Be a Part of the Solution

If companies make pre-competitive advances on manufacturing processes, noted Peter Marks, director of the Center for Biologics Evaluation and Research at FDA, to the audience at an FDA Town Hall session at BIO 2018, they can concentrate more resources on making a better drug. Industry-wide cooperative efforts, however, are difficult to accomplish. Overworked bio/pharma professionals cannot spare time, and drug companies do not want to invest in efforts that cannot demonstrate bottom-line results. Perhaps the greatest hurdle to cooperation is the resistance to share information about internal business or technical operations outside of the company.

As an independent channel for information and insight about pharmaceutical formulation, development, and manufacturing, BioPharm International stands ready to publish and share the latest advances, technologies, and processes for biopharmaceutical development. We need, however, input from experts working in biopharma.

Although 2019 is four months away, for the publishing world, the new year is right around the corner. The editorial calendar, a list of topics that BioPharm International will cover each month, is complete, and the editors are seeking contributions. Now is a good time to remind biopharma experts of ways to contribute.

Peer-review papers provide science and technical insight into drug formulation and manufacturing processes including method development, materials analysis, validation studies, equipment testing, and regulatory process analysis. Four types of peer-review submissions are considered: standard data-driven, novel research papers; technical case studies/application notes; topical literature or patent reviews; and science-based opinion papers.

The double-blind review period typically takes four to six weeks. Accepted papers are scheduled for publication on a first-accepted basis and usually are published four to six months following acceptance.

BioPharm International editors welcome technical articles written by experts at bio/pharmaceutical companies, regulatory authorities, industry suppliers, and consultants on development, manufacturing, quality, regulatory, analytical, operational, supply chain, and outsourcing topics. Topics are listed on the editorial calendar.

Industry experts also can participate by providing expert commentary for articles authored by the editors. Ideas for contributions should be discussed with the editors in advance. To start the process, contact us about four months prior to publication.

Submission guidelines

The editors employ the following guidelines:

• BioPharm International does not charge a fee to publish an editorial-driven article; however, all submissions are reviewed and edited by the editorial team; final publication is determined by the editors.

• All submissions must be original and cannot have been published previously in any format-including company literature or website postings. The paper cannot have been published previously in another language.

• The contributed paper must be objective and cannot promote a company’s products or services.

• Authors are expected to provide suitable references to published third-party lit­erature to support all statements in submitted manuscripts.

• Authors are required to sign a license agreement prior to publication.

Detailed submission guidelines are listed on www.BioPharmInternational.com. On the site, click the Submission Guidelines link to learn more about authoring a peer-review paper or technical article; review instructions to prepare the document, figures, and tables; and view the editorial calendar for 2019 to see the topics BioPharm International is covering during the year.

Our theme for the year is Transforming Biopharmaceutical Development and Manufacturing. I hope you collaborate with us.

Article Details

BioPharm International
Vol. 31, No. 9
September 2018
Page: 6

Citation

When referring to this article, please cite it as R. Peters, " Be a Part of the Solution," BioPharm International 31 (9) 2018.