with lyophilization of biologic drug products.
The Significant Need For Flexible Aseptic Filling And Isolation Systems In Pharma10/23/2020
Primary packaging of pharmaceutical products often involves filling containers (including vials, syringes and bottles) with powders and/ or liquid solutions. Manufacturing staff, equipment and premises are all subject to stringent quality controls – and for good reason: patient safety. This document intends to provide information on the latest status, trends and technologies in parenteral filling equipment.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
Since the pandemic began, we’ve seen disruptions to regulatory inspection and enforcement. What has this looked like, and what has been the impact to the pharmaceutical industry? In this e-book, we dive in specifically to the regulatory agencies of the FDA in the U.S. and the MHRA in the UK.More Content Collections
PHARMA ONLINE PRODUCTS & SERVICES
LIFE SCIENCE CONNECT SPOTLIGHT JOB OPENING: TARSUS
Tarsus, a late clinical-stage biopharmaceutical company focused on the development and commercialization of therapeutic candidates to address large market opportunities, is hiring a VP Manufacturing Operations & Supply Chain Management. Reporting to the COO, you will be accountable for the overall CMC development, manufacturing and supply chain strategy for clinical and commercial supply of drug substance, drug product and IMP.
Sound interesting?Read the Job Posting to learn more.