The biotech industry is growing at a rapid pace every day. Life science consultants are becoming increasingly in-demand for SMBs to be able to access specialist skills easily. This article explores 5 ways life science, biotech and pharma organizations can benefit from contract services.
Biotechnology uses living organisms and matter to create products and technologies that are beneficial to us. Its applications include pharma & healthcare, food, environment and agriculture. Major pharma companies around the world offer a range of biologics and biotech-based therapies: Johnson & Johnson, Pfizer, Novartis, Roche, Sanofi, Merck and Novo Nordisk, to name a few. Biopharma companies that focus on biotech and genetic therapies include Amgen, Celgene, Gilead Life Sciences and Seattle Genetics.
Biotech companies of all sizes have to go through rigorous regulatory process to bring a drug to the market. There is painstaking research that goes into every product, involving several skills including data analysis, statistics and writing. While companies with large budgets may have in-house resources, smaller companies frequently outsource these tasks to contract organizations. Here are some of the top five biotech contract services offered by experts.
1. Regulatory affairs consulting
Regulatory affairs consultants can help companies with regulatory strategy, gap analysis, transplant registration and regulatory interactions. Regulatory medical writers can help with submissions such as those for the Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH). Medical device companies worldwide (some of which form a part of biotech/pharma companies) also support from clinical evaluation report writers to develop CERs for MDR compliance.
2. Life science consulting services
Qualified industry experts can help with the development of business strategies and R&D activities required to develop and launch a successful product in the market. Genetics & genomics experts can advise on gene editing and gene therapy, whereas biotechnologists can provide guidance on lab-grown meat strategies. A quick look at areas life science consultants can help with:
- Process scale-up and scale-out, closure and automation
- Process scale-up strategy, Key consideration for formulation development
- Process scale-down strategy and troubleshooting
- Media formulation and development
- Selection of media or customization of media
- Regulatory framework for the media formulation development
- Gene editing and cell reprogramming
- CRISPR knock-in and knock-out protocols and design
- TALEN protocols
- siRNA and other gene editing transfection protocols
- miRNA sequence design and selection
- Cell (iPSC, CAR-T, MSC, NK, HEK) and viral vector (LVV, AAV) process development
- Assistance for Lab-grown meat startups (Cell-based meat techs)
- Assistance in optimization of various iPSCs differentiation processes (to blood and non-blood lineages)
- Biologics product development
- Assistance in enabling transition from 2D to 3D culture
- Assistance in optimization for commercial manufacturing
3. Clinical and Statistical Services
Biotech firms of all sizes need help with clinical trials and statistics. Small biotech firms often outsource this work to specialists, or hire specialists to verify their data and optimize experiments. A clinical trial consultant can advise on sample size, research methodology, data collection methods, validation methods and data analysis. Biostatisticians can suggest which parameters to change and routes to getting desirable results. Services include:
- Study design, emphasis on adaptive-by-design
- Causal analyses for post-marketing
- Statistical methodologies to maximize efficiency
- Clinical trial and statistical analysis
- Data Quality Oversight via the creation of Statistical Monitoring Reports
- Safety Surveillance & Pharmacovigilance
- Pharmacokinetics & Pharmacodynamics
- Observational, registry, real-world evidence study designs and analyses
- Determine which statistical approach is best (Bayesian, precision, etc)
- Consulting services to regulatory bodies, FDA, EMA and Health Canada
- Statistical Analysis Plans (SAPs)
- Technology consulting services such as data conversion, eTMF, EDC, IVR, etc
- Statistical sample size calculation
- Endpoint selection and confirmation
- Resource planning &
- Randomization scheduling
- Case report form (CRF) design
- Literature reviews
4. Analytical assay development
Several analytical tools are used in biotechnology and biopharma companies. From PCR to flow cytometry, these are complex procedures that need strong statistical and analysis skills. Services freelancers can help with include:
- Process development protocol preparation
- Analytical method troubleshooting
- Flow cytometry protocol preparation and assistance
- IHC protocols and data mining
- Antibody selection and sequence design
- Assistance in PCR protocols and study design
5. Scientific writers
The biotech and pharma industries are always looking for content, a vast amount of which they need to maintain. Hiring freelancers can help save precious cost and time, while getting the work done by a trusted expert. Some services freelance scientific writers can help with include:
- Regulatory writing and submissions
- IRB related documents
- Clinical research documents – case study reports, clinical trial protocols, clinical evaluation reports
- Biotech content writing
- Medical SEO copywriting, white paper writing, web copy development
- Manuscript preparation for research journals
- Journal selection
- Scientific editing
Freelance grant writers can be hired to prepare grant applications, research proposals and other funding applications.
Life science consultants & the expert economy
The growing pool of industry experts and academic researchers who are available on a freelance basis means that this talent is readily available to businesses looking for it. Given the revolution in workplace policies and remote working, life science consultants are now accessible on demand. Consulting an expert directly helps organizations save precious time and money, while building a reliable team of go-to experts under one roof.
Kolabtree offers end-to-end support for the full spectrum of biotech services ranging from protocol design, analytical and scientific services, regulatory, preclinical and clinical services to commercialization. Our PhD-qualified subject matter experts and highly experienced industry experts can help with biologics, scientific affairs, IP, clinical, regulatory and medical affairs. Kolabtree’s scientists can also help with Nobel-prize winning services such iPSCs, CRISPR, DNA sequencing, and more.
Need help with biotech research, regulatory strategies or product development? Contact experienced biotechnology consultants on Kolabtree. POST YOUR PROJECT NOW
Kolabtree helps businesses worldwide hire freelance scientists and industry experts on demand. Our freelancers have helped companies publish research papers, develop products, analyze data, and more. It only takes a minute to tell us what you need done and get quotes from experts for free.
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